Dr. Vinayak Prasad Fired

The other side's view of the Prasad firing, presented by Alex Berenson:

https://alexberenson.substack.com/p/on-big-pharmas-demolition-of-dr-vinay

On Big Pharma's demolition of Dr. Vinay Prasad, one of the most honest people in medicine
Prasad came to the Food & Drug Administration in May, hoping to set high, evidence-based standards for new medicines. He didn't even last three months. The industry's power has never been clearer.
By Alex Berenson - July 31, 2025

*    Big Pharma just taught its critics a powerful lesson: Don’t mess with companies selling million-dollar drugs.

*    Even if they don’t work. Especially if they don’t work.

In May, Dr. Vinay Prasad joined the Food & Drug Administration as the top regulator for vaccines, as well as stunningly expensive “biological” medicines.1 I cheered his hire, writing Prasad knows “the games Big Pharma plays to win approvals for expensive new drugs that all-too-often have little benefit — and hidden risks.”

But Prasad apparently knew the games too well. Last week, Laura Loomer attacked him for years-old social media posts criticizing Donald Trump. The Wall Street Journal joined her. They won - with stunning speed. On Tuesday, Prasad resigned.

Prasad’s posts made him vulnerable, no doubt. But they’re not why he was targeted. He was targeted because he posed a direct threat to Big Pharma profits. As he proved to a company called Sarepta Therapeutics just days before Loomer came for him.

On July 18, Prasad and the FDA told Sarepta, a Massachusetts biotechnology company, it needed to halt shipments of its gene therapy for Duchenne muscular dystrophy, or DMD.

DMD is devastating. It robs kids of their ability to walk and eventually kills them. Sarepta’s treatments work by helping them produce more of a protein they need.

In theory.

In reality, Sarepta has never shown its drugs actually benefit patients.

It has shown they raise levels of a protein that kids with DMD lack.2 But those protein levels are a marker on a blood test. They don’t necessarily translate into giving kids with DMD better, much less longer, lives.

Sarepta won approval for its first drug based on protein production in 2016. At the time, the company itself said “a clinical benefit [of the drug] has not been established” and promised “confirmatory trials.”

Nine years later, Sarepta still hasn’t completed those trials. But that hasn’t stopped it from selling the drug — for up to $1.5 million per year. Yes, per year.

Sarepta then asked the FDA to approve a gene therapy it called Elevidys — again based on protein levels. In 2023, the FDA reviewed Sarepta’s application and reported:

A notes that the clinical studies conducted to date do not provide unambiguous evidence that [the drug] is likely beneficial... Additionally, FDA has safety concerns related to the possibility of administering an ineffective gene therapy.

(Vinay did need some hair gel. That’s not a crime. I hope.)

But in the end, the FDA buckled to the pressure. It is very hard to say no to parents who are looking for any possible help for their sick children, and Sarepta has proved masterful at using them to apply pressure.

Unfortunately, the agency’s safety concerns proved real.

At least two people have died of acute liver failure from Elevidys. A third died from a similar Sarepta gene therapy in clinical trials.

Those deaths and the lack of proof Elevidys works — not concerns about its $3.2 million per-patient cost — were what led Prasad and the FDA to demand that Sarepta pull the drug. As Prasad said in the July 18 announcing the FDA’s move:

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.

The news immediately caused Sarepta’s stock, which had already been tumbling, to crash another 35 percent. Days later, Loomer began her campaign against Prasad.

The question isn’t whether desperate patients have the right to try unproven treatments. It’s whether pharmaceutical companies should be allowed to sell and profit from drugs that haven’t been shown to benefit anyone and may even be dangerous.

In desperate cases, where people are dying of cancer or kids face terrible genetic illnesses, the FDA should move drugs forward as quickly as possible. But basic clinical trial work is still crucial. And if we’re going to allow these “accelerated approvals” based on non-clinical data or single-arm trials3 at all, the companies that run them need to agree to sell their drugs at the cost of production until they receive full approval.

As the nine-years-and-counting Sarepta delay shows, keeping pharmaceutical companies from profiting off drugs approved on weak data is the only way to make them keep their promises to run and finish confirmatory trials - and show real patient benefit.

If parts of this disaster remind you of the mRNA Covid jab fiasco, you’re getting the picture. The shots were also moved forward based on rushed trials — at great profit to Pfizer and Moderna. We still have no idea how safe they are. And at this point we probably never will.

The irony is that stepping on science doesn’t benefit the industry in the long run either.

Drugmakers charge extraordinary prices for their medicines. They need real evidence their products work to justify those prices — and to convince doctors to prescribe them and patients to take them at all.

If the FDA doesn’t hold them to that standard, doctors and patients will. Even desperate parents of sick kids aren’t going to subject their children to gene therapies without hard proof they help.

Pfizer stock is lower than it was before Covid started, despite its relentless promotion of the mRNAs. And Sarepta is down almost 90 percent this year and made only small gains after Prasad was forced out.

Yes, Big Pharma scalped Prasad for his honesty. Congratulations.

If only it were half, or a tenth, as good at making drugs that work.

Notes

1
Most drugs used to be fairly simple chemical compounds like aspirin that were synthesized in factories or in some cases derived from plants. Generally, they could be taken in pill form and. But today, many new medicines are far more complex “biologics” - much larger proteins, grown in genetically engineered cells and frequently used to treat autoimmune conditions and cancer.

2
It’s even more complicated than that, because the version of the protein that Sarepta’s medicines help kids produce is different and less effective than the ones healthy people naturally make.

3
A single-arm trial is one where a drug has not been tested against placebo but given to all patients, in the hope of showing they do better than patients with their disease have fared on average in the past. The problem is that single-arm trials by definition cannot show a drug works better than placebo — perhaps the patients who enrolled were highly motivated and would have done better than the average patients anyway.

Are we ready to talk about the evils of monopoly power yet?

The FDA is part of the federal government, inextricably enmeshed in politics. And no politician can resist feeding the hope (no matter how slender) that industry offers to tragically ill children. Nor should they! It's simply not the job of government. And shame on us for looking to government to "keep us safe" from innovation for so long.

I say, either privatize the FDA with all possible haste, or destroy its monopoly by some other means. Or both.

MedPage is not there yet, of course. But it does offer some more detail to the saga, with a boatload of hot links available on their site.

https://www.medpagetoday.com/washington-watch/fdageneral/116734

FDA's Top Vaccine Official Resigns
— Vinay Prasad was only in place as CBER director for a few controversial months

July 30, 2025 

After just a few controversial months, Vinay Prasad, MD, MPH, has stepped down as director of FDA's Center for Biologics Evaluation and Research (CBER).

His brief tenure was characterized by a public feud with Sarepta Therapeutics over its gene therapy for Duchenne muscular dystrophy (DMD), and by overriding FDA scientists on decisions around COVID vaccines. He recently became a target of conservative media for his past statements.

An HHS spokesperson told news outlets that Prasad "did not want to be a distraction to the great work of the FDA in the Trump administration," and that he decided to return to California to "spend more time with his family."

Prasad stepped down just a day after Sarepta resumed shipments of its gene therapy delandistrogene moxeparvovec (Elevidys) for ambulatory patients. It was the latest turn in a roller-coaster ride over the therapy, which began in June when FDA said it was investigating the deaths of two boys who had died soon after treatment.

Sarepta had paused shipments of the treatment to non-ambulatory patients at that time.

But in July, a third patient died in a Sarepta trial of a different gene therapy, for a different type of muscular dystrophy, and FDA requested that the company halt all shipments of the DMD gene therapy.

Sarepta initially refused, but said on July 21 it would comply with the request while FDA investigated.

Then, just a few days later, the FDA announced that it was investigating the recent death of an 8-year-old boy in Brazil who received the treatment. But by July 28, the agency had concluded the 8-year-old's death was unrelated to treatment, and Sarepta resumed shipping delandistrogene moxeparvovec to ambulatory patients.

It's not clear, exactly, how the back-and-forth played into Prasad's departure, but it's rare for the public to witness such spats between companies and regulatory agencies.

Prasad's division also rejected multiple drugs this month -- a gene therapy from Ultragenyx for patients with Sanfilippo syndrome type A, a cell therapy from Capricor Therapeutics aimed at treating cardiomyopathy associated with DMD, and an advanced melanoma treatment from Replimune.

Prasad also overruled agency scientists on two decisions around COVID vaccines -- though these decisions were more in line with the overall Trump administration strategy on COVID shots. FDA's vaccine staff scientists had signed off on approving the Novavax shot, and on the next-generation mRNA shot by Moderna (mNexspike) for anyone age 12 and over, according to the New York Times.

But Prasad had overruled those decisions, and instead both the next-generation Moderna shot and the Novavax shot were approved for all adults age 65 and older, and then people ages 12 to 64 years who have at least one underlying condition.

He also overrode FDA staff scientists' recommendations for full approval of Moderna's pediatric COVID shot, according to Inside Medicine, limiting its use to high-risk kids.

And back in June, FDA required Pfizer and Moderna to beef up the warnings on myocarditis in the labeling.

Even though these power plays should have appealed to COVID critics on the right, things started unraveling for Prasad last week when right-wing activist and President Trump associate Laura Loomer posted a piece titled "Meet Vinay Prasad: The Progressive Leftist Saboteur Undermining President Trump's FDA."

A Wall Street Journal (WSJ) columnist matched Loomer's accusations with a piece this week titled, "Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag." The same day, WSJ's editorial board criticized FDA for its actions around Sarepta's gene therapy for DMD, suggesting the move might "chill investment in new drugs."

"If Americans wanted fewer novel treatments," the editorial board stated, "they could have elected Kamala Harris."

Prasad's boss, FDA Commissioner Marty Makary, MD, MPH, defended Prasad earlier this week in an interview with Politico.

"There's not a political bone to his body," Makary said. "He's an impeccable scientist, I think one of the greatest scientific minds of our generation."

"He has done a phenomenal job," Makary continued. "The staff love him, the culture there is much improved, and we're seeing great decisions come out of the FDA."

In addition to his role as CBER director, Makary had also given Prasad the title of chief medical and scientific officer. The two had worked closely together, co-authoring papers in JAMA and the New England Journal of Medicine about changing FDA policies. They also co-hosted a weekly podcast on happenings at the agency.

Prasad replaced Peter Marks, MD, PhD, who was forced out of CBER in April after clashing with HHS Secretary Robert F. Kennedy Jr.

Prasad's first speech to the agency was described as polite and measured, and he even said that randomized controlled trials are "not always necessary" -- which ran counter to his persona of being a stickler for solid evidence.

"Evidence must also contextualize the condition -- how rare and dire it is, and we should be flexible for the many people who do want to try things," he said, as reported by Inside Medicine.

It's not yet clear whom the Trump administration will select to replace Prasad.

Kristina Fiore leads MedPage’s enterprise & investigative reporting team. She’s been a medical journalist for more than a decade and her work has been recognized by Barlett & Steele, AHCJ, SABEW, and others.

RCTs are not the sole path to truth. Prasad was right about that. Does it really matter that it's the path academics, Big Pharma, and lawyers find most comfortable?

The primary path to healthcare truth is practical, face-to-face, and focused on one individual's needs.

Take 10 steps back, and view treatment from a parent's perspective.

Clipped for length; worth a full read.

https://tobyrogers.substack.com/p/mapping-autism-causation-studies

Mapping autism causation studies, Part II
It's silly to restrict ourselves to RCTs given that corporate RCTs are rigged and there is a mountain of other valid data available

Toby Rogers    |    Jul 22, 2025

I. RCTs are not the exclusive or final criterion

As I showed in my two previous articles, the exclusive focus on double-blind, randomized controlled trials (RCTs) by Evidence-Based Medicine is ridiculous because:

There are no proper RCTs of vaccines. Pharma and regulators do not want any data that might contradict their biases and interfere with their profits.

The Contract Research Organizations (CROs) that conduct clinical trials (usually in China and the Third World) work at the behest of the pharmaceutical industry and use a wide variety of tricks to give their clients any results they want.

RCTs perform no better than other types of studies according to the former head of the MHRA in the U.K. (Michael Rawlins, 2008) and the former head of the CDC in the U.S. (Thomas Frieden, 2017).

Even Bradford Hill, one of the key figures in the development and popularization of modern RCTs, cautioned against overreliance on them, saying, “Any belief that the controlled trial is the only way would mean not that the pendulum had swung too far but that it had come right off the hook” (Hill, 1966).

During World War II, RCTs showed that antibiotics can treat some bacterial infections. By the early 1970s, the pharmaceutical industry figured out how to rig RCTs to produce any results they wish. And so now RCTs are just a way to give the appearance of safety and efficacy to toxic, useless, and deadly drugs.

We can and must do better than this, particularly when it comes to autism research.

II. Activist-Initiated Participatory Science and Samizdat literature

It turns out that independent autism research is the best example of Activist-Initiated Participatory Science in history — but almost none of the mainstream academics in this field will talk about autism because they don’t want to lose their jobs.

From my doctoral thesis:

According to Moore (2006), Activist-Initiated Participatory Science has a long history going back to the social movements of the 1960s and 1970s that were alarmed by the role of scientists in the chemical and weapons industries. Scientists were both targets of and sometimes participants in these activist social movements. Activist-Initiated Participatory Science has often been a key feature of anti-toxics/anti-pollution campaigns [Brown, 1992; Bullard, 1994; Lichterman, 1996; and Allen, 2003] and health-related social movement groups [Morello-Frosch, 2006]. Many of these studies could also be considered examples of “popular epidemiology” which is defined as “the process by which laypersons gather scientific data and other information, and also direct and marshal the knowledge of other experts in order to understand the epidemiology of a disease” [Brown, 1992].

As I will show below, in the autism debate some of the most insightful data are from:

• parents’ groups;
• censored, banned, and blacklisted academics and doctors;
• independent and foreign scholars;
• court proceedings;
• registries and testimonials; and
• documentaries.

Historically, this was called the “gray literature” in academia and library sciences (neither the mainstream “white literature” nor the completely inaccessible classified “black” documents). But this term does not do justice to the context in which this groundbreaking autism research is being produced. A more fitting description is Samizdat literature. From Grok:

Samizdat literature refers to the clandestine production, reproduction, and distribution of written works, often political, literary, or dissident in nature, that were banned or censored by authorities, particularly in the Soviet Union and other Eastern Bloc countries during the 20th century. The term comes from Russian, meaning “self-published” (sam = self, izdat = publishing), and typically involved individuals or small groups secretly copying and sharing manuscripts, poems, essays, or books using typewriters, carbon paper, or other rudimentary methods to evade state censorship.

Independent autism research is being done amidst the most extreme propaganda and censorship regime in history. Elected officials, regulators, the media, and the entire knowledge production process in science and medicine are captured by and work at the behest of the pharmaceutical industry. The fact that any independent research is produced at all is remarkable. The fact that this independent autism research often attracts world-class scholars who are willing to risk everything to tell the truth is a testament to the indomitable human spirit.

Nearly all of the studies that I discuss in this article are censored by the search engines and ignored or covered up by public health agencies and medical associations. But this article will help you to find many of them.

There is also a substantial body of proprietary data that would likely demonstrate autism causation and we’ll need to find creative ways to access those data in the years to come.

III. Ginger Taylor’s database of 237+ autism studies shows mechanisms of causation

Autism parents approach the autism data differently from mainstream academics. Autism parents start with the question: “How can I help my child get better (regain speech, have fewer seizures, have less pain)?” Mainstream academics approach the autism data with visions of publishing and career advancement — and the knowledge that if they ask too many forbidden questions they’ll get fired.

Many autism parents had high level training in statistics, science, or medicine before their children regressed and that serves them in good stead when they are reading late into the night trying to figure out what happened. Also, autism parents have a tremendous advantage in that they can try treatments with their child to detox, improve gut health, reduce inflammation, etc. and see which ones work.

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Dr. Vinayak Prasad has been reinstated as the director of the FDA's Center for Biologics Evaluation and Research:

https://thehill.com/policy/healthcare/5444760-fda-reinstates-vinay-prasad/

FDA reinstates ousted top vaccine regulator Vinay Prasad
By Steff Danielle Thomas - August 9, 2025

Vinay Prasad, a top vaccine regulator ousted from the Food and Drug Administration (FDA) late last month, is set to return to his post, according to the Department of Health and Human Services (HHS).

“At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” HHS spokesperson Andrew Nixon told The Hill in a statement. “Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration.”

Prasad’s July 30 resignation as the FDA’s chief science officer followed criticism from right-wing figures — including activist Laura Loomer and former Sen. Rick Santorum (R-Pa.) — that ran parallel to a regulatory showdown with drug manufacturers over a gene therapy treatment for boys with Duchenne muscular dystrophy.

Loomer, a key ally of President Trump with noticeable influence, lavished attacks on the FDA official in recent weeks — calling him a “saboteur” and “trojan horse” for HHS’s “Make America Healthy Again” initiative.

She called his return “another egregious personnel decision” in a Saturday post on social platform X, vowing to “ramp up” her pressure campaign.

“In the coming weeks, I will be ramping up my exposes of officials within HHS and FDA so the American people can see more of the pay for play rot themselves and how rabid Trump haters continue to be hired in the Trump administration,” she wrote. “There are several Senate Confirmation hearings coming up and I have multiple oppo books ready for distribution! Should be a good time.”

Prasad was named head of the FDA’s Center for Biologics Evaluation and Research in early May as a replacement for Peter Marks, who resigned from the position in March after clashing with HHS Secretary Robert F. Kennedy Jr.

The doctor, just one of several health officials tapped by Trump who criticized COVID-19 vaccines, had been in the role for less than three months when the FDA announced he would step down.

“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,” an HHS spokesperson said at the time. “We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”

The division at the time was also involved in a dispute between the administration and Sarepta Therapeutics. The FDA had paused shipments and clinical trials of its Elevidys treatment for those with Duchenne muscular dystrophy following reports of two patients that died after receiving the drug.

Prior to his role in the administration, Prasad had argued against the treatment’s approval after Marks overrode multiply agency reviews.

He also recently made headlines for restricting the approval of two COVID-19 vaccines while disregarding recommendations from government scientists. Two memos issued last month by the FDA showed how the doctor personally intervened to place limitations on drugmakers Novavax and Moderna after their coronavirus shots were approved for anyone 12 years or older.

Again, this appears to be a fight promoted by Big Pharma, which is now on the losing end - for a while!

Politico offers some background on Dr. Vinayak Prasad's reinstatement.  It might even be true:

https://www.politico.com/news/2025/08/14/rfk-trump-prasad-wiles-sarepta-loomer-maha-00508819

Wiles intervened to save RFK Jr.’s top vaccine aide
A well-connected drug company and Laura Loomer wanted Kennedy ally Vinay Prasad gone. Trump chief of staff Susie Wiles got his job back.
By David Lim, Dasha Burns and Tim Röhn - August 14, 2025

White House chief of staff Susie Wiles was behind President Donald Trump’s highly unusual decision last week to rehire a vaccine regulator he’d just fired at the urging of MAGA influencer Laura Loomer.

Wiles’ intervention in getting Vinay Prasad’s job back, as described by two senior administration officials granted anonymity to discuss sensitive details, followed pleas from both Prasad’s boss, Food and Drug Administration Commissioner Marty Makary, and Health Secretary Robert F. Kennedy Jr. They insisted that Prasad is part of Kennedy’s broader Make America Healthy Again movement and integral to the Trump coalition.

“After Vinay left, Marty and Bobby worked very, very, very hard through Susie Wiles, the president’s chief of staff, to tell the president that Vinay was not anti-Trump,” one of the senior administration officials said. “The MAHA movement is an expansion of the MAGA, sort of, you know, big tent.”

Trump’s reversal demonstrated the limits of Loomer’s influence and marked a fragile win for Kennedy in pursuing his plans to overhaul U.S. regulation of vaccines and drugs — and confirmation that the White House still sees Kennedy as a useful political ally as the midterm elections approach.

Trump had forced Prasad out of his FDA job less than two weeks earlier after the Cambridge, Massachusetts, pharmaceutical manufacturer Sarepta Therapeutics, joined by GOP allies and Loomer, sought his ouster. Prasad in July had pushed the FDA to ask Sarepta to stop selling its Duchenne muscular dystrophy drug Elevidys due to safety concerns, according to one of the senior administration officials.

Sarepta spokesperson Tracy Sorrentino wrote in an email that the company will “continue working with the FDA, its leadership and review teams, as we have always done.”

In arguing Prasad was disloyal to Trump, Loomer had pointed to social media posts he made during the pandemic, in which Prasad said that he was once a Bernie Sanders supporter.

Prasad’s rehiring isn’t the end of the war between Kennedy and his allies, and Loomer and corporations – from pharma to food manufacturers – that see Kennedy as a threat. Loomer, for instance, has only amped up her critique, most recently telling POLITICO that she planned to go after more Kennedy aides. Loomer remains close to Trump, and he has occasionally, though not always, followed her advice on personnel decisions.

Loomer did not respond immediately to a request for comment. The FDA referred questions to the White House.

“Secretary Kennedy and the entire HHS team are doing a terrific job as they deliver on President Trump’s mandate to Make America Healthy Again,” White House spokesperson Kush Desai said. “Scores of prominent restaurant chains and food brands dropping artificial ingredients from our food supply and historic reforms at the FDA to fast track lifesaving drugs and treatments prove that the entire HHS team is delivering for the American people.”

According to the officials, Makary and Kennedy persuaded the White House to review statements by Prasad that Loomer said showed disloyalty, arguing they were taken out of context.

“I think it really is something good about the president that he’s willing to change his mind when persuaded,” one of the senior administration officials said.

But the victory could prove pyrrhic if Prasad’s ability to set policy is diminished. Before his firing, Makary had named him not only the head of the FDA’s Center for Biologics Evaluation and Research, which oversees regulation of vaccines and gene therapies like Elevidys, but also the agency’s chief medical and scientific officer.

Makary, like Prasad, was a leading critic of the Biden administration’s response to the Covid pandemic. Prasad, a University of Chicago-trained hematologist and oncologist, was previously a professor of epidemiology and biostatistics at the University of California, San Francisco.

Sen. Ron Johnson (R-Wis.), the author of a 2018 law Trump signed that permits patients greater access to experimental therapies, told POLITICO he texted Trump days ahead of Prasad’s ouster to raise concerns of the Duchenne muscular dystrophy patient community about the FDA’s efforts to restrict Elevidys.

The company initially refused to comply with the agency’s July 18 request that it halt shipment. It agreed on July 21 to stop shipping the medicine by the end of business the next day to maintain a “productive and positive working relationship with FDA.” The agency then allowed the company to resume distribution to ambulatory patients on July 28, a day before Prasad’s ouster.

Those patients are a subset of people with the condition, which weakens muscles and leads to the loss of the ability to walk, typically by age 12. Most die before they reach 30.

Johnson’s Right to Try Act, which Trump repeatedly touted on the campaign trail as a signature achievement of his first term, aims to allow patients with life-threatening diseases to try experimental medicines without FDA involvement. The agency has a separate longstanding program known as compassionate use that allows such patients to access experimental treatments when other options do not exist.

“I have never met or spoken to Dr. Prasad,” Johnson said when asked about Prasad’s return. “I hope all the new appointees within HHS and its subsidiary agencies restore integrity to scientific research, fully respect both the letter and spirit of the Right to Try Act, and carefully listen to and empathize with the patients who are impacted by their decisions.”

Former FDA officials said they expect the power struggle between Republicans who support pharma and Kennedy to continue.

Loomer, meanwhile, says she now wants Trump to dismiss Stefanie Spear, Kennedy’s principal deputy chief of staff and senior counselor, and Casey Means, Trump’s nominee to be surgeon general. Casey Means is a close Kennedy ally and sister of Kennedy adviser Calley Means.

“I think she wants to split the MAHA and MAGA coalition,” one of the senior officials said of Loomer. “She wants to split them in two.”