The fight over experimental drugs

Some thoughts on an interesting piece in today's USA Today. Buried way down in the middle of the piece is the real news: that...

Some thoughts on an interesting piece in today's USA Today. Buried way down in the middle of the piece is the real news: that an imminent ruling from the US Court of Appeals for the District of Columbia could dramatically change the access terminally ill patients have to potentially life saving treatments.

There are, of course, a number of risks associated with this possibility. The Food and Drug Administration says that easier access could shorten lives just as easily as lengthen them. But here's the tidbit that caught my eye:
If the FDA loses the lawsuit, "companies could come along and sell false hope to patients," says Allen Lichter, CEO of the American Society of Clinical Oncology (ASCO), which submitted a "friend of the court" brief in February siding with the FDA.


This is not a nice accusation obviously. And it also doesn't seem to play out if you weigh the pros and cons from a communications standpoint. First, a drug company would have little to gain by providing small numbers of patients access to drugs before they've been approved by the FDA. There's nothing there that good results of a clinical trial doesn't already provide. Second, the companies could potentially find themselves in a more hazardous situation since the drug now exists outside the controlled environment of the trials.

Pharmaceutical Research and Manufacturers of America (PhRMA), the prescription drug industry's main trade group, has come out against improved access, saying that it could hamper clinical trials. Should the court rule in favor of improved access, it will be interesting to see how PhRMA and the FDA respond.

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