COVID-19 contrarian Dr. Vinay Prasad meets real world responsibility

Dr. Prasad vs. accelerated approval

I’ll start with the less emotionally charged case, namely how Dr. Prasad appears to have intervened in the late stages of the process for granting accelerated approval for RP1, the oncolytic melanoma treatment being developed by Replimune, putting the brakes on and demanding more data. Here’s a good description of just what RP1 is from Dr. Sean Khozin:

RP1 is sophisticated biological engineering at the intersection of virology, immunology, and cancer therapeutics. This modified herpes simplex virus carries two carefully designed genetic modifications: GM-CSF to recruit and activate immune cells, and GALV-GP-R⁻ to enhance viral spread through tumor tissue. Unlike traditional chemotherapy that indiscriminately kills dividing cells, or targeted therapies that block specific molecular pathways, oncolytic viruses like RP1 employ a dual strategy—directly destroying cancer cells while simultaneously awakening the immune system to recognize and eliminate tumors throughout the body.

Clever, right? For those unfamiliar with it, the accelerated approval process was initiated largely in response to activism from HIV/AIDS patients to allow for the approval for drugs that fill an urgent unmet need for the treatment of serious conditions and allowed that approval to be based on what are known as surrogate endpoints:

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Cancer therapies are generally evaluated using a number of endpoints. The most commonly used include overall survival (OS), progression-free survival (PFS), or recurrence-free survival (RFS). There are, of course, other endpoints related to survival that are measured, but these three are the most relevant for this discussion. Overall survival is what it sounds like: How long do patients survive their cancer after diagnosis? Period. It’s hard for an endpoint to be more objective than that: At a certain timepoint after diagnosis, either the patient is alive or she is dead. This number is usually expressed in terms of median survival, which is the period of time after which half of the patients under study are still alive and half have died. It should be noted that OS includes all causes of death, not just cancer. If a patient with cancer under study dies of a heart attack that is not related to his cancer or his cancer treatment, that counts.

Traditionally, OS has been the “gold standard” endpoint in measuring the efficacy of a cancer therapy, because the primary goal has been to prolong survival, the ideal case being prolonging survival to the point where it is indistinguishable from life expectancy if the patient never had cancer in the first place. PFS, on the other hand, is survival without progression; i.e., how long the patient with cancer survives without evidence that his or her tumor has measurably grown or metastasized, with dying of other causes with disease counting in the calculation. While PFS is often measured as well as OS, it’s generally considered less useful because it is entirely possible for a treatment to prolong PFS without prolonging OS. This sort of result can happen when the treatment is effective at shrinking a tumor and/or slowing its progression but its toxicities contribute to death from other causes. In such a case, PFS improves with no improvement in OS. Finally, RFS (also called disease-free survival, or DFS) is how long the patient survives without a recurrence of her cancer after successful initial treatment. PFS and RFS are often used as surrogate endpoints in cancer therapy clinical trials, although increasingly there is one other. In neoadjuvant chemotherapy (chemotherapy given before surgery), a pathologic complete response (pCR) has traditionally been considered a good surrogate endpoint. A pCR occurs when, at surgery, there are no viable cancer cells detectable in the specimen removed at surgery. In aggressive forms of breast cancer the correlation between pCR and improved overall survival is high.

Other surrogate endpoints include response rate (RR), defined as the percentage of patients whose tumor shrinks significantly in response to the therapy (usually 30% or more is the cutoff); and time to tumor progression (TTP, which is the same as PFS but doesn’t include deaths; it just measures time until the tumor detectably progresses). To these is being added a dizzying array of molecular surrogate endpoints that are less accepted, and it’s hard not to be tempted to pick your favorites if you’re an oncology researcher. The debate about the use of surrogate endpoints in oncology has been going on as long as I can remember, dating back to before I entered the field of surgical oncology as a fellow back in the late 1990s

In my discussion I noted that one big problem with the accelerated approval process wasn’t so much the use of surrogate endpoints as a basis for provisional “accelerated approval.” Rather the problem was that the FDA wasn’t always so rigorous about following up and demanding confirmatory phase 4 trials leading to traditional FDA approval. I didn’t have any objections to the idea of an accelerated approval process per se; my main problem with it was followup. That was where I thought reforms were needed. In that, I was for a time in agreement with Dr. Prasad. I like to point that out because, after all the rancor over COVID-19 and Dr. Prasad’s embrace of COVID-19 contrarianism, fear mongering about COVID-19 vaccines, and “natural herd immunity” approaches to the pandemic, people forget that there was a time when I thought Dr. Prasad was doing valuable work (for instance, his 2019 study that concluded that only around one in five treatments granted accelerated approval were later proven to show a real clinical benefit in OS). That time ended in 2021 at the latest.

Be that as it may, here’s how the company put it in a press release last week:

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

The CRL indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. Furthermore, the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components. Importantly, no safety issues were raised.

The Company will request a Type A meeting and expects it will be granted within 30 days. Replimuneplans to urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1without which the development of RP1 for advanced cancer patients with limited options will not be viable.

“We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data,” said Sushil Patel, Ph.D., Chief Executive Officer, Replimune. “The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews. Additionally, we had also aligned on the design of the confirmatory study. We strongly believe that RP1 in combination with nivolumab can bring substantial benefit to advanced melanoma patients.”

In brief, Replimune had been on track to be granted accelerated approval of RP1, with no concerns having been raised by the FDA about its application during mid- and late-cycle review. In other words, the company had played by the rules, only to have a new CBER director yank the rug out from under them. We can, of course, argue about whether the rules are appropriate from a scientific and regulatory standpoint. In fact, I have discussed just that in my discussion of accelerated approval for oncology treatments when I discussed the concerns that Dr. Prasad has long been raising about the program six years ago.

So what? You might say. It’s just one biological designed to treat melanoma. What’s the big deal? Dr. Sean Khozin describes why it’s a big deal:

We all woke up today (July 22, 2025) to a sobering reality check. The FDA’s complete response letter for RP1—Replimune’s oncolytic virus therapy—appears to signal the end of an era in oncology drug development, one where scientific promise and unmet medical need could occasionally trump methodological perfection.

Within hours of the announcement, Replimune’s stock had shed three-quarters of its value, plummeting from over $12 to barely $3. Yet this dramatic market correction merely reflects a deeper structural shift: the regulatory landscape for cancer therapeutics is fundamentally changing, and the old playbook for bringing innovative treatments to patients may soon become obsolete.

Of course, one can argue whether the accelerated approval program brings so many “innovative treatments to patients” as Dr. Khozin seems to believe. I, for one, am skeptical. My differences with biotech boosters aside, I have to point out that Replimune did follow the current rules for the accelerated approval program and quite reasonably expected that RP1 would be approved under that program; that is, until Dr. Prasad changed the rules in mid-course, thus moving the goalposts. It is, of course, within his power as CBER director to do that, but I wonder if he appreciates that there will be consequences for him to pay, and among those consequences, besides pissing off Replimune, the biotech industry at large, and boosters of gene therapy, in the age of Trump, RFK Jr., MAHA, and “right-to-try,” those consequences include political attacks from “health freedom” advocates who want to burn down the FDA in order to get “cures” to the people faster, as Dr. Howard so amusingly documented and I’ll touch upon again in the next section.

One can argue about what should be required in terms of surrogate endpoints for an application for accelerated approval, but that’s why companies and the FDA meet extensively and agree beforehand what evidence the FDA will require, which is what Replimune and the FDA did. The IGNYTE trial studied 140 patients with melanoma refractory to PD-1-targeted immunotherapy, a very bad subset of melanoma with few treatment options, and showed that RP1 combined with nivolumab achieved a 32.9% overall response rate and a 15% complete response rate. These outcomes compared favorably with existing standards of care, whose results in this subset of melanoma is dismal. The study also was consisted with the proposed biological mechanism, that RP1 appeared, as Dr. Khozin put it, “to convert cold tumors to hot at injection sites,” while simultaneously triggering immune responses against metastases. He also notes:

By conventional measures of clinical benefit, RP1 appeared poised for approval under the accelerated pathway, particularly given its breakthrough therapy designation and the urgent need for new options in this patient population.

So why did Dr. Prasad put on the brakes? As Dr. Khozin explains:

The FDA’s rejection hinged not on the magnitude of clinical benefit but on the interpretability of the evidence. In its complete response letter, the agency concluded that the IGNYTE trial was not “adequate and well-controlled”—regulatory language that carries precise legal meaning. The core issue was attribution: because all patients received both RP1 and nivolumab, and because this population had previously been exposed to PD-1 inhibitors, it became impossible to determine RP1’s independent contribution to the observed responses.

This distinction might seem academic, but it reflects a fundamental tension in modern drug development. As therapies become more sophisticated and treatment paradigms increasingly rely on rational combinations, the traditional regulatory framework—designed for single agents with clearly measurable effects—struggles to accommodate biological complexity. The very features that made RP1 scientifically compelling—its multifaceted mechanism and synergy with checkpoint inhibition—also made it regulatorily challenging to evaluate.

This is another case where Dr. Prasad might have a point, but it also might be a case of where his EBM fundamentalist methodolatry (“RCTs or STFU”) might be hamstringing the FDA and hampering innovation. There is a conflict inherent in Dr. Prasad’s approach, as Dr. Khozin points out:

His appointment to lead CBER in May 2025 marked a philosophical shift toward what might be termed “regulatory minimalism”—a framework that demands compelling, interpretable evidence before approving new therapies, regardless of theoretical promise or unmet medical need. This approach prioritizes internal validity and methodological rigor over expedience or optimism about biological mechanisms.

The doctrine is not without intellectual merit. Prasad’s academic work has documented instances where accelerated approvals based on surrogate endpoints failed to translate into meaningful patient benefit when subjected to randomized controlled trials. His emphasis on confirmatory evidence and skepticism toward single-arm studies reflects legitimate concerns about regulatory capture and the potential for marginal therapies to consume healthcare resources without proportionate benefit.

However, this philosophy also creates tension with the innovation ecosystem that has driven much of the progress in cancer treatment over the past two decades. Many breakthrough therapies—from CAR-T cell treatments to PD-1 inhibitors—initially gained approval based on dramatic single-arm trial results in desperate patient populations. The current regulatory environment might have delayed or prevented some of these advances, potentially costing lives while pursuing methodological perfection.

This has always been the tension at the heart of the regulatory endeavor, balancing innovation and getting new treatments onto the market, so that patients can benefit from them, with methodological rigor. CAR-T cells and PD-1 inhibitors are good examples where such innovation occurred because of the accelerated approval. PD-1 inhibitors, for instance, became standard-of-care for triple-negative breast cancer in an astonishingly fast timeframe because of their obvious benefits when the RCTs were done. The problem, as the second example will illustrate more clearly, is that Dr. Prasad was chosen because RFK Jr. and the new medical establishment in charge at HHS believed that he would use his EBM fundamentalist methodolatry to make the approval of new or updated vaccines much, much more difficult, which he seems to be doing. What he forgets is that Donald Trump wants the illusion of cures flowing through the FDA to the people through decreased regulatory requirements and RFK Jr. wants dubious stem cell treatments to get the rubber-stamp of FDA approval that they wouldn’t have gotten under previous administrations.

Dr. Prasad’s putting the brakes on the accelerated approval of RP1 was just one incident, and probably one that those attacking him could have overlooked if not for his decision on Elevidys.

Dr. Prasad vs. Elevidys

Last Friday, the FDA published a rather remarkable press release regarding Elevidys, which is an adneo-associated virus (AAV)-based gene therapy for Duchenne muscular dystrophy, a fatal genetic condition due to abnormalities in, or absence of, dystrophin, a protein that helps keep the body’s muscle cells intact. The result is progressive muscle wasting that is ultimately fatal at a young age. (This is the disease for which Jerry Lewis did his yearly telethons for decades last century.) The AAV vector is designed to introduce a gene into the body that leads to the production of Elevidys micro-dystrophin, a shortened protein (138 kDa, compared to the 427 kDa dystrophin protein of normal muscle cells) that contains selected domains of the dystrophin protein present in normal muscle cells. In brief, the press release stated that the FDA had placed the clinical trials for Elevidys on clinical hold:

The U.S. Food and Drug Administration today announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold following three deaths potentially related to these products and new safety concerns that the study participants are or would be exposed to an unreasonable and significant risk of illness or injury. The FDA has also revoked Sarepta’s platform technology designation.

The FDA leadership also met with Sarepta Therapeutics and requested it voluntarily stop all shipments of Elevidys today. The company refused to do so.  

“Today, we’ve shown that this FDA takes swift action when patient safety is at risk.” said FDA Commissioner Marty Makary, M.D., M.P.H. “We believe in access to drugs for unmet medical needs but are not afraid to take immediate action when a serious safety signal emerges.”

The three deaths appear to have been a result of acute liver failure in individuals treated with Elevidys or investigational gene therapy using the same AAVrh74 serotype that is used in Elevidys. One of the fatalities occurred during a clinical trial conducted under an investigational new drug application for the treatment of Limb Girdle Muscular Dystrophy.

“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,” said Director of the FDA’s Center for Biologics Evaluation and Research Vinay Prasad, M.D., M.P.H.

When I learned of this action, my first thought was that Dr. Prasad probably did the right thing here, even if it turns out that the deaths weren’t related to Elevidys. This was even after I learned some context from Dirk Haussecker at the RNAi Therapeutics blog:

When Vinay Prasad was appointed to head CBER 3 months ago, it caused a sell-off in biotech stocks relying on accelerated approval pathways aimed to ultimately provide patient choice in a timely manner.  Gene therapy companies in particular rely on these pathways (e.g. biomarker-based, natural history comparisons) with their ongoing programs and Prasad has been public with his disdain for the Elevidys approval under Peter Marks.

In subsequent weeks and months, the investor and sector panic subsided as Vinay tagged along FDA Chief Makary advocating regulatory flexibility (approval at the slightest sign of efficacy or plausible biological mechanism).  After recent rejections of Capricor’s DMD cell and Replimmune’s oncolytic viral therapies and now the controversy around Elevidys and Sarepta, this view is changing quickly again.

Unsurprisingly, Trump’s loyalty enforcer Laura Loomer has picked up the scent and identified Prasad as a Bernie Sanders-style progressive, a wolf in sheep’s clothing undermining Republican healthcare philosophy.

That being said, Haussecker also puts the deaths into perspective:

This death occurred and was reported to the FDA in early July.  To be clear, it was an unforced error by Sarepta to not publicly disclose that death for transparency reasons as it claimed that it retiring most LGMD gene therapy programs had nothing to do with safety.  It is, however, becoming increasingly evident that pre-existing poor liver health such as cholestatic disease (à XLMTM-related AAV gene therapy deaths) is the major risk factor for dying from AAV-related liver failure.  The fact that none of the ~800 ambulatory and therefore younger DMD subjects have died due to high-dose AAVrh74 gene therapy, but 3 out of ~140 non-ambulatory (à hepatic steatosis risk) patients treated with AAVrh74 fits neatly, making it the hypothesis that needs to be disproven first.

Reasonable people can disagree whether this is sufficient context not to have placed a halt on the drug based on these recent deaths. The problem, of course, is that Dr. Prasad is in a bind of his own making. For example, compare Dr. Prasad’s promise in June to make rare disease drugs available at the “first sign of promise,” as well as Makary and Prasad’s embrace of a “more fluid concept of evidence” for regulatory approval, to what seems to be a rather standard regulatory action that most heads of CBER probably would have taken under similar circumstances, and here we are. Indeed, this is one of the situations where I would agree with Dr. Prasad that evidence for the drug’s efficacy other than at favorably altering biomarkers is, from my perspective, fairly weak, as described in this New York Times article:

The F.D.A. first approved the treatment under its accelerated approval program for young Duchenne patients who do not use wheelchairs. That pathway is for drugs that have had a successful study showing changes in the body but have not been proved to extend survival or markedly improve quality of life.

Dr. Peter Marks, who at the time was director of the F.D.A.’s vaccine and gene therapy division, pushed the approval through, overruling staff scientists who opposed the move.

The treatment had not been rigorously shown to improve patients’ motor abilities, such as standing, walking and rising. But it had been shown in clinical trials to increase production of a key protein, a signal that the company said was predictive of meaningful benefits for patients. Some patient groups applauded Dr. Marks’s decisions, saying they were willing to take a risk with such a devastating disease.

The article also notes that Dr. Marks agrees with the FDA decision:

In another interview on Friday evening, Dr. Marks said that he supported the decision to step back and re-evaluate the safety of the medication.

“This is a different finding than what we originally made the benefit-risk determination on,” he said. “So I don’t disagree with a statement that maybe it would be good to take a breather and look at what’s going on here, particularly given the potential implications for the larger field of gene therapy.”

Again, this is one decision that Dr. Prasad has made that I consider to be pretty reasonable and one that almost any director of CBER probably would have made, even if it turns out that the Sarepta’s conclusion that the Brazilian boy’s death was “deemed unrelated to treatment” and, as Haussecker seems to think, more likely due to the child’s immunosuppression.

Here’s the second part of the bind that Dr. Prasad has placed himself in, through the fault of no one but himself. Even in the case of a making a decision that was not unreasonable based on science and caution, one with whom his predecessor who approved Elevidys agrees, Dr. Prasad’s past words have come back to haunt him, and the article by Robert Goldberg, Vice President of The Center for Medicine in the Public Interest, cited by Rick Santorum takes full advantage of that:

Imagine telling a poor cancer patient they can’t access the same genomic test their wealthier neighbor receives—not because it doesn’t work, not because it’s unsafe, but because a bureaucratic panel has declared the science behind it “not pure enough.” 

This isn’t a dystopian hypothetical. It almost happened in Oregon, where a Medicaid board nearly blocked coverage for genetic testing that could guide life-saving cancer treatment. At the helm of that chilling deliberation? Dr. Vinay Prasad. 

And:

Prasad’s hostility toward breakthrough therapies is not confined to policy memos. He has dismissed Elevidys as “disgusting” because of its $3.2 million price tag, decried its “unclear benefit,” and labeled it a “useless drug.” He lumped it together with Sarepta’s earlier exon-skipping therapy Exondys 51, calling its approval the result of “shenanigans” and “FDA politics” overriding science. 

To Prasad, the danger isn’t a fatal disease killing your child—it’s the prospect that someone might get a new medicine he doesn’t think is worth using.  In 2016 he wrote: The case for rationing: Why we should limit public spending on cancer drugs.”

Any other director of CBER who made this difficult decision would have faced major heat from patient advocates. That just comes with the territory, because regulatory positions are not just scientific and medical positions, but political positions, and the key stakeholders are the patients affected by regulatory decisions. Unfortunately, thanks to his activities prior to joining the medical establishment, Dr. Prasad has zero trust among patient advocates and advocacy organizations. Why is that? It’s all because his past penchant for shooting his mouth off didn’t involve just dumping on public health and vaccine advocates. Oh, no. Dr. Prasad was never shy about pontificating about FDA decisions and making highly inflammatory characterizations of decisions with which he’s disagreed. In this case, his past statements have really come back to haunt him, because he said a lot of inflammatory things about the accelerated approval of Elevidys under Dr. Marks, as discussed above. Here’s another good example:

That Dr. Prasad said this a mere four months before he had to investigate deaths potentially associated with Elevidys is—shall we say?—not a good look. Seriously, even if Dr. Prasad’s decision here turns out to have been 100% in the right, he’s in a trap of his own making because, thanks to his past statements, his decision, right here right now, easily takes on the appearance of being driven far more by personal bias, animus towards Dr. Marks, and score settling, rather than science, patient protection, and public policy. A different CBER director might have made the same decision, but have been given more the benefit of the doubt by patient groups because a different CBER director wouldn’t have spent the last decade Tweeting and writing inflammatory things about, well, anything he disagreed with, including heaping opprobrium on Elevidys and Dr. Marks for having overseen the approval of Elevidys. A more politically adept, less obnoxious CBER director might have been able to craft the FDA letter and press release in such a way as to mollify patient advocates for the moment and persuade them to give him a chance. Unfortunately, Dr. Prasad is not a less obnoxious, more politically adept CBER director,

There’s another element to this story as well. Remember, the people agitating for Dr. Prasad to be removed are part of the right wing, anti-government regulation, “tear down the FDA” wing of the Republican Party, the same wing that agitated for several years to get “right-to-try” laws passed. Right-to-try, as you will recall, only requires that there be an open IND for an investigational drug and there be clinical trials open. For drugs that meet those conditions, right-to-try states that terminally ill patients who want the drug get the drug. Sen. Ron Johnson (R-Wisc), the sponsor of the final version of the federal right-to-try bill that became law in 2018 made the real purpose of the law very clear, namely weakening the FDA:

As I made clear to my colleagues in the Senate and the House before each body voted on S.204, this legislation is fundamentally about empowering patients to make decisions in cooperation with their doctors and the developers of potentially life-saving therapies. This law intends to diminish the FDA’s power over people’s lives, not increase it.

That was the only purpose of right-to-try, and guess what? Right-to-try advocates are sharpening their knives for Dr. Prasad as well:

Prasad has long made clear that he would reverse what he sees as the FDA’s leniency. “Their job is the safety and efficacy of drug products,” he snapped on social media, listing Exondys, Aduhelm, and COVID boosters as examples of supposed failure. “Now they want to tweet snark?” 

But families aren’t asking for snark or leniency They’re asking for the same moral urgency the Right to Try law was built upon—urgency that President Trump understood viscerally. The 2018 law wasn’t just policy; it was a declaration that in America, a desperate parent has more standing than a bureaucratic panel. That a patient facing death deserves a shot at hope—even if the clinical endpoint isn’t yet statistically significant. 

Prasad rejected that vision outright. He mocked Right to Try as symbolic and insisted it had no value. And now he sits atop the very agency that Trump sought to unshackle from bureaucratic inertia. 

This is no small irony, given that Prasad has become a darling of some conservative commentators. A few vaccine-hesitant soundbites and critiques of lockdowns, and suddenly he’s portrayed as a maverick ally of the populist right. But don’t be fooled. 

And:

They (patients) deserve better. From Sarepta. From the FDA. From a system that promised them hope. 

If the FDA wants to preserve its integrity, restore public confidence, and honor the spirit of the President’s Right to Try vision, then Prasad must resign—or at least recuse himself from all matters related to Sarepta and gene therapy review. 

Poor, poor, pitiful Dr. Prasad. The President’s flying monkeys are circling, lead by Laura Loomer. He’s learning painfully that, once you go into politics—again, any FDA regulatory leadership position is a political position in addition to a scientific and medical one—anything and everything you’ve ever said becomes fair game to attack and discredit you. My schadenfreude comes from the realization that Dr. Prasad made this bed with his long history of arrogance and dismissiveness towards anyone who disagrees with him, even those of us who have spent a long time combatting alternative medicine quackery like homeopathy, as well as his hilariously performative claims that he was a Sanders/Warren liberal, although, in fairness, I do think that his original expressions of dislike of Donald Trump were genuine. Loomer and her fellow flying monkeys are far better on the attack than Dr. Prasad ever was; he’s strictly bush league when it comes to political attack, which is why I suspect that Dirk Haussecker is likely correct in his assessment:

To me it is clear that this is coming down to a showdown between Sarepta, and in particular its CEO Doug Ingram and Board of Directors, and Vinay Prasad.  The company is taking the high road saying that it is working to resolve the shipment halt ‘within the ordinary and well-established FDA channels and procedures’.  You bet, however, that Sarepta is also working through unofficial political channels and Vinay Prasad has not taken into account how Sarepta got to where it is today in the first place and, being tone deaf to patient concern, certainly not the strength of DMD patient advocacy which clearly wants Elevidys to remain a choice for them.  With Replimmune and Capricor showing that Elevidys is part of a broader pattern, his fate has been sealed in my opinion.  If not, expect a Jesse Gelsinger-type scenario for gene therapy.

Jesse Gelsinger, you might recall, was the young man who died undergoing treatment in an early clinical trial of gene therapy in 1999, leading to a several year halt in gene therapy development an d testing in the US.

Whether or not Dr. Prasad can survive the attacks on him coming from Loomer and her flying Trump monkeys, I feel as though I must conclude by shamelessly echoing Dr. Howard and asking Dr. Prasad how as part of the medical establishment he plans to rebuild trust with the public and the muscular dystrophy patient advocacy groups. This will be a task made so much more difficult in light of his history of hostility towards Elevidys, the accelerated approval program, and Dr. Marks, all of which is extremely is well-documented in his social media posts and all of which make his decisions seem driven more by his own beliefs rather than science, safety, and the law. I expect to experience more schadenfreude observing him struggle. Even if he ultimately manages to hold on to his job, the inherent contradictions between his “RCTs or STFU” ethos with respect to drug regulation, which help him when applied to making the approval of vaccines more difficult, compared to the more fluid concept of evidence demanded by his boss RFK Jr. to approve cell therapies, will likely ultimately do him in.

One can always hope. And get some popcorn.