There have always been faculty members who omit or outright lie about commercial relationships on the disclosure form; and speakers who won't return your calls or send in forms and materials by the deadline. And everyone seems to have a horror story about a speaker who turns into a one-man pharmaceutical company band once the mike's in hand. Now, with increasing commercial support available for honoraria causing speakers to expect — or even demand — higher speaking fees, working with faculty has just gotten a whole lot more complex.

And while you may applaud many of its restrictions, don't look to the new Pharmaceutical Research and Manufacturers of America's Code on Interactions with Health Care Professionals to help when it comes to speaker fees — it only covers consultant fees at training meetings and speakers bureau arrangements, not CME. All you have for now are the rather vague American Medical Association and Accreditation Council for Continuing Medical Education guidelines that honor-aria be “reasonable,” your organization's policies, and your own good common sense. But is that enough to keep your meeting clean and bias-free?

HIGHER FEES, TIGHTER STRINGS

The ever-increasing amounts of cash commercial supporters are paying for promotional events has speakers circling in on the idea of higher fees for CME as well. “There have been times (and they're becoming more frequent) when a speaker will ask me if he's being sponsored, and if so, by whom. They ask because they know what fee the drug companies are paying them for promotional events, and they feel they should get the same amount for CME-accredited events,” says Selina Mirza, CME conference manager with the Texas Academy of Family Physicians in Austin.

While Mirza just says no to excessive demands, others may be persuaded to comply under certain circumstances. R. Van Harrison, PhD, thinks this is an ominous trend. While CME organizations usually do have their own guidelines for honoraria, “things start to fall apart when a company comes to the provider with a big wad of money in hand, saying ‘We'd like to support you to do this, and here's what we usually pay for someone of this caliber,’” he says. “So an institution begins to shift from its standard to someone else's standard.

“There are many subtle inducements that go along with letting someone else set honoraria,” says Harrison, who is the CME director with the University of Michigan. For example, many educational organizations use their own faculty, who speak gratis as part of their position responsibilities. But in a biennial medical school survey Harrison conducts, several respondents this year said they made an exception to their policy when there was commercial money available to pay their faculty. “I read this to say, ‘We usually don't pay, but if someone is willing to pay for our faculty to do a certain course, we should take it — it's a nice thing to be able to do for our faculty.’ They don't stop to think that this is an inducement to shift your organization and faculty to be more favorable to certain types of programs.”

A decade or so ago, Harrison had written into his institution's honoraria policy that “the availability of support to pay higher honoraria is not justification to pay higher honoraria. If additional funds are available, they should be used in ways that further the mission of the institution, period.”

Linda Wilhelm, director of education and organizational development, Floyd Medical Center in Rome, Ga., adds, “We would not accept $2,000 for a speaker who's just driving up from Atlanta for the day. We would never go above our maximum, because then the influence seems to shift from the education to the money.”

FAIR MARKET = FAIR FEES?

In a letter sent to leaders at the Association of American Medical Colleges, ACCME, and AMA in March, Harrison said, “Some CME providers — particularly for-profit companies that derive most of their funding from industry — honestly believe that a reasonable amount is what the market will bear, specifically what the commercial company funding the activity is willing to pay. Some faculty agree that this is the definition of reasonable…. And with this circular definition, any honorarium that is paid is by definition ‘reasonable.’ How can anyone complain that your guidelines concerning honoraria amounts are ever being violated?”

Many, most notably folks in the communication company community, do tend to use a fair-market definition of reasonable. Jacqueline Parochka, vice president and director of education with Discovery International in Deerfield, Ill., says that while most medical education and communication companies work within similar price ranges, “The high muck-a-mucks generally get what they ask for. If you want the top dog, you pay for the top dog.”

“There are no hard-and-fast rules,” says Richard Tischler, PhD, president of Viator Medical Communications Inc., Mount Airy, Md. “It's a negotiation process in which the potential speaker is acting as a sort of entrepreneur at times. They supplement their incomes — some to a great degree — with speaking engagements. Some speakers make more in a series of morning presentations than what most of us make in half a year. But I don't think you can say they're being unfairly compensated if you believe in a market economy.”

Murray Kopelow, MD, chief executive of the Accreditation Council for CME in Chicago, has a bit of a problem with that notion. “The issue is that the market forces that drive speaker prices are not the competitive forces between CME providers; they're the competitive forces between the commercial companies, which have different mind-sets and goals than CME providers.”

Which leaves CME providers on their own when it comes to defining what's reasonable. Veronica Baez, CME administrator with the Arizona Heart Institute Foundation in Phoenix, says, “We always revert to our honoraria policy, and actually faculty tend to respect my organization for sticking to it.” And for Wilhelm, it's not just a matter of what's reasonable, but also what's fair. “If I pay one of our local speakers $250, and he finds out the guy next door got $1,000, it hurts my credibility, and I'm going to have a hard time getting that speaker again.”

One way to combat the trend is to sit down with new industry reps and explain the ACCME guidelines and your organization's policies — and how it actually benefits the supporter to stay within boundaries. “They may know what their legal department requires, but they may not know that working with a CME provider gives them the protection their legal department is looking for,” says Baez. “Our restrictions help the companies by giving them the distance they need. But ultimately, it's our image that's on the line. Our audience needs to know that our event is unbiased — it is not a cloaked pharmaceutical event.”

She adds that CME providers can counter demands for higher fees by being more aggressive about pointing out the benefits of their programs. “Here's my track record as a CME provider, here's the kind of audience I can bring in, and here's the visibility I'm providing for the physician and the company. CME providers need to show them the benefits of working with us.”

THUMBS DOWN FOR FEE-FIXING

Despite the widely differing opinions on how to set what should be considered reasonable honoraria for different types of faculty, most CME providers balk at the idea of a mandated cap on how much money can go toward speaker fees. “Standardizing honoraria is not going to happen,” states Parochka. “It doesn't happen in other professions, why should it happen in ours? Why should a physician who has written and published widely get the same price as someone who hasn't done those things?”

“I'm in business helping organizations deal with regulation,” says Tischler. “I don't want to be regulated myself! I want to have room to negotiate, and I think some of the speakers do as well. Putting a cap on it is, in my opinion, unreasonable.”

Karen Overstreet, executive vice president, operations, Nexus Communications, North Wales, Pa., joins in the anti-cap chorus. While the vagueness of the current guidelines “does make our job as providers more difficult, I'd hate to have some sort of regulation that ties our hands,” she says. “You have to walk a fine line between flexibility to compensate speakers for their time out of the office, and regulation in order to be able to do our jobs. We need to be able to use our own judgment as professionals.”

Harrison notes that while he's also reluctant to put a cap on honoraria paid, it might be reasonable to limit the amount of commercial support going toward an honorarium. For example, say the maximum total commercial support could be $750 or $1,000. “If the accredited provider decides that a higher amount is appropriate, registrant fees or other revenue sources could be used to make up the total amount,” says Harrison.

Wilhelm suggests that national guidelines would be useful — especially if CME providers across the country worked within those guidelines. Most providers contacted for this article say guidelines outlining broad ranges for speakers based on compensation for time spent out of the office — fee ranges for one-hour local presentations; half-day and full-day activities; and regional and national programs — would be welcomed with open arms. “We'd have a lot of strength when negotiating with faculty. They wouldn't be able to say, ‘but the hospital down the road paid me $2,000,” she says.

“There's definitely a gap there that hasn't been addressed,” says Kopelow. “We need to start a discussion on a national level to find out what the value system is, and what kind of policy we need to put in place to address it — if any. The issue of what constitutes ‘reasonable’ honoraria will be high on the ACCME's priority list over the next year.”

LIES, SLIDES, AND VIDEOTAPES

But honoraria is only one fish in the CME speaker sea. While the ACCME provides guidelines to help providers uncover any potential bias beforehand, there's only so much you can do to make sure speakers actually comply.

As Leslie Ingraham, director of continuing medical education, coordinator graduate certificate in public health, College of Osteopathic Medicine, University of New England College of Medicine, Biddeford, Maine, says, “Short of reading a presenter's mind, we have very little to go on except what the speaker discloses to us.” Adds Mirza, “The funny thing about speakers is how many are not honest on their disclosure form.”

Most providers say they try to talk with speakers up front to make sure they understand what is required and why. Baez says, “We make it very clear to the speakers and the supporting companies right off the bat that the funding comes directly from us. If we're clear about that, they're willing to do whatever they need to do to make sure that that faculty member can participate. Of course, we document all conversations via e-mail, letter, or fax, so it's very clear what everyone's signed off on.”

But getting them to submit and sign off can be sticky. “The organizations I've worked with in the past always required speakers to submit their slides and any of their materials ahead of time so they can be reviewed,” says Overstreet. “These speakers tend to be very busy, and sometimes working with other organizations can be low on their priority list. A CME provider may be working with a faculty member who's on a [pharma] speakers bureau, which should be on the disclosure form, but sometimes you're working with the faculty long before the disclosure form comes in.” (For an explanation of how speakers bureaus work, see sidebar page 41.)

“I've run into speakers on speakers bureaus who won't even talk to me,” says Wilhelm. “But I'm not comfortable bringing in a speaker who would not have direct contact with me — we've decided to cancel programs in those cases rather than end up with severe miscommunications.”

She had to learn this the hard way: A few years ago, her organization was putting together a program on alternative medicine and cardiology. She communicated that topic to the drug rep, who provided the curriculum vitae of several possible speakers. “We selected one, and communicated to that speaker what our topic was. We never heard back from the speaker until our program's date was near. That's when he told us the drug rep had told him to give a talk on [a particular drug]. We canceled the program, and that drug rep didn't work with our programs anymore. If the speaker doesn't return all the materials in a timely manner, I'm stuck behind the eight ball.”

Mirza nudges them by sending lime green or neon orange speaker reminder cards, stamped on the front with messages like “Past Due” or “Urgent” as deadlines draw near. “Speakers remember those ‘obnoxious’ reminder cards they keep getting from me!” she says.

Baez says it also helps to make it absolutely clear that you are the ones who conduct all conversations with the speaker as soon as the agreements are signed. “A communication company can speak to us, but we speak to the speaker. Everything has to go through us so we can ensure that it will be completely unbiased and that the speaker is indeed covering the topic our audience is expecting.”

PROVIDERS AS BIAS-BUSTERS

Even when faculty submit their materials and forms on time, determining potential bias can be tough. Most CME providers are not content experts, and they often have to delegate the responsibility for objectivity and balance to their speakers, authors, and physician CME committees. But not always: “Part of the challenge is to be able to go to a high-powered speaker and say ‘I'm not a physician, but this stuff looks really biased.’ One of the job requirements is to be a diplomat,” says Tischler.

And when they hit the podium, all bets are off. “Once they get up and start talking, you can't control what they're going to say,” says Tischler. “You're often dealing with high-powered people who are used to acting without too much regulation. You can't restrict them too much when they're giving their opinion. They should be able to back up their opinion, and be able to be challenged by the CME audience, which has been fully informed of their financial relationships.”

Kopelow says that CME providers should not have to be put in the position of trying to be bias police. “That's like putting the responsibility for spouse abuse on the beaten wife. That provider may want to go to the faculty member and say ‘Don't you have any morals and ethics? Don't you know the difference between right and wrong?’ But no one should have to do that. What we expect is that any well-respected expert is going to say that to himself.” But the problem is that all too often, they don't.

The current disconnect comes from the fact that the nature of speaker-commercial entity relationships has yet to be addressed sufficiently, says Kopelow. Faculty “are ethical and principled professionals, and they will behave properly once they know what proper is. We haven't been very explicit on that up to now, but the issue of how conflicts of interest and disclosure impact professionalism is something that needs to be addressed — and we need to do it without accusing people of being corrupt, or wrong, or evil. That's not what this is about.”

But until that takes place, Ingraham wonders if “the best that we as responsible CME providers can do is to include in our attendee packets, or on a brochure, or on a sign or slide displayed at the educational sessions, a statement that reminds the audience that while all reasonable steps may have been taken to ensure a balanced, unbiased program, personal or professional bias may be present. In that case, the CME provider can assure the audience that they should feel comfortable pointing out their perceptions, and that all possible remedies will be applied, if necessary.”

And most attendees do tend to be like Mirza's: not at all shy. “Our attendees give us written comments specifically detailing any instances of bias.” She then sends copies of the evaluations to all her speakers, and brings any bias issues to their attention. “If the Academy chooses to use that speaker in the future, we will remind the speaker that they are not to be commercially biased toward a particular drug simply because they serve on a drug company's speakers bureau. If the speaker fails to follow our rule, the Academy refuses to use that speaker again, and we do not hesitate to let pharma companies who want to use him or her know about the problem as well. We also alert the company that provides us with a grant about this policy.”

As Wilhelm says: “It's not the drug company's program or the medical communication company's program. It's our program. We're committed to doing it right.”

Inside the Speakers Bureau

Many pharmaceutical companies recruit, train, and pay professionals to speak about their products. These speakers are available for promotional and non-CME-accredited activities through a speakers bureau. The bureau also may include a set of professionals with expertise in a specific clinical area involving the company's products. These speakers are made available for CME-accredited events. Pharma sales reps often are involved in suggesting faculty from their company's bureau for a specific activity, which is perfectly OK under the Accreditation Council for CME's Standards for Commercial Support — as long as the choice of speakers remains with the CME provider.

These speakers can be, and often are, physicians at the top of their therapeutic area, but there can be conflicts of interest and the potential for bias by virtue of the nature of the arrangement. Selina Mirza, CME conference manager with the Texas Academy of Family Physicians in Austin, is wary of presenters who are affiliated with a pharma speakers bureau. “My experience shows me that any time a speaker does disclose what bureaus he or she belongs to, most likely he or she will be biased in some way,” she says. “I've had speakers actually say, “Oh, XYZ company is supporting the activity, so I better make sure to put the emphasis on the XYZ drug.”

However, Richard Tischler, PhD, president of Viator Medical Communications Inc., Mount Airy, Md., says, “There is a set of speakers that speaks about a specific drug, and another set that speaks about a particular therapeutic area in which that drug lives — and sometimes, the same people are in both sets. It's not impossible for faculty members to forget which talk they are supposed to be giving. But it's usually a mistake; it's seldom the case where it was an overt commission of wrongdoing.”

Widen Your World View

It's all too easy for CME providers to get so caught up in the details of their everyday work that issues outside of their normal purview don't make it onto the radar screen. But they should, says R. Van Harrison, PhD, the CME director with the University of Michigan, because there are lots of factors that directly and indirectly affect CME and CME faculty that you may not be aware of.

For example, he warns that CME providers can be left out of the loop when it comes to the many ways in which commercial entities are entwined with their own institutions. Clinical research trials, formularies, and other areas of commercial involvement may influence decision-makers in their faculty and CME commercial support decisions.

And, while Murray Kopelow, MD, chief executive of the Accreditation Council for CME, believes that the current disclosure rules are fine, it's not enough to have faculty disclose — someone has to act on the disclosure information. “Learners can become more discerning, learn to have higher expectations about education. Then when relationships are disclosed, they can say, ‘Thanks for disclosing that, but now you're not eligible to teach us.’ Or CME providers can do what some specialty societies do and say they're going to do CME like organic food in a grocery store — completely commercial-support-free. Disclosure needs to be a part of the screening process.”

But not all industry relationships are created equal. “Receiving pharma money for a research project that has no obligations to the firm is a little different than being paid $45,000 a year to be on a speakers bureau where you're out if you say the wrong thing,” says Kopelow. So some screening criteria would need to be put in place if providers begin to use disclosure as an eligibility requirement. “Say if someone receives a certain proportion of their income from industry, or is a certain standard of deviation from the norm, that defines the role, and they'd be out of the loop. This is something ACCME needs to work on with the CME community and enterprise.”