Whether prescribing physicians should reject the drug and medical device industry's financial support for their continuing medical education is shaping up as the next major fight in the ongoing war over conflicts of interest in medicine.

An early skirmish took place last week at the Drug Industry Association's annual conference in Washington, where for-profit CME providers, the field's accrediting agency and industry officials battled back against the activists, academics and congressional investigators who would limit industry influence over the practice of medicine generally and CME in particular.

"Continuing medical education is critical to improving provider outcomes and the studies show there's very little difference in outcomes depending on who funds CME," said Thomas Sullivan, president of Rockpointe Communication, one of the nation's leading for-profit CME providers.

While the bulk of the $4 billion in CME activities presented every year takes place at 123 academic medical centers, more than 400 hospitals and through medical journal on-line offerings, there are 740 national providers of accredited continuing medical education and 1,600 accredited state providers. The nation's 800,000 active physicians signed up for more than 7 million course offerings in 2008, largely because it is a requirement of continued state licensing.

Growing Divide On For-Profit CME

But the burgeoning for-profit sector, composed of medical education and communication companies like Rockpointe, accounted for 30 percent of CME activities and 33 percent of CME income, despite offering just 9 percent of CME credit hours, according to 2008 data from Accrediting Council for Continuing Medical Education. By contrast, medical schools provided 45 percent of CME hours while receiving just 17 percent of income.

It is the offerings of these for-profit companies, which are 80 to 100 percent industry-funded, that would be sharply curtailed if critics of industry-funded CME get their way. Overall, industry provides about half of all funding for CME activities.

The DIA session where Sullivan spoke was entitled, appropriately enough, "Is Industry-supported Education the Next Taboo?" "I don't see it as the next taboo; it's the next opportunity," Sullivan said.

But the movement to limit or even eliminate those opportunities is growing. Indeed, even the DIA conference itself rolled out a new policy of potential conflicts this year, requiring speakers to announce conflicts from the podium and in their slide presentations.

Last year, the blue-ribbon Institute of Medicine report, "Conflicts of Interest in Medical Research, Education and Practice," called for eliminating industry support of CME activities. "Many providers of accredited continuing medical education - a usual requirement for relicensure of physicians - receive the majority of their funding from industry," the study found. Its recommendation: "A broad-based consensus process to develop a new system for funding high-quality accredited continuing medical education that is free of industry influence."

"The IOM report was clear," said Eric Campbell, Harvard professor and IOM panel member. "It suggested the elimination of industry influence from all aspects of undergraduate, graduate and professional practice medical education."

FDA Key-Notes Anti-Industry CME Conference

On June 25, Georgetown University's Pharmed-Out project, organized by professor Adriane Fugh-Berman, an alternative and complementary medicine specialist, will hold an all-day conference aimed at jump-starting a movement to accomplish the IOM goal. She expects more than 100 people to attend "Prescription for Conflict: Should Industry Fund Continuing Medical Education?"

The question in the conference title is rhetorical. "We think industry and education should be separate," Fugh-Berman said. "Industry has no place in the education of health care professionals."

FDA Principal Deputy Commissioner Joshua Sharfstein will be conference keynote speaker. Other speakers include Daniel Carlat, a psychiatrist who runs his own "industry-free" CME newsletter, and Paul Thacker, an investigator on the staff of Sen. Charles Grassley, R-Iowa.

Thacker's prowess in exposing NIH-funded psychiatrists and other academics who failed to disclose their financial ties to industry set the stage for including the Physician Payments Sunshine Act in health care reform. As a result of that law, every drug and device company, starting in 2013, will have to post nearly every payment to every physician, patient advocacy group and CME provider in a publicly accessible database (¹ Also see "Reform's "Sunshine" Clause Prompts Firms To Review Disclosure Web Sites" - Pink Sheet, 26 April, 2010.).

That disclosure of funding sources coupled with ACCME's strict rules against industry influencing CME activities ought to satisfy the critics, said Murray Kopelow, who leads ACCME. The voluntary association accredits more than 2,200 organizations that offer CME classes every year. "Promotion disguised as CME is already against the law," he said. "It's against everything we're trying to do at ACCME."

The critics, on the other hand, contend that by choosing the topics suitable for funding, companies create a platform where CME activities inevitably point learners in the direction of using particular products, and, in some cases, overusing those products. "Health care providers need to be aware that the marketing messages built into industry-funded CME are quite subtle and there is a good chance they won't be able to pick them out," said Fugh-Berman.

While Kopelow recognized the concern, he said ACCME has created a "public health prevention model" to limit those effects. It starts with a professional code of ethics among physician-presenters that they shouldn't let their ties to industry influence their presentations during CME activities, he said. The model ultimately relies on ACCME guidelines that not only require disclosure, but prohibit industry from having any say in the details of the activity.

"There is no influence by industry on the conduct of CME," he declared. "Those are our standards for a self-managed, self-regulated system. Industry may fund CME, but it's not a collaborative process."

Kopelow also pointed out that 42 percent of CME activities have no industry support at all. Two-thirds of providers get less than 10 percent of their total revenue from drug and device companies.

Could Pooling Solve The Problem?

One possible solution for limiting industry's subtle influence over subject choice is to create an anonymous pool for industry contributions to CME, which CME providers could then tap to fund self-chosen activities. Pfizer recently took a half-step in that direction by giving Stanford University Medical School an unrestricted $3 million grant to fund independent CME activities.

Kopelow said an ACCME committee had recommended pooling industry contributions in 2008, but the proposal has languished, largely because most companies have no interest in giving unrestricted grants to fund activities where they have no say over the broad subject matter. He also expressed skepticism about the ability of pooling at the institutional level - the Pfizer-Stanford model - to eliminate industry influence.

"If you just move it to the dean's office, all you've done is move the locus of control," Kopelow said. "You'll have the same possibilities of conflicts of interest influencing the process."

"If it is truly in the interest of industry to support CME, then there wouldn't be any opposition to pooling," Dave Davis, vice president of continuing health care education and improvement for the American Association of Medical Colleges, said at the DIA conference. "The practicalities and arms length nature of it means it probably won't happen."

In any case, it's unlikely that a pooling arrangement will assuage critics. "Stanford is planning CME activities in areas where Pfizer has drugs," charged Fugh-Berman. "I don't think these are areas that would be a first priority if they were independently evaluated."

Downturn In CME

Some industry officials at the conference privately suggested they may get out of the CME business, if for no other reason than it would save money. The recession has meant industry contributions are down significantly. "The sad truth is that over the last year, all support for CME has shrunk, especially on the industry side," AAMC's Davis said. "Yet we did the same number of courses. It's just they were done in a Holiday Inn instead of a Ritz-Carlton. I'll leave it to you to decide which is better."

Davis wondered where support for CME would come from if industry didn't help defray its cost. Eric Campbell, whose research at Harvard over the past decade has documented the extent of industry payments to physicians, replied that physicians themselves ought to pay for the cost of their continuing education. "There is no justification for physicians passing along the cost of their continuing medical education to the American consumer in the form of higher drug prices," he said. "Medicine needs to take back its education."

But Sullivan of Rockpointe, the commercial CME provider, argued that industry-funded CME ought to be encouraged because it is crucial to the diffusion of new products. "If you have the best product in the world and there's no education behind it, that's not very effective medicine," he said.

"It takes forever for physicians to adopt the best practices contained in guidelines," he said. "Doctors are not zombies, but you have to find good ways - like CME - to reach them."

Indeed, the movement away from close involvement with industry is being reconsidered by NIH, which is reconsidering its conflict of interest policies and reportedly airing criticism of an American Heart Association policy that prohibits industry employees from being the lead presenters at educational forums (see ² Also see "NIH's Revised Conflict Of Interest Policy Will Close The Nemeroff Loophole, Collins Tells Congress" - Pink Sheet, 21 June, 2010.).

- Merrill Goozner ( ³ pinkeditor@elsevier.com )

Industry-Funded CME Is Next Battleground On Drug Promotion

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