Okay, I’m going to open a can of worms, and I’ll need the commentors to help me with this one.
Last week, Professor Richard Epstein of the University of Chicago School of Law published an oped in the Wall Street Journal. Epstein’s a charming fellow, and I like him, but I wouldn’t want to live in a world where he is in charge of things! Most of the article discusses pharmaceutical regulation and the changing winds in Congress. But he ends with this whopper, which isn’t really even related to his main argument, and exposes the Journal’s editorial excess:
But neither Congress nor the FDA has mastered the fundamental lesson of risk analysis. Keeping drugs off the market deprives all informed
patients the opportunity to correct FDA errors. Letting new drugs on the market leaves individual patients the option to decline their use. In the long term, Congress must wean the FDA from its misapplied “first, do no harm” principle, which causes far more harm than it prevents.
Wow! Where to start (commentors, help me here!)? Like, maybe with history? As in, didn’t we try that approach? Isn’t the altie med market a great example of how even informed people waste money and try potentially dangerous treatments in a less-regulated market?
Anyway, Epstein suggests that perfectly informed individuals will make perfect choices in this best of all possible worlds. I guess that’s an argument. But what’s even more interesting is that in yesterday’s Journal, Saying No to Penelope tells the story of a 4-year-old girl who cannot get an experimental cancer treatment. Guess who’s the boogeyman? The FDA? No! It’s safety, but it’s also the market. That most perfect of perfect perfections is denying a little girl her treatment. There ought to be a law!
For the past month, Mr. London [Penelope’s father] has been begging a small biotechnology firm to allow Penelope to be treated with an experimental cancer drug that might help. Mr. London has received high-powered support: Several legislators, including House Speaker Nancy Pelosi, have lobbied the company and its board to make the drug available. The Food and Drug Administration isn’t blocking the way.
Neotropix Inc. of Malvern, Pa., says it would like to help, but the drug may not be safe for a child and dispensing it would be bad business. “For us to provide the drug to this child would be to put at significant risk a small company with limited financial resources,” says P. Sherrill Neff, managing partner of Quaker BioVentures, a major investor in the firm, which is trying to tie up a vital round of financing of about $20 million. “You could delay the opportunity for lots of patients to get this drug if you sidetrack it for one patient,” he says.