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Federal health agencies are expected to adopt so-called "gold standard science" in line with an executive orderopens in a new tab or window, but many in the research community worry this framework creates yet another avenue for political appointees to control what is deemed legitimate evidence.
Characteristics of gold standard science listed in the order include being reproducible, transparent, communicative of error and uncertainty, accepting of negative results, and without conflicts of interest, among others.
Vesta Silva, PhD, a professor of rhetoric and global health studies at Allegheny College in Meadville, Pennsylvania, said naming this approach to research gold standard science is "rhetorically kind of brilliant," since by definition the gold standard is optimal and thus difficult to argue against. Plus, some research, like the randomized controlled trial, is colloquially referred to as the gold standard of medical evidence.
"It's like you've named your new form of research 'the best ever,'" she said. "How could you have critiques of 'the best ever' research?"
Federal agencies must submit their plans to implement gold standard science by Aug. 22, according to a memoopens in a new tab or window from the president's science advisor, Michael Kratsios, head of the Office of Science and Technology Policy. Senior appointees at each agency, designated by agency heads, are expected to evaluate and correct violations and discipline those who veer from the gold standard science framework.
This part of the executive order has raised eyebrows. Gary Schwitzer, who ran Health News Review for years and is now adjunct associate professor at the School of Public Health at the University of Minnesota, told MedPage Today that by sliding in this clause alongside some tenets of solid evidence-based science, the administration is able to adopt it "like a wolf in sheep's clothing."
Schwitzer said the executive order "criticizes others for politicizing science when it brings politicizing of science to an unprecedented new level," which he called ominous and concerning.
In an editorial in Science, David Michaels, PhD, MPH, of the Milken Institute School of Public Health at George Washington University in Washington, D.C., and Wendy Wagner, JD, of the University of Texas at Austin School of Law, wrote that this "officially empowers political appointees to override conclusions and interpretations of government scientists, threaten their professional autonomy, and undermine the scientific capacity of research and regulatory agencies."
Especially in light of the administration's debilitating cuts to federal health research, they argued the government's actions have gutted "the national capacity to produce any science at all, much less 'gold standard' science."
In response, Kratsios also published an editorial in Science imploring the community to not dismiss gold standard science but to "take this government-led effort at self-reform and review how it, too, can support the highest standards of scientific integrity."
Science's editor-in-chief, Holden Thorp, PhD, weighed in himself in a third editorial, noting that the scientific community's skepticism towards gold standard science is warranted given the Trump administration's actions in recent months. But he also said that "the sluggishness of journals and institutions to respond to problems in research integrity is also fodder for criticism," and that in some ways, the scientific community's own actions have fed the White House's perspective.
"A remedy for this situation is for the scientific enterprise to reaffirm its values and hold its members to them, irrespective of actions from a government entity in the United States or elsewhere," Thorp wrote.
Ivan Oransky, MD, editor-in-chief of The Transmitter and co-founder of the blog Retraction Watch, said it's important to both criticize what the Trump administration has done wrong while also acknowledging which components of so-called gold standard science have merit and may actually align with how science already aims to operate.
"At a high level, it all sounds great, but it has to be applied equally to everything," Oransky said, noting that the concern is that these standards won't be equally applied to research that aligns with the interests of influential federal officials. "That's a problem," he said.
One of the architects of the evidence-based medicine system, Gordon Guyatt, MD, a professor of medicine at McMaster University in Hamilton, Ontario, told MedPage Today that much of the individual components of gold standard science are already done some or all of the time, but also identified the ending clause of the executive order as alarming.
"They want to make everything open to interpretation, where they can make their interpretation. That is what this is all about, in my view," Guyatt said. "Evidence-based medicine would say vaccines are hugely important as public health interventions, and their standard of science will say they're not so important."
The evidence-based medicine framework, he explained, holds that some research is higher quality than other research, that systematic evidence reviews are vital, and that evidence never tells a clinician what to do; rather, it must be interpreted in the context of a patient's values and preferences. Guyatt said that much of HHS Secretary Robert F. Kennedy Jr.'s views and initiatives "would be completely discredited by the standards of evidence-based medicine."
Federal health agencies are expected to adopt so-called "gold standard science" in line with an executive orderopens in a new tab or window, but many in the research community worry this framework creates yet another avenue for political appointees to control what is deemed legitimate evidence.
Characteristics of gold standard science listed in the order include being reproducible, transparent, communicative of error and uncertainty, accepting of negative results, and without conflicts of interest, among others.
Vesta Silva, PhD, a professor of rhetoric and global health studies at Allegheny College in Meadville, Pennsylvania, said naming this approach to research gold standard science is "rhetorically kind of brilliant," since by definition the gold standard is optimal and thus difficult to argue against. Plus, some research, like the randomized controlled trial, is colloquially referred to as the gold standard of medical evidence.
"It's like you've named your new form of research 'the best ever,'" she said. "How could you have critiques of 'the best ever' research?"
Federal agencies must submit their plans to implement gold standard science by Aug. 22, according to a memoopens in a new tab or window from the president's science advisor, Michael Kratsios, head of the Office of Science and Technology Policy. Senior appointees at each agency, designated by agency heads, are expected to evaluate and correct violations and discipline those who veer from the gold standard science framework.
This part of the executive order has raised eyebrows. Gary Schwitzer, who ran Health News Review for years and is now adjunct associate professor at the School of Public Health at the University of Minnesota, told MedPage Today that by sliding in this clause alongside some tenets of solid evidence-based science, the administration is able to adopt it "like a wolf in sheep's clothing."
Schwitzer said the executive order "criticizes others for politicizing science when it brings politicizing of science to an unprecedented new level," which he called ominous and concerning.
In an editorial in Science, David Michaels, PhD, MPH, of the Milken Institute School of Public Health at George Washington University in Washington, D.C., and Wendy Wagner, JD, of the University of Texas at Austin School of Law, wrote that this "officially empowers political appointees to override conclusions and interpretations of government scientists, threaten their professional autonomy, and undermine the scientific capacity of research and regulatory agencies."
Especially in light of the administration's debilitating cuts to federal health research, they argued the government's actions have gutted "the national capacity to produce any science at all, much less 'gold standard' science."
In response, Kratsios also published an editorial in Science imploring the community to not dismiss gold standard science but to "take this government-led effort at self-reform and review how it, too, can support the highest standards of scientific integrity."
Science's editor-in-chief, Holden Thorp, PhD, weighed in himself in a third editorial, noting that the scientific community's skepticism towards gold standard science is warranted given the Trump administration's actions in recent months. But he also said that "the sluggishness of journals and institutions to respond to problems in research integrity is also fodder for criticism," and that in some ways, the scientific community's own actions have fed the White House's perspective.
"A remedy for this situation is for the scientific enterprise to reaffirm its values and hold its members to them, irrespective of actions from a government entity in the United States or elsewhere," Thorp wrote.
Ivan Oransky, MD, editor-in-chief of The Transmitter and co-founder of the blog Retraction Watch, said it's important to both criticize what the Trump administration has done wrong while also acknowledging which components of so-called gold standard science have merit and may actually align with how science already aims to operate.
"At a high level, it all sounds great, but it has to be applied equally to everything," Oransky said, noting that the concern is that these standards won't be equally applied to research that aligns with the interests of influential federal officials. "That's a problem," he said.
One of the architects of the evidence-based medicine system, Gordon Guyatt, MD, a professor of medicine at McMaster University in Hamilton, Ontario, told MedPage Today that much of the individual components of gold standard science are already done some or all of the time, but also identified the ending clause of the executive order as alarming.
"They want to make everything open to interpretation, where they can make their interpretation. That is what this is all about, in my view," Guyatt said. "Evidence-based medicine would say vaccines are hugely important as public health interventions, and their standard of science will say they're not so important."
The evidence-based medicine framework, he explained, holds that some research is higher quality than other research, that systematic evidence reviews are vital, and that evidence never tells a clinician what to do; rather, it must be interpreted in the context of a patient's values and preferences. Guyatt said that much of HHS Secretary Robert F. Kennedy Jr.'s views and initiatives "would be completely discredited by the standards of evidence-based medicine."