Poor Reviews

Profit pressures gut guinea pigs' only safeguard: institutional review boards.

Read also: When you risk life and limb in a clinical trial, are you helping science—or Big Pharma? One patient's deadly story.

ESTABLISHED IN the 1970s in response to scandals such as the Tuskegee syphilis experiment, institutional review boards are the primary means of protecting research subjects in the United States. Until recently, most IRBs were volunteer committees of clinicians and researchers in the teaching hospitals and medical schools where the research in question was being conducted. But as clinical research began to enter the private sector, a new type of IRB emerged: independent boards that review studies in exchange for a fee, promising a faster review. There are about 40 for-profit IRBs operating in the US, generating more than $100 million in annual revenue. Some for-profit IRBs are professional and serious-minded, while others present a more entrepreneurial face. Take Liberty IRB, a for-profit IRB in Florida that boasts on its website that it is the winner of the 2008 "Make Mine a Million $ Business" competition, a contest described as "a cross between The Apprentice and American Idol."

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Paid by the companies whose protocols they review, for-profit IRBs have a direct interest in keeping their clients happy. If one for-profit IRB rejects a study as too dangerous, the sponsor can simply send it to another one. Defenders argue that companies have an interest in getting a strict ethical review, if only to ward off potential litigation. But recent events suggest otherwise. In March 2009, the Government Accountability Office revealed the results of a sting operation (PDF) it conducted on Coast IRB, a Colorado outfit with more than $9 million in revenue in 2008. The GAO set up a phony company testing an obviously dangerous "bogus medical device" in a research protocol so "excessively vague" no reputable IRB should approve it: The protocol lacked results from animal studies and didn't reveal where the study would take place, or what institution would carry it out. The principal investigator listed had an expired medical license; the only contact information was a post office box and a cell phone number. Yet Coast IRB approved the product unanimously and deemed it "probably very safe." According to the GAO, Coast IRB had reviewed 356 research studies in five years and rejected only one.

So are the old academic IRBs any better? Located within academic health centers that now compete with contract research organizations for clinical trials, they also face pressure to approve trials quickly. As trials have become more complex, academic IRBs have become expensive, costing an average of nearly $750,000 per year—with some costing more than $4 million. As a result, some universities are outsourcing reviews to for-profit IRBs. Others have decided to shift the cost back to the pharma companies, like the University of Minnesota, which charges $2,500 to review industry-sponsored studies.

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