On November 26, 2010, the medical journal, Human Reproduction, published online the results of a study by the Centers for Disease Control and Prevention (CDC), which found that the fertility drug, Clomid (clomiphene citrate), was associated with a significant increased risk for 9 different types of birth defects following use of the popular drug.
The implicated abnormalities included a 130% increased risk for anencephaly (open cranium with absence of a brain); a 130% increased risk for esophageal atresia (closed esophagus); a 120% increased risk for omphalocele (protrusion of part of the intestine through the abdominal wall); a 90% increased risk for craniosynostosis (premature fusion of the skull bones); increased risks for 3 different types of heart defects, ranging between 60% and 390%; and an increased risk of 340% for a defect of the brain (Dandy Walker malformation). The ninth defect (cloacal exstrophy) involves multiple defects of the gastrointestinal and genitourinary tracts, and the study reported a 440% increased risk for this severe congenital abnormality.
Drawing on 8 years of data from the National Birth Defects Prevention Study, CDC epidemiologist Dr. Jennita Reefhuis and her colleagues compared the drug's exposure to 36 types of birth defects with 6,500 live born babies born without major birth anomalies, used as controls. No less than 22 of the remaining 27 birth defect categories likewise showed an increased risk, ranging from 10% up to 170% after exposure to Clomid, although the numbers were insufficient to reach the scientific standard for "statistical significance."
The FDA is now faced with a dilemma which will be more difficult to side-step. The agency had previously ignored preliminary findings from the CDC study, which reported in July 2008 that exposure to Clomid was associated with an increased risk of developing 4 different types of birth defects - a list that has now grown to nine. The purported justification for challenging these findings was that they had not yet been reported in a journal.
But earlier studies appearing in peer-reviewed journals involving the same drug have likewise been ignored. These include reports of an increased risk of craniosynostosis in 2003 (Reefhuis, et al.); an increased risk of neural tube defects in 2004 (Medveczky, et al.); an increased risk of penoscrotal hypospadias in 2006 (Meijer, et al.); an increased risk of spina bifida in 2006 (Wu, et al.); and an increased risk of neural tube defects when ovarian cysts are produced by the drug, in 2008 (Banhidy, et al.). Since anencephaly (involving the cranium) and spina bifida (involving the spine) are both neural tube defects (NTDs), there are now 4 studies involving an association between Clomid and NTDs published in the last 6 years - none of which have motivated the FDA to require a warning.
In December 2007, a citizen petition was filed with the FDA demanding, among other things, that the regulatory agency require the manufacturers of Clomid and its generic to include a birth defect warning in the drugs' labeling. After sitting on the petition for a year and 9 months, the FDA denied the request. However, in October 2009, a petition for reconsideration was filed, citing multiple errors in the reasoning of the FDA's ruling. Fourteen more months have now passed without a final decision - a delay which has provided a window of opportunity for presentation of the recent findings by the CDC.
Will the FDA also ignore an official study by another branch of the federal government? After 43 years on the market, will the users of this popular fertility drug finally be warned about the potential risks to the babies they so desperately desire? Stay tuned, as this saga continues to unfold. For anyone interested in the debated exchanges over the citizen petition, I would encourage you to go to http://www.regulations.gov and enter the docket number of FDA-2007-P-0234. In addition to a debate over the science on the issue, these filings reflect an agency determined to maintain the status quo, rather than acquiesce to the mandate of federal law to require warnings of potential serious adverse reactions to drugs.
Time will tell whether the FDA is committed to protecting the general public or, instead, the interests of the industry it is required to regulate.
Terence Mix is a trial attorney who spent over 2 1/2 decades successfully litigating fertility drug cases on behalf of malformed babies. He is a former president of the Los Angeles Trial Lawyers Association and spent 12 years on the Board of Governors of California Trial Lawyers Association. He is a legal author and lecturer on trial techniques and strategies, including the trial of drug product cases, which was his specialty for over 30 years. He is a former biographee in Who's Who in California (1983) and Who's Who in American Law (1985). He has recently completed a nonfiction book: "THE PRICE OF OVULATION: The Truth about Fertility Drugs and Birth Defects - and a Solution to the Problem." During the course of researching the book, he reviewed in excess of 1000 scientific papers on the subject. He has also testified in front of the FDA on the topic of fertility drugs and birth defects. www.terencemix.com
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