The Sarepta Scandal: Laura Loomer, Vinay Prasad, and the history of pharma's latest attempt to reassert control at Trump's FDA

On the pharma swamp's latest attempt to re-capture the FDA by dislodging one of its most decorated and critical officials

Vinay Prasad has been ousted from FDA. Reporting suggests that Laura Loomer and the pharmaceutical industry may have played an instrumental role. This post details what happened but more importantly the background history of similar attempts by the company responsible to undermine drug regulation at the FDA. The question is: what do we do to prevent this from happening again?

Sarepta’s series of drug-related deaths

Sarepta Therapeutics, a Roche partner facing an 88% stock plunge and burning through $1 billion annually, was on the brink of financial insolvency unless it could keep selling its controversial gene therapy Elevidys [1,2]. The drug, priced at $3.2 million per injection, was linked this year to two child deaths—reported in March and June—due to acute liver failure, a known risk [3-8]. Then, in July, there was another death. Sarepta reported the third death to the FDA but in an investor call announcing a company "reset" and layoffs, omitted any mention of it [9].

In response, FDA official Vinay Prasad, alongside Commissioner Marty Makary, reportedly urged Sarepta to halt distribution, but the company refused, continuing shipments for certain patients [10-12]. The pharma connection As deaths mounted and FDA pressure grew, public records show Sarepta paid $40,000 in June 2025 to Michael Best Strategies (MBS), a lobbying firm that had recently hired Chris LaCivita, a veteran Trump campaign strategist with ties to far-right activist Laura Loomer [2,13,14]. While direct evidence is lacking, these connections have fueled speculation that MBS was enlisted to address regulatory hurdles posed by Prasad. Reports suggest LaCivita's network may have played a role in mobilizing criticism against Prasad. Friends who I trust have told me that Loomer has been known to have received money from DC lobbying firms, circumstantially supporting the view that she may have received money in this case. More on that in a moment.

Loomer’s smear campaign

Just a couple of days before Loomer launched her media assault, Sarepta acceded to FDA’s requests to halt shipments and did so. Then, in her initial attacks on July 20th, Loomer dug up old posts portraying Prasad as anti-Trump despite his known support for the president and criticism of Fauci [15-17]. The final straw before Prasad’s ouster was Loomer posting a carefully cropped video that misrepresented Prasad's views about Trump. In the video, Prasad was shown playfully suggesting that Trump could be blamed for the pandemic, with Prasad hyperbolically suggesting that he repeatedly stabs a Trump voodoo doll out of personal spite. The final straw: Vinay Prasad’s Trump voodoo doll What Loomer’s video leaves out is that Prasad’s statements were made in the context of a discussion about media attacks on scientist John Ioannidis (Prasad’s interviewee), who advocated for less stringent COVID-19 countermeasures, broadly consistent with the approach taken by Sweden, the preferred approach of Trump, and the one advocated by most senior officials currently under RFK Jr.’s leadership at HHS, including Prasad.

In content that Loomer (or those who supplied Loomer the video) omitted, after joking about his voodoo doll, Prasad immediately suggests that he could also blame Ioannidis, then goes on to say that he could blame everyone, explaining that trying to find blame in times of crisis like the pandemic is a part of human nature. Prasad wasn’t blaming Trump. He was mocking scapegoating in general, then explaining why it happens, even if it is irrational. He was mocking and explaining a kind of Trump Derangement Syndrome, not endorsing it [18].

https://x.com/kevinnbass/status/1951707986260611168

Prasad himself would later come under fire in the media for his critical views of the pandemic response, last year confessing that he had had to tone down his criticism because he had nearly been fired from his prestigious professorship at the University of California San Francisco.

If Prasad is “Trump hater”, he’s a highly orthodox one with many views that aligned with Trump’s about the pandemic, and others that are critical of DEI. His intellectual firepower and willingness to skewer orthodoxies is precisely why Prasad was brought on to his position at the FDA.

Pharma fingerprints

Now, in her posts, Loomer claimed she was defending Trump, but pharma lobbying fingerprints throughout her posts tell a different story: specialized jargon exclusive to industry insiders, including policies that insiders frequently harp on, strongly suggest that she was fed the relevant talking points. Biotech wonk wasn’t Loomer’s cup of tea. Until, suddenly, it was. The question then becomes: what was this really about? Was it really about Trump loyalty, or was that just a smokescreen to try to hammer an opponent of the pharma swamp in DC?

An orchestrated assault: or at least, an opportunistic one, with Loomer as recruited attack dog, and the rest piling on

Sarepta had spent years developing Elevidys, a gene therapy that failed to show benefits in its key clinical trial [19,20]. Despite internal FDA horror at the "cooked" studies, it gained accelerated approval amid political pressure [21].

Patient groups, some funded by Sarepta, criticized the drug, prompting alleged threats of lawsuits or funding cuts from the company [22,23]. As deaths mounted, Prasad struck with the "ban hammer," terrifying regulators and sending Sarepta's stock to new lows [24].

The timeline of events suggests an orchestrated assault. Just days after Loomer’s initial attacks on Prasad, a top PhRMA lobbyist echoed identical smears to those of Loomer in Real Clear Health, with social media accounts piling on [25]. Lawmakers like Rick Santorum, Ron Johnson, and Bill Cassidy reportedly lobbied Trump directly, emphasizing "innovation" and children [26-28]. Trump, frustrated by the controversy, is said to have questioned Prasad's loyalty before his abrupt firing [15-17,26,29-31]. RFK Jr. praised Prasad privately, and Makary called him an "impeccable scientist" publicly [32,25]. Post-firing, some FDA Democrats celebrated, while Republicans hailed it as a win for innovation [33]. Sarepta's stock doubled.

Victory for pharma, defeat for America.

Sarepta: a history of bad drugs and regulatory capture

Sarepta has a long, troubled history. For over a decade, every major FDA approval has involved intense political intervention, with scientists repeatedly overruled and some resigning in protest [34-38]. Prasad's ouster follows this pattern, as he tried to hold the line against deteriorating standards. The first Sarepta drug approved by FDA was called Exondys 51 [39]. This drug was for patients with mutations in dystrophin, a muscle protein [39]. This is a debilitating and fatal disease affecting children [39]. Exondys 51 increased dystrophin by 0.3% of normal levels [39,40].

Unsurprisingly, Sarepta was unable to show that the drug actually worked [39,40]. Why would it? It increases the protein from zero to 1/400th of normal levels. One reviewer wrote: "I can find no precedent of an accelerated approval for a marketing application where the effect size on the surrogate endpoint is as small as 0.3%." [40] The study submitted by the company included no proper control group [40]. The techniques used were so bad not even a first-year PhD student would do a study that way.

One reviewer wrote: "The Western blots submitted by the applicant for Study 201 were oversaturated, unreliable, and uninterpretable." [40] Another wrote: "Because CDER also determined that the conditions under which the original IHC analysis was performed were inadequate, including that the reader was not masked to sequence and time, the Center requested a re-reading of the stored images by three masked pathologists under different conditions. The IHC results from the reread were not nearly as favorable, as compared to the initial IHC results reported by Sarepta." [40] They continued: "The lack of concordance between the IHC and the Western Blot results is 'striking'". [40] Then: "Study 201/202 had fundamental flaws, including baseline biopsies from external controls who could differ in unknown ways from study subjects, Week 180 biopsies from different muscles than baseline, and potential protein degradation in stored baseline samples." [40]

And on and on.

FDA commissioner Robert Califf wrote at the time: the submitted study was "characterized by major flaws in the clinical study design" and "Blinded experts assembled by the FDA fundamentally debunked this study, which has yet to be retracted and continues to be cited" [41,40]. That's right, the FDA commissioner expressed dismay that the study that the company used to gain approval hadn't yet been retracted, it was so bad [41]. Senior FDA official Janet Woodcock decided to approve before scientific review team had even voted [41,40].

Pharma-funded mobbing of FDA scientists—and how FDA caved

So why did the drug get approved?

Basically, Sarepta propagandized extremely desperate patients [60,61]. They used miraculous snake oil promises and patients believed them. Remember that this is life or death for patients, and they are extremely vulnerable. Sarepta also professionally trained some patients to give testimonials to FDA and congress [61]. The patients then went to congressmen who don't have time to understand the science [61]. They gave emotional stories to congressmen [61].

The result: a letter from 109 House members [61] and a letter from 24 Senate members [61], along with a media circus documented in the New York Times [62]. Patients even screamed at scientists during meetings [60].

There were 2,792 emails written to FDA urging approval [40]. One of them: "Dear Dr. califf: How is it that everyone in and around DMD understands this simple Idea and the science geniuses at FDA don't? You stupid fckers are costing each and every DMD kids days of their lives with your Moronic Dystrophin dance. Time to get a fcking clue" [40].

Upon approval, a journalist for Reuters wrote: "owing to pressure from patient advocates, the U.S. Food and Drug Administration on Monday approved a treatment for Duchenne muscular dystrophy even though an outside panel of experts and the agency's own reviewers questioned the drug's efficacy" [63]. A commentary in Nature Medicine was also published called "Railroading at the FDA" [60]. Its author wrote: "In the words of one FDA committee member, Exondys lowers the agency's evidentiary standard for drug effectiveness 'to an unprecedented nadir.'" [60]. A highly critical commentary was also published in Science, titled "Sarepta gets an approval - Unfortunately" [64]. The article's author pharma veteran Derek Lowe wrote: "The company... called up Duchenne-affected boys and their families to plead with the FDA, and won over Janet Woodcock, and that appears to be enough. Is this going to be the new way to get a drug approved? Run a trial in a dozen people, generate unconvincing data, and then lobby Janet Woodcock? I share the worries that this might open the floodgates, because after all, Sarepta got their drug through." [64].

One FDA reviewer ended in an equally grim note: "Approval of this NDA would send the signal that political pressure and even intimidation – not science – guides FDA decisions, with extremely negative consequences. The public is well aware of this development program: the meager size of the study population, the marginal (at best) effect size, the Division’s dim view of the efficacy data, and the robust activism of some members of the DMD community. Many would be amazed at an approval action, because other DMD drugs, recently turned down for approval, appeared to provide stronger evidence of efficacy. ...The ramifications here are profound. The public will perceive that it was their unprecedented lobbying efforts that made the difference and earned eteplirsen its accelerated approval. For the future, this will have the effect of strongly encouraging public activism and intimidation as a substitute for data, which is one of the worst possible consequences for communities with rare diseases. This type of activism is not what was envisioned for patient-focused drug development." [40].

A new era was born. Activism had replaced data. Facebook had fried people's brains. And now Facebook-fried brains had fried FDA too. FDA's credibility as a regulatory agency would now be hollowed out. FDA's Facebook age had begun.

Showdown inside FDA

Yet, despite external intense pressure, FDA scientists voted against Exondys 51's efficacy [41,40]. They then, despite Woodcock’s pre-overruling, voted against its accelerated approval [41,40]. The review team filed an appeal with FDA commissioner citing "passionate" disagreement with Woodcock [41,40]. One reviewer called Woodcock's decision "unprecedented" [40]. In a 126-page report, FDA commissioner Califf called Woodcock's decision "highly unusual" [41]. The FDA board wrote: "[Woodcock's] involvement here appears to have upended the typical review and decision-making process. ... Care should be taken to avoid the appearance of interfering with the integrity of scientific reviews at the lower levels of a Center." [41]

FDA's chief scientist accused Sarepta of "serious irresponsibility" for selectively publishing only some of the data [41]. Even Woodcock, who approved the drug, called the research "seriously deficient" [40]. Yes, even the person who approved the drug over the heads of FDA's scientists said the research was bad [40].

The mysterious ever-missing trial

Still, FDA tried to bury their heads in the sand and beg, basically: Sarepta, pretty please do a better job next time. FDA commissioner: "The utmost attention should be paid to optimizing the methodological rigor of [future] trial[s]" [41]. FDA also demanded a clinical trial "to verify the benefit" of the drug [39].

This was in 2016 [39]. The trial results are supposed to be available in 2026, maybe [42]. Or maybe later, depending on how much money needs to be made first. As an article published in Nature three years later despaired of the decision: "The approval was conditional on the company agreeing to conduct a two-year post-approval trial to show Exondys 51’s efficacy. But by August 2019, the company had yet to begin such a trial and in the meantime had profited from sales of $300 million in 2018." [43] If it sounds like Sarepta used political pressure to get its drug approved and then tried to avoid actually publishing the study showing it didn't work, it sounds that way because that's exactly what happened [43].

The “not a precedent” that became a precedent

FDA commissioner after deferring to Woodcock: "I am confident this unique situation will not set a general precedent for drug approvals under the accelerated approval pathway, as the statute and regulations are clear each situation must be evaluated on its own merits based on the totality of data and information." [41] This statement was profoundly naive, and the historical record bears this out [39,44]. Three FDA scientists resigned, including the lead reviewer of the drug, understanding the grave implications of the collapse of scientific standards and where they would lead [45,46]. One was John K. Jenkins, M.D. Director, Office of New Drugs Center for Drug Evaluation and Research/FDA [45]. In a presentation given just before his resignation, he wrote: "Path taken by Sarepta NOT a good model for other development programs" [45]. Crucially: "Upholding statutory standards for approval in face of hopes and desires of patients, families, sponsors, and investors is a very difficult job" [45]. "Personal attacks on FDA reviewers creates an atmosphere of distrust and isolation rather than collaboration" [45].

The dubious science of Elevidys

FDA Commissioner Robert Califf that promised Exondys 51 was an isolated case, but three more Sarepta drugs followed on similar grounds. This set the stage for Elevidys, a gene therapy priced at $3.2 million per dose. In 2024, a rigorous Phase 3 trial finally provided hard clinical data on Elevidys. Designed to measure actual patient outcomes, it was meant to resolve ongoing debates.

But the trial failed its primary endpoint: no significant benefit in motor function as measured by the North Star Ambulatory Assessment (NSAA) [57]. The surrogate biomarker—micro-dystrophin levels—proved meaningless, correlating with no real improvement [57]. FDA scientists, reviewing the data, voted against approval. The drug simply didn't work. Yet, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, overruled them [57]. He focused on secondary endpoints, like time to rise from the floor and 10-meter walk/run tests, where treated patients showed minor improvements (about 0.5 seconds better on average) [57]. This decision ignored key caveats:

• Patients on Elevidys received higher corticosteroid doses, potentially biasing results [57].

• Blinding may have been compromised due to side effects like nausea and vomiting in ~70% of recipients [57].

• The differences were small and could stem from natural disease variability, not drug efficacy [57].

The trial protocol explicitly stated that if the primary endpoint failed, secondary endpoints couldn't be statistically interpreted as evidence of benefit [57]. A Bayesian/classical lens: assume harm until proven otherwise To grasp the gravity, consider a Bayesian approach: start with the prior that Elevidys is harmful. All drugs carry risks, and most fail to deliver benefits. Elevidys, a gene therapy integrating into the genome, amplifies this:

• It expresses a truncated dystrophin protein (one-third the normal length), limited by technology [40].

• As a foreign protein, it triggers immune attacks, inducing autoimmune-like responses [41].

• Patients require anti-inflammatories to counter drug-induced inflammation in muscles, heart, and liver [42].

• It has caused acute liver injury and at least three deaths in 2025 trials [3-8].

Given the failed primary endpoint, the default interpretation should be harm, not the minor secondary gains Marks cited.

An erosion of FDA standards

In 2016, Exondys 51's approval drew outrage for degrading scientific standards. Elevidys takes it further: overruling actual clinical data. Former FDA scientist Luciana Borio called it a "mockery of scientific reasoning," eroding trust in institutions [58]. A recent Wall Street Journal segment exemplified this ignorance [59]. Reporters claimed Elevidys was "clearly" beneficial based on those same secondary endpoints, ignoring an FDA memo stating they are "misleading and cannot guide stakeholders." They lamented that "90% of clinical trials fail" as a flaw, missing the point: failures protect patients from useless or harmful drugs. Their defense exploited social media hysteria from figures like Laura Loomer, further damaging WSJ's credibility.

The weaponization of patient advocacy groups and media: pharma's structural death grip on FDA

The rot is structural: Pharma has weaponized patient advocacy groups, turning desperate families into unwitting lobbyists for bad drugs [47-53]. Sarepta funds outfits like Parent Project Muscular Dystrophy (PPMD), which received millions while advocating for approvals despite weak evidence [54,55]. In July 2024, Sarepta reportedly demanded PPMD censor a critical video of Elevidys, threatening a lawsuit [22,23]. Industry funds 70-90% of rare disease groups. They use these to script FDA testimony and silence critics [47,56].

Where do we go from here?

Vinay Prasad's firing shatters any illusion of impartiality. Past leaders like Janet Woodcock and Peter Marks approved drugs and kept jobs; Prasad blocked and lost his. This sends a clear signal: oppose pharma and get axed. RFK Jr. and Marty Makary back Prasad. Trump should reverse this to restore FDA trust. Without action, drug regulation becomes explicitly political. A transparently political regulatory agency might as well be openly run by pharma.

Calls have been made to reinstate Vinay Prasad, with Marty Makary discussing his attempts to bring Dr. Prasad back to FDA. But if swamp influence peddlers can so easily launch attacks like this, what hope does Dr. Prasad—or future regulators—have?

https://x.com/emilyakopp/status/1952498867821580752

This is dirty business. There needs to be an investigation into Loomer’s connections with the pharmaceutical industry after the latest debacle. Legislation should be considered to restrict the pharmaceutical industry’s involvement in patient groups, or else endless cannon fodder of propagandized patients—or influencers—can be launched to FDA and Congress to ram a new drug through regulations at any time in the future—science be damned. Since the 2016 regulatory debacle of Sarepta’s first product, pharma has had a definitive a death grip on FDA.

This needs to end.

References

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