Can Thousands of Patients Complain More Loudly Than Sidney Wolfe?


As the flat-chested masses await a final decision on silicone implants, BusinessWeek notes that moving patient testimony, such as that offered up in favor of IBS treatment Lotronex, can be an important factor in convincing the FDA to reverse bans or not impose them in the first place:

Outspoken patients can be a potent force, heavily influencing whether a drug or medical device stays or is pulled from the market. Hundreds or even thousands of individuals frequently lobby the FDA for a given product—even one with life-threatening side effects—because they believe it is the only thing that works for them.

That puts the agency in a difficult spot. Although it's under pressure from Congress to be more diligent about policing serious drug side effects, the FDA is also beseiged by patients eager to take such risks.

But in offering up their pleas, patients who have come to rely on certain drugs face off against groups that purport to represent patients themselves:

Such lobbying often puts patients at odds with watchdog organizations meant to look after their interests. The consumer group Public Citizen labeled the Lotronex decision "a serious public health mistake," and it is just as opposed to the Cox-2 drugs, Iressa, and silicone implants.