Stiffer CME rules could close speakers' bureaus

Proposed changes in ACCME standards also could impinge on First Amendment rights to free speech, critics say.

By Myrle Croasdale, amednews staff. March 3, 2003.

The Accreditation Council for Continuing Medical Education is revising its guidelines on commercial support, much to the consternation of CME providers.

The draft CME guidelines have even raised the ire of a legal watchdog group, which says they violate First Amendment rights to free speech.

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"It did catch everybody's attention," said Marcia Jackson, president of the Alliance for Continuing Medical Education, of the proposed CME standards.

What's put CME companies on edge is what they see as a tougher stance on conflict of interest as it applies to CME faculty. Drug company speakers' bureaus are a popular resource for CME speakers, and the draft has left providers unsure whether they'll be able to use physicians on these rosters.

A paraphrase of the guideline many are questioning reads: A person with a true conflict of interest will be excluded from being a teacher, author or joint sponsor. Examples are a person who receives funds from a commercial interest to teach on the same content. This allows for the continuation of speakers' bureaus, but will exclude those persons whose relationships constitute an actual conflict of interest.

CME providers question whether it will be enough to disclose a speaker's connection to a commercial firm or if such physicians will be ineligible to teach CME.

"At what point does one say this individual has a conflict of interest to the degree that they'd likely be biased?" Jackson said of providers' concerns.

No change in intent

Murray Kopelow, MD, executive director of the ACCME, said concerns that the guidelines will require big operational changes for CME providers are overblown.

"We want to ensure that the control of the content of CME is out of the hands of commercial interests. That's the same intent as it's always been," Dr. Kopelow said. Shutting down pharmaceutical company speakers' bureaus is not the ACCME's goal, he said.

"When a teacher or author has a relationship that is in conflict with the interests of the public, that unreconciled interest can't influence the content of continuing medical education," he said. "That's huge. That's a very important thing, and that's not new."

What the rule in question seeks to define is what the person with the conflict of interest is allowed to speak about.

"That same person, who is beholden to a drug company, can talk of pharmacology but not therapeutics," Dr. Kopelow said.

Allowing this person to speak on the therapeutic benefits of a drug is equivalent to a pharmaceutical employee promoting a product, he said.

The Washington Legal Foundation, an advocate for the economic rights of private businesses, attacked the draft guidelines as a violation of the First Amendment.

Richard Samp, chief counsel for the WLF, said, "My main concern is that public health is generally improved the more you encourage participation in CME by knowledgeable medical professionals. If the concern is that some of the CME speakers have potential biases, the normal First Amendment conclusion is full disclosure and letting the audience make its own decision, not total censure of [the speaker's] speech."

The AMA's Council on Medical Education had not yet met to discuss the ACCME's standards on commercial support and did not have any comments on the draft.

The draft guidelines are open for comment until March 15, with the ACCME's board expected to vote on a final version as early as July.