A Medical Device Daily

Daniel Dueber, CEO of Coast Independent Review Board (Coast IRB; Colorado Springs, Colorado), testified Thursday before the Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee in the Rayburn House Office Building.

According to the committee, the hearing, "Institutional Review Boards that Oversee Experimental Human Testing for Profit," was to examine whether institutional review boards (IRBs) and the federal government are adequately protecting human subjects of biomedical research.

Coast IRB, a for-profit company, reported earlier this month that it had been the target of an apparent congressional sting operation in which government agents submitted false credentials and clinical trial data to Coast IRB for evaluation (Medical Device Daily, March 16, 2009). In his testimony Thursday, Dueber described the fraud as an "elaborate scheme" and that Coast IRB had "unnecessarily suffered significant harm to its business and business reputation" as a result.

Chairman Bart Stupak (D-Michigan) noted during his opening statement at the hearing that under current federal law, medical testing of human subjects that is federally funded or relates to federally regulated drugs or devices cannot proceed without the approval of an IRB – a panel of doctors, scientists, and non-scientists charged with ensuring the health and safety of the subjects.

Stupak said that the committee began investigating IRBs in 2007 when it learned that Copernicus IRB allowed the study of an antibiotic Ketek to continue without examining reports of fraud it had received. As part of the continued investigation, he said the committee asked the Government Accountability Office (GAO) to conduct undercover testing of the IRB review process. "We wanted to know whether IRBs are rubber stamping research studies, whether clinical researchers are IRB shopping or choosing IRBs based on how quickly and inexpensively they approve studies, and whether governmental oversight of IRBs is adequate," he said.

Besides Coast IRB, Stupak said the GAO sent its fictitious study to two other IRBs, and they both rejected it out of hand. Coast IRB, on the other hand, approved the protocol unanimously.

"Nobody at Coast IRB ever reviewed any of the data cited in the proposal to support those claims. If they had, they would have discovered that it didn't exist," Stupak said. "Why was this review so shoddy? The evidence suggests that Coast was more concerned with its financial bottom-line than protecting the lives of patients."

Coast IRB said it was singled out despite the absence of proof that it had committed any crime and that no crime was unearthed from the sting. Never before had Coast IRB been the victim of fraud from an actual clinical trial sponsor, and no patients in clinical trials reviewed by Coast IRB have ever suffered serious physical harm, the company noted.

According to Coast IRB, the GAO engaged in extensive mail and wire fraud in order to conduct its investigation. GAO falsified professional credentials, and submitted a fake medical device protocol. It created a fake medical device, Adhesiabloc, said to be a substantial equivalent to another device already given FDA market approval. It submitted a fake FDA 510(k) number and fake Federal Wide Assurance number for the device. It engaged in misleading telephone calls and emails. In violation of Virginia law it forged a Commonwealth of Virginia medical license in response to Coast IRB's request for proof that the clinical trial's principal investigator was duly licensed, the company said.

Dueber described the fraud as an "elaborate scheme" that worked, at first. Coast IRB approved the clinical trial for review. Then after receipt of a request for production of documents from the committee, Dueber looked behind the representations made and discovered the fraud, some four months after the trial had been approved.

In his opening statement, Dueber told the committee that if its "objective with this fraudulent and illegal GAO sting operation was to demonstrate that IRBs need to do more checking and verification of sponsor and PI licenses, verify the existence of companies and so on – fine – we will do that, and we have changed our SOPs to do just that because of this illegal fraud."

Dueber told the committee that his company has spent more than $100,000 defending itself as a result of this "charade" and that it has had to lay off at least five people to cover that cost.

"A better approach would have been for you to call a conference together of key industry leaders to identify what needs to be fixed. No one would have had to be harassed as Coast has with this sting," Dueber said.

According to a memorandum from Emord & Associates, the office of Jonathan Emord, Coast IRB's attorney in this matter, the GAO and Congress violated the separation of powers doctrine in order to conduct its investigation of Coast IRB. Congress and the GAO, however, argue that the investigation is properly within its powers.

Stupak said during the hearing that the GAO's investigation also exposed other problems with the IRB system. GAO was able to create a fictitious IRB that it registered with the U.S. Department of Health and Human Services with no questions asked, he said, adding that the president of the fake IRB was a three-legged dog named Trooper, who is now deceased.

"GAO's findings raise serious questions not only about the specific IRB involved in this investigation, but with the entire system for approving experimental testing on human beings. As a society, we have a moral obligation to ensure that human testing is done in the most responsible and ethical manner," Stupak said.

Health groups unite on new standard

The Advanced Medical Technology Association (AdvaMed; Washington) reported that, for the first time, 11 major healthcare organizations have worked together to develop a uniform national standard to credential clinical healthcare industry representatives (Clinical HCIRs) in an effort to ensure patient safety, privacy, high-quality and efficient care and access to advanced medical technologies.

Vendor credentialing is the setting of requirements and procedures by hospitals and others to allow industry representatives to enter an institution. Clinical HCIRs include industry professionals who provide technical support related to procedures ranging from knee replacements to programming cardiac pacemakers.

Currently, HCIRs face varying facility-specific credentialing requirements, which are compounded by redundancies and a lack of reciprocity among institutions, according to the organizations. These factors not only unnecessarily increase costs, but also delay patient access to advanced medical technologies, the groups noted.

AdvaMed said it initiated the multi-association work group to promote a broader understanding of the scope of concerns and review best practices concepts. The group hopes that its recommendation for best practices can be adopted as a national standard for the credentialing of Clinical HCIRs. According to AdvaMed, the new proposal would end the duplicative and sometimes conflicting regulations set up by each health care facility, which require health industry representatives to undergo divergent, redundant and burdensome credentialing procedures.

"We believe that patients will benefit from greater uniformity in HCIR credentialing. Our proposed best practices promote patient safety while decreasing administrative costs and burdens caused by divergent and overbroad facility access policies," said Terry Chang, MD, AdvaMed's director of medical and legal affairs.

The recommendation focuses on five basic criteria for Clinical HCIRs: updated vaccinations; product or general liability insurance; background verification; hospital unit orientation; policy and procedures and training documentation.

In addition to AdvaMed, signatories to the recommendation include: American Association of Critical-Care Nurses (Aliso Viejo, California); Association for Healthcare Resource & Materials Management (Chicago); Association of peri-Operative Registered Nurses (Denver); Health Industry Distributors Association (Alexandria, Virginia); Health Industry Representatives Association (Denver); Healthcare Manufacturers Management Council (Savannah, Georgia); Independent Medical Manufacturer Distributors Association (Downers Grove, Illinois); Industry Partners for Patient Safety; Innovative Healthcare Access Coalition; and Medical Device Manufacturers Association (Washington).

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