Do the Pros of Brown Rice Outweigh the Cons of Arsenic?

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 is increasing 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 sideshowing 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:

And you may be interested in Benefits of Turmeric for Arsenic Exposure.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

India’s Covid-19 Vaccine Drive Begins

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

India’s Covid-19 Vaccine Drive Begins

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

India’s Covid-19 Vaccine Drive Begins

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

India’s Covid-19 Vaccine Drive Begins

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

A Mix of Pride and Doubts as Modi Launches India’s Covid-19 Vaccine Drive

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

How Much Arsenic in Rice Is Too Much?

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?

What?!

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:

You may also be interested in Benefits of Turmeric for Arsenic Exposure.

Only two major questions remain: Should we moderate our intake of white rice or should we minimize it? And, are there unique benefits to brown rice that would justify keeping it in our diet despite the arsenic content? I cover these issues in the final two videos: Is White Rice a Yellow-Light or Red-Light Food? and Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other

The approvals, which include a shot developed by Bharat Biotech, an Indian pharmaceutical company, begin a vast campaign to inoculate the hard-hit nation’s 1.3 billion people.

Arsenic in Rice Milk, Rice Krispies, and Brown Rice Syrup

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.

Do you know where Americans get most of their rice arsenic? From Rice Krispies, though brown rice crisps cereal may have twice as much, as I discuss 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 could make 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.

I have released several videos on soy milk, but only one on almond milk video so far: Prostate Cancer and Organic Milk vs. Almond Milk. I plan on producing many more on choosing between various milk options, so stay tuned.


If you’ve missed any of the useful material on dietary arsenic I’ve also shared, please see:

The final four videos in this series take all of this information and try to distill it into practical recommendations:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Shots:

  • In the agreement, Aurobindo has obtained the exclusive rights to develop, manufacture & sell COVAXX’s UB-612 vaccine in India & UNICEF & also non-exclusive rights in other selected emerging & developing markets
  • UB-612 is presently being assessed in P-I will be manufactured by Aurobindo in its Hyderabad facility has a manufacturing capacity of 220M doses with an upcoming capacity of ~480M doses by June 2021
  • COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in P-I and plans to initiate P-II/II by Q1 2021 in Asia, Latin America, and the USA

Click here ­to­ read full press release/ article | Ref: PRNewswire  | Image: The Loadstar

The post Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF first appeared on PharmaShots.

Which Rice Has the Least Amount of Arsenic: Black, Brown, Red, White, or Wild?

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:

 

It seems like each of these videos just raises more questions, but don’t worry because I’ve got answers for you. See:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

Will everyone in the world have access to a Covid vaccine? – video explainer

The hunt for a coronavirus vaccine is showing promise but it is premature to say the end of the pandemic is nigh. Several rich countries have signed a ‘frenzy of deals’ that could prevent many poor nations from getting access to immunisation until at least 2024. Also, many drug firms are potentially refusing to waive patents and other intellectual property rights in order to secure exclusive rights to any cure.

Michael Safi, the Guardian’s international correspondent, explains why ‘vaccine nationalisation’ could scupper global efforts to kill the virus and examines what is being done to tackle the issue

Continue reading…

CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test

Shots:

  • Co-Diagnostics’ JV CoSara has received CDSCO’s clearance to manufacture and sell its Saragene COVID-19 2-gene multiplex RT-PCR test as an IVD, intended for the qualitative detection of the SARS-CoV-2 virus
  • The kit leverages CoPrimer technology & is based on a test originally designed by Co-Diagnostics, who secured CE marking for its Logix Smart SARS-CoV-2 multiplex test in Feb’2020
  • To identify the virus presence, both the tests target two gene markers of the SARS-CoV-2 genome i.e. RdRp and E-gene. Additionally, CoSara prior received CDSCO’s approval for RT-PCR tests for mycobacterium tuberculosis, malaria, hepatitis B & C and HPV to be manufactured & sold as IVDs in India

Click here ­to­ read full press release/ article | Ref: Co-Diagnostics | Image: Co-Diagnostics

The post CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test first appeared on PharmaShots.

ViewPoints Article: Digital Healthcare in India – Current Trends & Future

Digital healthcare means using communications and information technologies in medicine to diagnose, predict, treat, and monitor diseases. It is also widely used for prognosis, rehabilitation, behavioral health, and public health.  Indians have witnessed a surge of smartphone and internet use since the last decade. This had led to an easier delivery of smart digital solutions. Known inequalities in access to healthcare, lack of trained professionals, outdated infrastructure, and low healthcare budget are some of the problems in India. Modern healthcare technology and innovation is the solution to improve the health status of the country. Similarly, the healthcare system is continuously being transformed with the latest technology. It is believed that in the coming decade, all pharmaceutical companies will leverage available technology to improve clinical outcomes.  India`s healthcare industry has grown from $100 Billion (2015) to $280 Billion (2020) and is rapidly surging at a CAGR of 18.3%

Amidst Covid-19, there is a fortunate surge in innovation and locally made technology in India. The government is enthusiastic about digital solutions for rapid diagnostic methods among other innovations. Technology should be consumer-friendly, efficacious, and affordable. India is not far behind in terms of innovation.

The objectives of digital health products and services are: 

  • To improve clinical outcomes
  • To improve the patient experience
  • To be consumer-friendly
  • To improve the physician provider experience.
  • To address health problems 

Need of Digital Technology to Manage Health

A plethora of issues exist in India`s healthcare sector which are still untouched by digital technology. Antibiotic resistance, medical reimbursement, TB, malaria, diabetes should be targeted in the coming decade.

The ratio of patients to doctors is below the acceptance rate. India does not meet minimum WHO recommendations for the healthcare workforce and infrastructure.

Image Source: PwC Analysis

In short, Digital healthcare is needed for the following:

  • To improve access to healthcare
  • To reduce healthcare inefficiency
  • To improve the quality of care
  • To lower the cost of healthcare
  • To Provide individualized health care

Current Scenario

India is climbing the peak of the digital health revolution. The majority of healthcare professionals (HCPs) use electronic medical records (EMRs) for more efficient medical practice.

For a few years, novel digital solutions are gaining popularity with joints from private and public sectors. The government has recently launched the much needed National Digital Health Mission (NDHM). The private sector has rolled out mobile apps, telemedicine, research centers among other initiatives. Telemedicine, Artificial Intelligence (AI), mobile apps, robotics, and virtual reality (VR) are gaining popularity. Digital intervention in healthcare is expected to drive the industry at a CAGR of 23% by 2020.

India is climbing the peak of the digital health revolution. The majority of healthcare professionals (HCPs) use electronic medical records (EMRs) for more efficient medical practice.

Top 10 Digital Health Solutions

  1. M-health: A simple mobile app that provides online video consultation and an added feature to book laboratory tests online. It has an estimated market size of 5,184 crore INR in 2020.
  2. Remote diagnosis – These products provide point-of-care diagnostics, teleconsultation, and online prescription capabilities thus increasing access to healthcare in rural areas. For example, a wireless monitor that measures blood pressure, oxygen saturation, pulse, body temperature, blood sugar, blood cholesterol, and total hemoglobin (Hb) count with a mobile application on your smartphone. It is expected to grow at a CAGR of 20%.
  3. Telemedicine – It is the use of digital technology for remote diagnosis, monitoring, and patient counseling. The high volume of patient load (millions) on a few doctors (thousands) may burden the whole system and reduce its efficiency. Telemedicine or Virtual consultation will enhance patient experience and engagement; fewer tests would be prescribed; the rate of hospital re-admission will be less; better medication and patient adherence would lead to desired clinical outcomes.  It is a rapidly emerging sector in India and the telemedicine market in India is expected to reach $32 million by 2020
  4. Digital Connectivity – support groups and knowledge portals for patients and digital chatting platforms for medical professionals.
  5. Wearables – They are used to measure basic health parameters such as heart rate, number of steps, sleep pattern, etc. For example, exercise trackers, oximeters. The overall market for this is currently valued at 30 crore INR.
  6. Big Data Analytics – Healthcare players have realized the value of combining consumer insights and internal company data to optimize their products. Advantages are a) lower rate of medication errors, b) Facilitating Preventive Care c) More Accurate.
  7. Artificial Intelligence (AI) – It helps in automation of clinical tasks and virtual nursing assistants. AI has the capability to transform health management. It is used in precision medicine, medical imaging, drug discovery, and genomics. DeepGenix helps the user in understanding their problems based on questions and then predicts the diagnosis. It uses deep phenotyping and deep learning (a form of AI).
  8. Electronic medical records (EMR): This should help reduce medical errors and improve health outcomes. Automated patient history has a lot of benefits. Arintra, an AI-based software incorporates branching techniques to collect and store patient history. It also helps in diagnosing and suggesting laboratory tests. It can also be used in telemedicine before the consultation.
  9. Virtual reality – Surgeons are using virtual-reality simulations to improve their skills or to plan complicated surgeries. 
  10. Blockchain – It is proven to be effective in preventing data breaches, improving the accuracy of medical records, and reducing costs.
Image Source: PwC Analysis

Future

Digital healthcare will continue to remain an essential part of healthcare in India. Now medical tasks like analyzing radiology, pathology, or ophthalmology images are performed by computers. Telemedicine, E-pharmacy, fitness apps, wearable devices have become an integral part of the patient`s lives, especially during Covid-19.

Opportunities for the future

  • Electronic medical records (EMRs)
  • Robotics
  • Smart health monitor
  • Mobile health apps
  • Computer processing
  • Genomics
  • Virtual Reality (VR)

Though some innovations are still in the early stages, they look promising. For example, research on 3D-printed hearts and other organs is being carried out; doctors are using VR instead of medication to treat pain; robots are being used in surgeries; genomic analysis. The need for digital innovations has become even more urgent during the Covid-19 pandemic. 

Conclusion

There is a significant need for digital technology to bridge healthcare gaps. India holds the potential for digital growth, given its innovation rate, identification of problems, growing population, and surging healthcare industry. Digital technology will help India achieve healthcare for all and will soon emerge as a global leader in digital health.

References

  1. PwC Digital Health Whitepaper: Indian Healthcare on the cusp of a digital transformation.
  2. Digital Healthcare in India
  3. Digital Health

Related Article: ViewPoints Article: Digital Revolution in Healthcare and Strategic Role of Medical Affairs Amidst Covid-19 Outbreak

The post ViewPoints Article: Digital Healthcare in India – Current Trends & Future first appeared on PharmaShots.

FDC Launches Two Variants of Favipiravir for COVID-19 in India

Shots:

  • FDC has launched two variants of Favipiravir under the brand names PiFLU and Favenza to treat mild to moderate COVID-19 in India. The products will be available across the country
  • Both the variant will be available at $0.74 (Rs. 55) /tablet. The DCGI had earlier approved the use of Favipiravir as an off-patent, oral antiviral drug that has shown clinical recovery in COVID-19 patients with mild to moderate symptoms
  • Additionally, FDC has increased the production of Enerzal and Electral, as according to ASPEN guidelines, 03 liters of fluid intake in a day (60-20ml in every 30 min) helps in speedy recovery of people who are home quarantined

Click here ­to­ read full press release/ article | Ref: FDC | Image:  Business Insider

Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

Shots:

  • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
  • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
  • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patients

Click here ­to­ read full press release/ article | Ref: Zydus | Image: PharmaShots

Cadila Pharma Launches NuPTH Biosimilar to Forteo for the Treatment of Osteoporosis in India

Shots:

  • Cadila has launched NuPTH an osteoporosis biosimilar of Forteo in India. The NuPTH is used for the treatment of osteoporosis and in patients with increased risk of fracture. The biosimilar NuPTH aims to be cost-effective for patients and will be available as easy to use, pre-filled disposable pen
  • NuPTH is the third biosimilar launched by the company following the launch of Rituximab and Bevacizumab biosimilars, recommended in multiple indications under the brand names Ritucad and Bevaro respectively
  • The launch strengthens the company’s ortho care portfolio and helps in increasing choice and access for osteoporosis care to patients in the Indian Market

Click here ­to­ read full press release/ article | Ref: Cadila Pharma | Image: Cadila Pharma




Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. Mylan with its partner Kyowa Kirin received the US FDA’s approval for its adalimumab biosimilar, Hulio (adalimumab-fkjp). Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar). Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020.

1. Samsung Bioepis Reported the Initiation of P-III Study for SB15 Proposed Biosimilar to Eylea (aflibercept)

Date: Jul 01, 2020  

Product: SB15 Biosimilar

  • The P-III study compared the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration
  • The company has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reported 24-week interim results from a P-III study of SB11 (proposed ranibizumab biosimilar)
  • SB15 is a proposed biosimilar referencing Regeneron’s Eylea, currently under preclinical treatment for diabetic macular edema, diabetic retinopathy, retinal edema, and retinal vein occlusion

2. Mylan and Fujifilm Kyowa Kirin Received the US FDA’s Approval for its Hulio (biosimilar, adalimumab)

Date: Jul 09, 2020

Product: Hulio (adalimumab-fkjp)

  • The US FDA has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab) to treat RA, JIA (in patients aged ≥4yrs.), PsA, AS, adult CD,  UC, and PsO, in both prefilled syringe and auto-injector presentations
  • The approval was based on an analytical, pre/ clinical program. The P-III ARABESC study conducted by Fujifilm Kyowa Kirin, demonstrated no differences in terms of safety, efficacy, and immunogenicity compared to its reference product in patients with RA
  • In 2018, the companies collaborated to commercialize Hulio in the EU while expanded the agreement globally in 2019. As per the patent license agreement with AbbVie, Mylan will be able to launch Hulio in the US in Jul’2023

3. Bio-Thera Signed a License Agreement with Pharmapark for BAT2506 (golimumab, biosimilar)

Date: Jul 17, 2020  

Product: BAT2506 (golimumab, biosimilar)

  • Bio-Thera will take care of full development, and commercial supply of BAT2506 out of the manufacturing facilities in Guangzhou, China. Additionally, the agreement will utilize Pharmapark’s local presence, sales, and marketing capabilities in Russia and other CIS countries
  • Pharmapark to get exclusive rights to distribute and market the product in Russia and other CIS countries including its filing practices. In Q4’20, Bio-Thera to begin its global P-III trial in PsA patients and will include patients from China, Russia, and many other countries 
  • Bio-Thera’s BAT2506 is a mAb while the company plans for regulatory submission with NMPA, EMA and the US FDA in 2023

4. Cadila to Launch its Bevaro (bevacizumab, biosimilar) in India

Date: Jul 22, 2020  

Product: Bevaro (bevacizumab, biosimilar)

  • Cadila plans to launch multiple biosimilars including Bevaro in 2020 which are safe and efficacious compared to conventional treatment therapies
  • The company has also cleared he USFDA inspection in Feb’20 and holds approved 16 ANDAs plus currently filed 30 ANDAs  
  • Bevaro is a mAb will be available in two strengths of 100 and 400 mg targeted for Ovarian Cancer, Glioblastoma Multiforme (a type of Brain cancer), Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer in India

5. Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Received CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Date: Jul 27, 2020

Product: Equidacent (bevacizumab, biosimilar)

  • The EMA’s CHMP has adopted a positive opinion that recommended the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
  • Equidacent will be available as 25 mg/ml as the solution for infusion targeting VEGF and act by inhibiting the binding of VEGF to its receptors on endothelial cell
  • The company anticipates EC’s decision in ~60days. The clinical data demonstrated that Equidacent has comparable quality, safety, and efficacy to Avastin

6. NCCN Collaborated with Pfizer to Explore Adoption of Biosimilars in Oncology

Date: Jul 27, 2020

Products: Biosimilars

  • NCCN and Pfizer issued an open RFP that can develop and validate enduring approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology
  • The RFP supports approaches to improve the processes related to biosimilar adoption in oncology. Letters of Intent are welcome from academic or community centres, patient advocacy groups, and HCPs organizations in the US and are due on Sept 09, 2020
  • The NCCN ORP will boost up the discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology

7. Celltrion’s Remsima SC (infliximab, CT-P13) Received the EC’s MAA for Additional Five Indications

Date: Jul 27, 2020  

Product: Remsima SC (infliximab, CT-P13)

  • The approval followed the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis, evaluating its PK, efficacy, and safety
  • The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment time to approximately 2-5 minutes
  • Remsima is a world’s first mAb indicated to treat eight autoimmune diseases including RA & IBD and approved in the US & EU with Inflectra & Remsima respectively. Till now the product is approved in 94 countries including the US, Canada, Japan and throughout EU

8. Cadila to Launch its Ritucad (rituximab, biosimilar) in India

Date: Jul 27, 2020  

Product: Ritucad (rituximab, biosimilar)

  • Cadila to strengthen its biosimilar portfolio and oncology footprints in India with the launch of Ritucad and has cleared USFDA inspection in Feb’20
  • Additionally, the company has launched its Bevaro (bevasizumab, biosimilar) a mAb targeted for multiple cancer indications like Ovarian Cancer, Glioblastoma Multiforme, Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer in India
  • Ritucad is the second biosimilar in Cadila’s portfolio of biosimilars and will be available in a single-dose vial of two strengths, 100 mg & 500mg targeted to treat Non-Hodgkin’s lymphoma and RA

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Received the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Date: Jul 30, 2020

Product: Zercepac (trastuzumab, biosimilar)

  • The approval was based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy, and safety of Zercepac (HLX02) vs Herceptin
  • Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and a global multi-centre P-III clinical study
  • Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

Related Post: Insights+ Key Biosimilars Events of June 2020




Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development

Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept the “new normal” until we have a vaccine.

What is a Vaccine?

Vaccines, in a way, activate the immune system without the disease. Getting a particular vaccine is somewhat like having survived the disease once, without the health burden. Vaccines can be made with weakened viruses, inactivated viruses, and protein from a virus or even just the biological material (mRNA).

How Do Vaccines Provide Immunity?

Immunity is the body’s defense mechanism is to resist the effects of a microorganism. Immunity induced by a vaccine is weaker than that induced naturally after an infection. After you get a vaccine shot, your body will develop long-lasting antibodies that circulate in the blood. Such virus-specific antibodies will help to prevent severe disease. The vaccine will not prevent the entry of the virus into the body (infection), but it will prevent severe infection.

Vaccine Development

Scientists have gone from the discovery of the virus to more than 165 candidate vaccines in record time, with 27 vaccines already in clinical trials.

Challenges in Vaccine Development

  • Laboratory development & Preclinical testing
  • Large Clinical Trials
  • New technology for production
  • Availability: manufacturing millions of doses especially of a novel coronavirus
  • Developing an integrated and fair plan for vaccine distribution
  • Order of priority – health workers, elderly, and those with underlying conditions
  • Logistic –storage temperature
  • Resistance from the public – lack of awareness
  • Supply to rural areas
  • Multiple-dose may be needed

When Can We Expect A Vaccine And How Has Development Been Stepped Up?

Vaccine development normally takes years to complete, but the continuing crisis has prompted the multilateral system to accelerate the process. Regulatory approvals are up to speed but no important stages are skipped. This means that different tests of the vaccine are conducted in “parallel”.

The pandemic situation requires multiple activities and tests to be conducted at financial risk to stakeholders without knowing whether the vaccine candidate will be safe and effective.

Clinical Status of Vaccines Around the Globe

Research in India

The Indian government agency is working at lightning speed to test and approve an Indian origin COVID-19 vaccine. The government has permitted six Indian companies to develop vaccines against COVID-19. Recently, Bharat Biotech and Zydus Cadila were granted permission to start Phase I and II human clinical trials of their most advanced vaccines, named COVAXIN and ZyCoV-D respectively.

India Will Be The Manufacturer of The Covid-19 Vaccine

India is known for its mass manufacturing of pharmaceuticals. Leading international bodies like the World Health Organisation and the Bill and Melinda Gates Foundation to obtain their vaccines from India. Now is the time when India can definitely leverage its ability to mass-produce a Covid-19 vaccine whenever it is ready and also help reduce the price of these vaccines. Reasonable price provided by India`s mass production ability would be the only factor in assuring the Covid-19 vaccine’s access across the globe.

Serum Institute of India (SII) located in Pune has entered a manufacturing partnership with British pharmaceutical giant AstraZeneca to produce and supply 1 billion doses of the Covid-19 vaccine. These vaccines will be for India and middle- and low-income countries across the world (GAVI countries).

What Happens If You Choose Not To Get A Vaccine?

Firstly, you will not be protected from the deadly respiratory disease and may end up suffering from a severe infection. Secondly, refusal by many people might not get the country to herd immunity.

What Lies In The Future?

Even when a vaccine is introduced, we will have several months of significant infection or at least a risk of infection to take care of. This means that we may have to face more months under the threat of the novel coronavirus than we have already survived. If precautions are not taken and guidelines are not followed, there will continue to be more outbreaks, more deaths. The availability of the vaccine will be the slow start of the flattening of the curve. The total time taken to completely flatten the curve cannot be predicted, as it depends on awareness, accessibility, affordability, and adoption. With the world joining hands to find a vaccine for Covid-19, all eyes are on India, the powerhouse of vaccine manufacturing. It is a race between humans and the virus, rather than between countries or pharmaceutical companies.

Conclusion

Putting an end to this viral disaster with a vaccine has led to a global vaccine race to coherently extinguish Covid-19. Each week brings news on early success, low cost, fast track results, promising effects because of vaccine optimism. There is too much uncertainty that continues to be pondered upon. The vaccine won’t extinguish the disease itself but offer protection and immunity. It certainly will not immediately return life to “old normal”. The virus is too widespread but the vaccine could make Covid-19 easier to live with and prevent severe cases.

Finally, there seems to be a ray of hope amidst this tunnel of misery!

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Dr. Anish Desai

Dr. Anish Desai is a trained Clinical Pharmacologist and Pharmaceutical Physician with 3 decades of experience in Academia, Research, and Healthcare industry with proven leadership skills, strong business acumen, and a deep understanding of the Healthcare System, including Pharmaceutical, Nutraceutical & Medical device industry. He has been recognized for driving positive change, delivering solutions, developing talent, and nurturing strong relationships with external stakeholders. Holding Senior Management Position for the last 20 years and involved in strategic decision making. ‘IntelliMed Healthcare Solutions’ is a Healthcare startup launched by him with an intent to focus on strategic medical affairs for business growth, thereby infusing science into business. IntelliMed specializes in scientific, Clinical & medical support from conceptualization/Ideation to launch.

Sunaina Anand

Dr. Sunaina Anand, Pharm. D is a Clinical Pharmacist. She currently serves as Medical Affairs Executive in IntelliMed Healthcare Solutions. She previously interned in Tata Memorial Hospital and Columbia Asia Hospital, Bengaluru.

Related Post: Insights+ KOL Articles: Immunity & Pregnancy: Unique and Complex

Image Source: DNAIndia




UK must ensure medicines replenished for Covid-19 second wave

The trade committee urged ministers to develop “parallel supply chains” as a solution

Britain needs to ensure its stockpile of medicines is replenished to deal with a second wave of coronavirus and any shocks to a supply chain dominated by China and India, the trade committee warned in a report released today.

The cross party committee said the pandemic had revealed that 70% of the active ingredients used in pharmaceuticals in the UK are made in China – while India manufactured “virtually all” the paracetamol in British shops.

Continue reading…

Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India

Shots:

  • Jenburkt became the second company to launch Favivent (favipiravir) to treat mild to moderate COVID-19 symptoms at a price of ​Rs. 39/tablet
  • Cipla receives the DCGI approval for Ciplenza (favipiravir, 200mg) targeting the unmet medical needs for COVID-19 treatment options in the country through restricted emergency use. The company will launch Ciplenza in the first week of August priced at Rs 68/ tablet
  • Moreover, Brinton gets DCGI approval drug favipiravir under the brand name Faviton (Rs 59/ tablet) for the treatment of COVID-19 patients. Faviton is a generic version of Avigan of Fujifilm Toyama, a subsidiary of Fujifilm Corporation

Cipla, Jenburkt, Brinton­ read full press release/ article | Ref: Cipla, Jenburkt, Brinton | Image: Pharmashots




Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Shots:

  • Mylan launches Desrem (remdesivir) addressing the unmet needs amid COVID-19. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalized with severe symptoms
  • Mylan will manufacture Desrem in its state-of-the-art injectable facility in Bangalore, India, and other export markets where Mylan has received a license from Gilead for the commercialization of remdesivir
  • The company has released the first batch of its generic remdesivir and will continue to increase its supply across the country in the wake of the rising demand for the drug. Patients and HCPs can access information about the availability of Desrem in India through Mylan’s 24/7 national helpline number, +91.78299.80066

Click here to read full press release/ article | Ref: Mylan | Image: Ommcom News

Related News: Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India




Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Shots:

  • Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing
  • The Adaptive P-I/II dose escalation study will assess the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches of the vaccine candidate for the clinical trials
  • ZyCoV-D has demonstrated a strong immune response and a high level of neutralizing Abs in its preclinical studies

Click here to read full press release/ article | Ref: Zydus | Image: The Quint

Related News: Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020




How to Prevent the Infection that May Trigger Type 1 Diabetes

The compelling finding of Mycobacterium avium paratuberculosis (MAP) circulating disproportionately within the bloodstream of type 1 diabetics was subsequently confirmed by culturing it straight out of their blood. MAP infection and type 1 diabetes appear to go together, but we didn’t know which came first. Does the infection make kids more susceptible to diabetes? Might diabetes make kids more susceptible to infection? Maybe this MAP bug just likes hanging out in sugary blood. In that case, we might expect to also see it in type 2 diabetics, but, no: Paratuberculosis infection is not associated with type 2 diabetes, which makes sense since type 2 is not an autoimmune disease.

In order for the idea of MAP infection triggering type 1 diabetes to be sound, there would have to be an immune response mounted to the bug, and, indeed, there is. Researchers in Sardinia found an “extremely significant” antibody response against paratuberculosis (paraTB) bacteria in type 1 diabetics. But do the antibodies attacking the bug cross-react with our own insulin-producing cells to generate that autoimmune reaction? Apparently so. Antibodies recognizing the molecular signatures of MAP cross-react with the molecular signatures present on our insulin-producing beta cells in the pancreas, as you can see at 1:09 in my video Does Paratuberculosis in Meat Trigger Type 1 Diabetes?.

Is this just in Sardinia, or might we find these same results elsewhere? The same results were in fact found on mainland Italy with a group of type 1 diabetics “with a genetic background different from Sardinians”—a strong association between paraTB bacteria exposure and type 1 diabetes. The findings were confirmed in further studies, confirmed once more in other pediatric populations, and confirmed in a group of type 1 diabetic adults, as well.

The paratuberculosis bacterium may also explain why type 1 diabetes risk is associated with a specific gene on chromosome 2 called SLC11A1. What does that gene do? SLC11A1 activates the immune cell that eats mycobacteria for breakfast. This could explain how a mutation in that gene could increase the susceptibility to type 1 diabetes—namely, by increasing the susceptibility to mycobacterial infections, like Mycobacterium avium paratuberculosis. Indeed, an “[a]ccumulating line of evidence points…[to] MAP in the development of T1DM [type 1 diabetes] as an environmental trigger.” It’s likely no coincidence. These types of bacteria have evolved to disguise themselves to look like human proteins for the express purpose of avoiding detection by our immune system. These are not the droids you’re looking for. If, however, our immune system sees through the disguise and starts attacking the bacteria, our similar-looking proteins can become a victim of friendly fire, which is what nearly all of these studies have been pointing to. Nearly, but not all.

A 2015 review found that seven out of seven human studies found an association between type 1 diabetes and paratuberculosis exposure, but it’s actually seven out of eight. Since that review came out, a study in India was published finding no link. A few possible explanations were offered. Maybe it’s because vaccination for regular TB is compulsory in India, which might offer “cross protection from MAP as in case of leprosy,” or because they eat so much less meat due to “certain cultural and culinary practices such as widespread vegetarianism,” or because of their “compulsory boiling of milk before consumption…” If we measure the heat inactivation of milk with high concentrations of naturally infected feces, which is probably the main source of milk contamination, pasteurization may not completely inactivate the bacteria, but sterilization at boiling temperatures should (as you can see at 3:40 in my video). This may depend on the degree of fecal clumping, though. MAP bacteria may be able to ride out pasteurization by hiding in tiny fecal clumps in milk, but only rarely should MAP survive over 100 degrees Celsius, perhaps explaining the disparate India findings. 

Bottom line: “To reduce human exposure to MAP via consumption of dairy and meat products…[more] studies are needed for estimating the amount of MAP” in milk, meat, and feces, as well as “the amount of faecal contamination of milk and carcasses [meat]” to figure out what we need to do to kill it. In the meanwhile, what’s the potential public health impact of Mycobacterium avium paratuberculosis? The majority of specialists in the field agree that it “is likely a risk to human health” and should be “a high- or medium-priority…public health issue.” 


I started speaking out about the link between human disease and paratuberculosis infection in milk and meat 15 years ago. As cynical as I can be at times, even I am shocked that the industry hasn’t done more to clean up its act. It reminds me of the bovine leukemia virus story. See:

If you missed the first two installments in this series, check out Does Paratuberculosis in Milk Trigger Type 1 Diabetes? and Meat Consumption and the Development of Type 1 Diabetes.

In health,
Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations: