E-DRUG: Human guinea pigs pay for lax FDA rules
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2-part series from Bloomberg News, reprinted in the Seattle Times:
http://seattletimes.nwsource.com/html/businesstechnology/2002606640_drugtesting06.html
Sunday, November 6, 2005
Human guinea pigs pay for lax FDA rules
By David Evans, Michael Smith and Liz Willen
(tomorrow's article will be entitled : Watchdogs on Company Payrolls)
excerpts:
Across the U.S., 3.7 million people have enrolled in drug tests sponsored by the world's largest pharmaceutical companies. The companies have outsourced 75 percent of experimental drug trials to centers such as SFBC, a leader in a $14 billion industry.
At the same time, the U.S. Food and Drug Administration has farmed out much of the responsibility for overseeing safety in these tests to private companies known as institutional review boards. These boards are also financed by pharmaceutical companies.
So, the drug industry is paying the people who do the tests — and most of the people who regulate those tests. And that combination can sometimes be deadly.
"The fundamental problem is a system in which investor-owned businesses have control over the evaluation of their own products," says Marcia Angell, editor in chief of the New England Journal of Medicine from 1999 to 2000. "Oversight of clinical trials is too important to leave in the hands of drug companies and their agents."
Ken Goodman, director of the Bioethics Program at the University of Miami, says pharmaceutical companies are shirking their responsibility to safely develop medicines by using poor, desperate people to test experimental drugs.
"The setting is jarring," says Goodman, after spending 90 minutes in the waiting rooms at SFBC's Miami center, which is also the company's headquarters. "It's an eye-opener. Every one of these people should probably raise a red flag. If these human-subject recruitment mills are the norm around the country, then our system is in deep trouble."
Pharmaceutical companies distance themselves from the experiments on humans by outsourcing most of their trials to private test centers across the U.S. and around the world, says Daniel Federman, a doctor who is a senior dean of Harvard Medical School in Boston.
The FDA, the principal federal agency charged with policing the safety of human drug testing, has farmed out much of that responsibility to a network of private companies and groups called institutional review boards, or IRBs.
The review boards that oversee drug-company trials operate in such secrecy that the names of their members often aren't disclosed to the public. These review boards are paid by Big Pharma — just like the testing centers they're supposed to be regulating.
Fundamental problem'
The drug-testing companies and the private oversight firms have more incentive to satisfy pharmaceutical companies wanting speedy results than they have to ensure the safety of participants or integrity of research data, says Angell, of the New England Journal of Medicine.
"The fundamental problem is a system in which investor-owned businesses have control over the evaluation of their own products," she says. "Oversight of clinical trials is too important to leave in the hands of drug companies and their agents."
The chief executives of drug companies should be held accountable for any lack of ethics in these tests, says Harvard's Federman, who chaired a national committee on clinical trial safety in 2003.
"It's not possible to insist on ethical standards unless the company providing the money does so," Federman says.
CEOs of 15 pharmaceutical companies that outsource drug testing to firms including SFBC — among them, Pfizer, the world's largest drugmaker; Merck & Co.; and Johnson & Johnson — declined to comment for this story.
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Joana Ramos, MSW
Cancer Resources & Advocacy
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