Drug Money

Meetings & Conventions - Drug Money - May 2003 Current Issue
May 2003

Living large: (right) The Gaylord Opryland in Nashville and (left) the Hyatt Regency Huntington Beach (Calif.)

Drug Money

New rules force planners to crack down on pharmaceutical sponsorships

By JONATHAN VATNER

This year, for the first time, Mary Mireles was unable to sell enough exhibit space to fund the annual meeting of the American Medical Students Association. The students would have to subsist on pizza for lunch, even after paying a substantial registration fee, and the meeting was in danger of being reduced from four to three days.

The problem? AMSA is “pharm-free,” meaning it doesn’t allow pharmaceutical company sponsorship at its meeting. In the down economy, forgoing such a lucrative source of funds is a painful proposition.

“The students have taken a stance that they just don’t want to be unethical,” says Mireles, advertising coordinator for the Reston, Va.-based association. But that doesn’t make her job any easier. “We’re two weeks out,” she said in March, “and I’m supposed to sell more booth space, yet I’m turning money away.”

In fact, accepting drug company dollars is no longer an option for Mireles. In spring 2002, the House of Delegates, AMSA’s legislative body, passed an official resolution that barred the companies from its meeting while urging members not to accept gifts from providers not even those ubiquitous logoed pens.

AMSA is attempting to buck a very entrenched system.

“The pharmaceutical industry spends more on marketing than it does on research,” says Dr. Eric J. Hodgson, president of AMSA. Indeed, according to a report by Families USA, a Washington, D.C.-based nonprofit organization devoted to ensuring universal high-quality health care, eight out of nine top pharmaceutical companies studied spent more than twice as much on marketing and administration as they did on research and development in 2001.

Another study found the companies spend, on average, between $8,000 and $13,000 on individual doctors for marketing purposes. This money typically goes toward medication samples, gifts and symposia, some of which are infamously lavish. “And that cost is being passed on to patients who have to choose between food and medicine,” says Hodgson.

The mere fact that pharmaceutical companies pay for medical education from their marketing budgets “should speak for itself,” says Dr. Arnold S. Relman, former editor-in-chief of The New England Journal of Medicine.

Relman, Hodgson and other critics argue that aggressive drug marketing influences prescribing practices, is particularly biased in favor of new, expensive brands and sometimes even promotes incorrect uses of medications.

Some of the claims are buttressed by research. In a review of 29 studies about the impact of drug marketing, the Journal of the American Medical Association found that a pharmaceutical firm’s sponsorship of continuing education, including paying for doctors’ attendance and meals, tends to steer future prescribing toward that company’s products.

“It isn’t enough for you to say, ‘My professional judgment can’t be bought,’” says Relman. “If it didn’t pay off in influencing sales, the companies wouldn’t do it. They’re not out to give charity.”

Shady ethics
To be sure, medical associations are well aware of influence peddling, and most have guidelines concerning sponsorships and the promotion of medicines. But when pharmaceutical companies fund meetings, they find ways around restrictions, according to Dr. Dean Whiteway, a physician at Gundersen-Lutheran Medical Center in La Crosse, Wis.

For example, says Whiteway, associations have long required that all educational grants be “unrestricted,” meaning the pharmaceutical company has no say in the content of seminars. Almost inevitably, though, the drug companies get their fingers into speaker selection or meeting planning.

In one common scenario, an association chooses its own speakers but then allows a drug company to take them out to a fancy dinner for what Whiteway calls “preparation.” The drug firms “are very careful not to tell speakers what to say,” he says, “but the implication is there: ‘You’re doing this for us, and we’ll do this for you.’”

“There are many ways the pharmaceutical companies can get around the regulations,” adds Relman. “They can provide retreats for physicians whom they consider to be consultants or whom they’re training to be speakers, under the guise of consulting. Those outings are very lavish.”

At meetings, associations keep the pharmaceutical exhibits separate from the educational sessions, but Relman believes the promotion is so over-the-top that the divide doesn’t matter. “The question is, how much ballyhoo should be allowed?” he asks. “How many posters, how many signs, how many drug reps? Some medical conventions are just like shopping malls.”

New regulations
In light of increasing criticism from doctors and the media, and to avoid government regulation, the drug industry is making an attempt to clean up its promotional efforts. Last year, the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA), a major association of pharmaceutical and biotechnology companies, updated its Code on Interactions with Health Care Professionals “to help us to remove the perception of anything inappropriate,” according to a spokesperson. For example, under the code, pharmaceutical companies are not to pay for extravagant meals or to finance the travel for attendees.

Other groups are following suit. The Chicago-based Accreditation Council for Continuing Medical Education recently updated its set of prohibitions, first released in 1992, as did the Council of Ethical and Judicial Affairs of the American Medical Association.

The federal government has issued its own guidelines to keep pharmaceutical companies honest. In 1997, the Food and Drug Administration released a Final Guidance on Industry-Supported Scientific and Educational Activities; this year, the Office of the Inspector General is finalizing its own roster of rules for pharmaceutical-sponsored meetings. (For more details, see “A Guide to Guidelines,” this page.)

Whether such moves have changed anything is up for debate. “It would be difficult to gauge any effect,” admits PhRMA’s spokesperson. “We are not monitoring it.”

Perceptions rule
For their part, many pharmaceutical planners say they care less about specific rules than they do about the overall perception of a meeting. But here they tread a virtual minefield.

For example, planners considering a property with the word “resort” or “spa” in its name might risk raising some eyebrows. But think about the number of hotels that added spas in the late ’90s are they all out of the running?

Nancy Clow, meeting manager at the U.S. headquarters in San Diego for Dublin, Ireland-based Elan Pharmaceuticals, does not shy away from such properties, or even four- and five-star brands, as long as she can justify why she booked that hotel. “The higher-tier properties are dropping their rates substantially,” she notes. “Yes, we went to Ritz-Carlton, but look at the price.”

Judy R. Johnson, president and CEO of Rx Worldwide Meetings in Carrollton, Texas, says doctors rarely see the light of day, particularly during the investigator meetings she plans, which involve long hours devoted to drug trials. The perks of a comfortable bed and a nice meal the night before is important, she says, adding, “You have to show respect for their interest and time.”

“You have to look at your customer, the doctor, who is spending 10 hours in a meeting room,” says Marly Hays, meeting manager at Phase V Communications, a division of Gray Healthcare Group Inc. in New York City. “Why not have a nice meeting? Why not have good food?” As for gifts, long gone are the days when pharmaceutical firms gave out sets of golf clubs and tickets to sports events. “Today, I hear about people giving out stethoscopes,” says Johnson, who opts for practical leather-encased travel clocks, if she even is allowed to give something.

Some pharmaceutical companies have become so fearful of being the next subject of a 20/20 exposé that top-tier properties are out of the question, no matter the rate.

“I’ll get a rate at a top tier of $199, but we’ll go to tier two for $249,” says Hays. While she is doing her best to navigate among such properties, she is concerned that the level of service attendees are experiencing will reflect poorly on her job performance. “One CSM is working on 10 meetings at once,” says Hays. “The staff doesn’t care very much and it shows. People aren’t being checked in properly and they’re not looking to blame the hotel. They are looking at me. They don’t realize that when things are flawless, it’s because you’re booking good vendors.”

Working with restrictions
The increasing pressure of regulations isn’t fazing Wyeth Pharmaceuticals. “We took an active role in the creation of the new PhRMA guidelines,” says a spokesperson for the Madison, N.J.-based firm. “Our goal is not just to comply. We’ve been ahead of the curve on this issue.”

Wyeth continually trains its representatives to maintain the company’s principles and performs frequent checks. Among its restrictions for sponsoring a seminar (or CME, for continuing medical education), the pharmaceutical firm compensates only the physician’s expenses, not the spouse’s. In addition, Wyeth doesn’t hand out promotional gifts not even pens.

However, in the shadow of new rules coming this fall from ACCME, meeting planners increasingly are assuming the role of ethics watchdogs. If they and their groups’ CME committees aren’t careful, their associations could lose accreditation. Despite this worry, many planners find the regulations important to maintaining credibility.

“The rules are not burdensome,” says Kathleen Debenham, CME director for the Washington, D.C-based American Psychological Association; instead, she considers them helpful in keeping drug companies and associations on the same ethical page.

Others, however, fear that ever-stricter guidelines might do more harm than good.

“They’re trying to tighten it too tight,” says Patricia Cozad, CME coordinator at Salem Hospital in Salem, Ore. Already, pharmaceutical money for meetings has diminished, she notes, and the hospital now keeps all meetings but one on site. To worsen matters, Cozad says the new ACCME guidelines promise to complicate speaker selection. For instance, one guideline would bar anyone with a possible commercial interest in pharmaceutical companies from taking part in an educational program. Thus, an expert who has been involved in pharmaceutical research might not be able to speak about a class of medications he has studied. “We’re going to lose some major national speakers,” Cozad says.

Likewise, Beth Hunter, CME coordinator for the Birmingham, Ala.-based American Society for Reproductive Medicine, says the new guidelines will mean that “if Eli Lilly makes a menopause drug, an affiliated speaker might not be able to speak on birth control. These are usually the leaders in that particular area. We will be hard-pressed to find someone who can speak knowledgeably.”

Due to the impending rules, Hunter has had to make serious changes to CME schedules in the midst of the planning stages. Also, to keep from making an ethical faux pas, ASRM has stopped coordinating with third parties, who typically are hired by medical firms. “From our perspective, we will do everything we can to make sure we’re clean,” says Hunter.

The rules are more of a mixed bag for Felix Niespodziewanski, manager of conventions and meetings for the Chicago-based American College of Surgeons. “It’s going to make things a little bit more difficult for us, but that’s not the issue,” he says. “The more important part is to make sure we’re complying.”

Shrinking support
As the potential for promotion during medical meetings disappears, so do the unrestricted grants from drug firms. Thus, one side effect of heightened regulation is a drop in funding for many meetings.

“The pharmaceutical companies are seeing their budgets clash with the new regulations,” says Jan Murdock, director of education for the Portland, Ore.-based Foundation for Medical Excellence, a nonprofit foundation that administers CME programs to local physicians. “The funding definitely has become weakened over the last five years.”

In response to diminished support, some CME providers are trimming their programs. Planners say funded dinners nearly always include an educational presentation, while other meals are kept spare and recreation is no longer paid for.

“Gone are the days of major budgets designed to wow participants,” says Merrill Corry, senior vice president and director of meeting services of MediVia, a medical education and marketing firm based in New York City. “Now we’re really focused on the meeting objectives.” Some planners, however, are able to find alternative backers. Murdock, for example, has sought individual contributions to keep up his foundation’s programs. A group such as the Chicago-based American Dietetic Association can rely on food companies to fund the meeting. And Mary Mireles, who cannot bring in exhibitors from pharmaceutical companies or the armed forces (the medical students oppose the military’s policy on homosexuality), is approaching other government agencies, medical equipment manufacturers and hospital residency programs for backing.

Meanwhile, it still helps to be big to avoid monetary problems. “We haven’t noticed any changes in spending,” says Pat Johnson, program director for the Chicago-based American Dental Association’s annual meeting.

Tougher rules and alternate sponsors might help, but “it would be better for the medical establishment to be totally in charge of their own CME and not be beholden to anyone for support,” says Dean Whiteway. “If this will ever happen, I don’t know.”

When he gives presentations, Whiteway takes steps to keep things honest. He refuses slides offered by the sponsoring pharmaceutical company and donates his honoraria to the foundation in charge of the meeting.

Relman, too, believes the most important form of regulation “has to do with general good taste and professionalism. The professionals can choose to be casual and fairly nonrestrictive, or they can take a stand,” he says.

Additional reporting by Carla Benini

Privatizing Education

Pharmaceutical companies are not as focused on unbiased education as they claim, according to Dr. Arnold S. Relman, former editor-in-chief of The New England Journal of Medicine. One way they have sidestepped the guidelines, he says, is by separating themselves from the meetings while maintaining financial control.

How so? Drug companies hire MECCs (medical education and communication companies), which plan medical conferences, seminars and retreats. More than 100 MECCs are accredited by the Accreditation Council for Continuing Medical Education to give educational credits to doctors. Hundreds of others are not ACCME accredited. In either case, MECCs are entirely funded by drug companies.

“This astonishingly incestuous arrangement makes it clear that research and education have both become subordinate to sales promotion,” Relman wrote in The New Republic.

But are MECCs lackeys of the drug industry? Merrill Corry, senior vice president and director of meeting services of MediVia, a medical education and marketing firm based in New York City, says her company keeps ethical lines clearly drawn. It is her job, she says, to know industry and federal guidelines so seminars can be held without being under a cloud of suspicion. “When we work with a pharmaceutical company, we’re looking to support a fair balance,” she insists. “My clients don’t want to skirt the issues.”

• J.V.

A Guide to Guidelines
Pharmaceutical and other medical organizations and governmental agencies alike keep tweaking their guidelines on ethics issues. Here is a summary of the latest rules and recommendations.

PhRMA
The Code of the Pharmaceutical Research and Manufacturers of America, aimed at pharmaceutical companies and updated last year, calls for dramatically reduced spending on the perks of medical meetings. www.phrma.org

ACCME
The Accreditation Council for Continuing Medical Education has authority only over organizations that want to be accredited, a process that is all but mandatory in these times of ethical tiptoeing. New guidelines, still under review, require that no one with commercial interests in pharmaceutical companies be allowed to participate in the educational component of a meeting. Even if a company is sponsoring education, its product information cannot be given out to doctors at the session. www.accme.org

AMA/CEJA
The Council of Ethical and Judicial Affairs of the American Medical Association continually updates its rules for physician conduct. Basic guidelines stipulate that doctors should attend only meetings that will be of educational value and should not accept anything from pharmaceutical companies that could imply future obligations. www.ama-assn.org

FDA
The Food and Drug Administration’s guidelines, published in 1997, fall on pharmaceutical companies’ shoulders to uphold, though planners should take note. The FDA says promotion must be separate from education to prevent misleading information from reaching doctors. This means speakers should not be chosen by pharmaceutical companies, and attendees must know if speakers have ties to such firms. Multiple brands of medication must be presented on equal footing, and only FDA-approved uses may be discussed. www.fda.gov/cder/guidance/isse.pdf

OIG
The Office of the Inspector General’s rules, which were not finalized as of press time, are mainly concerned with preventing Medicare and Medicaid fraud, which occurs when pharmaceutical companies give kickbacks for various prescribing practices. Retreats, recreation and gifts, among other perks, can be construed as kickbacks. oig.hhs.gov/authorities/frnotices.html

• J.V.

Resort Courses

Some resorts are teaming up with accredited institutions to offer CME programs themselves.

Beginning this year, the Disney Institute in Lake Buena Vista, Fla., is partnering with the Palm Desert, Calif.-based Annenberg Center for Health Sciences at Eisenhower Medical Center, an ACCME-accredited institution. Health care administrators and doctors can earn up to 16 credit hours learning, among other things, how to apply the principles of Disney’s renowned customer service to improving patient care. (321) 939-7221; www.disneyinstitute.com

The Life Enhancement Center at Canyon Ranch in Tucson, Ariz., under the auspices of the University of Arizona College of Medicine, has been teaching members from all walks of the medical community about preventive medicine and wellness since 1995. A week of education and relaxation will earn a doctor or nurse 27 credits. (800) 742-9000; www.canyonranch.com/cme

This year, after 15 years of providing housing for a regular CME program, the Sea Pines Resort in Hilton Head, S.C., has joined with the University of South Carolina to offer its own four-day, fully accredited courses for doctors and some nurses in various fields of medicine. When they’re not learning, attendees can play golf, fish or relax on the beach with their families. (800) 335-2582; www.seapinescme.com

• J.V.