17 Dec – AHRP – In 2008, 6,485 trials were conducted off shore with almost no FDA oversight. Seventy-eight percent of all human test subjects were enrolled at foreign sites. A disturbing report by the Inspector General of the US Dept. of Health and Human Services, “Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials,” issued in June, 2010, went unnoticed by healthcare officials and the media–until investigative reporters, Donald Barlett and James Steele revealed its findings in the January 2011 issue of Vanity Fair.
“Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.”
The Office of the IG reviewed all clinical trial data contained in pharmaceutical marketing applications submitted to the FDA, for drugs and biologics approved in Fiscal Year 2008.
In 1990, 271 clinical trials were conducted in foreign counties:
“By 2008, the number had risen to 6,485—an 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 general’s 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… All of this is taking place when more drugs than ever—some 2,900 different drugs for some 4,600 different conditions—are undergoing clinical testing and vying to come to market.”
“Throw a dart at a world map and you are unlikely to hit a spot that has escaped the attention of those who scout out locations for the pharmaceutical industry.”
A disproportionate, ever increasing number of human test subjects–78%–are foreign.
Thousands of clinical trials are taking place in countries with large concentrations of poor, often illiterate people, who in some cases sign consent forms with a thumbprint, or scratch an “X.”
China (with 1,861 trials) and India (with 1,457) are the fastest growing clinical trial locations. Others include: Bangladesh (with 76 clinical trials), Malawi (with 61), the Russian Federation (1,513), Romania (876), Thailand (786), Ukraine (589), Kazakhstan (15), Peru (494), Iran (292), Turkey (716), and Uganda (132).
The IG Report indicates that a recent analysis of the ClinicalTrial.gov Web site found that the 20 largest United States-based pharmaceutical companies were conducting one-third of their clinical trials exclusively at foreign sites. FDA inspected 1.9% of US clinical trials and even less 0.7% of foreign trials.
“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. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.”
Barlett and Steele cite two of all too many examples of deadly drugs that had won FDA approval thanks to the aid of “rescue countries”: Pfizer’s pain killer, Celebrex, that is linked to heart attacks and strokes, and Avantis’ antibiotic, Ketek that is linked to liver damage.
“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 2004—on April Fools’ Day, as it happens—the F.D.A. certified Ketek as safe and effective. The F.D.A.’s 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 couldn’t sign up to participate in a drug trial. She enrolled more than 400 volunteers, about 1 percent of the town’s 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.”