Latest news with #VinayPrasad
Hindustan Times
9 hours ago
- Health
- Hindustan Times
Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag
Meet Vinay Prasad, a young disciple of Bernie Sanders who ranks as one of the most powerful officials in the federal government. He determines whether patients get access to many life-saving medicines. Or not. Think of him as a one-man death panel. Dr. Prasad was named by Marty Makary, the Food and Drug Administration commissioner, as head of the agency's biologics division in May, and last month as its chief medical and scientific officer. More on why he was tapped to these posts later. But it isn't an exaggeration to say that Dr. Prasad wields more power than Anthony Fauci ever did at the National Institutes of Health. Vinay Prasad. Like Dr. Fauci, Dr. Prasad thinks he knows what's best for people, and that it's government's job to make it happen. 'I favor a strong regulatory state,' he proudly professes. And just as Dr. Fauci slowed experimental HIV treatments during the 1980s by rigidly adhering to strict trial protocols, Dr. Prasad is now scuttling potentially life-saving therapies. In recent weeks, the FDA has rejected three therapies for debilitating diseases that have shown promise in clinical trials. The agency has also forced off the market a gene therapy that can slow the degenerative loss of muscular function in young boys with certain genetic mutations. Behold America's strong and arbitrary regulatory state at work. If you read Dr. Prasad's paper—or follow his smash-mouth Substack and feeds—the FDA's recent actions are no surprise. Dr. Prasad has long criticized the FDA for approving too many treatments that, in his view, provide only marginal benefits. He's also lambasted President Trump's first-term 'right to try' law, which lets terminally ill patients try experimental drugs not yet approved by the FDA. 'It is crucial to question whether non-curative therapies . . . are worth it,' Dr. Prasad wrote in a 2021 paper about an FDA-approved cell therapy for multiple myeloma. The therapy reduced disease progression or death by half in patients with advanced cancers who hadn't responded to already approved therapies. Impressive. But Dr. Prasad complained that the treatment was pricey (then $419,500 for a course) and may 'only delay inevitable progression' in some patients. In other words, sick patients should just give up and die. Got that? In 2016 he wrote an op-ed titled 'The case for rationing: Why we should limit public spending on cancer drugs.' He exalted the United Kingdom's socialized health system for restricting access to new treatments until they demonstrate a high degree of efficacy in multiple trials and that their benefits—as determined by the government—exceed their costs. Such government rationing is why survival rates for hard-to-treat cancers are much lower in the U.K. than in America—and why British patients with the financial means cross the pond to receive innovative and often life-saving treatments. Tough luck to Brits of average means. Of course, Dr. Prasad insists he really has patients' best interests at heart. Why would terminally ill patients want to waste their precious remaining time on earth schlepping to hospitals for treatments that may not cure them when they could be preparing for their deaths? That's the gist of his 2022 paper, which estimated patients with advanced cancers spend 16 more hours a month accessing and receiving novel treatments than if they accepted hospice or home palliative care. 'Time is a valuable resource for people who have cancer,' the paper noted. Yes, and that's why they want to continue living. He has also argued that 'genome-informed cancer medicine'—treatments targeted based on a patient's genes or tumor mutations—'is mostly hype,' no matter that such treatments have produced most recent improvements in cancer survival. Take CAR T-Cell therapies that re-engineer a patient's immune cells to target proteins on tumor cells. Such therapies can cure aggressive cancers that not long ago carried a death sentence, though Dr. Prasad has hyped their side effects. He has done the same for Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy, which the agency this month forced off the market after two patients in the advanced stages of the disease died from apparent side effects. The deaths look to have been a pretext for Dr. Prasad to deep-six the drug, which he had previously criticized as too costly for its benefits. Most treatments carry rare, life-threatening side effects, but doctors and patients can weigh their risks against their benefits. Perhaps Dr. Prasad doesn't trust people to do so any more than Dr. Fauci did. Dr. Prasad found common cause with Dr. Makary and conservatives in opposing paternalistic Covid policies including vaccine mandates and school shutdowns. But his other positions are at odds with Dr. Makary's stated support for more flexible reviews of drugs that treat rare and deadly diseases and the MAHA ethos of patient empowerment. Dr. Makary in spring 2021 lambasted the FDA for using the 'eternal excuse of safety' to pause the Johnson & Johnson Covid vaccine after a rare blood-clotting side effect cropped up, mostly in middle-aged women. 'This is a life-saving medication,' he then wrote. 'What ever happened to giving people the data and letting them make their own health decisions?'
Wall Street Journal
21 hours ago
- Health
- Wall Street Journal
Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag
Meet Vinay Prasad, a young disciple of Bernie Sanders who ranks as one of the most powerful officials in the federal government. He determines whether patients get access to many life-saving medicines. Or not. Think of him as a one-man death panel. Dr. Prasad was named by Marty Makary, the Food and Drug Administration commissioner, as head of the agency's biologics division in May, and last month as its chief medical and scientific officer. More on why he was tapped to these posts later. But it isn't an exaggeration to say that Dr. Prasad wields more power than Anthony Fauci ever did at the National Institutes of Health.
Yahoo
5 days ago
- Health
- Yahoo
Talc Is Suddenly in the Spotlight. Is it Bad for You?
Credit - Photo-Illustration by TIME (Source Images: Liudmila Chernetska—Getty Images, LanaSweet/Getty Images) Federal health officials are scrutinizing a mineral—added to some makeup, medications, and foods—that many people have never thought twice about: talc. In a recent viewpoint article called 'Priorities for a New FDA,' published in the medical journal JAMA, Dr. Martin Makary, commissioner of the U.S. Food and Drug Administration (FDA), and Dr. Vinay Prasad, the FDA's Chief Medical and Scientific Officer, wrote that the FDA conducted an expert panel on talc in May. They also noted that some companies have removed talc from baby powder because it's a carcinogen. Johnson & Johnson, for example, stopped using talc in 2023 following more than 60,000 legal claims from ovarian cancer patients. The JAMA article added that talc remains common, since people still 'ingest it regularly' as an ingredient in various medications and foods. Despite the lawsuits, though, research hasn't confirmed whether talc causes cancer, especially when consumed through food. Meanwhile, companies continue to use talc in powders and cosmetics. Here's how people get exposed to talc, the potential health risks, and what to do about them. Talc and asbestos A naturally occurring mineral, talc consists of several elements like magnesium and silicon. When ground into fine particles, talc becomes talcum powder, which works to absorb moisture and soothe the skin. People have used cosmetics and powders with talc for more than a century. Before talc is mined by companies from deep within the earth, it mixes with another mineral, asbestos. This often results in talc's contamination with asbestos, which is proven to cause cancer. Talc, when laced with asbestos, is a carcinogen, especially when it's inhaled. Less clear is the cancer-causing potential of talc when it's not contaminated. In theory, talc on its own could drive cancer because its particles create inflammation when inhaled or migrating into the body after talc is applied to skin, according to Joellen Schildkraut, professor of epidemiology at Emory University. 'Inflammation can promote cancer,' Schildkraut says. 'Many studies have shown an association.' Some research shows that asbestos-free talc leads to tumors in animals, but animals reveal little about ovarian cancer in humans, Schildkraut says. Read More: The Race to Explain Why More Young Adults Are Getting Cancer Regardless, it's impossible for consumers to learn if products with talc are contaminated. Since the 1970s, companies have tested talc voluntarily, but the methods aren't sensitive enough to detect asbestos in their products—and the FDA doesn't require proof that they're asbestos-free. 'This means a lot of contaminated talc likely went through without anybody detecting the asbestos,' Schildkraut says. Using better tests, researchers have spot-checked whether cosmetics are asbestos-laced. From 1948 to 2017, two-thirds of these tests (conducted as part of litigation) came up positive for asbestos, typically in trace amounts. In 2020, the nonprofit Environmental Working Group found asbestos contaminated 15% of makeup samples with talc. In 2023, the FDA detected no asbestos in 50 talc-containing cosmetics. (The agency didn't reply to TIME's request for comment.) However, conclusions can't be drawn about the entire market from these checks because they involved small sample sizes, says Kaley Beins, a senior scientist at the Environmental Working Group. Later this year, the FDA is expected to finalize a new rule aimed at improving companies' testing methods. Ovarian cancer risk Some data show links between cancer of the ovaries and a specific type of talc exposure: the use of baby powder in intimate areas for personal hygiene. But the findings have been mixed. In a June letter to Makary, several talc researchers—some with ties to companies that make products with talc—criticized the recent FDA roundtable on talc's health impacts. The roundtable discussions, the authors wrote, were skewed because they 'included several paid plaintiff-side experts in talc-related litigation' without any defense-side experts. The letter says that studies involving several different groups of women have found only very weak associations with ovarian cancer. Schildkraut—an expert participant in the May roundtable without any ties to the lawsuits—notes that some of these studies involved relatively few women diagnosed with ovarian cancer. It's possible there simply wasn't enough data to yield stronger evidence. However, in 2020, scientists pooled together data from groups studied previously and still found no significant link. Read More: Scientists Are Finding Out Just How Toxic Your Stuff Is An important factor is that 'people may not be good at reporting their personal talc use,' says Katie O'Brien, a staff scientist at the National Institute of Environmental Health Studies and lead author of the 2020 research. In another study last year, she tried to correct for reporting errors while reanalyzing data from over 50,000 women and found that frequent users of talcum powder did have higher risk of ovarian cancer. 'This type of research doesn't determine causation,' says Schildkraut, who emphasized the same point during the public roundtable. 'But we do see a consistent relationship.' The self-report issue noted by O'Brien could extend to powder use for babies. 'People may not know whether baby powder was used on them,' O'Brien explains. Meanwhile, some laboratory research shows that human ovarian cancer cells, when exposed to talc, have more inflammation and cellular growth, mechanisms that can fuel cancer. Read More: Inflammation May Be the Culprit Behind Our Deadliest Diseases But Jennifer Permuth, an epidemiologist at the Moffitt Cancer Center who has served as an expert witness for J&J and signed the letter to Makary, questions how talc would migrate from where it's applied to cause cancer in the ovaries—without causing cancer in other organs along the way, such as the cervix. 'We would expect cancer to also develop in those other organs,' but studies find only weak links to these cancers, says Permuth. In a 2024 review, the World Health Organization found that, overall, evidence doesn't prove talc causes cancer, but it's 'probably carcinogenic.' The review focused on ovarian cancer 'because that's where the most evidence was' compared to other cancers, says Schildkraut, who served on the review committee. Meanwhile, the American Cancer Society states that, if there's an increased cancer risk, it's 'likely to be very small.' The E.U. has designated talc as a carcinogen, and it's expected to ban talc from cosmetics in 2027. Other potential health issues There's less research on other health issues related to talc. Some studies suggest that when miners repeatedly inhale talc, even if it's asbestos-free, their risk of lung cancer increases—but evidence on inhaling baby powder is more limited. In addition, a deadly cancer called mesothelioma is closely linked to asbestos exposure, though links to talc are less clear (partly because mesothelioma is extremely rare). Read More: What to Expect at a Mammogram Karen Selby, a patient advocate for the Mesothelioma Center at team of advocates, doctors, and attorneys supporting people with mesothelioma—works with patients who developed the disease decades after early-life exposure to cosmetics, she says. Every Christmas as a kid, Selby got a new box of cosmetic powder to play with. She'd cover herself and act like Casper the Friendly Ghost. She doesn't have mesothelioma, but recalling the haze of talc dust, she sometimes thinks, 'Holy cow, what was I doing to myself?' These makeup kits often have cheaper ingredients like asbestos-contaminated talc, despite that 'children are a susceptible group in environmental health,' says Beins, the Environmental Working Group scientist. 'I would try to keep talc away from them.' Safety precautions As researchers continue to study talc, Beins recommends using products with talc substitutes like cornstarch. (That's what J&J now uses instead of talc.) 'We can acknowledge the uncertainty and use safer alternatives,' Beins says. The Environmental Working Group has a database called Skin Deep that tracks which cosmetics contain ingredients like talc. Currently, the database lists about 150,000 products, and 8,000 have talc, Beins estimates. 'I wouldn't use talc personally,' Schildkraut says. 'It's not worth the risk because you don't need much exposure to asbestos to develop cancer.' Read More: 6 Things to Eat to Reduce Your Cancer Risk If possible, try passing on baby powders in general. Even if they lack talc, 'there may be other chemicals of concern,' such as ones added for fragrance or texture, O'Brien notes. If you've been exposed to talc for decades—whether through personal product use or occupations that often involve talc, like those in hair care—share this information with your doctors. They may recommend screening for ovarian cancer and other conditions, O'Brien says. What about food and medicine? Talc is commonly added to several foods like chewing gum and candy to keep them from sticking to wrappers and caking together. However, relatively few foods have talc. 'It's there and present sometimes, but it's not in a ton of food,' Beins says. To find which foods contain talc, you can search EWG's Food Scores, which tracks ingredients. Out of 80,000 products in the database, only 39 are currently listed to contain talc. In addition, the Environmental Working Group's Verified program certifies brands that meet its strictest health standards. To be certified, brands must disclose their ingredients, provide testing data, and avoid ingredients of concern. Products with talc can't be certified. Read More: Why Food Chemicals Are a Problem—And How to Reduce Your Exposure Talc is also added to some pill coatings because it helps pills travel smoothly through manufacturing equipment during production. But very little is known about cancer risk from talc in either food or pills. 'There's some thought that gastrointestinal issues might happen due to food exposure, because it's pro-inflammatory,' Beins says. However, this effect is mostly theoretical at this point. 'For the sake of public health, we shouldn't raise false alarms and make people scared of their food and medications,' says Permuth, who researches gastrointestinal cancer. 'Frequent users of talc-based personal care products or cosmetics are at the highest risk,' O'Brien says, adding that there's no medical reason for using these products. Whereas other established environmental risks like air pollution may be hard to avoid, O'Brien notes that for the most part, the 'use of talc products is something that individuals can control.' Contact us at letters@ Solve the daily Crossword
Yahoo
7 days ago
- Health
- Yahoo
Sarepta refuses to pull gene therapy despite FDA order
Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the US Food and Drug Administration (FDA). Speaking on 18 July, shortly after the FDA ordered the pull for Elevidys, Sarepta said it will continue to ship Elevidys to the ambulant population as studies show no signs of new or changed safety signals, adding it first heard of this potential request earlier in the day through media reports. A statement from the company reads: 'At Sarepta, patient safety and well-being are always our top priority. We are committed to upholding the highest safety standards for all of our therapies. "This guides every decision we make, as evidenced by our conservative decision to pause shipments of Elevidys for non-ambulant patients while we work with the FDA to update the label and evaluate the use of an enhanced immunosuppression regimen to mitigate the risk of acute liver failure (ALF).' Trial of LGMD therapy also put on hold The FDA has also put a hold on Sarepta's gene therapy SRP-9004 in limb girdle muscular dystrophy (LGMD) after a patient died in an early-stage study due to ALF. Speaking about the patient death in the Phase I trial of SRP-9004, the company's statement added: 'We recognise that the death of any patient is heartbreaking, including the recent death of a 51-year-old non-ambulant LGMD patient. "We also want to clarify that this tragic event occurred in a Phase I clinical trial for an investigational gene therapy called SRP-9004. SRP-9004 is a clinical-stage therapy that is intended to treat a different disease, is administered using a different dose, and is manufactured using a different process. The LGMD study participant who passed away was not treated with Elevidys, and the dosing for the SRP-9004 trial had concluded at the time of his death.' This patient's death, which was reported to the FDA on 3 July, is the third that has impacted Sarepta's gene therapy programme, with the first two deaths earlier this year in patients treated with Elevidys, both also due to ALF. Both Elevidys and SRP-9004 are adeno-associated virus (AAV) gene therapies that use the same AAVrh74 serotype. The FDA's Center for Biologics Evaluation and Research (CBER) director Dr Vinay Prasad, said: 'Protecting patient safety is our highest priority, and the FDA will not allow products whose harms are greater than benefits. The FDA will halt any clinical trial of an investigational product if clinical trial participants would be exposed to an unreasonable and significant risk of illness or injury.' This comes just days after Sarepta said it has agreed to change the black box on the Elevidys label to include ALF and acute liver injury (ALI) warnings. In the same announcement, Sarepta said it would be cutting 500 jobs as part of company restructuring. Speaking after the third patient death was announced, GlobalData healthcare analyst Momna Ali said the recent setbacks for Sarepta put the cell and gene therapy (CGT) sector at a 'crossroads'. Ali said: 'Following Sarepta's announcement of a third patient death, a new label for Elevidys and them laying off 500 employees, or 36% of its workforce, shelving parts of its pipeline to save $420m, and shifting focus from gene therapy to siRNA programmes, this is going to put the CGT sector at a pivotal crossroad. 'While the scientific potential of CGT therapies remains extraordinary, this moment serves as a reminder of the complexity, cost, and responsibility involved. There is a lot of buzz around therapies 'beyond the pill'; however, for the landscape to keep evolving at the pace it has been in the last 3-5 years, there has to be greater transparency, patient safety, and sustainable innovation – otherwise, it'll be met with more setbacks.' The news of the LGMD death came to light on 17 July in media reports. After this was reported, Sarepta's stock has dropped 43.21%, from $22.54 at market open on 17 July to $12.80 at market open on 21 July. The FDA also said it has revoked the platform technology designation for Sarepta's AAVrh74 Platform Technology. "Sarepta refuses to pull gene therapy despite FDA order" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Mint
17-07-2025
- Business
- Mint
Sarepta Slashes Workforce After Patient Deaths on Gene Therapy
(Bloomberg) -- Sarepta Therapeutics Inc. is cutting more than one-third of its workforce and will add a black box warning label to its gene therapy for a fatal muscle disorder after two patient deaths raised doubts about the future of the company. The Cambridge, Massachusetts-based biotech company said Wednesday it would eliminate about 500 employees as part of a sweeping restructuring. It's also pausing several drugs in its pipeline. Sarepta said the moves would contribute to an estimated $400 million in annual cost savings. The company agreed to warn doctors and patients about the risk of liver failure from Elevidys, its gene therapy to treat Duchenne muscular dystrophy, at the request of the US Food and Drug Administration. Black box labels are the most serious safety warnings a drug can have, and indicate severe or potentially deadly complications. Sarepta said the job cuts will help it maintain access to a $600 million revolving credit line and create cash flow that could help it repay a convertible note due in 2027. The company also disclosed preliminary second-quarter results showing total net product revenue of $513 million. More than half came from Elevidys. Last month, Sarepta reported that a second teenage boy died of acute liver failure while being treated with its $3.2 million gene therapy. Both fatalities occurred in patients who weren't able to walk because of the muscle-wasting disease. At the time, the company suspended its 2025 revenue guidance, and pledged to take a careful look at its costs going forward. Sarepta also paused a clinical trial and halted shipments of the drug for non-ambulatory patients. Sarepta said it will submit a plan to the FDA for patients who can't walk that includes suppressing their immune systems before administering Elevidys, which may reduce their risk of complications. It will also discuss a path to resuming shipment of the therapy for those patients, typically older boys and young men. The FDA is investigating the Elevidys deaths. The fatalities pose one of the first big tests for Vinay Prasad, the new head of the regulator's gene therapy division. As an academic at the University of California San Francisco, prior to his current role, he was highly critical of the FDA's expedited approval process and its use for Sarepta's gene therapies in particular. In social media posts in March, Prasad questioned Sarepta's treatment, saying it 'seems to be killing kids' with Duchenne and 'destroying their livers.' More stories like this are available on
