How the EpiPen drug price story went viral — and what may be next

first_img Meghana Keshavan A mind-boggling price hikeMartin Shkreli’s 5,000 percent price hike for the drug daraprim, often used to treat infections in patients with AIDS, turned him into the poster boy for pharmaceutical greed. Mylan steadily hiked the price of the EpiPen year after year after year — often, twice a year, with no explanation other than that the market would bear it.Another company with this ingredient: Insulin makers. The cost for insulin has more than tripled since 2002 — despite the fact that improvements in insulin in the past decades have been merely incremental.A compelling patient storyThe very thought of an anaphylactic 7-year-old does tug at the heartstrings — and the prospect of such a child being unable to easily access an epinephrine auto-injector has clearly struck a nerve. Similarly, it wasn’t simply Shkreli’s bombast that incited the public. It was the fact that daraprim was used primarily in HIV patients — already a marginalized population.“We’re seeing increases all the time in drug prices — so the key here is whether the issue can excite an audience’s passion,” said Peter LaMotte, senior vice president of Chernoff Newman, a firm that works in crisis communications and reputation management. “For some companies, it blows up. For other companies, it goes completely under the radar.”Another company with this ingredient: Teva Pharmaceuticals has increased the price of multiple sclerosis drug Copaxone 118 percent since 2011, according to Reuters — despite competing with a generic form of this drug that’s been available since last year. Patients with MS must regularly imbibe a costly cocktail of medications to ward away the devastating symptoms of this disease.The Bernie Sanders factorWe’re in an election cycle, and the presidential candidates — particularly Hillary Clinton and former Democratic contender Bernie Sanders — have often made a punching bag of pharma. Sanders, in particular, has helped push along the drug pricing issue. He weighed in early, and critically, about Valeant Pharmaceuticals’s price hikes. He publicly rejected a campaign donation from Martin Shkreli. And just this week, he tweeted out (in reference to Mylan) that “something is very, very wrong when drug companies value their profits over the lives of customers.”Another company with this ingredient: Medivation, which was just purchased by Pfizer. Sanders just called it out for over-pricing its prostate cancer drug Xtandi, calling its $129,000 price tag — which is quadruple the cost of the drug in other countries — “unconscionable.” Alex Hogan/STAT What’s the recipe for a drug pricing controversy?The biopharmaceutical industry is under attack for its bafflingly complex pricing, and the target du jour is Mylan: The public and politicians are seething over the fact that the drug maker’s epinephrine injector, the EpiPen, has more than quintupled in cost since 2007. It now retails for more than $600 for a two-pack.But what’s so special about the EpiPen? And why has the anger suddenly gone viral?advertisement Related: Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. Hillary Clinton, AMA urge EpiPen manufacturer to rein in ‘exorbitant’ costs Mylan may have violated antitrust law in its EpiPen sales to schools, legal experts say BusinessHow the EpiPen drug price story went viral — and what may be next NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. By Meghana Keshavan Aug. 26, 2016 Reprints [email protected] About the Author Reprints Privacy Policy Talia Bronshtein/STAT Source: Elsevier Clinical Solutions’ Gold Standard Drug Database At Mylan, CEO Heather Bresch is also inviting uncomfortable scrutiny. The simple fact that her father is Senator Joe Manchin (D-W.Va.) makes her an easy target in some quarters. Then there’s the fact that her salary has been rising right along with EpiPen prices, up more than 600 percent since 2007. Last year, her compensation was $19 million.Another company with this ingredient: Vertex Pharmaceuticals CEO Jeff Leiden took in a salary of $36.6 million in 2015, though he did accept a 23 percent pay cut this year, to $28 million. The company’s not necessarily raising prices, but it is setting them sky-high to begin with, like the cystic fibrosis drug Orkambi, priced at $259,000 for a year’s worth of treatment. How does the EpiPen work?Volume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/08/26/epipen-recipe-price-controversy/?jwsource=clCopied EmbedCopiedLive00:0001:5201:52  EpiPens can stop a body from going into overdrive when it’s exposed to an allergen. Alex Hogan, Hyacinth Epinado/STAT We, the mediaThe media — and we, at STAT, are complicit — fueled the fire of both Shkreli outrage and what we’ve (somewhat shamelessly) taken to calling EpiPendimonium.Other companies with this ingredient: Basically every drug company out there is increasing its drug pricing. The cost of generic tetracycline, for instance, climbed from 6 cents in 2013 to $4.60 in 2015. On the other end of the spectrum, earlier this year, Vanda Pharmaceuticals increased the cost of Hetlioz, a drug that treats a sleep disorder in blind people, up to $148,000 per year — a cost that’s 76 percent higher than it was in 2014.Occasionally, one case study catches fire and fuels a predictable cycle of media coverage, Twitter storms, online petitions, and congressional statements. What will be next? Use the comment field below to nominate your picks. Reports of the device’s price increases have circulated for years. And Mylan (like other drug makers) has been raising plenty of other prices, too: In recent years the list price for its gallstone drug ursodiol is up 542 percent, its irritable bowel syndrome drug dicyclomine is up 400 percent, and its antihypertensive drug verapamil has tripled in price.We’ve broken down the ingredients for a public uproar — and identified some other drug makers that may well find themselves in the hot seat next. To excite the public’s ire, there has to be:advertisement Leave this field empty if you’re human: A controversial CEO with a hefty paycheckShkreli’s general inability to keep quiet (and antics such as smirking his way through a congressional chastising) has made him a bit of an outlier compared to your standard chief executive. It was his personality, as much as the spiked cost of daraprim, that invited the outpouring of disgust. The rising cost of EpiPens050100150200250300350EpiPen inflation-adjusted (2016) list priceper 2-Pak in US dollarsDateEpiPen priceMay 16, 2016$304.31Nov 23, 2015$268.9May 1, 2015$234.03Nov 5, 2014$203.92May 2, 2014$177.47Nov 8, 2013$156.97Jul 17, 2013$136.62Nov 7, 2012$126.12Jul 27, 2012$114.76Mar 6, 2012$104.42Oct 18, 2011$96.98May 12, 2011$88.25Dec 15, 2010$82.84Aug 3, 2010$75.38Oct 12, 2009$69.71Jan 14, 2009$58.05Jan 16, 2008$55.09Feb 22, 2007$54.48Feb 23, 2006$53.88Feb 23, 2005$53.48Nov 1, 2004$53.16The rising cost of EpiPens Related: Please enter a valid email address. Tags EpiPenMylan @megkesh last_img read more

Continue Reading

Which drug makers do a good job getting poor patients access to their medicines?

first_imgPharmalotWhich drug makers do a good job getting poor patients access to their medicines? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. The pharmaceutical industry is regularly chastised for failing to do enough to ensure that people in low and middle-income countries have access to its medicines. Yet the real picture is actually more nuanced, according to a newly released report that finds some — but not all — drug makers are making headway.Some companies, for instance, are partnering to develop needed medicines. Others are pledging to waive or abandon patent rights and granting licenses so that generic versions of their drugs become available.At the same time, the report finds that much more can be done.advertisement The foundation analyzed policies and practices meant to ease access to medicines for 50 different diseases in 107 countries. To assess performance, the foundation examined pricing; patents and licensing; R&D, quality manufacturing and safety monitoring; product donations and philanthropic activities; and public policy, which included anti-competitive marketing, lobbying, and corruption.The foundation then took its findings and compiled an index that ranked the top 20 pharmaceutical companies on their efforts to improve access to medicine in low- and middle-income countries. Funding, by the way, came from the Bill & Melinda Gates Foundation, the UK government and the Dutch Ministry of Foreign Affairs.So what did the foundation conclude? Here are some key findings:GlaxoSmithKline led the index for the fifth time and was followed by Johnson & Johnson and Novartis, while Astellas had the poorest showing.Roche dropped on the list, from number 12 to number 19, since the last index was compiled in 2014. Novo Nordisk fell even more steeply, from 2 to 10.Conversely, AstraZeneca climbed to 7 from 15, and Takeda Pharmaceutical went to 15 from 20.In a statement, Glaxo chief executive Andrew Witty said the “fundamental changes we have made to our business model enable us to make our products as available and affordable as possible while generating the returns we need to sustain our business and invest in research.”Significantly, the report found progress is “static” in some areas. There were no signs of improvement in a key measure of affordability — the proportion of drugs covered by pricing plans that consider the ability of people to pay for medicines. Only 5 percent of 850 drugs had pricing strategies that met key criteria set by the index, notably achieving affordability for different population groups within countries.Over the past four years, the number of companies using equitable pricing strategies increased from 16 in 2012, to 18 in 2014, to 19 in 2016. Ischemic heart disease replaced HIV/AIDS as the disease with the most products with equitable pricing. Gilead Sciences had the highest proportion of products — 50 percent — with equitable pricing strategies that target priority countriesThe foundation also identified what it called 84 product gaps —where there is an “urgent need, but low commercial incentive to engage in R&D” — concerning the 50 diseases covered in the index. Drug makers developed 151 medicines for 31 of these gaps, but only six companies account for the bulk of this activity, the report found. Leading the pack was Glaxo, followed by AbbVie.The foundation also examined product registration, which refers to filing an application to market a drug in a particular country. Such registrations ensure that medicines reach the people who need them. However, the analysis found that registration is “limited, particularly where the need for better access is greatest.”As for drugs being developed, the report counted 420 R&D projects that address specific needs of people in low and middle-income countries, up from 93 in 2014. The pipeline focuses heavily on five diseases —lower respiratory infections, diabetes, malaria, viral hepatitis and HIV/AIDS — that cause relatively large burdens and either have large commercial markets or are high priorities.The report also sought to identify the extent to which drug makers are transparent about their policy positions; political contributions; marketing activities and memberships in associations and the associated financial support provided and board seats held. But the foundation concluded that “transparency remains low in all areas.”Iyer noted that Gilead was not very transparent when it came to ensuring clinical trials are conducted ethically and sharing trial data, as well as sharing sales information and pricing strategies for certain drugs in specific countries.This is a lengthy report and there is much to read, so please look here. [email protected] “There is a social contract between pharmaceutical companies and the people who need their products. Our research suggests that many people in the industry are committed to fulfilling this contract. But progress is slower than many of us would like,” wrote Jayasree Iyer, executive director of the Access to Medicine Foundation, a nonprofit based in the Netherlands.On the bright side, Iyer told us that, “overall, there’s no area where the industry, as a whole, is doing less. And there are several areas where they are doing more.” For instance, most drug makers have a detailed access-to-medicine strategy. But, she added “there are some areas where we need to move the conversation forward — affordability for more products and stopping the occurrence of misconduct.”advertisement @Pharmalot center_img Ed Silverman By Ed Silverman Nov. 13, 2016 Reprints APStock About the Author Reprints Tags Gilead SciencesGlaxoSmithKlineJohnson & JohnsonNovartislast_img read more

Continue Reading

Blowing smoke: Profit motive — and scant evidence — propel dire warnings about surgical fumes

first_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. @ushamcfarling Blowing smoke: Profit motive — and scant evidence — propel dire warnings about surgical fumes National Science Correspondent Usha covers the toll of Covid-19 as well as people and trends behind biomedical advances in the western U.S. What’s included? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Usha Lee McFarling About the Author Reprintscenter_img [email protected] Tags cancernursingphysicianspolicystates GET STARTED What is it? Special Report The claims sound terrifying:Just breathing the air in an operating room where hot surgical tools are being used to slice and cauterize tissue — emitting puffs of caustic smoke in the process — is said to be the equivalent of smoking up to 30 unfiltered cigarettes a day. The smoke contains an array of carcinogenic toxins. And nurses regularly exposed to it report they are are twice as likely as the general public to suffer congestion, coughing, and asthma. Dom Smith/STAT By Usha Lee McFarling May 11, 2017 Reprintslast_img read more

Continue Reading

David Cameron: Biotech execs can still count on doing business in a post-Brexit U.K.

first_imgBiotech David Cameron: Biotech execs can still count on doing business in a post-Brexit U.K. By Rebecca Robbins June 20, 2017 Reprints Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED Tags biotechnologypolicySTAT+ STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. SAN DIEGO — Keep Calm and BIO on: That was the slogan on a T-shirt for sale at BIO 2017, the big biotech convention underway this week. It was also the message delivered on Tuesday by former British Prime Minister David Cameron, the convention’s keynote speaker.He came on stage to the soundtrack of the English indie rock band Florence + The Machine crooning the lyric “It’s always darkest before the dawn” — an interesting choice for a politician whose globalist worldview has been rejected twice in recent months by British voters, first in the referendum last year to leave the European Union, and more recently in the election that resulted in a hung parliament in a defeat for Cameron’s Conservative Party. What’s included? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More GET STARTED Former British Prime Minister David Cameron Geert Vanden Wijngaert/AP What is it?last_img read more

Continue Reading

How can Gilead make the Kite deal work? Here’s what the wags say …

first_img [email protected] After months of urging from Wall Street, Gilead Sciences (GILD) finally made a big acquisition — paying nearly $12 billion in cash to buy Kite Pharmaceuticals (KITE), a leader in developing so-called CAR-T therapies that leverage the body’s own immune system to fight cancer.For Gilead, the move is a way to quickly diversify beyond its infectious-disease franchise. Although its HIV portfolio remains dominant, declining sales of its hepatitis C drugs have hurt its stock price. Moreover, this may finally help Gilead dive into the lucrative cancer market, where the company has suffered several notable setbacks. Kite Pharmaceuticals Kite Pharma GET STARTED By Ed Silverman Aug. 28, 2017 Reprints About the Author Reprints Log In | Learn More Ed Silverman Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.center_img Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Pharmalot @Pharmalot What is it? What’s included? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. How can Gilead make the Kite deal work? Here’s what the wags say … Tags cancerfinancepharmaceuticalsSTAT+last_img read more

Continue Reading

Genealogy site MyHeritage says 92 million user accounts compromised

first_img MyHeritage, one of the nation’s most popular online genealogy sites, said a security breach had affected the email addresses and hashed passwords of 92 million users, raising concerns about the security of more sensitive data that the company collects.The website allows users to create family trees, search historical records, and look for possible relatives. It also operates MyHeritage DNA, a genetic testing service that lets users to send in their spit and have their genetic information analyzed.In a statement issued late Monday afternoon, MyHeritage said there was “no reason to believe” that data other than email addresses and hashed passwords had been accessed without authorization. Family trees or genetic data, it said, are stored on different systems with “added layers of security.”advertisement By Megan Thielking June 5, 2018 Reprints Researchers at the University of Washington encoded a strand of DNA to contain malware, which allowed them to take remote control of a computer that was being used to process genetic data. And while the researchers stressed the chances of that kind of attack are minimal, they found a host of vulnerabilities in the commercial programs that are used to analyze DNA.“Any programs that process data can potentially be attacked,” said Peter Ney, a doctoral student in UW’s Paul G. Allen School of Computer Science & Engineering, told STAT at the time. “In many cases, the best practices for security are not being used.”Even if genetic data from a commercial site like MyHeritage is compromised, it’s not clear how they might be used. That does not tend to allay consumer anxiety, experts say.“When you put DNA and privacy together in a sentence, understandably and correctly, it makes people nervous,” said Laura Hercher, a professor at Sarah Lawrence College who teaches about genetics and ethics. But, Hercher said, the security breach involving MyHeritage doesn’t seem to be any different than security breaches at other companies that don’t work with genetic information.“I would rather give someone my DNA than my social security number, my search history, or my credit card,” she said.MyHeritage said it will hire an independent cybersecurity firm to help probe the breach and provide recommendations about how to prevent security lapses going forward. The company said it’s also speeding up its work to roll out two-factor authentication for users. In the meantime, MyHeritage said all users should change their passwords. Related: Adobe Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Other genealogy sites, such as 23andMe, have security systems similar to the one apparently used by MyHeritage. Last year, 23andMe CEO Anne Wojcicki told Recode that the company keeps genetic information “totally separate” from information that could be used to identify a user, such as email addresses.A study published in 2017 found that genetic testing sites could be vulnerable to computer hacks that expose personal genetic information. Privacy Policy Leave this field empty if you’re human: The security breach underscores growing concerns about the privacy of data submitted to genealogy platforms. Last month, news that investigators tracked down their suspect in the case of the Golden State Killer sparked worry about the privacy of genetic data shared with commercial sites such as MyHeritage.advertisement [email protected] Is it ethical to use consumer DNA sites to solve crimes? HealthGenealogy site MyHeritage says 92 million user accounts compromised About the Author Reprints Megan Thielking News Editor A security researcher contacted the company after discovering a file named “myheritage” on a private server, MyHeritage said. The company reviewed the file and confirmed it contained the email addresses of every user who had signed up for MyHeritage before Oct. 26, 2017, along with their hashed passwords, which conceal a user’s actual password. Tags genetics Please enter a valid email address. @meggophone last_img read more

Continue Reading

Amazon’s acquisition of PillPack is a first step, but not a fatal blow for the pharmacy industry

first_img [email protected] What is it? Business GET STARTED Log In | Learn More Let’s get this out of the way first: Amazon’s acquisition of PillPack could dramatically shake up the U.S. pharmacy industry and change the way Americans purchase prescription drugs.But the announcement of this deal is the first step on a long and crooked path, and there is no guarantee that Amazon (AMZN), for all its size and success, will quickly become a major player in the nation’s $370 billion drug business. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED @caseymross What’s included? The co-founders of PillPack, T.J. Parker (left) and Eliot Cohen. Pat Greenhouse/Boston Globecenter_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. By Casey Ross June 28, 2018 Reprints About the Author Reprints National Technology Correspondent Casey covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. He is the co-author of the newsletter STAT Health Tech. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Tags pharmaceuticalsSTAT+ Amazon’s acquisition of PillPack is a first step, but not a fatal blow for the pharmacy industry Casey Rosslast_img read more

Continue Reading

Walgreens shareholders want to know how the retailer manages opioid risks

first_img About the Author Reprints Walgreens shareholders want to know how the retailer manages opioid risks @Pharmalot Pharmalot GET STARTED Reflecting growing concern over the opioid crisis, Walgreens Boots Alliance (WBA) shareholders voted in favor of a proposal calling for the company to issue a regular report on how it manages the risk of distributing these addictive prescription painkillers, according to preliminary results.The proposal requires the pharmacy chain to prepare a report by June 30 detailing any changes the company has made to corporate governance since 2012 concerning opioid sales. The report should include specific board oversight of programs pertaining to opioids and whether and how executive compensation has been changed to reflect incentives. APStock What is it? Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry.center_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More By Ed Silverman Jan. 25, 2019 Reprints Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Tags opioidspharmaceuticalsSTAT+ [email protected] What’s included?last_img read more

Continue Reading

Pharmalittle: Botox rival hosts party for doctors in Cancun; Dems split over drug pricing strategy

first_img About the Author Reprints Good morning, everyone, and how are you today? We are doing just fine, thank you, thanks to a warm and shiny sun enveloping the Pharmalot campus. And now that the short people have left for their respective destinations, we are also enjoying a bit of quiet. That said, there is much to do. So time to fire up the coffee kettle, down a few cups of stimulation, and get on with it. So here are a few tidbits to help you on your own journey. Hope your day is a success and do keep us in mind if you hear something interesting. …Top plastic surgeons and cosmetic dermatologists gathered at the Ritz-Carlton in Cancun one weekend this month to learn about a wrinkle-smoothing injection, Jeuveau, that goes on sale this week, The New York Times reports. Jeuveau’s manufacturer, Evolus, billed the event as an advisory board meeting. But it also appeared to double as a lavish launch party for Jeuveau, which the company is hoping will compete against Botox. More than a dozen top doctors gushed about the event on social media without disclosing that Evolus had paid for their trips. By Ed Silverman May 16, 2019 Reprints STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Log In | Learn More Pharmalittle: Botox rival hosts party for doctors in Cancun; Dems split over drug pricing strategy Alex Hogan/STAT Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. [email protected] Ed Silvermancenter_img Pharmalot @Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What is it? Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED GET STARTED What’s included? Tags Congressdrug pricingfinanceHIV/AIDSlegalopioidspharmaceuticalspharmalittleSTAT+last_img read more

Continue Reading

Trump has launched an all-out attack on the FDA. Will its scientific integrity survive?

first_img In the race for a Covid-19 vaccine, Pfizer turns to a scientist with a history of defying skeptics — and getting results Stunning FDA rejection signals potential new hurdles for gene therapies “It’s a political agency, and it has a political appointee at the head, but it has maintained a reputation for decades of being a science-focused agency,” said Holly Fernandez Lynch, a health policy expert and University of Pennsylvania professor of medical ethics. “There have definitely been slip-ups, but the level of interference that we’re seeing from the White House is so concerning.”In the past two weeks alone, the Trump administration has installed a right-wing journalist best known for her gun-rights advocacy as the FDA’s top spokeswoman — empowering her to aggressively reshape the FDA’s typically nonpolitical, straight-laced public messaging. On Saturday, Trump, with no evidence, accused the FDA of taking part in a “deep state” political conspiracy to harm his reelection campaign. And two key White House aides, including Trump’s chief of staff, have taken the rare step of criticizing the agency publicly, with one reportedly advocating for the approval of an unproven plant extract as a Covid-19 cure.advertisement Miller is an unconventional choice. She has no experience in science or medicine, and her work in politics and journalism has focused far more on foreign policy or gun-rights issues than on health care.Miller’s book, titled “Emily Gets Her Gun: But Obama Wants to Take Yours,” is a treatise on gun rights and the difficulties of buying firearms in Washington, D.C. (Miller writes that a D.C. home break-in motivated her to purchase a gun, though her description of the incident is factually inconsistent with police reports.)As a Washington Times columnist, Miller penned articles with titles including, “Maryland’s bathroom bill benefits few transgenders, puts all girls at risk from pedophiles,” and, referencing advertisements promoting insurance coverage for birth control, “New Obamacare ads make young women look like sluts.”She later worked as a correspondent for the cable channel One America News Network, a right-wing news source openly allied with Trump and known for promoting conspiracy theories. @levfacher Please enter a valid email address. WASHINGTON — President Trump has instigated an all-out crusade against the Food and Drug Administration at a critical point in the federal government’s fight against Covid-19.Three senior FDA officials and several outside experts told STAT that Trump’s attacks threaten to permanently damage the agency’s credibility — especially when combined with a disastrous series of public misstatements on Sunday from Stephen Hahn, the cancer doctor who became FDA commissioner in December.Beyond long-term concerns, these officials expressed a more immediate fear: that political incentives could interfere with approval decisions surrounding a Covid-19 vaccine, which Trump has repeatedly suggested could come before the Nov. 3 election. A premature approval, experts said, could further weaken Americans’ confidence in vaccine safety, especially if it appears rushed or politically motivated.advertisement Related: Privacy Policy [email protected] Support STAT: Trump, reportedly, has expressed his wish that the FDA issue a similar authorization for oleandrin, a plant extract, be approved for use as a Covid-19 treatment. There is no scientific backing for his interest: Instead, Axios reported, Trump’s interest stems from the recommendation of Mike Lindell, a major Trump backer who works as the CEO of MyPillow.Com and recently acquired a stake in a company developing the experimental dietary supplement.The FDA antagonism extends to Trump’s senior aides, too. Peter Navarro, a top White House trade adviser, has reportedly told FDA officials: “You are all Deep State, and you need to get on Trump Time.”Mark Meadows, the former Republican congressman serving as Trump’s chief of staff, also defended the president’s “deep state” tweet in an ABC News interview, citing “a real frustration with some of the bureaucrats” and a desire to make sure FDA scientists “feel the heat.” Her presence is already evident: A press release sent soon after Miller joined the agency, announcing the emergency authorization of blood plasma as a Covid-19 therapy, took a political tone that unnerved longtime FDA observers: The emergency approval, it said, represented “Another Achievement in Administration’s Fight Against [the] Pandemic.”Shortly thereafter, Miller aggressively defended Hahn, the agency chief, after he made scientifically misleading claims about plasma’s medical benefits while standing alongside Trump at a press briefing Sunday night. In a series of tweets, she falsely asserted that the treatment, known as convalescent plasma, “has shown to be beneficial for 35% of patients.”The misleading claim alarmed agency scientists, according to two senior FDA officials: Not only did it misrepresent scientific data, they said, but it was seen as a politically motivated attempt to co-opt the FDA’s message to bolster Trump’s reelection bid.“Trump is in a reelection battle,” said Daniel Carpenter, a Harvard professor of government and FDA expert. “And unlike past presidents, he’s willing to use the FDA as part of his arsenal.” As Covid-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege Related: Some agency higher-ups view Miller’s hiring, and that of her boss, former Republican National Committee operative and Veterans Affairs spokesman John “Wolf” Wagner, as being driven by Michael Caputo, a Trump loyalist who serves as the top communications official at the Department of Health and Human Services, the FDA’s parent agency. (FDA officials, however, only expressed concerns about Miller, and largely reserved judgment about Wagner.)Another hiring earlier in 2020 has similarly troubled FDA insiders: that of David Gortler, a former policy adviser at the Heartland Institute, a conservative think tank. Gortler has extensive experience in drug regulation and has served at the FDA previously, but is also a known agency critic: In a 2016 STAT op-ed, he advocated for “a good personnel sweep,” calling a number of FDA colleagues “petty people who have personal agendas” and who “abuse” small drug companies.Gortler, one FDA official said, returned to the agency in June. But the Heartland Institute, his former employer, trumpeted his hiring only in the wake of the controversy over blood plasma. In a statement on Monday, the think tank described the FDA as a “sclerotic” agency that “deprives Americans of the latest available biotechnology.” Related: FDA staff have been equally alarmed by overt attempts from Trump and other administration officials to influence decisions about emergency authorizations for medical products that would otherwise be based solely on safety and evidence. Heightening that alarm: Trump’s baseless new assertion that the agency is part of a “deep state” plot intent on hurting his reelection odds by intentionally slowing down medical product approvals.At an Aug. 19 press conference, Trump suggested scientists at the National Institutes of Health were holding up an emergency approval for blood plasma as a Covid-19 treatment for political reasons. Saturday morning, he tweeted his displeasure with the FDA alongside his “deep state” accusation. Sunday evening, he announced the emergency authorization from the White House podium alongside Hahn and health secretary Alex Azar, both of whom dramatically overstated the treatment’s anticipated impact on coronavirus death rates. FDA commissioner needs to push back and tell Trump the agency is not part of the ‘deep state’ Exclusive analysis of biopharma, health policy, and the life sciences. Related:center_img Leave this field empty if you’re human: In a statement, White House spokesman Judd Deere told STAT: “Every decision the FDA has made under the Trump administration has maintained the agency’s gold standard for safety and been data-driven to save lives,” and labeled accusations that politics influence approvals as a “false narrative.” An FDA spokeswoman declined to comment.Political interference at the agency “has been an issue in past administrations Republican and Democratic,” said Margaret Hamburg, the FDA commissioner who served under President Barack Obama from 2009 to 2015 who had a major dust-up with Obama’s health secretary, Kathleen Sebelius, over emergency contraceptives. “But never at this level, and never accompanied with the kind of public derision and undermining of both the employees who work at the agency and, frankly, the very mission of the agency.” Related: Presidents have sparred with the Food and Drug Administration for decades: over birth control, over tobacco, and over Americans’ right to take untested drugs that aren’t yet proven to be safe. But taken together, the actions represent an extraordinary new frontier for presidential attacks on the scientific agency.Even before the latest examples, the president repeatedly challenged the agency’s decision-making on a litany of potential Covid-19 treatments, misleadingly casting scientifically dubious treatments as “breakthroughs.” The FDA ended up issuing emergency authorizations for two of the products: the malaria drug hydroxychloroquine and blood plasma from recovered Covid-19 patients. Trump has even agitated for the FDA to approve oleandrin, an unproven plant extract, touted, without evidence, by the CEO of MyPillow.Com, a major Trump backer, though the agency has made no move to sanction its use. PoliticsTrump has launched an all-out attack on the FDA. Will its scientific integrity survive? Four scenarios on how we might develop immunity to Covid-19 The drama over plasma mirrors the spring controversy over the FDA’s emergency use authorization for hydroxychloroquine, the malaria drug that Trump cast as a Covid-19 cure-all for months. When the FDA rescinded its emergency approval for  hydroxychloroquine, Sean Hannity, the Fox News commentator and a de facto Trump adviser, agitated for mass firings: “If we have an FDA that is not looking out for the best interests of the American people,” he said, “why don’t we clean that out?”FDA officials also expressed concern over the Trump administration’s recent decision to bar the agency from regulating some lab-developed diagnostic tests, including many that test for Covid-19. While the move likely has little to do with presidential politics, FDA insiders nonetheless see it as yet another Trump administration move to reduce the agency’s scope and authority. Scott Gottlieb, the first FDA commissioner under Trump, has slammed the move, arguing it would hamper the FDA’s ability to fulfill its public health duties.Trump’s scientific overreach during Covid-19 is not specific to the FDA: On Wednesday, CNN reported, the Centers for Disease Control and Prevention suddenly changed its coronavirus testing guidelines, enraging public health officials by advising that even those who’ve come into close contact with infected individuals don’t need tests. The directive reportedly came from the Trump administration’s “upper ranks.” About the Author Reprints Chip Somodevilla/Getty Images Related: STAT+: Newsletters Sign up for D.C. Diagnosis An insider’s guide to the politics and policies of health care. The most striking change at the agency is the appointment of ultra-political conservatives — an emerging pattern that some FDA insiders see as the start of a takeover of an otherwise largely apolitical agency.The appointment of Emily Miller, a right-wing activist who has ping-ponged between government and conservative journalism for the past two decades, has particularly dispirited FDA staff, senior agency officials said, speaking on the condition of anonymity.Miller joined FDA on Aug. 17 as assistant commissioner for media affairs. The position is typically filled by nonpolitical civil servants, not overtly political activists, making her appointment all the stranger. Miller is now the agency’s top spokeswoman and liaison to the public, wrangling Hahn’s media interviews and providing information to journalists covering the agency. Washington Correspondent Lev Facher covers the politics of health and life sciences. Straight talk on the FDA’s tumultuous weekend — and new questions about its independence By Lev Facher Aug. 27, 2020 Reprints Trump’s moves to delegitimize FDA, and other administration decisions that effectively stripped it of regulatory power, have taken place against the backdrop of other controversial advocacy surrounding the agency’s authority. In the first years of his presidency, Trump aggressively supported “right-to-try” legislation, which became law in 2018. The administration has argued the law helps patients with terminal illnesses request unapproved drugs from pharmaceutical companies as a last resort, even if they haven’t been thoroughly vetted for safety or effectiveness.That law has not led to a significant increase in patients’ access to investigational, unapproved drugs, but the debate surrounding it is reflective of a broader school of thought regarding FDA’s role. The bill’s sponsor, Sen. Ron Johnson (R-Wis.), told then-commissioner Scott Gottlieb in a 2018 letter: “This law intends to diminish the FDA’s power over people’s lives, not increase it.”“It plays into the same theme,” said Hamburg, the former commissioner. “It also signals that even after we get out from under this Covid crisis, the FDA will be very, very vulnerable if Trump remains in office and these kinds of anti-FDA, anti-regulatory policies continue to be elaborated and implemented.”Nicholas Florko and Ed Silverman contributed reporting.  If you value our coronavirus coverage, please consider making a one-time contribution to support our journalism. Lev Facher Tags CoronavirusDonald Trumpgovernment agencieslast_img read more

Continue Reading