5/4/06 News Release

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Susan Wood quit a top government job to protest how scientific analysis was overruled in health policy decision

STANFORD, Calif. — Last summer, when top officials at the U.S. Food and Drug Administration overruled the advice of their professional staff and declined to grant over-the-counter status to Plan B emergency contraception, Susan Wood, PhD, made the ultimate protest: she resigned her position as the director of the FDA Office of Women's Health.

On May 10, Wood will be at Stanford University School of Medicine to discuss her decision and the FDA’s increasing reliance on ideology over science. The free public event, which will be held at 6 p.m. in M104 of the Alway Medical Building at the medical school, is being sponsored by Women’s Health @ Stanford. In the Q&A below, Wood provides a preview of her talk.

 

Q: Have you had any second thoughts about walking away from the FDA?

Wood: No. The thing I miss most about the FDA and the federal government is the dedicated colleagues whom I left behind. I wish I didn’t have to do that. But I feel it was the best decision for my own credibility in terms of science and public health. It was not a tenable situation.

 

Q: What was so egregious in the FDA’s handling of Plan B?

Wood: The scientific and medical evidence was ignored. The process and the professional staff at FDA who are normally counted on were completely overruled and at certain points completely cut out from discussion. Also, the decision was clearly not in the best interest of women and families.

Q: You’ve said that the religious right has hijacked the FDA. Are there other examples aside from the Plan B controversy?

Wood: The case people have been asking me about lately—which I hope winds up not being a similar case—is the HPV vaccine against cervical cancer. The same people who opposed emergency contraception also oppose the HPV vaccine because it will counter the abstinence message. The issue is pending before the FDA, and the Centers for Disease Control and Prevention is also looking at it. The decisions are due in June. I’m reasonably hopeful that the scientists at FDA will be allowed to do their job properly, and the decision will be made based on the evidence. But I do worry.

 

Q: Since your resignation, have you seen any evidence of positive changes at the FDA?

Wood: No. Unfortunately, what I’m seeing is that things that aren’t controversial at all are being deemed controversial. What was pending before the FDA in August 2005 was simply timely access to safe and effective contraception for women 17 or older. This is not a controversial subject: the vast majority of people in the United States—regardless of religion or belief—use contraception and support its access. It’s astonishing to me that we’re even having this debate.

The issue isn’t just about contraception: It’s about the credibility of the entire agency and its ability to make its decisions on science. We’re putting the agency’s credibility at risk because of something as simple and uncontroversial as emergency contraception. It’s stunning to me that this is the issue that would overthrow the FDA’s process and independence.

 

Q: The dean of the medical school was recently nominated for a White House panel, and during the interview process, he was asked about his political views and affiliation. What do you think of the administration’s vetting of its scientific advisers? 

Wood: I’m appalled. He’s not the only one—I’ve heard of similar people going through interviews and being stunned by the types of questions being asked of them, in a way that seems significantly different from those posed to people who were appointed in the past. We’ve seen appointments at FDA and CDC that seem to be based on ideology, not scientific expertise. We have also seen people not being allowed to be on committees because they don’t have views consistent of administration, though those views have little or nothing to do with science or medicine. This is something the scientific community needs to be aware of and express concern about.

 

Q: You’ve been encouraging scientists to fight against what you call the organized assault on science. But traditionally scientists have been above the fray. Why should they speak out and how is it going to make a difference?
Wood: Scientists and health professionals need to speak out because the FDA has an extremely broad scope of responsibility: drugs, devices, vaccines, etc., and they need to be able to count on information provided by the agency. The debate that health professionals have with the FDA should be on scientific levels—how to interpret data—not on other issues.

Scientists need to take a moment out of their busy schedules and push back and say, ‘We don’t expect our federal agencies to operate like this.’ I believe doing that and broadly disseminating information and knowledge is the best way to restore the independence of the FDA and other science-based agencies.

 

Q: Will the new acting commissioner, Andrew C. von Eschenbach, approve the application to give Plan B over-the-counter status?

Wood: I am not hopeful that emergency contraception will become OTC anytime soon. If the usual regulatory process that this decision is now in goes forward, it will take years to complete. Given that Dr. Eschenbach’s appointment [to permanent status as commissioner] is being held up in Congress over this issue, anything is possible. I don’t know if Dr. Eschenbach will resolve the question in either direction. I can’t predict what he’ll do.

 

Q: Many of your colleagues continue to work at the FDA and have, at least for the moment, chosen not to follow in your footsteps. Is it irresponsible for them to stay there? Do you think they're able to influence any decisions being made?

Wood: Although they are not able to influence the outcome of the Plan B emergency contraception decision, I admire them for staying, and I appreciate the hard work they do. The nation’s safety depends on the people at FDA, and we need competent dedicated scientists and health professionals to be on the staff.

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