Angry Toxicologist

Get a friggin’ backbone, FDA

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).

Comments

  1. #1 Anna
    September 29, 2007

    The FDA doesn’t do what they are supposed to do because they are too busy harassing family farmers who sell raw milk to consumers who want it. I find it interesting that the FDA seem to have loads of time “protect our health” from raw milk yet raw milk (when produced cleanly from pastured herds – not grain-fed – and intended for raw consumption – not for bulk co-mingling and pasteurization) is very safe and there are few, if any, health issues caused by it (though there is a whole lot of propaganda about it that is not based in facts). On the contrary, many people feel their health is benefited when they consume dairy in its whole form, rather than adulterated, devoid of its original nutrients, and full of burst dead probiotics.

    Yet the FDA seemingly does little to protect the hundreds of thousands of people (equivelent to a jetliner crashing, at least!) who die each year from antibiotic-resistant infections (many of which are infected duing hospital stays and successful treatment for non-fatal health conditions), or the people harmed and killed by dangerous drug side effects, etc. No one seems to have enough outrage over the FDA’s lack of action toward these more serious issues.

  2. #2 Anna
    September 29, 2007

    My favorite source for diabetes info ( http://diabetesupdate.blogspot.com/2007/09/fda-doesnt-police-clinical-trials-many.html ) has a great post on this article also. Diabetes drug-related trials are big business (my local newpaper is filled with ads seeking trail participants) and the issues in the NYT article has huge implications for patients with diabetes.

  3. #3 Nat
    October 1, 2007

    Does anybody else find the USDA site funny. The top banner is grass. I would have thought that coca fields might have been more appropriate. But then that’s just me.

  4. #4 FoodSciYogi
    October 2, 2007

    Yes indeed it was ConAgra — and you’re right on. It’s ridiculously difficult for FDA to enforce what little power they actually do have. Not to mention the fact that most food plants see an FDA inspector about once every 3 years or so!

    http://www.foodkarmaalert.blogspot.com

  5. #5 Cellulite
    October 31, 2009

    Its wrong that when inspectors encountered problems they rarely followed up to make sure that the sites had complied with the information.

  6. #6 Abercrombie
    November 30, 2009

    Yet the FDA seemingly does little to protect the hundreds of thousands of people (equivelent to a jetliner crashing, at least!) who die each year from antibiotic-resistant infections (many of which are infected duing hospital stays and successful treatment for non-fatal health conditions), or the people harmed and killed by dangerous drug side effects, etc. No one seems to have enough outrage over the FDA’s lack of action toward these more serious issues.

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