Pharmaceuticals

Barriers to biosimilar adoption

When typical drugs lose their period of exclusivity, new generic competitors arrive on the market with drastically lower prices. As patients switch from brand to generic drugs, the price of treatments declines. For biologic drugs, biosimilar uptake, however, is significantly less. In part, this is because biosimilars are difficult to manufacture so the price differences …

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Public Health Experts ‘Flabbergasted’ That Biden Still Hasn’t Picked an FDA Chief

President Joe Biden’s failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it’s baffling for the agency to be without a permanent leader during a national health crisis. The pandemic has taxed the FDA, an 18,000-person agency whose chiefs …

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Congress Cites KHN Investigation in Probe of National Academies

The House Committee on Oversight and Reform is requesting a ream of documents from the prestigious National Academies of Sciences, Engineering and Medicine, spurred by a recent KHN investigation that revealed deep ties between pharmaceutical companies and two members of a committee that took a pharma-friendly stance in a recent report on drug waste. The …

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What will be the impact of adopting reference pricing in the US?

That is the question that a recent JAMA study–Mulcahy et al. (2021)–aim to answer. The authors use IQVIA MIDAS data to estimate sales price and volume in the US. These can can be used to estimate drug wholesale acquisition cost (WAC), but they ignore rebates. To account for rebates in the US they use SSR …

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KHN’s ‘What the Health?’: Much Ado About Drug Prices

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. Congressional Democrats are finding it harder to actually write legislation to lower drug prices than it is to make promises about it. But the drug price provisions of the $3.5 trillion social-spending bill …

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Complexities of COVID-19 manufacturing

Getting from a mRNA COVID-19 vaccine to scaling to manufacture these vaccines for billions of people is far from simple: Manufacturing mRNA vaccines for the first time in a very short timeframe required significant innovation and remains a technically challenging endeavor. The process proved to be technically challenging as Pfizer developed a 50,000 step process. …

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Relative importance of pharmaceuticals on health outcomes: 1990-2015

Health outcomes have improved in the US over the last 25 years. Clearly public health initiatives (e.g., reduced smoking rates) is having an impact, but another key key question is, what is medical technologies are driving these gains? Is it new surgical techniques, better diagnostics, improved medical devices, or new pharmaceuticals? This answer is difficult …

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Distributional Cost Effectiveness Analysis: A simple example

I have written previously about the need for distributional cost-effectiveness analysis (DCEA) which would increase the value of treatments who improve the health for individuals who currently have the worst expected quality-adjusted life expectancy (QALE). I’ve written about this in AJMC and Health Affairs among other places. One key question many individuals may have is …

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CBO: Impact of price control legislation on new drug development

It stands to reason that policies that aim to reduce drug prices or squeeze life science companies profits are likely to decrease incentives to finance the research and development needed to bring a drug to market. Previous estimates claim that bringing a new drug to market may cost over $2 billion, and life science companies …

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Hot Spots Where Covid Vaccination Lags Push Experimental Antibody Treatment

For months, Joelle Ruppert was among the millions of Americans who are covid vaccine holdouts. Her reluctance, she said, was not so much that she opposed the new vaccines but that she never felt “compelled” by the evidence supporting their experimental use. Nonetheless, after she fell ill with covid last month, Ruppert, a Florida preschool …

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From Uber Vouchers to Patient Advocates: What It Takes to Increase ER Addiction Treatment

For years, Kayla West watched the opioid epidemic tear through her eastern Tennessee community. As a psychiatric nurse practitioner, she treated people with mental illness but felt she needed to do more to address addiction. So in 2020, when the state created a position to help hospitals improve addiction care in the emergency room, West …

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Physician Switching After Drug Request Refusal

That is the title from a study from Lee and Bagley (2011). They examine the potential impact of direct to consumer advertising (DTCA) and the impact of physicians decisions not to prescribe a patient-preferred drug on patient retention. A total of 818 of 2,988 participants in a national telephone survey (27.4%) who had received DTCA …

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‘We Sent a Terrible Message’: Scientists Say Biden Jumped the Gun With Vaccine Booster Plan

The Biden administration’s plans to make covid-19 booster shots available next month has drawn a collective scream of protest from the scientific community. As some scientists see it, the announcement is rash and based on weak evidence, and they worry it could undercut confidence in vaccines with no clear benefit of controlling the pandemic. Meanwhile, …

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Biden brings plan for prescription drug pricing reform to Congress

That is the title of an article published in Pharmaceutical Technology today. I am quoted extensively. For instance, President Biden proposes to cap drug prices at genera rates of inflation. The article highlights some limits this would pose to value-based pricing that could evolve over time: Shafrin also says while Biden’s plan to penalise companies …

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Lo que debes saber sobre el refuerzo de la vacuna contra covid

La administración de Biden anunció el miércoles 18 de agosto planes para ofrecer refuerzos de la vacuna contra covid-19 a todos los adultos estadounidenses a partir del próximo mes, y dijo que los datos recientes, incluidos algunos disponibles solo en los últimos días, jugaron un papel en esa decisión. “Si esperan a que suceda algo …

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Rush to Boosters Sparks Confusion, Differing Recommendations

When the Food and Drug Administration announced last week that a third dose of Moderna or Pfizer-BioNTech covid-19 vaccine may boost the immunity of some people who are immunocompromised, officials repeated their stance that fully vaccinated, healthy people do not need another dose. With this caveat: “The FDA is actively engaged in a science-based, rigorous …

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Have Vaccines, Will Travel: On the Road With a Covid Entrepreneur

VIRGINIA CITY, Mont. — While many businesses in this southwestern Montana “ghost town” reel in tourists with its mining and Wild West vigilante past, one businessman arrived offering a modern product: covid-19 vaccines. Kyle Austin, a traveling pharmacist, set up his mobile clinic in Virginia City on a recent Saturday, the latest stop on his …

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Pharmaceutical Contract Manufacturing: The Solution to Production of Complex Substances

The inherent expertise of CMOs and CDMOs is believed to be capable of enabling reduction in the time-to-market a product, significant cost-benefits, as well as access to larger production capacities and novel technologies.  It is worth mentioning that there has been substantial merger and acquisition activity in the pharmaceutical contract manufacturing market in the past …

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Mensaje del CEO de Pfizer al público: confíen en nosotros con el refuerzo de la vacuna contra covid

El CEO de Pfizer, Albert Bourla, confiaba en junio en la capacidad de la vacuna de su empresa para proteger contra la variante delta, altamente contagiosa, mientras se diseminaba por el mundo y llenaba de pacientes los hospitales estadounidenses. Apenas unas semanas después, Pfizer comunicó que solicitaría autorización para una vacuna de refuerzo, después que …

Mensaje del CEO de Pfizer al público: confíen en nosotros con el refuerzo de la vacuna contra covid Read More »

Pfizer CEO to Public: Just Trust Us on the Covid Booster

Pfizer CEO Albert Bourla was confident in June about the ability of his company’s vaccine to protect against the highly contagious delta variant, as it marched across the globe and filled U.S. hospitals with patients. “I feel quite comfortable that we cover it,” Bourla said. Just weeks later, Pfizer said it would seek authorization for …

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KHN’s ‘What the Health?’: The Senate Acts

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The Senate has set the stage for a busy fall that will include debate on a broad array of health issues, such as prescription drug prices, Medicare …

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National Academies’ Report Took Pharma-Friendly Stance After Millions in Gifts From Drugmakers

To several U.S. senators, it looked wasteful, even outrageous. Every year, taxpayers pay for at least $750 million worth of expensive pharmaceuticals that are simply thrown away. Companies ship many of the drugs in “Costco”-size vials, one lawmaker said, that once opened usually cannot be resealed or saved for other patients. Yet pharma gets paid …

National Academies’ Report Took Pharma-Friendly Stance After Millions in Gifts From Drugmakers Read More »

FDA: Why we approved Prograf based on real-world data

Recently, the Food and Drug Administration (FDA) approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection for patients who have received a lung transplant. While the FDA approving a new indication isn’t typically news, this is a noteworthy event because (i) it marks the first approval of …

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Biosimilar use in France

Like generic drugs for small molecules, biosimilars offer the hope for reducing drug prices after biologic therapies lose their patent protections. But how big an impact do biosimilars have and how comfortable are physicians with using these substitute products? A paper by Robinson and Jarrion (2021) use data from France as a case study to …

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Pharmacies Face Extra Audit Burdens That Threaten Their Existence

The clock was about to strike midnight, and Scott Newman was desperately feeding pages into a scanner, trying to prevent thousands of dollars in prescription payments from turning into a pumpkin. As the owner of Newman Family Pharmacy, an independent drugstore in Chesapeake, Virginia, he was responding to an audit ordered by a pharmacy benefit …

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KHN’s ‘What the Health?’: Delta Blues

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The U.S. is experiencing another surge of covid-19, particularly in Southern states where vaccination rates are generally lower than in other regions. But partisan fights rage on …

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2+2=? Senate Uses Murky Math as It Shelves Drug Pricing Rule to Fund Infrastructure

The Senate’s release of its bipartisan infrastructure plan signals that lawmakers are poised to throw former President Donald Trump’s belated bid to lower Medicare drug prices under the bus — not to mention trains, bridges, tunnels and broadband connections. That’s because the massive spending bill is the first of two likely to at least delay …

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Diabetes Drug’s New Weight Loss Formula Fuels Cost-Benefit Debate

The long list of side effects that follow ads for the newer expensive drugs to treat Type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people — especially those with Type 2 diabetes, which is associated with obesity — may desperately want. So it’s …

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Pfizer Court Fight Could Legalize Medicare Copays and Unleash ‘Gold Rush’ in Sales

Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs. By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, …

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As Holdout Missouri Joins Nation in Monitoring Opioid Prescriptions, Experts Worry

Kathi Arbini said she felt elated when Missouri finally caught up to the other 49 states and approved a statewide prescription drug monitoring program this June in an attempt to curb opioid addiction. The hairstylist turned activist estimated she made 75 two-hour trips in the past decade from her home in Fenton, a St. Louis …

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Journalists Dig in on Delta Variant Risks and Opioid Overdose Deaths

KHN Midwest correspondent Lauren Weber discussed outbreaks caused by the covid-19 delta variant in Missouri and elsewhere on Newsy on Thursday. Click here to watch Weber on Newsy Read Weber’s “The Delta Variant Thrives in a State of Political and Public Health Discord“ KHN correspondent Aneri Pattani discussed opioids and the rise in overdose deaths …

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Facing Headwinds on New Alzheimer’s Drug, Biogen Launches Controversial Campaign

Do you sometimes lose your train of thought or feel a bit more anxious than is typical for you? Those are two of the six questions in a quiz on a website co-sponsored by the makers of Aduhelm, a controversial new Alzheimer’s drug. But even when all responses to the frequency of those experiences are …

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Integrated Delivery Network-based Specialty Pharmacies

Increasingly, integrated delivery networks (IDNs) are creating their own full-blown specialty pharmacies. Many are familiar with the integrated payer-provider model from groups such as Kaiser Permanente. However, other IDNs are getting into the game according to a recent white paper. Why are IDNs considering creating their own specialty pharmacies? Address patient access concerns. The number …

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Analysis: Necessary or Not, Covid Booster Shots Are Probably on the Horizon

The drugmaker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of covid-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right …

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Sen. Wyden: $3.5T Budget May Have to Trim but It Can Set a Path to ‘Ambitious Goals’

Exactly what American health care will look like if Democrats can pass their $3.5 trillion spending plan is unclear, but the senator negotiating its health-related provisions hopes what emerges will be dramatic: the first complete health care system for older Americans and significantly reduced costs for everyone else. “We are setting very, very ambitious goals,” …

Sen. Wyden: $3.5T Budget May Have to Trim but It Can Set a Path to ‘Ambitious Goals’ Read More »

Public-Private partnership in biologic drug development

A paper from Nayak et al. (2021) in JAMA Internal Medicine describes how public-private partnerships have helped bring new biologic drugs to market. Using data on new biologic drugs approved by the FDA’s Center for Drug Evaluation and Reseach (CDER) and US patent office data, the authors find that: Twenty-nine drugs (42%) showed evidence of …

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Biden’s July Executive Order Includes Drug Pricing Provisions. But Will They Do Enough?

President Joe Biden’s executive order of July 9 included various steps toward making good on campaign promises to take on pharmaceutical companies by allowing the importation of prescription drugs and curbing the high cost of medicines. These issues were key to candidate Biden’s 2020 health care platform, which stated he would “stand up to abuse …

Biden’s July Executive Order Includes Drug Pricing Provisions. But Will They Do Enough? Read More »

Journalists’ Topics Range From Rural Pharmacy Deserts to Opioid Overdoses

KHN senior Colorado correspondent Markian Hawryluk discussed how a rural Colorado town is crowdsourcing ways to get prescription medicines delivered on KUNC’s “Colorado Edition” on Monday. Click here to hear Hawryluk on KUNC Read Hawryluk’s “How One Rural Town Without a Pharmacy Is Crowdsourcing to Get Meds“ KHN Editor-in-Chief Elisabeth Rosenthal discussed how medical education …

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KHN’s ‘What the Health?’: Here Comes Reconciliation

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The expansion of health benefits is a major piece of the tentative budget deal reached this week by Democrats in Congress. They plan to press ahead — …

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Senate Democrats’ Plan Boosts Spending on Medicare, ACA Subsidies, Long-Term Care

The budget package Democrats are assembling in Congress would likely provide the biggest jolt to the American health care system since the passage of the Affordable Care Act in 2010, according to sources familiar with work on the plan. Democrats in the Senate announced Tuesday night that they had reached a framework for a $3.5 …

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Dying Patients With Rare Diseases Struggle to Get Experimental Therapies

At 15, Autumn Fuernisen is dying. She was diagnosed at age 11 with a rare degenerative brain disorder that has no known cure or way to slow it down: juvenile-onset Huntington’s disease. “There’s lots of things that she used to be able to do just fine,” said her mom, Londen Tabor, who lives with her …

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As Congress Wrestles With Plans to Expand Medicare, Becerra Says Any One Will Do

The Biden administration will support whatever expansions to Medicare Congress is willing to make, Health and Human Services Secretary Xavier Becerra said Tuesday. Democratic lawmakers on Capitol Hill are working on plans both to add benefits to the health program for seniors and to lower its eligibility age from 65 to 60. But the efforts …

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KHN’s ‘What the Health?’: Becerra Urges Congress to Expand Medicare, Address Rx Prices

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The Biden administration stands ready to work with Congress to address drug prices and expand Medicare, Health and Human Services Secretary Xavier Becerra said in a wide-ranging …

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Biden’s Executive Order on Promoting Competition in the American Economy: What does it say about health care?

Last Friday, President Biden released an executive order titled “Promoting Competition in the American Economy” While the order talk about transportation, internet companies, and farming, there were a number of provisions related to health care. I summarize each of these below. Specifically I review OTC hearing aids. Currently, many patients need to visit a doctor …

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Why We May Never Know Whether the $56,000-a-Year Alzheimer’s Drug Actually Works

The Food and Drug Administration’s approval in June of a drug purporting to slow the progression of Alzheimer’s disease was widely celebrated, but it also touched off alarms. There were worries in the scientific community about the drug’s mixed results in studies — the FDA’s own expert advisory panel was nearly unanimous in opposing its …

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Doctores sopesan pros y contras de recetar la nueva droga para el Alzheimer

Mientras médicos y expertos en políticas de salud debaten los méritos de Aduhelm, el primer fármaco para el Alzheimer aprobado en 18 años, los pacientes simplemente quieren saber: “¿me ayudará?”. Los médicos no tienen una respuesta definitiva. “En cada persona, será absolutamente imposible de predecir”, dijo el doctor Allan Levey, director del Centro de Investigación …

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Doctors Weigh Pros and Cons of Prescribing Hot-Button Alzheimer’s Drug

As physicians and health policy experts debate the merits of Aduhelm, the first new drug for Alzheimer’s disease approved in 18 years, patients want to know: “Will this medication help me — and how much?” Doctors explaining the pros and cons of Aduhelm won’t have a definitive answer. “On an individual basis, it will be …

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Drugmakers’ Spending on Stock, Dividends and Executive Pay Exceeds Research, Democrats Say

The largest drug companies are far more interested in enriching themselves and investors than in developing new drugs, according to a House committee report released Thursday that argues the industry can afford to charge Medicare less for prescriptions. The report by the House Oversight and Reform Committee says that contrary to pharmaceutical industry arguments that …

Drugmakers’ Spending on Stock, Dividends and Executive Pay Exceeds Research, Democrats Say Read More »

Paying Billions for Controversial Alzheimer’s Drug? How About Funding This Instead?

If you could invest $56 billion each year in improving health care for older adults, how would you spend it? On a hugely expensive medication with questionable efficacy — or something else? This isn’t an abstract question. Aduhelm, a new Alzheimer’s drug approved by the Food and Drug Administration last month, could be prescribed to …

Paying Billions for Controversial Alzheimer’s Drug? How About Funding This Instead? Read More »

New Research Finds J&J Vaccine Has Muscle Against Covid’s Delta Variant

In the past two weeks, many medical experts started to question whether the Johnson & Johnson vaccine, which is administered in a single dose, would be as effective as the two-dose Pfizer-BioNTech or Moderna vaccine in protecting against the new, highly transmissible delta variant that is poised to become the dominant strain in the U.S. …

New Research Finds J&J Vaccine Has Muscle Against Covid’s Delta Variant Read More »

California Lawmakers Push Feds to Allow a Therapy That Pays Meth Users to Abstain

In his multiple attempts to overcome a methamphetamine addiction that ground through two decades of his life, Tyrone Clifford Jr. remembers well the closest he came. “The most success I had,” he said, “is when my dealer was in jail.” Then Clifford walked into a rehab clinic in San Francisco called PROP, the Positive Reinforcement …

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KHN’s ‘What the Health?’: Un-Trumping the ACA

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The Biden administration this week proposed a series of changes aimed at boosting insurance enrollment under the Affordable Care Act, undoing changes made by the Trump administration …

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How One Rural Town Without a Pharmacy Is Crowdsourcing to Get Meds

WALDEN, Colo. — The building that once housed the last drugstore in this town of fewer than 600 is now a barbecue restaurant, where pit boss Larry Holtman dishes out smoked brisket and pulled pork across the same counter where pharmacists dispensed vital medications more than 30 years ago. It’s an hourlong drive over treacherous …

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How easy is it for patients to access cell and gene therapies in Europe?

Cell and gene therapies have the potential to produce dramatic improvements in quality of life and survival for severe and often rare diseases. Currently, however, the cost of these treatments is high and access is sometimes limited. To identify some of these challenges in Europe EURODIS conducted an evaluation of country-specific challenges with respect to …

How easy is it for patients to access cell and gene therapies in Europe? Read More »

States Step Up Push to Regulate Pharmacy Drug Brokers

Under pressure to rein in skyrocketing prescription drug costs, states are targeting companies that serve as conduits for drug manufacturers, health insurers and pharmacies. More than 100 separate bills regulating those companies, known as pharmacy benefit managers, have been introduced in 42 states this year, according to the National Academy for State Health Policy, which …

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Do most Medicare Part D drugs have CEA studies?

That is the question that a recent study by Tisdale et al. (2021) aim to answer. They first look at the top 250 Medicare Part D drugs in terms 2016 total spending based on the 2016 Medicare Part D Prescriber Public Use File. Drug characteristics were identified from the 2016 FDA Orange Book. The authors …

Do most Medicare Part D drugs have CEA studies? Read More »

GAO report on prescription drug advertising

Medicare beneficiaries are largely elderly individuals, many of whom suffer from a variety of health conditions. Pharmaceutical manufacturers want these patients and their physicians to be aware of new medical treatments that become available (i.e., new approvals) as well as new uses for existing drugs (i.e., new FDA indications). Direct-to-consumer advertising (DTCA) is one way …

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Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products

Dr. Kingsley R. Chin was little more than a decade out of Harvard Medical School when sales of his spine surgical implants took off. Chin has patented more than 40 pieces of such hardware, including doughnut-shaped plastic cages, titanium screws and other products used to repair spines — generating $100 million for his company SpineFrontier, …

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Rebates and out-of-pocket cost

In recent decades, drug prices have risen. To offset this cost, pharmacy benefit managers have negotiated increasingly large rebates which drug manufacturers pay health insurers. PBMs argue that rebates help keep net drug prices down. Manufacturers argue that PBMs want higher list prices so they can negotiate larger rebates. Patients may not like rebates if …

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KHN’s ‘What the Health?’: Our 200th Episode!

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The Food and Drug Administration found itself in the hot seat this week when it approved a controversial new drug to treat Alzheimer’s disease with scant evidence …

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Change to Gilead Assistance Program Threatens PrEP Access, HIV Advocates Say

Dr. John Carlo is concerned that patients at Prism Health North Texas who rely on the health care safety net will soon be struggling even more to stay on PrEP, a medication that prevents HIV transmission. Carlo, chief executive officer of the clinic, which runs three locations in Dallas, offers free PrEP to roughly 250 …

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Unused Johnson & Johnson Covid Doses Are Piling Up as FDA Waits to See if Shelf Life Can Be Extended

The Biden administration is encouraging states to hold on to hundreds of thousands of soon-to-expire covid vaccine doses from Johnson & Johnson, given the possibility that additional data will show the shots are viable beyond their expiration date at month’s end. Dr. Janet Woodcock, acting commissioner of the Food and Drug Administration, told state officials …

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FDA Weighs Approval of a Lucrative Alzheimer’s Drug but Benefits Are Iffy

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process. This story also ran on The Daily Beast. It can be republished for free. The agency said it …

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Biden Administration Signals It’s in No Rush to Allow Canadian Drug Imports

Use Our Content It can be republished for free. The Biden administration said Friday it has no timeline on whether it will allow states to import drugs from Canada, an effort that was approved under President Donald Trump as a key strategy to control costs.  Six states have passed laws to start such programs, and Florida, Colorado and New Mexico are the furthest along in plans to get federal approval.    The …

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Opioids like ‘Lean’ Permeate Hip-Hop Culture, but Dangers Are Downplayed

Nykerrius Williams knows about the close relationship between hip-hop and opioid use. Williams, 27, an independent rapper from Gibsland, Louisiana, who goes by the name Young Nyke, took oxycodone pills for the first time when he was 16 and has continued patterns of misuse of those pills, as well as Lortabs, Xanax and codeine cough …

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KHN’s ‘What the Health?’: The Return of the Public Option

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The “public option” is back — both in Washington, D.C., and the states. President Joe Biden as a candidate supported the idea of a government-run or heavily regulated insurance …

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Colorado Lawmakers Wage Multifront Assault on High Drug Costs

DENVER — Tired of waiting for federal action to reduce prescription drug costs, Colorado is acting on its own — even if it must do so with one arm tied behind its back. Unable to set prices or change patent protections, the state is exploring creative legislative and administrative approaches to lower out-of-pocket costs on …

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KHN Journalists Comment on Abortion Case, Wasted Covid Doses

KHN chief Washington correspondent Julie Rovner discussed the Supreme Court’s decision to hear a challenge in an abortion case from Mississippi on Newsy on Tuesday. Click here to watch Rovner on Newsy KHN freelancer Sara Reardon discussed allegations by a rail company that a clinic in Libby, Montana, is defrauding Medicare by overdiagnosing asbestos-related diseases on …

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Are drug prices higher in the US than in other countries?

Conventional wisdom holds that the prices of pharmaceuticals are higher in the US than in other countries. But is that really the case? And if so, by how much? Which price? The question we need to answer is “which price” do you mean? There is the manufacturer wholesale price (i.e., gross price) which is how …

Are drug prices higher in the US than in other countries? Read More »

“Mr. Biden is wrong”

That was the conclusion of The Economist on his decision to suspend intellectual property protections for the makers of COVID-19 vaccines. In the article “Ten million reasons to vaccinate the world“, they write: Many experts argue that, because some manufacturing capacity is going begging, millions more doses might become available if patent-owners shared their secrets, …

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KHN’s ‘What the Health?’: Drug Price Effort Hits a Snag

Can’t see the audio player? Click here to listen on SoundCloud. The high cost of prescription drugs is a top health issue for the public and politicians, but concerns raised by a group of moderate Democrats threaten to derail a bill being pushed by House Democratic leaders. Meanwhile, the Food and Drug Administration has authorized the …

KHN’s ‘What the Health?’: Drug Price Effort Hits a Snag Read More »

From Covid Coverage to ‘Public Option’ Plans, Journalists Delve Into Details

KHN senior correspondent Julie Appleby discussed changes in insurance coverage for covid-19 care on Newsy on Thursday. Click here to watch Appleby on Newsy Read Appleby’s “Time to Say Goodbye to Some Insurers’ Waivers for Covid Treatment Fees” KHN senior correspondent Mary Agnes Carey discussed Connecticut’s legislative efforts to pass a “public option” insurance plan …

From Covid Coverage to ‘Public Option’ Plans, Journalists Delve Into Details Read More »

This Small Canadian Drugmaker Wants to Make J&J Vaccines for Poor Nations. It Needs More Than a Patent Waiver.

Biolyse Pharma Corp., which makes a cancer medication, was gearing up to start making generic biologic drugs, made from living organisms. Then the pandemic hit. Use Our Content It can be republished for free. Watching the covid death toll climb, the company decided its new production lines and equipment could be converted to making vaccines …

This Small Canadian Drugmaker Wants to Make J&J Vaccines for Poor Nations. It Needs More Than a Patent Waiver. Read More »

KHN’s ‘What the Health?’: Sharing Vaccines With the World

Can’t see the audio player? Click here to listen on SoundCloud. The Biden administration — keeping a campaign promise — announced it would back a temporary waiver of patent protections for the covid-19 vaccines, arousing the ire of the drug industry. The administration is also picking a fight with tobacco companies, as the Food and Drug …

KHN’s ‘What the Health?’: Sharing Vaccines With the World Read More »

Are prices for diabetes drugs rising or falling?

Conventional wisdom would hold that the prices are rising…aren’t they? To correctly answer this question, one must define which prices you are talking about. Are we looking at the list price that is widely available or the net price after we take into account discounts are rebates life sciences firms pay? A paper by Sarpatwari …

Are prices for diabetes drugs rising or falling? Read More »

Covid Shot in the Arm Not Enough to Keep Pharmacies in Business

Tobin’s pharmacy and department store had already stocked its shelves with Easter and Mother’s Day items last spring, and the staff had just placed the Christmas orders. The shop in Oconomowoc, Wisconsin, had been operating on a razor’s edge as retail sales moved online and mail-order pharmacies siphoned off its patients. It was losing money …

Covid Shot in the Arm Not Enough to Keep Pharmacies in Business Read More »

Democrats Disagree About How to Spend Potential Prescription Drug Windfall

One of the few surprises in President Joe Biden’s social safety-net proposal, the American Families Plan, was something that didn’t make it into the final version: any mention of reining in the price of prescription drugs. Use Our Content It can be republished for free. The American Families Plan, the second part of Biden’s expansive …

Democrats Disagree About How to Spend Potential Prescription Drug Windfall Read More »

CVS and Walgreens Have Wasted More Vaccine Doses Than Most States Combined

Two national pharmacy chains that the federal government entrusted to inoculate people against covid-19 account for the lion’s share of wasted vaccine doses, according to government data obtained by KHN. This story also ran on NBC News. It can be republished for free. The Centers for Disease Control and Prevention recorded 182,874 wasted doses as …

CVS and Walgreens Have Wasted More Vaccine Doses Than Most States Combined Read More »

Detecting Rare Blood Clots Was a Win, But US Vaccine Safety System Still Has Gaps

The quick detection of an ultra-rare blood clotting reaction in some covid-19 vaccine recipients showed the power of a federal warning system for vaccine safety issues, but experts worry that blind spots in the program could hamper detection of other unexpected side effects. This story also ran on NBC News. It can be republished for …

Detecting Rare Blood Clots Was a Win, But US Vaccine Safety System Still Has Gaps Read More »

Journalists Track Biden’s First 100 Days

Chief Washington correspondent Julie Rovner discussed Biden’s first 100 days on WAMU/NPR’s “1A” on Wednesday. She also joined Wisconsin Public Radio’s “Central Time” to talk about why hospitals aren’t cooperating with price transparency requirements. Click here to hear Rovner on WAMU/NPR Read Rovner’s “The Great Undoing: Which of Trump’s Policies Will Biden Reverse?” Click here …

Journalists Track Biden’s First 100 Days Read More »

Addiction Treatment Providers in Pa. Face Little State Scrutiny Despite Harm to Clients

This investigation is a joint project of KHN, a national newsroom that produces in-depth journalism about health issues, and Spotlight PA, an independent, collaborative newsroom dedicated to producing investigative journalism for all of Pennsylvania. This story also ran on Spotlight PA. It can be republished for free. When Ian Kalinowski was at work, his mom usually texted …

Addiction Treatment Providers in Pa. Face Little State Scrutiny Despite Harm to Clients Read More »

KHN’s ‘What the Health?’: 100 Days of Health Policy

Can’t see the audio player? Click here to listen on SoundCloud. It’s been a busy 100 days for the Biden administration on health policy. The promise Joe Biden made as president-elect to get 100 million covid vaccinations in arms was doubled, healthcare.gov reopened to those without insurance, and steps were taken to undo a raft of …

KHN’s ‘What the Health?’: 100 Days of Health Policy Read More »

Doctors More Likely to Prescribe Opioids to Covid ‘Long Haulers,’ Raising Addiction Fears

Covid survivors are at risk from a possible second pandemic, this time of opioid addiction, given the high rate of painkillers being prescribed to these patients, health experts say. Use Our Content It can be republished for free. A new study in Nature found alarmingly high rates of opioid use among covid survivors with lingering …

Doctors More Likely to Prescribe Opioids to Covid ‘Long Haulers,’ Raising Addiction Fears Read More »

International Reference Pricing: List vs. Net Pricing issues

Leah Rand and Aaron Kesselheim have an interesting commentary in Value in Health reviewing some of the challenges of implementing international reference pricing (IRP) in the U.S. IRP would set drug prices in the U.S. as no higher than a basket of drug prices in other developed countries. This issue is of particular interest due …

International Reference Pricing: List vs. Net Pricing issues Read More »

Like it or not, value-based contracting is coming for drugs and medical devices

Value-based contracts covering the reimbursement of drugs and medical devices are slowly gaining acceptance. A panel at the MedCity News INVEST conference discussed the challenges and opportunities for these contracts, which aim to improve patient outcomes and control the cost of care.

KHN’s ‘What the Health?’: Picking Up the Pace of Undoing Trump Policies

Can’t see the audio player? Click here to listen on SoundCloud. The Biden administration is speeding up the pace of efforts to undo Trump administration health policies. The two most recent: overturning a ban on fetal tissue research funded by the National Institutes of Health and canceling a last-minute extension of a Medicaid waiver for Texas. …

KHN’s ‘What the Health?’: Picking Up the Pace of Undoing Trump Policies Read More »

Strides Against HIV/AIDS Falter, Especially in the South, as Nation Battles Covid

Facing a yearlong siege from the coronavirus, the defenses in another, older war are faltering. This story also ran on NPR. It can be republished for free. For the last two decades, HIV/AIDS has been held at bay by potent antiviral drugs, aggressive testing and inventive public education campaigns. But the COVID-19 pandemic has caused …

Strides Against HIV/AIDS Falter, Especially in the South, as Nation Battles Covid Read More »

The Shock and Reality of Catching Covid After Being Vaccinated

Robin Hauser, a pediatrician in Tampa, Fla., got covid in February. What separates her from the vast majority of the tens of millions of other Americans who have come down with the virus is this: She got sick seven weeks after her second dose of the Pfizer-BioNTech vaccine. Use Our Content It can be republished …

The Shock and Reality of Catching Covid After Being Vaccinated Read More »

KHN’s ‘What the Health?’: Pause and Effect on Covid Vaccines

Can’t see the audio player? Click here to listen on SoundCloud. The effort to vaccinate Americans against covid-19 took a hit this week. The Centers for Disease Control and Prevention and the Food and Drug Administration jointly called for a pause in use of the vaccine made by Johnson & Johnson while experts try to figure …

KHN’s ‘What the Health?’: Pause and Effect on Covid Vaccines Read More »

Average cost to bring a drug to market is over $1 billion

The cost to bring a drug to market is a hotly debated topic. The costs include not only the costs for basic science and clinical trials. However, one must also take into account the cost of capital (since most cost are incurred up front, but revenue begins only after drug approval) and the likelihood of …

Average cost to bring a drug to market is over $1 billion Read More »

The FDA Seeks a New Way to Review Old Drugs Without Causing Prices to Soar

Chuck Peterson of Omaha, Nebraska, recently experienced a swollen, painful knuckle caused by arthritis. He got a prescription for colchicine. Doctors have used the drug for treating gout and other rheumatic conditions for well over two centuries. When Peterson went to the pharmacy, he was shocked to discover that a two-month supply of 120 pills, …

The FDA Seeks a New Way to Review Old Drugs Without Causing Prices to Soar Read More »

Is value in the eye of the beholder? Value frameworks and inter-rater reliability

A new drug comes on the market. Is the health benefit worth the cost? What is it’s value? Value assessment frameworks are one way to answer this question. Value frameworks take the evidence of the treatments benefits, risk and cost and output some notion of the treatment’s value. Ideally, if anyone applied a given value …

Is value in the eye of the beholder? Value frameworks and inter-rater reliability Read More »

Cuatro respuestas sobre el freno a la vacuna contra covid de Johnson & Johnson

Cuatro meses después del lanzamiento del plan de inmunización masiva más grande del país en décadas, ha quedado claro que los mensajes que rodean los esfuerzos de vacunación contra covid-19 son tan importantes como la ciencia que los respalda. Se observó cuando se comenzaron a usar las primeras vacunas en diciembre en hospitales y hogares …

Cuatro respuestas sobre el freno a la vacuna contra covid de Johnson & Johnson Read More »

4 Things to Know About the J&J Covid Vaccine Pause

Four months into the largest U.S. vaccine rollout in decades, it’s become clear that the messaging surrounding covid-19 vaccination efforts is as important as the science behind them. That was true when the first covid vaccines were introduced in December at hospitals and nursing homes and even more so after the federal government on Tuesday …

4 Things to Know About the J&J Covid Vaccine Pause Read More »

Highlights from MedPAC’s Spring 2021 Report

Here are a few highlight’s from the March 2021 report on Medicare Payment Policy from the Medicare Payment Advisory Commission (MedPAC). Leading causes of death The leading cause of death are heart disease, cancer, and respiratory disease. Note that these figures are from 2018. MedPAC notes that the 3rd leading cause of death in 2020 …

Highlights from MedPAC’s Spring 2021 Report Read More »

Backed by Millions in Public and Private Cash, Rapid Covid Tests Are Coming to Stores Near You

Scientists and lawmakers agree that over-the-counter covid tests could allow desk workers to settle back into their cubicles and make it easier to reopen schools and travel. This story also ran on Fortune. It can be republished for free. But even as entrepreneurs race their products to market, armed with millions of dollars in venture …

Backed by Millions in Public and Private Cash, Rapid Covid Tests Are Coming to Stores Near You Read More »

KHN’s ‘What the Health?’: Planning for Round Two

Can’t see the audio player? Click here to listen on SoundCloud. Congress is out of session, but that hasn’t stopped Democrats from planning their next round of health legislation. Together with President Joe Biden, they are looking at a broad array of possibilities, from allowing Medicare to negotiate drug prices to adding more benefits to the …

KHN’s ‘What the Health?’: Planning for Round Two Read More »

Covid Vaccine Hesitancy Drops Among All Americans, New Survey Shows

A new poll of attitudes toward covid vaccinations shows Americans are growing more enthusiastic about being vaccinated, with the most positive change in the past month occurring among Black Americans. Use Our Content It can be republished for free. About 55% of Black adults said they had been vaccinated or plan to be soon, up …

Covid Vaccine Hesitancy Drops Among All Americans, New Survey Shows Read More »

Ask KHN-PolitiFact: How Can Covid Vaccines Be Safe When They Were Developed So Fast?

The development of the first covid vaccines may have seemed to occur at a dizzying pace. After all, scientists identified a new virus and created vaccines to protect against its most severe effects within a year. This story also ran on PolitiFact. It can be republished for free. But the research underpinning these vaccines isn’t …

Ask KHN-PolitiFact: How Can Covid Vaccines Be Safe When They Were Developed So Fast? Read More »

Medicamentos ya conocidos, y baratos, podrían ser clave para tratar covid

¿Podría un antidepresivo que se usa desde hace décadas ser un arma secreta contra covid? Algunos científicos creen que sí, después de que dos pequeños estudios demostraran que la fluvoxamina, que se suele recetar para el trastorno obsesivo compulsivo (TOC), evitara que los participantes desarrollaran una forma grave de la enfermedad. Sería algo impresionante. Un …

Medicamentos ya conocidos, y baratos, podrían ser clave para tratar covid Read More »

Scientists Seek Covid Treatment Answers in Cheap, Older Drugs

Could a decades-old antidepressant be a secret weapon against covid? A few scientists think so, after two small studies showed that fluvoxamine, typically prescribed for obsessive-compulsive disorder, prevented serious illness in all participants who took the pills soon after developing symptoms. This story also ran on San Francisco Chronicle. It can be republished for free. …

Scientists Seek Covid Treatment Answers in Cheap, Older Drugs Read More »

The Great Undoing: Which of Trump’s Policies Will Biden Reverse?

KHN has put together an interactive tool of significant health policies implemented by the Trump administration using its own authority — executive orders, agency guidance or formal regulations — and is tracking Biden administration and court actions. We will update this chart as actions are taken. Topics: Affordable Care Act | HHS Operations | Immigration …

The Great Undoing: Which of Trump’s Policies Will Biden Reverse? Read More »

KHN’s ‘What the Health?’: Getting Down to Work at HHS

Can’t see the audio player? Click here to listen on SoundCloud. As questions swirl about the covid vaccine made by AstraZeneca, public health experts are worried the confusion could create more doubts among people already hesitant to get a vaccine. Meanwhile, the first Senate-confirmed officials are settling into their offices at the Department of Health and …

KHN’s ‘What the Health?’: Getting Down to Work at HHS Read More »

Democrats Eye Medicare Negotiations to Lower Drug Prices

Democrats, newly in control of Congress and the White House, are united behind an idea that Republican lawmakers and major drugmakers fiercely oppose: empowering the Department of Health and Human Services to negotiate the prices of brand-name drugs covered by Medicare. This story also ran on Fortune. It can be republished for free. But they …

Democrats Eye Medicare Negotiations to Lower Drug Prices Read More »

The Case for Donating US Covid Vaccines Overseas

A Senate committee grilled federal officials about the shortage of vaccines to protect Americans against a pandemic virus. Two months later, the U.S. public had lost interest in the virus, and millions of vaccines were sitting in warehouses — although poor countries still needed them. Use Our Content It can be republished for free. This …

The Case for Donating US Covid Vaccines Overseas Read More »

KHN’s ‘What the Health?’: ACA Packs More Benefits — And More Confusion

Can’t see the audio player? Click here to listen on SoundCloud. The covid relief bill signed by President Joe Biden a week ago includes billions of dollars in new health benefits for consumers. But those benefits may be hard for people to take advantage of because of the interaction with the income tax system and the …

KHN’s ‘What the Health?’: ACA Packs More Benefits — And More Confusion Read More »

‘Super-Sized’ Vaccine Clinic Offers Food Workers Some Relief

LONG BEACH, Calif. — Cristina Davila wasn’t used to being happy about waiting in line. As a server at the Navy Proof Restaurant and Bar, the specter of covid has weighed heavily on her mind for the past several months. Davila has been especially worried about the possibility of bringing the virus home to her …

‘Super-Sized’ Vaccine Clinic Offers Food Workers Some Relief Read More »

What is the FTC’s stance on pharmaceutical mergers?

The answer to this question likely will be shaped in part by a new multilateral working group that will include not only representatives from the U.S. (U.S. Department of Justice Antitrust Division, and Offices of State Attorneys General), but also Canada (Canadian Competition Bureau), Europe (the European Commission Directorate General for Competition) and the United …

What is the FTC’s stance on pharmaceutical mergers? Read More »

How much does the U.S. federal government pay for pharmaceuticals?

A number of different federal agencies buy prescription drugs. However, the price at which these pharmaceuticals are purchased varies dramatically. To quantify this variation, a 2021 report from the Congressional Budget Office examines the following prices: Medicare Part D: the prescription drug program for Medicare beneficiaries. Prices are set when private insurers (or pharmacy benefit …

How much does the U.S. federal government pay for pharmaceuticals? Read More »

The size of U.S. pharmaceutical benefits managers (PBMs)

The list price for pharmaceutical price is not what health insurers have to pay. Sure there are patient copayments and coinsurance, but the main reason why insurers don’t pay full list prices are due to pharmacy benefit managers (PBMs). PBMs contract with payers to negotiate rebates by which pharmaceutical manufacturers discount their prices for specific …

The size of U.S. pharmaceutical benefits managers (PBMs) Read More »

High Obesity Rates in Southern States Magnify Covid Threat

In January, as Mississippi health officials planned for their incoming shipments of covid-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity. Obesity and weight-related …

High Obesity Rates in Southern States Magnify Covid Threat Read More »

Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of Recalls

Pfizer’s management knew last year there was “a mold issue” at the Kansas facility now slated to produce the drugmaker’s urgently needed covid-19 vaccine, according to a Food and Drug Administration inspection report. This story also ran on The Daily Beast. It can be republished for free. The McPherson, Kansas, facility, which FDA inspectors wrote …

Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of Recalls Read More »

KHN’s ‘What the Health?’: Good and Not-So-Good News on Covid

Can’t see the audio player? Click here to listen on SoundCloud. There’s good news and bad news on covid-19 this week. On the one hand, several million doses of the one-shot Johnson & Johnson vaccine authorized by the FDA for emergency use are already going into the arms of people around the nation. And the Biden …

KHN’s ‘What the Health?’: Good and Not-So-Good News on Covid Read More »

A Plan to Conquer U.S. Drug Shortages

By JESSICA DALEY and WAYNE RUSSELL COVID-19 has focused the nation’s attention on the risks associated with complex, global supply chains, particularly related to healthcare products and prescription drugs. While supply disruptions of personal protective equipment (PPE) captured headlines, the pandemic also compromised the drug supply chain. With much of the United States’ generic drugs manufactured overseas, exportation …

A Plan to Conquer U.S. Drug Shortages Read More »

Accidentally Trashed, Thawed or Expired: Reports of Covid Vaccine Spoilage

As the speed of covid vaccinations picks up, so do the reports of doses going to waste. And it’s more than just a handful at the end of the day because of a few appointment cancellations. Health officials are trying to rein in waste without slowing down vaccinations. This story is from a partnership that …

Accidentally Trashed, Thawed or Expired: Reports of Covid Vaccine Spoilage Read More »

Rechazan a cuidadores familiares en sitios de vacunación contra covid de California

En California, la confusión y la comunicación fallida han provocado que algunos padres elegibles y cuidadores familiares de personas con discapacidades sean rechazados en los sitios de vacunación de covid. Oscar Madrigal es uno de esos cuidadores. Sus dos hijos están en el espectro del autismo y el menor requiere cuidados casi constantes. Cuando se …

Rechazan a cuidadores familiares en sitios de vacunación contra covid de California Read More »

In California, Caregivers of People With Disabilities Are Being Turned Away at COVID Vaccine Sites

This story is part of a partnership that includes KPCC, NPR and KHN. It can be republished for free. In California, confusion and botched communication has caused some eligible parents and family caregivers of people with disabilities to be turned away at covid vaccination sites. Oscar Madrigal is one of those caregivers. His two sons …

In California, Caregivers of People With Disabilities Are Being Turned Away at COVID Vaccine Sites Read More »

Is the UK destined to be the next life science hub?

That is a question considered in the latest edition of The Economist. In the article “How British science came to the rescue“, the magazine notes that COVID-19 had highlighted some of the advantages the UK has. Alongside vast clinical trials, the country has been home to most of the world’s genetic sequencing, the development of …

Is the UK destined to be the next life science hub? Read More »

Why AstraZeneca and J&J’s Vaccines, In Use the World Over, Are Still on Hold in America

This story also ran on Fortune. It can be republished for free. The World Health Organization greenlighted emergency use of AstraZeneca and Oxford’s covid-19 vaccine this month, following in the steps of the United Kingdom, the European Union and others, who are already injecting it as quickly as possible into the masses. But the United …

Why AstraZeneca and J&J’s Vaccines, In Use the World Over, Are Still on Hold in America Read More »

How representative are clinical trials of the US population?

Diversity in clinical trials Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the report examines the demographics of participants in clinical trials for the 53 drugs that FDA approved in 2020 either as new molecular entities (NMEs) under new drug applications (NDAs) or …

How representative are clinical trials of the US population? Read More »

Why R&D expenses rising and productivity falling could be a good thing

A few facts: Pharma is increasingly a key driver of US R&D. Pharmaceutical firms share of R&D increased from <10% in the early 1970s to 24% in 2018 (among firms in Compustat data). Moreover, 5 out of top 10 largest R&D spenders in Compustat in 2010 were pharmaceutical firms. A majority of drugs are targeted …

Why R&D expenses rising and productivity falling could be a good thing Read More »

After Billions of Dollars and Dozens of Wartime Declarations, Why Are Vaccines Still in Short Supply?

This story also ran on Fortune. It can be republished for free. The U.S. government has invested billions of dollars in manufacturing, used a wartime act dozens of times to boost supplies and yet there’s still not enough covid vaccine on the way to meet demand — or even the government’s own goals for national …

After Billions of Dollars and Dozens of Wartime Declarations, Why Are Vaccines Still in Short Supply? Read More »

Use of real-world evidence for regulatory decision-making

How do you evaluate treatment efficacy and safety outside of the clinical trial setting? This is not just a question of academic interest. In last week’s JAMA, Rubin 2021 writes about some of the challenges of evaluating COVID-19 vaccines outside of a clinical trial setting. In an interesting, two-day workshop last week, the Duke Margolis …

Use of real-world evidence for regulatory decision-making Read More »

KHN’s ‘What the Health?’: Open Enrollment, One More Time

Can’t see the audio player? Click here to listen on SoundCloud. An estimated 9 million Americans eligible for free or reduced premium health insurance under the Affordable Care Act have a second chance to sign up for 2021 coverage, since the Biden administration reopened enrollment on healthcare.gov and states that run their own marketplaces followed suit. …

KHN’s ‘What the Health?’: Open Enrollment, One More Time Read More »

What kind of HTA does the US need?

Should the US have a formal, centralized health technology assessment (HTA) organization? In the United Kingdom, the National Institute for Health and Care Excellence (NICE) plays this roles and has a significant impact on drug pricing in the UK. However, the UK relies on a single payer system and NICE’s recommendations can be directly implemented …

What kind of HTA does the US need? Read More »

Can Pfizer and Moderna End the Pandemic by Sharing Their Vaccine Designs? It’s Not that Simple

“Pfizer and Moderna could share their design with dozens of other pharma companies who stand ready to produce their vaccines and end the pandemic.” — Feb. 3 in a Facebook post This story was produced in partnership with PolitiFact. It can be republished for free. Vaccine makers Pfizer and Moderna earned praise for creating highly effective …

Can Pfizer and Moderna End the Pandemic by Sharing Their Vaccine Designs? It’s Not that Simple Read More »

Farmworker Camps to Urban Tent Cities: Tailoring Vaccine Info to Where It’s Most Needed

This story also ran on The Charlotte Observer. It can be republished for free. Kim Wagenaar has been preparing to bring covid-19 vaccines to western North Carolina for months. She’s signed up the community health center she operates in Asheville to receive and distribute the doses. She’s ordered a subzero freezer to store the Pfizer-BioNTech …

Farmworker Camps to Urban Tent Cities: Tailoring Vaccine Info to Where It’s Most Needed Read More »

Medicare Part D: Do beneficiaries shop for high-value plans?

Medicare Part D covers prescription drugs for largely elderly Americans in the U.S. Those who qualify for both Medicare and Medicaid receive Part D drug coverage with no premiums and reduced copayments through the low-income subsidy program (LIS). Although federal and state government pays for about 6 out of every 7 dollars of the Part …

Medicare Part D: Do beneficiaries shop for high-value plans? Read More »

KHN’s ‘What the Health?’: Covid and Kids

Can’t see the audio player? Click here to listen on SoundCloud. Nearly a year into the pandemic, many public schools are still closed to in-person instruction. But while there is increasing evidence that schools are not a major source of infection, teachers and staffers remain concerned about going back to class before they are vaccinated. Meanwhile, …

KHN’s ‘What the Health?’: Covid and Kids Read More »

Cien millones de vacunas contra covid en 100 días no nos hará volver a la normalidad

El 30 de abril se cumplirán los primeros 100 días de mandato del presidente Joe Biden. Este es un punto de referencia que los presidentes suelen establecer para cumplir con las promesas de campaña de alta prioridad. A principios de diciembre, Biden anunció que una de sus promesas sería administrar 100 millones de vacunas a …

Cien millones de vacunas contra covid en 100 días no nos hará volver a la normalidad Read More »

100 Million Covid Shots in 100 Days Doesn’t Get Us Back to Normal

April 30 will mark the end of the first 100 days of President Joe Biden’s tenure. That’s a benchmark presidents often set for making good on high-priority campaign promises. In early December, Biden announced that one promise would be to get 100 million covid-19 vaccines into the arms of Americans in the first 100 days, …

100 Million Covid Shots in 100 Days Doesn’t Get Us Back to Normal Read More »

When Your Chance for a Covid Shot Comes, Don’t Worry About the Numbers

Use Our Content It can be republished for free. When getting vaccinated against covid-19, there’s no sense being picky. You should take the first authorized vaccine that’s offered, experts say. The newest covid vaccine on the horizon, from Johnson & Johnson, is probably a little less effective at preventing sickness than the two shots already …

When Your Chance for a Covid Shot Comes, Don’t Worry About the Numbers Read More »

States Move Ahead With Canada Drug Importation While Awaiting Signal From Biden

Florida, Colorado and several New England states are moving ahead with efforts to import prescription drugs from Canada, a politically popular strategy greenlighted last year by President Donald Trump. But it’s unclear whether the Biden administration will proceed with Trump’s plan for states and the federal government to help Americans obtain lower-priced medications from Canada. …

States Move Ahead With Canada Drug Importation While Awaiting Signal From Biden Read More »

KHN’s ‘What the Health?’: The Long Road to Unwinding Trump Health Policies

Can’t see the audio player? Click here to listen on SoundCloud. Thursday was “health day” in President Joe Biden’s sprint to launch his presidency, and he signed two executive orders addressing health coverage and women’s reproductive rights. The orders will reopen enrollment under the Affordable Care Act from February to May and reverse the so-called Mexico …

KHN’s ‘What the Health?’: The Long Road to Unwinding Trump Health Policies Read More »

COVID-19 vaccine manufacturers capture less than 2% of total social value

How can we best accelerate vaccine availability? This is the question that Ahuja et al. (2021) try to answer in their Becker-Friedman Institute (BFI) working paper. First, they state the obvious: the cost of the COVID-19 pandemic is large. Specifically: Each month, the COVID pandemic kills 300,000 people (as of Jan. 2021) and reduces global …

COVID-19 vaccine manufacturers capture less than 2% of total social value Read More »

Remdesivir, Given to Half of Hospitalized Covid Patients in U.S., Is Big Win for Gilead — Boosted by Taxpayers

It was the end of April — just as the U.S. confirmed its millionth covid-19 case and 50,000 deaths — when White House adviser Dr. Anthony Fauci announced “highly significant” news about a drug called remdesivir. That was surprising because the antiviral drug, owned by Gilead Sciences and developed with investment from the federal government, …

Remdesivir, Given to Half of Hospitalized Covid Patients in U.S., Is Big Win for Gilead — Boosted by Taxpayers Read More »

Por qué ni siquiera la presión presidencial podría acelerar las vacunas contra covid

Miles de estadounidenses están muriendo a causa de covid-19, pero los esfuerzos para aumentar la producción de vacunas que potencialmente salvan vidas están en un callejón sin salida. Moderna y Pfizer-BioNTech, los fabricantes de las dos vacunas disponibles hasta el momento, están operando al máximo, bajo una enorme presión por expandir la producción o colaborar …

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Why Even Presidential Pressure Might Not Get More Vaccine to Market Faster

Americans are dying of covid-19 by the thousands, but efforts to ramp up production of potentially lifesaving vaccines are hitting a brick wall. Vaccine makers Moderna and Pfizer-BioNTech are running their factories full tilt and are under enormous pressure to expand production or collaborate with other drug companies to set up additional assembly lines. That …

Why Even Presidential Pressure Might Not Get More Vaccine to Market Faster Read More »

Health Issues Carried Weight on the Campaign Trail. What Could Biden Do in His First 100 Days?

Joe Biden ran on an expansive health care platform during his 2020 presidential campaign, with a broad array of promises such as adding a government-sponsored health plan to the Affordable Care Act and lowering prescription drug prices. Perhaps most significantly, he pledged to get control of the covid pandemic that claimed more than 400,000 American lives …

Health Issues Carried Weight on the Campaign Trail. What Could Biden Do in His First 100 Days? Read More »

KHN’s ‘What the Health?’: On Capitol Hill, Actions Have Consequences

Can’t see the audio player? Click here to listen on SoundCloud. The reverberations from the Jan. 6 storming of the U.S. Capitol by supporters of President Donald Trump continue. A broad array of business groups, including many from the health industry, are halting contributions to Republicans in the House and Senate who voted against certifying the …

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Delicate Covid Vaccines Slow Rollout — Leading to Shots Given Out of Turn or, Worse, Wasted

For Heather Suri, a registered nurse in Virginia, the race to vaccinate Americans against covid has thrown up some unprecedented obstacles. The vaccines themselves are delicate and require a fair bit of focus over time. Consider Moderna’s instructions for preparing its doses: Select the number of shots that will be given. Thaw the vials for …

Delicate Covid Vaccines Slow Rollout — Leading to Shots Given Out of Turn or, Worse, Wasted Read More »

Is Your Covid Vaccine Venue Prepared to Handle Rare, Life-Threatening Reactions?

As the rollout of covid-19 vaccines picks up across the U.S., moving from hospital distribution to pharmacies, pop-up sites and drive-thru clinics, health experts say it’s vital that these expanded venues be prepared to handle rare but potentially life-threatening allergic reactions. “You want to be able to treat anaphylaxis,” said Dr. Mitchell Grayson, an allergist-immunologist …

Is Your Covid Vaccine Venue Prepared to Handle Rare, Life-Threatening Reactions? Read More »

Biden’s First Order of Business May Be to Undo Trump’s Policies, but It Won’t Be Easy

The party split in Congress is so slim that, even with Democrats technically in the majority, passing major health care legislation will be extremely difficult. So speculation about President-elect Joe Biden’s health agenda has focused on the things he can accomplish using executive authority. Although there is a long list of things he could do, …

Biden’s First Order of Business May Be to Undo Trump’s Policies, but It Won’t Be Easy Read More »

KHN’s ‘What the Health?’: Georgia Turns the Senate Blue

Can’t see the audio player? Click here to listen on SoundCloud. Surprise Democratic victories in Georgia’s two runoff elections this week will give Democrats control of the Senate, which means they will be in charge of both houses of Congress and the White House for the first time since 2010. Although the narrow majorities in the …

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San Francisco Wrestles With Drug Approach as Death and Chaos Engulf Tenderloin

This story also ran on Los Angeles Times. It can be republished for free. SAN FRANCISCO — In early 2019, Tom Wolf posted a thank-you on Twitter to the cop who had arrested him the previous spring, when he was homeless and strung out in a doorway with 103 tiny bindles of heroin and cocaine …

San Francisco Wrestles With Drug Approach as Death and Chaos Engulf Tenderloin Read More »

Listen: How Operation Warp Speed Became a Slow Walk

KHN Editor-in-Chief Elisabeth Rosenthal appeared on Diane Rehm’s “On My Mind” podcast on NPR to discuss the bottlenecks that have prevented doses of precious covid-19 vaccine from making it from drugmakers’ factories into patients’ arms. It didn’t have to be this way, she explains. Kaiser Health News (KHN) is a national health policy news service. …

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Many Health Plans Now Must Cover Full Cost of Expensive HIV Prevention Drugs

Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up. Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month …

Many Health Plans Now Must Cover Full Cost of Expensive HIV Prevention Drugs Read More »

Children’s Hospitals Are Partly to Blame as Superbugs Increasingly Attack Kids

COLUMBIA, Mo. — A memory haunts Christina Fuhrman: the image of her toddler Pearl lying pale and listless in a hospital bed, tethered to an IV to keep her hydrated as she struggled against a superbug infection. “She survived by the grace of God,” Fuhrman said of the illness that struck her oldest child in …

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Seniors Face Crushing Drug Costs as Congress Stalls on Capping Medicare Out-Of-Pockets

This story also ran on Fortune. It can be republished for free. 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 …

Seniors Face Crushing Drug Costs as Congress Stalls on Capping Medicare Out-Of-Pockets Read More »

Analysis: Some Said the Vaccine Rollout Would Be a ‘Nightmare.’ They Were Right.

This story also ran on The New York Times. It can be republished for free. WASHINGTON — Even before there was a vaccine, some seasoned doctors and public health experts warned, Cassandra-like, that its distribution would be “a logistical nightmare.” After Week 1 of the rollout, “nightmare” sounds like an apt description. Dozens of states …

Analysis: Some Said the Vaccine Rollout Would Be a ‘Nightmare.’ They Were Right. Read More »

KHN’s ‘What the Health?’: 2020 in Review — It Wasn’t All COVID

Can’t see the audio player? Click here to listen on SoundCloud. COVID-19 was the dominant — but not the only — health policy story of 2020. In this special year-in-review episode of KHN’s “What the Health?” podcast, panelists look back at some of the biggest non-coronavirus stories. Those included Supreme Court cases on the Affordable Care …

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At Risk of Extinction, Black-Footed Ferrets Get Experimental COVID Vaccine

In late summer, as researchers accelerated the first clinical trials of COVID-19 vaccines for humans, a group of scientists in Colorado worked to inoculate a far more fragile species. About 120 black-footed ferrets, among the most endangered mammals in North America, were injected with an experimental COVID vaccine aimed at protecting the small, weasel-like creatures …

At Risk of Extinction, Black-Footed Ferrets Get Experimental COVID Vaccine Read More »

Inside the First Chaotic Days of the Effort to Vaccinate America

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 …

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Single-Cell Sequencing: The New Era of Gene Expression Analysis

For developing an improved understanding of the interactions of individual cells within their microenvironment, advanced molecular probing solutions are being used by researchers across the globe. In this context, high-throughput single-cell analysis, has emerged as a powerful analytical technique for studying individual cells, enabling researchers to study gene expression at single cell resolution. Single-cell sequencing …

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Law Will Allow Calif. to Produce, Distribute Biosimilars, Generics

That is the title of an article by Angela Maas in Radar on Specialty pharmacy (reprinted here). A few excerpts: “Although state governments frequently pay for health care through programs such as Medicaid, in the past, state governments have not manufactured drugs,” says Jason Shafrin, vice president of health economics at PRECISIONheor. “Thus, this is a …

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Agrícolas, bomberos y azafatas buscan estar entre los primeros en recibir la vacuna

Se espera que los trabajadores de salud de primera línea, así como los residentes y el personal de los hogares de adultos mayores, reciban las dosis iniciales de la vacuna contra COVID. La cuestión más espinosa es averiguar quiénes serán los siguientes. La respuesta probablemente dependerá de en dónde vivas. Aunque una influyente junta asesora …

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Supply Is Limited and Distribution Uncertain as COVID Vaccine Rolls Out

Use Our Content It can be republished for free. High stakes and big challenges await as the U.S. prepares to roll out vaccines against COVID-19, with front-line health care workers and vulnerable nursing home residents recommended as the top priority. Doses could be on their way very soon. An independent advisory committee to the Food …

Supply Is Limited and Distribution Uncertain as COVID Vaccine Rolls Out Read More »

Farmworkers, Firefighters and Flight Attendants Jockey for Vaccine Priority

With front-line health workers and nursing home residents and staff expected to get the initial doses of COVID vaccines, the thornier question is figuring out who goes next. The answer will likely depend on where you live. While an influential federal advisory board is expected to make its recommendations later this month, state health departments …

Farmworkers, Firefighters and Flight Attendants Jockey for Vaccine Priority Read More »

Orphan Drug Policies Around the World

How do you incentivize pharmaceutical companies and researchers to develop new drugs for rare diseases? Drug development is expensive and–by definition–rare diseases have a small market. One solution to this problem is that governments have used orphan drug policies to provide monetary incentives for innovators to research drugs for rare diseases. But which countries have …

Orphan Drug Policies Around the World Read More »

Demand for COVID Vaccines Expected to Get Heated — And Fast

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated. But with two promising vaccines primed for release, likely within weeks, …

Demand for COVID Vaccines Expected to Get Heated — And Fast Read More »

Feds Look to Pharmacists to Boost Childhood Immunization Rates

Torey Watson is trained as a pharmacist but aims to do more than simply fill prescriptions. Pharmax Pharmacy — a small drugstore chain where Watson works as a clinical services coordinator, about an hour and 30 minutes southwest of St. Louis — will soon allow him to offer childhood vaccines to patients without a doctor’s …

Feds Look to Pharmacists to Boost Childhood Immunization Rates Read More »

What is the impact of FDA review time on pharmaceutical R&D investments?

This is the question that a recent paper by Chorniy et al. (2020) attempt to answer. This issue is clearly very relevant as the UK recently has approved the Pfizer/BioNTech vaccine for COVID-19 before the US. Unlike most studies that attempt to examine the relationship between FDA review time and R&D investment dollars, the authors …

What is the impact of FDA review time on pharmaceutical R&D investments? Read More »

Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Shots: Boston Scientific signs an agreement with Stark International and SERB SAS to sell its BTG specialty pharma business for $800M in cash. The transaction is expected to close in H1’21 The agreement includes the transfer of 5 facilities & ~280 employees globally. This transaction will help the BTG specialty pharma business enhance its potential …

Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M Read More »

How COVID-19 Highlights the Uncertainty of Medical Testing

Dr. Jacqueline Chu considered the man with a negative coronavirus test on the other end of the phone, and knew, her heart dropping, that the test result was not enough to clear him for work. The man was a grocery store clerk — an essential worker — and the sole earner for his family. A …

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Drug importation from Canada won’t work

I’ve mentioned this in a number of previous posts, but large scale importation from Canada won’t work to bring down US drugs prices. The US market is too large and Canada does not have the supply to meet US demand. Further, policies proposing drug importation from Canada assume that Canadians will be passive actors in …

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How Pharma Money Colors Operation Warp Speed’s Quest to Defeat COVID

April 16 was a big day for Moderna, a Massachusetts biotech company on the verge of becoming a front-runner in the U.S. government’s race for a coronavirus vaccine. It had received roughly half a billion dollars in federal funding to develop a COVID shot that might be used on millions of Americans. This story also …

How Pharma Money Colors Operation Warp Speed’s Quest to Defeat COVID Read More »

Why does the US spend so much more on health care than other countries?

If we break down the numbers, it turns out that medical costs–rather than pharmacy cost–are the key drivers of differences in health care spending per capita. This is the findings from Kaiser Family Foundation (KFF) study comparing US spending against an average from 9 other countries rich countries (i.e., Austria, Belgium, Canada, France, Germany, the …

Why does the US spend so much more on health care than other countries? Read More »

New Legal Push Aims to Speed Magic Mushrooms to Dying Patients

Back in March, just as anxiety over COVID-19 began spreading across the U.S., Erinn Baldeschwiler of La Conner, Washington, found herself facing her own private dread. Just 48 and the mother of two teenagers, Baldeschwiler was diagnosed with stage 4 metastatic breast cancer after discovering a small lump on her chest, no bigger than a …

New Legal Push Aims to Speed Magic Mushrooms to Dying Patients Read More »

Surprise Federal Drug Rule Directs Insurers to Reveal What They Pay for Prescription Drugs

Health insurance companies will have to give their customers estimated out-of-pocket costs for prescription drugs and disclose to the public the negotiated prices they pay for drugs, under an unexpected new Trump administration rule. The administration said those requirements, part of a broader rule issued Oct. 29 forcing health plans to disclose costs and payments …

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Government-Funded Scientists Laid the Groundwork for Billion-Dollar Vaccines

When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr. Barney Graham, then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic. Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design …

Government-Funded Scientists Laid the Groundwork for Billion-Dollar Vaccines Read More »

Patients Struggle to Find Prescription Opioids After NY Tax Drives Out Suppliers

NEW YORK — Mike Angevine lives in constant pain. For a decade the 37-year-old has relied on opioids to manage his chronic pancreatitis, a disease with no known cure. But in January, Angevine’s pharmacy on Long Island ran out of oxymorphone and he couldn’t find it at other drugstores. He fell into withdrawal and had …

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¿Es hora de discutir los potenciales efectos secundarios de las vacunas para COVID? Científicos dicen que sí

Se espera que la farmacéutica Pfizer solicite permiso federal para lanzar su vacuna para COVID-19 a fines de noviembre. Una medida que promete acorralar la pandemia, pero que no ofrece mucho tiempo para asegurarse de que los consumidores estén bien informados. Esta vacuna, y probablemente las otras, requerirá de dos dosis para funcionar, inyecciones que …

¿Es hora de discutir los potenciales efectos secundarios de las vacunas para COVID? Científicos dicen que sí Read More »

Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes.

Drugmaker Pfizer is expected to seek federal permission to release its COVID-19 vaccine by the end of November, a move that holds promise for quelling the pandemic, but also sets up a tight time frame for making sure consumers understand what it will mean to actually get the shots. This story also ran on NBC …

Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes. Read More »

Cinco preguntas críticas sobre la vacuna contra COVID-19 de Pfizer

El anuncio de Pfizer de que su vacuna contra COVID-19 prevendría que nueve de cada 10 personas contraigan la enfermedad hizo que el precio de sus acciones se disparara. Muchos titulares describieron a la vacuna como si fuera la liberación de la pandemia, aunque se dieron pocos detalles. Ciertamente hay para presumir: la vacuna de …

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Five Important Questions About Pfizer’s COVID-19 Vaccine

Pfizer’s announcement on Monday that its COVID-19 shot appears to keep nine in 10 people from getting the disease sent its stock price rocketing. Many news reports described the vaccine as if it were our deliverance from the pandemic, even though few details were released. There was certainly something to crow about: Pfizer’s vaccine consists …

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Search for a Snakebite Drug Might Lead to a COVID Treatment, Too

Dr. Matthew Lewin, founder of the Center for Exploration and Travel Health at the California Academy of Sciences, was researching snakebite treatments in rural locations in preparation for an expedition to the Philippines in 2011. The story of a renowned herpetologist from the academy, Joseph Slowinski, who was bitten by a highly venomous krait in …

Search for a Snakebite Drug Might Lead to a COVID Treatment, Too Read More »

Spending on specialty drugs: 2010-2017

Specialty drugs are often injectibles, biologic drugs, or other drugs that require specialized administration, handling, or ongoing clinical assessment. Specialty drugs are often more expensive than standard pharmaceuticals. As the use of specialty pharmaceuticals has become more common, a paper by Hill, Miller and Ding (2020) aims to quantify how much spending on specialty pharmaceuticals …

Spending on specialty drugs: 2010-2017 Read More »

VA Joins Pentagon in Recruiting Volunteers for COVID Vaccine Trials

The Department of Veterans Affairs is recruiting 8,000 volunteers for the Phase 3 clinical trials of at least four COVID-19 vaccine candidates at 20 federal medical facilities across the U.S., according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine. The largely unpublicized effort follows a …

VA Joins Pentagon in Recruiting Volunteers for COVID Vaccine Trials Read More »

A $200 Debit Card Won’t Do Much for Seniors’ Drug Costs

If they’ve been listening to President Donald Trump, seniors may be expecting a $200 debit card in the mail any day now to help them pay for prescription drugs. He promised as much this month, saying his administration soon will mail the drug cards to more than 35 million Medicare beneficiaries. But the cards — …

A $200 Debit Card Won’t Do Much for Seniors’ Drug Costs Read More »

Científicos advierten que se espera demasiado de una vacuna para COVID

La Casa Blanca y muchos estadounidenses han depositado sus esperanzas de derrotar a la pandemia de COVID-19 en una vacuna que se está desarrollando a la “velocidad de la luz”. Pero algunos científicos advierten que se espera demasiado, y demasiado pronto. “Todos piensan que COVID-19 desaparecerá con una vacuna”, dijo el doctor William Haseltine, presidente …

Científicos advierten que se espera demasiado de una vacuna para COVID Read More »

Readers and Tweeters Shed Light on Vaccine Trials and Bias in Health Care

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names. On the ‘Subject’ of Vaccine Trial Participants In the piece about the AstraZeneca vaccine trial subject who suffered severe spinal cord inflammation, that person was repeatedly referred to as a …

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Scientists Warn Americans Are Expecting Too Much From a Vaccine

The White House and many Americans have pinned their hopes for defeating the COVID-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon. “Everyone thinks COVID-19 will go away with a vaccine,” said Dr. William Haseltine, chair and president of Access Health International, …

Scientists Warn Americans Are Expecting Too Much From a Vaccine Read More »

Harnessing The Power of Real World Evidence to Fight COVID-19 Pandemic

With the ongoing pandemic of COVID-19, there is long wait for the vaccine to be approved. Even after the vaccine gets approved, there is no assurance of the complete eradication of virus. There will still be percentage of people who contract the illness. Therefore, it is very important to trace and detect the treatments in …

Harnessing The Power of Real World Evidence to Fight COVID-19 Pandemic Read More »

Florida Fails to Attract Bidders for Canada Drug Importation Program

Florida’s plan to import cheaper prescription drugs from Canada — designed by Gov. Ron DeSantis and endorsed by President Donald Trump — has tasted its first bitter pill. No private firms bid on Florida’s $30 million contract to set up and operate a drug importation program. Bids were due at the end of September. The …

Florida Fails to Attract Bidders for Canada Drug Importation Program Read More »

HTA are ignoring the value of reduced caregiver burden

While many health technology assessment (HTA) organizations acknowledge that many new treatments reduce the burden placed on caregivers, the value that these new treatments provide is rarely incorporated into formal cost effectiveness analyses. This is the finding from Pennington (2020) based on a review of ll published technology appraisals (TAs) and highly specialized technologies (HSTs). …

HTA are ignoring the value of reduced caregiver burden Read More »

FDA’s use of real-world data

The 21st Century Cures Act required the Food and Drug Administration (FDA) establish a program for evaluating the use of real-world data (RWD) to support the approval of new indications for drugs. Real-world data is typically data from either health insurance claims, electronic health records (EHRs), patient registries, or mobile devices. But how has FDA …

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REAL-WORLD EVIDENCE: THE GAME CHANGER IN DRUG DEVELOPMENT

While the definition of real world evidence is still evolving, most proponents associate it with data that is derived from medical practice among heterogeneous sets of patients in the real world setting. It is the integration of data gathered from various sources, such as EHRs, medical charts, patient claims and billing activities, product and disease …

REAL-WORLD EVIDENCE: THE GAME CHANGER IN DRUG DEVELOPMENT Read More »

Progressive Group Highlights Trump, Tillis Weakness on Insulin Price Tags

    During the first presidential debate of 2020, President Donald Trump touted his efforts to curb skyrocketing drug prices and declared that insulin is now “so cheap, it’s like water.” The response on social media was swift, and divided, with some people sharing pharmacy bills showing thousands of dollars they’d spent on insulin, while …

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Inhaled and Intranasal Drug Delivery: A Deeper Look into Service Providers Landscape

The techniques used for the drug delivery are found to be have an enormous impact on the efficacy of the treatment. In fact, the slow progression of the efficacy, has suggested the need of different approaches for the effective delivery of drug to the target area, along with the optimal bioavailability. Over the years, several …

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COVID-19: las farmacéuticas elogiadas por Trump mandan dinero a Biden

Los gigantes farmacéuticos Regeneron y Gilead Sciences obtuvieron el tipo de publicidad que el dinero no puede comprar luego que el presidente Donald Trump tomara sus medicamentos experimentales para tratar su infección por coronavirus, y se declarara completamente recuperado después de dejar el hospital. “Fue increíble. Me sentí bien de inmediato”, dijo Trump el miércoles …

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As Trump Touts His ‘Great’ COVID Drugs, the Pharma Cash Flows to Biden, Not Him

Pharmaceutical giants Regeneron and Gilead Sciences got the kind of publicity money can’t buy this week after President Donald Trump took their experimental drugs for his coronavirus infection, left the hospital and pronounced himself fully recovered. “It was, like, unbelievable. I felt good immediately,” Trump said Wednesday in a tweeted video. “I call that a …

As Trump Touts His ‘Great’ COVID Drugs, the Pharma Cash Flows to Biden, Not Him Read More »

5 Things to Know About a COVID Vaccine: It Won’t Be a ‘Magic Wand’

President Donald Trump makes no secret he would like a COVID-19 vaccine to be available before the election. But it’s doubtful that will happen and, even after a vaccine wins FDA approval, there would be a long wait before it’s time to declare victory over the virus. Dozens of vaccine candidates are in various testing …

5 Things to Know About a COVID Vaccine: It Won’t Be a ‘Magic Wand’ Read More »

FDA sets guidelines for drug importation from Canada

Last month, the US Food and Drug Administration published a final rule providing guidance for allowing drug importation from Canada. The drugs have to be approved by the Government of Canada’s Health Canada’s Health Products and Food Branch (HPFB) and can be imported by States or Indian Tribes, or in certain circumstances by pharmacists or …

FDA sets guidelines for drug importation from Canada Read More »

Old Drug Turned ‘Cash Cow’ as Company Pumped Price to $40K a Vial, Emails Show

For a dad whose infant son was afflicted with a rare seizure disorder, a drug invented in 1952 was indispensable for his boy. It was also indispensable to executives at the pharmaceutical firm that acquired the drug in 2014 — not because it was a cure, but because it was a “cash cow,” according to …

Old Drug Turned ‘Cash Cow’ as Company Pumped Price to $40K a Vial, Emails Show Read More »

Linking pharma financial returns to drug access in low-income countries

Novartis raised EUR 1.85 billion euros of funds through a bond sale earlier this month. A bond sale by a large multinational corporation is not news. What is news is the type of bonds they were: sustainability-linked bonds (SLBs). From the Novartis press release: The new bond is the first of its kind in the …

Linking pharma financial returns to drug access in low-income countries Read More »

Republican Convention, Day 4: Fireworks … and Shining a Light on Trump’s Claims

President Donald Trump accepted the Republican Party’s nomination for president in a 70-minute speech from the South Lawn of the White House on Thursday night. Speaking to a friendly crowd that didn’t appear to be observing social distancing conventions, and with few participants wearing masks, he touched on a range of topics, including many related …

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Trump Again Claims He’s Bringing Down Drug Prices, But Details of How Are Skimpy

President Donald Trump has long considered lowering the high cost of prescription drugs to be one of his signature issues, and it is likely to be a talking point he relies on throughout the upcoming campaign. During his afternoon speech Monday ― delivered on the first day of the Repubublican National Convention after delegates had …

Trump Again Claims He’s Bringing Down Drug Prices, But Details of How Are Skimpy Read More »

LA Hospital Seeks Vaccine Trial Participants Among Its Own High-Risk Patients

The patients at Dr. Eric Daar’s hospital are at high risk for serious illness from COVID-19, and he’s determined to make sure they’re part of the effort to fight the disease. He also hopes they can protect themselves in the process. When Daar and his colleagues at Harbor-UCLA Medical Center on Wednesday announce the start …

LA Hospital Seeks Vaccine Trial Participants Among Its Own High-Risk Patients Read More »

Democratic Convention, Night 4: ‘Facts Over Fiction’ in Biden’s Speech

In a near-empty arena on the river in his hometown of Wilmington, Delaware, former Vice President Joe Biden accepted the Democratic nomination for president, promising hope over fear, fairness over privilege, love over hate. And, he said, “Facts over fiction.” Let’s see about that. Our partners at PolitiFact examined a range of claims made by …

Democratic Convention, Night 4: ‘Facts Over Fiction’ in Biden’s Speech Read More »

KHN’s ‘What the Health?’: Kamala Harris on Health

Can’t see the audio player? Click here to listen on SoundCloud. California Sen. Kamala Harris, the newly named running mate for presumptive Democratic presidential nominee Joe Biden, doesn’t have a lot of background in health policy. But that’s unlikely to prevent Republicans from using her on-again, off-again support for “Medicare for All” against her in the …

KHN’s ‘What the Health?’: Kamala Harris on Health Read More »

What is the “reputational value” of developing a COVID vaccine?

COVID-19 is a global pandemic and finding a vaccine for COVID-19 would be a boon to societal. The value would be enormous. One study found that the value would be more than 1.1% of GDP. Since global GDP is $87.7 trillion, the value of a vaccine would be nearly $1 trillion. In a recent colloquium …

What is the “reputational value” of developing a COVID vaccine? Read More »

Trump executive orders on drug prices: Much ado about nothing?

President Trump signed 4 executive orders on drug pricing on July 24, 2020. How are they likely to affect drugs prices? Passing along rebates to patients The one of the executive orders mandates that rebates go to reduce patient cost sharing: These middlemen — health plan sponsors and pharmacy benefit managers (PBMs) — negotiate significant …

Trump executive orders on drug prices: Much ado about nothing? Read More »

What Seniors Can Expect as Their New Normal in a Post-Vaccine World

Imagine this scenario, perhaps a year or two in the future: An effective COVID-19 vaccine is routinely available and the world is moving forward. Life, however, will likely never be the same — particularly for people over 60. That is the conclusion of geriatric medical doctors, aging experts, futurists and industry specialists. Experts say that …

What Seniors Can Expect as Their New Normal in a Post-Vaccine World Read More »

Fauci Unfazed as Scientists Rely on Unproven Methods to Create COVID Vaccines

With millions of lives on the line, researchers have been working at an unprecedented pace to develop a COVID-19 vaccine. But that speed — and some widely touted breakthroughs — belie the enormous complexity and potential risks involved. Researchers have an incomplete understanding of the coronavirus and are using technology that’s largely unproven. Among many …

Fauci Unfazed as Scientists Rely on Unproven Methods to Create COVID Vaccines Read More »

Don’t Fall for This Video: Hydroxychloroquine Is Not a COVID-19 Cure

Millions of people, including the president of the United States, have seen or shared a video in which a doctor falsely claims there is a cure for the coronavirus, and it’s a medley starring hydroxychloroquine. The video shows several doctors in white coats giving a press conference outside the Supreme Court in Washington, D.C. It persists on social media despite …

Don’t Fall for This Video: Hydroxychloroquine Is Not a COVID-19 Cure Read More »

KHN’s ‘What The Health?’: Republicans in COVID Disarray

Can’t see the audio player? Click here to listen on SoundCloud. President Donald Trump’s pivot to a more serious view of the coronavirus pandemic didn’t last long. This week, he was again touting hydroxychloroquine, an antimalarial drug that has not been shown to work against the virus. Meanwhile, on Capitol Hill, Republicans continue to struggle to …

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Must-Reads of the Week From Lauren Olsen

Hiya! I’m Lauren Olsen, your new Newsletter Editor. That’s right — the totally official, no more fill-ins, always-here-for-you Newsletter Editor. As the replacement for editor extraordinaire Brianna Labuskes, I’m here to tackle all your health news needs. Why yes, you’re right — a pandemic is a heck of a time to take over this job. …

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Vacuna contra el coronavirus: ¿en qué punto está la investigación?

Use Nuestro Contenido Este contenido puede usarse de manera gratuita (detalles). A más de cuatro meses del comienzo de la pandemia en los Estados Unidos, ¿qué tan cerca está el país y el mundo de una vacuna segura y efectiva? Científicos dicen que ven un progreso constante y expresan un optimismo cauteloso de que una …

Vacuna contra el coronavirus: ¿en qué punto está la investigación? Read More »

A Coronavirus Vaccine: Where Does It Stand?

More than four months into the coronavirus pandemic, how close are the U.S. and the world to a safe and effective vaccine? Scientists say they see steady progress and are expressing cautious optimism that a vaccine could be ready by spring. As of early July, roughly 160 vaccine projects were underway worldwide, according to the …

A Coronavirus Vaccine: Where Does It Stand? Read More »

Treatment effect heterogeneity, self-selection into RCTs, and racial disparities

In drug development, clinical trials typically aim for a population that is representative of the patients who would be eligible for the treatment. While randomized controlled trials (RCTs) typically focus on measuring the average health impact of a drug across this population, a paper Basu and Gurjal (2020) argue that treatment effect heterogeneity and self-selection …

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$1 billion antibiotic venture fund launched

Antibiotic resistance is a problem. One study from Europe found that in 2015 there were 33,110 deaths attributable to antibiotic resistance; accounting for morbidity as well, antibiotic resistance lead to a a decrease of 874,541 disability-adjusted life years. CDC data show that antibiotic resistant bacteria and fungi caused 35,900 deaths in 2019, 12,800 deaths due …

$1 billion antibiotic venture fund launched Read More »