Pharmaceutical companies should do more to transfer vaccine technology to prevent the poorest countries falling behind in the distribution of Covid-19 vaccines, according to an expert.
The warning came from Dag-Inge Ulstein, the co-chair of the global council trying to speed up access to Covid vaccines for the world’s poor, known as the Act (Access to Covid-19 Tools) Accelerator. Ulstein, Norway’s international development minister, oversees the drive to ensure vaccines reach the poor – the Covax programme.
Increased transparency on the vaccine deals, including the number of vaccines, the delivery date and price.
Full value for money on the collective funds that the world has given to purchase these vaccines for the world’s poorest so they are purchased at cost price, and not to make a profit.
Increased production of vaccines can be boosted internationally by technology transfer and sharing by pharma companies to local and regional manufacturing firms.
NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance.
The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a).
But in its first draft guidance NICE said that Zeposia’s effect on progression of disability is unclear.
NICE also noted the range of other disease-modifying drugs already available, oral rivals Novartis’ Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) from Biogen.
There are also some powerful injected drugs on the market such as Roche’s Ocrevus (ocrelizumab), Sanofi’s Lemtrada (alemtuzumab).
In its guidance, NICE did not give details of cost-effectiveness estimates because of confidential commercial arrangements for Zeposia and comparators.
But NICE said that the drug was likely to fall outside its cost-effectiveness threshold of £30,000 per Quality Adjusted Life Year (QALY).
There was also no analysis supporting Zeposia’s use as a second-line treatment.
Along with other technical data, NICE said it wanted to see data comparative with other second line treatments such as Lemtrada and Gilenya.
In a statement, the MS Society said it was “frustrating” that NICE had decided not to recommend funding for Zeposia.
Dr Sara Rawlings, director of research and external affairs at the MS Society said: “While there are a range of treatments for this form of the condition, oral options are limited, and people could benefit enormously from a new, more convenient alternative.
“NICE’s decision isn’t final, and we are urging them and the manufacturer to review the evidence and consider what’s best for those living with MS. Ozanimod would be the only oral first-line treatment for some people with relapsing MS, and we are hopeful both sides will act on the significance of this.”
Over a month into a massive vaccination program, most older Americans report they don’t know where or when they can get inoculated for covid-19, according to a poll released Friday.
Nearly 6 in 10 people 65 and older who have not yet gotten a shot said they don’t have enough information about how to get vaccinated, according to the KFF survey. (KHN is an editorially independent program of KFF.)
Older Americans are not the only ones in the dark about the inoculation process. About 55% of essential workers —designated by public health officials as being near the front of the line for vaccinations — also don’t know when they can get the shots, the survey found. Surprisingly, 21% of health workers said they are unsure about when they will get vaccinated.
Black and Hispanic adults, as well as those in low-income households, are among the groups struggling most to find vaccine information. Within each of those groups, at least two-thirds said they do not have enough information about when they can get vaccinated, the survey found.
The covid vaccines, which were first distributed in mid-December to health care workers and people living in nursing homes or assisted living centers, are now available for other older adults in most states, though age restrictions vary. Ohio, for example, opened up vaccinations to all residents 80 and older. In Virginia, the minimum age for the second wave of shots is 65. In Indiana, it’s 70; Maryland, 75. Some states, such as Florida and Texas, started vaccinating anyone 65 and up in December, though many states did not begin vaccinating all seniors until January.
Limited doses have left many seniors scrambling to get an inoculation appointment.
For example, at 9 a.m. Thursday, Washington, D.C., opened 2,200 covid vaccine appointment slots for people 65 and older in several hard-hit neighborhoods. Within 20 minutes, they were all filled.
To date, more than 15 million Americans have been vaccinated for covid, which has infected 24 million and killed more than 400,000. The two covid vaccines authorized for emergency use by the Food and Drug Administration require two doses either three or four weeks apart.
Despite the rocky rollout of vaccines, two-thirds of respondents were “optimistic” that things will get better.
Sixty-five percent of adults said they believe the distribution of the vaccines is being done fairly, but half of Black adults said they were concerned that the efforts are not adequately considering the needs of the Black community.
The KFF survey of 1,563 adults was conducted Jan. 11-18. The margin of sampling error is plus or minus 3 percentage points.
A World Health Organization program for pharmaceutical companies to voluntarily share Covid-19 related knowledge, treatments and technology so they can be more widely distributed has attracted zero contributions in the eight months since it was established, the Guardian has learned.
The Covid-19 technology access pool (C-Tap) was launched in May last year to facilitate the sharing of patent-protected information to fight the virus, including diagnostics, therapeutics and trial data. The “pooling” of treatments and data would allow qualified manufacturers from around the world to produce critical equipment, drugs or vaccines without fear of prosecution for breaching patents.
This easy guide on how to meal plan will make you a meal plan expert in no time!
1. Look at your lifestyle
“Think about how meals fit into your current routine,” says Cara Harbstreet, M.S., R.D., L.D. “This helps you gain clarity on your goals and expectations, as well as how you can make meal planning sustainable.”
Some reasons for meal planning are saving money, portion control (which also saves money), eating fewer processed foods, or simplifying meal-time decision-making when you’re busy.
Before starting a meal plan, be realistic about how much time you have to prep, cook, clean up, and go to the grocery store.
You may choose to mix home-cooked meals and prepared foods.
2. Start with a week
“If you’re new to meal planning, try tackling a shorter amount of time,” says Harbstreet. “A week is a good starting point.”
Thinking about how to meal plan for the week is doable for most people, but this doesn’t mean you have to cook every day of the week.
Sit down with a calendar, a notebook, a dry erase board, or even your computer and chart out the meals you typically eat each day, such as breakfast, lunch, dinner, and any snacks.
Meal planning happens before you shop for groceries, so that you’re not stuck with a bag of broccoli wilting in your crisper drawer.
3. Fill in the blanks
“Nail down the basics, but stay flexible,” says Rachel Naar, M.S., R.D., C.D.N. “Try to plan meals with four components, a carb, a protein, a vegetable or fruit, and a fat.”
This is the hard part of how to make a meal plan, but it can also the fun part — think of it as a game of Tetris, but with food!
If you’re stumped, go with a daily theme, like Meatless Monday, Taco Tuesday, or Healthy Homemade Pizza Friday.
4. Work your leftover magic
To save time, choose recipes you can slot in for dinner and lunch the next day, recommends Naar, or freeze portions to carry over into a meal plan for a different week.
Another time-saving hack is choosing recipes with similar ingredients to cut down on meal prep and waste. Seasonal vegetables are also a good source of inspiration.
“Chicken, salmon, rice, and quinoa are some solid staples,” says Naar. “But also work variety into your meal plan.”
5. Keep it simple
The goal of a meal plan is to help you shop wisely and plan ahead, not prove your culinary mastery, explains Naar.
You don’t need to create a weekly menu filled with complicated recipes.
If a snack is a serving of nuts or some carrot sticks and hummus, write that down even if it seems simple or obvious.
You’ll also want to schedule meal prep into your meal plan.
“It’s really about what works for you,” says Naar. “If you have time each day to make dinner, then do that. If you’re busy all day and don’t want to think about cooking, I would suggest batch cooking ahead of time.”
Making a double batch of your favorite dishes yields twice the deliciousness, but usually doesn’t take twice the time. It’s a win-win.
6. Assemble your list
Once you’ve narrowed down your meals, compile your list of ingredients.
It’s also a good time to make sure you have the right equipment for a recipe or enough food containers for the week.
Check off what you already have in your pantry or fridge. Then shop online or head to the supermarket.
To streamline in-person shops, group your list into produce, dried goods, meat and seafood, and frozen.
Now that you know how to meal plan, you’re ready to put that meal plan into action!
Maybe your clothes don’t fit right, your stomach seems fuller than it did yesterday, or you just don’t feel quite like your usual self.
Whatever the feeling, bloating after eating can be a big bummer — and it’s only natural to want to ditch the bloat, especially if it comes with excessive gas or burping.
While it might feel like you’re alone in feeling this way, the truth is that bloating is very common, says Jesse P. Houghton, M.D., F.A.C.G., senior medical director of gastroenterology at Southern Ohio Medical Center.
The good news? “It’s not usually a sign of anything dangerous, but it can be quite bothersome and can even disrupt your daily life,” he adds.
Luckily, there are things you can do to banish bloating after eating.
Symptoms of Bloating After Eating
Most of the time you know if you’re experiencing bloating. Warning signs include:
“Spreading out your fiber intake throughout the day can help prevent bloating after eating,” says Acharya.
There’s some science to back that up: One study found that a reduced-fiber diet helped relieve bloating in people with idiopathic constipation.
2. Limit the fat
High-fat foods help keep you full because they take longer to digest, but this slow process can delay emptying of the stomach and cause feelings of bloating.
You don’t “automatically have to avoid” higher-fat foods, says Houghton. “Rather, be aware of how your symptoms are affected by them. If you notice that you have an increase in cramping or gassiness (and it bothers you), then you may want to limit your intake of these foods.”
3. Skip artificial sweeteners
Artificial sweeteners and sugar alcohols like sucralose, aspartame, saccharin, sorbitol, xylitol, and mannitol are known to cause bloating.
“These ingredients, especially sorbitol, tend to be poorly digested and can cause symptoms similar to lactose intolerance when ingested,” says Houghton. “It is always a good idea to read your food labels and avoid these ingredients.”
4. Get some exercise
Don’t high-tail it to the couch after a big meal. Instead, look for a way to get in some simple movement or even a light workout.
One study found that exercising after a meal — like taking a walk or using a stationary bike — helped clear out gas and reduce bloating in participants.
5. Add enzymes to your diet
Digestive enzymes can ease bloating by helping break down substances that the body has difficulty digesting, says Acharya.
These supplements come in a variety of forms. One of the most popular is a-galactosidase, an enzyme sold over the counter as Beano.
Constant bloating can be a sign that something more serious is up. If nothing seems to alleviate your bloating — or you have other symptoms like severe pain, vomiting, diarrhea, or bleeding — then it’s a good idea to see your doctor.
Additionally, if you notice that you always feel bloated after particularly consuming a specific food item, it may be a sign of a food allergy or intolerance,” adds Acharya.
Patients with rheumatoid arthritis (RA) in England will be able to get treatment with Gilead Sciences and Galapagos’ JAK inhibitor Jyseleca, after it was backed by cost-effectiveness agency NICE.
Jyseleca (filgotinib) has been recommended for moderate and severe active RA in patients who have responded inadequately to intensive therapy with two or more conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate or hydroxychloroquine.
It can be prescribed in combination with methotrexate or as a monotherapy if the patient isn’t able to receive methotrexate, according to the final appraisal document (FAD).
Other JAK inhibitors have already been cleared by NICE for RA – including Pfizer’s class-leading Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib) – but can be used in patients with severe symptoms only.
Having moderate disease on the label means that thousands more patients will be eligible for treatment with Jyseleca, according to Gilead and Galapagos. They note that more than 400,000 people across the UK live with RA, and around 70% have moderate or severe disease.
“This is a landmark decision from NICE and represents a pivotal moment for the treatment of RA,” said Dr James Galloway, consultant rheumatologist at King’s College Hospital.
“The goals of treatment in this condition are to control pain, prevent disability and improve quality of life. This requires us to act quickly to control the disease, preventing irreversible joint damage as soon as possible, for as long as possible,” he added.
“While no single medicine works for everyone, the addition of filgotinib is an important step forward that we believe will help more patients achieve remission, even when their disease is at a less advanced stage.”
Rinvoq is currently being appraised by NICE for use in moderate RA, but a timeframe for that review hasn’t been revealed.
The recommendation is a boost for Jyseleca, which is sold in Europe and Japan but suffered a big setback last year when the FDA rejected the drug over concerns that it could damage male fertility, saying it wanted further data from ongoing studies before completing its review.
Last month, Gilead said it would no longer pursue approval of the drug in the US after an FDA meeting to discuss the way forward revealed the agency is unwilling to approve the higher 200mg daily dose of the drug.
Gilead – feeling that the 100mg dose only wouldn’t be competitive with Jyseleca’s rivals – opted to pare down its involvement in the product dramatically.
It abandoned plans to pursue US registration for RA, and handed responsibility for Jyseleca in Europe to Galapagos, agreeing to pay its partner €160 million (around $194 million) to fund further development and the formation of a commercial operation for the drug which is due to come into full force at the end of this year.
Gilead will receive royalties on European sales from 2024, and retains commercial rights elsewhere.
Among the many evolving technologies in the healthcare industry, there may be none more important or impactful than remote patient monitoring (RPM) hardware and software solutions. This technology is opening up new possibilities in extended healthcare – saving patients money, limiting visits to the doctor’s office, and providing healthcare professionals with powerful tools for diagnosing and treating patients. As these tools continue to mature, software and hardware developers are solving critical challenges to enhance their capabilities and impact.
According to a 2019 report published by the Consumer Technology Association, 88% of healthcare providers have invested in, or are evaluating investments in, RPM technologies and services. Increased demand is driven primarily by the rising age of the baby boomer generation and an increase in chronic disease among the American population.
Medical device manufacturers are helping healthcare providers gather data on patients everywhere they go using wearable technology. These connected health monitoring devices come in the form of smartwatches, wearable heart monitors, blood pressure kits, and more. They’re developed with mobile communication technology that sends data using a patient’s smartphone or directly from the wearable device to software platforms that make the information available to healthcare providers and first responders, notifying them in real-time of accidents and/or healthcare concerns.
The need to monitor patients outside of a clinical setting, especially during the pandemic, has become extremely important and demanding. We’re witnessing limited capacity in hospitals, significant challenges related to social distancing and other pandemic-related stressors. RPM technology can be a tremendous help in mitigating these issues.
Despite significant advancements in the art of the possible, RPM is still in its infancy in terms of the potential impact it could have on health and safety. Data security, data accuracy, and systems integration are core challenges that developers of the next generation of innovative RPM devices need to address. This includes overcoming technological and regulatory barriers preventing patient data from being received, making use of machine learning algorithms, and combining real-time data with medical histories.
Developers of RPM devices must also move beyond model-building and into operationalization for the real potential of technology to be realized and create value for healthcare professionals. Specifically, abstract concepts need to be turned into measurable observations. In its blog “Operationalization of Machine Learning Models,” Open Data Science opines, “Data scientists create beautiful models that no one can understand, and the models don’t usually translate to real business value. If a process is isolated from the enterprise, the insights won’t feed into the overall process.”
To make significant advancements in RPM innovation, software developers must build a digital framework that includes:
– Data storage
– Machine learning and artificial intelligence
– User interface and user experience
It begins with a data storage framework that organizes legacy data and real-time data in the cloud and feeds it into the algorithm. Volumes of data can be huge and the types of data can be various, yet they need to be monitored and managed by a single system.
The next layer of the framework is data security. The challenge is developing a security framework that keeps data confidential for unauthorized users. At the same time, patients must be allowed to establish clear boundaries of ownership over the data, whether that access is given to family members or primary care providers. In the case of an emergency where the patient is incapacitated and unresponsive – the authorized user must be able to quickly access the data to treat the patient.
Next is the middleware, which is software that provides common services and capabilities to applications outside of what’s offered by the operating system. The middleware is customized to meet the needs of the user, in this case, the healthcare provider.
All of the organized and secure data is then funneled into AI and ML algorithms which will learn and recognize patterns derived from a wide range of data points. There needs to be a high level of trust in the data derived from RPM devices. This is achieved through the collection and proper management of data from large and diverse demographic groups. For example, if AI and ML algorithms are fed significant amounts of data from African American females between the age of 50-65, the algorithm can begin to recognize patterns that lead to more informed diagnoses and patient care plans.
The final piece of framework is the user interface and user experience. One of the most significant challenges to developing a healthcare platform for RPM devices is engineering how the data is presented to a healthcare provider. These professionals don’t have time to learn how to decipher data points on a screen –designers and engineers need to create a user interface that translates patterns in the algorithm into valuable and easy to read information that can improve patient outcomes.
When it all comes together, the results are rewarding. Let’s take a look at one of the most promising examples of RPM in the real world today. Lark Health, a chronic disease prevention and management company that uses a cognitive behavioral therapy framework, conversational A.I., and connected devices to help people stay healthy and in control of their conditions. Lark’s A.I. is continuously learning how to personalize the experience for the member and communicates via text-message-like interactions to monitor patients remotely, 24/7, while live nurses and health coaches are available when issues need to be escalated such as severe readings or medication changes.
The challenge of getting the most out of RPM technology is not an easy one. It takes high-level expertise in design, software engineering, and data science, as well as knowledge of AI and ML algorithms to learn how to operationalize it. But with the right framework and data, RPM will continue to revolutionize the healthcare industry.
Roberto Martinez, president, Encora, MexicoRoberto Martinez has been working in the software nearshoring industry for 20+ years. As a senior executive, he is familiar with the needs, obstacles, and challenges faced by small startups as well as big teams. As a leader at Encora, Roberto has helped the company acquire important clients such as OpenTable, Siemens, ZED Connect (Cummins), and others. Roberto has a software engineering background from the prestigious Tecnologico de Monterrey and strategic direction from IPADE.
My Daily Dozen checklist includes all the healthiest of healthy foods I try to fit into my routine each day. Whether you have been tracking your Daily Dozen for years or are brand-new to it, you’re invited to join us for 11 weeks of support emails to help you Do the Dozen with ease! Each week, we will send you an email with tips, tricks, facts, and tasty recipes to help you incorporate some of the Daily Dozen into your regular meal rotations.
Registration is now open, and you’ll get your first Do the Dozen email as soon as you sign up. If you participated in this series last fall, you’re invited to register again if you want a refresher or another round of support. Sign up here.
Valentine’s Gift Fundraiser
This Valentine’s Day, give your loved one the gift of a personal message from Dr. Greger in a special video he’ll record on your behalf. The first 100 supporters to donate $100 using this form will get a personalized video via email for their loved one. Just tell Dr. Greger what you’d like him to say!
Last Day to Register for Our Free Webinar
With death rates as much as six times higher in Black America than white America, COVID-19 pointed a glaring spotlight at racial health disparities in the United States. In my upcoming hour-long live webinar, I’ll address the question of why Black Americans have been living sicker and dying younger than their white counterparts way before the pandemic started. Even with the same education and socioeconomic resources, Black Americans suffer disproportionately from chronic disease. What role may dietary patterns be playing, and what happens when you feed people soul food that’s good for the soul and put plant-based diets to the test?
Webinar Date & Time: Friday, January 22 from 3pm to 4pm ET
Free B12 Infographic
New subscribers to my newsletter will receive a free infographic on my latest B12 recommendations.
Don’t worry if you’re a current subscriber. You can download your copy right here!
New Year’s Resolutions Already Slipping?
Join Dr. Greger and psychologist Dr. Doug Lisle in this mini course, hosted by health coach Dr. Jen Howk. From January 26 to 29, this new webinar series will discuss why willpower alone is often not enough to enable us to reach our health goals. Register at www.jenhowk.com.
Dr. Greger whips up some matcha ice cream inspired by a recipe in his How Not to Die Cookbook.
Volunteer Spotlight: Viviana Garcia
Reading How Not to Die back in 2016 had a great impact on me, so I adopted a WFPB diet and joined NutritionFacts as a volunteer translator. It is an honor to contribute so that science-based information on nutrition is available to people in Spanish-speaking countries. Our healthier choices have a positive effect on our families, on public health worldwide, and on the health of our planet, so I appreciate this opportunity to collaborate with a great team.
My favorite recipe: Golden quinoa tabouli from Dr. Greger’s How Not to Die Cookbook, as I love chickpeas and turmeric!
Live Q&As January 28
Every month, I do live Q&As right from my treadmill, and January 28 is the day.
Join on our Facebook page or YouTube channel at 3pm ET. I’ll be streaming to both at the same time.
I am also excited to have the opportunity to speak live with Tracye McQuirter, MPH. Join us on Instagram at 5pm ET.
Tracye McQuirter, MPH, is an award-winning public health nutritionist, 34-year vegan, and author of Ageless Vegan and By Any Greens Necessary. She recently created the 10,000 Black Vegan Women movement, helping 12,000 women and counting to take back control of their health.
You can find links to all of my past live Q&As here on NutritionFacts.org. If that’s not enough, remember I have an audio podcast to keep you company.
We aim to share helpful health content each month, but we also want your input on how we can make it even better. Please complete this short survey to share your feedback.
In health, Michael Greger, M.D.
PS: If you haven’t yet, you can subscribe to my free videos hereand watch my live, year-in-review presentations:
If you’ve been stressed lately and you’ve noticed your pants aren’t fitting quite the same, you may be wondering if they’re related.
“There are many reasons for weight gain including increased caloric intake, decreased physical activity, and stress,” says Cody Braun, CPT, Assistant Manager of Fitness at Beachbody.
“Our bodies are complex machines, which makes it hard to find the root cause of weight gain for each individual. The best we can do is assess our environment and find where we can make improvements,” he explains.
But there’s no denying that we’re feeling excess stress right now.
You’re likely aware if you’ve been eating more than usual, even if you’re not sure why you stress eat.
But weight gain isn’t always as simple as that.
Stress is associated with weight gain, and you may be dealing with a case of stress belly.
What Is “Stress Belly”?
“‘Stress belly’ usually refers to that weight gain around your midsection that occurs when there has been a change in your daily stress level, emotions, and life changes,” says Emily Tills, M.S., R.D.N., C.D.N.
“Although this weight gain usually feels like it is from excess eating, which is a big contributing factor to stress belly, it also has to do with our body’s physiological response to stress,” she adds.
Dana Hunnes, Ph.D., M.P.H., R.D., a senior dietitian at the Ronald Reagan UCLA Medical Center, adds that not all stress is likely to cause stress belly.
Short-term stressors are unlikely to lead to weight accumulating, whereas excessive and chronic stressors (like working a toxic job) can turn on and keep on a hormonal cascade that promotes weight gain.
Ultimately, there are two hormones at play here: cortisol and insulin.
That’s not to say that cortisol is a bad thing. We need some of it. Though cortisol is commonly known as the “stress hormone,” it also helps us get up and go.
A cortisol spike in the mid-morning, called the cortisol awakening response, helps us be alert enough to tackle that to-do list, for example.
The problem comes when there’s chronic stress. Your cortisol levels are constantly high and the body shuts down other bodily processes until the “stressor” is resolved.
But in this case the “stressor” doesn’t go away and your health is impacted.
The Stress Response and Weight Gain
When you need to fight or run to survive — how our ancestors’ stress happened — our bodies pump out cortisol.
This hormone does several things that help you survive: It’s a powerful anti-inflammatory agent (to help you keep running even if you break your foot). It turns off non-vital body functions (you don’t need to digest, you need to run).
And it mobilizes glucose in order to get your muscles the fuel they need.
What’s the problem with that?
Our bodies are primed to run or fight — but we don’t. In fact, many times we just sit at our desks.
So our bodies call for more fuel to escape, but as Tills points out, “the body is already in a fed state and actually suppresses digestion as a response to stress, therefore causing the body to store this excess energy as fat, causing stress belly.”
Hunnes explains that this is because the combination of cortisol and insulin creates lipoprotein lipase, “which is an enzyme that tends to increase the amount of fat we store in our midsections.”
For women, this often means fat gain in the abdomen during perimenopause or menopause.
Lower thyroid function, increased cortisol production, and estrogen out of balance with progesterone all tend to happen as women age and may contribute to gaining belly fat.
Though fat storage is the primary driver of “stress belly,” there may be digestive problems at play, too.
“It is possible that digestive problems can add to a small fraction of weight gain,” Braun says. “If you notice bloating or other digestive problems it is important to reassess your nutrition and your stress levels.”
“Cortisol has been linked to the storage of visceral fat,” Braun points out — and this is where the health risks come in.
Unlike subcutaneous fat, the kind that accumulates under your skin (you can pinch it), visceral fat forms around your organs in your abdomen.
Subcutaneous fat storage is more individual: Some people tend to gain weight around their midsections, while others may accumulate it on their hips, thighs, and butt.
“Everyone is predisposed to store fat differently, but visceral fat inside the abdomen can be more detrimental to health when you accumulate too much,” Braun explains.
And there are risks to having visceral belly fat even if you’re at a normal weight.
Women with higher abdominal obesity — fat gain in the abdomen specifically — had a higher risk of having asthma and their asthma was more severe than women with smaller waist measurements, one study found.
The risk was still higher for those with waist measurements pointing to visceral fat even if their weight was normal.
The potential dangers of visceral fat aren’t simply because it’s found around the internal organs.
GlaxoSmithKline’s big gamble on a cancer drug developed by Germany’s Merck KGaA looks unlikely to pay out, after bintrafusp alfa failed to outperform US-based Merck & Co’s Keytruda in a lung cancer trial.
GSK had high hopes in 2019 that Merck KGaA’s bintrafusp alfa could be a substantial addition to a pipeline that was in need of attention, paying more than $4.2 billion for the cancer immunotherapy in early 2019.
GSK secured co-development and co-marketing rights to the bifunction fusion protein, an anti-PD-L1/TGF beta trap for solid tumours including lung cancer.
The companies were so confident in the bispecific antibody that they began trialling it against Merck & Co’s blockbuster immunotherapy in first line lung cancer.
This is the most lucrative indication that has allowed Keytruda to establish a foothold as the most successful cancer immunotherapy on the market.
German Merck and GSK were testing the drug in patients with stage IV non-small cell lung cancer, with high expression of the PD-L1 biomarker, a mutation that tends to make tumours more susceptible to immunotherapy.
But an Independent Data Monitoring Committee has said the trial dubbed [email protected] Lung 037 should be halted.
Merck agreed, confirming the halt after admitting that the trial looks unlikely to meet its efficacy endpoint.
Although development is continuing in other forms of cancer, the results cast doubt on the future of the drug formerly known as M7824.
It also means that German Merck is set to miss out on some hefty “biobucks” milestone payments due from GSK under the terms of the deal, which began with a €300 million ($363 million) payment upfront.
There was another €500 million ($605m) tied to the lung cancer development programme, plus up to €2.9bn ($3.5bn) in development and commercial milestones.
The deal came off the back of phase 1 results announced at the 2018 European Society for Medical Oncology (ESMO) conference.
The data showed a much higher response rate with bintrafusp alfa in patients with NSCLC than would be expected with first-generation PD-1/PD-L1 inhibitors such as Keytruda (pembrolizumab).
The year has been a tough journey for all of us. It has taught us many lessons that are going to stay with us for the whole of our lives. Thus, DelveInsight has decided to take you all on a ride full of experiences – some bitter and some sweet – yet with the power to impact lives positively and assure everyone that “We’re all in this together!”
So, Let’s hear from our COO.
Last year has been so full of stress and anxiety for most of us in some or the other way. I realized the depth of the situation more when I connected virtually with all of my employees on a one-to-one basis where we could not just hear each other voices after so long, but also could feel each other’s emotions. Few were freshers who joined during the pandemic, few who attended the office in person for a few months, and our dear old folks.
Each one seemed to be waiting for this doomsday scenario to end. For most of them, someone in their immediate family, or they appeared to be anxious. And the prolonged situation, without a doubt, made it worse for many. However, connecting helped all of us in more than one way. We could feel that we are not alone, there are similar people out there going through the same and were willing to lend an ear, and extend a helping hand to those who needed it.
Honestly, this unprecedented situation taught us several things. Now that I turn back and think of it, there is so much to talk on mental health, anxiety and depression. Here, I would take this opportunity to pen down my journey through the situation and share my learnings with you.
Even though I could not just stop writing about it, still I have tried to keep it crisp and relatable so that I could connect with you. While writing, my intent was to share the information, but my purpose was also to connect with you emotionally.
Just like we can feel happiness, sadness, anger, and anguish. Similarly, anxiety is also a feeling. All of us go through it at one point or another, and it is perfectly normal to feel it. For instance, let us talk about stage-fright. Howsoever well prepared we might be, just before going on the stage and facing the audience, we all feel a bit of nervousness, don’t we?
Similarly, let us rewind to our good old school days. Before a day of any exam, we all feared results. Talking about current times, what about heebie-jeebies that we feel while talking to managers regarding appraisals. By now, I am pretty sure directly, you can relate to what exactly I am trying to say.
So, friends, what exactly is anxiety? Anxiety feels different depending on the person experiencing it. Feelings can range from butterflies in your stomach to a racing heart. You might feel out of control like there’s a disconnect between your mind and body. Or you may have nightmares or panic attacks. And sometimes, painful thoughts or memories resurface that may be beyond your control. You may have a general feeling of fear and worry, or you may fear a specific place or event. If I talk about myself, I hesitate to use the lift, flight or be in any closed space. Symptoms of general anxiety may include:
Increased heart rate
Difficulty falling asleep
Because, ultimately, prolonged anxiety can lead a sane person to experience depression. Knowing anxiety the way I do, I know that we need to work on it. Whosoever can deal with it emerges as a winner, others struggle. Those who struggle, all of their wisdom or intellect fail to help them.
Putting it scientifically, we have two kinds of the nervous system, sympathetic and parasympathetic. The sympathetic nervous system prepares the body for intense physical activity and is often referred to as the fight-or-flight response. On the other hand, the parasympathetic nervous system has almost the exact opposite effect and relaxes the body and inhibits or slows down many high energy functions.
No doubt both are very much required for our existence, but just imagine if all the time, we start gearing up our nervous system? What would happen to our body? Imagine a car is given the amount of petrol needed to reach Chennai from Delhi and it moves just fine if handled with the right gear, functional brakes and accurate acceleration, as required. If we start rushing it by accelerating unnecessarily on the top-most gear – the one which is meant to pull through the steeps, what would happen then? We would finish our fuel halfway through our journey.
Same happens with our lives. People in early days were calm, peaceful and much contented with what they had; therefore, they did not worry much about anything. They used to remain on their parasympathetic infrastructure, contrary to what happens today when most of us run on sympathetic most of the time, exhausting our energy much too soon. So, friends, activate your sympathetic nervous system for a war-like situation to fight emergency, because do remember your body in that mode cut supplies to all other vital organ and sends its resources more to heart and muscles to fight that situation. Also, do not forget to switch off the machine when the need is over.
Anxiety is the result of worry. Often, we cannot identify the actual reason behind it; however, identifying the cause is as important as addressing the issue itself. Suppose you are not well or tired, you would feel the pain somewhere in the body, you would take proper medicine/rest for that. Similarly, have you ever thought, that if our mind or brain is not feeling that well, how would it notify you?
Yes, it sends apparent signals in sadness, mood swings, and anxiety; we need to pick them fast before it gets more difficult for us. Stop everything and first work on maintaining your mind, because it is the boss of your body and believe me, our mind is just like a small child who also needs a break from the daily stressful, mundane routine.
Do what you love, sing out loud, listen to some lovely music, chill with friends, meditate, do whatever you love to. It is imperative. Our positivity can help us overcome anxiety very well. This is why we are told to develop hobbies. Hobbies are something where we tend to forget about, but we need to pick them up along with the rest of the things and spend time on what we love, and that brings us back to our real self, which is meant to be cheerful, happy and relaxed.
So, guys, it is OK to be NOT OK. But unfortunately, many of us do not understand this language. Some feel confused, or to be precise, shy about it. Few are not comfortable talking about it to anyone. If we immediately seek medical attention for physical ailments, then why not for emotional/mental stress? Instead, this is more important. It is a massive taboo in a society that needs serious attention. It is high time we start to talk about it.
I will dig deeper into my case. My claustrophobia was well handled by a psychologist. I was able to travel several countries, and each was a separate win for me, travelling for so long in flights, encouraged by my partner who supported me at each level and celebrated all of my small and big wins.
What I am trying to say is, situations change if we learn to do something about it. If we do not, then our sufferings will continue to pile up. We need to find ways to overcome it.
Now you ask, how? Right? Build a strong network of friends and family, love them unconditionally, strengthen the bond, and the happiness you get in return would not be more comfortable to explain.
Okay! Stretch your muscles now for a small activity. List down the names of at least 3 people whom you could connect and open your heart without thinking twice at any hour of the day, could share your lows, your weaknesses, in short, you can be your true self.
Keep it in your front-most drawer, and during an emotional emergency, take a look, you are the luckiest if you have even one. Just pour your heart out. If you don’t have any name, for now, become one.
There is sometimes a loop of thoughts which becomes difficult to break.
Few rules to be followed which, I have learnt with experience:
Learn to pick the signals your mind sends.
Check whether you are running on sympathetic or parasympathetic. For immediate relief, control your breaths because that is the one which gets disturbed first. It gets faster when you are anxious. Close your eyes, sit at a peaceful place, try to slow down its pace for 5 minutes and experience the result.
Identify the activity which soothes you, relaxes you. Switch to that when you need. It can be anything… stitching, painting, singing, yoga, dancing… the list is endless.
It’s never too late to develop a hobby, which is the best escape route from mundane life.
Identify the people with whom you are close, invest in building rich relationships. When I say rich, friends are the richness we all should strive for with all our might. If you have even one who understands you truly, who can listen to you tirelessly, with whom you can be yourself, you have won the world. Talk your heart out, do not give it a thought, express your genuine emotions, and not hesitate.
It’s perfectly ok not to be okay, seek medical help if needed, take medicine if advised, shake off the taboo, life is far more precious than these petty things, enjoy it, live it to the fullest.
Follow a healthy routine, it elevates the mood. Inculcating the habit to exercise releases endorphin – the happiness hormone- which helps our mind reduce stress.
Take a break without applying logic, have fun, this is only one life that we have got. Be yourself.
Meditation is one of the most helpful tools, just imbibe it within. Your subconscious mind can do wonders, just keep repeating and reminding it that you are a beautiful soul, powerful soul and perfectly fine. What we say, we ultimately become. Sit quietly by yourself for at least 10 minutes. I am not a meditation expert, just have begun but felt the wonders.
Last but not least, become a true friend of someone as you wish for yourself, you never know you might be his/her only trustworthy friend. Believe me, happiness doubles when spread.
That’s all my friend, I won’t say thank you, instead I would express my gratitude for giving your precious time to read, which at the first place empowered me to express myself.
Signing off. Preeti Agrawal COO DelveInsight
Our COO, Preeti Agrawal, is a market research consultant with around 16 years of experience. She is a science graduate and has done her masters in computer application. Prior to joining DelveInsight, she worked with Toluna (GreenField), Kadence, and Internationallinx. She was actively engaged in client interaction, handling client queries, providing them with feasible solutions & building healthy relationships thereby achieving high customer satisfaction. She has mastered the art of maintaining relationships with customers to achieve repeat/referral business.
Are there unique benefits to brown rice that would justify keeping it in our diet despite the arsenic content?
For years, warnings had been given about the arsenic levels in U.S. rice potentially increasing cancer risk, but it had never been put to the test until a study out of Harvard. The finding? “Long-term consumption of total rice, white rice or brown rice[,] was not associated with risk of developing cancer in US men and women.” This was heralded as good news. Indeed, no increased cancer risk found even among those eating five or more servings of rice per week. But, wait a second: Brown rice is a whole grain, a whole plant food. Shouldn’t brown rice be protective and not just neutral? I discuss this in my video Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.
If you look at whole grains in general, there is “a significant inverse”—or protective—“association between total whole-grain intake and risk of mortality from total cancers,” that is, dying from cancer. My Daily Dozen recommendation of at least three servings of whole grains a day was associated with a 10 percent lower risk of dying from cancer, a 25 percent lower risk of dying from heart attacks or strokes, and a 17 percent lower risk of dying prematurely across the board, whereas rice consumption in general was not associated with mortality and was not found to be protective against heart disease or stroke. So, maybe this lack of protection means that the arsenic in rice isincreasing disease risk, so much so that it’s cancelling out some of the benefits of whole-grain brown rice.
Consumer Reports suggested moderating one’s intake of even brown rice, but, given the arsenic problem, is there any reason we should go out of our way to retain any rice in our diet at all? With all of the other whole grain options out there, should we just skip the rice completely? Or, are there some unique benefits we can get from rice that would justify continuing to eat it, even though it has ten times more arsenic than other grains?
One study showed that “a brown rice based vegan diet” beat out the conventional Diabetes Association diet, even after adjusting for the extra belly fat lost by the subjects on the vegan diet, but that may have been due to the plant-based nature of their diet rather than just how brown rice-based it was.
Another study found a profound improvement in insulin levels after just five days eating brown rice compared to white rice, but was that just because the white rice made people worse? No, the brown rice improved things on its own, but the study was done with a South Indian population eating a lot of white rice to begin with, so this may have indeed been at least in part a substitution effect. And yet another study showed that instructing people to eat about a cup of brown rice a day “could significantly reduce weight, waist and hip circumference, BMI, Diastole blood pressure,” and inflammation—and not just because it was compared to white. However, a larger, longer study failed to see much more than a blood pressure benefit, which was almost as impressive in the white-rice group, so, overall, not too much to write home about.
Then, another study rolled around—probably the single most important study on the pro-rice side—showing a significant improvement in artery function after eight weeks of eating about a daily cup of brown rice, but not white, as you can see at 3:18 in my video, and sometimes even acutely. If you give someone a meal with saturated fat and white rice, you can get a drop in artery function within an hour of consumption if you have some obesity-related metabolic derangements. But, if you give brown rice instead of white, artery function appears protected against the adverse effects of the meal. Okay, so brown rice does show benefits in interventional studies, but the question is whether it shows unique benefits. Instead, what about oatmeal or whole wheat?
Well, first, researchers needed to design an artery-crippling meal, high in saturated fat. They went with a Haagen Daaz, coconut cream, and egg milkshake given with a bowl of oatmeal or “a comparable bowl of whole rolled wheat.” What do you think happened? Do you think these whole grains blocked the artery-damaging effects like the brown rice did? The whole oats worked, but the whole wheat did not. So, one could argue that brown rice may have an edge over whole wheat. Do oats also have that beneficial long-term effect that brown rice did? The benefit was of a similar magnitude but did not reach statistical significance.
So, what’s the bottom line? Until we know more, my current thinking on the matter is that if you really like rice, you can moderate your risk by cutting down, choosing lower arsenic varieties, and cooking it in a way to lower exposure even further. But, if you like other whole grains just as much and don’t really care if you have rice versus quinoa or another grain, I’d choose the lower arsenic option.
Tada! Done with arsenic in the food supply—for now. Should the situation change, I’ll produce another video on the latest news. Make sure you’re subscribed so you don’t miss any updates.
Here are all 13 videos in the series, in case you missed any or want to go back and review:
The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE backed the drug in England.
Rozlytrek (entrectinib) can now be used by the NHS in Scotland as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
ROS1 is a rare mutation found in fewer than 2% of NSCLC cases, and patients have few treatment options, especially when the disease has spread to the brain. NICE has previously estimated that roughly 412 patients across the UK are have NSCLC eligible for treatment with Rozlytrek.
The SMC cleared Rozlytrek via its Patient and Clinician Engagement (PACE) programme, a mechanism that brings agency reviewers, clinicians and patient group representatives together in order to discuss benefits of a medicine that may not be fully captured in the conventional appraisal process.
In the meeting, patients and clinicians said ROS1-positive NSCLC is often diagnosed at an advanced stage, so is associated with a short life expectancy, and there are limited treatment options available.
“This type of advanced NSCLC is a very rare and incurable lung cancer that often occurs in non-smokers and affects many under 60 years old,” commented Gemma Boni, head of lung cancer at Roche Products Ltd.
“Our commitment is to ensure that people in Scotland with lung cancer live longer and healthier lives, and today’s news shows how we are advancing science to achieve this,” she added.
In 2018, Pfizer’s ALK and ROS1 inhibitor Xalkori (crizotinib) was cleared by NICE in England – via the Cancer Drugs Fund (CDF) – as well as in Scotland by the SMC as a first-line option for treating ROS1-positive advanced NSCLC in adults.
Second-line treatment options include pemetrexed with carboplatin or other platinum doublet chemotherapy, with pemetrexed as a maintenance therapy.
Rozlytrek is also approved to treat people aged 12 years of age and older with solid tumours that have an NTRK gene fusion – regardless of where they appear in the body – and the SMC should decide whether that use is cost effective in the next couple of months. NICE has already approved Rozlytrek for that use in England via the CDF.
The SMC also backed NHS use for four other medicines in its January update, including Janssen’s Darzalex (daratumumab) for adults with newly-diagnosed multiple myeloma who are eligible for autologous stem cell transplant. NICE is due to deliver a verdict on this use for the drug in April.
Meanwhile, Rigel Pharmaceuticals’ Tavlesse (fostamatinib) – sold by Spain’s Grifols in Europe – can now be used in Scotland to treat chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. NICE is also conducting an appraisal of Tavlesse, but hasn’t yet set a timeframe for review.
Also backed were Takeda’s Adcetris (brentuximab vedotin) for systemic anaplastic large cell lymphoma (sALCL) – a use already approved by NICE in England – and Novartis’ Cosentyx (secukinumab) for non-radiographic axial spondyloarthritis which NICE expects to decide on in May.
The SMC rejected RAD Neurim Pharma’s Slenyto (melatonin) for the treatment of insomnia in children with autism spectrum disorder and rare neurogenetic disorder Smith-Magenis syndrome, ruling the company had not provided strong enough evidence to show it was cost-effective.
NHS patients in England will be among the first in the world to receive Gilead’s Tecartus cancer cell therapy for certain types of lymphoma, after the company’s specialist Kite unit struck a deal with NICE.
Marketed as Tecartus (autologous anti-CD19-transduced CD3+) in Europe, the drug was approved in the EU in December for adults with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
It has been approved in the US since July last year and like other CAR-Ts the one-time therapy is expensive at $373,000 a shot in the US.
NICE said in guidance that the treatment can be considered for those with relapsed or refractory mantle cell lymphoma, after treatment with drugs such as AbbVie/Janssen’s Imbruvica (ibrutinib).
Kite has signed a managed access agreement with NHS England that allows for funding via the Cancer Drugs Fund (CDF) at a commercially confidential discount, so more data can be collected for NICE’s cost-effectiveness calculations.
While in most cases reimbursement from the CDF results in regular NHS funding in the long run, manufacturers must usually produce convincing overall survival data before NICE gives this the go-ahead.
But as Bristol-Myers Squibb found out earlier this month with its Opdivo immunotherapy in head and neck cancer, NICE is prepared to say “no” in the absence of the required data after a period of funding on the CDF.
NICE said in a statement that it is looking for further data on progression-free survival, overall survival and age when treatment with Tecartus starts.
This will help reduce uncertainty in evidence while NHS is used on NHS patients.
The NHS has ten providers around the country which will be able to offer this treatment option.
Many parts of the country continue to experience pressures on critical care services, that are required for the administration of a CAR-T therapy and patients can travel to centres further afield to receive their treatment if necessary, NICE said.
There is no standard treatment for adults, who are usually in their 70s, with relapsed or refractory mantle cell lymphoma after a BTK inhibitor. A combination of rituximab, bendamustine and cytarabine (R BAC) is the most common treatment option.
Around 100 patients each year could be treated with this CAR-T therapy.
NHS England has been leading the way with funding of CAR-T (Chimeric Antigen Receptor T-cell) therapies after it became an early adopter of Novartis’ Kymriah the first approved drug from this class in September 2018 in acute lymphoblastic leukaemia (ALL).
CAR-T therapies are made by harvesting a patient’s T-cells, genetically engineering them to target cancer cells and reintroducing them into the body.
Who should get the COVID-19 vaccine first? Since I am an economist, let’s try to figure this out mathematically. Let’s give each person or group of people a score or ranking and vaccinate each individual in priority.
One key factor, is that we should the vaccine to the people most at risk for the disease. In this case, our ranking (R) is just a function of people’s mortality risk conditional on getting COVID-19. Older individuals and those in nursing homes are at much higher risk. Thus, we should vaccinate based on how likely people are to die if they get COVID
R = f[mortality]
However, fairness is also important. Front line health care workers are putting their lives on the line to treat patients with COVID and should also be prioritized. Let’s make sure that fairness considerations are included. I’ll update our prioritization as follows: where both mortality and fairness matter. Of course we’ll have to weigh these priorities, but we can worry about that later. The relative weighting coefficient’s I’ll include with the vector θ.
R = f[mortality, fairness; θ] Getting back to mortality, previously, we (implicitly) noted that older people are at higher risk of dying if they get COVID. But so are younger people such as those with comoribidities such as asthma or COPD. Thus, let’s be a bit more specific on the factors that affect mortality.
R = f[mortality(age, nursing home, comorbidities),fairness; θ]
We focus on the risk of people dying conditional on getting COVID-19. In practice, however, the chance of getting COVID-19 may depend on individual behavior. Older people may be more cautious and less likely to leave the house or travel than younger individuals., especially if they are retired and do not need to work As younger individuals have less health risk and will need to work as they have less savings, they may be more likely to engage in risky behaviors and spread COVID-19. Thus, we’ll want to focus on likelihood of getting COVID-19 or the cost of staying at home. We will update the scoring to incorporate COVID-19 incidence and cost of isolation as follows:
R = f[mortality(age, nursing home, comorbidities), fairness,incidence,cost of isolation; θ]
Now we’re getting closer. However, the vaccinating people in rural areas may be more challenging than those in urban areas. Those in urban areas come into contact with more people and are more likely to spread the disease. Let’s add that dimension to our ranking formula.
R = f[mortality(age, nursing home, comorbidities), fairness,incidence,cost of isolation, urban; θ]
Now we have the perfect system…once we figure outθ.
But wait! The cost of figuring out each individuals risk score will require an army of statisticians at each vaccination site or at a minimum a data entry team that can feed each individual’s characteristics into a computers algorithm to calculate each person’s priority score.
The telehealth company and managed care organization are launching a new HMO plan on the Texas health insurance exchange. The ‘virtual-first’ plan is designed for those who do not qualify for Medicaid or Medicare.
Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic.
According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some people needing medical attention in a 24-hour period.
For now there is little information about the Moderna vaccine reactions, other than they are centred around a specific manufacturing lot – number 041L20A – and that “fewer than 10” cases of allergic reactions were reported.
More than 330,000 doses from that lot have already been administered in California since the start of the vaccine roll-out, according to state department of public health. The clinic in question switched to another lot of Moderna vaccine after closing for a few hours.
There were also reports of allergic reactions during the initial roll-out of the Pfizer/BioNTech vaccine, including some cases of anaphylaxis, which also resulted in a temporary pause in dosing at some centres.
Last week, the Centers for Disease Control and Prevention (CDC) published new data which identified 21 cases of anaphylaxis after administration of a reported 1.9 million first doses of the Pfizer/BioNTech shot, mainly within 15 minutes of the injection.
That was equivalent to 11 cases per million doses, according to the agency, which says the reactions can be managed using patient screening for allergies, observation periods after dosing and having epinephrine injections on hand as a precaution.
Both the Pfizer/BioNTech and Moderna vaccines are based on mRNA and use an excipient – called polyethylene glycol (PEG) – that some scientists suggest could be responsible for the allergic reactions, according to a report in the journal Science.
“Our goal is to provide the COVID vaccine safely, swiftly and equitably,” said Dr Pan in a statement.
“Out of an extreme abundance of caution and also recognising the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause the administration of vaccines from Moderna lot 041L20A until the investigation by the CDC, FDA, Moderna and the state is complete.
While no vaccine or medical procedure is without risk, the risk of a serious adverse reaction is very small, according to the department. At last count, California had recorded almost 3 million COVID-19 cases, with just over 33,000 deaths, placing it among the worst affected states in the US.
The complete dose-finding part of P-Ib/II study assessed the safety, feasibility, and RP2D of NBTXR3 (intratumoral inj.) in 20 patients with LA (T3 to T4) or unresectable rectal cancer
The study showed ORR after CCRT in >70% patients, 90% patients underwent total mesorectal excision (surgery); 17.6% achieved pCR; 50% receiving surgery had good tumor regression; therapy was feasible and was well tolerated at all dose levels
Nbtxr3 is a novel, potentially first-in-class therapy designed to destroy tumors through physical cell death when activated by radiotherapy.
Click here to read full press release/ article | Ref: Businesswire | Image: Wikipedia
It also helps to think of the side effects of not eating healthy.
Poor nutrition might increase your risk for a number of health problems.
Can You Overdo Healthy Eating?
In a word: yes. “For some, healthy eating can turn into orthorexia or an unhealthy obsession with following the ‘perfect’ diet,” says Brittany Crump, M.P.H., R.D. at Savor Nutrition.
“It’s essentially an unrealistic goal, and those who try to follow it can damage their well-being. When an orthorexic can’t follow their diet perfectly (maybe life gets in the way), they may feel shame or self-loathing,” she explains.
Orthorexia isn’t officially recognized as an eating disorder like anorexia, but it can result in similar health consequences, namely malnutrition.
“With orthorexia, it’s more about the individual’s mindset than the diet they follow,” says Crump. “You can have orthorexia with any type of diet — vegan, gluten-free, clean eating, calorie counting, and more.”
It’s essential to have a healthy mindset, especially if you want to develop healthy habits that are sustainable.
Make a Healthy Eating Plan
A good plan is full of healthy habits you can maintain over time.
Here are five not-too-rigid rules to help you make healthy habits that stick:
1. Choose mostly whole, unprocessed foods
Try to eat more of these foods:
Fruits and vegetables — they should make up the bulk of your diet since they’re low in calories and high in fiber and other valuable vitamins and minerals. Include primarily veggies (generally lower in kcal, sugar, higher in fiber), as fruit contains naturally occurring sugar, which should not be eaten in an unlimited amount.
Whole grains — oats, whole grain pasta, brown rice, farro, quinoa, and popcorn are examples of fiber-licious whole grains.
Lean proteins — chicken, fish, eggs, yogurt, cottage cheese, nuts, seeds, beans, and legumes are examples of nutritious lean protein.
Healthy fats — enjoy omega-3 fats from fatty fish, walnuts, and flax seeds plus monounsaturated fats from nuts, olive oil, avocado, and peanut butter.
By choosing mostly whole foods, you’ll naturally avoid the unhealthy stuff that’s mainly in processed foods such as trans fats, added sugars, preservatives, and dyes.
Plus, whole foods are a natural canvas to create exciting flavors and textures.
1 cupped hand = 1 serving of complex carbohydrate (whole-grain preferred)
1 thumb = a serving of fat
This is only used to demonstrate an average portion size of each food group, but depending on your daily needs, you may require larger portions.
If you struggle with fixing your portion size, our Ultimate Portion Fix containers can take the guesswork out it.
4. Have a balanced, healthy-ish mindset
As noted above, you don’t need to eat healthy 100% of the time. A healthy mindset leaves room for you to enjoy foods based on emotional appeal, not just nutrition.
Having this balanced mindset can help you feel less like a failure if you stray, which is totally normal.
According to Crump, “Food is for celebrating, too. You should be able to enjoy birthdays and holidays without feeling guilty about food. Even if you have a day that’s less than ideal, it’s OK. You can get back on track tomorrow.”
5. Celebrate your wins
Don’t forget that you’re making healthy eating habits for the long haul, which means you’ll need to stay motivated.
One way to do that is to reward yourself when you see progress.
Maybe you finally kicked that sugary soda habit for six straight months. Give yourself a non-food reward (like a new pair of shoes) to acknowledge the win.
What Prevents You From Eating Healthy?
Healthy eating setbacks are personal to your circumstance and lifestyle, but common hurdles include:
Not having social support
A common question that people ask is, “How can I eat healthy when no one else is healthy?”
If your friends and family are not on board with healthy eating, try to find a group of people who are.
You can join online groups to connect with like-minded individuals to help you stay on track.
Lack of time
To make healthy habits stick, you may need to front time to meal plan, grocery shop, and food prep.
You’re less likely to make impulsive food choices with healthy meals and snacks conveniently in place.
At the start, it can feel like you’re giving up the foods you like. But healthy eating doesn’t mean giving up your favorite foods forever — that would be an unhealthy mindset.
“A healthy mindset around food involves letting go of the idea that foods are ‘good’ or ‘bad.’ All foods can fit into a healthy diet. Don’t expect yourself to eat healthy 100% of the time. Maybe try 80% or 90% at most. Leave room to indulge in foods you love,” says Crump.
Losing motivation too early
Results don’t always come immediately after you adopt healthy eating habits.
Instead of fixating on numbers (e.g., pounds on the scale, body fat percentage, waist circumference), find small, promising signs of progress.
They keep your leftovers fresh-tasting, make it easy to meal prep in bulk, aid in portion control, and are easily stackable for total organization junkies.
But finding the right containers is essential to avoid continually cleaning up messes, wasting food, or using multiple dishes.
Here’s everything you need to know about freezer containers!
What are the Best Freezer Containers to Use?
Stick with containers made from microwave-safe BPA-free plastic or glass.
That way, you can go from freezer to microwave without dealing with multiple dishes.
According to the USDA, your leftovers and prepped meals are safe after 3-4 days in the refrigerator and 2-3 months in the freezer.
Also, don’t skimp on that leak-proof lid feature. You’ll want airtight lids to keep your food extra fresh and prevent spills and messes.
“Even if you aren’t freezing a liquid, leak-proof equals freezer burn-proof,” says Brian Casey, Chef, hunter, and founder of Knifegeeky.
“Leak-proof containers have the best seal, meaning they will keep the contents fresh and not let in any weird freezer flavors over time,” he explains.
These leak-proof containers might also save the day in an emergency.
“In case of a power outage or other situation where your freezer is unable to perform, you’ll wish you used a leak-proof container!” says Caleb Chen, a Servsafe certified food safety expert.
Are Plastic Freezer Containers OK?
As long as they’re BPA-free, plastic containers are OK. You’ll also want to make sure they’re microwave and dishwasher safe.
“Don’t put thin plastic (like reused takeout containers) or metal of any kind in your microwave,” says Casey. “Most containers will say on the bottom or the label if they are safe for reheating,” he adds.
When freezing contents for extended periods of time (like meat), vacuum-sealed plastic bags are your best bet, says Chen.
What Can I Put Inside Freezer Containers?
Anything you want to freeze! The container shape will depend on what you’re putting inside them:
Opt for a round container if you’re storing soups.
Choose a rectangular shape if you want to pre-portion meals.
“Remember that liquids will expand if frozen, so always leave a little extra room in the container. Leave an inch or so of space at the top to be safe,” advises Casey.
Can I Freeze Take Out Boxes?
“Generally, you shouldn’t freeze food that comes in a take out box because you can’t be sure if the materials used are freezer safe,” advises Chen.
Move your leftovers into your freezer containers so you can be sure your food is adequately protected.
Now that you know the basics, here are five of our favorite freezer containers.
1. Prep Naturals Food Storage Containers with Lids
This 50 pack of 25 oz freezer and microwave safe storage containers is affordable, leak-proof, and reusable.
They’re also stain-proof and BPA-free for safe, easy, and efficient stacking.
– FCC announces initial 14 pilot project selected for $100M Connected Care Pilot Program that will support connected care service across the country and focus on low-income and veteran patients.
The Federal Communications
Commission (FCC) today announced an initial set of 14 pilot projects with
over 150 treatment sites in 11 states that have been selected for the Connected
Care Pilot Program. A total of $26.6 million will be awarded to these
applicants for proposed projects to treat nearly half a million patients in
both urban and rural parts of the country.
Connected Care Pilot Program Background
Overall, this Pilot Program will make available up to $100
million over a three-year period for selected pilot projects for qualifying
purchases necessary to provide connected care services, with a particular
emphasis on providing connected care services to low-income and veteran
Program will use Universal Service Fund monies to help defray the costs of
connected care services for eligible health care providers, providing support
for 85% of the cost of eligible services and network equipment, which include:
broadband Internet access services
2. health care
provider broadband data connections
connected care information services
These pilot projects will address a variety of critical
health issues such as high-risk pregnancy, mental health conditions, and opioid
dependency, among others. Here is the list initial list of healthcare providers
that were selected into the Pilot Program:
Banyan Community Health Center, Inc.,
Coral Gables, FL.
Banyan Community Health Center’s pilot project seeks $911,833 to provide
patient-based Internet-connected remote monitoring, video visits or consults,
and other diagnostics and services to low-income and veteran patients who are
suffering from chronic/long-term conditions, high-risk pregnancy, infectious
disease including COVID-19, mental health conditions, and opioid
dependency. Banyan Community Health Center plans to serve an estimated
20,847 patients in Miami, Florida, 85% of which are low-income or veteran
Duke University Health System, Durham,
University Health System’s pilot project seeks $1,464,759 to provide remote
patient monitoring and video visits or consults to a large number of low-income
patients suffering from heart failure, cancer, and infectious diseases.
Duke University Health System’s pilot project plans to serve an estimated
16,000 patients in North Carolina, of which 25% are low-income.
Geisinger, consortium with sites in
Lewiston, PA; Danville, PA; Jersey Shore, PA; Bloomsburg, PA; Coal Township,
PA; and Wilkes-Barre, PA.
Geisinger’s pilot project seeks $1,739,100 in support to provide connected care
services and remote patient monitoring to low-income patients in rural
communities in Pennsylvania. Geisinger’s pilot project would serve an
estimated 1,000 patients and would focus on chronic disease management and
high-risk pregnancies, while also treating infectious disease and behavioral
health conditions. Through its pilot program, Geisinger plans to directly
connect all participating patients, 100% of whom are low-income, with broadband
Internet access service.
Grady Health System, Atlanta, GA. Grady Health System’s pilot
project seeks $635,596 to provide Internet connectivity to an estimated 1,896
primarily low-income and high-risk patients who are unable to utilize video
telemedicine services due to lack of a reliable network connection in
Atlanta. The program will focus on using connected care services such as
patient remote monitoring and video visits/consults to treat vulnerable
patients with conditions such as congestive heart failure, COVID19,
hypertension, diabetes, heart disease, and HIV.
Intermountain Centers for Human
Development, consortium with sites in Casa Grande, AZ; Nogales, AZ; Coolidge,
AZ; and Eloy, AZ. Intermountain
Centers for Human Development’s pilot project seeks $237,150 in support to
treat mental health conditions, opioid dependency, and other substance abuse
disorders. The pilot project plans to serve 3,400 patients in Arizona,
including rural areas, of which 90% are low-income.
MA FQHC Telehealth Consortium,
consortium with 76 sites in Massachusetts. MA FQHC Telehealth Consortium’s pilot project
seeks $3,121,879 in support to provide mental health and substance abuse
disorder treatment through remote patient monitoring, video visits, and other
remote treatment to patients in Massachusetts, including significant numbers of
veterans and low-income patients. The pilot project will expand access to
these services by leveraging program funding to increase bandwidth at its
sites, and to provide patients with mobile hotspots. This project would
serve 75,000 patients through 76 federally qualified health centers in
Massachusetts, including rural areas, with an intended patient population of
61.5% low-income or veteran patients.
Mountain Valley Health Center,
consortium with 7 sites in Northeastern California. Mountain Valley Health Center’s
pilot project seeks $550,800 in support to provide telehealth capabilities and
in-home monitoring of patients with hypertension and diabetes. Mountain
Valley’s pilot project plans to serve an estimated 200 patients in rural
Northeastern California, of which at least 24% will be low-income patients and
10% will be veteran patients.
Neighborhood Healthcare – Escondido,
Escondido, CA, Neighborhood Healthcare – Valley Parkway, Escondido, CA,
Neighborhood Healthcare – El Cajon, El Cajon, CA, Neighborhood Healthcare –
Temecula, Temecula, CA, Neighborhood Healthcare – Pauma Valley, Pauma Valley,
Healthcare’s pilot project seeks $129,744 to provide patient broadband access
to primarily low-income patients suffering from chronic and long-term
conditions (e.g., diabetes and high blood pressure). Neighborhood
Healthcare’s collective project plans to serve an estimated 339 patients, 97%
of which are low-income patients, in five sites serving Riverside and San Diego
OCHIN, Inc., consortium with 15 sites in
Ohio, 16 sites in Oregon, and 13 sites in Washington. OCHIN’s pilot project seeks
$5,834,620 in support to lead a consortium of 44 providers in Ohio, Oregon, and
Washington, encompassing 8 federally qualified health centers (FQHCs) serving
rural, urban, and tribal communities. OCHIN’s pilot project will provide
patient broadband Internet access service and wireless connections directly to
an estimated 3,450 low-income patients to access connected care services,
including video visits, patient-based Internet-connected patient monitoring,
and remote treatment and will deliver care to treat high-risk pregnancy,
maternal health conditions, mental health conditions, and chronic and long-term
conditions such as diabetes, hypertension, and heart disease.
Phoebe Worth Medical Center – Camilla
Clinic, Camilla, GA; Phoebe Physicians Group Inc – PPC of Buena Vista, Buena
Vista, GA; Phoebe Physicians Group – Ellaville Primary Medicine Center,
Ellaville, GA; Phoebe Physicians dba Phoebe Family Medicine & Sports
Medicine, Americus, GA; Phoebe Putney Memorial Hospital, Albany, GA; Phoebe
Putney Memorial Hospital dba Phoebe Family Medicine – Sylvester, Sylvester, GA. The Phoebe Putney Health System
projects seek $673,200 to provide patient-based Internet-connected remote
monitoring, video visits, and remote treatment for low-income patients
suffering from chronic conditions or mental health conditions. These projects
plan to serve an estimated 4,007 patients, approximately 1,000 of which will be
low-income patients in six sites serving southwest Georgia.
Summit Pacific Medical Center, Elma, WA. Summit Pacific Medical Center’s
pilot program seeks $169,977 in support to provide patient-based
Internet-connected remote monitoring, other monitoring services, video visits,
diagnostic imaging, remote treatment and other services for veterans and
low-income patients suffering from chronic conditions, infectious diseases,
mental health conditions, and opioid dependency. Summit Pacific Medical
Center’s pilot project would serve an estimated 25 patients in Elma,
Washington, 100% of which would be low-income or veteran patients.
Temple University Hospital,
Temple University Hospital’s pilot project seeks $4,254,250 to provide
patient-based Internet connected remote monitoring and video visits to
patients, including low-income patients, suffering from chronic/long-term
conditions and mental health conditions. This pilot project plans to
serve an estimated 100,000 patients in Philadelphia, Pennsylvania, 45% of which
are low-income patients.
University of Mississippi Medical
Center, Jackson, MS.
The University of Mississippi Medical Center’s (UMMC) pilot project seeks
$2,377,875 in support to provide broadband Internet access service to patients,
enabling remote patient monitoring technologies and ambulatory telehealth
visits to low-income patients suffering from chronic conditions or illnesses
requiring long-term care. UMMC’s pilot project would impact an estimated
237,120 patients across Mississippi and serve up to 6,000 patients
directly. Of these patients, UMMC estimates that 52% would be low-income.
University of Virginia Health System,
Charlottesville, VA. The
University of Virginia (UVA) Health System’s pilot project seeks $4,462,500 in
support to expand the deployment of remote patient monitoring and telehealth
services to an estimated 17,000 patients across Virginia, nearly 30% of whom
will be low-income. The UVA Health System pilot project will support
patient broadband and information services, including systems to capture,
transmit, and store patient data to allow remote patient monitoring, two-way
video, and patient scheduling.
In a recent interview with PharmaShots, Dr. Jing Watnick, Co-Founder and Chief Executive Officer, and Dr. Lou Vaickus, Interim Chief Medical Officer at Vigeo shared their views on the data findings presented at the SITC 2020 Annual Meeting that demonstrated VT1021 as a single-agent has a favorable safety profile and shows early signals of clinical activity across a wide variety of solid tumors, including pancreatic cancer and glioblastoma.
VT1021 is a first-in-class, dual-modulating therapy that blocks the CD47 immune checkpoint and activates CD36, stimulating cytotoxic T-cell functions, inducing apoptosis in tumor and endothelial cells, and increasing the phagocytosis of the tumor by M1 macrophages by stimulating the production of Tsp-1
The compound initially targets pancreatic cancer, glioblastoma multiforme (GBM) and ovarian cancer
Vigeo Therapeutics is open for collaborations to advance its clinical program and build pipeline
Tuba: Can we have a glimpse of the poster presented at the Society for Immunotherapy of Cancer’s (SITC) 2020 Annual Meeting?
Tuba: Highlight the key points of the VT1021 development program and its mechanism of action.
Lou: VT1021 is a first-in-class, dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, stimulating cytotoxic T-cell functions, inducing apoptosis in tumor and endothelial cells, and increasing the phagocytosis of the tumor by M1 macrophages by stimulating the production of thrombospondin-1 (Tsp-1). Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.
Tuba: Describe in brief about the specific disease targets of VT1021.
Lou: Currently the target indications for VT1021 are pancreatic cancer, glioblastoma multiforme (GBM) and ovarian cancer. Vigeo is also targeting patients with tumors that express high levels of both CD47 and CD36 as a biomarker based/indication agnostic strategy.
Tuba: Discuss the key findings from the interim clinical data from the P-I/II study of VT1021.
Lou: Dual modulation of CD47 and CD36 promotes complementary anti-tumor activity as 75% of patients who achieved a PR or SD had high expression of both CD47 and CD36 prior to entering the study.
Tuba: When can we expect the complete results of the P-I/II study and initiation of P-II study?
Lou: Escalation has been completed and expansion is expected to be completed by 2Q of 2021. We expect to initiate combination studies in 2Q of 2021.
Tuba: What are the unique attributes about Vigeo’s lead candidate VT1021?
Lou: Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis and increases the M1:M2 macrophage ratio. VT1021 achieves this through stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or “cold,” tumors that don’t respond to immuno-oncology agents, to immuno-stimulated, or “hot,” tumors that are potentially more receptive to immuno-oncology agents. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. Pre-clinical results have demonstrated that single-agent VT1021 causes tumor regression at both the primary and metastatic sites.
Tuba: What were the major highlights about the dose escalation portion of first in human trial with VT1021?
Lou: The dose escalation study was marked by a very clean safety profile, an expected and dose dependent pharmacokinetic profile, and the attainment of changes in desired biomarkers in patients that were predicted in nonhuman animal models. As such the recommended Phase 2 dose was determined based on a combination of safety, pharmacokinetic, and pharmacodynamic parameters. Additionally, there was a very overall high disease control rate (SD+PR) of 43% (12/28). When analyzing patients with high levels of both CD36 and CD47, the disease control rate increased to 80% (8/10).
Tuba: How do you feel about the development status of VT1021 so far?
Lou: We are very encouraged by the development of the biomarker-based strategy and feel that this will significantly impact the clinical development of VT1021. Early results in the indication expansion cohorts are promising and we are cautiously optimistic. In addition, the clean safety profile allows for combinability with other immunomodulatory and chemotherapy drugs.
Tuba: What are the other programs that we can expect to escalate further from Vigeo’s pipeline?
Lou: There are several preclinical-stage programs in the pipeline focusing on TME modulation.
Tuba: Do you plan for any partnerships for the commercialization strategies of VT1021?
Lou: We are continuously evaluating potential partnerships and remain open to any number of possibilities as we work to advance our clinical program and build out our pipeline.
Dr. Jing Watnick is a co-founder of Vigeo and leads the company as its CEO. She has over 20 years of experience in the pharmaceutical industry, including roles in program and portfolio management, strategic planning, business development, alliance management, and preclinical and clinical research.
Lou Vaickus serves as Interim CMO of Vigeo. He has over 30 years of experience that began as an academic scientist, then practicing physician, then spanned into the industry with preclinical, clinical, and globally marketed pharmaceutical products.
Dr. Monte Junker, an Oregon dentist, is waiting for his turn to get vaccinated for covid even though he considers himself a front-line health worker.
“If they offered it to me today, I would be there,” he said.
In December, just before the first vaccines were cleared for emergency use, the Centers for Disease Control and Prevention immunization advisory board recommended that health care workers — as well as nursing home residents and staff members — be the first to be inoculated because of their high risks of infection.
But Oregon is one of a handful of states, including Colorado, North Carolina and Texas, that have put dentistslower in priority order than other health professionals who treat patients — even though they have their hands in people’s mouths and are exposed to aerosols that spray germs in their faces during procedures.
As a result, dentists in those states must wait while many of their peers got their shots in December.
Dr. Tam Le, president of the Connecticut State Dental Association, was vaccinated in December along with employees at his practice in Cheshire. He said he lobbied the state to include dentists with other front-line hospital and health workers.
“In Connecticut, we are doing really well,” he said, noting that the state set up an online registration system for eligible health workers and then contacted them about when and where they could get the vaccine. Le said he and his staff went to a nearby community health center for their shots.
Dentists gained goodwill from state officials last spring by donating gloves and masks to hospitals, Le said. They also offered to help administer the shots since they have experience with that.
States are increasingly diverging from CDC guidance in their vaccination plans, according to an analysis by KFF. “Timelines vary significantly across states, regardless of priority group, resulting in a vaccine rollout labyrinth across the country,” the report said. (KHN is an editorially independent program of KFF.)
The American Dental Association said it’s aware that the lack of a national immunization strategy has meant that dentists and their staffs are not being treated equally across the country.
The CDC advisory board included dentists when it recommended that front-line health workers get priority.
“Each state government’s approach to vaccination will be different based on populations and need, but all dental team members should be prioritized in the first-tier distribution as the vaccines roll out by the different state and county public health departments,” said Daniel Klemmedson, the ADA president. An oral surgeon in Arizona, he has been vaccinated.
In Florida, dentists and their staffs are included among front-line workers eligible for vaccines in the first wave, but a lack of supply has hindered some from getting their shots, according to Drew Eason, CEO of the Florida Dental Association. Some county health departments have also incorrectly turned dentists away, he added.
Dr. Cindy Roark, a Boca Raton dentist and chief clinical officer of Sage Dental, which has 15 offices in Florida and Georgia, said she has no idea when she’ll get vaccinated. She said Georgia dentists in her company have been vaccinated, while those in Florida must wait. The only exceptions appear to be the relatively few dentists affiliated with hospitals. “We are equally vulnerable,” she said.
Still, Roark said she is not upset. “I know I can protect myself,” she said, adding that her office staffers wear N95 masks, face shields and gloves to protect themselves and patients. “Most dentists feel completely safe running their practice and preventing transmission.”
Junker, regional dental director at Advantage Dental in The Dalles, Oregon, said he understands that intensive care staff members, emergency department workers and the elderly in nursing homes need the vaccine first.
“But we are definitely up there for the copious quantities of aerosol in our faces each day,” he said. “The atmosphere is highly concentrated” with virus.
He’s upset at the poor planning and coordination between states and the federal government to make dentists a priority.
In cases where hospital staffers are declining the vaccine because they don’t trust it, Junker said, hospitals should offer shots to dentists and others who are eager for them.
“I don’t think it’s fair for them to sit on the vaccine for a month or two. It needs to get used, and if the hospital workers later decide to get vaccinated, they can get back in line,” he said.
Dr. Stan Hardesty, a Raleigh, North Carolina, dentist and president of the state dental society, said it’s disappointing to see dentists in other states get the vaccine while he and his colleagues have been told to wait.
“We have been advocating on behalf of our members to have dentists and our team members included in phase 1a as recommended by the CDC,” he said. “Unfortunately, the decision-makers [in the state government] have decided to utilize a different prioritization in their vaccine implementation.”
North Carolina dentists will be in “phase 1b,” which includes adults 75 and older, essential workers such as police officers and firefighters.
Chances are, you’ve heard someone complaining about their “muffin top”
Alas, they’re not talking about perfectly-crusty top of a blueberry muffin or pumpkin muffin.
More likely, the “muffin top” in question is a common problem area around the midsection and includes what many people refer to as love handles.
Here’s what causes this stubborn belly fat and what you can do to prevent it.
What Is a Muffin Top?
“Muffin top” is a slang term used to describe an accumulation of fat around the midsection, just above the hips.
In tight-fitting pants, this extra fat may spill out over the waistband — “just like a muffin above the paper cup,” explains Robert Ziltzer, M.D., FACP, FAAP, obesity medicine physician and coauthor of “Chasing Diets.”
Two types of belly fat may contribute to a muffin top, Ziltzer adds: subcutaneous fat (the soft, pinchable fat just below the skin) and visceral fat (a deeper layer of fat that surrounds the abdominal organs).
What Causes a Muffin Top?
A few factors can make this midsection bulge more likely to occur:
Much like actual muffins, “muffin tops” are also made in the kitchen.
Consuming excessive calories every day can contribute to fat storage around the midsection, so make sure you are burning more calories than you are eating, says Brittany Noel Robles, M.D., M.P.H., C.P.T., an OBGYN and NASM-certified personal trainer.
Genetics determine how and where you store fat, Ziltzer says. While you can’t control your genes, exercise and healthy eating can help with fat loss.
Anxiety, worry and distress can also play a role in creating those midsection rolls.
“Stress leads to the release of cortisol in your body, which tells your body to hold on to that fat, specifically in the midsection,” says Abby Nouis, ACSM-certified personal trainer and facility director of QuickHIT Fitness in Madison, WI.
The video-sharing giant is partnering with providers and groups, like Mayo Clinic and the American Public Health Association, to create evidence-based health content. YouTube has also added CVS Health’s former chief community health officer to lead those efforts.
Arsenic is not just considered to be a carcinogen; it’s also designated as a “nonthreshold carcinogen, meaning that any dose, no matter how small, carries some cancer risk”—so there really isn’t a “safe” level of exposure. Given that, it may be reasonable to “use the conservative ALARA” approach, reducing exposure As Low As Reasonably Achievable.
I have a low bar for recommending people avoid foods that aren’t particularly health-promoting in the first place. Remember when that acrylamide story broke, about the chemical found concentrated in french fries and potato chips? (See my video Acrylamide in French Fries for more.) My take was pretty simple: Look, we’re not sure how bad this acrylamide stuff is, but we’re talking about french fries and potato chips, which are not healthy anyway. So, I had no problem provisionally bumping them from my list of yellow-light foods into my red-light list, from “minimize consumption” to “ideally avoid on a day-to-day basis.”
One could apply the same logic here. Junk foods made out of brown rice syrup, rice milk, and white rice are not just processed foods, but also arsenic-contaminated processed foods, so they may belong in the red zone as red-light foods we should avoid. What about something like whole brown rice? That is more difficult, because there are pros to help outweigh the cons. I discuss this in my video Is White Rice a Yellow-Light or Red-Light Food?, where you can see a graphical depiction of my traffic light food system at 0:49.
The rice industry argues that the “many health benefits of rice consumption outweigh any potential risk,” which is the same sentiment you hear coming out of Japan about the arsenic-contaminated seaweed hijiki: Yes, “the cancer risk posed by hijiki consumption exceeds this acceptable [cancer risk] level by a factor of 10,” an order of magnitude, but the Japanese Ministry of Health stresses the “possible health benefits,” such as lots of fiber and minerals, as if hijiki was the only weed in the sea. Why not choose any of the other seaweeds and get all the benefits without the arsenic? So, when the rice industry says the “many health benefits of rice consumption outweigh any potential risk,” it’s as if brown rice was the only whole grain on the planet. Can’t you get the whole grain benefits without the risks by eating oatmeal, barley, or quinoa instead? Or, is there some unique benefit to rice, such that we really should try to keep brown rice in our diet?
Consumer Reports recommended moving rice to the yellow-light zone—in other words, don’t necessarily avoid it completely, but moderate your intake. The rice industry, in a fact sheet entitled “The Consumer Reports Article is Flawed,” criticized Consumer Reports for warning people about the arsenic levels in rice, saying “[t]here is a body of scientific evidence that establishes…the nutritional benefits of rice consumption; any assessment of the arsenic levels in rice that fails to take this information into account is inherently flawed and very misleading.” The rice industry cites two pieces of evidence. First, it asserts that rice-consuming cultures tend to be healthier, but is that because of, or despite, their white rice consumption? And what about the fact that rice-eating Americans tend to be healthier? Perhaps, but they also tend to eat significantly less saturated fat. So, once again, how do we know whether it’s because of—or despite—the white rice?
The rice industry could have cited the study I discuss at 3:12 in my video that showed that brown rice intake of two or more servings a week was associated with a lower risk of diabetes, but presumably, the reason it didn’t is because intake of white rice is associated with an increased risk of diabetes, and white rice represents 95 percent of the U.S. rice industry. Switching out a third of a serving of white rice a day for brown rice might lower diabetes risk by 16 percent, but switching out that same white rice for whole grains in general, like oats or barley, might work even better! So, other grains have about ten times less arsenic and are associated with even lower disease risk. No wonder the rice industry doesn’t cite this study.
It does cite the Adventist studies, though, and some in vitro data. For example, in a petri dish, as you can see at 4:05 in my video, there are rice phytonutrients that, at greater and greater doses, can inhibit the growth of colon cancer cells while apparently leaving normal colon cells alone, which is exciting. And, indeed, those who happened to eat those phytonutrients in the form of brown rice once or more a week between colonoscopies had a 40 percent lower risk of developing polyps. (The consumption of green leafy vegetables, dried fruit, and beans were also associated with lower polyp incidence.) But, the only reason we care about the development of polyps is that polyps can turn into cancer. But, there had never been studies on brown rice consumption and cancer…until now, which I discuss in my video Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.
In this second ‘Nine for 2021‘ article, IQVIA’s Sarah Rickwood looks at four issues which will directly impact pharma in 2021: the permanent changes in customer engagement models, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate.
Focus on customer engagement impact
The customer engagement story of 2020 could be summarised in three themes: trend break, agility and remote interaction. The trend break was the most immediately measurable commercial model impact. For April 2020 almost all face-to-face contact with healthcare professionals (HCPs) ceased. Preventing virus transmission, as well as “getting out of the way” of healthcare professionals pivoting to address the virus was key, and HCPs largely welcomed the way pharma reacted as responsible and necessary.
However, qualitative interviews conducted by IQVIA with HCPs in the top 5 European countries on their experience of engagement with pharma during 2020 show that doctors still valued interaction, including face to face interaction, with pharma and missed it when it was absent.
Pharma moved rapidly to remote interactions, even to the point of all virtual launches of new products. The overall volume of interactions fell, and those remaining became more remote and less interactive. The agility of many organisations effecting this rapid change was impressive, and a more resilient hybrid model seemed to be emerging as face-to-face interactions returned post the first wave.
This has, of course, been more recently challenged in Europe by second wave infections and new lockdowns, but this masks more fundamental and as yet unresolved challenges for 2021’s commercial model, which could be defined by environment divergence and the need to achieve impact.
The promotional environments of major pharmaceutical markets were already divergent in 2019 – some, like Italy and Spain were very high on traditional face to face interactions, others, like the UK, were the complete opposite, and still others, like Japan and the US, had high volumes of both digital and face to face contacts. The ways in which country promotional environments recovered from the first lockdowns has accentuated that divergence. This has implications for the commercial model companies employ by geography.
Environment divergence has been accelerated by recovery post the first infection wave – IQVIA ChannelDynamics data shows that in Europe, countries have recovered to a different promotional mix.
The UK has diverged most – it was always the country with the lowest volume of face-to-face contacts, and those contacts remain at negligible levels, replaced (but not completely) with remote rep contacts, creating a near 100% remote engagement model.
Other European countries have seen face to face contacts recover, then fall back because of second waves, but the model that emerged towards the end of 2020 was lower in volume and much more hybrid – a greater proportion of interactive contact was remote. The US, Japanese and Chinese promotional environments saw contact volumes recover to close to or greater than 2019 levels, with a channel mix that was more heavily remote.
The divergence of promotional environments is especially stark in the difference in the total interactive time the pharma industry had with healthcare professionals in 2020, compared to 2019. Up to November, the US and Japan actually saw increases in interactive time in 2020. Not so China, and especially not so the lead five European countries – on average European pharmaceutical companies saw a loss of 30% of the interactive time they previously had with healthcare professionals in 2020. Much of this lost time would have ordinarily been spent introducing and establishing new innovations and building growing products.
The need to achieve impact
As interactive time with HCPs is likely to be scarce, companies need to be even more ruthless in prioritising content and in deciding what content to generate in the first instance – for example, in Real World Evidence, as outlined in IQVIA’s white paper, ‘Excellent Launches are winning the Evidence battle’.
CNS (re) emerges
The 2010s were the decade of oncology: the decade started with oncology tipping hypertension off the top spot as the world’s most valuable therapy area, and during the next ten years, via continuous introduction of significant innovation, oncology grew its share of global prescription medicine value from 8% to 13% of sales. Oncology will continue to dominate the world market in the 2020s, albeit with slower growth, but that is not news. Instead, we will focus on therapy areas which will take on new significance in the 2020s. Of these, the most significant in terms of the conditions’ prevalence, and unrealised therapeutic potential, is CNS.
CNS is a “Back to the Future” story – scroll back to the 1990s and 2000s and CNS was one of the largest segments of the Rx market by value, driven by anti-depressants, atypical neuroleptics, anxiolytics and hypnotics. Then, by the 2010s, a wave of genericisations took down the blockbusters across all leading classes, and innovation stalled. Hopes for an effective disease modifying Alzheimer’s treatment, the holy grail of CNS research, were repeatedly dashed by late stage failures. By the end of the 2010s, CNS as a whole was highly genericised, with low innovation and few important launches. From 2021 onwards, this will change. Over the next five years we expect the global CNS market to accelerate ten-fold in list price value from near-flat historical growth of 0.4% CAGR for the past 5 years to 3-5% CAGR for the period of 2020-2025 to reach $100 billion globally by the middle of the decade.
The drivers behind this transformation are two classic elements – perennial unmet need and innovation, but with some very specific 2020s twists. The pandemic and consequent lockdowns have led, in some countries, to an explosion of mental health disorders. The pandemic has accelerated the trend to remote and digital healthcare at a time when the development and use of digital diagnostics and biomarkers has become possible and very relevant to many CNS conditions. Psychiatry has proven one of the areas of clinical practice most amenable virtual delivery.
Underlying this all, long term innovative investment is finally yielding fruit in a range of CNS therapy areas, for example new therapies for treatment-resistant depression (e.g. Janssens’s Spravato), the novel CGRP inhibitors for migraine, or dual orexin receptor antagonists (DORAs) developed for insomnia. Two of the three largest selling products launches in 2020 by 2020 sales were CNS products: the oral migraine treatments Ubrelvy and Nurtec. Progress on the holy grail of an effective disease modifying Alzheimer’s treatment is also possible in 2021, but not a foregone conclusion.
CNS will end 2021 with a renewed relevance and powered by new innovation, both molecular and digital, placing the therapy class in a strong position to re-ascend the rankings as one of the most valuable therapy areas for the remainder of the 2020s.
Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. 2021 marks the start of the era when these healthcare systems really need biosimilars to come good on their promise to realise cost savings. As economic crisis leads to healthcare spend constraints, the proportion of product value that will lose exclusivity in the next five years that is biologic has never been higher, at 44% of the $200m of the 2019 pharmaceutical market which will lose exclusivity in the next five years.
Counting from infliximab, the first of the monoclonal antibodies to face biosimilar competition, uptake of the biosimilar into the originator molecule has improved significantly, with the last volley of biosimilar launches reaching 40% of all treatment days within 12 months of in Europe, compared to nearly three years for infliximab to reach that level. Bevacizumab (Avastin) is on track to achieve 40% average European biosimilar treatment day penetration in six months, the first to do so. However, biosimilar uptake is not evenly distributed, and savings are still not always realised where they are most needed. Given the very powerful incentives that especially European countries will have to realise savings on medicines budgets where they can, we expect further measures to be implemented to promote the use of biosimilars in 2021.
Pharma pivots East
Increasingly, pharmaceutical companies add China to their launch priority countries group, typically the US, EU, and Japan, and from 2021, this trend is likely to accelerate. Europe, still in the throes of lockdowns and second waves will be living with healthcare system disruption for much of 2021, as well as economic austerity. Fragmentation of the European top 5 as the UK pursues its own regulatory regime post Brexit may also impact Europe’s attractiveness. The US, also still to effectively manage the infections crisis, will enter a new phase with the Biden presidency, and that could mean changes to healthcare system and pharmaceutical pricing reform.
China entered the first wave of the pandemic crisis earliest and emerged earliest, and (as at January 2021) has so far managed to avoid the debilitating second waves which have precipitated further lockdowns and healthcare system disruption in Europe and the US. Whilst the details of China’s economic recovery have been disputed, one forecaster, the Centre for Economics and Business Research, has predicted that China will now overtake the US as the world’s leading economy in 2028, five years earlier than was previously forecast.
China has been the world’s second most valuable pharmaceutical market since 2013, but it has not been an important market in terms of contribution to the sales of the newer innovative pharmaceutical products – in fact, whilst China ranked second on total Rx market sales, it ranked below 30 in terms of sales of newly launched innovative products. This is now changing and will be accelerated in 2021 by how China exits the pandemic crisis.
Pre-pandemic, China had already worked hard to reform its regulatory systems, reducing the backlog of medicines applications under or awaiting review by 80% by the end of 2019. New Active Substances, as monitored by IQVIA audits, entered the Chinese market in 2020 at historically high rates – by August 2020, 27 new active substances were in the Chinese market, as opposed to a five-year historic average of 15 by that point in the year for China.
Approval is not everything, and there remain significant market access and pricing challenges for innovative launches in China, but China’s domestic appetite for innovation is growing fast – the innovative branded products segment of the market grew by 12% in value between 2015 and mid-2020, while the remainder of the market grew by 3%. In addition to China, Japan, already one of the key country contributors to early innovative launch sales, has also accelerated the introduction and uptake of innovation in recent years. Japan has also emerged from the pandemic relatively unscathed, in terms of healthcare system, although economic recovery might be slow.
Because of these trends, from 2021, the importance of China and Japan to innovative product value is likely to progressively increase, driven both by increases in attractiveness of these two markets, and challenges in the European (and possibly US) environment. This will tip the geographic balance of the global pharmaceutical industry east, which will not just influence where pharmaceutical companies get their value from, but also usher a new collection of Chinese innovators into the global market.
If 2020 was the crisis year, 2021 is the year of transformation. Some of our nine 2021 trends were set pre-crisis, for example the re-emergence of CNS, but may see some acceleration or change because of the crisis. Others, for example the transformation of the commercial model and the renewed focus on impact, have been dramatically shaped by the events of 2020, leading the industry into a much-accelerated change and possibly taking commercial environments in directions they would not have moved without the pandemic. Others, and especially the pandemic-accelerated tilt towards the East in terms of innovative market, have ramifications that will be decades long in realisation. 2020 was a year in which, by rising to the challenge of the pandemic, the pharmaceutical industry demonstrated it can accomplish that which would previously have been labelled impossible. Whatever the challenges, the pharmaceutical industry enters 2021 with a new sense of purpose.
About the author
Sarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.
For weeks, doctors’ phones have been ringing off the hook with anxious older patients on the other end of the line.
“When can I get a covid-19 vaccine?” these patients want to know. “And where?”
Frustration and confusion are rampant as states and counties begin to offer vaccines to all seniors after giving them first to front-line health care workers and nursing home residents — the groups initially given priority by state and federal authorities.
My 91-year-old mother-in-law, who lives in upstate New York, was one of those callers. She said her doctor’s office told her it could be several months before she can get her first shot.
That was before New York’s Gov. Andrew Cuomo announced on Friday that the state would begin offering vaccines to residents age 75 and older starting Monday. On Tuesday, the state changed vaccine policies again, this time making residents 65 and older eligible.
In this chaotic environment, with covid cases and deaths skyrocketing and distribution systems in a state of disarray, it’s difficult to get up-to-date, reliable information. Many older adults don’t know where to turn for help.
Since the holidays, I’ve heard from dozens of people frustrated by poorly informed staffers at physicians’ offices, difficult-to-navigate state and county websites, and burdensome or malfunctioning sign-up arrangements. Below are some questions they posed, with answers drawn from interviews with experts and other sources, that may prove helpful.
Keep in mind that states, counties and cities have varying policies, and this is a rapidly shifting landscape with many uncertainties. Foremost among them are questions regarding vaccine supply: how many doses will become available to states and when and how those will be allocated.
Q: How can I make an appointment to get a vaccine?— James Vanderhye, 77, Denver
Vanderhye is a throat cancer survivor who suffers from sarcoidosis of the lungs and heart — an inflammatory disease.
Colorado Gov. Jared Polis announced on Dec. 30 that residents 70 and older could start getting covid vaccines, but Vanderhye wasn’t sure whether he needed to sign up somewhere or whether he’d be contacted by his physicians — a common source of confusion.
UCHealth, the system where Vanderhye’s doctors practice, has created a registry of patients 70 and older and is randomly selecting them for appointments, Dr. Jean Kutner, its chief medical officer told me. It’s reaching out to patients through its electronic patient portal and is planning to notify those who don’t respond by phone down the line. Then, it’s up to patients to finalize arrangements.
Nearly 200,000 people 70 and older are patients at UCHealth’s hospitals and clinics in Colorado, Wyoming and Nebraska.
TIPS: Although some health systems such as UCHealth are contacting patients, don’t assume that will happen. In most cases, it appears, you will need to take the initiative.
Check with the physician’s office, hospital or medical clinic where you usually receive care. Many institutions (though not all) are posting information about covid vaccines on their websites. Some have set up phone lines.
Some health systems are willing to vaccinate anyone who signs up, not just their patients. Kaiser Permanente, which operates in California, Colorado, Georgia, Hawaii, Oregon, Washington, Washington, D.C., and parts of Virginia and Maryland, is among them, according to Dr. Craig Robbins, co-leader of its national covid vaccination program. (Within the next few weeks, it will post an online registration tool on plan websites.) Check with major hospitals or health systems in your area to see what they’re doing. (KHN is not affiliated with Kaiser Permanente.)
Most places are asking people to sign up online for appointments; some sites require multiple steps and their systems may seem hard to use. If you don’t have a computer or you aren’t comfortable using one, ask a younger family member, friend or neighbor for help. Similarly, ask for help if you aren’t fluent in English.
If you can’t figure out how to sign up online, call your local county health department, Area Agency on Aging or county department on aging and ask for assistance. Every state has a covid-19 hotline; see if the hotline can direct you to a call center that’s taking appointments. Be prepared for long waits; phone lines are jammed.
Q:My mother has stage 3 renal failure, high blood pressure and dementia. She’s unable to take care of herself or be left alone. When can I get her vaccinated with the COVID shot?— Wendy, 61, Chandler, Arizona
Wendy had checked Maricopa County’s website days before we talked on Jan. 5 and couldn’t figure out when her 84-year-old mother might get a vaccine appointment. The week before, her 90-year-old father died, alone, of renal failure complicated by pneumonia in a nursing home.
Three days after our conversation, Maricopa County announced that people 75 and older could start making appointments to be vaccinated on a “first-come, first-served” basis on Monday, Jan. 11. (The state’s appointment site is https://podvaccine.azdhs.gov/; callers should try 844-542-8201 or 211, according to information provided by the county.)
In Arizona, “it’s up to each county to come up and execute a plan for vaccine distribution,” said Dana Kennedy, state director of AARP Arizona.
Demand is high and vaccine supplies are limited, other places have found. For example, on Jan. 7, a 1,200-slot vaccine clinic in Oklahoma City for adults 65 and older filled up within four minutes, according to Molly Fleming, a public information officer at the Oklahoma City-County Health Department.
“Once we get more vaccine supplies coming more frequently, we will do more clinics,” Fleming said. “The challenge we have right now is, we need the vaccine and we don’t know when it’s coming in.”
TIPS: Consult AARP’s state-by-state covid vaccine guides, focused on older adults and updated daily. (To access, go to https://www.aarp.org/coronavirus/. In the right-hand column, click on “the vaccine in your state.”) More than 20 states are listed there now, but guides for all states should be available by the end of January.
Meanwhile, check local media and your county’s and state’s health department websites regularly for fresh information about covid vaccine distribution plans.
Be prepared to be patient as problems with distribution surface. States and counties around the country are learning from problems that have arisen in places such as Florida — crashed phone lines, long lines of older adults waiting outdoors, massive confusion. It may take some time, but vaccine rollouts should become smoother as more sites come online and supplies become more readily available.
Q: When can a 72-year-old male with chronic lymphocytic leukemia expect to be vaccinated at Kaiser Permanente in Southern California?— Barry
California last week announced that counties that have made significant progress and have adequate supplies can move toward offering vaccines to residents 75 and older.
How soon this will happen isn’t clear yet; it will vary by location. But even then, Barry wouldn’t qualify immediately since he’s only 72 and it could take several months for vaccines to become available to people in his age group (65 to 74), said Robbins, who’s helping lead Kaiser Permanente’s vaccination program.
Barry is at especially high risk of doing poorly if he develops covid because of the type of cancer he has — leukemia. But, for the most part, medical conditions are not being taken into account in the initial stages of vaccine distribution around the country.
An exception is the Mayo Clinic. It’s identifying patients at highest risk of getting severe infections, being hospitalized and dying from covid at the Mayo Clinic Health System, a network of physician practices, clinics and hospitals in Iowa, Minnesota and Wisconsin. When states allow older adults outside of long-term care institutions to start getting vaccines, it will offer them first to patients at highest risk, said Dr. Abinash Virk, co-chair for Mayo Clinic’s vaccine rollout.
TIPS: Even if vaccines aren’t available right away, production is increasing, new products are in the pipeline, and new ways of distributing vaccines — notably mass distribution sites — are being planned. If you have to wait several weeks or months, don’t give up. Persistence is worth the effort, given the vaccine’s benefits.
At home, you can reduce food waste by simply organizing your fridge.
A clean, organized refrigerator is an often-overlooked healthy eating habit.
When your fridge is a mess, you may end up snacking on chips because you can’t find the carrot sticks and hummus you planned to eat — or wasting a pricey carton of cage-free eggs that you bought with the intention of making healthy breakfasts.
“A well-organized fridge can reduce waste and ultimately save you money,” says Beth Stark, R.D.N., L.D.N.
Learning how to organize your fridge saves you time when cooking and snacking.
They also help you organize your fridge without overstuffing it. Glass bowls or plastic containers with lids are tidier, sturdier alternatives to plastic- or foil-covered plates.
Clear containers make it harder to overlook leftovers, too.
Adding a piece of masking tape with the contents and an “eat-by” date written on it is also helpful.
5. Keep ready-to-eat foods up front
“On the upper shelves and those in your direct line of sight, place grab-and-go foods like pre-cut veggies, hard-boiled eggs, cubed cheese, and yogurt for snacking or efficient meal prep,” says Gorski.
What you see is what you’ll want to eat. This tip is a win-win since you’ll see the “good” stuff first, and it won’t go to waste!
6. Separate fruits and veggies
“The purpose of the crisper drawer is to keep fruits and vegetables at maximum freshness,” says Gorski.
To be extra safe, store these foods in a clear bin, and wash it with hot, soapy water at least weekly.
9. Check dates and rotate
“Follow the ‘first in, first out’ rule, which means rotating highly perishable foods — like milk, eggs, and even leftovers — to the front so you use them before items you’ve just purchased,” says Gorski.
In December, all states began vaccinating only health care workers and residents and staffers of nursing homes in the “phase 1A” priority group. But, since the new year began, some states have also started giving shots to — or booking appointments for — other categories of seniors and essential workers.
As states widen eligibility requirements for who can get a covid-19 vaccine, health officials are often taking people’s word that they qualify, thereby prioritizing efficiency over strict adherence to distribution plans.
“We are doing everything possible to vaccinate only those ‘in phase,’ but we won’t turn away someone who has scheduled their vaccine appointment and tells us that they are in phase if they do not have proof or ID,” said Bill Christian, spokesperson for the Tennessee Department of Health.
Among the states pivoting to vaccinating all seniors, timelines and strategies vary. Tennessee started offering shots to people 75 and older on Jan. 1. So, Frank Bargatze of Murfreesboro, Tennessee, snagged an appointment online for his father — and then went ahead and put his own name in, though he’s only 63.
“He’s 88,” Bargatze said, pointing to his father in the passenger seat after they both received their initial shots at a drive-thru vaccination site in Murfreesboro, a large city outside Nashville. “I jumped on his bandwagon,” he added with a laugh. “I’m going to blame it on him.”
Bargatze does work a few days a week with people in recovery from addiction, he added, so in a way, he might qualify as a health care worker.
Some departments are trying more than others, but overwhelmed public health departments don’t have time to do much vetting.
Dr. Lorraine MacDonald is the medical examiner in Rutherford County, Tennessee, where she’s been staffing the vaccination site. If people seeking the vaccine make it through the sign-up process online, MacDonald said, and show up for their appointment, health officials are not going to ask any more questions — as long as they’re on the list from the online sign-up.
“That’s a difficult one,” MacDonald acknowledged, when asked about people just under the age cutoff joining with older family members and putting themselves down for a dose, too. “It’s pretty much the honor system.”
People getting vaccinated in several Tennessee counties told a reporter they did not have to show ID or proof of qualifying employment when they arrived at a vaccination site. Tennessee’s health departments are generally erring on the side of simply giving the shot, even if the person is not a local resident or is not in the country legally.
The loose enforcement of the distribution phases extends to other parts of the country, including Los Angeles. In response, New York’s governor is considering making line-skipping a punishable offense.
Still, many people who don’t qualify on paper believe they might need the vaccine as much as those who do qualify in the initial phases.
Gayle Boyd of Murfreesboro is 74, meaning she didn’t quite make the cutoff in Tennessee, which is 75. But she’s also in remission from lung cancer, and so eager to get the vaccine and start getting back to a more normal life, that she joined her slightly older husband at the Murfreesboro vaccination site this week.
“Nobody’s really challenged me on it,” she said, noting she made sure to tell vaccination staffers about her medical issues. “Everybody’s been exceptionally nice.”
Technically, in the state’s current vaccine plan, having a respiratory risk factor like lung cancer doesn’t leapfrog anyone who doesn’t otherwise qualify. But in some neighboring states such as Georgia, where the minimum age limit is 65, Boyd would qualify.
Even for those who sympathize with such situations, anecdotes about line-skipping enrage many trying to wait their turn.
“We try to be responsible,” said 57-year-old Gina Kay Reid of Eagleville, Tennessee.
Reid was also at the Murfreesboro vaccination site, sitting in the back seat as she accompanied her older husband and her mother. She said she didn’t think about trying to join them in getting their first doses of vaccine. “If you take one and don’t necessarily need it, you’re knocking out somebody else that is in that higher-risk group.”
But there is a way for younger, healthier people to get the vaccine sooner than later — and not take a dose away from anyone more deserving.
A growing number of jurisdictions are realizing they have leftover doses at the end of every day. And the shots can’t be stored overnight once they’re thawed. So some pharmacists, such as some in Washington, D.C., are offering them to anyone nearby.
Jackson, Tennesse, has established a “rapid response” list for anyone willing to make it down to the health department within 30 minutes. Dr. Lisa Piercey, the state’s health commissioner, said her own aunt and uncle received a call at 8 p.m. and rushed to the county vaccination site to get their doses.
Piercey called it a “best practice” that she hopes other jurisdictions will adopt, offering a way for people eager for the vaccine to get it, while also helping states avoid wasting precious doses.
This story is part of a partnership that include WPLN, NPR and Kaiser Health News.
What are some strategies to reduce arsenic exposure from rice?
Those who are exposed to the most arsenic in rice are those who are exposed to the most rice, like people who are eating plant-based, gluten-free, or dairy-free. So, at-risk populations are not just infants and pregnant women, but also those who may tend to eat more rice. What “a terrible irony for the health conscious” who are trying to avoid dairy and eat lots of whole foods and brown rice—so much so they may not only suffer some theoretical increased lifetime cancer risk, but they may actually suffer arsenic poisoning. For example, a 39-year-old woman had celiac disease, so she had to avoid wheat, barley, and rye, but she turned to so much rice that she ended up with sky-high arsenic levels and some typical symptoms, including “diarrhea, headache, insomnia, loss of appetite, abnormal taste, and impaired short-term memory and concentration.” As I discuss in my video How Much Arsenic in Rice Is Too Much, we, as doctors, should keep an eye out for signs of arsenic exposure in those who eat lots of rice day in and day out.
As you can see at 1:08 in my video, in its 2012 arsenic-in-rice exposé, Consumer Reports recommended adults eat no more than an average of two servings of rice a week or three servings a week of rice cereal or rice pasta. In its later analysis, however, it looked like “rice cereal and rice pasta can have much more inorganic arsenic—a carcinogen—than [its] 2012 data showed,” so Consumer Reports dropped its recommendation down to from three weekly servings to a maximum of only two, and that’s only if you’re not getting arsenic from other rice sources. As you can see from 1:29 in my video, Consumer Reports came up with a point system so people could add up all their rice products for the week to make sure they’re staying under seven points a week on average. So, if your only source of rice is just rice, for example, then it recommends no more than one or two servings for the whole week. I recommend 21 servings of whole grains a week in my Daily Dozen, though, so what to do? Get to know sorghum, quinoa, buckwheat, millet, oatmeal, barley, or any of the other dozen or so common non-rice whole grains out there. They tend to have negligible levels of toxic arsenic.
Rice accumulates ten times more arsenic than other grains, which helps explain why the arsenic levels in urine samples of those who eat rice tend to consistently be higher than those who do not eat rice, as you can see at 2:18 in my video. The FDA recently tested a few dozen quinoa samples, and most had arsenic levels below the level of detection, or just trace amounts, including the red quinoas that are my family’s favorite, which I was happy about. There were, however, still a few that were up around half that of rice. But, overall, quinoa averaged ten times less toxic arsenic than rice. So, instead of two servings a week, following the Consumer Reports recommendation, you could have 20. You can see the chart detailing the quinoa samples and their arsenic levels at 2:20 in my video.
So, diversifying the diet is the number-one strategy to reduce exposure of arsenic in rice. We can also consider alternatives to rice, especially for infants, and minimize our exposure by cooking rice like pasta with plenty of extra water. We found that a 10:1 water-to-rice ratio seemed best, though the data suggest the rinsing doesn’t seem to do much. We can also avoid processed foods sweetened with brown rice syrup. Is there anything else we can do at the dining room table while waiting for federal agencies to establish some regulatory limits?
What if you eat a lot of fiber-containing foods with your rice? Might that help bind some of the arsenic? Apparently not. In one study, the presence of fat did seem to have an effect, but in the wrong direction: Fat increased estimates of arsenic absorption, likely due to the extra bile we release when we eat fatty foods.
We know that the tannic acid in coffee and especially in tea can reduce iron absorption, which is why I recommend not drinking tea with meals, but might it also decrease arsenic absorption? Yes, by perhaps 40 percent or more, so the researchers suggested tannic acid might help, but they used mega doses—17 cups of tea worth or that found in 34 cups of coffee—so it isn’t really practical.
What do the experts suggest? Well, arsenic levels are lower in rice from certain regions, like California and parts of India, so why not blend that with some of the higher arsenic rice to even things out for everybody?
Another wonky, thinking-outside-the-rice-box idea involves an algae discovered in the hot springs of Yellowstone National Park with an enzyme that can volatize arsenic into a gas. Aha! Researchers genetically engineered that gene into a rice plant and were able to get a little arsenic gas off of it, but the rice industry is hesitant. “Posed with a choice between [genetically engineered] rice and rice with arsenic in it, consumers may decide they just aren’t going to eat any rice” at all.
This is the corresponding article to the 11th in a 13-video series on arsenic in the food supply. If you missed any of the first ten videos, watch them here:
Big Tobacco did something unusual in Marlboro Country last fall: It stood aside while Colorado voters approved the state’s first tobacco tax hike in 16 years.
The industry, led by Altria Group, one of the world’s largest tobacco companies, has spent exorbitantly in the past to kill similar state ballot initiatives. In 2018, Altria’s lobbying arm spent more than $17 million to help defeat Montana’s tobacco tax ballot initiative. That same year, it spent around $6 million to help defeat South Dakota’s similar measure.
And four years ago, Altria was the leading funder in a successful $16 million campaign to quash Colorado’s previous proposed tobacco tax increase.
In November, by contrast, Altria didn’t spend a penny in opposition and Colorado voters overwhelmingly approved the tax with two-thirds support. Likewise, in Oregon, Big Tobacco stayed on the sidelines while a tax hike passed there.
The tax measures are major wins for anti-smoking advocates after a string of defeats but, in an example of how politics makes strange bedfellows, Colorado’s tax might not have been possible without Altria’s help. And, advocates said, the way those measures passed could provide a blueprint for states to follow in future elections.
In Colorado, Altria, the parent company of Marlboro cigarette maker Philip Morris, insisted that a minimum price be included in the proposal, according to The Colorado Sun, citing emails between political consultants and Gov. Jared Polis’ office. So while supporters see an increased tobacco tax as more revenue for the state, a disincentive for kids to smoke and a win for public health, the measure could also allow America’s premium tobacco companies to gain market share.
The Colorado measure will increase the total state-levied tax from 84 cents to eventually $2.64 per pack by 2027. The tax rate on vaping products, not currently taxed, will be 30% of the manufacturer’s list price in 2021, gradually increasing to 62% by 2027. The proposition also set the minimum price per pack of cigarettes at $7 as of Jan. 1 and that floor rises to $7.50 in 2024. The change could effectively help premium cigarette companies corner the market, since discount cigarettes would rise to at least $7.
Discount cigarette companies Liggett Group, Vector Tobacco and Xcaliber International — which funded opposition to the tax initiative, Proposition EE — tried to sue the state over the minimum tax provision, alleging “Philip Morris will reap huge benefits from the new legislation” and the changes will “destroy their ability to compete in Colorado.” In December, a federal judge rejected the company’s request for a preliminary injunction. A spokesperson for Liggett said the company plans to appeal.
“When it came to entities like Altria and other stakeholders that we engaged in the legislative process, I think that they saw the writing on the wall,” said Jake Williams, executive director of Healthier Colorado and one of the key organizers behind Proposition EE. “And it helped us get through the legislative process, not just with Democratic votes, but Republican votes to refer the measure to the ballot.”
Altria officials said in a statement that their tobacco companies oppose excise tax increases, but they did not say whether they had worked with Colorado lawmakers.
“Altria did not advocate for or against Proposition EE, and after evaluating the content and intent of this measure, Colorado voters decided to vote in favor of it, some aspects of which were focused on tobacco harm reduction and may help transition adult smokers to a non-combustible future,” the statement said.
Polis’ office did not respond to a request for comment. The Colorado Attorney General’s Office said it would not comment on matters under active litigation. State Democratic Sen. Dominick Moreno and Rep. Julie McCluskie, both state sponsors for the legislation, declined to comment for the same reason. Fellow Democrats Rep. Yadira Caraveo and Sen. Rhonda Fields, also state sponsors for the legislation, did not respond to requests for comment.
Colorado campaign finance records show Altria and Altria’s lobbying arm in 2020 contributed to funds that support both Democratic and Republican candidates in the state — a pattern playing out nationally.
Williams said Altria’s absence of public opposition wasn’t the only factor in the initiative’s success. The tax revenue will initially fund revenue lost during the covid-19 pandemic, then fund tobacco use prevention and eventually preschool education.
The American Lung Association, which supported the Colorado measure, said it believes tobacco taxes are among the most effective ways to reduce tobacco use, especially among youths, who are more sensitive to changes in price. The organization cites studies that found every 10% increase in the price of cigarettes reduces consumption by about 4% for adults and 7% for teens.
“Without tobacco industry opposition, it’s very popular among the public,” Thomas Carr, the association’s director of national policy, said of the tax increase. “We’ve long seen it in polling on the subject.”
There was no major industry opposition to the Oregon increase, either. Its tobacco tax increase — Measure 108 — also got a resounding two-thirds of support. But Oregon didn’t negotiate with Altria lobbyists or set a minimum price provision, according to Elisabeth Shepard, campaign manager for Yes for a Healthy Future.
“I don’t know what the [Colorado] deal was,” Shepard said. “All I know is that before it even made it to the ballot, Altria indicated that they were not going to oppose the measure and stuck with their word.”
While Shepard worried until Election Day whether Big Tobacco would swoop in with opposition in Oregon, it didn’t. She believes her campaign worked because the effort had early resources and money, the tax was targeted to fund the Oregon Health Plan (the state’s Medicaid), and her campaign’s coalition had 300 endorsers, including those in health and business communities.
“We had the left, we had the right, we had the far-right, we had the far-left,” Shepard said.
Her campaign paid its advisory committee members, including representatives from affected communities such as Indigenous Oregonian tribes. At least 30% of American Indian and Alaska Native adults in the state smoke cigarettes. Oregon’s measure increases tobacco taxes $2 per pack, from $1.33 to $3.33, as well as creates a new tax for e-cigarettes. The revenues will help fund an estimated $300 million for the state’s health plan.
Altria did not respond to a request for comment about Oregon tobacco taxes, but the company has previously said it opposed Oregon’s measure.
Shepard believes her campaign model could work in other states. Other anti-smoking advocates took note of the 2020 election.
“We certainly support establishing minimum prices for all tobacco products in conjunction with tobacco tax increases, as we know increasing the price of tobacco products is one of the most effective ways to reduce tobacco use,” said Cathy Callaway, director of state and local campaigns for the American Cancer Society Cancer Action Network.
It could just come down to a state’s voters and its politics, according to Mark Mickelson, a former Republican in South Dakota’s legislature. Mickelson was behind creating his state’s failed 2018 tobacco tax ballot initiative.
“We just got beat,” Mickelson said. The opposition “got ahead of us on the message. They had a lot more money and had just played on doubts that the [tax revenue] money would go to tech ed.”
The average state cigarette tax is $1.88 per pack, but it varies across the country — as high as $4.35 in New York but only 44 cents in North Dakota, where a 2016 ballot initiative to increase that to $2.20 was defeated.
Tax increases can translate into hundreds of millions of dollars in new revenue for states, said Richard Auxier, senior policy associate at the nonpartisan Urban-Brookings Tax Policy Center.
“It’s a little easier to pass a tax on someone else, which is often how this is seen — passing this tax on smokers, rather than passing it on all working people, [compared to] if you were to increase income tax or … a sales tax.”
But not all voters get a say.
In Kentucky, which isn’t a referendum state, Republican state Rep. Jerry Miller said there’s not a lot of sympathy for tobacco companies anymore.
“The agriculture community, which used to be on the same page with cigarette companies, are now always in opposition because the cigarette companies are always trying to tweak their formula to use cheaper tobacco,” he said.
Miller’s recent vaping tax bill failed in the state legislature, but he’s working on a new one.
“We don’t have that tradition or the mechanism that somebody collects 10,000 signatures and they get a referendum on a ballot,” he said. “That’s why things like this have to go through the legislature — and so it really just depends on the state [government].”
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Depending on your personal style and favorite types of teas, there are tons of teawares to jazz up your kitchen, from electric kettles with tea infusers to Japanese tea sets and reusable, travel mugs and carafes perfect for hiking or camping.
For a spicier blend, try our chai-inspired Golden Chai Coconut Milk Latte with a scoop of Collagen Boost. It has an aromatic mix of allspice, nutmeg, ginger, and cinnamon — and turmeric which makes it golden.
6. Chill options for evenings
“Chamomile acts as a mild sedative,” says Malinowski. If you’re looking for an alternative to a nightcap (since alcohol can interfere with sleep), chamomile on its own or in a herbal blend for sleep is a soothing way to unwind before bedtime.
7. A ‘Bevvy’ of options
Not into hot tea? For an iced option, stir up our Strawberry Basil Bevvy Lemonade made with Bevvy, a 15-calorie, plant-based tea supplement formulated to help curb cravings and support healthy weight loss.
– Teladoc Health and Dexcom announced an expanded
partnership on a new offering measures the impact of continuous glucose
monitoring and real-time health recommendations for people with Type 2 diabetes
at no cost.
“We are excited to announce the next phase of our relationship with Teladoc Health, along with launching a commercial pilot demonstrating how Dexcom’s leading CGM combined with Teladoc Health’s data science capabilities enhance the diabetes management experience,” said Matt Dolan, senior vice president and general manager of new markets for Dexcom. “We have received powerful feedback from people with Type 2 diabetes using our technology, and through additional innovative product features, we fully anticipate that we will deliver an even greater impact.”
The expanded partnership includes two developments:
1. Enhanced product capabilities through CGM-powered
insights, a new set of features and reports that help members more easily
visualize their health information and understand how lifestyle decisions
affect their blood glucose levels. By combining Dexcom CGM data with additional signals from
Teladoc Health, including activity data and food intake, CGM-powered insights offer members a complete health profile and recommendations
that support ongoing diabetes management.
2. A pilot program demonstrating the impact of CGM-powered
insights for people with Type 2 diabetes. Eligible members will receive an
integrated product experience including the Livongo for Diabetes program, Dexcom
CGM technology and CGM-powered insights at no cost.
“Teladoc Health’s partnership with Dexcom further empowers whole person health through an innovative combination of advanced technology and human expertise,” said Amar Kendale, chief product officer of Teladoc Health. “Our focus is to offer a consumer experience that makes it easy, safe and affordable for people to manage their health with confidence. We are excited about our continued work with Dexcom and new features that enable smarter care, leading to measurable consumer behavior change and better health outcomes.”
Why It Matters
It is estimated that 463 million adults around the world
live with diabetes,
a number expected to rise to 700 million by 2045. According to the Centers for
Disease Control and Prevention, regular physical activity, weight management,
and improved blood pressure management are important factors for preventing
– Frenova Renal Research, a global division of Fresenius
Medical Care, announced today that it has started to enroll patients in its
new endeavor to build the world’s largest genomics registry targeting kidney
– The registry will be used to help advance understanding
of the genetic drivers of kidney disease and shape more precise, individualized
Medical Care, the world’s leading provider of products and services for
people with chronic kidney failure, announced today that the company’s Frenova division has enrolled the first
participants in its new initiative to develop the largest renal-focused genomic
registry in the world. In addition, the company announced that Ali Gharavi, MD,
Chief of the Division of Nephrology at Columbia University Irving Medical
Center and Professor of Medicine at Columbia University Vagelos College of
Physicians and Surgeons, will lead the project and provide scientific guidance
as Principal Investigator.
Why It Matters
Nephrology has been under-represented in clinical research,
even as rapid progress in gene sequencing and analysis has led to advances in
precision medicine and individualized care in oncology, cardiology and other
medical areas. Frenova’s new genomic registry will contain genetic sequencing
data from chronic kidney disease patients worldwide, which will be used by
researchers to improve the understanding of kidney disease. Frenova developed
the registry after researchers identified the lack of a large-scale,
renal-focused registry of genomic and clinical data as a major impediment to
kidney disease research.
As a contract clinical development services company
dedicated exclusively to medicines and medical products in renal research,
Frenova orchestrates studies within the clinical footprint of Fresenius Medical
Care, which provides dialysis treatments to about 350,000 patients around the
globe. The renal-focused genomic registry represents a new business line within
Frenova, which is based in Fresenius Medical Care’s Global Medical Office. As
part of its growth strategy 2025, Fresenius Medical Care is using digital
technologies and the capability to analyze huge amounts of data to develop
new forms of renal therapy.
“The new Frenova registry will close this gap by generating data that adds a clinical and genetic backbone to help support and fuel scientific innovation,” said Franklin W. Maddux, MD, Global Chief Medical Officer of Fresenius Medical Care. “The evidence for genetic drivers in kidney diseases is substantial, but much larger data sets will be needed to untangle the complex interactions that lead to kidney injury. By combining clinical and genetic sequencing data from ethnically and pathologically diverse participants, this genomic and phenotypic research resource will help scientists better understand how genetic variations in patients can lead to more precise diagnoses and therapies that help improve outcomes by individualizing care.”
The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged≥12yrs.
The approval follows the CHMP’s positive opinion for Xofluza and is based on P-III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies
Xofluza is a first-in-class, single-dose oral therapy, reduces the societal burden of influenza with a rapid reduction in viral replication
Click here to read full press release/ article | Ref: GlobeNewswire | Image: Krauthammer
Among those who received a first dose of varicella (n = 16 075), hepatitis A (n = 594 917), and hepatitis B (n = 590 445) vaccine, relatively few completed the series (55%–65% for hepatitis B vaccine and 40%–50% for hepatitis A and varicella vaccines in most age groups). Compliance was lowest among adolescents (35.9%) and Medicaid recipients (29.7%) who received varicella vaccine and among younger adult age groups who received hepatitis A vaccine (25%–35% across those age groups). Even among series completers, there was a relatively long interval of undervaccination between the first and last doses.
On the one hand, these vaccinations didn’t have the public attention of COVID-19 so perhaps compliance would be better. In particular, conditional on someone agreeing to a first COVID-19 vaccine–which will be a selected population given the (unfortunate) politics of the vaccine–perhaps second dose compliance would be higher than those observed in Nelson et al. for other vaccines. Additionally, there is evidence that the COVID-19 vaccines are very effective even after one dose. Nevertheless, this is some concerning historical precedent in the scientific literature.
– COVID-19 care deferrals lead to three major boomerang
conditions that payers and providers must proactively address in 2021,
according to a newly released report by Prealize.
– COVID-19’s hidden victims—those who avoided or deferred
care during the pandemic—will increasingly return to the healthcare system, and
many will be diagnosed with new conditions at more advanced stages. Healthcare
leaders must act now to keep this boomerang from driving worse outcomes and
Many procedures and diagnoses fell significantly in 2020,
with several dropping nearly 50% below 2019 levels between March and June. Total
healthcare utilization fell 23% between March and August 2020, compared to the
same time period in 2019.
To explore the full scope of healthcare utilization and
procedural declines in 2020, and assess how those declines will impact
patients’ health and payers’ pocketbooks in 2021, Prealize Health conducted an
analysis of claims data from nearly 600,000 patients between March 2020 and
Prealize identified the three predicted conditions likely to
see the largest increase in healthcare utilization in 2021:
1. Cardiac diagnoses will increase by 18% for ischemic
heart disease and 14% for congestive heart failure
These increases will be driven by 2020 healthcare
utilization declines, for example, patients deferring family medicine and
internal medicine visits. These visits, which help flag cardiac problems and
prevent them from escalating, declined 24% between March and August of 2020.
“Cardiac illnesses are some of the most serious and
potentially fatal, so delays in diagnosis can lead to significant adverse
outcomes,” said Gordon Norman, MD, Prealize’s Chief Medical Officer.
“Without early recognition and appropriate intervention, rates of patient
hospitalization and death are likely to increase, as will associated costs of
2. Cancer diagnoses will increase by 23%
Similar to cardiac screening trends, significant declines in
2020 cancer screenings will be a key driver of this increase, with 46% fewer
colonoscopies and 32% fewer mammograms performed between March and August 2020
than during that same time period in 2019.
“Cancer doesn’t stop developing or progressing because
there’s a pandemic,” said Ronald A. Paulus, MD, President and CEO at RAPMD
Strategic Advisors, Immediate Past President and CEO of Mission Health, and one
of the medical experts interviewed for the report. “In 2021, when patients
who deferred care ultimately receive their diagnoses, their cancer sadly may be
more advanced. In addition, an increase in newly diagnosed patients may make it
harder for some patients to access care and specialists—particularly for those
patients who are insured by Medicaid or lack insurance altogether.”
3. Fractures will increase by 112%
This finding, based on combined analysis of osteoporosis
risk and fall risk, is particularly troubling for the elderly patient
A key driver of increased fractures in 2021 is the number of
postponed elective orthopedic procedures in 2020, such as hip and knee
replacements. These procedural delays are likely to decrease mobility, and
therefore, increase risk of fractures from falls.
“In elderly patients, fractures are very serious events
that too often lead to decreased overall mobility and quality of life,”
said Norman. “As a result, patients may suffer from physical follow-on
events like pulmonary embolisms, and behavioral health concerns like increased
Why It Matters
“These predictions are daunting, but the key is that providers and payers take action now to mitigate their effects,” said Prealize CEO Linda T. Hand. “It’s going to be critical to gain insight into populations to understand their risk at an individual level, build trust, and treat their conditions as early as possible to improve outcomes. The COVID-19 pandemic has challenged every aspect of our healthcare system, but the way to get ahead of these challenges in 2021 will be to proactively identify and address patients most at risk. We’re going to see proactive care become an important driver for success next year, as providers and payers seek to mitigate unnecessary and expensive procedures that result from 2020’s decreased medical utilization. The right predictive analytics partner will be critical to providers and payers being able to take the right course of action.”
EU leaders are to hold a pandemic video summit on 21 January after the bloc said it had reached a deal with Pfizer and BioNTech for 300m more doses of their Covid-19 vaccine, giving the EU nearly half the firms’ global output for 2021.
The move raised hopes for speedier inoculation across the continent as the European regulator, which this week approved the Moderna shot, said it would authorise six doses from each vial of the BioNTech/Pfizer vaccine, increasing available jabs by 20%.
The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.
As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses.
When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.
After months of turbulent lockdown measures, the dawn of approved vaccinations signalled hope COVID-19 could finally be under control.
Sadly, the chaos is continuing as the UK grapples with the emergence of a new variant of SARS-CoV-2, estimated to be up to 70% more transmissible than the previous form of the virus.
As cases surge, the UK’s decision to delay second doses of the vaccine beyond the 3-4 weeks tested and approved during Phase III clinical trials is causing widespread concern. Many believe the strategy is too risky – prioritising political expediency over science and using the British public as laboratory subjects during an already severe crisis.
The advice, which first came from the UK’s Joint Committee on Vaccination and Immunisation (JCVI), stated a maximum interval of 12 weeks should take place between the first and second doses of both Pfizer and AstraZeneca’s vaccines.
JCVI said this is likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19.
“The rate of vaccine delivery in the UK is currently limited by vaccine supply rather than by workforce capacity,” said the committee. “An extended interval between vaccine doses together with initial prioritisation of the first vaccine dose would increase the flow of vaccine supply in the short term. This will allow for more first doses to be delivered to more people earlier.”
The advice has been endorsed by the UK’s four chief medical officers but has been met with backlash from the medical community. Many healthcare workers have aired grievances on Twitter protesting the changes.
Just received this email cancelling my 2nd dose of the Pfizer vaccine. On the basis of UK government guidance yesterday. This means that the vaccine is not being delivered as licensed. I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. pic.twitter.com/ZDtIjm1z8W
The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”.
“The Government must see that it’s only right that existing bookings for the oldest and most vulnerable members of our society are honoured, and it must also as soon as possible publish a scientifically-validated justification for its new approach,” said the BMA.
“As doctors, we believe this can and should be done even as practices and the wider NHS step up the COVID-19 vaccination programme to deliver initial doses of vaccination to other vulnerable people, including frontline healthcare professionals – many of whom still have not even received their first vaccination.”
‘Erosion of public trust’’
The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why.
“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorised dosing schedule for each COVID-19 vaccine”
“Protecting frontline staff from infection is vital to help them care for patients with COVID, as well as delivering the vaccination programme,” said NHS Confederation director Layla McCay. “However, there has been concern about changes to the vaccination schedule, which were announced at short notice and led to confusion and anxiety for patients and could lead to an erosion of public trust in healthcare providers. As always, NHS teams will pull out all the stops to respond to changing guidance, but the government must do more to explain the rationale for this change.”
Internationally, the decision has been met with scepticism. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccines to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.
“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”
In a joint statement Pfizer and BioNTech warned there was no data to demonstrate that protection after the first dose is sustained after 21 days. “The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” said the companies.
The Oxford-AstraZeneca vaccine trial did include difference spacing between doses and showed longer gaps (two to three months) yielded a greater immune response. The combined trial results published in the Lancet showed that vaccine efficacy 14 days after a second dose was higher in the group that had more than six weeks between the two doses (65.4%) than in the group that had less than six weeks between doses (53.4%).
Andrew Pollard, head of the Oxford Vaccine Group and chief trial investigator vaccine told the BMJ that extending the gap between doses made sense.
“Generally, a longer gap between vaccine doses leads to a better immune response, with the second dose causing a better boost. (With HPV vaccine for girls, for example, the gap is a year and gives better responses than a one-month gap.) From the Oxford vaccine trials, there is 70% protection after the first dose up to the second dose, and the immune response was about three times greater after the second dose when the second dose was delayed, comparing second dose after four weeks versus second dose after two-three months.”
Akiko Iwasaki, professor of immunobiology at Yale Medical school also tweeted support for the changes, stating the new SARS-CoV-2 variant as the deciding factor.
I am still a proponent of 2 dose vaccine but given the urgency, we can delay the 2nd dose until more vaccines become available. I know many others have been saying this all along, but it was the B.1.1.7 variant transmission rate that did it for me. (8/n)https://t.co/qrwvtOLyGv
“I am still a proponent of two-dose vaccine but given the urgency, we can delay the seconnd dose until more vaccines become available. I know many others have been saying this all along, but it was the B.1.1.7 variant transmission rate that did it for me,” said Iwasaki.
David Grainger, chief scientific advisor at life sciences investment firm Medicix, also expressed confidence in the strategy, referring to modelling by the University of Toronto that predicts increasing the number of people protected, by limiting individuals to a single dose, reduces severe COVID events (ICU stays and death) by between 30-40% over a 6-month period. This could amount to over 20,000 lives saved.
“The vaccine only must be 50% effective in two people to reduce the overall risk of infection that is achieved with 95% protection in one person,” said Grainger. “If I protect 10,000 people out of a population of 20,000 with 1% risk of infection at 95% efficacy, I get five cases from the protected subgroup and 95 cases in the unprotected subgroup for a total of 100 infections; if I protect all 20,000 people with 50% efficacy, again I get 100 infections. The existing data strongly suggests that a single dose will deliver at least 50% protection for at least a few months.”
He added that during the pandemic, decisions often needed to be made in the absence of proper data. “It teaches us that we cannot just ‘follow the science’ because that pathway is way too conservative (at least if that means only do things for which there is clear, direct evidence).
“This is why we should have scientific advisors, but not rely on scientists to make decisions. It is why scientists rarely make good investors or businessmen – too many decisions need to be made in the absence of much information.”
Pizza is the ultimate comfort food pretty much any time of year.
If you crave a slice when you’re feeling stressed, you’re not alone — a 2016 poll found pizza is the top comfort food in the US. Not surprisingly, during the pandemic, pizza delivery chains have seen an uptick in business.
Delivery and frozen pizza are fast and convenient, but they often come with nutritional compromises, such as overly processed ingredients, sodium, and added sugar.
Making your own healthy homemade pizza is an easy alternative and a lot simpler than you think.
Whether you’re a pizza purist sticking to cheese and tomato, or a culinary innovator experimenting with plant-based, gluten-free, or globally inspired spins, pizza is essentially crust, sauce, and topping.
With those basic elements, you can get as creative as you want.
Here are 10 ways to turn healthy homemade pizza into a meal:
1. Tweak a traditional pizza dough recipe
If you’re making your own homemade pizza dough, mix up all-purpose (refined) and whole-wheat flour. “I like to sub in about 25% whole wheat flour to a basic pizza dough recipe,” recommends Talia Hauser, R.D.
An ultra-basic pizza dough is pretty much flour, salt, yeast, and water.
2. Choose a healthier crust
Don’t have time for DIY pizza dough? “Use a whole-wheat pita or tortilla,” says Lisa Young, Ph.D, R.D.N.
They’re perfectly portioned for thin-crust pizza, while split multigrain English muffins or bagels are good stand-ins for chewy, deep-dish-style crusts.
The gluten-free bread in our gluten-free pepperoni pizza is another tasty choice. “Using dough made from chickpeas is another option,” adds Young, and this option is also gluten-free.
3. Make a veggie-based crust
Frozen cauliflower crusts are a reasonable shortcut for a weeknight meal.
However, making your own homemade cauliflower crust from scratch is simple and satisfying. Our cauliflower crust pizza is a low-carb, low-calorie fave.
It takes less than 10 minutes to make (which is faster than delivery) and has 20 grams of protein with only 4 grams of fat and 165 calories (which is better than delivery).
5. Try healthy homemade pizza sauce
“Homemade pizza can be healthier than delivery or frozen because you are in complete control of the ingredients,” says Hauser.
Store-bought pizza sauces are often a surprising source of added sugar.
Making your own sauce from fresh tomatoes or no salt added or low-sodium canned tomatoes eliminates sneaky ingredients.
6. Use fresh tomatoes for a saucy shortcut
For a fast way to add tomato flavor to a healthy homemade pizza, simply slice up a ripe tomato and arrange it on your base before adding the toppings and cooking.
7. Load on the veggies
“It’s hard to find store-bought or delivery pizza that is heavy on vegetables and light on cheese,” says Hauser, who loves loading up healthy pizza toppings, such as sliced bell peppers, mushrooms, and eggplant.
“You can also add fresh herbs or arugula on top,” adds Lexi Endicott, RD.
8. Use flavorful cheeses
“Boost the flavor of your pizza by using tasty cheeses, such as feta or goat cheese, brie, or a really good, fresh mozzarella,” says Endicott.
9. Toss on some homemade pepperoni
Pepperoni is a pizza shop classic, but processed cured meats are sometimes loaded with nitrates, preservatives, and saturated fat.
“Adding lots of veggies on top and a large salad on the side is a great way to turn a healthy homemade pizza into a satisfying meal,” says Young. “At home, you can control how pizza is made and the portion size is custom-made to order.”
Getting rice down to the so-called safe water limit for arsenic would still allow for roughly 500 times greater cancer risk than is normally considered acceptable. Given the level of arsenic in rice, how could we figure out how much rice is too much? There are no U.S. standards for arsenic in rice, even though “food sources are the main source of exposure.” There are limits on arsenic in apple juice and tap water, though. To calculate those, experts must have sat down, determined out how much arsenic a day was too much—too risky—then figured people typically drink about four to eight cups of water a day, and set the limits that way, right? Okay, well, can’t we just use their how-much-arsenic-a-day-is-too-much-arsenic-a-day number, and, based on the average arsenic content in rice, figure out how-much-rice-a-day-is-too-much-rice? I discuss this in my video How Risky Is the Arsenic in Rice?.
“The allowable level established by the FDA for arsenic in bottled water is 10 ppb,” assuming people might drink a liter a day. So, based on that daily 10 ppb limit, how much rice is that?
“Each 1 g increase in rice intake was associated with a 1% increase in urinary total arsenic, such that eating 0.56 cups [a little over a half cup] of cooked rice was considered comparable with drinking 1 L/d,” one liter per day, of that maximally contaminated water. Well, if you can eat a half cup a day, why does Consumer Reports suggest eating just a few servings of rice a week? You could eat nearly a serving every day and still stay within the daily arsenic limits set for drinking water.
Well, Consumer Reports felt the 10 ppb water standard was too lax, so, it went with the “most protective standard in the country,” at 5 ppb. Guess where it came from? New Jersey. Good for New Jersey! So, by using 5 ppb instead of 10 ppb in the calculation, you can see how Consumer Reports got to its only-a-few-servings-of-rice-a-week recommendation. Presumably, that’s based on average arsenic levels in rice. If you choose a lower-arsenic rice, one with only half the level of arsenic, can you have four servings a week instead of two? And, if you boil rice like pasta and drain off the excess water, doesn’t that also cut levels in half? If so, then you are up to about eight servings a week. Based on the water standard, apparently, you could still safely eat a serving of rice a day if you choose the right rice and cook it right. I assumed the water limit is ultra-conservative since people are expected to drink water every day of their lives, whereas most people don’t eat rice every day, seven days a week. I made that assumption, but I was wrong. It turns out the opposite is true.
All this time, I had been assuming the current drinking guideline exposure would be safe, which in terms of carcinogens, is usually “1 in a million chances of getting cancer over a lifetime.” I’ve mentioned this before. It’s how cancer-causing substances are typically regulated. If a company wants to release some new chemical, it has to show that it doesn’t cause more than one in a million excess cancer cases. Of course, there are 300 million people in this country, so that one-in-a-million doesn’t make the 300 extra families who have to deal with cancer feel any better, but that’s just the kind of agreed upon “acceptable risk.”
The problem, according to the National Research Council, is that with the current federal drinking water standard for arsenic of 10 μg/L, we are not talking about an excess cancer risk of 1 in a million people, but as high as 1 case in 300 people. Those 300 extra cases of cancer just turned into a million more cases? A million more families dealing with a cancer diagnosis? “This is 3000 times higher than a commonly accepted cancer risk for an environmental carcinogen of 1 case in 1 000 000 people.” If we were to use the normally accepted 1 in a million odds of cancer risk, the water standard would have to be 500 times lower, .02 instead of 10. Even the New Jersey standard is 250 times too high. “While this is a rather drastic difference… it underlines just how little precaution is instilled in the current guidelines.”
Hold on. So why isn’t the water standard .02 instead of 10? Because that “would be nearly impossible to implement” as we just don’t have the technology to get arsenic levels in water that low. The technologically feasible level has been estimated at 3. Okay, so why is the limit 10 and not 3? The decision to use a threshold of 10 instead of 3 was “mainly a budgetary decision.” A threshold of three would cost a lot of money.
So, the current water “safety” limit “is more motivated by politics than by technology.” Nobody wants to be told they have toxic tap water. If they did, they might demand better water treatment and that would be expensive. “As a result, many people drink water at levels very close to the current guideline… and may not be aware that they are exposed to an increased risk of cancer.” Even worse, millions of Americans drink water exceeding the legal limit, as you can see at 5:10 in my video. But, even the people living in areas that meet the legal limit “must understand that current arsenic guidelines are only marginally protective.”
Perhaps we should tell people who drink water—i.e., everyone—“that current arsenic regulations are a cost-benefit compromise and that, based on usual health risk paradigms, the standards should be much lower… People must be made aware that regulatory targets for arsenic should be as close to zero as possible,” and, when it comes to water, we should aim for the reachable limit of 3. What does this mean for rice, though?
Well, first of all, so much for just trying to get rice down to the so-called safe water limit, since that “already exceeds standard [carcinogen] risks and is based on feasibility and cost-benefit compromises,” which “allows for a roughly 500 times higher risk of cancer” than is normally considered acceptable. So, “while authorities ponder when and how they will regulate arsenic concentration in rice,” perhaps we should “curtail or strongly limit our consumption of rice.”
This is the corresponding blog post to the pivotal video in my 13-part series on arsenic in the food supply. The final three videos focus on how to deal practically with the repercussions:
“Coffee counts towards your fluid intake, within reason,” says Jordan. “The caffeine in coffee does have a slightly diuretic effect, meaning it can cause you to lose water.”
However, studies have found coffee only has a dehydrating effect when drunk in high amounts of at least 250-300 mg. That equals around two to three cups of coffee. Another study showed no evidence of dehydration with moderate caffeine consumption.
That sounds like good news if you love your morning cup of joe. But wait, there’s more.
Research has also found that there are actual perks to drinking coffee besides waking you up, namely phytochemicals that have antioxidant properties.
To keep coffee beneficial, “try not to exceed more than one or two cups per day and avoid adding extra sugar or syrups,” recommends Jordan.
One strategy for scaling back your coffee intake is replacing it with water — and that’s also a way to drink more water — so a win-win.
Does Tea Count as Water?
“The water in tea can contribute to our daily hydration,” explains Danielle Gaffen, M.S., R.D.N.
Black tea and green tea contain caffeine, but they have less than the average cup of coffee. Many herbal teas, such as chamomile, peppermint, and ginger, are completely caffeine-free.
“Numerous studies have shown that teas have a variety of health benefits,” says Jordan. “Green tea is one of the healthiest teas due to its polyphenol content,” which may lower inflammation. We’re also fans of matcha green tea, for increased energy, focus, and relaxation.
“I recommend choosing a high-quality green tea and allowing it to brew for several minutes to maximize the health effects,” says Jordan.
What Else Counts as Water?
The reason we need water is to keep us hydrated, but there are other hydrating liquids and foods in addition to H2O.
In a nutshell, the CDC explains: “Although daily fluid intake can come from food and beverages, plain drinking water is one good way of getting fluids as it has zero calories.”
Water is the most basic beverage to stay hydrated and keep it simple without drinking extra calories, but there are other ways to get the fluid intake you need for survival.
Coffee and tea both can count towards staying hydrated, but so do milk, juice, and most beverages. Keep in mind these drinks tend to be higher in sugar and calories.
“If you don’t like the taste of plain water, try adding in natural flavorings, such as a sprig of mint or a slice of lemon,” says Jordan.
“Some fruits and vegetables are also particularly hydrating,” she adds. “Watermelon is 90% water and makes a refreshing snack. Other hydrating fruits include oranges, grapefruits, and strawberries.”
On the veggie side, celery, tomatoes, cucumbers, and lettuce are some water-rich options.
The takeaway? Drink plenty of plain water every day, but other beverages, such as coffee and tea, also hydrate (but skip the added sugars and cream).
There are actually hundreds of onion varieties, but that’s just information overload.
Instead, we listed the common types of onions, plus a few tips for cook and prep.
Lucky for you, no matter which onion type you eat, you’ll still score nutritional benefits.
1. Yellow Onions
When in doubt, yellow onions are the safest pick for recipes that don’t specify the onion type.
They’re very versatile and can be tucked into soups, stews, and roasts. Yellow onions are more balanced between sweet and spicy.
But, they can have a pungent enough flavor that you may not want to eat them raw unless you try this trick: To tame the onion bite, try slicing them ultra-thin and soaking them in a bowl of cold water 15 minutes before serving.
2. Red Onions
Red onions have a slightly crisper texture and are a deep ruby color. The color comes from anthocyanin, a powerful antioxidant.
With crisp and color, red onions are often used for salads and pickling. You’ll also see them sprinkled over tacos and pizzas for a pretty pop of color.
– RenalytixAI and DaVita announce a program partnership that
aims to slow kidney disease progression and improve outcomes for the nation’s
estimated 37 million adults with chronic kidney disease (CKD).
– This is the first clinical-grade program that delivers
advanced early-stage prognosis and risk stratification, combined with
actionable care management to the primary care level where the majority of
kidney disease patients are being seen.
– The program will use the KidneyIntelX in vitro
diagnostic platform from RenalytixAI to perform early risk assessment; after
risk stratification, patients identified as intermediate- and high-risk will
receive care management support through DaVita’s integrated kidney care program
a developer of AI-enabled
clinical in vitro diagnostic solutions for kidney disease, and DaVita, the largest provider
of kidney care services in the U.S., today announced a partner program aimed at
slowing disease progression and improving health outcomes for the nation’s
estimated 37 million adults with chronic kidney disease (CKD). The program is
expected to improve patient outcomes and provide meaningful cost reductions for
health care providers and payors by enabling earlier intervention for patients
with early-stage kidney disease (stages 1, 2 and 3) through actionable risk
assessments and end-to-end care management.
The collaboration is expected to launch in three major
markets this year. As the program expands, DaVita and RenalytixAI intend to
pursue risk-sharing arrangements with health care providers and payors to drive
kidney disease patient care innovation, cost efficiencies and improve quality
Early Risk Identification at Core of Innovative Kidney
The program utilizes the KidneyIntelX in vitro diagnostic platform from RenalytixAI, which uses a machine-learning algorithm to assess a combination of biomarkers from a simple blood draw with features from the electronic health record to generate a patient-specific risk score. The initial version of the KidneyIntelX risk score identifies Type 2 diabetic patients with early-stage CKD as low-, intermediate- or high-risk for progressive decline in kidney function or kidney failure. The integrated program may also help reduce kidney disease misclassification, which leaves some higher-risk patients without recommended treatment. The expected outcome of the collaboration will also be used to expand indicated use claims for KidneyIntelX.
After risk stratification, program patients identified as
intermediate- and high-risk will receive care management support through
DaVita’s integrated kidney care program, for which Renalytix will compensate
DaVita in lieu of providing those services itself. DaVita’s integrated kidney
care program is comprised of a coordinated care team, practical digital health
tools, award-winning patient education and other offerings. Focused on the
patient experience, these services are designed to empower patients to be
active in their care, delay disease progression, improve outcomes and lower
costs. DaVita’s team also closely collaborates with the treating nephrologist,
who leads the care team, to create a seamless care experience.
For patients whose kidney disease does progress, earlier
intervention can provide the patient and treating nephrologist more time to
make an informed decision about the treatment option that is best for them,
including pre-emptive transplantation, home dialysis or in-center dialysis. For
those patients who choose to begin dialysis, the extra time increases their
chance for an out-patient dialysis starts, which can help them to avoid
starting dialysis with a costly hospitalization.
“This is the first clinical-grade program that delivers advanced early-stage prognosis and risk stratification, combined with actionable care management right to the primary care level where the majority of kidney disease patients are being seen,” said James McCullough, Renalytix AI Chief Executive Officer. “Making fundamental change in kidney disease health economics and outcomes must begin with providing a clear, actionable understanding of disease progression risk.”
There is no scientific evidence for a delay of more than six weeks in administering the second dose of the Pfizer/BioNTech vaccine against Covid, say experts from the World Health Organization.
The UK is planning to postpone giving the second dose of both the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines by up to 12 weeks – twice the length of time for which there is data, according to the WHO.
Episode two of the Alderley Park Discovery Podcast covers access to skills in the life sciences sector, with a focus on support for aspiring scientists and UK staffing trends.
In this instalment Dominic Tyer’s guests on the podcast are Sai Life Sciences’ head of global R&D Dean Edney, Joynes & Hunt’s managing director Steve Joynes and Dr Kath Mackay, managing director at Bruntwood SciTech’s Alderley Park.
Dr Mackay talks about why university connections are vital for a life science and tech cluster like Alderley Park and how the campus works to inspire the next generation of scientists.
From Dean Edney there’s a look at the expansion story of India-headquartered Sai Life Sciences and what the research development services company needed when it came to setting up its first European base of operations.
The podcast also features a rundown of recruitment trends in UK life sciences from Steve Joynes from specialist staffing solutions provider Joynes & Hunt. He discusses how recruitment has changed over the past decade and reveals some of the impacts from the COVID-19 pandemic on staffing.
The Alderley Park Discovery Podcast, produced in partnership with pharmaphorum, presents perspectives on UK and global bioscience innovation trends, with input from leading experts at Alderley Park in the North West of England.
In episode one of the podcast Dr Mackay talked about the challenges of rapidly building capacity to test thousands of patients a day for coronavirus at the Alderley Park Lighthouse Lab.
Alderley Park, a development by Bruntwood SciTech, is the UK’s largest single-site life science campus and offers bioscience facilities for R&D-focussed life science companies at every stage of their lifecycle, from start-up to global corporate.
Episode two of the Alderley Park Discovery Podcast is available in the player below, where you can listen to it, download it to your computer or find – and subscribe to the series, and other pharmaphorum podcasts – in iTunes, Spotify, acast and Stitcher.
NutritionFacts.org arises from my annual review of the medical literature. With the help of a team of hundreds of volunteers, we churned through tens of thousands of papers published in the peer-reviewed scientific nutrition literature and are ramping up to break new records in 2021. How do I choose which studies to highlight? In general, I strive to focus on the most groundbreaking, interesting, and useful findings; but which topics resonate the most? The practical ones, offering cooking or shopping tips? Or those that dissect the studies behind the headlines? Maybe it’s the geeky science ones exploring the wonderfully weird world of human biology? As you can see from the below list, the answer seems to be a bit of all of the above.
Biotech Clene Nanomedicine has gone public with a mission to use nanotherapeutics that will use gold to treat devastating neurological diseases including Parkinson’s disease.
Over the Christmas period Clene closed a reverse merger with Tottenham Acquisition I Limited, allowing shares to be publicly traded on the Nasdaq stock exchange.
The US-based company says it aims to revolutionise treatment of diseases including multiple sclerosis and amyotrophic lateral sclerosis with a new class of drugs that use gold to catalyse the cellular reactions fundamental to life.
Proceeds from the transaction totalled $31.9 million, combining funds held in Tottenham’s trust account and financing from Clene shareholders.
The current pipeline includes a phase 3 study in ALS and four phase 2 studies in ALS, MS and Parkinson’s.
Lead candidate is CNM-Au8, is an orally administered, bioenergetic gold nanocatalyst designed to enhance critical intracellular bioenergetic reactions necessary for repairing and reversing neuronal damage.
The company says its approach is based on the understanding that energy is the essential building block to life and that bioenergetic failure underlies the makeup of many neurodegenerative diseases.
Clene says its technology is based on active nanocrystals to activate reactions within the body that have shown to enhance cellular repair and regeneration.
Preliminary blinded data from the phase 2 RESCUE-ALS trial announced at the Symposium on ALS/MND show that more than 40% of enrolled patients with completed 12-week data experienced an improvement in motor neuron function as assessed by a standardised score.
Compared to baseline values the average score showed an increase that exceeded the expectations on which the study was based, the company said.
This suggested that CNM-Au8 may have neuro-reparative potential in ALS and expects completed unblinded results from the RESCUE-ALS study in the second half of 2021.
CNM-Au8 was selected as one of the first drug regimens to be evaluated in the phase 3 HEALEY ALS Platform Trial, a placebo-controlled study testing several novel ALS therapies at the same time to cut costs.
It includes substantial financial support from philanthropic donors and foundations and provides access to 54 expert ALS clinical trial sites across the US.
Dosing was initiated in the Clene-specific portion of the platform trial in July 2020 and full enrolment is expected by the end of Q2 2021, with top-line data available in the first half of 2022.
Sharon Clark is able to get her life-sustaining cancer drug, Pomalyst — priced at more than $18,000 for a 28-day supply — only because of the generosity of patient assistance foundations.
Clark, 57, a former insurance agent who lives in Bixby, Oklahoma, had to stop working in 2015 and go on Social Security disability and Medicare after being diagnosed with multiple myeloma, a blood cancer. Without the foundation grants, mostly financed by the drugmakers, she couldn’t afford the nearly $1,000 a month it would cost her for the drug, since her Medicare Part D drug plan requires her to pay 5% of the list price.
Every year, however, Clark has to find new grants to cover her expensive cancer drug.
“It’s shameful that people should have to scramble to find funding for medical care,” she said. “I count my blessings, because other patients have stories that are a lot worse than mine.”
Many Americans with cancer or other serious medical conditions face similar prescription drug ordeals. It’s often worse, however, for Medicare patients. Unlike private health insurance, Part D drug plans have no cap on patients’ 5% coinsurance costs once they hit $6,550 in drug spending this year (rising from $6,350 in 2020), except for very low-income beneficiaries.
President-elect Joe Biden favors a cap, and Democrats and Republicans in Congress have proposed annual limits ranging from $2,000 to $3,100. But there’s disagreement about how to pay for that cost cap. Drug companies and insurers, which support the concept, want someone else to bear the financial burden.
That forces patients to rely on the financial assistance programs. These arrangements, however, do nothing to reduce prices. In fact, they help drive up America’s uniquely high drug spending by encouraging doctors and patients to use the priciest medications when cheaper alternatives may be available.
Growing Expense of Specialty, Cancer Medicines
Nearly 70% of seniors want Congress to pass an annual limit on out-of-pocket drug spending for Medicare beneficiaries, according to a KFF survey in 2019. (KHN is an editorially independent program of KFF.)
The affordability problem is worsened by soaring list prices for many specialty drugs used to treat cancer and other serious diseases. The out-of-pocket cost for Medicare and private insurance patients is often set as a percentage of the list price, as opposed to the lower rate negotiated by insurers.
For instance, prices for 54 orally administered cancer drugs shot up 40% from 2010 to 2018, averaging $167,904 for one year of treatment, according to a 2019 JAMA study. Bristol Myers Squibb, the manufacturer of Clark’s drug, Pomalyst, has raised the price 75% since it was approved in 2013, to about $237,000 a year. The company believes “pricing should be put in the context of the value, or benefit, the medicine delivers to patients, health care systems and society overall,” a spokesperson for Bristol Myers Squibb said via email.
As a result of rising prices, 1 million of the 46.5 million Part D drug plan enrollees spend above the program’s catastrophic coverage threshold and face $3,200 in average annual out-of-pocket costs, according to KFF. The hit is particularly heavy on cancer patients. In 2019, Part D enrollees’ average out-of-pocket cost for 11 orally administered cancer drugs was $10,470, according to the JAMA study.
The median annual income for Medicare beneficiaries is $26,000.
Medicare patients face modest out-of-pocket costs if their drugs are administered in the hospital or a doctor’s office and they have a Medigap or Medicare Advantage plan, which caps those expenses.
But during the past several years, dozens of effective drugs for cancer and other serious conditions have become available in oral form at the pharmacy. That means Medicare patients increasingly pay the Part D out-of-pocket costs with no set maximum.
“With the high cost of drugs today, that 5% can be a third or more of a patient’s Social Security check,” said Brian Connell, federal affairs director for the Leukemia & Lymphoma Society.
This has forced some older Americans to keep working, rather than retiring and going on Medicare, because their employer plan covers more of their drug costs. That way, they also can keep receiving financial help directly from drugmakers to pay for the costs not covered by their private plan, which isn’t allowed by Medicare.
‘This Is a Little Nuts’
All this has caused financial and emotional turmoil for people who face a life-threatening disease.
Marilyn Rose, who was diagnosed with chronic myeloid leukemia three years ago, until recently was paying nothing out-of-pocket for her cancer drug, Sprycel, which has a list price of $176,500 a year. That’s because Bristol Myers Squibb, the manufacturer, paid her insurance deductible and copays for the drug.
But the self-employed artist and designer, who lives in West Caldwell, New Jersey, recently turned 65 and went on Medicare. The Part D plan offering the best deal on Sprycel charges more than $10,000 a year in coinsurance for the drug.
Rose asked her oncologist if she could switch to an alternative medication, Gleevec, for which she’d pay just $445 a year. But she ultimately decided to stick with Sprycel, which her doctor said is a longer-lasting treatment. She hopes to qualify for financial aid from a foundation to cover the coinsurance but won’t know until sometime this month.
“It’s just strange you have to make a decision about your treatment based on your finances rather than what’s the right drug for you,” she said. “I always thought that when I get to Medicare age I’ll be able to breathe a sigh of relief. This is a little nuts.”
Given the sticker shock, many other patients choose not to fill a needed prescription, or delay filling it. Nearly half of patients who face a price of $2,000 or more for a cancer drug walk away from the pharmacy without it, according to a 2017 study. Fewer than half of Medicare patients with blood cancer received treatment within 90 days of their diagnosis, according to a 2019 study commissioned by the Leukemia & Lymphoma Society.
“If I didn’t do really well at scrounging free drugs and getting copay foundations to work with us, my patients wouldn’t get the drug, which is awful,” said Dr. Barbara McAneny, an oncologist in Albuquerque, New Mexico, and past president of the American Medical Association. “Patients would just say, ‘I can’t afford it. I’ll just die.’”
The high drug prices and coverage gaps have forced many patients to rely on complicated financial assistance programs offered by drug companies and foundations. Under federal rules, the foundations can help Medicare patients as long as they pay for drugs made by all manufacturers, not just by the company funding the foundation.
But Daniel Klein, CEO of the PAN Foundation, which provides drug copay assistance to more than 100,000 people a year, said there are more patients in need than his foundation and others like it can help.
“If you are a normal consumer, you don’t know much about any of this until you get sick and all of a sudden you find out you can’t afford your medication,” he said. Patients are lucky, he added, if their doctor knows how to navigate the charitable assistance maze.
Yet many don’t. Daniel Sherman, who trains hospital staff members to navigate financial issues for patients, estimates that fewer than 5% of U.S. cancer centers have experts on staff to help patients with problems paying for their care.
Sharon Clark, who struggles to cover her cancer drugs, works with the Leukemia & Lymphoma Society counseling other patients on how to access helping resources. “People tell me they haven’t started treatment because they don’t have money to pay,” she said. “No one in this country should have to choose between housing, food or medicine. It should never be that way, never.”
That is the question by a recent paper in by Baugh et al. (2020) in JAMA Open. The authors surveyed nearly 300 current college football players from 4 teams in the 5 most competitive NCAA football conferences. They found that:
Of the 265 participants for whom all relevant data were available, 111 (42%) underestimated their risk of concussion (χ2 = 98.6; P = .003). A similar proportion of athletes (113 [43%]) underestimated their risk of injury, although this was not statistically significant (χ2 = 34.0; P = .09). An alternative analytic strategy suggested that 241 athletes (91%) underestimated their risk of injury (Wilcoxon statistic, 7865; P < .001) and 167 (63%) underestimated their risk of concussion (Wilcoxon statistic, 26 768; P < .001).
Overall, the answer seems like that answer is ‘yes’, athletes are underestimating their risk of concussion, but not at widely low rates. This study does not, however, get at whether individuals perceive the severity of a concussion accurately. In expected value terms, football’s risk involves likely probability of injury times the expected injury levels conditional on the event occurring. The Baugh et al. study only deals with the first issue. A follow-on study should examine whether football players are accurately understanding concussion severity.
An important topic to insure that football players and their families internalize risks and benefits of playing this game.
BioNtech has criticised the EU’s failure to order more doses of its coronavirus vaccine, saying it is now racing with its US partner Pfizer to boost production amid fears of a European “gap” left by the lack of other approved vaccines.
The Pfizer/BioNTech vaccine was the first to be approved by the bloc late last month, after being accepted by the UK, Canada and the US. They and other countries have also since approved the Moderna or Oxford/AstraZeneca vaccine, leaving the EU trailing behind.
I recommend people switch away from using rice milk
For kids and teens, the amount of arsenic flowing through their bodies was found to be about 15 percent higher for each quarter cup of rice consumed per day, and a similar link was found in adults. A study of pregnant women found that consuming about a half cup of cooked rice per day could raise urine arsenic levels as much as drinking a liter of arsenic-contaminated water at the current upper federal safety limit. These findings “suggest that many people in the United States may be exposed to potentially harmful levels of arsenic through rice consumption.” which I explore in my video Arsenic in Rice Milk, Rice Krispies, and Brown Rice Syrup.
“Organic brown rice syrup (OBRS) is used as a sweetener in organic food products as an alternative to high-fructose corn syrup.” Big mistake, as organic brown rice syrup products “may introduce significant concentrations” of toxic arsenic into people’s diets. For example, two energy chews sweetened with brown rice syrup might hit the provisional upper daily arsenic intake based on the water standards.
“Toddler formulas with added organic brown rice syrup have 20 times higher levels of inorganic [toxic] arsenic than regular formulas,” and in older children, thanks to brown rice syrup, a few cereal bars a day “could pose a very high cancer risk.”
What about rice milk? A consensus statement of both the European and North American societies for pediatric nutrition recommends the “avoidance of rice drinks for infants and young children,” and, generally, toxic “inorganic arsenic intake in infancy and childhood should be as low as possible.”
To this end, the United Kingdom has banned the consumption of rice milk for young children, a notion with which Consumer Reports concurred, recommending no servings a week of rice milk for children and no more than half a cup a day for adults, as you can see at 1:56 in my video.
The arsenic in various brands of rice milk ranges wildly—in fact, there’s a 15-fold difference between the highest and lowest contamination, suggesting manufacturers could make low arsenic rice milk if they wanted. As you can see at 2:16 in my video, Consumer Reports found rice drinks from Pacific and Rice Dream brands were right about average, though, for Rice Dream, it appears the vanilla or chocolate flavors may be lower. It doesn’t seem we have anything to worry about with rice vinegar, but rice pasta and rice cakes end up similar to pure rice in terms of arsenic levels, which makes sense because that’s pretty much what they are—pure rice. However, pasta is boiled, so we’d expect the levels to be cut 40 to 60 percent, like when you boil and drain rice.
If you just couldn’t live without rice milk for some reason, you couldmake your own using lower arsenic rice, like brown basmati from India, Pakistan, or California, but then your homemade rice milk might have even less nutrition, as most of the commercial brands are at least fortified. Better options might be soy, oat, hemp, or almond milk, though you don’t want kids to be drinking too much almond milk. There have been a few case reports of little kids drinking four cups a day and running into kidney stone problems due to its relatively high oxalate content, which averages about five times more than soy milk. More on oxalates in my video series starting with Oxalates in Spinach and Kidney Stones: Should We Be Concerned?
I have about 40 videos that touch on soy milk, discussing such topics as how it may normalize development in girls and reduce breast cancer risk, as well reduce prostate cancer risk in men. Some of the latest science on soy milk includes an association with better knee x-rays, suggesting protection from osteoarthritis, and an interventional study suggesting improved gut health by boosting the growth of good bacteria. However, drinking 3 quarts a day, which is 10 to 12 daily cups, for a year may inflame your liver, but two cups a day can have an extraordinary effect on your cholesterol, causing a whopping 25 percent drop in bad cholesterol after just 21 days.
An ounce and a half of almonds, about a handful, each day, can drop LDL cholesterol 13 percent in six weeks and reduce abdominal fat, though a cup of almond milk only contains about ten almonds, which is less than a third of what was used in the study. So, it’s not clear if almond milk helps much, but there was a study on oat milk compared to rice milk. As you can see at 4:37 in my video, five weeks of oat milk lowered bad cholesterol, whereas rice milk didn’t, and even increased triglycerides and may bump blood pressure a bit. However, the oat milk only dropped LDL about 5 percent and that was with three cups a day. As plant-based alternatives go, it appears soy milk wins the day.
So, why drink rice milk at all when there are such better options? There really isn’t much nutrition in rice milk. In fact, there are case reports of severe malnutrition in toddlers whose diets were centered around rice milk due to multiple food allergies. Infants and toddlers have increased protein requirements compared to adults, so if the bulk of a child’s diet is rice milk, coconut milk, potato milk, or almond milk, they may not get enough, as you can see at 5:23 in my video. In fact, cases of kwashiorkor—that bloated-belly protein- and calorie-deficient state of malnutrition—due to rice milk have been reported in Ethiopia…and Atlanta, Georgia, because literally 99 percent of the child’s diet was rice milk. So, these malnutrition cases were not because they drank rice milk, but rather because they drank rice milk nearly exclusively. I just use these examples to illustrate the relative lack of nutrition in rice milk. If you’re going to choose a milk alternative, you might as well go for one that has less arsenic—and more nutrition.
2020 has been the most remarkable year for the global financial markets. After the Covid-19 pandemic triggered the worst crash in a generation, unprecedented stimulus measures and vaccine breakthroughs have sent stocks roaring back to record highs.
In a year in which at least 1.7 million people died from coronavirus and unemployment soared in a global recession, world stock markets are ending 2020 up 13% – despite the latest surge in cases forcing further lockdowns this winter.
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Download the Free Evidence-Based Eating Guide
As you get ready for 2021 and healthy resolutions, remember we have a free downloadable guide that summarizes my Traffic Light and Daily Dozen systems, as well as tips and simple recipes. Get your free download here, or order hard copies here at cost.
Can you reverse heart disease with food? An entire issue of a cardiology journal dedicated to plant-based nutrition explores the role an evidence-based diet can play in the reversal of congestive heart failure.
The genomic test, known as Oncotype DX, can help predict whether women with certain forms of breast cancer will benefit from chemotherapy — and those who won’t. The latest trial results extend the test’s reach.
We just finished off a loaf of this not long ago around here; it’s a recipe that my wife makes when we have overripe bananas (and since we have both our college-aged kids at home for now, it goes pretty quickly). Like most such recipes, it comes together quickly. You’ll need shortening (vegetable shortening or butter), sugar, an egg, some lemon or lime juice, flour, baking soda, a bit of salt, and (of course) two or three ripe bananas, mashed up. Past that, there are variations without number (nuts, other fruit, chocolate – see below).
First, you’ll need 1/2 cup of soft (room temperature) shortening. That’s about 100 grams, if it’s vegetable shortening – if butter, it will weigh about 110 grams, since it has some more water in it. Add 3/4 cup granulated sugar (150g) to it and “cream” them together, either with an electric mixture or by hand if you’re feeling vigorous. Mix in one large egg, and then mix in 4 teaspoons (20 mL) of lemon or lime juice. At this point, it would be a good idea to start warming up the oven to 350F (about 177C).
In a separate bowl, mix together 2 cups of flour (250g), 1 teaspoon baking soda (5g), and 1/2 teaspoon salt (2.9g). Figure out first if you want any additions (see next paragraph), because once you mix everything together, you will of course be bringing the lemon juice and baking soda together, and the resulting carbon dioxide will not sit around forever. So add the dry mixture in portions to the shortening/sugar/egg mixture with very light stirring, and then add 1 cup of the mashed ripe bananas (about 300g) and mix that in lightly as well.
At this point, if you desire, there are many possible additions. 1/2 cup of chopped nuts (100 to 120g) will always work well (we’ve used walnuts or pecans). I’ve seen golden raisins in there, or chopped cranberries or cherries, or chocolate chips as well – it all depends on which direction you want to go! Or you can stick with the plain austerity that comes with a bowl full of butter, sugar, and ripe bananas. No matter what you add, remember the light stirring part – the key thing about all “quick bread” recipes (and muffins, etc.) is that you don’t want to work the flour mixture very much to avoid the formation of stretchy gluten. I have been given banana bread that was run through an automatic bread machine (with kneading, etc.), and it was. . .unusual.
Scrape the batter into a bread loaf pan and cook it for at least an hour – depending on your additions, you may need more. The “stick a straw/wooden toothpick/skewer into it” is probably the best test – this probe should come out cleanly, not with stuff still clinging to it. Once done, turn the bread out to cool.
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When it comes to rice and rice-based products, pediatric nutrition authorities have recommended that arsenic intake should be as low as possible.
“The US Food and Drug Administration (FDA) has been monitoring the arsenic content in foods” for decades, yet despite the “well-established science describing the health risks associated with arsenic exposure, no standards have been set limiting the amount of arsenic allowable in foods” in the United States. In 2001, the EPA “adopted a new stricter standard for arsenic in drinking water,” and in 2013, the FDA proposed a legal limit for apple juice. “There are still no standards for arsenic in food products despite the fact that food sources are our main source of exposure.”
Unlike the United States, China has standards. As of 2014, China set a maximum threshold of inorganic arsenic at 150 parts per billion, stricter than the World Health Organization’s limit of 200 ppb. In the United States, a 200 ppb limit wouldn’t change the cancer risk much. If we had China’s safety limits of 150 ppb, though, cancer risk would be reduced up to 23 percent and a maximum threshold of 100 ppb would lower cancer risk up to 47 percent—but that could seriously affect the rice industry. In other words, U.S. rice is so contaminated with arsenic that if a safety standard that really cut down on cancer risk were set, it “would wipe out the U.S. rice market.” However, with no limits, what’s the incentive for the rice industry to change its practices? Setting arsenic limits would not only directly protect consumers but also encourage the industry to stop planting rice paddies on arsenic-contaminated land.
Those cancer estimates are based on arsenic-contaminated water studies. Might the arsenic in rice somehow have a different effect? You don’t know…until you put it to the test. We know rice has a lot of toxic arsenic that urine studies have shown we absorb into our body, but there hadn’t been any studies demonstrating “deleterious health impacts” specific to rice arsenic—until now. Since arsenic causes bladder cancer, the researchers figured they would see what kind of DNA mutations the urine of rice eaters can have on human bladder cells growing in a petri dish. And, indeed, they clearly demonstrated that eating a lot of arsenic-contaminated rice every day can “give rise to significant amounts of genetic damage,” the kind that‘s associated with cancer. Yes, but the study used pretty contaminated rice. However, only about 10 percent of the rice in certain parts of Asia might ever reach those levels of contamination, though a quarter of rice in parts of Europe might and more half in the United States, making for considerable public health implications.
So, “there remains little mystery surrounding the health risks associated with arsenic levels in rice. The remaining mystery is why long-overdue standards for arsenic levels in rice have not been set by the FDA” in the United States, but that may be changing. In 2016, the FDA proposed setting a limit on toxic arsenic—at least in infant rice cereal, which I discuss in my video Arsenic in Infant Rice Cereal.
As you can see at 3:24 in my video, infants and children under four years of age average the highest rice intake, in part because they eat about three times the amount of food in relation to their body size, so there’s an especially “urgent need for regulatory limits” on toxic arsenic in baby food.
Pediatric nutrition authorities have recommended that when it comes to rice and rice-based products, “arsenic intake should be as low as possible,” but how about as early as possible? Approximately 90 percent of pregnant women eat rice, which may end up having “adverse health effects” on the baby.
You can estimate how much rice the mother ate while pregnant by analyzing arsenic levels in the infant’s toenail clippings. “Specifically, an increase of 1/4 cup of rice per day was associated with a 16.9% increase in infants toenail [arsenic] concentration,” which indicates that arsenic in rice can be passed along to the fetus. What might that arsenic do? A quarter cup of rice worth of arsenic has been associated with low birth weight, increased respiratory infections, and, above that, a 5- to 6-point reduction in IQ, among other issues. So, “based on the FDA’s findings, it would be prudent for pregnant women to consume a variety of foods, including varied grains (such as wheat, oats, and barley),” which is code for cut down on rice. Saying eat less of anything, after all, is bad for business.
Once the baby is weaning, “what’s a parent to do?” Asks Consumer Reports, “To reduce arsenic risks, we recommend that babies eat no more than 1 serving of infant rice cereal per day on average. And their diets should include cereals made of wheat, oatmeal, or corn grits, which contain significantly lower levels of arsenic”—that is, rely on other grains, which are much less contaminated than rice. As the American Academy of Pediatrics has emphasized, “there is no demonstrated benefit of rice cereal over those made with other grains such as oat, barley, and multigrain cereals, all of which have lower arsenic levels than rice cereal.” As you can see at 5:28 in my video, reducing consumption of infant rice cereal to just two servings per week could have an even more dramatic effect on reducing risk.
The proposed limit on toxic arsenic in infant rice cereals would end up removing about half of the products off the shelves. The FDA analyzed more than 500 infant and toddler foods, and the highest levels of toxic arsenic were found in organic brown rice cereals and “Toddler Puffs.” Based on the wording in the report, these puffs appear to be from the Happy Baby brand. Not-so-happy baby if they suffer brain damage or grow up to get cancer. A single serving could expose infants to twice the tolerable arsenic intake set by the EPA for water. I contacted the Happy Baby company and was told they “are not able to provide any comments” on the FDA’s results.
“Eliminating all rice and rice products from the diets of infants and small children up to 6 years old could reduce the lifetime cancer risk from inorganic arsenic in rice and rice products by 6% and 23% respectively.” That is, there would be a 6 percent lower chance of developing lung or bladder cancer later in life if infants stopped, and a 23 percent lower chance if young kids stopped. However, switching to other grains is a move described as “drastic and dramatic,” creating “a huge crisis”—for the rice industry, presumably—and therefore “not feasible at all.”
I was hoping Happy Baby, upon learning of the concerning FDA arsenic toddler puffs data (regardless of whether the data were about its brand or not) would have kicked its own testing and potential remediation into high gear like Lundberg did (see Which Brands and Sources of Rice Have the Least Arsenic?). But, unfortunately, in my email correspondence with the company, I got no sense that it did.
Boiling rice like pasta reduces arsenic levels, but how much nutrition is lost?
Cooking rice in a high water-to-rice ratio reduces toxic arsenic content, which I discuss in my video How to Cook Rice to Lower Arsenic Levels. What exactly does that mean? Well, as you can see at 0:16 in my video, if you boil rice like pasta and then drain off the water at the end, you can drop arsenic levels in half—50 to 60 percent of the arsenic gets poured down the drain—whereas the typical way we make rice, boiling off the water in a rice cooker or pot, for example, doesn’t help. In fact, it may even make things worse if the water you’re using to cook the rice has arsenic in it, too, which is a problem that exists for about three million Americans, as about 8 percent of public water supplies exceed the current legal arsenic limits.
“Cooking rice in excess water”—and then discarding the excess water—“efficiently reduces the amount of inorganic As [that is, toxic arsenic] in the cooked rice,” but how much nutrition are you pouring down the drain when you do pour off the excess water?
“Unpolished brown rice naturally contains vitamins and minerals that are lost when the bran layer and germ are removed to make white rice. To compensate, since the 1940s polished white and parboiled rice sold in the United States is often enriched”—that is, white rice has had vitamins and minerals sprayed on it to so it’s “enriched” and “fortified.” That’s why cooking instructions for enriched white rice specifically say you shouldn’t rinse it and you should cook it in a minimal amount of water. In other words, you should do the opposite of what you’d do to get rid of some of the arsenic. But brown rice has the nutrients inside, not just sprayed on.
“Rinsing [white] rice,” by putting it in a colander under running water, for example, “removes much of the enriched vitamins sprayed onto the rice grain surface during manufacture,” removing most of the B-vitamins. But, “rinsing had almost no effect on vitamins in whole grain brown rice”—because brown rice has got the nutrition inside. It’s the same with iron: Rinsing white rice reduces iron levels by about three-fourths, but the iron in brown rice is actually in it, so rinsing only reduces the iron concentration in brown rice by about 10 percent. Rinsing didn’t seem to affect the arsenic levels, so why bother?
Well, if you reallywash the rice, for example, agitating the uncooked rice in water, rinsing, and repeating for three minutes, you may be able to remove about 10 percent of the arsenic. So, one research team recommends washing rice as well as boiling it in excess water, but I don’t know if the 10 percent is worth the extra time it takes to wash the rice. However, as we discussed, boiling rice like pasta and then draining off the excess water does really cut way down on the arsenic, and, while that cooking method also takes a whack at the nutrition in white rice, the nutrient loss in brown rice is “significantly less,” as it is not so much enriched as it is rich in nutrition in the first place.
“Cooking brown rice in large amounts of excess water reduces the toxic arsenic by almost 60% and only reduces the iron content by 5%. It reduces the vitamin content of brown rice by about half,” however. You can see a graph of what I’m talking about at 3:18 in my video. A quick rinse of brown rice before you cook it doesn’t lower arsenic levels, but boiling it and draining off the excess water, instead of cooking to dry, drops arsenic levels by 40 percent. That was using about a ratio of 6 parts water to 1 part rice. What if you use even more water, boiling at 10-to-1 water-to-rice ratio? You get a 60 percent drop in arsenic levels.
With white rice, you can rinse off a little arsenic, but after cooking, you end up with similar final drops in arsenic content, but the iron gets wiped out in white rice by rinsing and cooking, whereas the iron in brown rice stays strong. There are similar decrements in the B vitamins with cooking for brown and unrinsed white rice, but once you rinse white rice, the B vitamins are mostly gone before they even make it into the pot.
What about percolating rice? Well, we know that regular rice cooking doesn’t help reduce arsenic levels, but boiling then draining rice like pasta does, while steaming doesn’t do much. What about percolating rice as a radical rethink to optimize arsenic removal? Researchers tried two types of percolating technology: One was a mad scientist-type lab set-up, and the other was just a regular off-the-shelf coffee percolator. Instead of putting in coffee, they put rice and percolated 20 minutes for white and 30 for brown. The result? As you can see at 4:39 in my video, they got about a 60 percent drop in arsenic levels using a 12-to-1 water-to-rice ratio. Raw brown rice started out at about double the arsenic levels of raw white rice, but, after cooking with enough excess water and draining, they end up much closer. Though, a 60 percent drop in arsenic levels by percolating at a 12-to-1 ratio was about what we got boiling at just 10-to-1. So, I don’t see a reason to buy a percolator.
But, what does that 60 percent drop really mean? By boiling and draining a daily serving of rice, we could cut excess cancer risk more than half from about 165 times the acceptable cancer risk to only about…66 times the acceptable risk.
At this point, I can imagine you thinking, Wait, so should we avoid rice or not? I’m getting there. First, I’m just laying out the issue. Here are videos on the latest on the topic, if you’re interested:
The chief executive of the German pharmaceutical company BioNTech has said he is confident its coronavirus vaccine works against the new UK variant, but that further studies are need to be certain.
Uğur Şahin told a press conference that his team had been working on trying to find out whether the vaccine worked on the UK variant or whether it would be necessary to adapt it. Results would be known within two weeks, he said.
The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.
One tray of COVID-19 vaccine from pharmaceutical giant Pfizer contains 975 doses — way too many for a rural hospital in Arkansas.
But with the logistical gymnastics required to safely get the Pfizer vaccine to rural health care workers, splitting the trays into smaller shipments has its own dangers. Once out of the freezer that keeps it at 94 degrees below zero, the vaccine lasts only five days and must be refrigerated in transit.
In Arkansas — where over 40% of its counties are rural and COVID infections are climbing — solving this distribution puzzle is urgently critical, said Dr. Jennifer Dillaha, the state’s epidemiologist.
“If their providers come down with COVID-19,” Dillaha said, “there’s no one there to take care of the patients.”
Such quandaries resonate with officials in Georgia, Kentucky, Utah, Indiana, Wisconsin and Colorado. The first push of the nation’s mass COVID vaccination effort has been chaotic, marked by a lack of guidance and miscommunication from the federal level.
With Washington punting most vaccination decisions, each state and county is left to weigh where to send vaccines first and which of two vaccines authorized by the Food and Drug Administration for emergency use makes the most sense for each nursing home, hospital, local health department and even school. And after warning for months that they lacked the resources to distribute vaccines, state officials are only now set to receive a major bump in funding — $8.75 billion in Congress’ latest relief bill, which lawmakers are likely to pass this week.
The feat facing public health officials has “absolutely no comparison” in recent history, said Claire Hannan, executive director of the Association of Immunization Managers.
Officials who thought the H1N1 swine flu shot in 2009 was a logistical nightmare say it now looks simple in comparison. “It was a flu vaccine. It was one dose. It came at refrigerator-stable temperatures,” Hannan said. “It was nothing like this.”
Within just a few days, the logistical barriers of the vaccine made by Pfizer and BioNTech were laid bare. Many officials now hang their hopes on Moderna, whose vaccine comes in containers of 100 doses, doesn’t require deep freezing and is good for 30 days from the time it’s shipped.
The federal government had divvied up nearly 8 million doses of Pfizer and Moderna’s vaccines to distribute this week, on top of roughly 3 million Pfizer shots that were sent last week, said Army Gen. Gustave Perna, chief operating officer of the Trump administration’s Operation Warp Speed effort.
Perna said he took “personal responsibility” for overstating how many Pfizer doses states would receive.
Federal delays have led to confusion, Dillaha said: “Sometimes we don’t have information from CDC or Operation Warp Speed until right before a decision needs to be made.”
Officials in other states painted a mixed picture of the rollout.
Georgia’s Coastal Health District, which oversees public health for eight counties and has offices in Savannah and Brunswick, spent more than $27,000 on two ultra-cold freezers for the Pfizer vaccine, which it’s treating “like gold,” said Dr. Lawton Davis, its health director. Health care workers are being asked to travel, some up to 40 minutes, to get their vaccinations, because shipping them would risk wasting doses, he said. Vaccination uptake has been lower than Davis would like to see. “It’s sort of a jigsaw puzzle and balancing act,” he said. “We’re kind of learning as we go.”
In Utah, sites to vaccinate teachers and first responders starting in January had no capability to store the Pfizer vaccine, although officials are trying to secure some ultra-cold storage, a state department of health spokesperson said. Very few of Kentucky’s local health offices could store the Pfizer shots, because of refrigeration requirements and the size of shipments, said Sara Jo Best, public health director of the Lincoln Trail District. Indiana’s state health department had to identify alternative cold storage options for 17 hospitals following changes in guidance for the vaccine thermal shippers.
And in New Hampshire, where the National Guard will help administer vaccines, officials last week were still finalizing details for 13 community-based sites where first responders and health care workers are due to get vaccinated later this month. Jake Leon, a state Health and Human Services spokesperson, said that while the sites will be able to administer both companies’ vaccines, most likely they’ll get Moderna’s because of its easier transport. Even as the earliest vaccines are injected, much remains up in the air.
“It’s day to day and even then hour by hour or minute by minute — what we know and how we plan for it,” Leon said Friday. “We’re building the plane while flying it.”
In all, the Trump administration has bought 900 million COVID vaccine doses from six companies, but most of the vaccines are still in clinical studies. Even the front-runners whose shots have received FDA emergency authorization— Pfizer and BioNTech on Dec. 11, Moderna on Dec. 18 — will require months to manufacture at that scale. The Trump administration plans to distribute 20 million vaccine doses to states by early January, Perna said Saturday.
By spring, officials hope to stage broader vaccine deployment beyond top-priority populations of health care workers, nursing home residents and staff, as well as first responders.
During the effort to vaccinate Americans against H1N1, Dillaha said, health departments set up mass vaccination clinics in their counties and delivered doses to schools. But hospitals are taking charge of parts of the initial COVID immunization campaign, both because health care workers are at highest risk of illness or death from COVID-19, and to pick up the slack from health departments overwhelmed by case investigations and contact tracing from an unending stream of new infections.
Best said her workforce is struggling to keep up with COVID infections alone, much less flu season and upcoming COVID vaccinations. Public health department personnel in Kentucky shrank by 49% from 2009 to 2019, according to state data she supplied. Across the country, 38,000 state and local health positions have disappeared since the 2008 recession. Per capita spending for local health departments has dropped by 18% since 2010.
Nationally, Pfizer and Moderna have signed contracts with the federal government to each provide 100 million vaccine doses by the end of March; Moderna is set to deliver a second tranche of 100 million doses by June. States were playing it safe last week, directing Pfizer vials mainly to facilities with ultra-cold freezers, Hannan said.
“A lot of that vaccine is destined for institutional facilities,” Sean Dickson, director of health policy for West Health Policy Center, said of the Pfizer shots. The center, with the University of Pittsburgh School of Pharmacy, found that 35% of counties have two or fewer facilities to administer COVID vaccines.
The analysis found tremendous variation in how far people would need to drive for the vaccine. Residents of North Dakota, South Dakota, Montana, Wyoming, Nebraska and Kansas face the longest drives, with more than 10% living more than 10 miles from the closest facility that could administer a shot.
Counties with long driving distances between sites and a low number of sites overall “are going to be the hardest ones to reach,” said Inmaculada Hernandez, an assistant professor at the University of Pittsburgh School of Pharmacy and lead author of the analysis.
Certain vaccines could be better suited for such places, including Johnson & Johnson’s potential offering, which is a single shot, and health departments could distribute in rural areas through mobile units, she said. The company is expected to apply for FDA emergency authorization in February, Operation Warp Speed chief scientific adviser Moncef Slaoui said this month.
Until then, Pfizer and Moderna are the companies supplying doses for the country, and they’re not considered equal even though each is more than 90% effective at reducing disease.
In Wisconsin, the Moderna vaccine “gives us many more options” and “allows for us to get doses to those smaller clinics, more-rural clinics, in a way that reduces the number of logistics” needed for ultra-cold storage, Dr. Stephanie Schauer, the state’s immunization program manager, told reporters Wednesday.
Alan Morgan, head of the National Rural Health Association, echoed that the Moderna vaccine is being looked to as a “rural solution.” But he said states including Kansas have shown that a Pfizer rural rollout can be done.
“It’s where these states put a priority — either they prioritize rural or they don’t,” he said. “It’s a cautionary tale of what we may see this spring, of rural populations perhaps being second-tier when it comes to vaccination.”
Virginia, too, has a plan for getting the Pfizer vaccine to far-flung places. It’s shipping the vaccines to 18 health facilities with ultra-cold freezers across the state. The hubs are distributed widely enough so vaccinators can bring shots from there to health workers even in thinly populated areas before they spoil, said Brookie Crawford, spokesperson for the Virginia Department of Health’s central region.
Washington, on the other hand, allows hospitals without ultra-cold freezers to temporarily store Pfizer vaccines in the thermal boxes they arrive in, said Franji Mayes, spokesperson for the state’s health department. That means a box needs to be used quickly, before doses expire. “We are also working on a policy that will allow hospitals who don’t expect to vaccinate 975 people to transfer extra vaccine to other enrolled facilities,” she said. “This will reduce wasted vaccine.”
Tamales are a Christmas menu staple for many families. This traditional Mexican and Native American dish is made by stuffing masa dough with a filling of meat, cheese, chili peppers, or beans, then steaming it inside a corn husk or banana leaf and serving it with salsa or hot sauce.
Whether tamales are already part of your family’s holiday tradition or you’re looking for new Christmas breakfast ideas, you may be wondering: Are tamales healthy?
“Tamales are generally considered healthy,” says Bansari Acharya, R.D.N., a registered dietitian and blogger at FoodLove. “Especially because they’re steamed instead of fried.”
Here’s how to make this holiday treat fit into your healthy eating plan — whether it’s Christmas morning or a random Tuesday night.
How Healthy Are Tamales?
Good news: Tamales may taste decadent, but they can still fit into a healthy meal plan (in moderation) and deliver some important nutrients.
“The merits of a tamale or two may surprise you!” says Libby Mills, M.S., R.D., L.D.N., registered dietitian and national spokesperson for the Academy of Nutrition and Dietetics.
Here’s what you need to know about the nutritional content in a tamale:
One large chicken tamale typically contains 305 calories, though the exact calorie count can vary depending on what ingredients are used in the filling.
Adding cheese, sour cream, or pork drippings to your tamales can rack up extra calories.
One large chicken tamale contains 19.4 grams of fat, which means more than half the calories come from fat.
That’s because traditional recipes call for lard to make the masa dough, Mills explains. Lard is high in saturated fat, but it’s fine to eat in moderation — especially if you limit saturated fat the rest of the day, Mills adds.
Carbohydrates and fiber
Each large chicken tamale contains 21 grams of carbohydrates and 1.7 grams of fiber, thanks to the corn flour used to make the masa dough.
Including beans and vegetables in the filling can help you amp up the fiber count, Mills says.
Tamales are typically made with chicken, pork, beef, or beans — all of which are sources of body-boosting protein. One large chicken tamale contains about 12.3 grams of protein.
Vitamins and minerals
Tamales provide healthy micronutrients, including folate, vitamin A, calcium, zinc, phosphorous, potassium, and iron.
AstraZeneca’s Tagrisso (osimertinib) has been approved by the FDA in a new lung cancer indication that extends its use to a group of patients with early-stage disease.
The new use covers adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after a potentially curative operation.
Patients must be tested to for the presence of the mutation to check they are eligible to receive the oral drug.
Up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery.
But disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.
Based on the findings of the phase 3 ADAURA study this could change, as Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in a primary analysis of patients with Stage II and Stage IIIa NSCLC with EGFR mutations.
This was also seen in the overall trial population of patients with Stage 1B-IIIA disease, the secondary endpoint of the trial.
Findings showed that Tagrisso cut the risk of disease recurrence by 83% compared with placebo in the trial that was stopped early because of the high efficacy shown in the treatment arm.
Results dazzled the oncologists who described the findings as a “home run” and the new indication will also have beneficial side-effect on AZ’s finances, adding substantially to the blockbuster revenues already generated by Tagrisso.
The results also suggest further uses for the drug in early disease and more revenues to come from one of the company’s biggest success stories from the last decade.
Tagrisso was first approved in 2015 to counter a single amino acid mutation known as T790M that nearly always occurs after about 10 months of treatment with tyrosine kinase inhibitor drugs, making tumours resistant.
But after approval in later stage disease, AZ found that the drug outperforms rival tyrosine kinase inhibitors as a first-line treatment in the FLAURA trial, leading to a second FDA indication two years ago.
Tagrisso is already a blockbuster bringing in revenues of more than $3.1 billion in the first nine months of this year, and the new indication will add further momentum to AZ’s biggest selling drug.
What do Hawaiian papaya, zucchini, and yellow squash have in common?
Besides being nutritious and delicious, these fruits are examples of foods that may sometimes be genetically modified.
While you’ve likely heard a lot of debate about GMO foods in recent years, it’s not always clear what the heck that means — and whether it’s something you really need to worry about.
Here’s what you need to know about GMO foods.
What Is GMO Food?
GMO is an acronym for “genetically modified organisms.”
“These are living organisms which have had their genetic material altered using genetic engineering to produce an organism that is not naturally occurring in nature,” says Bansari Acharya, R.D.N., a registered dietitian and nutritionist at FoodLove.
But these techniques can take years — or even decades — to see the results. Controlling the process through genetic modification drastically cuts down the time it takes.
Examples of GMO Foods
So what are the most common GMO foods?
According to the USDA’s 2020 data, more than 94 percent of soybeans and 92 percent of corn planted in the United States were genetically modified.
Most GMO crops are used as ingredients to make other foods.
Sugar beets, for example, are often used to make granulated sugar. Canola — another typical GMO food — is used to make margarine and cooking oil, while GMO soybeans are used as emulsifiers and other ingredients in processed foods.
Certain fruits and veggies may also be genetically modified, including:
Federal agencies like the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) consider GMOs to be safe for human consumption and don’t currently require foods to be marked GMO or non-GMO.
Nothing kills the holiday spirit like guilt and shame. This season, when things are anything but normal, focus on the positive and forming new habits.
Let go of those negative feelings and regain control of your eating habits, with tips for not binging on food during the holidays.
(And find out how to move on if you do binge.)
First up, know that binging isn’t the same as feeling like you ate too much (your stomach is full) or thinking you ate too much (you consumed more than you planned), explains Dr. Rachel Evans, a psychologist who specializes in eating disorder recovery.
Binging is consuming, within a specific timeframe, “an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances,” says Evans.
Another hallmark of binging is feeling like you lack control and that you’re unable to stop. While that can feel isolating and hopeless, you’re not alone.
Here are nine tips for avoiding a food binge over the holidays.
1. Connect with a therapist and/or dietitian
If you’re binging regularly, consider talking to a professional. A dietitian can “help you to evaluate why cravings, appetite, and eating issues are occurring,” explains Heidi Moretti, M.S., R.D.
Alternatively, consider talking to a therapist. They can help you not only prepare emotionally for big holiday meals ahead but also, as Evans explains, “reclaim the time, the brain space, and emotional energy that binge eating is taking from you.”
If you’re locked down or in quarantine, consider a text-based or video therapy service.
2. Take guilt off the table
Remind yourself ‘that everyone can and should have celebrations surrounding foods,” suggests Moretti. “Guilt is a set-up for restricting and then subsequent overeating.”
A therapist can help you unpack this guilt and strip it away from festive indulgences, especially if you start working with them in anticipation of these events.
3. Don’t let yourself get overly hungry
Don’t skip breakfast, lunch, or snacks to “save” calories for later, warns Evans. Instead, start your day with a healthy breakfast and a workout, just as you would on any other day.
Skipping meals can cause you to get too hungry, which can cause you to eat too fast.
It’s much easier to miss signs that you’re getting full this way and eat more than you planned. “Overeating because of physical hunger can trigger feelings of guilt or eating even more,” Evans explains.
4. Remember these meals aren’t your everyday meals
“A few days of indulgence or extra food isn’t going to derail your progress in the longer term,” Evans underscores.
Remind yourself that the holidays are a special time. In some cases, it’s the only time of the year you get to eat certain foods!
And remind yourself that, because the festivities do last longer than one meal, you can take it slow and try one treat a day, for example.
And if you prefer, make a healthier treat to enjoy and share.
When you’re eating more indulgent foods, “savor every bite slowly and feel good while doing it,” says Moretti.
Evans adds that you’re also more aware of feeling full when you eat mindfully, which can help prevent binging.
So turn off the TV and put away your phone. Set down your fork between bites, and soak up the ambiance and companionship, even if it’s via Zoom this year.
6. Be kind to yourself
For some of us, kind inner dialogue doesn’t come natural. That’s something a therapist can help you cultivate, and it’s worth the work.
A kind inner voice allows you to have a second slice of pecan pie, stripping away the guilt that might make you feel like you blew it so you might as well binge.
Reminder: If you wouldn’t say something out loud to a friend, you shouldn’t say it to yourself.
7. Skip (or limit) the alcohol
Pass up alcohol “because it can trigger overeating,” Moretti suggests. Although studies on the subject are small and more research is called for, one study found that certain amounts of alcohol increased appetite because participants felt hungrier after drinking.
Alcohol can also lower your inhibitions (while adding empty calories), so you might be less able to resist a food binge.
8. Check in with your feelings
If you’re worried about binging at a specific event, Evans advises that you dig into why that is beforehand.
If stress is causing the urge to binge, getting to the root issue will help you identify productive actions you can take, since “food isn’t really going to help with the stress.”
9. Redirect your attention
The holidays are known for special foods, but they also offer rare opportunities that may distract you from food binge urges.
If you’re near your family, focus on spending time with them (if you can do so safely).
Try something new with the extra free time you have or twist a tradition away from food. Evans suggests making cards instead of cookies.
The term Epilepsy isn’t new. It’s been present in the air for centuries now, however, only a few are aware that it is one of the most common neurological diseases in the world. It affects around 50 million people worldwide. However, public awareness regarding Epilepsy is quite less and it can result in the rise of false notions and stigma. Some of the most asked questions around Epilepsy are as follows:
What is epilepsy?
Epilepsy is a disorder of the central nervous system (neurological). It causes of unusual or abnormal brain activity characterized by seizures or periods of unusual behavior, sensations, and sometimes loss of awareness.
Epilepsy can develop in any person and at any age. However, it is more common in young children and older people. It was also observed that men are more at risk to develop epilepsy than women. About 1 in 100 people will have an unprovoked seizure in their lifetime.
What causes Epilepsy?
The causes of Epilepsy vary from person to person. Different conditions that affect the normal functioning of the brain can lead to Epilepsy. However, in most cases, the reason behind Epilepsy remains unclear. This type of epilepsy is called cryptogenic or idiopathic. Some known causes include:
Severe Head Injury.
Lack/ loss of oxygen to the brain (especially during birth).
Brain infection from parasites (malaria, neurocysticercosis), viruses (influenza, dengue, Zika), and bacteria.
Drug or alcohol abuse.
Some genetic disorders (such as Down syndrome).
Other neurologic diseases (such as Alzheimer’s disease).
What are the seizures?
A seizure is a sudden, uncontrolled, abnormal electrical disturbance or activity in the brain. It might or might not go unnoticed, however, in serious cases, it results in unconsciousness and convulsions accompanied by sudden uncontrollable jerks in the body.
Seizures can lead to changes in behavior, feelings, body movements and consciousness. Episodes of two or more seizures confirm Epilepsy.
What are the different types of Seizures?
Seizures are broadly classified into two groups.
Generalized seizures that affect all areas of the brain. It is further bifurcated into:
Absence seizures, also sometimes referred to as petit mal seizures, can cause rapid blinking or a few seconds of staring into space. It can also involve lip-smacking and cause a brief loss of awareness.
Tonic-clonic seizures, also called grand mal seizures, can make a person cry out, lose consciousness, lose balance, experience muscle jerks or spasms and get tired. It causes stiffness in arms and legs.
Atonic seizures also known as drop seizures, may lead to sudden collapsing or falling down of the body due to loss in muscle movements.
Clonic seizures are associated with repeated or rhythmic, jerking movements of the muscles usually of the neck, face and arms.
Febrile seizures are convulsions faced by a child from a high fever caused by an infection. They only last a few minutes but are often harmless.
Focal seizures are the seizures that are a result of abnormalities in just one area of the brain. These seizures are also called partial seizures.
Simple focal seizures affect a small part of the brain. These seizures can cause twitching or a change in sensation, such as a strange taste or smell.
Complex focal seizures make a person with epilepsy confused, dazed or lose consciousness. The person will be unable to respond to questions or direction for up to a few minutes.
How common are seizures?
According to the WHO, up to 10% of the total global population will experience one seizure during their lifetime. Seizures can happen anytime and so suddenly that it even gets undetected or unnoticed. Less than 1 in 10 people who have a seizure get epilepsy.
Why do people get epilepsy?
Factors such as health conditions, age, and race may act as triggers in developing epilepsy and seizures. Brain tumour or strokes can cause seizures. Stroke is a leading cause of epilepsy in adults older than age 35. It has been also observed that infectious diseases such as meningitis, AIDS and viral encephalitis can also cause seizures.
Can Seizures kill you?
Seizures can be fatal. Among people with uncontrolled epilepsy, sudden expected death in epilepsy (SUDEP) is responsible for the death of 1 in 1,000 people.
In what ways can a seizure kill you?
During a seizure, a person can face issues with breathing that can become fatal. An obstructed airway due to convulsion seizure can lead to suffocation. Abnormal heart rhythm during a seizure can also become fatal. However, the exact cause still remains in the dark and further research is underway.
How do seizures cause brain damage?
Epileptic seizures can cause severe damages to brain cells. There exists indirect evidence of uncontrolled epilepsies causing progressive brain injury. (Tasch E., et al). A study led by Thompson and Duncan demonstrated a particularly strong relationship between cognitive decline and the frequency of generalized tonic-clonic seizure. It also noted that frequent complex partial seizures were also associated with worsening scores in tests of verbal learning, delayed recall, and semantic fluency, suggesting site-specific cerebral effects of seizures or of epileptogenic pathology.
Why do people froth in seizures?
Usually, during a seizure, the mouth is shut closed. This leads to stimulation of salivary glands thus producing spit in excess. When the mouth opens, it comes out in the form of drool or forty salivate.
Can Epilepsy cause personality changes?
Epilepsy can be associated with changes in cognition, personality, and other behavioral aspects. Changes in emotional state can also be observed. The most important aspect of behavioral changes in epilepsy that needs attention is dysfunctional behavior. Depression is also a common problem that goes unrecognized and untreated. Other treatable problems include impotence, anxiety, panic attacks, and psychosis. (O Devinsky, B Vazquez – Behavioral changes associated with epilepsy)
Can you drive if you have epilepsy?
Seizures can prove to be dangerously fatal if they occur while driving. Thus. If a person experiences seizures, regardless of being epileptic or not,in an immediate effect it is advised to stop driving. Different countries have different guidelines for the same. For instance, in England, Scotland and Wales you need to tell the Driver and Vehicle Licensing Agency (DVLA). In Northern Ireland you need to tell the Driver and Vehicle Agency (DVA).
What should I do if I have a seizure and I’m home alone?
There is nothing much you can do. You should try knowing your triggers to keep a track on it and have a proper response plan made with the help of your doctors. For extra caution, you should get rid of any objects that might hurt you in any way. If it is your first time experiencing a seizure, you can call 911 and your family to inform them about your seizure episode. If you have experienced it before, then you can call your doctor to inform him about it. Some people experience an aura before the seizure, in that case, you can call to inform your family about it, you can lie down to a place away from any objects.
How accurate are EEG reading seizures?
EEG (electroencephalogram) is used to diagnose the cause of symptoms, such as seizures or memory loss. An EEG evaluates brain function by looking at the electrical activity within the brain, that appear as waves. The basic brain waves are alpha, beta, theta, and delta waves. Doctors examine each facet of the wave and determine unusual activities.
However, EEG only shows brain activity during that particular time. Therefore, a person experiencing seizures can have a normal EEG. Stats demonstrated that approximately one-half of all EEGs done for patients with seizures give normal results.
How can Epilepsy be cured?
Drugs and medications can control Epilepsy. These medications do not cure epilepsy, but can often control seizures very well. More than 20 different types of medications are available. About 80% of people with epilepsy today have their seizures controlled by medication at least some of the time. The first step towards managing a seizure is to prescribe Anti-epileptic drugs (AEDs), which help in reducing the number of seizures.
How can surgery treat epilepsy?
If in some patients AEDs fail to bring the desired results, they undergo different types of neurosurgery depending on the type of seizure. Surgery can remove the specific area of the brain thought to be causing seizures, or it also can involve separating the part of the brain that is causing seizures from the rest of the brain.
However, with surgery comes risks as well that varies from person to person and can range from memory, a partial loss of sight, depression to other mood problems.
What is the best treatment or medicine for epilepsy?
Treatment for epilepsy includes antiepileptic medications (AEDs), diet therapy, and surgery. Anticonvulsant therapy in adults comes into consideration usually after two unprovoked epileptic seizures. The various classes of AEDs include sodium channel inhibitors, calcium channel inhibitors, GABA A receptor agonists, synaptic vesicle protein SV2A modulator, Na/Ca channel modulators and AMPA receptor blockade.
Epidiolex is the first prescription, plant-derived cannabis oral formulation developed by the GW
Pharmaceuticals. Xcorpi (cenobamate) is an FDA-approved AED for the treatment of partial-onset seizures in adults. Nayzilam is an investigational midazolam formulation developed for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity. Fintepla, is an oral medication that is a low-dose solution of fenfluramine hydrochloride.
What is the difference between epilepsy and hysteria?
While Epilepsy is a commonly occurring neurological disorder characterized by recurring and unprovoked seizures, Hysteria, on the other hand, is usually a fear related to a certain part of the body or an imaginative state of mind.
What is the difference between epilepsy and eclampsia?
Preeclampsia is a complication that arises during pregnancy leading to high blood pressure and damage to another organ system, most often the liver and kidneys. Severe Preeclampsia can also lead to seizures known as Eclampsia. Less than 1% of women who have preeclampsia experience seizures. (Habli M, Sibai BM (2008))
What is the average lifespan of an epileptic?
Most people with epilepsy live a full life. However, this does not rule out the the risk of early death.
Not many have read or heard about Epilepsy. The public awareness and attitudes towards epilepsy vary from negative, neutral to positive as well, depending upon the understanding of the disease among common people. To tackle the situation, several organizations are running campaigns, and awareness programmes to help those living with Epilepsy and add to their quality of lives.
MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin in data gathered so far in advanced disease.
Margenza (margetuximab) won FDA approval in combination with chemotherapy to treat metastatic HER2-positive breast cancer after at least two previous rounds of therapy.
One of the talking points at the American Society of Clinical Oncology (ASCO) in 2019, Margenza is a tweaked version of Roche’s Herceptin (trastuzumab), which dominated the HER2-mutated breast cancer market for years until the recent launch of cut-price biosimilar competitors.
MacroGenics has altered the “Fc” part of the antibody – the tail of the ‘Y’-shaped molecule – so that it interacts more efficiently with the immune system when engaged with a cancer cell.
This has produced a small but significant benefit in progression-free survival, with the phase 3 SOPHIA study showing a 24% reduction in the risk of disease progression or death with Margenza plus chemotherapy, compared with trastuzumab plus chemo.
The median progression-free survival (PFS) of patients treated with Margenza and chemotherapy was 5.8 months compared to 4.9 months in patients treated with trastuzumab and chemotherapy.
The difference was more marked in patients carrying a genetic variation called CD16A 158F, where PFS was prolonged by 1.8 months in the margetuximab arm compared to the trastuzumab arm (6.9 months versus 5.1 months).
Response rate was also improved with the Margenza regimen at 22%, compared with 16% in those treated with the Herceptin regimen.
A final overall survival analysis is expected in the second half of 2021, after a planned launch in March next year.
No price has been officially decided but the company said it plans to price it at the low end of the price range seen in other HER2 metastatic breast cancer therapies.
Those competing therapies include Seagen’s Tukysa (tucatinib), which was approved in May for advanced HER2-positive disease in combination with trastuzumab and capecitabine after treatment with at least one HER2-targeted drug.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) was approved a year ago for HER2-positive breast cancer after two or more previous HER2 regimens and Puma’s Nerlynx (neratinib) is another FDA-backed option in this indication.
Amgen has filed its groundbreaking KRAS inhibiting drug sotorasib with the FDA for a group of lung cancer patients with an aggressive form of the disease.
The drug was the first targeted at the mutation known as KRAS to show activity in the clinic and provided the biggest talking point at the American Society of Clinical Oncology (ASCO) conference in 2019.
Since then Amgen has been gathering evidence to support a filing in a group of patients with advanced or metastatic KRAS G12C mutated non-small cell lung cancer.
The FDA is reviewing sotorasib under its Real-Time Oncology Review (RTOR) programme and could be the first to be approved in this indication, which covers around 13% of NSCLC patients.
Amgen’s filing is on track with a schedule laid out at the beginning of the year, following a top-line read out from a phase 2 trial in October.
These results came from the CodeBreaK 100 clinical study, which tested the drug in patients whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy.
In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile, Amgen said, although detailed results have yet to be announced.
Full results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium next month.
KRAS is a target that has long evaded pharma companies but early trial results in solid tumours at ASCO led to a round of deal-making involving rivals.
Mirati, a biotech from California, specialises in drugs targeting KRAS and is a step behind Amgen with its rival adagrasib.
Novartis signed a deal to evaluate Mirati’s drug soon after ASCO and Merck & Co and Boehringer Ingelheim are among those who have signed KRAS deals.
Although it looks like the molecules developed so far will work only in lung cancer, rather than the wider range of cancers with KRAS mutations, there is hope the drug will provide a new treatment option for an aggressive and deadly form of the disease.
David Reese, executive vice president of Research and Development at Amgen, said: “Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harbouring the KRAS G12C mutation.”
The newly created organization, dubbed OneTen, aims to create 1 million jobs for Black people over the next decade. Its founders include some big names in healthcare, such as Cleveland Clinic, Intermountain Healthcare and Humana.
Today is the start of our annual end-of-year fundraising drive. Year after year, more than half of our entire annual operating budget has been raised around these final few weeks of December, so we’ve come to count on your giving-season generosity to make a tax-deductible donation to keep NutritionFacts.org going and growing.
This year, we have a special opportunity: A very generous donor is matching the first $100,000 received. You read that right! You have the chance to have your contribution doubled!
I may be the face of NutritionFacts.org, but there’s a veritable army of volunteers and now more than a dozen staff behind the scenes. They help me churn through the thousands of studies a week to stay on top of the science and enable me to bring you daily videos and articles on the latest in evidence-based nutrition.
This is only possible because of you.
Did you know that annual access to even a single academic database like Web of Science can cost nearly $50,000? Every year, thousands of people step forward and make donations large and small to express appreciation for our work. Hundreds have even signed up to be monthly donors, which helps ensure a predictable steady stream of support. Please “root” for the facts by helping us fill the carrot! It’s a numbers game and even a gift of a single dollar can help.
There are many ways to support evidence-based nutrition. On the Donate Page, you can make a tax-deductible gift using a credit card or PayPal. You can also send a check made payable to “NutritionFacts.org” to PO Box 11400, Takoma Park, MD 20913. Federal employees can donate to NutritionFacts.org through the CFC workplace giving program with the designation number 26461.
Thank you for your support. We truly appreciate it!
Live Presentation on Dec. 18: Do Vegans Really Have More Bone Fractures?
Join Dr. Greger for a free, live, one-hour presentation on the recent EPIC-Oxford study findings that suggested plant-based eating has adverse effects on bone health. Is it true? And, if so, what is the mechanism and how can we best protect our skeletons into old age?
Tune in for this deep dive by going to our YouTube channel or Facebook page at 3pm ET on Friday, December 18. Dr. Greger will be streaming to both at the same time!
We are happy to welcome Lucy as our new Social Media Assistant. She comes to us after years of managing a small acupuncture clinic in her community. Lucy is passionate about health equity and drawn to the mission of NutritionFacts.org for this reason. She studied Environmental Studies at Lewis & Clark College in Portland, OR, and enjoys long bike rides and walks with friends, practicing yoga, and tries to read one or two books every week. Lucy currently resides in Minneapolis but tries to get out of Minnesota during the dark winter months as much as possible.
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Volunteer Spotlight: Brad Longworth
“I started working with NF in December 2012 after Dr Greger asked for volunteers at one of his speaking engagements. I have done numerous jobs over the years, but I currently enter all the content on the webpages for each video. I was truly honoured in 2018 by being invited onto the NutritionFacts.org Board of Directors. Helping others has always been a priority for me, and it is a great privilege to work with Dr Greger and observe close-hand his dedication to helping humanity regain and maintain their health. Choosing a favourite recipe is like choosing a favourite child–it can’t really be done! But, lately, I have been really into a BROL bowl (see the recipe in the brand new The How Not to Diet Cookbook!) with steamed spinach, green onion, garlic, and miso paste mixed in.”
Every month, I do a Q&A live from my treadmill, and today is the day.
Join on our Facebook page or YouTube channel at 3pm ET. I’ll be streaming to both at the same time!
You can find links to all of my past live Q&As here on NutritionFacts.org. If that’s not enough, remember I have an audio podcast to keep you company.
And a little reminder that The How Not to Diet Cookbook is now available wherever you get your books. If you’ve gotten it already, we’d love to read your reviews on Amazon!
In health, Michael Greger, M.D.
PS: If you haven’t yet, you can subscribe to my free videos hereand watch my live, year-in-review presentations:
Imagine this: Your elderly mother, who has dementia, is in a nursing home and COVID-19 vaccines are due to arrive in a week or two.
You think she should be vaccinated, having heard the vaccine is effective in generating an immune response in older adults. Your brother disagrees. He worries that development of the vaccine was rushed and doesn’t want your mother to be among the first people to get it.
These kinds of conflicts are likely to arise as COVID vaccines are rolled out to long-term care facilities across the country.
“This is a highly politicized environment, not only with respect to vaccines but also over the existence of the virus itself,” said Michael Dark, a staff attorney with California Advocates for Nursing Home Reform. “It’s not hard to imagine disputes arising within families.”
About 3 million people — most of them elderly — live in nursing homes, assisted living centers and group homes, where more than 105,000 residents have died of COVID-19. They should be among the first Americans to receive vaccines, along with health care workers, according to recommendations from the Centers for Disease Control and Prevention and various state plans.
But long-term care residents’ participation in the fastest and most extensive vaccination effort in U.S. history is clouded by a significant complication: More than half have cognitive impairment or dementia.
This raises a number of questions. Will all older adults in long-term care understand the details of the vaccines and be able to consent to getting them? If individual consent isn’t possible, how will families and surrogate decision-makers get the information they need on a timely basis?
And what if surrogates don’t agree with the decision an elderly person has made and try to intervene?
“Imagine that the patient, who has some degree of cognitive impairment, says ‘yes’ to the vaccine but the surrogate says ‘no’ and tells the nursing home, ‘How dare you try to do this?” said Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison Law School.
Addressing these issues will occur against a backdrop of urgency. Deaths in long-term care facilities are rising dramatically, with new estimates suggesting that 19 residents die of COVID-19 every hour. With viral outbreaks increasing, already-overwhelmed staffers may not have much time to sit down with residents to answer questions or have conversations with families over the phone.
Meanwhile, CVS and Walgreens, the companies operating vaccine programs at most long-term care facilities, have aggressive timetables. Both companies have said the large-scale rollout of the Pfizer-BioNTech vaccine — the first one that the Food and Drug Administration has authorized — will begin on Dec. 21.But facilities in some states may get supplies earlier. Altogether, there are more than 15,000 nursing homes and nearly 29,000 assisted living residences in the U.S.
At a meeting of the federal Advisory Committee on Immunization Practices early this month, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, acknowledged the agency was “very concerned” that information about vaccines be adequately explained to long-term care residents. “It’s very important for the frail elderly not only to ensure that they are understanding the vaccine that they’re getting but also that their family members do,” she said.
Each vaccine manufacturer will be required to prepare a fact sheet describing what’s known about benefits and risks associated with a vaccine, what’s not known, and making it clear that a vaccine has received “emergency use authorization” from the FDA — a conditional endorsement that falls short of full approval. A second vaccine, from Moderna, is poised to receive this kind of authorization after an FDA meeting on Thursday.
Something that will need to be made clear to residents: while vaccines have been tested on people age 65 and older, those tests did not include individuals living in long-term care, according to Dr. Sara Oliver, a CDC expert.
Some operators have crafted communication plans around the vaccines and already begun intensive outreach. Others may not be well prepared.
Juniper Communities operates 22 senior housing communities (a standalone nursing home, multiple memory care and assisted living facilities, and two continuing care retirement communities) in Colorado, New Jersey and Pennsylvania. This week, it is planning an hour-long town hall videoconferencing session for residents and families about coronavirus vaccines. Last week, it held a similar event for staffers.
Juniper has contracted with CVS, which is requiring that every resident and staff member fill out consent forms in triplicate before being inoculated. When written consent can’t be obtained directly, verbal consent, confirmed independently, may substitute. Walgreens has similar requirements.
For residents with memory impairment, two Juniper nurses will reach out by phone to whomever has decision-making authority. “One will ask questions and obtain verbal consent; the other will serve as a witness,” said Lynne Katzmann, Juniper’s founder and chief executive officer. Separately, emails, blog posts and prerecorded voice messages about the vaccines have gone out to Juniper residents and staffers, starting at the end of November.
A key message is “we’ve done this before, not at this scale, mind you, and not at this level of import, but we do flu vaccinations annually,” said Katzmann, who plans to be the first Juniper employee to get the Pfizer vaccine when it comes to New Jersey.
At Genesis Healthcare, crucial messages are “these vaccines have been studied thoroughly, tens of thousands of people have received them already, they’re very, very effective, and no steps have been skipped in the scientific process,” said Dr. Richard Feifer, executive vice president and chief medical officer. Genesis, the nation’s largest long-term care company, operates more than 380 nursing homes and assisted living residences in 26 states, with about 45,000 employees and more than 30,000 residents.
Medical directors at each Genesis facility have been scheduling video conferences with families, residents and staffers during the past few weeks to address concerns. They’ve also distributed a letter and a question-and-answer document prepared by the Society for Post-Acute and Long-Term Care Medicine, in addition to getting information out through closed-circuit TV channels and social media.
In partnership with Brown University researchers, the company will monitor daily the side effects that its long-term care residents experience after getting coronavirus vaccines. Most reactions are expected to be mild or moderate and resolve within a few days. They include fatigue, pain at the injection site, headaches, body aches, fever and, rarely, allergic responses.
Administering the vaccine will occur over three visits for all long-term care facilities. At the first, all Genesis residents and staffers will get inoculations. At the second, three to four weeks later, those same people will get a second dose, and new staffers and residents will get a first dose. At the third, those who still qualify for a second vaccine dose will get one.
What will happen if lots of people experience uncomfortable side effects and employees don’t come in for a couple of days while recovering? “It’s a very difficult problem and we’re making contingency plans to address it,” Feifer said.
And what about continuing care retirement communities — also known as “life plan communities” — where residents in skilled nursing, assisted living and independent living can reside in close proximity?
That’s the case at Bayview in Seattle, which houses 210 residents in a 10-story building. For the moment, independent living residents aren’t on the priority list but “I know there will be a contingent of residents and staff who won’t want to be vaccinated and we’ll see if we can use those vaccines for our independent living people instead,” said Joel Smith, Bayview’s health services administrator.
Logistical challenges are sure to arise, but many operators have an acute sense of mission. “It is critical that we lead the way out of this crisis,” Feifer of Genesis said. “Nursing homes need to go first and be the first ones to address vaccine hesitancy head-on and be successful at generating a high level of acceptance. There is no alternative, no Plan B right now. We have to be successful.”
When her husband was diagnosed with early-stage Alzheimer’s disease in 2015, Elizabeth Pan was devastated by the lack of options to slow his inevitable decline. But she was encouraged when she discovered the work of a UCLA neurologist, Dr. Dale Bredesen, who offered a comprehensive lifestyle management program to halt or even reverse cognitive decline in patients like her husband.
After decades of research, Bredesen had concluded that more than 36 drivers of Alzheimer’s cumulatively contribute to the loss of mental acuity. They range from chronic conditions like heart disease and diabetes to vitamin and hormonal deficiencies, undiagnosed infections and even long-term exposures to toxic substances. Bredesen’s impressive academic credentials lent legitimacy to his approach.
Pan paid $4,000 to a doctor trained in Bredesen’s program for a consultation and a series of extensive laboratory tests, then was referred to another doctor, who devised a stringent regimen of dietary changes that entailed cutting out all sugars, eating a high-fat, low-carbohydrate diet and adhering to a complex regimen of meditation, vigorous daily exercise and about a dozen nutritional supplements each day (at about $200 a month). Pan said she had extensive mold remediation done in her home after the Bredesen doctors told her the substance could be hurting her husband’s brain.
But two years passed, she said, and her husband, Wayne, was steadily declining. To make matters worse, he had lost more than 60 pounds because he didn’t like the food on the diet. In April, he died.
“I imagine it works in some people and doesn’t work in others,” said Pan, who lives in Oakton, Virginia. “But there’s no way to tell ahead of time if it will work for you.”
Bredesen wrote the best-selling 2017 book “The End of Alzheimer’s” and has promoted his ideas in talks to community groups around the country and in radio and TV appearances like “The Dr. Oz Show.” He has also started his own company, Apollo Health, to market his program and train and provide referrals for practitioners.
Unlike other self-help regimens, Bredesen said, his program is an intensely personalized and scientific approach to counteract each individual’s specific deficits by “optimizing the physical body and understanding the molecular drivers of the disease,” he told KHN in a November phone interview. “The vast majority of people improve” as long as they adhere to the regimen.
Bredesen’s peers acknowledge him as an expert on aging. A former postdoctoral fellow under Nobel laureate Stanley Prusiner at the University of California-San Francisco, Bredesen presided over a well-funded lab at UCLA for more than five years. He has been on the UCLA faculty since 1989 and also founded the Buck Institute for Research on Aging in Marin County. He has written or co-authored more than 200 papers.
But colleagues are critical of what they see as his commercial promotion of a largely unproven and costly regimen. They say he strays from long-established scientific norms by relying on anecdotal reports from patients, rather than providing evidence with rigorous research.
“He’s an exceptional scientist,” said George Perry, a neuroscientist at the University of Texas-San Antonio. “But monetizing this is a turnoff.”
“I have seen desperate patients and family members clean out their bank accounts and believe this will help them with every ounce of their being,” said Dr. Joanna Hellmuth, a neurologist in the Memory and Aging Center at UCSF. “They are clinging to hope.”
Many of the lifestyle changes Bredesen promotes are known to be helpful. “The protocol itself is based on very low-quality data, and I worry that vulnerable patients and family members may not understand that,” said Hellmuth. “He trained here” — at UCSF — “so he knows better.”
The Bredesen package doesn’t come cheap. He has built a network of practitioner-followers by training them in his protocol — at $1,800 a pop — in seminars sponsored by the Institute for Functional Medicine, which emphasizes alternative approaches to managing disease. Apollo Health also offers two-week training sessions for a $1,500 fee.
Once trained in his ReCODE Protocol, medical professionals charge patients upward of $300 for a consultation and as much as $10,500 for eight- to 15-month treatment packages. For the ReCODE protocol, aimed at people already suffering from early-stage Alzheimer’s disease or mild cognitive decline, Apollo Health charges an initial $1,399 fee for a referral to a local practitioner that includes an assessment and extensive laboratory tests. Apollo then offers $75-per-month subscriptions that provide cognitive games and online support, and links to another company that offers dietary supplements for an additional $150 to $450 a month. Insurance generally covers little of these costs.
Apollo Health, founded in 1998 and headquartered in Burlingame, California, also offers a protocol geared toward those who have a family history of dementia or want to prevent cognitive decline.
Bredesen estimates that about 5,000 people have done the ReCODE program. The fees are a bargain, Bredesen said, if they slow decline enough to prevent someone from being placed in a nursing home, where yearly costs can climb past $100,000 annually.
Bredesen and his company are tapping into the desperation that has grown out of the failure of a decades-long scientific quest for effective Alzheimer’s treatments. Much of the research money in the field has narrowly focused on amyloid — the barnacle-like gunk that collects outside nerve cells and interferes with the brain’s signaling system — as the main culprits behind cognitive decline. Drugmakers have tried repeatedly, and thus far without much success, to invent a trillion-dollar anti-amyloid drug. There’s been less emphasis in the field on the lifestyle choices that Bredesen stresses.
“Amyloids sucked up all the air in the room,” said Dr. Lon Schneider, an Alzheimer’s researcher and a professor of psychiatry and behavioral sciences at the Keck School of Medicine at USC.
Growing evidence shows lifestyle changes help delay the progress of the mind-robbing disease. An exhaustive Lancet report in August identified a long list of risk factors for dementia, including excessive drinking, exposure to air pollution, obesity, loss of hearing, smoking, depression, lack of exercise and social isolation. Controlling these factors — which can be done on the cheap — could delay or even prevent up to 40% of dementia cases, according to the report.
Bredesen’s program involves all these practices, with personalized bells and whistles like intermittent fasting, meditation and supplements. Bredesen’s scientific peers question whether data supports his micromanaged approach over plain-vanilla healthy living.
Bredesen haspublishedthree papersshowing positive results in many patients following his approach, but critics say he has fallen short of proving his method’s effectiveness.
The papers lack details on which protocol elements were followed, or the treatment duration, UCSF’s Hellmuth said. Nor do they explain how cognitive tests were conducted or evaluated, so it’s difficult to gauge whether improvements were due to the intervention, to chance variations in performance or an assortment of other variables, she said.
Bredesen shrugs off the criticism: “We want things to be in an open-access journal so everybody can read it. These are still peer-reviewed journals. So what’s the problem?”
Another problem raised about Bredesen’s enterprise is the lack of quality control, which he acknowledges. Apollo-trained “certified practitioners” can include everyone from nurses and dietitians to chiropractors and health coaches. Practitioners with varying degrees of training and competence can take his classes and hang out a shingle. That’s a painful fact for some who buy the package.
“I had the impression these practitioners were certified, but I realize they all had just taken a two-week course,” said a Virginia man who requested anonymity to protect his wife’s privacy. He said that he had spent more than $15,000 on tests and treatments for his ailing spouse and that six months into the program, earlier this year, she had failed to improve.
Bredesen said he and his staff were reviewing “who’s getting the best results and who’s getting the worst results,” and intended to cut poor performers out of the network. “We’ll make it so that you can only see the people getting the best results,” he said.
Colleagues say that to test whether Bredesen’s method works it needs to be subjected to a placebo-controlled study, the gold standard of medical research, in which half the participants get the treatment while the other half don’t.
In the absence of rigorous studies, said USC’s Schneider, a co-author of the Lancet report, “saying you can ‘end Alzheimer’s now and this is how you do it’ is overpromising and oversimplifying. And a lot of it is just common sense.”
Bredesen no longer says his method can end Alzheimer’s, despite the title of his book. Apollo Health’s website still makes that claim, however.
In the last few years, biopharma companies focusing on psychedelic medicines have been springing up like mushrooms – magic or otherwise – and venture capital money is starting to follow.
Today sees the launch of the first investment fund in the UK devoted to psychedelic healthcare, with plans to invest in “revolutionary mind-altering medicines to treat illnesses including depression, addiction, anxiety and inflammation.”
The fund has been set up by London-based VC Neo Kuma Ventures, a new group formed by Sean McLintock, Clara Burtenshaw and Nick David in 2019. The co-founders say it has already attracted “millions of pounds” in investment, and will continue to draw funds through the first half of next year.
Last year Neo Kuma’s founders backed ATAI Life Sciences AG, a part owner of Compass Pathways, which is a UK-based company trying to develop medicines based on a synthetic version of psilocybin, the main psychoactive constituent in magic mushrooms.
In September, Compass became the first psychedelic medicine company to float on the Nasdaq, raising $127 million, and is now trading at a market cap of $1.98 billion.
Shortly after, US biotech Mind Medicine – already trading publicly on Canada’s Neo exchange – applied for a Nasdaq up-listing as it advances a suite of psychedelic medicines based on MDMA, LSD and ibogaine derivative 18-MC. It is going after disorders like anxiety, opioid addiction and adult attention-deficit hyperactivity disorder.
Around the same time, Toronto-based Field Trip Psychedelics went public on Canada’s CSE after it completed a reverse takeover of oil and gas company Newton Energy Corp, which followed an CAD 12 million private placement deal.
As well as offering ketamine-assisted treatment clinics, the company is also working on FT104, a novel synthetic hallucinogen for mental health disorders. Meanwhile, other players in the sector include Cybin – which has just acquired rival Adelia Therapeutics for just under $16 million – as well as Numinus Wellness and Verrian Ontario.
Data Bridge Market Research published report earlier this year suggesting that the psychedelic drugs market is projected to grow at around 16% per year over the next eight years to reach $6.85 billion in 2027, spearheaded by new therapies like Johnson & Johnson’s Spravato (esketamine) for treatment-resistant depression.
NeoKuma draws parallels with the medicinal cannabis market, citing research which suggests that in the US it has surged from around $2 billion in 2014 to an estimated $35 billion this year.
“As the medical benefits of psychedelics become more well-known and regulators steadily increase their embrace of these types of drugs, the industry is set for a boom,” says McLintock.
“While much of the conversation on psychedelics is taking place in the US, Europe is the true hub of the burgeoning psychedelic healthcare sector. We look forward to investing in the most exciting, high quality and scientifically-sound European players in the industry to facilitate their ground-breaking research.”
– Artificial intelligence algorithms can predict outcomes
of COVID-19 patients with mild symptoms in emergency rooms, according to recent
research findings published in Radiology: Artificial Intelligence journal.
– Researchers trained the algorithm from data on 338
positive COVID-19 patients between the ages of 21 and 50 by using diverse
patient data from emergency departments within Mount Sinai Health System
hospitals (The Mount Sinai Hospital in Manhattan, Mount Sinai Queens, and Mount
Sinai Brooklyn) between March 10 and March 26.
Mount Sinai researchers have developed an artificial intelligence algorithm to rapidly predict outcomes of COVID-19 patients in the emergency room based on test and imaging results. Published in the journal, Radiology: Artificial Intelligence, the research reveals that if the AI algorithms were implemented in the clinical setting, hospital doctors can identify patients at high risk of developing severe cases of COVID-19 based on the severity score. This can lead to closer observation and more aggressive and quicker treatment.
They trained the algorithm using electronic medical records (EMRs) of patients between 21 and 50 years old and combined their lab tests and chest X-rays to create this deep learning model. Investigators came up with a severity score to determine who is at the highest risk of intubation or death within 30 days of arriving at the hospital. If applied in a clinical setting, this deep learning model could help emergency room staff better identify which patients may become sicker and lead to closer observation and quicker triage, and could expedite treatment before hospital admission.
Led by Fred Kwon, Ph.D., Biomedical Sciences at the Icahn School of Medicine at Mount Sinai, researchers trained the algorithm from data on 338 positive COVID-19 patients between the ages of 21 and 50 by using diverse patient data from emergency departments within Mount Sinai Health System hospitals (The Mount Sinai Hospital in Manhattan, Mount Sinai Queens, and Mount Sinai Brooklyn) between March 10 and March 26. Data from the emergency room including chest X-rays, bloodwork (basic metabolic panel, complete blood counts), and blood pressure were used to develop a severity score and predict the disease course of COVID-19.
Patients with a higher severity score would require
closer observation. The researchers then tested the algorithm using patient data on other patients in all adult age groups and
ethnicities. The algorithm has an 82 percent sensitivity to predict intubation and death within 30 days of
arriving at the hospital.
Many patients with COVID-19, especially younger ones, may show non-specific symptoms when they arrive at the emergency room, including cough, fever, and
respiratory issues that don’t provide any indication of disease severity. As a
result, clinicians cannot easily identify patients who get worse quickly. This algorithm can provide the probability that a patient may
require intubation before they get worse. That way clinicians can make more accurate decisions for appropriate
Algorithms that predict outcomes of patients with COVID-19 do exist, but they are used in admitted patients who have already developed more severe symptoms and have additional imaging and laboratory
data taken after hospital admission. This algorithm is different since it predicts outcomes in COVID-19 patients while they’re in the emergency room—even in those with mild symptoms. It only uses information from the initial
patient encounter in the hospital emergency department.
“Our algorithm demonstrates that initial imaging and laboratory tests contain sufficient information to predict outcomes of patients with COVID-19. The algorithm can help clinicians anticipate acute worsening (decompensation) of patients, even those who present without any symptoms, to make sure resources are appropriately allocated,” explains Dr. Kwon. “We are working to incorporate this algorithm-generated severity score into the clinical workflow to inform treatment decisions and flag high-risk patients in the future.”
The global scheme to deliver Covid-19 vaccines to poorer countries faces a “very high” risk of failure, potentially leaving billions of people with no access to vaccines until as late as 2024, internal documents say.
The Covax scheme has been beset by a number of issues, including a shortage of doses of approved vaccines, and a decision by India’s Serum Institute, which was initially earmarked to supply Covax, saying it would prioritise supplying India first.
The holidays are upon us, which means not only stay-cations and zooming with family and friends, but also treats, sweets, and much more imbibing.
Staying healthy over the holidays can be tricky for a variety of reasons — your routine is already gets thrown out of whack due to holiday parties (virtual or in-person) and time off, leading to lack of sleep and missed workouts.
Here are a few reasons why nutrition is important during the holidays.
Nutrition Can Impact Your Immune System
During the holiday season, most people are getting enough calories.
But do those calories come from a healthy balanced diet that includes a wide variety of fruit, vegetables, and other nutrient-dense foods?
And according to the Mayo Clinic, “Long-term lack of sleep also increases your risk of obesity, diabetes, and heart and blood vessel (cardiovascular) disease.”
But there’s no reason you can’t end the year on a good note.
“Eating healthy doesn’t mean that you have to eat perfectly,” says Quyen Vu, the culinary nutrition specialist for Beachbody. “Of course, we want to include mostly nourishing foods, but some foods nourish the body, and others nourish the soul — there’s a balance to it.”
Read on to find out how to dial up your nutritional self-care game during the holidays.
1. Eat when you’re hungry and stop when you’re full
Instead of zoning out in front of the latest Netflix holiday flick, focus on what you are eating and who you are with, whether it’s in person or a virtual space.
Focus on how you feel before you start eating so that you can know precisely when you are full and need to stop.
And don’t forget — you can always have leftovers if you aren’t done with that holiday ham or the last of those sugar cookies.
2. Cook in-season produce
Aim to add in a few fresh and timely ingredients to your regular holiday staples. As Vu says, in-season veggies and fruit will have the best taste, quality, and nutritional content.
Vu recommends eating foods that you crave and not letting one food rule over your thoughts and action.
Research shows that a non-dieting approach to eating healthy results in improvements in eating and weight-related behaviors, so say yes to balance and no to feeling guilty.
Rather than swearing off sugar, which will only leave you thinking about sweets, Vu recommends making sure you’re not ravenous before you have dessert.
Eat a balanced meal before so that you won’t overindulge. When eating dessert, really savor the flavor and experience it, instead of shoveling it down.
Be present and enjoy your sweet treat.
4. Alternate between alcohol and water
“Alcohol can increase appetite, so drinking water between drinks is important,” says Ben Walker, a certified personal trainer, founder of Anywhere Fitness, and a Precision Nutrition-certified coach. “Not only does it sober you up, but it also suppresses hunger and helps you avoid the temptation to eat more calories later.”
5. Learn to Say “No”
This might be easier this year than others, especially if you’re celebrating the holidays over zoom, but learning to decline a second helping politely is a necessary skill.
“It’s important to learn how to decline people for foods and snacks in the evening politely,” says Walker. “It’s important to not feel guilty passing up on more calories.”
Like Vu says, when you are full, stop eating, and don’t let anyone pressure you into that extra slice of pie.
Research shows that even though you think that extra cookie will make you feel better during a stressful time, it doesn’t.
A study in the journal of Psychoneuroendocrinology found that by replacing unhealthy comfort foods with fruits and vegetables, women can potentially improve the quality of their diet without sacrificing any of the stress-reducing benefits.
Plan to exercise on the mornings of these big holiday events, eat regular meals before the main event, and get plenty of rest.
If you need help choosing a nutrition program to follow, talk to your Team Beachbody coach or head to BODNutrition.com to get an overview of both programs so you can figure out which one is best for your lifestyle.
You can try Nutrition+ risk-free for 30 days by purchasing a Nutrition+ Membership or when you purchase select Beachbody On Demand Challenge or Completion Packs.
If you bought a bit more garlic than you need, no worries — as long as you know how to store garlic properly, unpeeled bulbs can stay fresh for up to five months.
Here are six techniques to help your garlic supply stay fresh for as long as possible.
1. Store It Somewhere Cool
Fresh bulbs should be stored somewhere cool, dark, and dry. “For most people, the pantry fits the bill,” says Adrien Paczosa, R.D., L.D., CEDRD-S.
If your pantry has a window, consider adding a shade to block light and heat.
The ideal storage temperature is around 60° F. It’s okay if your kitchen is typically a bit warmer than that, but don’t store garlic in a cabinet next to the stove.
Trapped moisture can cause garlic to spoil, so store bulbs in a well-ventilated container such as a wire or mesh basket.
2. Refrigerate It
The fridge generally isn’t the ideal place to store garlic. While storing whole, unpeeled garlic in the crisper drawer will help to prevent moisture, garlic will actually sprout faster in cold temperatures — so the pantry is still a better bet for fresh bulbs.
Leftover chopped garlic can be stored in the fridge, but use it up quickly as it may start to sprout or spoil within a few days.
“If you’re going to put it in the refrigerator, store it in an airtight, glass container because plastic is permeable and will absorb the smell,” Paczosa says. “I love Mason jars because they’re glass and you can get a tight seal.”
If garlic starts to sprout or change color, it’s time to toss it.
“When you open it, it should be white,” Paczosa adds. “If it’s tan or has spots on it, it’s going bad.”
3. Freeze Single Servings
If your garlic is nearing the end of its shelf life, prep it and store it in the freezer.
“Pulverize it by putting it in a blender, and then put it in an ice tray to freeze,” says Paczosa. “This gives you about a tablespoon ready to thaw and use.”
It’s much easier than peeling and chopping a fresh clove every time you cook — and you won’t have to worry about your hands smelling like garlic!
4. Buy Prepared Garlic
The strong flavor of fresh garlic isn’t for everyone. Prepared garlic — which may be stored in oil, water, or vinegar — tends to have a lighter flavor than fresh garlic, but it still has the same healthy benefits.
(Just keep in mind if the garlic is stored in oil, there will be added calories coming from the oil.)
If you want to avoid the flavor of vinegar or the added calories of oil, opt for prepared garlic that’s soaked in water.
5. Pickle It
If you’re looking for a new flavor profile for your garlic, try pickling it. By storing garlic cloves in vinegar, you not only extend the shelf life, but you also create a tasty treat.
“For the garlic lovers, you can have pickled garlic just like an olive on a charcuterie board,” Paczosa says. “Sliced pickled garlic with cheese and crackers adds a different texture and taste.”
6. Roast and Store
If you have a bunch of fresh garlic and don’t know what to do with it, simply roast it and freeze it to keep it fresh longer. Here’s how:
Peel the outer layers away from the garlic and cut the top off the bulb.
Rub with olive oil and sprinkle with salt and pepper.
Wrap garlic in foil and place in a baking dish.
Bake at 400°F for about 40 minutes.
Let cool and remove cloves.
Store the roasted cloves in the freezer and thaw as needed. Roasted garlic has a mellow garlic flavor and is great for cooking and spreading on toast or crackers.
But amid competing philosophies on nutrition and endless menu options, how do we know which foods are nutrient-dense foods?
What Are Nutrient-Dense Foods?
“Nutrient-dense foods are foods that are rich in nutrients in relation to the number of calories they contain,” says Rima Kleiner, M.S., R.D., and blogger at Dish on Fish.
“In other words, nutrient-dense foods provide a lot of nutrient bang — vitamins, minerals, antioxidants, dietary fiber — for a low-calorie buck,” she explains.
For example, both an apple and a handful of jelly beans clock in at about 100 calories.
Calorically speaking, they’re quite similar.
But while the jelly beans offer carbohydrates in the form of sugar (and not much else), the apple, a nutrient-dense food, contains carbohydrates, fiber, potassium, vitamin C, and vitamin B6.
Our bodies need nutrients like these to function properly and maintain our immune systems.
“Really, most whole foods that have been minimally-processed are typically nutrient-dense foods,” Kleiner says. “While it’s easy to get hung up on specific foods or nutrients, we should aim to get a variety of nutrients from a variety of whole foods.”
To ensure your diet is healthy and balanced, fill your plate with an assortment of these nutrient-dense foods.
1. Fruits and Vegetables
Unsurprisingly, fruits and vegetables top the list of nutrient-dense foods you need to maintain a healthy diet.
In addition to essential vitamins and minerals, fruits and vegetables are packed with antioxidants.
Antioxidants help counteract unstable molecules called free radicals, which can cause damage to the body’s cells through a process called oxidative stress.
A fruit or vegetable’s color is actually a sign of its antioxidant properties, says Quyen Vu, M.S., Culinary Nutrition Specialist at Beachbody.
“Red is an indicator of lycopene, which is found in tomatoes,” she says. “Yellow or orange means beta carotene, found in carrots. And blue or purple signifies anthocyanins, which are found in blueberries.
This is why it’s important to “eat the rainbow.”
2. Whole Grains
Oats, brown rice, whole wheat, and barley are all nutrient-dense foods that fall under the category of whole grains.
According to Kleiner, you should aim to fill a quarter of your plate with these nutrient-dense foods, which are rich in B vitamins, antioxidants, and fiber (including prebiotics).
Looking to drop a few pounds or just maintain a healthy weight? Don’t skip whole grains.
Brown rice contains more arsenic than white rice, but the arsenic in brown rice is less absorbable, so how does it wash out when you compare the urine arsenic levels of white-rice eaters to brown-rice eaters?
Arsenic in rice is a cause for concern, according to a consensus statement by the European and North American societies for pediatric nutrition. At the very least, “in areas of the world where rice consumption is high in all ages, authorities should be prompted to declare which of the rice [types] have the lowest arsenic content and are, therefore, the least harmful for use during infancy and childhood.” I look into the arsenic content of different rices in my video Which Rice Has Less Arsenic: Black, Brown, Red, White, or Wild?.
Extensive recent testing by the FDA found that long grain white rice, which is what most people eat, appears to have more arsenic than medium or short grain rice, but this may be because most of the shorter grains are produced in California, which has significantly less contaminated rice paddies than those in the South, such as in Texas or Arkansas, where most of the long grain rice is grown. So, it’s less long grain versus short grain than white rice versus brown rice, as the mean concentration of inorganic arsenic in parts per billion of long grain white rice is 102.0 and 156.5 in short, medium, and long grain brown rice, as you can see at 0:54 in my video.
What about some of the naturally pigmented varieties like red rice or black rice, which may be even healthier than brown? As you can see at 1:08 in my video, they may contain even less arsenic than white rice. One sample of black rice from China that was purchased in Kuwait had higher levels for total arsenic, so the toxic inorganic portion may only be half that, putting it on par with U.S. brown rice. The study’s red rice sample from Sri Lanka was even more extraordinary, with less than a fifth of the arsenic of the Chinese black rice. But, the Sri Lankan red rice sample had a ridiculous high amount of cadmium, evidently attributed to the cadmium content of widely used Sri Lankan fertilizers.
Colored rice samples purchased mostly in the United States were better than brown or white, and a dozen samples of red rice purchased in Europe were as bad, or even worse, as brown rice. I was hoping that wild rice would have little or no arsenic because it’s a totally different plant, but an average of eight samples showed it to be nearly comparable to white, though the wild rice samples contained only half as much toxic arsenic as brown rice.
As you can see at 2:06 in my video, the arsenic found in a daily serving of white rice carries 136 times the acceptable cancer risk, but brown rice is even riskier at 162. Brown rice averages two-thirds more toxic arsenic than white rice. But, is that just because brown rice tends to be a different strain or grown in different places? No. If you take the exact same batch of brown rice and measure the arsenic levels before and after polishing it to white, you do get a significant drop in arsenic content.
It’s not what you eat, though. It’s what you absorb. The arsenic in brown rice appears to be less bioavailable than the arsenic in white rice. The texture of brown rice may cut down on the release of arsenic from the grain, or perhaps the bran in brown rice helps bind it up. Regardless, taking bioavailability into account, the difference in arsenic levels in white versus brown rice may be a third more, rather than 70 percent more, as you can see at 2:57 in my video. This estimate, however, was based on an in vitro gastrointestinal fluid system in which researchers strung together beakers and tubes to mimic our gut, with one flask containing stomach acid and another intestinal juices. What happened when it was tested in humans? Yes, “evidence suggests that brown rice may contain more arsenic than white rice,” but the researchers aimed to determine how much is actually absorbed by measuring the urine levels of arsenic in white-rice eaters compared with brown-rice eaters. For the arsenic to get from the rice into your bladder, it has to be absorbed through your gut into your bloodstream.
As you can see at 3:45 in my video, the urine of thousands of American test subjects who don’t eat rice at all still contains about 8 micrograms of toxic, carcinogenic arsenic a day. It’s in the air, it’s in the water, and there’s a little bit in nearly all foods. But, eat just one food—a cup or more of white rice a day—and your arsenic exposure shoots up by 65 percent to about 13 micrograms a day.
What about those who eat a cup or more of brown rice every day, which technically contains even more arsenic? Their exposure shoots up the same 65 percent. There is no difference between the urine arsenic levels of white-rice eaters compared with brown-rice eaters. However, this was not an interventional study in which they fed people the same amount of rice to see what happened, which would have been ideal. Instead, it was a population study, so maybe the reason the levels are the same is that white-rice eaters eat more rice than do brown-rice eaters. Could that be why they ended up with the same levels? We don’t know, but it should help to put the minds of brown-rice eaters to rest. But would it be better to eat no rice at all? That’s what I’ll explore in my next few blogs.
If you’re just joining in on this topic, check out these lead-up videos:
The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose of single 600mg infusions were administered over a shorter, 2hrs. time
Results: frequency of IRRs post 600mg infusion (24.6% vs 23.1%), majority of IRRs were mild or moderate, and >98% resolved in both groups without complication
Ocrevus is a humanized mAb designed to target CD20-positive B cells and is the first and only therapy approved for both RMS and PPMS
Click here to read full press release/ article | Ref: Genentech | Image: Xconomy
The holiday season may look a little different for 2020, but it’s still a super busy time of year for many of us.
Whether you’ve got virtual meet-ups with close friends and family, you’re online shopping for thoughtful gifts for everyone on your list, or you’re working out (and working) at home, there’s a lot on your plate right now — including holiday treats.
When you’re trying to juggle work, life, and balanced eating, Shakeology can be a key part of your strategy for good nutrition.
Here are some tips for having a happy and healthy holiday season with the help of Shakeology, even when you’re surrounded by sugar cookies and candy canes.
Bring on the merrymaking!
1. Eat mindfully at big meals
“Shakeology’s protein and fiber help keep you feeling full and satisfied so you don’t overindulge this holiday season,” says Krista Maguire, R.D., C.S.S.D., Beachbody Nutrition Manager. “A clinical trial showed that drinking Shakeology before a meal reduced desire to eat and reduced hunger.”
2. Curb cravings with a nutritious alternative
Treats are part of what makes the holidays fun, and we all want to celebrate this time of year.
“Shakeology is a great way to quench your cravings for something indulgent while providing more nutrients than you’d get from traditional holiday desserts,” adds Maguire.
3. Stay charged when you’re short on time
Some days are so hectic, it’s hard to eat properly this time of year. However, this can slow down your metabolism, explains Shena Jaramillo, M.S., R.D.
“Shakes are an excellent thing to keep on hand in case you don’t have access to a full meal or snack,” she adds.
4. Eat regularly
When you skip meals in an effort to eat less, it can cause you to overdo it later.
“It usually leads to consuming more calories than we would have during the day,” says Jaramillo. Sipping a Shakeology shake can keep you nourished, to avoid “hanger.”
It’s OK to celebrate responsibly with a holiday cocktail and share a toast with friends.
For a modern spin on eggnog, our spiked Pumpkin Spice Shakeology Eggnog with Rum recipe combines the yumminess of a PSL with a Yuletide classic and a dash of rum. It’s a soul-warming mix for holiday cheer!
As the first microbiome-based therapeutic steps closer to market approval, the scientific community continue to demonstrate the functional role of the human microbiome as a novel source of therapeutic, biomarker and diagnostic development. Despite this progress, the vast potential to develop effective treatments that target the human microbiome is still limited by the complex challenges in developing them.
Part of the foremost conference series for microbiome researchers in industry, the 5th Microbiome Movement – Drug Development Europe 2021 will return to unite leading scientists from the biopharmaceutical and academic community to pursue the causal role of the microbiome in disease, and help create a new generation of microbiome-targeted therapeutics with predictable modes of action and consistent clinical outcomes.
Over three jam-packed days of case-studies, discussion and debates, this year’s event will shine a light on how industry and academic leaders are understanding microbiome functionality across key therapeutic modalities, leveraging big data platforms to deduce causality, and overcoming regulatory, clinical and manufacturing hurdles to further accelerate their pipeline across new disease targets.
So whether you’re part of a microbiome-focused biotech, a pharmaceutical organization assessing this exciting field, or an academic researcher with breakthrough findings, join the Microbiome Movement as we explore the global advances in translational microbiome research, and meet like-minded peers who are continuing to understand the causal and therapeutic potential of the ‘second genome’.
The approval is based on P-lll ETHOS involve the assessing of Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) vs Bevespi Aerosphere and PT009 in adult patients with mod. to sev. COPD. P-III KRONOS study also supported the approval
The study showed a reduction in rate of mod. or sev. exacerbations. EMA’s CHMP has recommended the MAA for Trixeo Aerosphere in Oct’2020
Trixeo Aerosphere is a single-inhaler, fixed-dose triple-combination of formoterol fumarate LABA, LAMA, with budesonide, an ICS, and delivered in a pressurized metered-dose inhaler. The approval marks the fourth major approval of the therapy
Click here to read full press release/ article | Ref: AstraZeneca | Image: Global Justice Now
Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which is tipped to become a multibillion-dollar blockbuster.
At its meeting last week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Enhertu (trastuzumab deruxtecan) for patients with unresectable or metastatic HER2-positive breast cancer, who have been previously treated with other anti-HER2 drugs.
Enhertu has already been approved for third-line use in HER2-positive breast cancer in the US at the end of 2019 and in Japan earlier this year, based on the results of the phase 2 DESTINY-Breast01 trial in 184 patients, which revealed that the drug shrank tumours in 61% of recipients.
Revenues from the drug in the first nine months of 2020 came in at $136 million – including $60 million in the third quarter.
Sales were recorded by Daiichi Sankyo, with AZ pocketing $63 million in profit sharing, and according to AZ the drug is now the most prescribed medicine in the third-line and fourth-line settings of HER2-positive metastatic breast cancer.
Enhertu consists of the antibody used in Roche’s blockbuster HER2 antibody Herceptin (trastuzumab), linked to a topoisomerase inhibitor that is toxic to cancer cells. Around one in five patients with breast cancer are considered HER2 positive, which is associated with aggressive disease, a high recurrence rate, and an increased risk of dying.
It works by latching on to HER2-positive cancer cells and delivering a payload to kill them, while ignoring healthy cells, in patients who have failed to respond to Roche’s HER2-targeting cancer drugs Herceptin, Perjeta (pertuzumab), and ADC Kadcyla (trastuzumab emtansine).
Kadcyla was once tipped to become the go-to treatment HER2-posiitve breast cancer when first line drugs like Herceptin/Perjeta had failed, but failed to meet the mark in pivotal trials, truncating its sales growth although it still managed to break into the $1 billion-plus bracket.
Daiichi Sankyo is confident Enhertu can top Roche’s ADC, and also expand the use of HER2 drugs into new cancers like HER2-positive gastric cancer – an indication that is under review by the FDA with a verdict due early next year – and HER2-positive non-small cell lung cancer (NSCLC).
The intention is to gradually position the drug for earlier-line use in breast, gastric and lung cancer, and eventually to try to expand its use into certain low HER2-expressing tumours.
If all the pieces fall into place it reckons peak sales could reach $4.5 billion, and there are plenty of analysts predicting that the drug could quickly breach the $2 billion-a-year threshold.
AZ’s confidence in the potential of Enhertu is evidence from the terms of its late 2019 licensing deal with Daiichi Sankyo, which included a hefty $1.35 billion upfronting a deal that could be worth up to $6.9 billion if all the ADC’s development and sales objectives are achieved.
If you’ve been waiting for a big recipe to showcase your culinary talents with Quest products, these Santa Hat Mini Cheesecakes are just the challenge for you this season! They’re a little involved to make, but when you’re done you an the others in your home are going to be […]
A global health crisis has thrust us into a scenario in which lives quite literally depend on the ability to virtually connect. Telehealth has rapidly emerged as a vital tool, enabling continuity of care, allowing vulnerable individuals to access their physician from home, and freeing up resources for providers to treat the most critical patients. The acceptance of telehealth and expansion of covered services for the senior population demonstrate that this technology will endure long after COVID-19 subsides.
Prior to the pandemic, just 11% of Americans utilized telehealth compared to 46% so far this year, and virtual healthcare interactions are expected to top 1 billion by year’s end. While the technology has been a life-saver for many, usage depends heavily on the availability of audio-video capabilities, internet access, and technological prowess – potentially leaving vulnerable patients behind.
Seniors Face Physical, Technical and Socioeconomic Barriers to Telehealth