To
I read an interesting article in the New York Times a few days ago (Where Cancer Progress Is Rare, One Man Says No. September 15th, 2009), which talks about the possibility that the FDA is over-regulating cancer drugs.
Reading the article got me thinking: When dealing with a disease like cancer, which in many cases is fatal, should the FDA be more lenient while approving drugs to treat cancer? The rationale behind this is that, people who have cancer already suffer from the terrible manifestations of the disease, so what’s the harm in giving them drugs which may have terrible side-effects and which may or may not cure their disease? To these patients or to their families, they have nothing much to lose.
My take on this:
The FDA is one of the most reputed regulatory agencies in the world. It has certain standards that it adheres to, no matter what. If the FDA started approving drugs, just because these drugs treat terminally ill people who may not live in any case, the agency would lose its credibility. Why should the FDA single out only cancer patients? Can’t an extremely obese people ask the FDA to approve drugs that help you slim down, even if these drugs may wreck havoc on the liver and kidneys? What about Alzheimer’s patients? They are generally headed down a dead end street. My paternal grandfather has a condition very similar to Alzheimer’s. I would love for regulatory agencies to say: Well, these people have nothing to lose. Let’s just approve the drug and hope for the best. No, it doesn’t really work that way.
The other drawback is that, if the FDA were to approve these drugs and if something went wrong, as with Rofecoxib, Nimesulide, or Thalidomide, nobody would remember that the FDA approved these drugs(I’m talking about hypothetical drugs which could be approved in the future because of pressure from patient advocates) because of public pressure. The outcome of this would be lawsuits, lawsuits, and more lawsuits.
The FDA may not always make the best of decisions but on this subject I stand by them.
Subscribe to:
Post Comments (Atom)
This is a hard issue and I can see both sides of it. I know that the FDA has a "fast-track" process for approving certain drugs and I believe that drugs for cancer indications fit into that category. However, it may be that patients who are sick with terminal cancer will get even sicker from drug side effects. So even though they have "nothing to lose", experimental drugs may further shorten the little time that they have remaining.
ReplyDelete