Follow the Science: Why Peter Marks Was Asked to Leave the FDA
On Friday, Dr. Peter Marks announced his resignation from the U.S. Food and Drug Administration (FDA) as Director of CEBR (Center for Biologics Evaluation and Research) citing differences with Health and Human Services (HHS) Secretary Kennedy regarding vaccines. The New York Times, Washington Post, and other media outlets such as STAT News breathlessly reported that 'FDA's top vaccine scientist had been pushed out.' We have been told that science is at risk. The irony of these reports is that Marks didn't resign and is not a vaccine scientist. Dr. Marks was asked to leave and then subsequently wrote that he did not want to become 'subservient to [Secretary Kennedy's] misinformation and lies.'
Peter Marks is not a hero of the resistance but instead has been subverting the scientific process at FDA for years.
The media proclamation that Dr. Marks' is 'FDA's top vaccine scientist' is ironic because he decided to give himself that position. Marks is a physician but has no clinical or scientific training in vaccines or immunology. Dr. Marks trained as an oncologist, a field far from the important and complex area of vaccine biology. At FDA in 2021, Dr. Marks removed top career vaccine scientists so he could force through the approval of the COVID vaccine to meet an arbitrary Biden administration deadline. He also declined to convene the FDA Vaccine Advisory Committee to review his decision. These events are clearly outlined in the June 2023 House Judiciary Hearings. Marks ousted Dr. Gruber and Dr. Krause, the top scientists at the Office of Vaccine Research, due to 'intransigence' of these real vaccine experts to not ram through the approval of the vaccine. Drs. Gruber and Krause had voiced concerns that they needed more time to understand the safety of the vaccine especially as it relates to inflammation of the heart, now a well known and accepted toxicity of the COVID vaccine. Marks approved the use of the vaccine in children despite the known fact that children have an extremely low risk of serious health effects of COVID-19 infection and yet a known significant increased risk of serious vaccine related toxicity.
On at least three additional, documented occasions during the Biden administration as Director of CBER, Marks disregarded the opinions and expert advice of long-time career scientists to advance his own dangerous agenda. In addition to ignoring and overruling FDA's top vaccine scientists during the pandemic, Marks also overruled FDA career scientists and supported the approval of the Alzheimer's drug ADUHELM; a decision later overturned. In 2023, he overruled his own staff scientists amid their concerns and those raised by an FDA Advisory Board to grant approval of ELEVIDYS, a gene treatment for Duchenne muscular dystrophy (DMD). Furthermore, in 2024 Marks expanded the approval of ELEVIDYS despite FDA staff objections and without FDA Advisory Committee input.
As tragic evidence of Marks' failed judgement, just 2 weeks ago, the company that markets the therapy ELEVIDYS announced that a treated patient died of fulminant liver failure. Marks overruled his own career staff and experts to drive through a risky and unproven therapy that has now killed a patient. This tragedy should not have happened. After the initial FDA approval, the company conducted a subsequent trial which failed to meet the primary efficacy endpoint. On top of that, ELEVIDYS has proven toxicity including liver failure (22% of patients) and increase in serious adverse events. Despite the lack of proven efficacy and the concerning toxicity profile, Dr. Marks rammed through the initial ELEVIDYS approval and the full approval in June of 2024 against the counsel of his staff and the expert panel. While advocates point to the need for new therapies in severe debilitating diseases such as DMD, giving patients and families hope on a toxic therapy that does not provide a clinical benefit rises beyond simple incompetence. A patient died needlessly, and others have been harmed due to this incompetence.
Dr. Marks also failed to protect public health when he overruled career FDA scientists and supported the approval of the Alzheimer's treatment AUDHELM, a controversial approval that was subsequently overturned. ADUHELM was approved in June 2021 despite strident objections from FDA staff and against the recommendations of an Advisory Board. In fact, two prominent members of that advisory board resigned in protest of the decision. These members cited a lack of clear efficacy and the risk of serious toxicity including brain swelling and bleeding that can be life threatening. These events led to a congressional investigation which found that FDA had 'unusually close' interactions with Biogen, the AUDHELM sponsor and applicant. In January 2024, Biogen decided to remove ADUHELM from the market after confirmatory trials failed to show patient benefit. So, Dr. Marks again supported a dangerous and ineffective therapy that cruelly gave patients hope and provided nothing but risk and cost to Americans.
Both the ADUHELM initial approval and the ELEVIDYS approvals demonstrate that ignoring basic tenants of the use and interpretation of clinical trial data can be very damaging to public health. By ignoring these well-tested tenants of FDA review and approval, Marks endangered patients, gave false hope to those in desperate need and cost vast amounts of money that our health case system can ill afford. It cannot be overstated how destructive this practice is to drug development. This uneven application of basic clinical trial data interpretation calls into question the impartiality and credibility of the FDA. This is particularly relevant now as a patient who otherwise could have lived many more years died from an expected toxicity. And we have yet to fully determine the harm caused by Dr. Marks decision to remove the most experienced and trusted vaccine scientists that simply wanted more time to understand the, now proven, risks of the COVID vaccine.
While Dr. Peter Marks may try to claim differences with Secretary Kennedy on vaccines and the legacy media try to paint Marks as the FDA hero, the real reason he was terminated is that he made bad decisions that were contrary to FDA long-standing policies and which ran counter to the evaluations of professional career staff at FDA. Thanks to Dr. Marks' terrible decisions, we are left with a drug that has no proven benefit and that just killed a young patient, a vaccine that is not completely safe is being administered to children that have no significant risk of harm from the underlying infection, and an overburdened healthcare system that had to pay billions for another unproven, harmful therapy. Advocates for Dr. Marks claim that he has acted to help patients with life-threatening conditions which have no alternative treatments. But in reality, he catered to industry and hurt patients. Of course, we should strive to advance safe and effective therapies for such conditions, but we should not approve ineffective and dangerous therapies simply to put something out on the market. Unfortunately, Dr. Marks has repeatedly disregarded long-held FDA policy that is in place to protect patients. That is malpractice not heroism.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
22 minutes ago
- Yahoo
PlushCare Launches Enhanced Online Weight Loss Program to Expand National Access to GLP-1 Prescriptions Through Board-Certified Doctors
Secure Online Access to GLP-1 Weight Loss Medications Like Semaglutide Now Available Nationwide Through PlushCare's Updated Virtual Health Platform San Francisco, June 10, 2025 (GLOBE NEWSWIRE) -- PlushCare, a leading virtual healthcare platform, has announced a significant upgrade to its online Weight Loss Program, enabling greater access to GLP-1-based prescription treatments such as semaglutide through board-certified physicians. This development marks a critical milestone in the company's mission to provide affordable, clinically supervised weight management across the United States. Accessible at the updated platform streamlines the process for eligible adults to consult with licensed physicians, receive lab work if necessary, and access customized treatment plans—all from the comfort of their homes. 'We're committed to making evidence-based weight loss solutions more accessible through modern telehealth,' said a PlushCare spokesperson. 'Our program is designed to connect people with experienced doctors who can evaluate eligibility for medications like GLP-1s and deliver a personalized plan that fits their health goals.' Expanded Features for 2025 The revamped Weight Loss Program now includes: Nationwide Access to medical providers via secure telehealth appointments Eligibility Evaluation for FDA-approved medications, including semaglutide Personalized Plans tailored to each user's metabolic profile Optional Lab Testing with integrated results for precision treatment Transparent Pricing with no insurance required The platform is optimized for mobile and desktop users, offering a seamless experience from appointment scheduling to prescription delivery. Addressing a Growing National Health Concern According to the CDC, over 40% of U.S. adults struggle with obesity, with rising demand for effective clinical support. PlushCare's integrated virtual care model delivers a scalable solution that removes traditional geographic and scheduling barriers. Patients can typically get started in under 15 minutes by completing an intake form and booking a same-day appointment with a licensed doctor. If clinically appropriate, a prescription is sent to their preferred pharmacy. About PlushCare PlushCare is a virtual primary care and mental health platform that connects patients with top U.S. medical professionals through its secure telehealth platform. With a commitment to quality care, convenience, and evidence-based treatment, PlushCare is redefining access to modern healthcare. For more information, visit Media Contact:PlushCare Media RelationsEmail: press@ 345 California Street, Suite 600, San Francisco, CA 94105, United States SOURCE: PlushCare Disclaimer: This release contains forward-looking statements and should not be considered medical advice. All treatments are subject to clinical evaluation and provider discretion. CONTACT: Email: press@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data


The Hill
28 minutes ago
- The Hill
Trump administration vs. mRNA vaccines
The Big Story President Trump once heralded the speedy development of an mRNA vaccine, but his new administration is casting doubts and fostering speculation over their use. © AP The Department of Health and Human Services (HHS) in late May canceled $766 million awarded to Moderna through the Biomedical Advanced Research and Development Authority (BARDA) to develop a potential mRNA vaccine for bird flu. This came soon after HHS Secretary Robert F. Kennedy Jr. announced COVID-19 mRNA vaccines would no longer be recommended for children and pregnant women, though the Centers for Disease Control and Prevention (CDC) kept the shot on its schedule of childhood vaccinations. The vaccines marked a breakthrough in medical technology, drastically reducing the timeline for development of targeted vaccines and even showing promise in cancer research. Trump called mRNA the 'gold standard' when he rolled out the first COVID-19 vaccines. In remarks in December 2020, the same month the first COVID-19 vaccines were deployed, Trump praised Operation Warp Speed's ability to develop a SARS-CoV-2 vaccine at a 'breakneck speed,' adding, 'the gold standard vaccine has been done in less than nine months.' According to Joseph Varon, president and chief medical officer of the Independent Medical Alliance, the concerns for mRNA vaccine skeptics are the expedited timeline and the conditions in which the COVID-19 vaccine was approved. 'The biggest concern is that this rushed treatment still remains in use, even under an Emergency Use Authorization in some cases. It needs to be sent back through proper studies and vetting,' Varon told The Hill. In a move that could prevent future mRNA vaccines from receiving approval, Kennedy on Tuesday announced he was removing every member of the independent panel advising the CDC on vaccines. In a Wall Street Journal op-ed, he wrote, 'A clean sweep is needed to re-establish public confidence in vaccine science.' Welcome to The Hill's Health Care newsletter, we're Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech — every week we follow the latest moves on how Washington impacts your health. Did someone forward you this newsletter? Subscribe here. Essential Reads How policy will be impacting the health care sector this week and beyond: Senators grill NIH director in budget hearing: 4 takeaways National Institutes of Health Director Jay Bhattacharya faced questions from senators during an Appropriations subcommittee hearing Tuesday, as the federal government agency has taken hits to its staffing levels and grant-making ability since under President Trump. Senators focused on the Trump administration's requested 2026 budget, which calls for cutting NIH's funding by $18 billion from 2025 levels. … States sue 23andMe over genetic data sales More than two dozen states, along with the District of Columbia, are suing biotechnology company 23andMe over plans to auction off personal genetic information without their customers' knowledge or consent. 'The Pitt' actor Noah Wyle to make push for health care workers at Capitol Noah Wyle is heading to the pit of political power, with a visit to Capitol Hill to push for funding for programs aimed at improving mental health services for health care workers. 'The Pitt' and former 'ER' star will touch down in Washington on Thursday to lead a panel discussion at the Cannon House Office Building focused on the 'daily mental health, financial, and bureaucratic challenges for … In Other News Branch out with a different read: Collins calls Kennedy's firing of vaccine experts 'excessive' Sen. Susan Collins (R-Maine) on Monday called Health and Human Services Secretary Robert F. Kennedy Jr.'s firing of all 17 experts on the U.S. Centers for Disease Control and Prevention's (CDC) vaccine panel 'excessive,' but she cautioned she needs to learn more about the decision. Kennedy announced the decision in an op-ed for The Wall Street Journal, catching many GOP lawmakers by surprise. 'I did not know that that had happened,' … Around the Nation Local and state headlines on health care: What We're Reading Health news we've flagged from other outlets: What Others are Reading Most read stories on The Hill right now: Judge declines to block Trump's Corporation for Public Broadcasting firings but allows board members to stay Correction: A previous version of this article gave incorrect names of the fired CPB board members. They are Laura Ross, Diane Kaplan and Thomas Rothman. … Read more Newsom asks judge for emergency intervention in Trump troop deployment in LA California Gov. Gavin Newsom (D) asked a federal judge to immediately intervene on Tuesday to limit President Trump's deployment of the National … Read more You're all caught up. See you tomorrow! Thank you for signing up! Subscribe to more newsletters here


New York Post
43 minutes ago
- New York Post
Mayor Adams' ‘emergency' spending is out of control — now NYC must hit the brakes
New Yorkers, like all Americans, tend to stock up when any crisis is about to hit: We fill up our gas tanks, empty the bread and egg shelves at grocery stores and buy enough toilet paper to last for months. It's human nature — and for far too long, New York City's government has been behaving the very same way. But City Hall's panic reaction is far worse, and does far more damage. Advertisement In recent emergencies, like the COVID-19 pandemic and the asylum-seeker influx, city government kept on 'crisis buying' for more than a year, without ever comparing prices or rooting out contractor abuse, fraud and waste. It's time for drastic change: We must reform the city's out-of-control emergency procurement practices and add vital checks and balances. Currently, when the mayor declares a state of emergency, the city's comptroller and corporation counsel suspend their ordinary oversight regarding contracts and procurement. Advertisement In theory, this allows City Hall to respond quickly and obtain necessary goods and services to alleviate the crisis. In practice, it means the city can award no-bid contracts for up to one year — contracts that, having bypassed the competitive bidding that's normally required, can be rife with waste and abuse. Imagine purchasing a car or searching for your next apartment without competitively price-shopping for those big-ticket items. That's what City Hall does whenever the mayor declares an emergency. City agencies aren't even required to send 'emergency' contracts to the comptroller for auditing before laying out taxpayer cash. In fact, 84% of such contracts filed between January 2022 and September 2023 were submitted more than 31 days after the contract start date. Advertisement Both Mayor Eric Adams and former Mayor Bill de Blasio spent billions of dollars on the asylum-seeker and COVID crises, respectively, drawing multiple allegations of corruption and pay-to-play politics. This uncontrolled spending was especially acute during the pandemic, as de Blasio extended 'emergency' contracts a whopping 100-plus times and spent nearly $7 billion on emergency supplies with no oversight or limiting guardrails. In the private sector, affordability is a prime factor when choosing bids on contracts. The city's emergency procurement process throws such considerations to the wind, leading to reckless overspending. During COVID, City Hall paid top dollar for ventilators and N95 masks it never received — and in one case, paid an absurd $7.50 apiece for cloth masks. Advertisement Its fire sale of nearly $224 million worth of COVID-era surplus items, from ventilators to face shields, only recouped $500,000, a downright outrage. The current administration is no better, awarding a $432 million emergency contract for asylum-seeker services to an untested company called DocGo. Its dreadful performance — with problems like chronic food waste, moldy hotel rooms, unlicensed security guards and an uncredentialed CEO who was forced to resign — resulted in an investigation by the state attorney general. Even in non-emergency circumstances, the city has never reined in city contractors who utilize loopholes to enrich themselves. Take the company owned by David Levitan, listed as one of New York City's worst landlords. For over a quarter century, the city has repeatedly used Levitan's properties as homeless shelters — buildings with rotted floors, broken elevators, rat infestations and peeling lead paint. Levitan has even required some of the nonprofits operating shelters within his buildings to subcontract with his own maintenance or extermination companies to service the properties — reaping even more revenue from our tax dollars. It's time for reform, top to bottom. Advertisement Emergencies, by their very definition, are short in duration. Accordingly, they should necessitate a strictly time-limited use of no-bid contracts, for instances when competitive bidding will truly hinder the city's response. That's why I am introducing two bills in the New York City Council this week to update our lackadaisical, irresponsible procurement processes. These bills will limit all emergency contracts to 30 days, unless both the comptroller and corporation counsel approve of an extension. If passed, the laws will require all contracts be sent to the comptroller for auditing within 15 days of signing, and will increase subcontractor transparency with fines of up to $100,000 for not disclosing to the city any conflicts of interest or competing contractual obligations. Advertisement New York's broken contracting system has price-gouged our taxpayers for far too long — and recent mayoral administrations have shown no appetite to follow good-government procurement practices. It's up to the City Council to advance this vital legislation, saving precious fiscal resources, restoring responsibility and rooting out corruption. City Council Member Julie Menin (D) represents the East Side of Manhattan and chairs the Consumer and Worker Protection Committee.