Today's Wall Street Journal contains an excellent editorial, "The FDA and Slower Cures," that points out the irony of a government that wants more new drugs (badly enough to get itself into the business of research and development, at taxpayers' expense) and yet does so much, via the FDA, to make it impossible for the pharmaceutical companies to offer any kind of real innovation.
The editorial follows the story of pixantrone, a drug for patients with an advanced form of lymphoma -- a drug doomed, not because it doesn't work, but because the FDA doesn't like the way the clinical trial used to prove that the drug does work was conducted. Says WSJ, "The Catch 22 is that if a trial deviates from protocol, even with such impressive real-world results, it becomes more difficult to generate the 'proof' beyond any doubt that the FDA requires." In other words, the drug is guilty until proven innocent -- and the result is that people who are dying don't get to decide for themselves whether to take a chance on a new drug.
As WSJ says, "The real victims" of this policy "are the patients with no attractive options who needlessly suffer when the government delays drugs like pixantrone." Too true. I submit that all of us are deprived, not just patients who have run out of options to treat a fatal disease. We have no idea what kinds of cures and therapies for all manner of ailments, from mild to serious, could have been developed if the FDA would just get the hell out of the way.
Monday, February 28, 2011
Subscribe to:
Post Comments (Atom)
0 comments:
Post a Comment