Pharm Exec Q&A: Inside View

Sep 30, 2006

AS IF FDA DIDN'T FACE ENOUGH TOUGH CRITICISM last summer: The Union of Concerned Scientists (UCS) added to the agency's distress with new and troubling revelations about FDA's own scientific culture. UCS, an environmental group with about 100,000 members, asked the agency's staff scientists about scientific independence, professionalism, management, and outside interference at FDA. UCS sent surveys to almost 6,000 FDA scientists. Nearly 1,000 mostly senior staffers responded. Turn the page for the grim results...

  • Three of every five respondents said they knew of cases in which political appointees from the Department of Health and Human Services or FDA "inappropriately injected themselves into FDA determinations or actions."
  • Only 47 percent agreed with this statement: "FDA routinely provides complete and accurate information to the public."
  • Four in five agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."
  • The full results of the survey (available at http://www.ucsusa.org/) are a bit more nuanced, but they still suggest that the agency is deeply divided and suffers from sagging morale.
  • When asked how often FDA scientific documents and reports rely upon the best available science, just 77 percent said always or frequently. Only 73 percent gave similar answers when asked whether FDA determinations and actions are consistent with the scientific findings contained in FDA.
  • Two thirds said they've never been asked, for non-scientific reasons, to inappropriately exclude or alter technical information. Another 18 percent say the question is not applicable.
  • About half said they knew of at least some cases when commercial interests have "inappropriately induced or attempted to induce the reversal, withdrawal, or modification of FDA determinations or actions."
  • Similarly, more than 60 percent of respondents said they did not know of cases in which "members of Congress have inappropriately injected themselves into FDA determinations or actions" or that the question was not applicable. It's a number that's difficult even to comprehend in a year when Plan B was seldom out of the news.

In addition, respondents were invited to provide their opinions in essay form. About half responded, many of them passionately. (For excerpts see.)

To find out more about the survey, Pharm Exec's associate editor, George Koroneos, recently spoke with Francesca Grifo, director of scientific integrity program at UCS. What follows is an edited transcript of the conversation.

Pharm Exec: Can you tell me a little bit about the history of your organization?

Grifo: We were founded by a group of MIT professors in the late 60s. They were concerned about nuclear security issues and wanted to make sure the science was really being taken into account. And that's pretty much what we do: Try to get the science into public debates.

The scientific integrity program was founded in response to a lot of the changes in the executive branch. Scientists across agencies and on advisory committees and in the community came to us. A group of 16 Nobel Laureates and National Academy members wrote a statement, which is on our Web site, objecting to the current manipulation of science. Out of that we began a campaign, and this year it was changed into a full-fledged program at UCS.

What was the catalyst for the US Food and Drug Administration Scientist Survey?

A number of scientists came to us about problems they were encountering at FDA, and we began to wonder if they were more pervasive than the anecdotal examples that we were getting. We have done surveys of other federal agencies. We did one of Fish and Wildlife Service and one of NOAA Fisheries. And we have others that will be coming out next year. We like them because they give us a snapshot of the agency.