What Could Be Wrong with “Gold Standard Science”?

If repetition is the mother of learning, then I am learning that the second Trump administration likes to use the term “gold standard science.” It is the subject of an executive order, a new set of requirements for federal agencies, and the answer to a host of questions.

Why fire the entire immunization advisory committee? Because the new appointees are committed to “gold standard science.” Why warn against Tylenol use during pregnancy? Because “this is gold standard science.” Why make unprecedented cuts in funding for the National Institutes of Health? Because the “tradition of upholding gold standard, evidence-based science” must be restored.

These answers raise the obvious question of what meaning the term “gold standard science” is intended to convey. The White House definition refers to “science conducted in a manner” that meets nine specific criteria, including reproducible, transparent, collaborative and interdisciplinary, accepting of negative results as positive outcomes, and without conflicts of interest.  

As a set of aspirational goals for improving science in policymaking, the administration’s definition is a reasonable place to start. Some have expressed fair concerns about whether too much transparency will lead to disclosure of private medical information and whether too many criteria will create unnecessary delays in the regulatory process. But even so, there is certainly room for improvement in using science to advance policy—as well as room for discussion to find consensus about overall goals.

The immediate problem is not the definition of “gold standard science.” It’s the fact that the administration is using the term to justify actions that appear to bear no relationship to its own criteria. How is it “transparent” to abruptly fire an entire committee of vaccination experts and replace them with people whose main qualifications seem to be vaccine skepticism or opposition? How is it “without conflicts of interest” to cite researchers who have received substantial sums from a related lawsuit? How is it “accepting of negative results as positive outcomes” to issue a fact sheet that only references studies finding an association between acetaminophen and adverse outcomes while ignoring the evidence showing no association?

 Deployed as a sound bite to counter objections to specific policies, the term “gold standard science” has done little to enhance confidence in the policy decisions being made that affect the health of millions of Americans.

An alternative concept to “gold standard science” is integrity in scientific decision making. Rather than suggest there is a single “gold standard” answer to every policy question, an approach centered on integrity calls for the policy process itself to be trusted. In 2009, after a controversy about the review of a medical device, several senior leaders of the FDA developed a three-part definition of integrity in public health policy decisions that has relevance and resonance today.

The first element of integrity in this definition is that decisions should be “based on a rigorous evaluation of the best available science”—as evidenced by discussion of the strengths and weaknesses of the data, appropriate use of advisory committees, and a thorough and objective analysis. The second element is that decisions should be “reached and documented through a process that promotes open mindedness”—including a process in which competing views are aired and discussed, and decisions are explained clearly. And the third element is that decisions should be made “without inappropriate internal or external interference”—such as pressure from outside parties or the suppression or distortion of data or opinions.

From this perspective, the administration has flatly failed to make several important policy decisions with integrity. New FDA leadership overrode key scientists without a well documented explanation in changing recommendations for COVID vaccines. Political officials stopped CDC staff from providing their analysis of a vaccine preservative to the vaccine committee, while permitting an outside, unvetted presentation on the same topic. The HHS Secretary himself announced a decision to stop recommending COVID vaccines during pregnancy, apparently based on an error-laden justification.

A key difference between the frame of “gold standard science” and that of “integrity” is the question of trust. To trust a policy action as “gold standard science” is to have confidence in the person who is making and announcing the decision. Yet, the historic relationship that Americans have with public health institutions, including the CDC and the FDA, has run deeper than any person or set of political appointees. It has risen and fallen with the underlying expertise of the agency, the fairness with which that expertise is deployed, and the thoughtfulness of the approach in using evidence to consider the best path forward.

Even those who believe that trust in agencies has been lost should recognize that the path back should be to enhance their integrity—not to override it. Asserting that specific policy outcomes represent “gold standard science”—but not working to improve the fairness of the underlying decision-making process—is a short cut that only deepens the crisis of confidence in health policymaking.

Examining the use of the phrase “gold standard” in medicine more than 30 years ago, the biochemist P. Finnbar Duggan noticed that the words shut off debate rather than encouraged a healthy scientific process. He wrote: “Because the phrase smacks of dogma its use should be discontinued in medical science. After all, the financiers gave up the idea of a gold standard years ago.”

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