GOP can't swallow safety of miracle pill

By the end of this month, we will know whether the University will be able to conduct research on the next miracle drug. Legal and proven safe in Europe, women have been using it with excellent results. Research on its use against disease is compelling. Endometriosis -- a disorder affecting as many as 20 percent of women -- shows great improvement on this drug in the latest foreign trials. The new drug has dramatically fewer side effects than other therapies. Its potential is enormous. The only problem is that this drug is Mifepristone. Mifepristone, commonly known as RU486, blocks the hormone that promotes pregnancy and results in medical abortion. It blocks progesterone at specific receptor sites, making it a much safer choice for hormone-related illnesses. Indeed, quite a few illnesses make excellent candidates for investigation with Mifepristone. Prostate cancer -- which affects all men who live long enough -- gynecological tumors and a multitude of other disorders await further clinical evaluation with this drug. Naturally, the primary use of Mifepristone, once approved, will be its most controversial. College women, who are most fertile around the age of 24, benefit from an increase in safe non-surgical options to end unwanted pregnancies. University researchers benefit by having permission to investigate a promising therapy. Even though the FDA is scheduled to decide how to handle RU486 by September 30, it is unlikely that clear provisions for broad research will be available, given our political climate. Although safety and efficacy have been well established for decades, Republican presidential candidate George W. Bush has publicly sworn that he will "never allow clinical trials of RU486." Bush is perhaps not aware that 15 clinical sites now study Mifepristone in the U.S., including Columbia-Presbyterian Hospital, the University of Rochester and sites in San Francisco, Atlanta and Cherry Hill, N.J. If elected, Bush will likely stop this research immediately upon taking office. In a rare instance of legislative interference with the drug-approval process, conservatives in Congress also oppose access. Why do Republicans try to block continued FDA clinical trial approval? Legislation such as the Coburn Amendment, which failed in the House over the summer, attempted to prevent all investigation of Mifepristone, a chilling example of political expediency at the expense of science. Bush and Congressional Republicans play by the numbers. A recent Gallup poll, conducted earlier this year, shows that 39 percent of Americans favor U.S. availability of RU486, compared to 47 percent who oppose availability. But any interpretation of a decline in public support must be reconsidered in light of the decreasing number of people aware of the issue. Gallup found that public awareness was lower today than it was in 1996 or 1993. But once women use the drug, they tend to agree that they would refer a friend to Mifepristone. And since the FDA allows only 15 clinical sites conditional access to the drug, a scant percentage of women have the opportunity to have a meaningful opinion for Gallup to gauge nationally. Those who argue that Republicans have no place in the decision to make Mifepristone available contend that the FDA should review the safety and efficacy data independent of politics. Recently, the FDA pulled drugs that were rushed to market under politically expedited provisions, only to find serious adverse effects with their use. Critics charged that the FDA was too influenced by large pharmaceutical companies, patrons that the safe -- though orphaned -- RU486 lacks. Oddly, the war over RU486 is a tempest in a teapot. Women who want to avoid surgical abortion have the ability to use "M&M;" -- a combination of methotrexate and misoprostol -- to end early pregnancy. What is the logic in having one pharmaceutical abortion option available in the U.S., but not another? Why are women expected to do without a choice of available treatments while men, for example, have immediate access to Viagra, a drug that has been linked to hypertension, stroke and mortality? The cost to women is obvious. However, the cost to Penn is enormous and needless. Foreign studies and certain U.S. institutions make significant scientific headway while patients and the University will continue to lose.

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