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By Michael Halpern
At one time in America, unscrupulous salesmen peddled elixirs and tonics that promised to cure all their ills. In truth, these “medicines” often contained opium, cocaine, and even uranium. The federal government intervened and in 1906 passed a law that would eventually lead to the creation of the U.S. Food and Drug Administration (FDA). Today, the agency’s mission is to ensure “the safety, efficacy, and security” of not only food and drugs, but also medical devices, vaccines, cosmetics, and the U.S. blood supply.
Recent scandals related to FDA approval of drugs such as Vioxx and Plan B, however, have shaken Americans’ consumer confidence. Even worse, a recent UCS survey demonstrates that the agency’s own scientists have little confidence in the FDA’s ability to protect public health.
Misplaced Priorities
Earlier this year, 997 FDA scientists responded to a survey from UCS and Public Employees for Environmental Responsibility (PEER) about the state of science at the agency. The scientists paint a troubling picture: hundreds reported significant interference in their scientific work, and many expressed concern that the agency’s decisions ignore or misrepresent the best available science.
Among the more disturbing findings:
561 scientists thought their managers did not consistently stand behind the scientist’s work when it was scientifically defensible but politically controversial
357 scientists felt they could not openly express any concerns about public health—even inside the agency—without fear of retaliation
145 scientists said they have been asked to inappropriately exclude or alter information from a scientific report
378 scientists thought the FDA is not acting effectively to protect public health
“Science must be the driving force for decisions made at the FDA,” says Francesca Grifo, senior scientist and director of the UCS Scientific Integrity Program. “FDA leaders should act now to improve transparency and accountability and renew respect for independent science at the agency.”
The Message Is Heard
Before the release of the survey on July 20, UCS met with several members of Congress to inform them of the results and urge swift and meaningful reform at the FDA. Both Republicans and Democrats have since demanded that the agency listen to its scientists and move quickly to improve morale, protect scientists who speak out, and restore its scientific integrity.
In August, UCS briefed acting FDA Commissioner Andrew von Eschenbach on the survey results and suggested specific reforms. Dr. von Eschenbach expressed his own concern and invited UCS to re-evaluate the situation in six months.
We will indeed continue to monitor the FDA to ensure it continues to set the gold standard for protecting and improving Americans’ health and safety. Without concrete reforms that ensure accurate and independent scientific analysis, the FDA cannot fulfill its mission, and our health is put at risk.
Michael Halpern is outreach coordinator for the Scientific Integrity Program.
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