FDA head uses great-sounding science standards to dismiss COVID vaccine benefits.
Iron pyrite, often called fool’s gold. Credit: manfredxy
On May 23, President Trump issued an executive order entitled “Restoring Gold Standard Science.” And, in news that may surprise our readers, it sounds remarkably good, focusing on issues like reproducibility and conflicts of interest. While there were a few things that could be phrased better, when it comes to basic scientific practices, the language was remarkably reasonable.
So, why didn’t we report on what appeared to be a rare bit of good news? I’d considered doing so, but the situation is complicated by the fact that the order is structured in a way that makes it very sensitive to who’s responsible for implementing it, a situation that’s subtle enough that I couldn’t figure out how to handle it well. Fortunately, I only had to wait a week for a member of the Trump administration to show just how dangerous it could be and highlight its biggest problem.
On Sunday, Food and Drug Administration Commissioner Marty Makary appeared on one of the weekend news programs, where he was asked about the decision to limit pregnant people’s access to the COVID-19 vaccines. The host mentioned that aggregation of studies involving a total of over 1.8 million women had shown the vaccine was safe and effective.
Makary dismissed all that data because it wasn’t “gold standard science,” perfectly illustrating how the phrase can be used as a tool to mislead the public.
Setting standards
The executive order defines gold standard science in various ways that have already been discussed and promoted by the scientific community itself, including groups like the open science movement. It mentions things such as reproducibility and the use of hypotheses you can show are wrong, the open communication of results and uncertainties, and a focus on collaborative work. It also includes a few obvious rules, such as forbidding federal employees from engaging in research misconduct.
Overall, when it comes to scientific practice, the elements of gold standard science appear to range from obvious and innocuous to highly positive.
But even the principles themselves are open enough to interpretation that their implementation will matter. It’s more than slightly ironic to call for more reproducibility at a time when budgets for even original research are being slashed severely, meaning that any money that goes to reproducing prior results will need to be met using a vanishing research budget. And, in the first Trump administration, “transparency” was used as a way to avoid using unpublished company data as part of considerations regarding whether the company’s products needed to be regulated.
The executive order also calls for agencies to form policies that “provide for consideration of different or dissenting viewpoints” and “protect employees from efforts to prevent or deter consideration of alternative scientific opinions.” Which again, don’t sound problematic but are coming from an administration filled with people like Robert F. Kennedy Jr., who wouldn’t accept scientific evidence unless it were delivered in the corpse of a bear. It’s notable that many non-scientific arguments about topics ranging from climate change to pandemic responses have been presented as simply “alternative scientific opinions.” So this is definitely subject to potential abuse as well.
Finally, there’s the enforcement of these rules—and thus final say on what actually constitutes gold standard science—which involves each agency naming a single political appointee to make the decisions. There’s the potential for honest misunderstandings; how could any one individual understand everything going on at a place like the National Science Foundation, which funds everything from evolutionary biology to high-energy physics? But there’s also the potential for abuse along the lines of what we’ve seen in authoritarian governments. That potential has already been widely recognized. And this weekend, we got a clear example of what it might look like in practice.
Concrete fears
Makary appeared on the news program Face the Nation over the weekend and showed exactly how this emphasis on gold standard science can be abused. The host, Margaret Brennan, challenged Makary on his recent participation in an announcement that would make it harder to get COVID vaccines during pregnancy, even though he had earlier helped pen an editorial that placed pregnant people in a high-risk category. Brennan also highlighted a meta-analysis of 67 different studies of COVID vaccines given during pregnancy. Collectively, these studies included over 1.8 million women, a large enough population to enable even rare side effects to emerge from the statistical murk.
“COVID-19 vaccines are effective in preventing SARS-CoV-2 infection and related complications in pregnant women,” the authors of the meta-analysis conclude. “Unvaccinated pregnant women are more likely to experience hypertensive disorders and caesarean sections, and their neonates are more likely to be admitted to a neonatal unit.”
That seems pretty clear. But Makary dismisses all of that data with a single short sentence: “There’s no randomized control trial, that’s the gold standard.”
In this, Makary is following a strategy adopted earlier by congressional Republicans, who desired to conclude that SARS-CoV-2 had been the product of a lab leak. So, they switched standards of evidence as needed, tightening the rules to exclude inconvenient information, while accepting studies without relevant empirical data in others. That congressional report now serves as the primary source for the Trump administration’s covid.gov website, in case there was any doubt that this strategy is appreciated by the people running the government.
The reality of science is that there are different qualities of evidence; some approaches produce data that can speak more definitively than others. When scientists talk about things like the weight of the evidence, they take these uncertainties into account. A sufficiently large and diverse collection of uncertain evidence can often outweigh a single result that appears definitive. In fact, the executive order at issue prominently describes how important it is to communicate scientific uncertainties clearly, one of its positive aspects.
Makary is not at all interested in discussing uncertainties. Instead, he’s using uncertainty as a tool, one that allows him to dismiss any evidence that runs against his preferred narrative. And there’s no reason to think that he’ll be the last member of this administration to use “gold standard science” in this way.
The only favors Makary is doing for the public is making it easier to see how the fine-sounding principles of gold standard science can so easily be abused.
John is Ars Technica’s science editor. He has a Bachelor of Arts in Biochemistry from Columbia University, and a Ph.D. in Molecular and Cell Biology from the University of California, Berkeley. When physically separated from his keyboard, he tends to seek out a bicycle, or a scenic location for communing with his hiking boots.
