The last of the DES babies are about to turn 40, and the two senators from Massachusetts wanted the US Food and Drug Administration to finally apologize for allowing the drug, diethylstilbestrol, to be prescribed to pregnant women to prevent miscarriages. In a Tuesday letter addressed to Senators John Kerry and Scott Brown, the FDA declined to do that but did acknowledge that the DES debacle was a "tragedy," citing the litany of health problems caused by the drug.
DES was on the market some 30 years before Massachusetts General Hospital researchers published a report that for the first time sounded warning bells: daughters born to mothers who took DES were developing rare vaginal cancers at much higher than expected rates. Since then, DES has been linked to higher rates of breast cancer in women who took the drug when pregnant, and a multitude of problems in their offspring.
Adult women whose mothers took DES are more likely to be infertile and are at higher likelihood of developing vaginal and cervical cancers. Adult men born to DES mothers are more likely to develop benign cysts on their testicles.
Both Brown and Kerry said in statements today that they were pleased by the FDA's acknowledgment of, well, not guilt or responsibility for DES but the fact that the drug had such a devastating impact on many of the 5 million to 10 million people who were exposed to it.
I'm not sure what the agency achieved by stating the ridiculously obvious.
Still, towards the end of the letter, the FDA outlines how it's trying to improve its system of monitoring for adverse drug events after medications hit the market. Instead of passively waiting for doctors to report problems, the FDA is in the process of implementing an electronic system for monitoring medical records to see if, say, an increase in heart attacks has occurred in patients on a particular drug.
Last summer, the agency began scanning anonymous electronic health records from 25 million patients and by July 2012, it will be scanning the records of 100 million patients. The FDA says it hopes "that our newer tools for identifying, monitoring, and mitigating drug risks will prevent other tragedies like those brought about by the widespread use of DES."
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