The agency is holding a two-day advisory committee meeting (here are the briefing documents) to look at clinical trial designs for contraceptives, specifically a more diverse pool of women. What the public doesn’t know is that women who smoke or are overweight or have heart problems often don’t make it into clinical trials.

The FDA is polite when it says this makes it hard to determine safety and effectiveness. To be direct, it’s unethical - such exclusions can make it impossible to know what these pills may do in a vast swath of the population. The FDA ought to mandate the widest possible mix of clinical trial subjects before approving any of these pills.

By the way, three of the panel members have declared conflicts of interest and at least two of them - Paula Hillard and Johanna Perlmutter - have ties to drugmakers that make contraceptive products, either in the form of research grants or speaking engagements.[tags]Birth Control, Clinical Trials, FDA, Wyeth[/tags]