6 January 2012

At the President’s Council of Advisors on Science and Technology (PCAST) bi-monthly meeting today, 5 representatives from different sectors in the reproductive health community addressed the Council on the topic of the overrule of the FDA’s decision on the safety of the Plan B pill. Each speaker had just 2 minutes to present their comments during the public comment period.

Kelly Cleland, Executive Director of the American Society for Emergency Contraception, said that the over-the-counter availability of Plan B offers great potential benefit to women. It allows them to get the right medication when they need it to avoid unwanted pregnancy. It would remove barriers to this need by easing the embarrassment or delay that is often involved in seeking a prescription from a pharmacist. Knowing the proven safety of Plan B, Ms. Cleland said she was profoundly disappointed when she learned that politics was chosen over science in the decision of the Secretary of Health and Human Services, Kathleen Sibelius.

Susan Wood, Associate Professor at the Jacobs Institute of Women’s Health, George Washington University School of Public Health and Health Service, reiterated that, since 2004, studies have proven that Plan B is very safe. Despite the overwhelming agreement of scientists about its safeness, politics has intervened once again.  What seems particularly dangerous about Secretary Sibelious’s decision, said Dr. Wood, is that it claimed to be a data-based judgment. This sets a bad precedent for public health in other areas of scientific enquiry too.

Doug Laube, Board Chair of the Physicians for Reproductive Choice and Health (PRCH), said that PRCH is deeply disappointed by the decision on Plan B. It has only very small risks and small side affects. Physicians often recommend it knowing that comparatively it is safer than even Tylenol. Secretary Sibelius’s decision had an unscientific rational that was based on political concerns. Dr. Laube finished by saying that he hoped that PCAST will push for better recognition of scientific integrity guidelines in future.

Wayne Shields, President and CEO of the Association of Reproductive Health Professionals (ARHP), said that ARHP has over 12,000 members and that its job is to translate research into clinical practice. But ARHP and other advocates of reproductive heath have found themselves in a collective moment of cognitive dissonance as a result of Secretary Sibelius’ decision, after President Obama had earlier promised to restore science to its rightful place.

Francesca Grifo, Program Director of the Union of Concerned Scientists Scientific Integrity Program, commented that it is a sad state of affairs that while many government agencies have written scientific integrity policies, few have actually released them. The action by Secretary Sibelius was unusual in that it was a decision against science from outside of the FDA rather than within it. The language that Sibelius used in justifying the overruling, such as “my review” also marks a particularly dangerous precedent.

A video of the event will shortly be available at http://www.tvworldwide.com/events/pcast/120106/.

Alex Ingrams
SPSSI Policy Coordinator