Most clinical trials are being done overseas with little oversight, the NIH scandal, and the placebo effect: Wednesday news and blogs

  • Concern Over Foreign Trials for Drugs Sold in U.S. — NYT — The report “highlights a very frightening and appalling situation,” said Representative Rosa DeLauro, Democrat of Connecticut. “By pursuing clinical trials in foreign countries with lower standards and where F.D.A. lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.”
  • So Many Foreign Clinical Trials, So Little Oversight — Pharmalot — Now, though, a new report quantifies the extent to which drugmakers are researching their meds in other countries and the results suggest the concerns will not go away – 80 percent of drugs approved in 2008 had trials in foreign countries, and 78 percent of all patients were enrolled at foreign sites, according to the US Human & Health Service Inspector General. And 10 drugs approved in 2008 were tested entirely abroad with no patients in the US. Meanwhile, the FDA inspected 1.9 percent of domestic clinical trial sites and just 0.7 percent of foreign sites. And while Western Europe accounted for most foreign trial subjects and sites, Central and South America had the highest average number of subjects per site.
  • Why You Should Care About the University of Miami NIH Scandal « SpeakEasy — NIMH director Thomas Insel, MD assured Pascal Goldschmidt, MD, UM’s medical school dean that Nemeroff ’s Congressional investigation for unreported drug industry income and NIH’s termination of his $9 million grant shouldn’t stop the government funding spigot – even as Insel personally revised NIMH’s “conflict of interest” rules.

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