Originally published November 27 2005
Pharmaceutical industry under fire for corrupt practices
by Mike Adams, the Health Ranger, NaturalNews Editor
Bloomberg News has produced an investigative article that exposes the many dubious practices that surround the clinical trials of pharmaceuticals, including looks at the FDA, Genentech and various institutional review boards like SFBC International, often compromised by its financial links to big Pharma.
Cabanerio is one of many regulars who gather at SFBC International Inc.'s test center, which, with 675 beds, is the largest for-profit drug trial site in North America.
Across the U.S., 3.7 million people have enrolled in drug tests sponsored by the world's largest pharmaceutical companies.
WIRB, an Olympia, Washington-based for-profit company, is responsible for protecting people in 17,000 clinical trials in the U.S.
The search for the next money-spinning drug is fueling the surge in human testing.
In 1978, the National Commission for the Protection of Human Research Subjects, an advisory committee appointed by President Richard Nixon, recommended, in what became known as the Belmont Report, that clinical trial participants be fully informed of risks and sign a consent form.
Bowen, whose Western IRB has overseen trials at SFBC sites, says phase I centers often don't conduct the informed consent process properly.
SFBC Chairwoman Krinsky says the company hasn't received a warning letter, which is more serious than a significant objectionable conditions citation, from the FDA in more than 20 years.
Bowen says WIRB is the best in the industry because of the professionalism of her members, their training and expertise and their willingness to turn down drug company tests they don't approve of.
In a 2002 Seton Hall Law Review article, WIRB's director of regulatory affairs wrote that there's an inherent conflict within independent IRBs because their fees come from the same pharmaceutical companies whose trials they're asked to monitor.
Nobody has ever studied the effectiveness of IRBs or tracked how many people are injured or killed each year while participating in clinical trials, says Harvard's Federman, who chaired a national committee on clinical trial safety in 2003.
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