Plan B Shenanigans: The Politics of Doubt and the Responsibility of Medical Leaders

Posted on | December 1, 2006 | Comments Off on Plan B Shenanigans: The Politics of Doubt and the Responsibility of Medical Leaders

Last month, Frank Davidoff, M.D., editor emeritus of the Annals of Internal Medicine, and James Trussell, Ph.D., director of the Office of Population Research at Princeton, went public on the shenanigans surrounding the regulatory process to approve the emergency contraceptive Plan B for over-the-counter (OTC) use. Both had been members of an FDA advisory committee that voted 23-4 to approve Plan B for OTC use in December of 2003. They discussed the “long and contentious regulatory process” in the October 11 issue of the Journal of the American Medical Association.

Considering that the Plan B pill was not approved for OTC use until August of this year and it didn’t become available in drug stores until November, the authors of the article say they, like many others, were surprised by the FDAs extended period of inaction. In fact, the JAMA article clearly reveals that its authors had a lot to get off their chests.

At issue is the fact that there are some 3 million unwanted pregnancies in the United States each year — 25,000 are the result of rape and 1 million end in abortion. Plan B can prevent pregnancy, and the potential abortion, but it needs to be taken within 12 hours of intercourse. After that point, it loses 50% of its effectiveness.

In their commentary, Davidoff and Trussell vent their frustrations, pointing to outside influences who undermined the integrity of the FDA process. They express agreement with assertions that the entire fiasco was “a story of the entanglement of politics, science, and religious beliefs.”

What I found most interesting, however, was their discussion — highly relevant to other events at the governmental-science interface in our recent past — of doubt to undermine the scientific process.

Here’s what they had to say:

“… what has been offered are assertions that ‘the exact mechanism of action of Plan B is unknown’ and that ‘the dirty little secret is, nobody really knows.’ Such sweeping statements of uncertainty not only directly contradict the claim that Plan B’s anti-implantation action is ‘proven’ but also promote general misunderstanding and misuse of doubt in science. Doubt is the very core of the scientific enterprise, an essential part of the process by which scientific hypotheses are tested; on the other hand, doubt is sometimes exploited as a powerful way of subverting sound science-based public policy. Driven by the belief by some that interference with implantation is a form of abortion, the politics of doubt about Plan B’s contraceptive mechanism appears to have contributed not only to the delay in its OTC availability but also to the continuing refusal by some emergency services to provide the drug to rape survivors as well as refusal by some pharmacists to make it available to individual patients.”

And all of this, I believe, is true. But I would add this: That when the story of science in the U.S. between 2000 and 2006 is written, it will recount the deliberate use of misinformation for political purpose to undermine the scientific process for a wide variety of reasons. But it will also catalogue that such action was enabled by tentative leadership within the scientific and medical communities in academia, industry and government, and that the voice of resistance was so faint as to be barely audible.

Davidoff and Trussell signal, along with courageous leaders from NASA and elsewhere, that we are at last awakening from our long sleep.