Stranger Than Fiction
Here’s a pitch for a low-budget comedy.
A college student, mistaken for a consultant, is contracted by the FDA to coordinate an oversight program to monitor the safety of human drug trials. Sure – it could happen. It’s Hollywood.
He and his pals are given a boatload of money to conduct inspections, maintain databases, and generally make sure thousands of drug trial subjects are not put in harm’s way.
Naturally, our hero starts his venture by cashing the first fat check and throwing a party so elaborate it almost makes national headlines. But when he falls hard for the attractive FDA liaison who periodically checks in with him to see how things are coming along, he decides to actually try and do what he’s been contracted to do. So for several years, between classes, he does his best to inspect all the trials he possibly can. And he manages to inspect exactlyone percent.
Of course, he’s found out, hilarious woe ensues, but somehow he manages to turn all the negatives into positives while finally winning over the sweet young thing at the FDA, and everyone lives happily ever after.
Well, except for thousands of research subjects whose safety may have been neglected.
Now you might be thinking, “No way, Jenny. Too implausible.” And I agree. But here’s where the pitch takes an unexpected twist: Except for the plot elements about the college student and his love interest, it’s based on a true story – produced and directed by the Health and Human Resources Office of Inspector General.
Oscar watch
About two months ago the Office of Inspector General (OIG), released a report that gives us a rare glimpse into one small section of the inner workings of the FDA. And it’s pretty ugly.
The report is titled “The Food and Drug Administration’s Oversight of Clinical Trials.” I would have added the word “Miserable” right before “Oversight,” but I guess that’s just one of the differences between me and a government bureaucrat. The introduction to the report notes that everyone involved with human studies – the sponsors, the investigators, the review boards, etc. – “must comply with FDA regulations designed to protect the human subjects participating in them.”
I’m not what you’d call a big fan of government regulation, but I’m a very big fan of public safety. And when it comes to drug company product testing, their track record clearly shows they have to be watched carefully. Given that, the following highlights from the OIG report could only be filed under “deplorable.”
- The FDA doesn’t maintain a clinical trial registry, so it’s unable to identify all ongoing clinical trials and their trial sites
- The FDA maintains databases to track inspections, but the databases don’t include complete information needed to track inspections
- Lack of coordination impedes the FDA’s ability to conduct inspections
- The FDA inspected few review boards, which are supposed to offer significant oversight of human subject protections
- The FDA relies on voluntary compliance to correct violations
- Between 2000 and 2005, the FDA inspected an estimated one percent of clinical trial sites
Arthur L. Caplan, M.D., chairman of the department of medical ethics at the University of Pennsylvania, told the New York Times that rats and mice get better protection as research subjects than humans do. And that’s no overstatement. Dr. Caplan notes that animal research centers are all registered with the government, have unannounced spot inspections, and face closure when problems aren’t addressed quickly. He says none of this is the case with human research.
What happens next?
In the OIG report, five recommendations were offered to the FDA. The recommendations basically boil down to this: Get it together and do your job!
The FDA responded to the recommendations and blah, blah, blah. From here the whole matter disappears into the black hole of bureaucracy. Maybe five or ten years from now the OIG will conduct another investigation and we’ll find out if safety oversight has improved at all.
Meanwhile, big questions are left hanging: Was safety oversight inept because FDA officials are inept? Were budget cutbacks to blame? Was the lack of oversight intentional? And if it was intentional, who benefited?
Don’t expect answers from the FDA or the OIG. You’ll just have to go see the movie.
Sources:
“The Food and Drug Administration’s Oversight of Clinical Trials” Department of Health and Human Services, Office of Inspector General, September 2007, oig.hhs.gov
“Report Assails F.D.A. Oversight of Clinical Trials” Gardiner Harris, The New York Times, 9/28/07, nytimes.com
