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Ethical issues in CME, clinical research

From the May 2001 ACP-ASIM Observer, copyright 2001 by the American College of Physicians-American Society of Internal Medicine.

By Phyllis Maguire

Atlanta—Is it ethical to take gifts from industry? Is there a problem when industry helps sponsor College functions and meetings like Annual Session? Is it OK to participate in community clinical research and get paid for enrolling your own patients?

These were some of the issues explored in “Ethical Challenges: Internists and Industry,” a panel discussion presented by the College's Ethics and Human Rights Committee at Annual Session. Moderator Risa J. Lavizzo-Mourey, FACP, Immediate Past Chair of the College’s Ethics and Human Rights Committee, used role-playing and audience participation to reveal the many layers of potential conflicts that physicians face in their career-long interactions with drug companies.

Drawing the line on CME

Dr. Lavizzo-Mourey set up the following scenario, which panel members acted out: A local chapter is planning educational programming for this year’s meeting, but it doesn’t have much in the way of resources.

A physician in charge of planning who is a new member of the local ethics committee remembers the great response at last year’s meeting, where attendees enjoyed free room service, hot tubs and golf. He wants a good turnout again this year, but doesn’t want to raise registration fees. He also has ethical misgivings about what he should and shouldn’t accept from industry.

Dr. Lavizzo-Mourey leads role-playing to explore physician interactions with drug companies.

A fellow physician urges him toward ample corporate sponsorship. “Get real!” exclaimed panelist Lee J. Dunn, JD, a Boston-based health care attorney and Ethics Committee consultant who played a wickedly pragmatic colleague. “Ethics are nice, but they just don’t pay. Good speakers cost money and without them, you won’t be able to get people through the door!”

But if he accepts industry’s speakers, the first physician wonders, will attendees be smart enough to see through their bias?

Solutions

An audience member said that his chapter resolves these types of problems several ways. First, drugmakers and other vendors are allowed to sponsor booths and provide funds for chapter meetings, but all funds must be paid to the chapter, not directly to speakers. Speaker honoraria are modest—$400, for example—and organizers make sure they print the fact that speakers are paid in the program.

Another physician in the audience pointed to a bigger problem: Doctor promotions add to the rising cost of medications. “Promotions to physicians are a long string that’s being pulled that increases the price of health care,” he said.

A physician from the United Kingdom explained that doctors there don’t regard industry as the enemy, but as associates. Drug companies are allowed to give funds to organizations for educational meetings, he said, but they are not allowed to choose speakers or determine meeting content.

“If the pharmaceutical company holds the meeting, then physicians don’t receive any CME credit,” he explained. “And even when they contribute, we eat porridge and oatcakes, not caviar and champagne.”

Panelist David W. Potts, FACP, Governor for the South Carolina Chapter and Vice Chair of the College's Ethics and Human Rights Committee, said that in considering what is ethical, planners should apply the "local media test”: Would you mind seeing a meeting deal you brokered with drug makers reported on the front page of your local Sunday paper?

He said that he has no problem if patients know about unrestricted pharmaceutical sponsorship of educational programs, but he wouldn’t want a local paper to report that drug companies took him out to a $150 prime rib.

Another physician asked how much industry support the College accepted for Annual Session. Dr. Potts replied that about half of Annual Session revenue comes from registration fees, while the other half comes from fees generated by the Exhibit Hall. (He noted that industry-sponsored symposia held in conjunction with Annual Session also help defray the cost of renting the convention center.)

The College also receives money from selling its list of attendees before Annual Session. Exhibitors use the list to send physicians marketing material, although attendees can opt out of those mailings by checking a box on their registration form.

Panelist David A. Fleming, FACP, a member of the College’s Ethics and Human Rights Committee, noted that physicians must find the right balance of marketing and education for medicine’s most vulnerable members: students and residents. One medical student in the audience said that at his institution, drug company representatives can meet only with administrators and are not allowed to approach residents.

That comment led another physician in the audience to comment, “If you wouldn’t send your children out into a world where there’s sex, fast cars and liquor without first talking to them about it, you also have to teach residents about drug reps.”

Several members of the audience commented on innovative programs now taking place at teaching hospitals where attending physicians walk housestaff through drug company slide presentations, pointing out the marketing biases—as well as the vital educational material—that they contain.

Research: contribution or conflict?

The panel presented a second scenario that explored the issue of community physicians doing clinical research. The physicians in the skit were preparing to enroll patients in a double-blinded, randomized trial comparing a new drug for type 2 diabetes to placebos. At issue? A for-profit contract research organization is sponsoring the trial.

Two panel members gleefully portrayed physicians anxious to receive $3,000 for each patient they enroll in the trial. They were also excited about the extra financial “kicker” they will get if they enroll patients within a short timeframe, as well as the prospect of co-authoring published studies.

The would-be investigators claimed that they had no qualms about the contract research organization using a centralized institutional review board. And they were happy that the trial medications would be free to their patients. Because they treat a largely urban population, they said, many of their patients are unable to pay the high cost of drugs already on the market.

After the role-playing session, panelists revealed the potential ethical problems raised by the skit. Patients receiving only placebos may suffer from lack of treatment; financial incentives may tempt physicians to enroll patients who are not ideal candidates; and the chance to co-author studies could lead some physicians to interpret trial data more favorably for the sponsor.

In addition, some panelists said that a centralized review board might not be as diligent as a local one. And while it is true that research subjects get free drugs during the trial, the cost of newly approved drugs is often prohibitive. Getting financially strapped patients used to drugs that patients won't be able to afford if approved may not be the best course of treatment.

Two physician audience members who develop drugs for pharmaceutical companies pointed out that actual community research projects do not necessarily raise the ethical problems presented by the panelists. First, they said, community physicians conducting trials usually do not get to co-author published studies. Typically, only executive committee members are given those opportunities.

The two audience members also claimed that centralized institutional review boards usually operate under the same restrictions as academic centers, so using centralized review board shouldn't be viewed as subpar. And patients given placebos are supposed to receive standard care and be removed from studies if they do not show improvement.

Practicing clinicians in the audience expressed a wide range of opinions. One physician said he had never participated in clinical research because patient enrollment fees struck him as just as corrupt as financial incentives from HMOs to limit patient care.

But another clinician said that he often serves as principal investigator for community trials. He said that 55% to 60% of fees paid to physicians are used to cover overhead, because research projects create work for office staff. The remainder, he said, is reasonable compensation for physician time spent on trial visits and review.

Another physician in the audience noted that academic researchers also get paid for research time and patient enrollment, and face the same conflicts of interest as their colleagues in the community.

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