Sounds like a nice business model.6,485 Overseas Clinical Trials and Counting
The venerable investigative reporters Donald L. Barlett and James B. Steele turn their focus to overseas clinical trials in an article in this month’s Vanity Fair on newsstands today and online here.
With their trademark exhaustive research – did you know there were 6,485 clinical trials overseas in 2008 on drugs intended for American use, 23 times more than the 271 in 1990? – the reporters note, several times, a gap in the system.
Nobody keeps track of all those trials.
“Data is made available to the public on a purely voluntary basis,” they wrote. “Its accuracy is unknown. The oversight that does exist often is shot through with the kinds of ethical conflicts that Wall Street would admire.”
Karen Riley, a spokeswoman for the F.D.A., confirmed on Thursday that some clinical trials are done overseas without submitting them to the drug review agency. She cited small feasibility studies, Phase 1 efficacy trials and some larger Phase 3 trials where a new treatment is compared to the standard treatment or a placebo.
But once a company files an Investigational New Drug Application, she said, all clinical trials for that purpose must be submitted and older trials may be reviewed. The F.D.A. can also decline to use data collected outside the United States if it believes the study did not follow good clinical practices such as protecting human protections, Ms. Riley said.
Based on a 2010 report by the inspector general for the Department of Health and Human Services,Mr. Barlett and Mr. Steele found the F.D.A. does occasional inspections, visiting 0.7 percent of trial sites outside the country in 2008, compared with 1.9 percent inside the United States.
But they seem to distrust some of the research done by overseas contractors in places with much less regulation and more willing, low-income subjects, and cite case after case. The article is titled “Deadly Medicine,” so you get the point.
Step 1, develop drug X.
Step 2, run clinical trials behind closed doors in some third world country where no one has accountability and where the right bribe can easily get you what you want.
Step 3, use the results of said trials to market drug X, billing the taxpayers of course.
Step 4, laugh all the way to the bank.