Latest news with #VinayPrasad
Wall Street Journal
3 hours ago
- Politics
- Wall Street Journal
Vinay Prasad, High-Risk Drugs and the FDA
In 'Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag,' Allysia Finley is off base in her criticism of Dr. Prasad (Life Science, July 28). He is an excellent clinical oncologist and highly skilled epidemiologist who understands the intricacies of scientific studies and data. It is a shame that criticism of him led to his resignation under pressure this week. He apparently couldn't manage the political jungle. The issue of U.S. Food and Drug Administration drug approvals is more nuanced than Ms. Finley makes it out to be. Dr. Prasad was right to encourage the thoughtful and careful evaluation of higher-risk drugs at the FDA.
Atlantic
4 hours ago
- Health
- Atlantic
The Man Who Was Too MAHA for the Trump Administration
Vinay Prasad, until Tuesday one of the country's top medical regulators, just got a bitter taste of what it means to have real power. In recent months, the academic hematologist-oncologist, medical contrarian, and polemic podcaster had become a central figure at the U.S. Food and Drug Administration. In May, he was chosen to lead its Center for Biologics Evaluation and Research—a position that gave him authority over vaccines and gene therapies. In June, Marty Makary, who is currently the FDA commissioner, bestowed upon him an even more important role: chief medical and scientific officer of the entire agency. This week, Prasad abruptly departed. We don't know the exact reason behind Prasad's departure. According to a Department of Health and Human Services spokesperson, he resigned to 'spend more time with his family.' (Neither Prasad nor HHS responded to my request for comment.) Politico reports that President Donald Trump ordered his removal this week over the objections of Makary and Health and Human Services Secretary Robert F. Kennedy Jr. Whatever the particulars, Prasad's sudden need for a better work-life balance suggests the administration is following a time-honored approach to medical regulation: Business comes first. Prasad's troubles began in the first weeks of his tenure at the FDA, when he overruled the agency's own scientific reviewers by limiting the use of COVID vaccines. In doing so, he managed to anger the country's pro- and anti-vaccine factions at the same time. While many public-health experts criticized the decision to limit access to the shots, Kennedy's allies in the 'Make America healthy again' movement felt betrayed by the fact that the government had allowed mRNA shots to remain available at all. Prasad also faced a blitz from the pharmaceutical industry and patient-advocacy groups after the FDA tried to suspend distribution of a gene therapy for Duchenne muscular dystrophy called Elevidys, over safety concerns. For those affected by this rare, incurable condition, the move was seen as an outrageous denial of their right to weigh the drug's risks and benefits for themselves, and an extinguishing of what had been at least a glimmer of hope. Two days later, the right-wing provocateur Laura Loomer publicly accused Prasad of 'sabotaging Trump's deregulatory agenda,' and an opinion writer for The Wall Street Journal declared him a 'one-man death panel.' I know Prasad a bit: I've twice been a guest on his podcast, and I've followed his prolific academic work and public commentary about evidence-based medicine since about 2016, when he was a young professor at Oregon Health & Science University working to identify low-value medical practices. We've had our disagreements over the years. But with respect to Elevidys and drugs like it, our views are in alignment. We share the worry, for example, that the FDA keeps lowering its approval standards for drugs that keep getting more expensive. 'The American economy can handle a great deal of wasteful health-care spending,' Prasad told me in an interview in 2021. 'But it can't tolerate an infinite number.' His skepticism of Elevidys, in particular, is both long-standing and well-founded. The therapy has not been conclusively shown to slow the progression of the muscle-wasting disease it targets, but it does often induce vomiting and damage patients' livers. Worryingly, it also appears to be related to a pair of deaths. Prasad's predecessor in his role at CBER, Peter Marks, approved the drug, which costs $3.2 million per course of treatment, in spite of his own staff's uncertainty about its benefit. (Marks was forced out by Kennedy this spring, after the two clashed over access to vaccine-safety data.) Read: The sanewashing of RFK, Jr. That Prasad should take a tough line on drug regulation was perfectly in keeping with his history. He rose to prominence on that basis: To his many fans, he was a dogged and courageous industry watchdog; to his many critics, a self-righteous pharma scold. That mainstream Republicans should balk at this approach, and strive to undo it, was equally predictable. Politicians, particularly those on the right, have for years supported patients' ability to obtain still-unproven therapies. During Trump's first term, the president signed into law the 'Right to Try Act,' which expanded access to experimental drugs. That law was championed by Republican Senator Ron Johnson, who, according to reporting from STAT, may have been instrumental in Prasad's ouster. One might have guessed that things were different now in Washington—that Kennedy's eccentric philosophy had ushered in a novel form of conservative leadership, in which business interests didn't always lead the way. Thus far, however, the MAHA movement has done little to adjust the status quo. Instead, it has mostly wallowed in its own contradictions. We've been told that cooking with seed oils is toxic but that treating measles with cod-liver oil is great; and that both deworming pills and microbe-laden raw milk are good for you. MAHA leaders have declared the FDA a ' sock puppet of industry ' from which Prasad himself would provide a ' welcome reprieve,' while also championing the public's right to choose its food and drugs (even as they interfere with the distribution of some vaccines). So which is it? Should people have easy access to almost any health-care intervention, or should the government protect vulnerable patients from drugs for which there isn't rigorous evidence of benefit? For years, Prasad has been clear on where he stands in that regard. 'It is not a case of patients who crave risk facing off with regulators who abhor it,' he wrote in a medical journal in 2019. Rather, the current system, in which 'reliable data are inconsistently generated,' has failed patients who wish to make informed decisions about their care. Whenever this tension has been tested in the Trump administration, MAHA leaders have almost always seemed inclined to move the other way. A recent op-ed by the FDA's Makary and Mehmet Oz, the head of the Centers for Medicare & Medicaid Services, summed up the current regulatory approach as follows: Agency bureaucrats should cooperate with industry leaders instead of antagonizing them, and the government should favor 'market solutions' over 'prescriptive regulation.' Indeed, even as the news of Prasad's firing was coming out, Makary was promoting his 'national listening tour' of private interests. 'Looking forward to hearing from more pharma and biotech CEOs!' he wrote on X. Prasad himself appeared to recognize which way the wind was blowing. From the moment he took office, he was tempering his point of view. Before he became a political appointee, Prasad was dogmatic in his dismissal of evidence that did not emerge from large, randomized clinical trials. ('As readers know, my philosophy is RCT or STFU,' he wrote in his newsletter in 2023.) But Prasad seemed to back away from this idea even in his opening remarks to his new colleagues and staffers. 'Randomized controlled trials are not always necessary, and when they are done, they are not always informative,' he reportedly said on May 7, his second day on the job. Such appeasement efforts proved insufficient to protect him from rival forces in the Republican Party, if not also in the MAHA movement itself. For the moment, Prasad has been replaced at CBER by the wealthy biomedical entrepreneur George Tidmarsh. Surely that will come as a relief to a constituency that seems to hold immense sway with this administration: America's drug companies and medical-device makers.
Time of India
12 hours ago
- Business
- Time of India
Social Security eyes massive reform in US: New policy could hit 3.4 million Americans this month
Under a prospective new Social Security Administrative (SSA) policy, senior citizens soon won't be able to simply call SSA to change their address or check the status of their benefit claim. They will have to first verify their identity online or go to a field office if they are unable to do so, reported CNN. Under the new SSA policy change, around 3.4 million people would have to travel to field offices to update their addresses, among other requests. The crucial development comes at a time when the agency's staff has been trimmed and offices experience extended wait times for appointments. Explore courses from Top Institutes in Please select course: Select a Course Category Data Science Degree MCA Management Leadership others Public Policy Project Management Technology Finance CXO Artificial Intelligence Data Analytics healthcare Others Operations Management Data Science PGDM Healthcare Product Management MBA Cybersecurity Digital Marketing Design Thinking Skills you'll gain: Duration: 10 Months IIM Kozhikode CERT-IIMK DABS India Starts on undefined Get Details Skills you'll gain: Duration: 10 Months E&ICT Academy, Indian Institute of Technology Guwahati CERT-IITG Prof Cert in DS & BA with GenAI India Starts on undefined Get Details Skills you'll gain: Duration: 30 Weeks IIM Kozhikode SEPO - IIMK-AI for Senior Executives India Starts on undefined Get Details Skills you'll gain: Duration: 11 Months E&ICT Academy, Indian Institute of Technology Guwahati CERT-IITG Postgraduate Cert in AI and ML India Starts on undefined Get Details Skills you'll gain: Duration: 11 Months IIT Madras CERT-IITM Advanced Cert Prog in AI and ML India Starts on undefined Get Details ALSO READ: Dr Vinay Prasad's FDA exit in less than 3 months linked to Sarepta gene therapy controversy? Check details by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Live like royalty for the cost of a coffee? Dream Home Art Union Buy Now Undo Big changes in Social Security In its latest bid to curb fraud, SSA is expanding its online authentication requirement for address changes, claim status requests, benefit verification letters and tax statements, according to a regulatory filing Social Security recently submitted to the Office of Management and Budget. The agency intends to implement the change by August 18, assuming OMB approves it. The SSA is also looking to expand the use of multi-step verification to generate a personal identification number (PIN) so that beneficiaries can change their addresses, among other requests. Live Events "Beneficiaries will be forced to take millions of unnecessary trips to field offices, where they will face longer waits for appointments and slower processing times," wrote Kathleen Romig, the director of Social Security and disability policy at the Center on Budget and Policy Priorities (CBPP) in a blog post. She added that this will create a "significant new burden", especially for those who reside in rural areas or have transportation or mobility difficulties. ALSO READ: Justin Trudeau may have a new romance brewing: Ex-Canadian PM's love life in spotlight after Sophie Gregoire separation The SSA stated prevention of fraud as the cause for this change. Nancy LeaMond, the American Association of Retired Persons' executive vice president and chief advocacy officer, said, 'AARP supports efforts to strengthen fraud prevention and identity verification. However, we are concerned that SSA's new Security Authentication PIN (SAP) process, particularly its expansion to additional telephone services, could create new barriers for older adults who rely on telephone access to manage their Social Security benefits." The SSA announced that beneficiaries could make the changes online, but that would still pose new difficulties, AARP said. 'Our experience shows that the option to verify identity online will be a challenge for the one in four older adults who report never going online. Creating an online 'My Social Security' account can be a complicated process for people who are uncomfortable with online systems or do not have reliable internet access,' LeaMond explained. ALSO READ: Katy Perry-Justin Trudeau spotted together a month after her breakup with Orlando Bloom. Why did they split? What are critics saying about SSA changes? Some advocacy groups have raised concerns that many senior citizens and people with disabilities won't be able to complete the verification process, which includes the generation of a one-time PIN, through their mySocialSecurity accounts. 'For many older Americans, the phone is how they access Social Security services without having to rely on complicated technology or long, difficult, or costly trips to field offices,' Nancy LeaMond wrote in a letter Tuesday to Social Security Commissioner Frank Bisignano. 'We are concerned that under this new policy, older Americans, especially those in rural areas, will have to call, wait on hold for possibly hours, and then wait weeks for an appointment — and in some cases even take time off work — to complete simple transactions they have long been able to do over the phone,' she wrote, urging the commissioner to reconsider the measure. ALSO READ: Julian Brown missing: Was Atlanta inventor working on "the most dangerous thing" he's ever done? Check details Meanwhile, a Social security spokesperson said the report was inaccurate. The new identification process will not lead to increased field office visits and is 'completely optional,' the spokesperson said in an email to CNN. However, in the agency's regulatory filing, there is no indication that the new policy is optional. The agency states in the filing that it expects there will be 3.4 million 'Respondents who decline to use SAP (Security Authentication PIN) and visit a field office for in-person identity proofing.'
San Francisco Chronicle
18 hours ago
- Health
- San Francisco Chronicle
UCSF's Vinay Prasad quits FDA under pressure from Trump allies
Dr. Vinay Prasad, a prominent UCSF oncologist and outspoken critic of the U.S. government's past pandemic policies, has resigned from his senior post at the Food and Drug Administration less than three months after assuming it. 'Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,' said a spokesperson for the Department of Health and Human Services on Tuesday. Prasad was appointed in May to lead the FDA's Center for Biologics Evaluation and Research, overseeing vaccines and gene therapies. He was later named the agency's chief medical and scientific officer. Known for his sharp critiques of federal health policies and drug approvals, Prasad's appointment immediately raised concerns among biotech stakeholders. His sudden exit followed mounting political pressure, including a sustained campaign led by right-wing commentator Laura Loomer, who accused him of being a ' progressive leftist saboteur.' Loomer's criticism focused on Prasad's past podcast episodes and social media activity, where he expressed skepticism of President Donald Trump. Former Sen. Rick Santorum also joined the fray, calling Prasad the man who is destroying the president's 'legacy for helping patients.' Prasad had previously criticized the FDA's 2023 approval of Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy. This month, the FDA briefly suspended shipments of the drug following a patient death, only to partially reverse the decision a day before Prasad's resignation. Defending his colleague days before the resignation, FDA Commissioner Dr. Marty Makary described Prasad as 'one of the greatest scientific minds of our generation.'
New York Times
a day ago
- Politics
- New York Times
‘Loyalty Enforcer' Laura Loomer Targets Additional Officials
Laura Loomer, the far-right activist and self-described Trump administration 'loyalty enforcer,' has had another busy stretch. Last Friday, April Falcon Doss, the general counsel of the National Security Agency, was fired after Ms. Loomer spotlighted conservative attacks of her previous work, including for the Senate Intelligence Committee's Democratic staff. Then the Food and Drug Administration's top vaccine official, Dr. Vinay Prasad, resigned on Tuesday after a post by Ms. Loomer on social media, in which she pointed out his past statements disparaging President Trump and describing his following as a 'cult.' On Wednesday, the Army secretary, Daniel Driscoll, ordered the U.S. Military Academy at West Point to rescind the employment offer it made to a cybersecurity expert and Army veteran, Jen Easterly. Ms. Easterly, who has worked for both Republican and Democratic administrations, had drawn Ms. Loomer's ire for serving as the director of the Cybersecurity and Infrastructure Security Agency under President Joseph R. Biden Jr. They are the most recent examples of government officials being 'Loomered,' in Ms. Loomer's own parlance. A podcaster and influencer who expresses fierce fidelity to Mr. Trump, Ms. Loomer has flexed the power of her broad social media following and her access to the White House to target those whom she views as insufficiently loyal. While it is difficult to know the extent of her reach, multiple officials across the administration have been pushed out after ending up in Ms. Loomer's sights. This year, she called for a purge of the National Security Council, targeted top officials at the National Security Agency and even went after a career federal prosecutor in Los Angeles. Want all of The Times? Subscribe.
