The chilling article on drugs killing Americans can be located here:
http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101
Drug companies are outsourcing their drug testing, beyond the reach of the FDA.
From the article:
Once upon a time, the drugs Americans took to treat chronic diseases, clear up infections, improve their state of mind, and enhance their sexual vitality were tested primarily either in the United States (the vast majority of cases) or in Europe. No longer. As recently as 1990, according to the inspector general of the Department of Health and Human Services,
a mere 271 trials were being conducted in foreign countries of drugs intended for American use. By 2008, the number had risen to 6,485âan increase of more than 2,000 percent. A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000. In 2008 alone, according to the inspector generalâs report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore. The inspector general found that the 20 largest U.S.-based pharmaceutical companies now conducted âone-third of their clinical trials exclusively at foreign sites.â All of this is taking place when more drugs than everâsome 2,900 different drugs for some 4,600 different conditionsâare undergoing clinical testing and vying to come to market.
One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. Thereâs even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: theyâre called ârescue countries.â Rescue countries came to the aid of Ketek, the first of a new generation of widely heralded antibiotics to treat respiratory-tract infections. Ketek was developed in the 1990s by Aventis Pharmaceuticals, now Sanofi-Aventis. In 2004âon April Foolsâ Day, as it happensâthe F.D.A. certified Ketek as safe and effective. The F.D.A.âs decision was based heavily on the results of studies in Hungary, Morocco, Tunisia, and Turkey.
The approval came less than one month after a researcher in the United States was sentenced to 57 months in prison for falsifying her own Ketek data. Dr. Anne Kirkman-Campbell, of Gadsden, Alabama, seemingly never met a person she couldnât sign up to participate in a drug trial. She enrolled more than 400 volunteers, about 1 percent of the townâs adult population, including her entire office staff. In return, she collected $400 a head from Sanofi-Aventis. It later came to light that the data from at least 91 percent of her patients was falsified. (Kirkman-Campbell was not the only troublesome Aventis researcher. Another physician, in charge of the third-largest Ketek trial site, was addicted to cocaine. The same month his data was submitted to the F.D.A. he was arrested while holding his wife hostage at gunpoint.) Nonetheless, on the basis of overseas trials, Ketek won approval.