The Accreditation Council for CME is not the only organization suggesting that regulations regarding CME presenters' financial ties to pharmaceutical companies should be strengthened. The American Society of Clinical Oncology has changed its rules regarding conflict of interest and clinical trials — and the new policy, adopted in April, is far stricter and can affect speakers at ASCO meetings.
ASCO's previous policy on financial conflicts of interest required that physicians disclose ownership of $1,000 or more in publicly traded companies underwriting the clinical trial, as well as speaking honoraria received from the company in excess of $2,000 per year or $5,000 over a five-year period. The updated policy, however, requires that physicians who present abstracts at ASCO meetings or publish abstracts in the ASCO journal, the Journal of Clinical Oncology, disclose any money they received from the firm funding the trial exceeding $100.
The policy also outright prohibits physicians from assuming leadership positions in clinical trials if they have certain financial conflicts with the pharmaceutical company funding the trial, including the receipt of non-mutual fund stock, royalty and license interests, and speaking honoraria. Additionally, the policy forbids certain practices, such as payments contingent on referral or outcome, or agreements that restrict the right of researchers to publish. The penalty for violating the policy: prohibition from publishing or presenting data, or dismissal from ASCO.
The more stringent policy comes hard on the heels of a new, but much less restrictive, policy by the Association of American Medical Schools released last November. Those rules provide that an individual (not necessarily a trial leader) with a financial conflict over the amount specified by the Public Health Service (presently $10,000) should be excluded from clinical trials. The AAMC policy provides that physicians who are disqualified have the right to present their case to an institutional conflict-of-interest committee; the AAMC policy also does not mention referral fees. On the whole, some of the differences between the two policies have some ASCO members steaming.
One criticism is that by setting the financial disclosure threshold so low, the policy obscures the more serious conflicts of interest. “The problem is that this policy is a smoke-screen,” says Mark Ratain, MD, Leon O. Jacobson Professor of Medicine at the University of Chicago. “It has a high signal-to-noise ratio. If you're trying to hear a noise, it's easier to hear it in a quiet room than in a noisy one, which is why the FDA likes a threshold of $25,000 or, for example, my institution requires disclosure of more than $10,000,” says Ratain, who argued for a limit of $2,000 when he served as an ASCO board member.
While ASCO's general membership was involved in drafting the policy, leaders predicted that some members would be unhappy, says the organization's immediate past president, Paul A. Bunn Jr. MD. “But our impression was that having the trust of patients was more important.”
In fact, one purpose for the new policy is to combat a public image problem regarding pharmaceutical company influence over clinical trials — a problem which may be keeping new therapeutic trials from accruing the necessary number of participants. There are more than 300 new cancer agents in the pipeline — but fewer than 5 percent of eligible cancer patients are participating in clinical trials.
While the ASCO policy is far-reaching, Bunn pointed out that it won't necessarily apply to those studies that were in effect before the policy was created. “There will be some grandfathering going on, but the disclosure requirements will still pertain,” Bunn says.
Others note that the policy has a specific exclusion for “uniquely talented individuals.” Who determines that exemption? The members of ASCO's ethics committee in conjunction with the ASCO board decide. There is also an exemption for physicians involved in National Cancer Institute — sponsored trials, despite the fact that, as some commentators point out, those chairing NCI's disease-specific cooperative groups are under a lot of pressure from the pharmaceutical industry.
But Bunn defends the NCI exemption. “The NCI has very tight controls over its data,” he says. “No single individual would be capable of changing the data.” Bunn noted that the NCI cooperative groups have roughly 200 separate sets of data and safety monitoring and auditing procedures.
John Otrompke, JD, specializes in writing about healthcare policy and law. Reach him at firstname.lastname@example.org.
ASCO Draws More International Docs
Like many other medical associations, ASCO saw a drop this year in international attendance at its annual meeting. In 2002, non-U.S. physicians were the majority of participants at the ASCO conference; however, international attendance was nonetheless substantial at the 2003 meeting, held this spring in Chicago, with 41 percent of attendees visiting from other countries. To encourage more attendees from overseas, this year, for the first time, ASCO offered international participants the opportunity to earn AMA PRA category 1 credit.
“We had a nice example of how important our international collaborators are at this year's meeting,” says Jeff Crawford, MD, interim chief of medical oncology at Duke University, Durham, N.C., and chair of ASCO's CME committee. “French investigators presented results from the International Adjuvant Lung Trial, which showed a reduced death rate in lung cancer patients who received post-surgery chemotherapy. That hasn't been standard here, but the presentation will probably change practice. If they're going to provide education for us, we might as well provide them with CME credit,” Crawford says.
Juan Zarba, MD, of Argentina, who has been attending ASCO meetings annually for 10 years, took home CME credits, but that isn't why he came. Zarba is participating in an international cervical cancer radiation and chemotherapy trial with doctors from India, Mexico, Peru, and Thailand, and the group decided that the meeting is a good place to congregate. While Zarba benefits from the credits — and the latest cancer news — not all the education is useful to international physicians, he observes. “Globally, cervical cancer is the seventh leading cause of death in women, and in developing countries, it's the first. ASCO focuses more on ovarian cancer, the gynecological cancer of most significance in the rest of the world,” he says.
Crawford admits that the cancer research needs differ in other parts of the world. “While lung cancer is the most common cancer in the rest of the world, in Japan, there's a higher incidence of stomach cancer, and more liver cancer in China, for example,” Crawford says.
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