Tuesday, March 02, 2010

Drug Trials Should Not be done by companies

In this article, Dr. Krumholz, talks about the recent diabetes drug issues. He advocates for all drug data (after a drug is approved) to be in the public domain. This way, academic researchers can look at the data and see if there are lots of adverse effects, instead of relying on drug company documents.
Drug Companies Disappoint Me Again - Forbes.com

I would go a step further. As I've said before, I think all drug trials should be done by FDA-designated academic centers. First a drug company puts the drug through Phase 1 and Phase 2 trials. (These are early trials that figure out the dosing and initial safety.) Then the FDA takes over. The drug company pays the FDA to do the Phase 3 trial (the major part of the trial that tests if the drug works). The FDA contracts an academic researcher to do the trial and publish the results. The FDA uses that data to determine whether the drug gets approved. (I also would have the drug tested against a drug that works, instead of a placebo.)

This process still allows the drug company to do the initial development. It just protects the research from too much industry bias in the development. The drug company then still gets to make the profits after the drug is approved.

We need to separate the research from the industry, after a certain point. Without this, we will continue to have more drug recalls.
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