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QUACK QUACK

Here Come Two More Enemies of Science About to Lead Vital Agencies

A Senate committee this week will almost surely push forward the FDA and NIH nominees. Neither one has the public interest at heart.

Dr. Jay Bhattacharya speaking with members of the House Freedom Caucus
Tom Williams/CQ-Roll Call, Inc/Getty Images
Dr. Jay Bhattacharya speaking with members of the House Freedom Caucus at the Heritage Foundation on November 10, 2022

Robert F. Kennedy Jr., our nation’s new Health and Human Services secretary, repeatedly says he wants “gold-standard science.” In my 15 years as a pharmaceutical physician, I oversaw over 200 clinical trials in oncology and supported regulatory approvals by global health authorities of 10 novel oncology treatments. I can confidently say: I know what “gold-standard science” looks like.

And I know what it doesn’t look like. It doesn’t look like the science endorsed by Jayanta Bhattacharya and Marty Makary, nominated respectively to head the National Institutes of Health and the Food and Drug Administration. This week, the Senate HELP Committee will hold hearings on their nominations and will undoubtedly send them through. That’s tragic, as these men are purveyors of poor-quality science.

When I hear Kennedy use the words “gold-standard science,” I cringe. Take the story of vaccines as a cause of autism, for example. After Andrew Wakefield’s 1998 Lancet paper was published, scientists all over the world rushed to replicate the findings and could not—not a surprise, given the paper was found to be fraudulent.

So what did Kennedy’s friends and affiliated organizations do? They continued to manufacture such studies, even setting up anti-vax journals to publish them in. Take the latest paper, for example, that he quoted near the end of his confirmation hearings. The authors themselves admit that the company from which they obtained the data for analysis “is no longer in existence.” The link they provide gives “Error 404.” So when Nature Medicine declined to review the paper, it was not, as Anthony Mawson, the paper’s author, complained to me, because of some pro-vaccine conspiracy, but simply because of its exceedingly poor quality.

Sadly, the same is true for papers in the Journal of the Academy of Public Health, where Makary and Bhattacharya are on the editorial board. Never mind that the “Academy of Public Health” is just a URL and an email address, or that another editor of this journal said that “traditional journals are more or less dead.” Let’s look at the first research paper this journal published, by Sood et al., from a “gold-standard” perspective.

This entire paper is based on one single Excel spreadsheet, which appears to have been uploaded three years ago. Neither the spreadsheet nor the paper overall indicates how the data was verified or that it may be partially incorrect or incomplete, which is always a concern in research. And since this journal publishes its peer reviews (which is a questionable practice), we know that the peer reviewers—who happen to be the outgoing and the incoming editors in chief of this very journal, creating an obvious conflict of interest—did not comment on this major limitation either. In fact, neither reviewer brought up a single criticism of the study or requested additional analyses—that’s probably a first in the history of peer review.

With this context, let’s examine the Make America Healthy Again Commission, which President Trump announced by executive order last month to improve life expectancy, mental health, and chronic disease. The E.O. calls, among other things, for “increasing methodological rigor.” But who on the committee can take this on? If they are all confirmed, there will be three physicians on the commission: Makary, Bhattacharya, and David Weldon, in his role as the head of the Centers for Disease Control and Prevention.

None of the three have published therapeutic clinical trials or basic science work—critical expertise when discussing causes and treatments of chronic disease in children. And given their antiestablishment views, it’s unlikely they will consult real experts beyond loyal figureheads. Makary in particular describes the entire medical establishment as “broken” in his recent book, Blind Spots. But the book itself is riddled with inaccuracies and erroneous conclusions. Take hormone replacement therapy, or HRT, for example. It was thought to prevent heart attacks and strokes in postmenopausal women. Unexpectedly, large trials showed evidence of harm, so the use of HRT for primary prevention dropped.

But recent evidence shows that shorter courses of HRT can be safely used in younger women for a different purpose: to reduce symptoms of menopause. Makary, however, concludes, “The data is clear. HRT saves lives,” citing a 20-year-old article that was subsequently refuted. This is dangerous not only because of the cherry-picking of data but also because presenting evolving evidence as “mistakes” and a “broken system” unnecessarily undermines trust in medicine. I asked an expert why this book has not been openly criticized. “Because those of us in a position to point out the errors are afraid to speak up for fear of being fired,” they said.

In this eerie silence, we are witnessing a revolt against science and medicine. Expert authority is undermined, as another member of the MAHA Committee, Russell Vought, does in Project 2025. Evidence-based interventions like vaccines are given silent treatment or openly attacked by activists like Del Bigtree, the CEO of the newly formed MAHA Alliance. Under the veneer of anti-pharma rhetoric, a pro-business agenda is unfolding: Project 2025 calls for raising the bar for generics, and drug prices are not mentioned. No wonder the industry is in quiet agreement. The FDA and the NIH used to serve as the last bastion of defense, the independent protectors of scientific integrity against special interests. Under Makary and Bhattacharya, this last bastion will fall.

“Gold-standard science” has been refined and defended over centuries. We have never been so close to breaking it.