Many would be surprised to learn that obese women are excluded from birth control trials. In today's society especially, obesity is an ever increasing statistic.
It is no wonder that an expert panel had recommended that the FDA impose the inclusion of obese women in future studies of birth control pills and other hormone contraceptives.
The FDA set up the Advisory Committee For Reproductive Health Drugs to investigate the recent rise in pregnancy rates in women using oral contraceptives. In the 1960s and 1970s pregnancy rates where 1 in about 100 women. Over the last decade the rate has been as much as 2 per 100 women.
While the reduction of the levels of hormones in the pills by the manufacturers to reduce side effects is one cause, the major contributor many experts believe is the rise in obesity in women and the lack of testing in such a group. Any changes in the FDA policy will not affect pills already on the market, but might impose challenges to drug candidates currently in clinical trials.
Especially of concern during the two day meeting on contraceptive drug issues are extended-dosing pills, which are intended for continued use and alter the frequency of the hormonal cycle.
Wyeth (WYE) for example, is holding its breath as any new standards imposed by the FDA could spell trouble for the company's drug Lybrel. If approved, Lybrel would eliminate the menstrual cycle during continued use.
Barr Pharmaceuticals (BRL) already has such a drug on the market but it reduces the hormonal cycle to few times a year.
The expert panel is also calling for improved studies of the side effects of hormonal contraceptives, and the implementation of comparative trials. Currently, most hormonal contraceptive trials pit the drug candidate against no use of any pills. The panel would like to see a new pill compared to an existing one on the market.
WYE vs. BRL 1-yr chart