Fellow Lab Rat

One last whine about the FDA in 2008? Thanks. In addition to actually killing Americans with bad policies, impeding science, and reducing investment in biotech, the FDA approvals process also forces rules that directly interfere with participants' treatment.

Fellow lab rat, Gideon J Sofer has a guest editorial in yesterday's WSJ that spells it out:

Under the Fifth Amendment's guarantee that "No person shall be deprived of life, liberty or property without due process of law," a critically ill patient should have access to a potentially lifesaving drug that has been deemed safe for human consumption, if the patient agrees to bear the risks involved. But earlier this year, the Supreme Court refused to hear a case on the issue, denying countless patients their right to pursue life.

FDA rules have a scientific foundation, but the slavery to the double-blind study needlessly interferes with self-directed treatment. Sofer suffers from Chron's Disease and his life is under threat. I suffered the same fate. If my case is less severe, it's not really less severe to me.

I was surprised -- though I should not have been -- when I completed a three-year clinical trial, I was not allowed to discover what treatments I had received over the trial. The drugs I took are now commercially available and it might have made sense for me to try something that I took in placebo form or a very low dose.

I read a great article in Reason that complained that the rules are stacked to provide a good supply of desperate people for clinical trials. I don't think that's the plan but it is a consequence that feeds back into the system. Hey, you can die or you can participate in this trial is pretty compelling.

When you're done, thanks for your time but don't expect any information that you might use to select future treatment. We're the FDA and we have a public to protect!

Posted by John Kranz at December 31, 2008 9:01 AM