Pharma companies: Damned if they do, damned if they don’t
From the Washington Post:
Five lawmakers asked the Government Accountability Office to investigate drug regulators’ acceptance of studies comparing experimental medications with approved products in deciding on approvals…”These studies — which were used to approve the antibiotic Ketek — are dubious because they don’t provide any evidence that a particular drug is any better than nothing at all,” said Sen. Charles E. Grassley (R-Iowa).
The report in the Post is very brief, and I don’t have the full contents of the letter, but it seems like a weird complaint. A more common complaint is that pharma companies test their new drugs against a placebo, which just proves that the drug is better than nothing. They then go on to promote the new product, which is still under patent protection, and prescribers are left in the dark about whether the new drug is better than drugs already on the market. Often it takes a government funded study to generate meaningful head-to-head clinical comparisons.
I don’t know the details of the Ketek studies Grassley refers to, but if Ketek worked better than a drug that was already shown to work better than a placebo, then we can say that Ketek worked better than a placebo.
I’m assuming there’s something more to Grassley’s argument than what was reported in the Post, but there’s nothing about it on his website. I’m going to send his office an email and see what they say.September 8, 2006