Applied Clinical Trials
Congressional sting operations put the IRB industry under the spotlight.
In late March, the House Subcommittee of Oversight and Investigations released the results of its three separate sting operations carried out in an attempt to uncover malpractice within the IRB industry. These were conducted by the Government Accountability Office (GAO).
Industry Response to IRB Investigation
One of the operations, which entailed submitting a fake and risky study to IRBs for approval, found unanimous authorization from only one of the three targeted companies: Coast IRB (Colorado Springs, CO).
On April 14, FDA issued Coast a warning letter, and the offending company pledged to postpone taking on any new studies as well as allowing any new subjects to be entered into already approved trials. Meanwhile, it also announced it would undertake sweeping reforms designed to exceed the level of protection required by existing law, it claimed in a statement provided by the company's public relations group.
In "the next 30 days this company will be completely different, said Coast chief executive officer Dan Dueber, "operated by different people, relying on different standard operating procedures, even having a different name." However, at press time, Coast instead opted to cease operations and shift ongoing trials to other IRBs.
This extensive investigation involved a fictitious lead researcher with a false medical license and resume, a fake FDA marketing approval, a fake protocol for a fake medical device from, you guessed it, a fake company.
While some risk that subjects face when participating in a clinical trial may be unavoidable, the question remains: How much risk should be tolerated?
Apparently not as much as the GAO's phony medical device study proposed, which was to pour a full liter of liquid into a woman's abdominal cavity after surgery to assist with healing.
GAO's fake protocol was based on an actual study for a product that FDA ultimately withdrew from the market because of deaths and infections among patients, Subcommittee Chairman Bart Stupak said in a statement.
The Subcommittee initially began looking at IRBs after discovering issues related to a clinical trial of an Aventis drug, Ketek, in 2007. And according to an aide to Stupak, "The Subcommittee knew from the Ketek investigation that there were problems with IRBs. This GAO study helped determine how widespread the problems were, as well as a realistic look at how IRBs operate."
GAOs choice of the three targeted IRBs was based on an online search of independent IRBs that had the least initial paperwork requirements for protocol submission.
"Anytime you look at the low end of a bell-shaped curve you will find problems...Essentially they reviewed the low-hanging fruit of the industry," observed Erica Heath, president of Independent Review Consulting (Corte Madera, CA), and Applied Clinical Trials' Editorial Advisory Board member. "Even then two of the three IRBs did not approve the study."
Along with the IRB investigation were two others: The Department of Health and Human Services (HHS) was fooled into registering a fake IRB, and GAO filed an assurance for federal funding with a fake company, which was granted.
The issue with these operations, according to Heath, is that "registration was not intended as an approval process. If the Subcommittee had spoken with OHRP about what they do and their processes, they could have uncovered that information without having to carry out the bogus registration."
As for being granted assurance, Heath explained that this is simply an agreement between the sponsor and HHS that they will conduct their activities using subjects in an ethical manner, abiding by current regulations. Once again, she noted, this in no way was intended as a form of approval of the sponsor company.
She goes on to raise the question, which perhaps is lingering in many IRB professionals' minds: "What was the ultimate goal of this entire operation? To make someone look bad, raise or make a point that more money for FDA and OHRP is needed to support the system?"
While most of industry seems reluctant to comment on this touchy subject, 83% of respondents to an Applied Clinical Trials online poll did reveal they felt the sting operation was justifiable, as opposed to the 17% that felt it definitely was not.—Marissa Shapiro