Tuesday, March 31, 2009

Sham Studies and the Commercial IRBs that Approve Them, and Sham IRBs and the Government Department that Registers Them

We have occasionally posted about the activities of for-profit contract research organizations (CROs). These are commercial entities that conduct human research, including clinical trials for pharmaceutical, biotechnology and device companies. More clinical research is being done by such CROs rather than by academic investigators. CROs seem to operate under the radar of most physicians, academics, and policy makers, but sometimes stories surface that raise questions about them.

For example, we discussed the trials by SFBC International (now PharmaNet Development Group) in Miami that enrolled immigrants, often undocumented, under questionable circumstances and in Montreal that resulted in the transmission of active tuberculosis (see post here and links backward); and the trial by Parexel International in London that put most of its subjects in intensive care (see post here, with links backward). Last year, as we discussed here, two articles questioning the ethics of research done under the auspices of CRO appeared in two major medical journals.

In academia, human research is supposed to be overseen by institutional review boards (IRBs). Research done by CROs is also supposed to be overseen by IRBs, but the IRBs that do so are often also commercial. Despite concern that commercial IRBs may be tempted to lower their standards to get more business, commercial IRBs have flown even lower under the radar than have CROs. However, last week, a story appeared about how a "sting operation" tested one commercial IRB with amazing results. Here are excerpts from the article by Alicia Mundy in the Wall Street Journal,

The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.

Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

'We realized it was a terrible risk for the patient … It is the worst thing I have ever seen,' an Argus IRB reviewer said, according to a slide shown at the hearing.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, 'Adhesiabloc.'

The GAO also ran an experiment to see if the US Department of Health and Human Services (DHHS)would register a truly dubious commercial IRB

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included 'April Phuls' and 'Timothy Wittless,' which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.

On one hand, these anecdotes suggest, along with the stories discussed above, that CROs and the commercial IRBs that are supposed to oversee them deserve further scrutiny. Beyond that, one wonders if it is good for society for human research, including experiments involving drugs and devices, to be done by commercial firms dependent for their income on the companies that make these drugs and devices, overseen by other commercial firms also dependent on these same companies. The fundamental conflict is embodied by Coast IRB's self-description:
as an advocate and a catalyst for an ever-stronger pharmaceutical industry, ethically and economically.
which also

recognizes the vital importance of our role in protecting individuals in all clinical studies and in continuously raising the bar on professional standards.

How can the company be an "advocate" for the industry while simultaneously protecting the people exposed to the industry's still experimental drugs?

See also comments on the GoozNews blog.


InformaticsMD said...

one wonders if it is good for society for human research, including experiments involving drugs and devices, to be done by commercial firms

You should add health IT to your list.

Anonymous said...

We need to look no further than these two WSJ Health Blog entries to see the questionable state of drug testing and guaranteed results,

March 11, 2009, 9:04 AM ET

A New Low in Drug Research: 21 Fabricated Studies

By Sarah Rubenstein

We’ve followed plenty of controversies around drug trials, from ghostwriting to keeping quiet about unflattering results. But the latest news is particularly eye-popping: A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies involving major drugs. Yikes

Baystate Medical Center in Springfield, Mass., has asked several anesthesiology journals to retract the studies, which appeared between 1996 and 2008, the WSJ reports. The hospital says its former chief of acute pain, Scott S. Reuben, faked data used in the studies.


March 20, 2009, 2:02 PM ET

Protocol Breach Reported in Biederman Study of Preschoolers

By David Armstrong

A 2005 study from Harvard psychiatrists testing the use of powerful antipsychotics in preschoolers was beset by breaches of research protocol, according to a letter from a committee monitoring the experiment.

Fraud and putting children at risk seems to be SOP in the drug testing area.

Steve Lucas