by Dan Vergano
March 9, 2000
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At first glance, Harvard Medical School and advertising giant Omnicom Group seem to have little in common. But they share one trait: the right to award medical education credits that doctors need to keep their licenses in 34 states.
Omnicom, working through subsidiary Pragmaton, is one of a growing number of advertising and marketing firms that provide continuing medical education (CME) courses for physicians. The firms are fully accredited, but because the marketing firms often are working for pharmaceutical companies, the practice increasingly is setting off ethical alarms.
"It is unconscionable," says Catherine De Angelis, editor in chief of the Journal of the American Medical Association.
Marketing firms "advertise wares under the guise of medical education," she says.
But advocates say commercial CME courses use faculty from top medical schools, ensuring objectivity, while delivering updates on drugs to the medical community more quickly than academic educators.
"Companies live through education" to ensure new products are used appropriately, says Bert Spilker of the Pharmaceutical Research and Manufacturers of America in Washington, D.C.
Without commercial CME firms, "you won't find enough Mother Teresas to provide everything doctors need," says Michael Scotti, a CME official with the American Medical Association. His organization is one of the seven medical groups that charter the Chicago-based Accreditation Council for Continuing Medical Education (ACCME), the office that accredits courses nationwide.
The drug companies provide "unrestricted" grants to the marketers, who hire the course faculty. But growing numbers of critics say there's nothing unrestricted about the involvement of pharmaceutical companies.
They fear that CME firms, which widely refer to course sponsors as "clients," stack their programs with faculty physicians overly friendly to their sponsors' products. Sponsors get a chance to market their products directly to doctors in a venue disguised as education, critics say. In fact, one company, Indianapolis-based Eli Lilly, is directly accredited for CME, raising further concerns.
Regulations going into effect in June promise higher standards of separation between grant providers and course faculty, but critics say they are weak and unenforceable. Meanwhile, attempts to change the practice have been rebuffed even as the number of commercial providers has increased. Last spring, a resolution condemning accreditation of commercial CME firms, signed by educators from 47 medical schools, was offered to the Society for Academic Continuing Medical Education. In November, the document was tabled because of "the possibility or likelihood of grant money to universities being reduced by pharmaceutical companies," says one of its authors, Ruth Glotzer of Tufts University School of Medicine in Boston.
In February, a federal appeals court turned away the Food and Drug Administration's latest bid for oversight of the CME industry, reaffirming a decision made on freedom-of-speech grounds.
Patient's best interest?
The concern comes at a time when pharmaceutical influence on doctors is under scrutiny. A January study in the Journal of the American Medical Association found that company-sponsored courses mentioned positive effects of the companies' drugs 2.5 to 3 times more often than other courses. Swayed by such marketing, doctors prescribed the sponsors' drugs 5.5% to 18.7% more often afterward, according to the study, without giving competitive products a similar bounce.
Critics fear that what's in the patient's best interest won't always be the determining factor when a doctor scribbles out a prescription.
They point to firms such as an accredited company called Interactive Medical Networks (IMN) of Rockville, Md., which promises pharmaceutical companies "a collaborative process with a provider who shares your expectations" on its Web site (http://www.cmemuscle.com). In translation, that means commercial grant providers can freely recommend faculty for courses, IMN head Jan Perez says. "If they're interested in Dr. Jones or Dr. Smith, we try to work with them."
Under current conditions, "it's up to doctors to identify who's shilling for a company," says cardiologist Richard Conti of the University of Florida at Gainesville, editor in chief of Clinical Cardiology.
Despite believing that the CME system works well overall, Conti wrote an editorial last year calling for all providers to have independent monitoring committees to ensure objectivity.
"We recognize that concern," says Murray Kopelow, head of the ACCME. Under the standards going into effect in June, parent companies of commercial CME firms must possess a mission "congruent" with medical education.
Kopelow says commercial course providers will meet the standards if they maintain a "firewall" between corporate departments whose mission is selling advertising to drug companies and the people preparing medical education courses.
Paying for the system
Accredited course providers report about $900 million in annual income to the ACCME. More than 40% of grant funding from drug and medical device firms goes to the 25% of those providers consisting of commercial organizations, not the medical schools and societies that control other aspects of physician training.
"We work the same way academic centers work," says Dennis Hoppe of Chicago-based Pragmaton. At the insistence of clients, employees involved with education cannot have a role in advertising activities. In addition, the company hires external doctors and pharmacists to review programs for objectivity.
Pragmaton has higher course standards than his hospital, says psychiatrist Michael Easton of Rush Presbyterian St. Luke's Medical Center in Chicago, a review board member.
If the accrediting group arbitrarily banned commercial firms from offering CME, it would result in a class-action lawsuit aimed not only at the organization, but also against critics, says Jack Angel, head of the Coalition for Healthcare Communication, an industry trade group. "As long as we meet the same standards, we have a right to participate," he says.
"Baloney," De Angelis says. "Show me one of their programs where (faculty) physicians push drugs not made by the sponsor."
On the industry side, Angel says academic providers may be complaining about commercial providers more for competitive than altruistic reasons. "They want more of the action."
Few physician complaints
In response to the dispute, Kopelow says, the ACCME has considered requirements that independent monitoring committees oversee all providers. But even with the new standards, critics note other potential problems with the group's oversight:
* Providers get to pick in advance which monitors review courses for objectivity.
* No requirements ensure that physicians take courses relevant to their specialties.
* No explicit requirement exists for physician involvement in CME planning.
"We rely on faculty professionalism to a large extent," Kopelow says. Industry participation in medicine is standard practice, he says, citing such examples as for-profit hospitals and health maintenance organizations as "the way we do things in the United States." Private companies offering CME simply reflect that phenomenon, in his view.
The required disclosure of who finances a course and of any faculty ties to corporate sponsors goes a long way toward ensuring doctors who take CME courses know where advice is coming from, Kopelow says. "We have millions of eyes out there watching" in some 600,000 annual hours of accredited courses.
Over the past three years his organization has received 56 complaints about programs, 14 resulting in warning letters. But some point out that doctors who want to renew their medical licenses have little incentive to call into question a program that helps them reach that goal.
"Patients should be concerned about this," Glotzer says. "The job and responsibility of these firms is to market drugs, not to teach doctors."
Disputes over industry involvement in medicine extend into many areas, some physicians note.
"It's somewhat insulting to think that doctors don't have inquiring minds that can tell the good from the bad," says Dolores Bacon of New York Presbyterian Medical Center.
"There's a huge variability in commercial (CME) programs," she adds. "Ultimately, as physicians, our job is to be informed consumers."
Correction: A report in Thursday's newspaper should have mentioned that continuing medical education firms enjoy the right to designate which of their courses will be reviewed for objectivity by the Accreditation Council for Continuing Medical Education.