Friday, July 09, 2004

Plan B and the FDA. An Insider's Report

The FDA does not approve over-the-counter (OTC) status for Plan B, and Drs. Charles Lockwood, Chair, Department of Ob/Gyn, Yale U School of Medicine, and Michael Greene, voting members of the FDA's Reproductive Health Advisory Committee, comment:

On May 7, the FDA issued a "Not Approvable" letter in response to Barr Pharmaceuticals, Inc.'s request for OTC status for its emergency contraceptive (EC), Plan B. This occurred despite overwhelming evidence of the product's safety and potential for reducing the number of abortions in the Unites States. As voting members of the Reproductive Health Advisory Committee, we were incensed and deeply disappointed by the decision but not entirely surprised, given the recent track record of the current administration.

Of course, you already knew that. A bit more medical background on Plan B:

[I]t reduces pregnancy rates from 8% to less than 1%, and to 0.4% when used within 24 hours of unprotected intercourse.
Right now the biggest drawback of all the ECs is that they require a prescription. In most cases, that means the woman must schedule an outpatient visit with her physician or make an unplanned trip to the emergency room. Having to contact a provider is inconvenient, expensive, embarrassing, and can prevent or delay a woman from starting the EC, which only increases her risk of an unwanted pregnancy. Despite these obstacles, prescription-based ECs have already reduced the number of induced abortions in the US by an estimated 51,000. Given that there are 3 million unwanted pregnancies and nearly 1 million abortions in this country each year, readily accessible and inexpensive ECs could prevent hundreds of thousands of induced abortions each year.

Now we leave the planet of Sciencia, and move right along into Politica galaxy:

We reviewed an enormous mass of material on Plan B. In two separate votes, the joint committees unanimously agreed 28 to 0 that the data showed the product was safe when used in an OTC setting and wouldn't encourage women to substitute emergency for regular contraception. We then voted overwhelmingly (23 to 4) to approve Plan B for OTC use, a conclusion that was also supported by the FDA's staff.
In an extraordinarily unusual decision, Dr. Steven Galson, Acting Director of the FDA's Center for Drug Evaluation and Research, overturned the recommendations of the joint committee and his own staff in issuing the "Not Approvable" letter. He based his decision on the fact that the sponsor's application contained no data on subjects under 14 and very limited data on the use of Plan B by adolescents aged 14 to 16.

And this is how medical decisions that affect your (and by "your" I mean exclusively women's) health are made:

What was behind this decision? The FDA never asked our committee to consider whether OTC use of Plan B by girls under age 16 should be restricted. During deliberations, the few opponents of approval voiced concerns about whether OTC availability would reduce condom use and opportunities for physicians to counsel sexually active adolescents and would increase risk of sexually transmitted diseases and adolescent sexual activity. Despite these concerns, they voted with the majority (28 to 0) that the data available from actual trials did not demonstrate these effects. Indeed, the FDA does not restrict access to Tylenol because a woman may delay seeking a physician's care for her brain tumor by self-treating her headache.
While we have no objective evidence that Dr. Galson's decision was politically motivated, his arguments mirrored those of more radical elements of the pro-life community. Moreover, the joint committee members know that unprecedented pressure has and is being brought to bear against the FDA approval by a small cadre of conservative congressmen, led by U.S. Representative David Weldon, MD (R-FL). In a press release, he stated, "As a physician, I have witnessed how patients treat themselves at the pharmacy with little knowledge of the potential health risks of their treatment of behavior--particularly sexual activity. Since adolescents are most vulnerable to STDs, anything that would create an enhanced perception of safety regarding this inherently dangerous behavior is bad public policy. It would leave physicians out of the treatment loop and could exacerbate the already epidemic level of STDs, including HIV/AIDS and HPV [Human Papilloma Virus]." Weldon then issued a letter to President Bush, signed by 49 like-minded colleagues. Aside from the obvious paternalism, the congressman's assertions are bereft of data, but not of political implications for an administration desperately trying to hold on to its conservative base.

We find it offensive that religious ideology and partisan politics have been introduced into the decision-making process regarding a public health issue. Those that oppose OTC status for Plan B have taken a position that defies logic. Whether someone is pro-life or pro-choice, how can he or she oppose a measure that would reduce the need for abortions? Moreover, anyone who thinks that maintaining the prescription status of Plan B will somehow stem the tide of teenage sex or increase chastity is hopelessly naive. Rates of teenage pregnancy and abortion have fallen steadily over the past decade, in part, because of increased access to contraception.

Finally, this action is a flagrant example of the intrusion of religious ideology and conservatism activism--enveloped in a thin veneer of pseudoscience--into what should be a scientific and empirical examination of the evidence by an objective, secular, and unbiased expert government advisory committee. Dr. Galson's action is just the latest in a disturbing pattern by the Bush administration of altering the membership or dismissing the opinions of government committees--and if all fails, disbanding them altogether when their conclusions run afoul of partisan political or conservative ideological positions. Regular readers of Contemporary OB/GYN's editorials know that congressional Democrats have stone-walled tort reform. While the Bush administration is our steadfast ally on professional liability, its recent actions on reproductive health issues create a real dilemma for America's ob/gyns come November.

On a happier, technical note, I figured out how to indent. Now if I can only decipher the mystery of posting tables and pictures, I could really delight you with some great pics of birth control methods.

Lockwood CJ, Greene M. Playing politics with women's health: The FDA and Plan B. Contemporary Ob/Gyn. 2004 Jul;49(7):11-15

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