I’m going to start this post with two quotes for you to contemplate. First, during the FDA Roundtable on Cell and Gene Therapy held last Thursday, I witnessed the new FDA Commissioner Marty Makary saying near the end of the proceedings:
I think we can learn a lot from individual experiences. We tend to talk in the lexicon of clinical medicine about level 1, 2, and 3 evidence. It has become this sort of dogma that we can only do things with evidence, and the evidence has been categorized in this artificial framework of level 1. 2. and 3, one defined as randomized control trials. Level one is better than two is better than three.
Now, compare and contrast the above to what Dr. David Katz said at a conference held at Yale University in April 2008 entitled the 1st Annual Integrative Medicine Scientific Symposium. By way of background for those who haven’t been reading SBM long enough to have read what Steve Novella, Kimball Atwood, and I wrote about this symposium as soon as video of the proceedings had hit YouTube, Dr. Katz is a fan of “integrative” medicine, which we at SBM like to characterize as “integrating” quackery like acupuncture and homeopathy with science- and evidence-based medicine.
Here’s the money quote:
I think we have to move beyond the results of RCTs in order to address patient needs, and to do that I’ve arrived at the use of a more fluid concept of evidence than many of us have imbibed from our medical educations…[Referring to an anecdote of a patient with chronic pain Dr. Katz went on.]…Now, we don’t want you on narcotics any more than you want to be on narcotics. We initiated a course of acupuncture and over the next two to three months weaned him off narcotics. He was pain-free on acupuncture and subsequently transitioned into homeopathy. Now, I don’t care to get into a discussion of how or even whether homeopathy even works, but this guy had tried everything.
This particular talk caused quite the kerfuffle among those of us who had long been trying to promote better science in medicine through the concept of science-based medicine. Three of us at SBM piled on, but so did David Colquhoun and Dr. R. W. Donnell, among others. Indeed, ever since, a “more fluid concept of evidence” has been one of our go-to sarcastic terms for the sorts of “evidence” that alternative medicine quacks routinely traffic in.
More saliently, note the similarity between what Dr. Makary said four days ago and what Dr. Katz said 17 years ago, specifically that anecdotes can trump randomized controlled clinical trials (RCTs). It goes beyond that, though. Both portray evidence-based medicine as “dogma,” with Dr. Makary calling it that explicitly. Although the quote above by Dr. Katz doesn’t express such a view, other parts of his talk back then most definitely did, such as when he referred to the evidence used as the basis of evidence-based practice as “indoctrination.” It’s a message that’s common to quacks, antivaxxers, and all manner of science deniers, portraying science that they don’t like as a religion.
Dr. Vinay “RCTs or STFU” Prasad joins the party
Sitting just two seats away from Dr. Makary was Dr. Vinay Prasad. We’ve criticized Dr. Prasad many times on his blog for his methodolatry, defined as the obscene worship of the randomized controlled clinical trial as the be-all and end-all of clinical investigation and the only valid method to use, all in order to weaponize the evidence-based medicine paradigm against COVID-19 mitigations, including “lockdowns,” masking, and vaccines, particularly boosters. Indeed, he routinely used to refer to his philosophy as “RCTs or STFU” (randomized controlled trials or…well, you know) to the point that before he was appointed to head the Center for Biologics Evaluation and Research (CBER), the center in the FDA responsible for evaluating and approving biologics such as vaccines, stem cell therapies, and gene therapy, he had even started to fall for the deceptive antivax narrative that tried to portray all the vaccines in the childhood schedule as dangerous because they hadn’t all undergone RCTs versus saline placebo, a deceptive narrative that new Secretary of Health and Human Services Robert F. Kennedy Jr. had been pushing for years (along with antivax lawyer Aaron Siri) and that has infested HHS since he was put in charge.
Yet there was Dr. Prasad, nodding along with his boss Dr. Makary as his boss intoned that RCTs aren’t always necessary and questioned the construct of “levels of evidence” as “artificial” and dogmatic, asserting that anecdotal evidence can be “causal until proven otherwise.” Dr. Makary, like Dr. Katz 18 years ago, even cited anecdotes, specifically that of a glioblastoma patient who had survived much longer than the average glioblastoma patient and another from parents who believed that certain that food dyes had caused their child’s aggressive behavior.
Indeed, Dr. Prasad appears to be all-in. Early in the roundtable, Dr. Prasad boasted:
How will we make our judgments? We will rely on, as Dr. Makary says, gold standard science and common sense. What does that mean practically? I’m often asked: What do you think about surrogate endpoints that do not intrinsically matter to patients but which often correlate with those that intrinsically matter? What do you think about overall survival? How do you weigh these two things? The answer is: We’re interested in both. We will rapidly make available therapies at the first sign or promise of biomedical success or action, but we’re also going to follow up overall survival and quality of life on the back end to ensure that we’re accomplishing what we think we’re accomplishing.
I’m often asked: Are you interested solely in randomized controlled clinical trials, or are you open to other methodologies? The answer is, we’re interested in all of the above: randomized controlled trials, whether or not people can serve as their own individual controls. We’re interested in target trial emulation, some of the more sophisticated epidemiological techniques, and we developed something called the iceberg plot, which develops patients against prior therapies, and something we call a parachute trial, which is a way in which we protect patients from old and dilapidated control arms, where we have efficacy.
This is “RCTs or STFU” How fluid Dr. Prasad’s view of medical evidence has become!
In fairness, I’ve long been saying that RCTs cannot be the be-all and end-all of medical evidence, given that medical ethics precludes trials that would be unethical, forcing us to rely on a preponderance of “lesser” evidence and that sometimes RCTs are simply impractical or so expensive as to be prohibitive. I’ve long viewed Dr. Prasad’s “RCTs or STFU” as methodolatry and EBM fundamentalism. That being said, it is amazing to see how fast Dr. Prasad has pivoted from “RCTs or STFU”—or, as I’ve sometimes characterized it, “RCTs über alles“—to Katzian fluidity with respect to medical evidence.
In addition, apparently Dr. Prasad’s “parachute trials” don’t apply to protecting children from having to be randomized to saline placebo and vulnerability to a vaccine-preventable disease when a second generation product is being developed of a vaccine with known efficacy. It’s also more hilarious that he claimed credit for developing a “parachute trial.” I did a PubMed search and could find only three references authored or coauthored by Dr. Prasad about “parachute trials.” In each of the references, Dr. Prasad is actually very critical of other physicians who liken RCTs of certain interventions versus placebo to the “parachute trial” proposed in a classic 2003 satirical paper that proposed an RCT of parachutes. The intent of the satire was to use a ridiculous example (that of parachutes preventing death in people jumping out of airplanes) to demonstrate why some clinical trials versus placebo are inherently unethical. Indeed, Dr. Prasad’s papers sport titles like, Most medical practices are not parachutes: a citation analysis of practices felt by biomedical authors to be analogous to parachutes, The use and meaning of the parachute metaphor in biomedicine: a citation analysis of a systematic review and a randomized trial of the parachute for freefall, and Where are randomized trials necessary: Are smoking and parachutes good counterexamples? The messages from all of these publications are that Dr. Prasad thinks that the parachute metaphor is overused and overblown and that RCTs of medical interventions likened to “parachutes” are not unethical because these interventions are not as effective as believed.
For instance, here’s Dr. Prasad in 2018:
Although there is widespread interest regarding the BMJ paper arguing that randomized trials are not necessary for practices of clear benefit, there are few analogies in medicine. Most parachute analogies in medicine are inappropriate, incorrect or misused.
Why, then, do people often assert that RCTs are unfeasible, despite the danger associated with adopting therapies without randomized data? How is it appropriate to use smoking and parachutes as counterexamples? Medicine cannot be likened to a parachute; our patients do not leap from planes, our treatments are not as successful as hitting-the-silk while falling from the sky, and demonstrating effectiveness in a patient group is much more complex than pulling a rip cord. As a result, almost everything in biomedicine can be randomized; in most cases, there is equipoise. A persistent bias in biomedicine is that more expensive, intrusive and novel treatments must improve outcomes; nevertheless, the only way to remove this bias is to confront it using empiricism. Ignoring evidence and relying on heuristics and personal judgement in the face of empiricism may result in a loss of credibility, a stalling of innovation and a loss of public confidence in our med-ical initiatives.
See what I mean? It’s fair enough that a lot of interventions portrayed as “parachute-like” don’t have evidence quite so strong as to justify the label. It’s even fair enough to point out that sometimes advocates of various treatments are too quick to invoke the parachute” metaphor. That’s not what Dr. Prasad has been about, though. He’s been about “RCTs or STFU,” and the parachute metaphor gets in the way of that argument. All of this is why I also find it hilarious that Dr. Prasad claims in the quote above to have developed the concept of a “parachute trial” to spare human subjects outmoded control treatments; unless I’m missing a publication or podcast statement, he’s done quite the opposite; yet a couple of the speakers invoked “parachutes” as though their stem cell therapies were the equivalent of parachutes for which an RCT would be unethical.
Moreover, a parachute RCT has been done. (Seriously, read the trial.)
It’s equally hilarious that Dr. Prasad seems to think he’s the first to have thought deeply about many of the concepts in clinical evidence that he trots out (other than the iceberg plot, which he does appear to have originated). Moreover, much of what Dr. Prasad said is nothing new. For instance, one phrase stood out: Make available therapies at the first sign or promise of biomedical success or action. These are basically surrogate endpoints (i.e., biochemical changes associated with activity of a drug or other endpoints associated with overall outcome, such as overall survival in an oncology trial). Such endpoints have been the very basis of accelerated approval programs, such as for HIV drugs or in oncology, for decades. One can’t help but note that Dr. Prasad has been very critical of even before he became a COVID-19 contrarian. Yet here he is, championing what sounds very much like an accelerated approval program on steroids for stem cell therapies, while others invoke the federal “right-to-try” law.
Remember, as I have written extensively, “right-to-try” is a cruel sham and an illusion. It sells false hope and paved the way for terminally ill patients to access experimental drugs after only phase I trials, a concept that easily can lead to the exploitation of desperate patients on par with that demonstrated by cancer quack clinics in Bavaria. Indeed, President Trump has claimed that right-to-try, passed during his first administration, has saved thousands of lives. It hasn’t. It’s doubtful that it’s saved even one life.
It would appear that Marty Makary and Vinay Prasad have embraced David Katz’s “more fluid concept of evidence”! At least, they have when it comes to their boss RFK Jr.’s favored treatments, like the topic of the roundtable, stem cell therapies. Indeed, as you will see, this “more fluid concept of evidence” is very selectively applied. Let’s take a look at the rest of the roundtable. Be warned. It’s nearly three hours long. I will confess that I sped through parts of It or just read the YouTube-generated transcript when I got bored, but the overall message was very clear: RFK Jr. wants stem cell therapies approved and that he will get stem cell therapies approved, even if Makary and Prasad must embrace a more fluid concept of evidence and like it.
First, a bit of background.
The sordid history of stem cell quackery
It is impossible to view this roundtable without briefly considering the history of stem cell clinics and the long history of FDA laxness when it comes to the regulation of stem cell therapies. It’s something that we at SBM have written about and lamented for a long time. Quite contrary to the portrayal in this roundtable of the FDA has an overweening, almost fascistic, bureaucratic presence that hampers innovation and getting the cures to the people, the FDA has been slow to shut down even stem cell clinics that are selling obvious quackery. Indeed, dubious stem cell clinics have sold stem cells to treat all manner of diseases for which the owners of the clinics have presented no RCT evidence—often no evidence at all except for anecdotal evidence—for the efficacy and safety of their concoctions.
Such clinics have, however, registered clinical trials on ClinicalTrials.gov, usually with no control group and questionable science behind them, as marketing tools. They’ve found willing dupes in academia to team up with them to set up “pay-to-play” clinical trials of dubious stem cell therapies for autism, a common condition targeted by stem cell quacks, many sold with overblown or outright fraudulent promises of great benefit, including that most suspect claim of all, anti-aging. Meanwhile, as has been documented by actual stem cell scientist Paul Knoepfler and myself, the sales techniques utilized by these clinics have more in common with a cross between techniques used by used car salesmen doing the “hard sell” and traveling snake oil salesmen touting “miracle cures” in the 19th century. Remember, to advocates of stem cell therapies, stem cells are basically magic. They can cure anything. While it is true that stem cell therapies do hold a lot of promise given the ability of these cells to differentiate into different tissues, the hype often far surpasses the reality.
Indeed, I first took an interest in dubious stem cell therapies over a decade ago, when hometown hockey hero Gordie Howe was enticed into traveling to Mexico for a dubious stem cell treatment sold by a company called Stemedica and touted as able to repair the neurological damage that he had suffered as the result of a severe stroke. There were a number of huge red flags in this story (documented in the links earlier in this paragraph), including the company administering the treatment in Mexico under the auspices of a highly suspect “clinical trial” because Howe was found not to be eligible for clinical trials in the US and the company paying the tens of thousands of dollars for the treatment because Gordie Howe was famous and it was good marketing. And, boy, was it ever great marketing! The media went wild, and pundits such as Keith Olbermann slurped up Stemedica press releases and carefully curated videos of Howe as if they were delivered from on high, producing interviews that read like infomercials for Stemedica. (Indeed, Olbermann actually used his platform to attack yours truly over my posts about the story.)
Now let’s look at who spoke (besides Drs. Makary and Prasad) and what the message was.
Is the FDA too harsh on stem cells and gene therapy?
Looking over the list of speakers featured at the roundtable, besides the five horsemen of the Quackocalypse—CMS Administrator Dr. Mehmet Oz, HHS secretary RFK Jr., FDA Director Dr. Marty Makary, NIH Director Dr. Jay Bhattcharya, and CBER Director Dr. Vinay Prasad—I had to admit that I was unfamiliar with most of these people. They are legitimate scientists, but they are also, by and large, very bullish on stem cells and rather dismissive of concerns about safety. A common theme is that regulation will stifle innovation, which is true to an extent, but lack of regulation also leaves patients the victim of charlatans, which is a largely the situation with respect to stem cell clinics now. Again, this whole roundtable was three hours in length; so I can only hit some of the “highlights” (or lowlights) that caught my attention.
For example, here’s Dr. Carl June, Director Center for Cellular Immunotherapies at the Perelman School of Medicine, University of Pennsylvania, who has an impressive record pioneering the development of CAR-T cell therapy. In brief, he raised the specter of “offshoring” the translation of basic science into actual stem cell and gene therapies. While this is a concern, he mentioned China, which has notoriously lax standards with respect to human experimentation and the regulation of, for instance, traditional Chinese medicine herbs and various pharmaceuticals. Do we want to race to the bottom with China?
Let’s see what Dr. June proposes, as it mirrors what a lot of the other speakers advocated for:
If we do not modernize our regulatory approach, we risk losing our leadership and undermining the long term viability of our biopharma industry. History shows that overcautious regulation can stifle progress. Bone marrow transplantation, where many of us started, was pioneered in the 1980s with only local IRB approvals outside of FDA oversight, and the field improved from initial mortality rates of over 20% to under 1% while improving efficacy. Had those high risk, early stage trial been subject to today’s FDA rules, they would have likely been halted, underscoring tha trigid early oversight can hold back promising advances. In my view, the FDA need not regulate early stage trials of autologous gene-modified cell therapies. Note here that I’m not referring to allogeneic products give to patients. I’m speaking of autologous products like hematopoietic cells that can be run under local IRB supervision. I propose a two-tier model like China does, where early models proceed under IRB approval and health review in China is required only once a therapie shows promise and is ready for larger multisite trials. In China, investigator-initiated studies begin without upfront authorization from the national regulatory bodies. Only if a product shows promise do they move into the standard regulatory process, which mirrors the FDA process.
This all sounds fairly reasonable as far as it goes. I note, however, that Dr. June comes out of academia and a standard scientific model of development of drugs, biologics, and other medical therapies. He assumes good faith. He also seems not to realize how easy it is for dubious clinics to set up compliant, rubber-stamp IRBs who will approve almost whatever they want to do, as per the examples of Drs. Stanislaw Burzynski and Mark Geier, who set up institutional review boards (IRBs) packed with their friends and cronies to approve their scientifically dubious and unethical studies, thus giving them the appearance of legitimacy. A two-tier system like the one proposed by Dr. June would seem desirable to me only if HHS also increased the stringency of its regulations covering IRBs or, at the very least, bothered to enforce the regulations already on the books.
Of course, one can’t ignore the context here, either. The current administration’s FY2026 budget proposal included massive cuts to the budgets of the FDA, CDC, and NIH. How is the FDA going to implement such modernization, even if such modernization is reasonable and desirable, given that if the administration’s budget passes Congress with those massive cuts intact it will have little or no funds to do so?
A recurring theme in all these talks was how much speed was necessary and the invocation of rare diseases as justification for “right-sizing” the current regulatory apparatus, which, depending on the speaker, involved proposals like those of Dr. June, such as Dr. Donald Kohn, Distinguished Professor of Microbiology, Immunology and Molecular Genetics, Molecular and Medical Pharmacology, and Pediatric Hematology/Oncology at UCLA, who complained about the regulatory hurdles for gene therapy and the difficulty commercializing new gene therapies and proposed steps to make the production of plasmids used in gene therapy less expensive. Others emphasized similar themes, some with compelling personal stories of family members with diseases.
It was, however, rather interesting to me, as it was to the aforementioned Dr. Paul Knoepfler, that most of these speakers didn’t even mention stem cell therapies all that much. (It was also puzzling to me how Dr. Knoepfler seemed to view this roundtable far more positively than it deserved, although in fairness he now appears to be having second thoughts.) Rather, they were talking about gene therapies, in particular gene editing technologies like CRISPR. In that context, Dr. June’s proposal of IRB-only approval for autologous therapies that are gene-altered, which presumably includes cells in which a gene has been modified by CRISPR, rather concerning to me given the current regulatory laxity with respect to IRBs in this country.
One speaker was a transplant surgeon named Dr. Jayme Locke, Vice President, Medical Development Xenotransplantation, United Therapeutics and an adjunct professor of surgery with a clinical practice at NYU Langone Health. Her work is in xenotransplantation, which is transplantation of an animal organ, often from an animal that has been genetically manipulated to make tissues organs more immunologically compatible with humans. It is an approach that could, if the challenges in overcoming the immune response to an organ from another species could be overcome, has the promise to open up the supply of organs in patients with organ failure on transplant lists:
What I would encourage the FDA and others is to not hold xenotransplantation and these other therapeutics to a standard that is different than what we hold allotransplantation to. Remember the patient voice. They want that right to try. Every day in human-to-human transplantation, I have patients who sign up to take organs that have hepatitis C, that have all these other risks, some known and some unknown, because they want the right to try, the right to live. I would just encourage us to not hold these therapies to a different standard. I would say that the thing that we must know and keep in mind is the patient’s voice. I thin it is critical to everything that we are doing, and I think we have to listen with the intent to understand, and I think that in many ways what our patients want is what the Trump administration did during their first administration, which is they want the right to ry. They want to feel that they have hope, that they’ve been afforded an opportunity.
This all sounds very compelling on the surface, but it is also our job as physicians, scientists, and clinical investigators to protect patients from experimental treatments in which the risk likely outweighs the potential benefit. Dr. Locke discussed a patient for whom she did xenotransplantation of a kidney from a genetically modified pig. The transplanted kidney lasted only four months before being rejected, but the patient viewed the effort as a success, even though the kidney had to be removed. To be honest, when Dr. Locke asks that xenotransplantation not be held to a “different standard” than allotransplantation (human-to-human transplantation), I can’t shake the feeling that that is exactly what she is asking, only with lower standards for xenotransplantation.
Again, I strongly suspect that all of these accomplished scientists and advocates calling for less FDA regulation of stem cell therapies were failing to see the elephant in the room, namely the stem cell quackery being sold at high cost by thousands of grifting clinics all over the country—all save one speaker, that is, the only one who provided a reality check on all the stem cell boosterism.
The real purpose of this roundtable: Lower the bar to approve stem cell quackery
Many of the issues brought up by the other speakers were not unreasonable. They are also ideas for altering FDA regulatory standards in response to new science that have been floated around and discussed for years, if not decades. It can indeed be argued that the FDA and its regulations do need modernization, given the era of genomic medicine and cell therapy and the incompatibilities between some of the treatments derived from these new sciences with the traditional pharma drug development model. The problem, again, is that the discussion at this roundtable almost completely ignored the context, including who RFK Jr. is and what he’s advocated over the years. Make no mistake, RFK Jr. is not about rationally “modernizing” the FDA per se. Rather, he’s about selectively applying different standards of evidence to facilitate a specific outcome. In brief, he wants to make it easier for charlatans to market quackery that he favors; e.g., bogus stem cell therapies, chelation therapy for autism, and unproven supplements. In parallel, he wants to make it more difficult for science-based treatments and preventatives (especially vaccines, to be approved, through the weaponization of the evidence-based medicine paradigm requiring RCTs even when they might be unethical, impractical, or unnecessary. In other words, he wants selectively alter standards of evidence at the FDA to favor his preferred “make America healthy again” (MAHA) remedies.
Only one of the speakers dared address this elephant in the room, stem cell quackery, although he did it without mentioning RFK Jr. or MAHA, which was probably wise from a strictly political standpoint. That one speaker was Sean J. Morrison, PhD, an investigator at the Howard Hughes Medical Institute and the director of the Children’s Research Institute at UT Southwestern in Dallas. He also serves as Chair of Public Policy Committee, International Society for Stem Cell Research. I’m going to quote his entire statement, because his is the only cautionary voice:
I just want to—I want to focus on a part of this issue that hasn’t been addressed so far. You’ve had really outstanding ideas this morning from serious people with deep insights and clinical evidence of safety and efficacy. But there area slso bad actors in this space who are attempting to sell essentially snake oil, to rip off desperate patients by capitalizing on the promise that you hear from the research in this room, but who are instead selling snake oil. These companies never do clinical trials. They have no plans to do controlled clinical trials. They are operating illegally, but it’s estimated that there’s 2,000 companies like this in the United States. They commonly claim to be able to cure diverse medical conditions with one-size-fits-all therapies, even conditions for which there is no plausible scientific rationale for stem cell therapy. For example, there’s no scientific rationale for how umbilical cord blood cells or placental cells could be used for the treatment of Parkinson’s disease or Alzheimer’s disease or orthopedic conditions or neuropathies. Yet there’s hundreds of companies out there that are selling to Americans making that claim.
Americans really need the FDA to protect them from those people. “Buyer beware” is not an effective strategy when it comes to experimental therapies, because even most physicians don’t have the expertise to evaluate which experimental therapies really have merit and which ones don’t. The companies, what we’ve learned is that the companies that ignore FDA regulations also commonly ignore good manufacturing processes. Scores of people have become septic as a result of injection of thes products. So I’ll just end by saying that the challenge here is to find ways of accelerating the development of real therapies with sound scientific rationales, clinical evidence of safety and efficacy, without deregulating to the point where you open the doors for the bad actors to sell snake oil to Americans. It would undermine confidence in the agency, and it would undermine confidence in the field in general.
Preach it, Dr. Morrison!
Unfortunately, Dr. Morrison’s wise warning was almost entirely ignored, and basically no discussion occurred subsequently regarding the entirely valid points that he had made. Instead we were treated after the last speaker to Dr. Makary referring to the EBM levels of evidence as “artificial” and “dogmatic.” I would counter by saying that the scientific method is “artificial.” Yet it works. After that, Dr. Bhattacharya touted the NIH-funded work that led to the recent gene therapy for sickle cell anemia, none of which occurred under his watch, and, given the proposed budget cuts to the NIH, similar advances are much less likely under his watch. Then we got Dr. Oz talking bout how stem cell therapy is MAHA because it gets at the “root cause” of disease, which is somewhat, but not entirely true, and real stem cell science has nothing to do with the other quackery and antivax nonsense promoted by MAHA.
When it came to RFK Jr.’s turn to give his closing remarks, I must admit to having been fairly nauseated as he praised the panel, particularly Drs. Makary, Bhattacharya, and Prasad as brave “renegades” who were “censored” during the pandemic, and how he likes to go to dinner with them and even on vacations because they all “enjoy each other’s company.” He then, even more nauseatingly, invoked his uncle President John F. Kennedy and his Presidency, going on to claim that only 3% of people had a chronic disease 60 years ago, while today 60% do. This is, of course, a narrative that leaves out a lot of relevant information. For instance, JFK’s presidency occurred near the tail end of the postwar baby boom, when only 12% of the population was 65 or older in 1963, compared with nearly 18% now. Diseases due to smoking have declined because the proportion of the population who smoke has declined dramatically since then.
“If R.F.K. Jr. makes the statement that more people are dying of chronic diseases now than in Jack Kennedy’s era, that’s undoubtedly true — we’ve got twice as many people, and a much larger chunk are old folks who have much higher chronic disease rates,” said Kenneth Warner, dean emeritus of the University of Michigan School of Public Health.
“Does that mean we’re doing worse than back then?” he added. “Absolutely not.”
And:
“When you look at chronic disease, you’re going to see that the diseases largely driven by cigarette smoking have declined since J.F.K. was president,” said Dr. JoAnn Manson, a professor of medicine at Harvard Medical School.
“But the chronic conditions driven by obesity or diet or sedentary lifestyle have increased,” she said, “including cardiometabolic diseases like Type 2 diabetes.”
That’s partly why progress toward improved health has stalled, she said.
Then, RFK Jr. said this:
Mehmet points out when my uncle was president we spent zero on chronic disease in this country. Now we spend $1.7 trillion.
One notes that Medicare and Medicaid only came into existence in 1965, nearly two years after JFK’s assassination. So, yes, during JFK’s presidency, the federal government likely paid very little to take care of chronic disease, because back then healthcare funding was nearly all private, paid for out-of-pocket or by employer-provided health insurance plans, with relatively little paid for by the federal government by comparison. The burden of chronic disease was thus borne by health insurance companies and individuals.
RFK Jr. also gives away the game later in his remarks:
President Trump has given us an executive order for every regulation put in place we have to get rid of ten. So I would solicit right now a list from all you of any regulations you think we ought to be getting rid of because we need to get rid of a lot of them in order to do the things you want to do.
There you have it. The real purpose of this roundtable is a precursor, a step on the way to radical deregulation of the stem cell therapies that RFK Jr. likes.
In fact, RFK Jr. had given the game away a week and a half before the FDA roundtable during an appearance on an episode of The Ultimate Human with Gary Brecka podcast. During the interview, RFK Jr. actually acknowledged that there are stem cell “charlatans” out there. (Really? I had never noticed.) In the same podcast, RFK Jr. (very) briefly related how he had gone to Antigua in order to receive stem cells for his spasmodic dystonia, the neurologic voice disorder that makes his voice the way it is, asking:
And that if you want to take an experimental drug, that you can do that. You ought to be able to do that. You shouldn’t have to go to Antigua to get stem cells, which I had to do for my throat.
Right. And they helped me enormously. Why did I have to go to Antigua for that?
This revelation, the first time that I’m aware of that RFK Jr. has admitted to having received dubious stem cell therapy, explains a lot. I also can’t help but note that, if anything, RFK Jr.’s voice has been sounding worse to me now compared to a few years ago, which is why I question his assessment that it had helped him. Here’s where he gives the game away, though, and reveals the real purpose of the roundtable, appropriately enough, right after an add for a supplement, liposomal NAD (no, seriously, you can’t make stuff like this up):
And you know, I thank you for what you’re doing and we’re going to end the war at FDA against alternative medicine. Thank you. The war on stem cells, the war on chelating drugs, the war on peptides, the war on anything that is not going to make big pharma money.
Just as he said he would, right after he had bent the knee last summer to Donald Trump and kissed his ring in return for a high-ranking health position in the Trump administration. Stem cells quackery is just part of his agenda for deregulation of quackery. But what about the charlatans? Well, what about them?
Per RFK Jr:
Our position is that FDA has a job just to do the science on these kind of issues and then tell the public what they’ve learned from the science, but not tell people and not tell physicians what they can and cannot prescribe.
And:
You know, we don’t want to have the Wild West. We want to make sure that information is out there, but we also want to respect the intelligence of the American people, the capacity of people who explore the outcomes that are going to benefit them the most. And of course, you’re going to get a lot of charlatans, and you’re going to get people who have bad results, but ultimately, you can’t prevent that either way.
And:
And that people may misuse them or stem cells or hyperbaric chambers for people for, you know, it’s not the government’s purview to tell people they cannot have access to those things because what they’re giving us access in the narrow range of drugs that they want to, products that they want to restrict us to are not making us healthier. We ought to rely on democracy and the good sense of the American people and the drive that we all have to take care of ourselves and God’s gift to us of a healthy body that has its own set of defenses that we need to respect.
Funny how RFK Jr. didn’t say any of this in his closing remarks at the FDA roundtable, in contrast to this podcast, where he lets his quack flag fly high. To paraphrase RFK Jr.: Sure there’ll be quacks and charlatans, but so what? Who cares? It’s not the FDA’s job to shut them down. It’s not the FDA’s job to tell doctors what they can and can’t do. It’s just up to the FDA to put the “science” out there and then let the buyer beware! Health freedom über alles!
You also need to understand some very important additional context. What RFK Jr. means by “gold standard science” and what scientists mean by good science tend to be related only by coincidence. As I like to say, RFK Jr. wouldn’t know good science if it bit him on the posterior. As an example, just look at the MAHA Report published a couple of weeks ago, which cherry-picked and misrepresented the science, apparently even using AI to write significant parts of the report, which included hallucinations of references that didn’t exist and studies that were never done.
This brings me back to Drs. Makary, Prasad, and Bhattacharya, especially Dr. Prasad. (I leave out Dr. Oz because he was always a quack, dating back to the 1990s, and so could be counted on to eagerly jump aboard RFK Jr.’s grift train if given the chance.) From my perspective, these pandemic-era self-proclaimed avatars of rigorous science who were “censored,” “canceled,” and “persecuted” by the medical establishment for advocating “RCTs or STFU” and related exaggerated and deceptive attacks on the science behind COVID-19 mitigations, including “lockdowns,” masking, and COVID-19 vaccine boosters, were always full of shit. After all, none of them could be so naive—at least, I don’t think they could be so naive, but have to admit the possibility—as not to have understood that RFK Jr. is not and never has been about rigorous science and that he certainly would never approve of Dr. Prasad’s “RCTs or STFU” attitude when it comes to his favored quackery and antivax pseudoscience. That they all so quickly capitulated and jettisoned their pandemic era approach to science they detested in favor of a Katzian “more fluid concept of evidence” leads me to the opinion that they were all either deluding themselves or lying all along. My only question now is: Are they useful idiots, opportunists, or both? You be the judge. (I vote for both.)
Finally, here’s one other tell, where Dr. Makary asserts, as he was in the middle of his little rant about levels of evidence being artificial and dogmatic:
We want to do things where evidence exists and want to pursue the creation of new evidence, but 60% of clinical decisions are purely discretionary where no evidence exists.
60% of clinical decisions have no evidence behind them? No evidence at all? While it’s true that a smaller fraction of clinical decisions have hard evidence in the form of rigorous RCTs behind them than we might like, I’ve never before seen an assertion that 60% of clinical decisions have no evidence behind them, not even from some of the biggest quacks I’ve ever encountered. Steve Novella took on the myth that most medicine is not based in rigorous science 18 years ago and tracked down a certain myth, namely that only 15% of clinical decisions are based on valid scientific evidence, and showed how it was a deceptive and almost certainly incorrect number and that more like 75% of medical interventions are based on compelling evidence, even if it’s not all RCT evidence. Basically, what Dr. Makary was doing was trying to claim that what most doctors do is not evidence-based in order to justify promoting RFK Jr.’s evidence-free stem cell quackery.
That’s because none of this is about “making America healthy again,” other than perhaps in the deluded minds of some MAHA true believers. Rather, it’s about making America safe for wellness influencers, health grifters, antivaxxers, and quacks. In this context, “health freedom” means freedom for quacks and charlatans to sell their wares unbothered by standards or law enforcement.