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...
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.