Commentary—

Leave The Science To Scientists At FDA

By Dr Francesca Grifo

 At one time in America, people were sold elixirs and tonics that unscrupulous salesmen promised would cure all of their ills. In truth, these “medicines” often contained opium, cocaine, grain alcohol, and, in some instances, uranium. Luckily, the federal government intervened and in 1906 passed a law that would eventually lead to the creation of the Food and Drug Administration (FDA). Its mission was “helping the public get the accurate science-based information they need to use medicines and foods to improve their health.” But 100 years later, recent events suggest the agency may be compromising that mission.

In 2006, my staff at the Union of Concerned Scientists (UCS), along with Public Employees for Environmental Responsibility, distributed a 38-question survey to 5,918 scientists at the FDA, asking them to comment on management, professionalism, independence, candor, and job satisfaction at the agency. Their responses document significant interference with the FDA’s scientific work and dissatisfaction at the agency. In fact, 497 respondents disagreed with the statement: “The FDA is moving in the right direction.” 

This is bad news for the American people, who spend 25 cents of every dollar they earn on products the FDA monitors. This year alone, the Department of Health and Human Services Inspector General, the United States Government Accountability Office, and the United States House of Representatives Committee on Government Reform have all issued reports calling attention to problems raised by our survey results. 

Hundreds of survey respondents described their lack of faith in agency leadership: 561 FDA scientists thought their managers did not stand behind their work when it was politically controversial, and 427 did not respect the integrity and professionalism of the FDA leadership. Several well-documented instances of inappropriate interference with drugs like antidepressants, Vioxx, Plan B, and Ketek give ample justification for such low morale and have dire consequences for our health. 

Respondents described an agency culture that ignores scientific data and prevents scientists from effectively doing their jobs; 378 scientists thought that the FDA is not effectively protecting public health. To be effective, FDA scientists must be allowed to present their data in an environment that values the truth, regardless of its political or commercial consequences. But 357 survey respondents felt they could not openly express any concerns about public health inside the agency without fear of retaliation. That must change. 

Safeguards must be put in place for all government scientists who speak out. FDA leadership must make certain that advisory panels making decisions at the agency are truly independent and that the experts who serve on those panels are free of ideological or commercial conflicts of interest. Additionally, the public should have free and open access to the FDA’s scientific research and its panels’ recommendations. 

A century ago, our government created the FDA to protect us from elixirs and snake oil. Today, products from pharmaceuticals to sunscreens require vigorous scientific testing to verify their safety. Without reform and strong leadership, the FDA cannot fulfill its mission, and our health is put at risk.

(Dr Francesca Grifo is senior scientist and director of the Scientific Integrity Program at the Union of Concerned Scientists. UCS is an independent nonprofit alliance of 50,000 concerned citizens and scientists across the country. )