PREGNANCY: Registries Examine Prescription Drug Use
In an effort to "fill in some of the sizable knowledge gaps about prescription drug use during pregnancy," federal agencies and organizations such as the American College of Allergy, Asthma and Immunology, are establishing registries, designed to collect data on pregnant women who take medication for asthma, epilepsy or other disorders. With less than 1% of all medications listed in the Physicians Desk Reference tested on pregnant women for safety, the need to secure such information is necessary. Next week, the FDA will hold the latest in a series of meetings to discuss registries and other means of evaluating the risks and benefits of taking prescription drugs during pregnancy, USA Today reports. Often, such studies are only conducted on pregnant animals. "It's very hard, ethically and morally, to test a drug" on a pregnant woman, Myron Lipkowitz, co-chair of the ACAAI's pregnancy committee, said, noting that animal studies are not optimal because "animal reproduction studies are not always predictive of human response." Anthony Scialli of Georgetown University School of Medicine added, "The prejudice that people have is that medicines during pregnancy must be bad."
Drug Companies Join In
Drug companies are also creating their own registries. Currently eight companies support a registry for antiretroviral drugs, operated by PharmaResearch, a contracted research agency. Five other drugmakers are supporting the Anti-Epileptic Drugs Pregnancy Registry, run out of Massachusetts General Hospital. Lewis Holmes, director of the latter registry with over 1,600 participants, said, "One of the strengths of our registry is we talk to a woman when she enrolls. She could tell us things she hasn't told her doctor." But other experts, while applauding their efforts, argue that drug registries "don't go far enough." Scialli said, "The companies feel that they're not entitled to get a lot of personal information," adding that some evaluations do not involve follow-up examinations. Further, some disorders are "too subtle to pick up." Scialli said, "These registries are difficult to do correctly. My hope is that ... companies will recognize they're difficult to do, and, rather than try to do them themselves, will come to groups like [ours]" (Rubin, 3/21).