Alarmed by the growing influence of pharmaceutical companies over physicians' drug-prescribing practices-and the possible threat of government oversight-the American Medical Association is inching closer to a major educational initiative to help reinforce its strict, decade-old ethics policy.
However, some physicians question whether the AMA's heart is really in it.
Officials quietly began making serious plans for the educational campaign after a national task force that the AMA created last year discovered that 40% to 50% of America's doctors were unaware of ethics guidelines that generally prohibited anything but "modest" or "token" gifts from drug-company sales representatives.
"I would hope that the medical profession wakes up and looks at these guidelines and realizes we have to control our own professional behavior," declared Herbert Rakatansky, M.D., a Rhode Island gastroenterologist who is chairman of the AMA's Council on Ethical and Judicial Affairs. "The alternative will be federal regulation."
The AMA ethics guidelines, formally adopted in 1992 and endorsed by the pharmaceutical industry, have been largely disregarded or misinterpreted by many doctors, Rakatansky said. He also pointed the finger at the powerful pharmaceutical industry, saying "drug companies have failed to adhere to these guidelines.
"After an initial period (in the early 1990s) of slowing down on these marketing efforts," Rakatansky said, "they've now decided they don't want to pay attention to (the guidelines)."
IMS Health, Westport, Conn., one of the nation's leading pharmaceutical market-research firms, said drug companies spent about $13.9 billion promoting their products in 1999-a 10% increase from the previous year. Estimates for 2000 cite total promotional spending of $15.7 billion, including $7.9 billion in drug samples and another $4.5 billion for office promotion, which covers all sales activities directed at office-based physicians (See chart, p. 5).
For now, at least, AMA officials are downplaying the educational campaign. One source said the nascent effort to publicize the conflict-of-interest rules is in the developmental stage. But some form of a national campaign-perhaps even accredited continuing medical education-is almost certain to evolve from the task force's discussions.
One reason the AMA may be moving slowly on the initiative is its own dwindling membership, which slid to little more than 290,000 last year out of America's 901,147 physicians (March 5, p. 16). Although the ethics guidelines are voluntary, shoving them down physicians' throats may alienate members further.
"There have been a lot of physicians trained in the last decade, and (ethics guidelines) have not been a focus for them," said Norman Kahn, M.D., a member of the American Academy of Family Physicians who also serves on the AMA's ethics task force. "We're in the early process of developing a message-and the message will go to both the (drug) industry and physicians."
A steady flow of drug samples, pricey gifts and invitations to fancy restaurants are just part of the drug industry's marketing machine, which is responsible for spending an estimated $8,000 to $13,000 per year on every doctor in America. Sales representatives from drug companies made an estimated 40 million visits to doctors' offices last year, according to industry sources.
The average U.S. physician sees about 10 pharmaceutical sales representatives every month, and most-about 84%-said presentations by specialty representatives have at least some impact on their decisions to prescribe certain drugs, according to a recent survey of 6,000 physicians by pharmaceutical consulting firm Scott-Levin, Newtown, Pa.
The AMA's ethical standards, for instance, require physicians to serve on a legitimate advisory panel before accepting cash or anything more than a modest meal from drug companies, Rakatansky explained.
"There is nothing wrong with a drug company that wants to convene a group of doctors for expert opinions," Rakatansky said. "But 99% (of these dinners) are marketing tools. The drug companies aren't looking for information from doctors; they're looking to give information to doctors about their products."
Bert Spilker, M.D., a spokesman for the drug industry's trade group, the Pharmaceutical Research and Manufacturers of America, disagrees sharply with Rakatansky's assessment. He said these dinners, where sales representatives provide vital briefings about new drugs, are frequently the only way to pass along information to physicians who are too busy during the day to listen to complicated product pitches.
"Many doctors won't even sit down and see sales reps during the day," said Spilker, PhRMA's senior vice president of scientific and regulatory affairs. "Even when they do, they're unable to absorb information with their undivided attention."
Modest dinners that meet AMA ethics guidelines, Spilker said, provide an unhurried forum that benefits doctors.
Rakatansky said the AMA is concerned enough about recent abuses that it wants to increase awareness of the ethics guidelines and help physicians interpret how the rules apply to the drug company sales force. He and other experts discussed the issue in detail during a seminar in early March at the AMA's National Leadership Council in Washington.
The seminar included comments from medical students and residents who complained about being targeted from the start of their career by sales representatives offering bags, books, lunches and dinners.
"They've got us on the corporate udder at an early stage," one resident said.
Al Herzog, M.D., vice president of medical affairs at Hartford (Conn.) Hospital and president-elect of the Connecticut State Medical Society, described the ethical issue as a "slippery slope-and we're sliding on it."
Donald Neel, M.D., a pediatrician from Owensboro, Ky., and president-elect of the state medical group, joined Herzog in speaking up at the AMA's seminar. He told attendees he thinks a casual disregard of ethical standards "is becoming a national problem.
"I have a sense that most doctors will feel that they are not influenced to change their prescribing habits by these gifts," Neel said. "But all the studies show differently."
Despite its emphasis on improving awareness of the voluntary ethics guidelines, the AMA itself is far from immune to criticism about conflicts of interest. Indeed, some observers have rebuked the AMA for attempting to enforce these strict standards at the same time that the organization earns about $20 million per year by selling information about doctors to a wide range of commercial interests, including drug companies that use that data to target physicians through prescriber profiles.
"Is this the pot calling the kettle black?" Neel asked. "I know that almost all of the companies that call on me already know my prescription habits. I feel like my privacy has been violated."
Yet Rakatansky said the AMA's so-called master list, which includes the names and demographic information of some 870,000 U.S. physicians, cannot by itself be used for prescriber profiling. Drug companies use a combination of information from several sources, including the AMA's master list and computerized pharmacy sales, to develop those prescriber profiles. What's more, AMA officials have said, almost all of the information in the database is available elsewhere-for a price.
Neel also pointed to what he characterized as another apparent inconsistency in AMA ethics policy. He questioned why the AMA would focus so much effort on examining the potential pitfalls of the drug industry's influence on doctors when the AMA's leadership conference, the very site of the debate on ethics, was underwritten in part by five drug companies: premier sponsors Genaissance Pharmaceuticals, Glaxo SmithKline, Pfizer and Merck & Co., and supporting sponsor Purdue Pharma.
"There's something that does not add up here," Neel said. "A lot of doctors will ask: `Why are they picking on us when the AMA itself is having a big meeting sponsored by large drug companies?' "
Adopted in June 1992, the AMA's ethics policy was created partly in response to threats of congressional action to halt what some described at the time as outright bribes by aggressive salespeople who felt no compunction about buying doctors' loyalty.
The policy states that many gifts to physicians, including funds for educational seminars to conferences, serve an important function. It says any gifts should entail a benefit to patients and should not be of substantial value. Thus, textbooks, modest meals and other gifts are appropriate if they serve a "genuine educational function." Also, drug industry subsidies "should not be accepted to pay for the costs of travel, lodging or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians' time."
Jeff Trewhitt, PhRMA's spokesman, acknowledged that many of the thousands of sales representatives hired since the mid-1990s, when competition among drug companies intensified, are unaware of the constraints imposed by the AMA's ethics guidelines. He estimated that the small army of drug company sales representatives numbers anywhere from 50,000 to 75,000. But he and Spilker both said the lack of awareness can be handled through some form of educational program.
Told of Spilker's assessment, Rakatansky replied: "I think he's wrong-this is a serious problem."
Many studies, including a comprehensive analysis in the January 2000 issue of the Journal of the American Medical Association, have clearly determined that expensive gifts, free trips and cash influence physicians' prescribing patterns.
During the seminar on ethics, Rakatansky told the group: "I would suggest to you that gifts do influence physicians' behavior."