After the American Medical Association rejected a proposal to water down its ethics code just three weeks ago, some physicians now wonder if the rigid policy governing gifts from drug companies needs to be even tougher.
The re-evaluation of the medical profession's ethics code comes at a time when federal authorities are investigating the marketing tactics of a number of big pharmaceutical companies, including allegations that some physicians received unsolicited checks of $10,000 or more to encourage them to prescribe a drug firm's most expensive medicines.
"This gives us all a black eye," said Michael Fleming, a family physician in Shreveport, La., who is president of the 94,300-member American Academy of Family Physicians. "It's a real problem."
In recent years, the AMA has attempted to address concerns about the overwhelming influence of marketing tactics on prescription patterns by highlighting a 14-year-old ethics code that limits gifts of less than $100 in most cases. In July 2002, the drug company's trade group, the Pharmaceutical Research and Manufacturers of America, or PhRMA, adopted a similar policy. Yet PhRMA's ethics code, strict but voluntary, apparently has not eliminated the practice by many drug salespeople of buying a doctors' allegiance through lucrative gifts, lavish dinners or huge payments that masquerade as "consulting" fees.
"I think the (AMA) policy is pretty strict," Fleming said. "I don't know the answer. But there needs to be a better way to enforce this. It's obviously very, very difficult to enforce. Maybe we need to come up with something that has a little more teeth to it."
Federal prosecutors in Boston, launching a wide-ranging investigation into the marketing practices of pharmaceutical companies, are looking into charges that drugmaker Schering-Plough sent unsolicited checks of $10,000 or more to doctors as a way to buy their allegiance, the New York Times reported last week. Several other major drug companies, including Johnson & Johnson and Bristol-Myers Squibb, have acknowledged receiving federal subpoenas as part of the inquiry.
Michael Goldrich, an otolaryngologist in New Brunswick, N.J., who is chairman of the AMA's Council on Ethical and Judicial Affairs, said he believes the medical association's long-standing ethics code has "been quite appropriate" in helping to educate physicians in their dealings with free-spending drug-company sales representatives.
"The goal, primarily, has been to increase education of physicians in regard to these guidelines," Goldrich said. "And the importance of that is the fact that physicians want to do the right thing."
Since PhRMA essentially duplicated the AMA's ethics code as a way to better regulate an army of about 80,000 or more salespeople nationwide, violations of the trade group's stringent guidelines are at a "low point" in terms of overall incidents, Goldrich said.
"That isn't to say that there aren't pharmaceutical representatives who offer things that aren't appropriate, or that there aren't physicians who accept things that aren't appropriate," he said. "Our job is to define the ethical boundaries, help disseminate the information and educate physicians."
Court Rosen, a spokesman for PhRMA, which represents virtually every major drug company, said the 2-year-old "marketing code" has had a positive impact. He said some cases highlighted in recent news reports involve allegations of incidents that occurred before the new code went into effect.
"This is a very inclusive (ethics) code," he said. "It's similar to the AMA's, and it's very detailed. And to our knowledge, our companies are complying with our principles."
In June, the AMA's House of Delegates, gathered in Chicago for an annual policy meeting, rejected a proposal to water down the long-standing ethics code, which states that "any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value." It adds that textbooks and "modest meals" are appropriate if they serve a "genuine educational function."
The resolution, sponsored by the AMA delegation from the District of Columbia, called on the organization to broaden the guidelines to allow doctors to accept drug-industry gifts "under more realistic guidelines and to reflect the value of a physician's time, education and opportunity costs (as in every other industry)."
But the proposal, which did not specify the types or amount of gifts that should be allowed, received no support among other delegates, including those who appeared to acknowledge that the largess of drug salespeople often has an impact on prescribing patterns.
"It's hard to admit that your own behavior can be changed (by gifts from drug salespeople)," said Michael Williams, a neurologist at Johns Hopkins Hospital in Baltimore.
Peter Lavine, an orthopedic surgeon from D.C. who submitted the resolution, called the AMA's guidelines ineffective and said they are routinely ignored by physicians. Lavine said during the debate on his resolution that he was personally insulted by the rigid guidelines. "They seem to imply that doctors can be bought by a couple of steaks," he said. "If physicians are willing, for the sake of a couple of bucks, to change their prescribing patterns, then we've got a far more serious problem."
Of course, Lavine, added, unsolicited checks amounting to $10,000 or more go well beyond a steak dinner, sample prescriptions or a night's lodging at an educational conference. "You've got a situation where the pharmaceutical industry is doing something that is clearly illegal (if the allegations are accurate)," he said. "It's outrageous."