Attorney Says CDC Study on Birth Defects Implicates Popular Fertility Drug

The implicated abnormalities included anencephaly (open cranium with absence of a brain), esophageal atresia (closed esophagus), omphalocele (protrusion of part of the intestine through the abdominal wall), craniosynostosis (premature fusion of the skull bones), 3 different types of heart defects and a defect of the brain (Dandy Walker malformation). The ninth defect (cloacal exstrophy) involves multiple abnormalities of the gastrointestinal and genitourinary tracts.

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 those of 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."

Recalling his early efforts, Mix expressed his frustration. "I was winning most of the battles," he said, "but not the war." The trial attorney had recently won a big verdict against the manufacturer of the drug, and following a series of letters to the FDA, he had been invited to make a presentation before the advisory panel. Within a month after the hearing, the drug company had been ordered to conduct further clinical studies to evaluate whether the use of Clomid involved an increased risk of birth defects. But the studies were never initiated. Eight years later the FDA requested that a birth defect warning be included in the drug's package insert. This request was likewise ignored. "I was somewhat naive at the time," Mix said. "I thought that when the FDA issued a request or an order to a drug company that it would be enforced. Unfortunately, as I later learned, when it came to addressing resistance by its regulated industry, the agency had more bark than bite."

Other efforts over the years met with similar results, which led the lawyer to write a book. After 3 1/2 years of research and writing, "The Price of Ovulation" (Tendril Press) was released in 2009. Winner of 7 national book awards, the book captures Mix's 35-year battle to bring the birth defect risk to the attention of the general public, while revealing what goes on behind the scenes in the drug industry and how a company can conceal the results of adverse studies and manipulate the FDA. It also recites numerous incriminating studies involving Clomid and other fertility drugs ignored by the FDA, some going as far back as 1973.

During his research on the book, Mix made a startling discovery. "I was reviewing scientific papers over the internet one evening, when I learned that depriving an embryo of cholesterol during early pregnancy can by itself cause a number of different birth defects. This was one of those jaw-dropping moments," says the lawyer, "because I knew that one of Clomid's side effects was to impair the body's production of cholesterol similar to the action of statin drugs, such as Lipitor. I had discovered the causal link - the actual biological manner in which Clomid was causing birth defects." Not only does Mix explain this discovery and phenomenon in the book, he also proposes a means of offsetting the risk of birth defects posed by the drug. "Similar to the way folic acid is used to offset the risk of neural tube defects and other birth anomalies, this method has the potential of eliminating thousands of birth defects, including those occurring with natural conceptions."

The lawyer is hopeful that this new study will have an impact on the FDA. "To date, the FDA has turned its back on several published studies showing an increased risk of birth defects following the use of Clomid," he laments. "In fact, the current labeling on the drug suggests that the premarket studies show that the drug is completely safe for the unborn baby. But given the size and importance of the CDC study, and the fact that it was conducted by an arm of the federal government, might just catch its attention. After 35 years of frustration, maybe now it might just happen."

Terence Mix is an attorney/author who writes about drug safety and reform of the FDA and drug industry. For additional information, please contact him at terry@terencemix.com or visit http://www.terencemix.com.

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