The NYTimes reports today on an upcoming HHS OIG (Health and Human Services Office of the Inspector General) report among other things audited less than 1% of clinical trial testing sites. When they did show up it was usually after the trial was finished. The worst part of it is, when the inspectors did find problems, they rarely followed up to make sure that the sites had complied with the information.
This reminds me of the inspectors on the food side. You may remember the story about them going to the peanut butter plant and asking for documents and when the company (ConAngra, I believe) refused, they just left. The NYTimes gives a similar story for the drug side. Sure, they need more inspectors (the number has been declining while the need has been growing), but in the meantime they’ve got to stop pussy-footing around with the investigators. If an investigator refuses to hand over documents, he should get a letter from an FDA attorney within a week. If there is a problem that is found, it should be the top priority to check up on that investigator. There’s no point in even doing investigations if those being investigated believe there aren’t any consequences.
PS The IG’s report comes out today. You can get it off of their site. From the looks of their splash page, they are hiring people from the 80s. Psst, they’re called stock photos. Okay, it’s better than DOT’s. Maybe they can’t look as stylish as NASA’s IG, but they could at least be like the classy USDA.
PPS A couple of people have e-mailed me/talked to me about the thimerosal study that came out yesterday. I’m only part-way through reading it. I’ll post on it tomorrow, but it looks pretty solid so far (i.e. no thimerosal shot-neurotox link for the parameters studied).