Tuesday, September 22, 2009

By Stuart Chaifetz

The Dark Side of Big Pharma III:
Institutional Review Boards
The first line of defense against dangerous practices occurring in Human Clinical Trials are Institutional Review Boards (IRB). These boards are meant to monitor and approve research that has been taken to the human level, and, specifically, to protect the rights of people who are being tested.
Thankfully, with these IRB’s Elliot Ness style of Untouchability, there are never any problems and corruption doesn’t exist at all within the biomedical/human research community.

In March of this year, the United States Government Accountability Office (GAO) released a report titled: “Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation.” And it gets so much worse from there:
“Our investigation shows that the IRB system is vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud, or who lack the aptitude or qualifications to conduct and oversee clinical trials. This vulnerability elevates the risk that experimental products are approved for human subjects testing with little or no substantive due diligence.”
The GAO goes on to give an example of how the failure of an IRB, and a poorly run human trial, had mortal ramifications:
“For example, in 2002, a 47-year-old man died after his heart stopped beating while participating in an experimental trial of antipsychotic medication at a Texas research center. Before his death, the man spent 22 days suffering from fever, severe diarrhea, a rapid heartbeat, and kidney failure while under the care of researchers. The warning label for the experimental medication listed some of these serious side-effects and other signs of heart failure, but the IRB failed to ensure the risks were communicated to participants at the outset of the trial. During the clinical trial, the lead researcher continually delegated control of the clinical trial to a man who was unlicensed to practice medicine in the United States. In its follow-up investigation after the death, the FDA noted that the IRB repeatedly violated regulations governing the proper conduct of clinical trials and did not adequately supervise the clinical trial.”
Another specific example of an IRB failing at its job comes from this letter from the FDA to the “CHRISTUS Schumpert Health System.” The FDA listed counts against this IRB, including failing to provide informed consent to “subjects,” failure “...to conduct continuing review of research,” and that oldie but goody, failure “...to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest...”

And here’s a really sad story on IRB’s, because it deals with protecting foster children with AIDS.
The job of appointing protective advocates for foster children in AIDS drug trials has been left up to local review boards at each study site. A recent review said those boards were overworked, were inappropriately dominated by scientists and lacked focus on patient safety.”

There are thousands of IRB’s out there, each one supposedly watching out for the adults and children who are involved in human clinical trials. There’s no way to know how many of them are acting against the best interests of the people they are supposed to protect, but it really says something when we see just how easy the GAO nailed IRB’s, as is stated in their report. And that was just from a random selection of a handful of these boards.
Sometimes the story isn’t about the bad guys you catch - it’s about all the bad guys out there that you never will.

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