Life Science Compliance Update

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June 17, 2010

AHA Ban on Industry Posters and Presenters: Conflict of Interest Run Amuck?

Each year, the American Heart Association (AHA) holds its annual Scientific Sessions comprised of scientists, researchers and physicians who present over 3,000 abstracts regarding research and discoveries from the past year.   Presenters include scientists from universities, industry, private physicians, and others. 

That is why it has concerned so many that AHA recently announced that pharmaceutical industry employees will no longer be allowed to present during medical education presentations later this year at AHA’s annual Scientific Sessions, one of the largest medical meetings in the world. Specifically, AHA’s website states that:

“In compliance with ACCME requirements, employees of a commercial interest entity cannot be the presenting author of the abstract.”

According to the AHA the ACCME defines a commercial interest “as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients,” and they define employee “as someone who is directly working for the commercial interest as their primary employer and the commercial interest provides their primary source of income.” A person acting as a contractor to a commercial interest, providing consultation, or other services secondary to their primary appointment at, for example, a university would not be considered an employee.  Click here for additional information.

The impact of this policy, which applies to all medical groups that offer ACCME approved CME, gained attention last week when the National Institute of Health (NIH) held its 100th Meeting of the Advisory Committee to the Director of the NIH (whatch video here advance to 108-111). During the meeting, Keith Yamamoto, Executive Vice Dean of the University of California, San Francisco School of Medicine, called the policy "blood-curdling,” and asserted that such a policy is "conflict-of-interest considerations run amok."

Echoing his concerns, NIH Director Francis Collins, who noted the gasps in the crowd after the policy was read, called it “a breathtaking sweep to squash something that is really important to us, the science going on in the private sector.” Director Collins further added that “this seriously distressing step….takes an important principle and pushes it in a direction that makes no sense for the progress of science.”

Clyde Yancy, president of AHA, who was at the meeting, said the association was aggressively appealing the decision, and that the recent attention was because the AHA is the first to have to enforce ACCME’s new policy with its meeting later this year. He noted that AHA was told they “could not integrate the science (from industry employees) into any sessions, they could not invite speakers to be in their programs unless they were in a separate venue, and they could not portray the work unless it was in a separate geographic location from other CME."

Accordingly, to address this problem AHA announced that it will open a call for abstracts in August from industry-employed researchers.  The same peer review process applied to all other abstracts will be implemented to insure fairness and freedom from bias.  Accepted abstracts will be presented at Scientific Sessions 2010 but the manner in which those data will be presented remains a work in progress. 

The response from AHA comes from an ACCME clarification released last year about policies regarding whether employees of commercial interests can serve as planners or speakers in accredited CME activities. According to ACCME’s website:

“If the content of CME that the employee of the commercial interest controls relates to the business lines and products of its employer – NO. If the content of CME that the employee of the commercial interest controls DOES NOT relate to the business lines and products of its employer – YES.”

Additionally, a recent clarification from ACCME about the involvement of industry employees in CME planning and presentations stated that industry employees cannot deliver oral presentations and cannot author enduring materials that are accredited CME if the CME content relates to business lines or products of their employees. It also states that they cannot serve as program planners if the CME content relates to business lines or products of their employees.

Last year, Keystone Symposia discontinued CME Accreditation due to ACCME policies banning speakers, since the organization has about 70 leading scientists from all types of research institutions, and about 30% of the Scientific Advisory Board members are from commercial institutions.

Consequently, the interpretation of this new policy is set to affect the upcoming Endocrine Society (ENDO) meeting, which starts Saturday, according to Society president Robert Vigersky, MD. He claimed to the Journal Sentinel that “employment in the pharmaceutical industry is a serious conflict of interest that should preclude investigators from speaking in or influencing the content of CME activities.” This claim led to the society’s decision to “no longer provide CME credit for any oral/abstract or poster presentation sessions at their meetings because many of these scientific reports do come from industry.”

Such a policy for scientific meetings is particularly problematic because scientific meetings which in the case of AHA a vast majority of the science presented by industry is pre-clinical science gives company scientists a venue for presenting their scientific work and brings about a great amount of discussion amongst the medical community.

Even the starkly anti industry AMA CEJA recognizes that "In certain circumstances, scientists from industry may be allowed to talk in CME activities if it is about the pathophysiology of a disease, but not if they are presenting on the clinical efficacy of their drug or medical device.” What exactly is the difference? It should not matter how the information gets to a physician because they are trained accordingly, and having an exception for use of industry clearly demonstrates that.

Additionally, claims that drug and medical device companies regularly use CME as a way to promote off-label uses for their products ignore a decade old legal precedent established in Federal Court that protects such speech under the First Amendment.

The media coverage of this recent development has once again been misinformed. For example, the Journal Sentinel uses a quote from Lewis Morris, chief counsel for the Office of Inspector General in the Department of Health and Human Services about drug companies using their sponsorship of medical education to increase market share and maximize their return on investment. This quote however, is attributed to promotional speakers' bureaus and does not pertain to CME.

While critics point to a study showing that every dollar spent by a drug company on doctor education activities generated $3.56 in increased revenue, they do not consider the amount of money saved by the impact such education has for physicians treating their patients with new drugs and devices. That value also does not measure the better quality and longer life span patients experience due to CME (e.g. MDS study).

Accordingly, those discussing this issue at the NIH meeting were in general agreement that the ACCME rule was counterproductive. In fact, ideas that industry doctors and scientists could make presentations that are not part of CME programs “implied that industry's science is inferior,” according to Rose Marie Robertson, chief science officer for the heart association. She noted that “the policy likely will affect fewer than 100 abstracts and presentations that would be available for medical education credit at the association's next annual meeting, which will be held in Chicago in November. That's out of about 3,000 such abstracts.”

Murray Kopelow, a physician and chief executive of the council of ACCME asserted that his organization “is not against science, and has no right to silence anyone." He maintained that ACCME “stands for doctor education that is independent from industry.” But he noted that “allowing industry employees to give medical education talks is not compatible with that goal,” although “it is perfectly acceptable for industry employees to give talks in settings that don't involve CME.”

Interestingly, after all the buzz today, AHA came out with a statement saying they are “currently examining their policies concerning CME credits at their scientific conferences, and are continuing to gather input from leading scientists as well as other national healthcare nonprofit organizations in order to work collectively to address what they believe are unintended consequences of the ACCME position.”

Conclusion

As ACCME and AHA sort out this relatively early interpretation of the policy, societies and organizations are beginning to feel the impact. Frequently, long-standing planning committees of scientific meetings have some members who are industry employees, and companies also have abstract submissions for several conferences where often the submission is by an industry employee. Such a policy would make these functions virtually impossible.

Other societies have had to sort through thousands of abstracts and hundreds of presentations to take out any session that had an industry presenter in it, which resulted in valuable time and resources being sacrificed, and sometimes only half of a scientific program being eligible.

Part of the difficulty is that some organizations have interpreted the policy as not allowing industry employees to present in the same geographic location as a non-industry CME event - although nothing in the published ACCME material would suggest that this it is necessary.

The policy also may be a problem because if a CME provider wanted to put on a debate between industry and surgeons on the role of industry relations in improved quality care using xyz products, under some interpretations they couldn’t because industry could not be there to represent itself.  Consequently, these policies are unnecessary, especially since recent evidence about industry funded CME by Steven Kawczak and William Carey, of the Cleveland Clinic Foundation, found no evidence of a difference between supported and non-supported programs.

For the vast majority of clinical meetings there is no need to include industry presentations but for scientific meetings there is vast precedence going back to the scientific meetings from the late 1800’s in which industry scientists participate.  One great concern to this whole discussion is when is this going to stop, is the next step banning anyone who conducts studies paid for by industry to present.  This is a slippery slope that history has not been kind to.

Ultimately these problems demonstrate the need for ACCME to find a policy that does not marginalize a slew of scientists and researchers who are fellows of a society but happen to work in industry. As George Lundberg, former editor of the Journal of the American Medical Association, correctly noted, “the people who should be doing medical education are the ones who are the most informed on the issues, and to rule out people who may know the most—including Nobel prize winners working in industry—is ill-advised and counterproductive."

We agree with NIH Director Francis Collins that these requirements are bone chilling, and we think the ACCME should call together a working group of science based organizations to come up with a solution because the inclusion of industry speakers in scientific discussions is invaluable. In fact, in the same way industry authors of clinical papers need to be recognized for the contribution to medicine so too do industry scientists need to present and defend their work at scientific meetings.

Since AHA is aware that valuable science has emanated from those pursuing scientific endeavors who are employed in industry, they must come up with a policy that does not impede this work because it would be inconsistent with their mission.

 

 

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a good step in the right direction.

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