STAT+: Drug middlemen switch tactics, but the outcome is the same: high prices
WASHINGTON — Prescription drug middlemen are shifting away from rebates that have been blamed in part for rising brand drug list prices and are using new tactics, including charging drugmakers and pharmacists increasingly larger administrative fees and overcharging for generics. But the outcome is the same for taxpayers and anyone in need of expensive medicines: higher costs.
The changes came to light at a Senate Finance Committee hearing Thursday on the impact of PBMs on drug costs — a meeting that made it clear both parties are considering reining in common industry practices. Of the five panel members who testified at the hearing, just one, University of Pennsylvania Wharton School professor Lawton Burns, had anything nice to say about PBMs. Members of both parties complained about the murkiness of PBM business practices and the incentives of the system, which Sen. John Thune (R-S.D.) said he would “blow up” if he could.
Gunshot injuries surged in U.S. during pandemic, CDC says
NEW YORK — For every American killed by gunfire, an estimated two or more more survive, often with terrible injuries — a fact that public health experts say is crucial to understanding the full impact of guns on society.
A new government study highlights just how violent the recent past has been in America by showing a surge in people wounded by gunshots during the pandemic, when the number of people fatally shooting each other — and themselves — also increased.
Listen: Biotech’s monkey shortage, the broken generics market, & conference cancel culture
What happened to the market for monkeys? Are some drugs too cheap? And why are biotech stocks still in the tank?
We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We explain how biotech is affected by a bizarre situation involving smuggled monkeys, international intrigue, and a criminal investigation. We also discuss what leads to generic drug shortages, whether every major pharmaceutical firm needs a weight-loss drug, and what it means when drug company cancels a conference appearance.
STAT+: FDA proposes a new plan to streamline updates to medical devices that use AI
The Food and Drug Administration on Thursday released a new plan allowing developers of medical devices that rely on artificial intelligence to automatically update products already being used in the clinic.
The agency’s draft guidance outlines a new process in which the makers of AI tools could get approval for modifications in advance by submitting a document describing how the changes will be implemented and tested.
Texas judge strikes down major Obamacare provision protecting birth control, PrEP coverage
WASHINGTON — A federal judge Thursday reversed a major Obamacare provision requiring plans to cover preventive care ranging from cancer and chronic disease screenings to pregnancy care and birth control pills.
The ruling deals a massive blow to the Biden administration’s efforts to lower maternal and infant mortality rates and bolster reproductive rights in the wake of Roe being overturned and could threaten the president’s moonshot goal of slashing cancer rates through early screenings. It also leaves the door open for insurers to refuse coverage of vaccines, statins, drugs preventing HIV transmission known as PrEP, and a vast range of health screenings recommended by federal officials.
STAT+: Pharmalittle: FDA approves over-the-counter Narcan; J&J exits the race for the first RSV vaccine
Rise and shine, another busy day is on the way. We can tell because the official mascot got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy parade of vehicles passing nearby on their way to who knows what? As for us, we are firing up the trusty coffee kettle to brew another cup of stimulation. Our choice today is roasted coconut. Please feel free to join us. Meanwhile, the time has come to get cracking. So here is the latest laundry list of interesting items for you to peruse. We hope you have a smashing day and, of course, do keep in touch. Best of luck, everyone. …
The U.S. Food and Drug Administration approved selling Narcan — the brand name for naloxone — without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter, the Associated Press writes. The move has long been sought by some advocates as a way to improve access to a lifesaving drug, though the exact impact will not be clear immediately. For the moment, the cost is also unknown since the manufacturer, Emergent BioSolutions, has not disclosed a price, although the company did say the treatment should be on store shelves and at online retailers by late summer.
STAT+: Former J&J exec, an in-demand free agent, takes the helm at privately held FogPharma
Mathai Mammen, who until recently led research at Johnson & Johnson, will become the CEO of a privately held biotech company working to find treatments for diseases deemed undruggable.
Mammen, previously a candidate for the top job at Biogen, will take over as chairman, president, and CEO of FogPharma, a Cambridge, Mass., company that spun out of the lab of Harvard University biologist Greg Verdine in 2015. The allure, Mammen said, was Fog’s proprietary approach to discovering medicines for biological targets that have long evaded pharmaceutical research — and the potential to develop, manufacture, and market them without selling out to a larger drugmaker.
Opinion: To deal with the next pandemic, the FDA needs an Office of Preparedness and Response
New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “none of them ever stopped worrying about H5N1.”
The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again? Could it get to a vaccine in just eight months, as with Covid-19? Does the country have the capabilities and resilience to do so?
STAT+: Is there $21 billion left for Covid response, or $5 billion? The White House is using fuzzy math
WASHINGTON — How much money does the federal government still have set aside for the Covid-19 response? It depends who you ask.
A government watchdog published a report last month showing that the Department of Health and Human Services had a remaining $20.6 billion from laws funding various Covid-19 response activities at the end of January. That total is tantalizing to members of the House Freedom Caucus, who have said that clawing back unspent Covid-19 response funds is a condition of their support for a deal to raise the country’s debt ceiling.
In the whitewashed world of Alzheimer’s research, one scientist is on a quest to understand the diversity of brains
CHICAGO — When she entered the field of Alzheimer’s research a quarter century ago, Lisa Barnes was deeply disappointed to find few Black people like her family members with dementia were being studied. A rarity herself — as a Black female cognitive neuropsychologist — she’s spent her career quietly pushing back.
Since 2004, Barnes has been running the Minority Aging Research Study, one of the nation’s largest studies of Alzheimer’s focused exclusively on Black people and has created a brain bank used by other researchers to understand the illness in this population. This was no easy feat, given that many of the people she hoped to study grew up amid Jim Crow laws and often held a deep mistrust of medical science and its experiments.
STAT+: Dutch health minister won’t cover a Gilead cancer drug due to the cost
In a rare move, the Dutch health ministry refused to provide coverage for a Gilead Sciences breast cancer treatment in a dispute over cost, one of the few times the government agency has taken such a step in recent years.
In explaining the decision, Health Minister Ernst Kuipers maintained that the price Gilead sought to charge for its medication, known as Trodelvy, did not justify the health benefits. The cost for each of the estimated 139 people who would be eligible for treatment would have been approximately $74,465, or a $10.4 million annual outlay.
STAT+: NIH releases data showing more clinical trial sponsors are reporting results, but most miss deadlines
In response to mounting criticism, the National Institutes of Health published data that shows an improvement in the reporting of results from clinical trials sponsored by the agency.
In fiscal year 2022, 41% of trial results were submitted to the federal database ClinicalTrials.gov, compared with 34% in the previous year and just 29% in fiscal year 2020. In fact, the vast majority of results — 96%, on average — were eventually submitted to the database. But results for most of the trials were late, with just over one-third submitted by the obligatory due dates.
New lupus partnership with FDA aims to end drug trials’ history of failure
Lupus is a disease long-plagued by failed clinical trials. And hopeful patients, many of them young women of color, are waiting — just three lupus drugs have been approved by the Food and Drug Administration in six decades. A key partnership is looking to change that.
On Wednesday, the nonprofit Lupus Research Alliance announced it was entering into a public-private partnership with the FDA. Together, they created what lupus advocates hope will be an engine for innovation: the Lupus Accelerating Breakthroughs Consortium, or Lupus ABC.
Cases of Marburg going unreported in Equatorial Guinea, WHO says
The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported.
To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases. Throughout this outbreak, which is believed to have begun in early January, the government has been slow to release updates; last week the WHO expressed fears there may be undetected chains of transmission.
STAT+: New research may give geneticists a long-sought tool: a targeted protein delivery device
Mark Hurst just wanted to kill some bugs.
A newly credentialed bacteriologist working for the New Zealand government in the early 2000s, his job was to invent new and exciting weapons in the war against grass grubs, the squishy, ectoplasmic beetle larvae that had long bedeviled the islands’ farmers. Fortunately, there were already multiple strains of bacteria that infected and killed these insects. Why not learn from the best?
STAT+: British Columbia to bar Americans from buying Ozempic over supply concerns
British Columbia plans to limit sales of the popular diabetes drug Ozempic to Canadian residents in response to a wave of Americans flocking to local pharmacies in search of the drug, potentially straining supplies in the province.
Ozempic, made by Novo Nordisk, is experiencing surging demand because it not only helps regulate blood sugar in people with diabetes, but it can also help people lose weight. In the first two months of this year, 15% of the roughly 16,000 Ozempic dispenses in British Columbia were sold to U.S. residents, according to a Tuesday release from the province. That’s an “unusually high percentage,” as the average proportion of other drugs sold to Americans is 0.4%, the province said.
FDA approves over-the-counter Narcan. Here’s what it means
The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter.
It’s a move that some advocates have long sought as a way to improve access to a lifesaving drug, though the exact impact will not be clear immediately.
STAT+: Pharmalittle: WHO may add obesity drugs to essential medicines list; monkey shortage may delay drug development
Good morning, everyone, and how are you today? We are doing just fine, thank you. After all, the birds are still chirping and a cool breeze is wafting by the placid Pharmalot campus. Moreover, this marks the middle of the week, which means we have managed to survive this far. And this calls for celebration, yes? So please join us as we hoist another cup of delicious stimulation. Remember, no prescription is required, so there is no need to negotiate rebates. Our choice today is mocha marshmallow. Meanwhile, here are a few items of interest. Have a grand day, and drop us a line if you hear something juicy. …
Drugs that combat obesity could for the first time be included on the World Health Organization’s “essential medicines list,” used to guide government purchasing decisions in low- and middle-income countries, Reuters reports. A panel of advisers to the WHO will review new requests for drugs to be included next month, with an updated essential medicines list due in September. The request to consider obesity drugs was submitted by three doctors and a researcher in the U.S, and covers the active ingredient in Novo Nordisk’s obesity drug Saxenda, which will come off patent soon, allowing for cheaper generic versions.
STAT+: Medical device companies now need to prove to FDA they’re protected against cyber attacks
Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and post-pandemic Medicaid, lies a little-noticed change with big implications: a mandate to protect medical devices connected to the internet from hacks or ransomware attacks.
The law, which goes into effect Wednesday, explicitly states that companies cannot sell their connected medical devices without first showing the Food and Drug Administration a solid cybersecurity plan. It also gives the FDA $5 million to see a higher security standard through. Historically, the agency has lacked the resources to keep up with rapidly-evolving security threats, or the authority to force device makers to comply with its draft guidelines.
STAT+: Shortage of monkeys for early-stage research jeopardizes timelines for developing some drugs
A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development.
In recent weeks, the U.S Fish & Wildlife Service began denying company requests to import long-tailed macaques from Cambodia in the wake of a federal investigation into a smuggling ring. Meanwhile, the cost of these monkeys, when they can be obtained, has jumped to more than $25,000 each, compared with $10,000 or less three years ago.