Life Science Compliance Update

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July 22, 2010

ACRE Response to NIH Proposed COI and Transparency Policy

In response to the National Institutes of Health (NIH) call for comments regarding proposed transparency rules, the Association of Clinical Researchers and Educators (ACRE) recommended that the agency “not adopt the proposed rules and recommendations until further discussion occurs.”

By offering to “be an active participant in this discussion,” ACRE noted that its members, Educators, Medial Society Leaders and distinguished Professors at academic centers, are ready to engage NIH in a more “careful and thoughtful deliberation” regarding healthy interactions between academia, the government and the private sector.

ACRE also noted that because it’s members are engaged in promoting excellence in medical service, education, and innovation, and have substantive track records in these endeavors, the group hoped to show NIH that the public “has much more to win by a vibrant and high level of engagement between the private sector and medicine.”

In addition, since the new NIH rules  propose further “restrictions on these interactions” without offering evidence to support its claims, ACRE recognized that the agency will “create an unnecessary burden on individuals and the government (wasting precious resources).” From these findings, and as described by some of the points below, ACRE urged NIH “to consider a delay in implementation until such issues have been carefully considered.”

Accordingly, ACRE pointed out that the framing bias used by NIH to propose the amended rules “represents a one-sided, prejudice view on a complex topic that disarms the arguments of the accused.” The problem with this approach is that a “massive financial conflict of interest (FCOI) ideology has flourished and created a compliance industry that has inherent COI on its perpetuation,” despite “overwhelming evidence that collaboration with industry has yielded immense value and little harm.”

Another significant problem ACRE points out with the proposed NIH rules is the tremendous administrative burden carrying out these regulations will have. The number of hours and cost alone will apply serious pressure and stress to already understaffed and underfunded agencies, not to mention institutions. This will have an adverse affect on physician’s willingness to participate in NIH funded research, which will ultimately harm patients by creating less opportunities and breakthroughs.

The impact of the rules will also be felt by non-profits and CME providers, due to new requirements to disclose payments for each of these stakeholders. Such reporting will create “a false innuendo that CME is something that creates a FCOI.”

ACRE also acknowledges the weakness in NIH’s proposed rules because the agency relies on the Wazana paper, and they do not cite any research that shows the many benefits of commercial contributions to medicine. Consequently, ACRE correctly points out the fallacy in using the Wazana study because it “explicitly stated that of the publications reviewed “…no studies used patient outcome measures.”

It was also noted in their response that the proposed NIH rule is no longer necessary since the implementation of the Physician Payment Sunshine Act is already underway.

What ACRE also found problematic about the proposed rules is that they would hurt the willingness of physicians to participate in NIH funded research, because the rules “risk strengthening the misperception that all significant financial interests (SFI) constitute FCOI.” 


Since public trust in doctors is high and stable, according to a series of Harris polls on "most trusted professions," ACRE asserted that “physician-industry collaboration should be regarded as a “win-win” relationship because it adds value and aligns the interests of medicine.”

Ultimately, because Americans want better ways to fight disease and improve health, ACRE noted that NIH is misguided to assert that Americans do not want “FCOI”s to influence the federally funded research. Accordingly, because innovation, in large part, results from industry translation of NIH-funded research and has delivered these desired outcomes, ACRE hopes to be actively involved in discussion with NIH to help encourage such partnerships and maintain their integrity.



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