Under a media spotlight, the CME community is issuing new rules to govern relations between pharmaceutical companies, educators, and physicians.

You've all heard about the escalating trend of dine 'n' dash meetings, where pharmaceutical companies invite physicians for an educational (or, as some argue, promotional) seminar served up with a tasty (some say extravagant) meal. But here's a new twist. Recently a company offered physicians the following deal: they could get a take-out dinner for themselves and their families at the Outback Steakhouse if they agreed to listen to a rep's drug pitch while waiting for their order.

"If I had to pay a doctor to listen to what I had to say, that would embarrass me," said former drug rep David F. Lichtenauer, president of Medical Education Consultants, in Indianapolis. "Why do the companies do it? My God - it works!" he quipped.

The audience laughed, but the atmosphere was anything but light as Lichtenauer kicked off the American Medical Association's 11th Annual Conference on CME Provider/Industry Relations, held September 25 to 29 at the Sheraton Inner Harbor Hotel in Baltimore. The conference, which attracted a record crowd of 376 attendees, couldn't have been more timely. Prescription drug prices and health care were top election issues; and just the day before the conference, USA Today ran a front page story claiming that the FDA's drug approval process was biased, as many of the physicians evaluating the drugs had conflicts of interest. The story was just one of many recent press pieces exposing physician/drug company relations to public scrutiny. (For an analysis of pharmaceutical companies' increased spending on seminars, see "Pharmaceutical Firms Step Up Meetings Activity," page 10.)

"We need to demonstrate that CME provider/industry relations benefit patients," said Lichtenauer. "Otherwise, there will be a trial of the CME community in front of the press and public. It's up to all of us to make sure that doesn't happen."

In the past, the CME community has monitored itself, successfully staving off government intervention. Faced with growing public and press scrutiny, CME leaders are proposing new rules to address old, but growing, problems. But some CME veterans say those approaches are not enough.

Bribes or Benefits? During a packed breakout session on gifts to physicians, Herbert Rakatansky, MD, chair, AMA Council on Ethical & Judicial Affairs, told the audience that he'd recently received an invitation from a sales rep to attend a luncheon program. If he attended, the invite said, he would receive a check for $100. "That's a hundred-dollar bribe," he said. "You have to preserve your trustful relationship with patients and free yourself from bias. If you accept a bribe of one hundred dollars cash, or at trip to Bermuda, you have compromised that relationship."

Under the AMA's Ethical Opinion on Gifts to Physicians from Industry, doctors are supposed to accept gifts of only $100 value or less that enhance patient care, such as textbooks and notepads. Cash gifts are not acceptable, nor are gifts with strings attached. (For the complete text of the Opinion, visit www.amaassn.org/cmeselec/cmeres/cme6.htm#8.061.)

Nevertheless, what Rakatansky sees as a bribe, other physicians see as their due. That's why it's important to re-examine the ethical opinion, said Lichtenauer. "As MD income levels fall, physicians are tempted to take [what companies] offer," he said.

The AMA's Council on Ethical & Judicial Affairs recently developed a working group to revisit its Ethical Opinion on Gifts to Physicians from Industry, address the escalating trend of companies showering physicians with incentives and rewards, and educate physicians. Eight major pharmaceutical companies are supporting the effort with hard dollars, Lichtenauer announced. Pharmaceutical companies were not involved when the AMA created its Ethical Opinion on Gifts to Physicians from Industry, Lichtenauer noted. "This time, industry is sitting at the table."

So far, the group decided not to rescind the resident exception, which allows pharmaceutical companies to provide scholarships for medical students, residents, and fellows to attend "carefully selected" conferences. (Companies are not allowed to underwrite physicians' travel or other meeting attendance costs.)

Eating Orders Next, the group is slated to provide an addendum this month that defines the "modest meal" physicians are allowed to accept under the guidelines.

So, what is a modest meal? For one thing, a physician living on Park Avenue is not going to have the same definition as one living in Lubbock, Texas, said Rakatansky. He said the addendum would probably describe the meal as one a doctor would generally order for him- or herself on a routine basis.

That announcement sparked a barrage of aggravated comments from attendees. "To be compensated for a meal but not for travel seems schizophrenic to me," said one attendee. "I live in New Hampshire and have to travel an hour and a half [to a seminar]. I can't see the clear distinction between accepting the meal and not the travel [costs.]" Another audience member echoed that view, saying that for rural physicians travel costs were an important factor in receiving education.

But physicians shouldn't expect a green light from the AMA on that one. "A meal is intrinsic to the education function," answered Rakatansky.

"These edicts come down from the ivory tower. Most doctors don't feel they are doing anything ethically wrong. Most doctors feel there is no evidence that they are changing their behavior [based on gifts]. They are still prescribing the best drug," said an attendee.

"If the assumption is wrong and industry's gifts to physicians don't influence their prescribing behavior, then an awful of money is spent uselessly," said Rakatansky. "Members of CEJA are not academic ethicists, in an ivory tower. We are all practicing physicians."

But another audience member countered that the AMA "did the industry the greatest favor by [instituting] the $100 glass ceiling."

Toothless Tactics Of direct impact on CME providers is the guideline stating that speakers can accept "reasonable" honoraria. "I offer speakers reasonable honoraria of $1,500 to $2,000," said one CME provider, "and they say, `I'm accustomed to $10,000." Responded Rakatansky: "Hire somebody else."

Such answers did not satisfy some attendees. "As a CME provider, I am frustrated," said Melinda Steele, director, CME, Texas Tech University Health Sciences Center, in Lubbock. "A lot of docs are not aware of the Opinion. I'm bound, as a CME provider, to adhere to it. I have no qualms about it. But unless there are penalties, unless there is something at stake, physicians see no problem [with their relations with drug companies]. As long as there are no teeth [in the Opinion] CME providers will continue to be the bad guys."

Where There's Smoke... In a standing-room-only session, appropriately titled "Managing Ourselves at Boundaries," Murray Kopelow, MD, executive director, Accreditation Council for CME, announced that the ACCME's new firewall was being built, or rather, implemented. Designed to ensure that CME remains bias-free, even if the accredited provider is, for instance, a pharmaceutical company, the firewall specifically sets guidelines for providers that are themselves, or are owned by, "interested companies" - corporations with a financial interest in health care products. (For background, see "ACCME Proposes Firewall to Protect CME," MM June 2000, page 8; for the text, see "ACCME's New Bias-Buster," page 36.)

More than 300 people responded to the initial proposal, and based on those comments, the ACCME revised and clarified the policy, Kopelow explained. The biggest change is that while the proposed version called on providers to seek feedback from attendees as to whether a CME activity was biased, the final guidelines stipulate that providers must go further. If attendees have perceived commercial influence, providers must document the steps they will take to detect and prevent such bias in future activities.

Although Kopelow said that the guidelines apply to only 20 to 30 of the ACCME's 600-plus providers, attendees from a variety of settings fired, numerous questions at Kopelow about how the firewall would pertain to them. We've synthesized the questions and provided the answers Kopelow gave during the session:

Q: Does the definition of "interested company" include vendors, such as communication companies?

A: The firewall defines "interested company" as one under the FDA regulatory jurisdiction. The devil is in the details - we'll see.

Q: The policy says that no "interested company" staff can be involved in CME activities. As you move up in corporate management, bosses that have oversight of products may also have oversight of CME. How far up the corporate hierarchy does that apply?

A: That's a governance vs. management issue. We are not interested in where the stationery comes from.

Q: A member of my planning committee is on a pharmaceutical company's speaker's bureau. Is that all right?

A: I won't answer that here. Call me.

Are You Happy? "Is this right? Are you happy? Is it nonsense?" Kopelow asked attendees after answering the first round of questions.

"I think it's a step in the right direction," said Texas Tech University Health Sciences Center's Steele. But not everyone agreed. Richard Tischler Jr., PhD, president, RF Tischler & Associates Inc., Mount Airy, Md., and former director of accreditation and recognition services for the ACCME commented: "This appears to be the first time the ACCME has defined a class of providers based on the nature of their business and said to them: `You must comply with these additional standards to remain accredited.' That is a potentially dangerous precedent. What other classes of providers will be held to additional standards in the future?"

For at least the last few years, attendees at this conference and other CME meetings have asked the Accreditation

Council for CME for guidance on implementing the Standards for Commercial Support when offering Web-based CME. And, until now, the ACCME responded that providers should view the Internet as just another delivery mechanism, and treat online education just as they would enduring materials or live activities. To those of you hankering for more specific answers, take heart.

The ACCME's initial approach was probably too simplistic, acknowledged Murray Kopelow, MD, executive director, and the organization is now working to develop rules for Internet CME. During a session at the AMA's 11th Annual Conference on CME Provider/Industry Relations in September, Kopelow floated some ideas past attendees.

The major issue, from the ACCME's point of view, is separating promotion and advertising from education. What if, he suggested, when a physician was doing an online CME activity, that window could not be minimized, so that, no matter what, advertisements could not be scrolling around the edges. If that is technically feasible, Kopelow asked, wouldn't that solve the issues?

Attendees responded favorably to that concept, but had questions about disclosure. Under the ACCME's Standards for Commercial Support, faculty must disclose their financial relationships with commercial supporters, and disclose when they will be discussing an off-label use of a drug. Since online CME is nonlinear, and physicians can jump in and out of activities, how can providers ensure that learners see disclosures? Physicians need to see disclosures at whatever point they enter an online activity, pointed out an attendee. Remember the FDA's rule prohibiting an obligate pathway at CME activities? In FDA-speak, that meant attendees should not have to pass by promotional materials when entering or leaving educational activities. Suppose providers created an "obligate pathway" for disclosure so that no matter what, a physician would have to see disclosure statements before participating in a CME activity?

Just one of the many questions for which there are, as yet, no hard-and-fast rules. Stay tuned.

The Bigger Picture The broader Internet health industry is currently taking steps to regulate itself in hopes of avoiding government regulation, said speaker Beth Nash, MD, Mediconsult.com Inc. in New York. Four organizations have issued guidelines toward that end. The CME community paved the way for such ethical standards, she said; in fact, organizations used AMA and ACCME regulations to develop their guidelines. Though the policies cover a broad spectrum of online health care issues, such as privacy and security, "CME Web sites need to adhere to the same set of ethical principles," Nash said.

For more information on ethical guidelines for the online health care industry, visit:

- Health on the Net Foundation at www.hon.org

- Internet Health Coalition at www.ihealthcoalition.org

- Hi-Ethics at www.hiethics.org.

Here's the partial text of the Accreditation Council for CME's newly approved firewall policy:

When the ACCME considers a provider with, or an applicant for, ACCME accreditation, to be owned by, or to be, a corporate entity with a proprietary or financial interest in a medical or health care product over which the FDA has regulatory jurisdiction (an "interested company"), then the following will be among the criteria ACCME will use to judge the provider's compliance with the ACCME's Standards for Commercial Support:

1. There must be no staff or consultants of the interested company . . . involved in the development of the CME activities of the accredited provider or accredited CME unit within the interested company. . . .

2. All in-kind support, or funds, supplied by the interested company to the accredited provider will be considered "commercial support" . . . . (To be compliant with SCS 5 and 7, which cover management of funds and disclosure.)

3. After each activity, the ACCME accredited provider must ascertain directly from the learners and faculty if [they] perceived that the activity was commercially biased, and if [they did], the accredited provider must have documented the steps that will be taken to detect and prevent the presence of such bias in the future. (To be compliant with SCS 1 and 3, which address the integrity and independence of content, and exhibits and other commercial activities.)

Currently accredited providers, to whom this policy applies, will be asked to demonstrate compliance with the policy after October 1, 2001.

For more information, visit www.accme.org.