Previous administrations, including Donald Trump’s first, usually upheld the ideal that the Food and Drug Administration and other federal health agencies would adhere to the “gold standard” for research.

For the FDA, whose jobs include the approval of new drugs, vaccines and medical devices, the gold standard meant requiring rigorous clinical studies to prove that experimental products were both efficacious and safe. That usually means a manufacturer has to submit at least two trials, both of which are placebo-controlled and double-blinded (neither patients nor their physicians know if they received the real thing). Patients in the trials are randomly assigned to one group or the other — hence its name, the randomized controlled trial or RCT.

The Center for Disease Control and Prevention is charged with monitoring the extent and seriousness of health threats in the U.S. Its gold standard is different because it involves epidemiological studies, where researchers measure the extent of a disease and its outcomes in the population by mining medical records or conducting surveys drawn from well-matched cohorts. It often relies on data collected by state and city public health agencies.

In recent weeks, the press has reported that both agencies’ staff scientists have had studies withdrawn from medical journals (the FDA) and an in-house publication (the CDC). On Tuesday, the New York Times reported that “In October, (FDA) scientists were directed to withdraw two Covid-19 vaccine studies that had been accepted for publication in medical journals. In February, top F.D.A. officials did not sign off on submitting abstracts about studies of Shingrix, a shingles vaccine, to a major drug safety conference.”

Two weeks ago, the Washington Post and other publications reported top officials at the CDC refused to allow publication of a study showing the effectiveness of the Covid vaccine in reducing hospitalizations. It had been scheduled for publication in Morbidity and Mortality Weekly Report, the agency’s well-regarded in-house journal.

Jay Bhattacharya, who runs the National Institutes of Health and is the interim head of the CDC, defended his decision to deep-six the study in a a op-ed. “I raised specific concerns about the statistical methodology chosen for the study in question,” he wrote. “These concerns about the test-negative design used go directly to the validity of the study’s conclusion.”

I’ll have more to say on test-negative design in a moment.

A new journal for CDC

Bhattacharya also announced plans for the agency to launch a peer-reviewed journal “to elevate scientific rigor across all CDC publications,” he wrote. “Peer review remains the gold standard because it subjects findings to independent scrutiny, forces transparency about limitations and strengthens confidence in the results.”

The peer review panels for this new journal, when chosen, will definitely warrant “independent scrutiny.” Should they follow in the footsteps of how the CDC has remolded its vaccine advisory committee, it should provide plenty of grist for the Retraction Watch, which monitors medical and scientific journals for published retractions. The RW website database lists tens of thousands of incidents where peer reviewed failed to catch factual errors, deliberate falsifications and other misfeasance and malfeasance in the academic journal publication process.

I have served on several peer-review panels. I will never forget the note I received from one author after I made a number of pointed suggestions for improving his study’s conclusions. He thanked me for giving him one of the most comprehensive reviews he had ever received, one that was very helpful in improving the manuscript.

I don’t offer this anecdote to pat myself on the back. It confirmed something I’ve often heard said about peer review. A better name for the process might be “colleague review,” or “friendly review,” or even “ideological fellow-traveler review.” It would be out of character (and I will be pleasantly surprised) if the Trump regime’s CDC sets a higher standard.

“I cannot recall CDC stopping an MMWR report in the publication phase after scientific clearance and editorial review.” — Michael Iademarco, who directed the CDC center that publishes MMWR from 2014 to 2022.

Bhattacharya, who trained as an economist and physician at Stanford, has never worked as an epidemiologist or as a practicing physician. But he emerged as an expert during the Covid pandemic by co-authoring the Great Barrington Declaration, which called for allowing the general population to opt out of vaccination while adopting special measures to protect seniors, who were most vulnerable to the disease. The one country that tried that approach (Sweden) quickly abandoned it due to mounting mortality among its working-age population.

'Test-Negative' Epidemiological Research

His demand for something better than “test-negative” design sounds to me like obfuscating jargon that could be used to call into question most epidemiological research. “The core problem” with that approach, he wrote, “is that, to measure the effectiveness of a vaccine in keeping people out of a hospital (for instance), this method throws away all data about people, vaccinated or not, who are never hospitalized. Instead, it replaces data with unverifiable assumptions, leading to bias. Factors such as prior infection, behavioral differences and who shows up for care can all skew results in ways that are hard to adjust for.”

Yes, all epidemiological studies that compare outcomes among two groups that haven’t been randomized have unmeasured factors that might skew the results. And there’s lots of junk science in the medical literature that makes no attempt to adjust results for unmeasurable factors. Here’s one: Martin Makary’s most recent book (he now runs the FDA) cited a study that “proved” fluoride reduces intelligence by comparing the average IQ scores in two Canadian communities, only one of which had fluoridated water (and slightly lower IQ scores among its school age children).

But most studies, especially those published in reputable journals, attempts to adjust for those unmeasured factors. The Times in its story pointed out that the “test-negative” design has been used in numerous CDC studies over the years and is well accepted in the peer-reviewed medical literature. It was used in a 2021 study on Covid vaccine effectiveness that was published in the New England Journal of Medicine, and in numerous peer-reviewed studies published in journals like JAMA Network Open, The Lancet, and Pediatrics.

The Post, in its story two weeks ago, quoted Michael Iademarco, who directed the CDC center that publishes MMWR from 2014 to 2022, which included Trump’s first term in office. “I cannot recall CDC stopping an MMWR report in the publication phase after scientific clearance and editorial review,” he said.

That is, not until contrarians like Bhattacharya and Makary and the anti-science, anti-vaccine Robert F. Kennedy Jr. took over the agencies that are charged with protecting the public’s health. Now, science is whatever they say it is.

Merrill Goozner, the former editor of Modern Healthcare, writes about health care and politics at GoozNews.substack.com, where this column first appeared. Please consider subscribing to support his work.

Reprinted with permission from Gooz News