Responding to growing criticism of the marketing techniques drug makers use to promote their wares among physiciansincluding lavish meals and sports tickets, resort trips and golf ballsthe pharmaceutical industrys trade association has issued new guidelines to curb excessive gift-giving.
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The code states that gifts worth $100 or less may be given only if they are directed at patient education or other patient benefit. So anatomical models are OK, but VCRs are not. Meals may be offered in connection with "presentations and discussions that provide valuable scientific and educational benefits," as long as they are "modest by local standards," and "occur in a venue and manner conducive to informational communication."
Treating doctors to entertainment and recreational events, or treating their spouses or guests to meals, are now out of bounds. And providing take-out meals or meals to be eaten in the absence of the salesperson is also considered inappropriate.
Increasing publicity in recent years about these and similar practices has led to complaints that such blatantly mercenary interactions are not only unseemly, but also they may undermine patient care by making doctors beholden to the drug companies that offer the best inducements.
The Office of the Inspector General for the U.S. Department of Health and Human Services plans to look into the practice of pharmaceutical gift giving, according to its fiscal year 2002 work plan. "Some [gifts to physicians] may present an inherent conflict of interest between the legitimate business goals of manufacturers and the ethical obligation of providers to prescribe drugs in the most rational way," the plan states, adding that gifts "may also violate the federal anti-kickback statute if they are intended to induce referrals."
PhRMA spokesman Jeff Trewhitt said that such gifts-for-scripts situations have never been the norm.
"There are obvious exceptions that have caused controversy and made it seem like the exceptions are commonplace," he added.
Nevertheless, big money is involved. According to Scott-Levin, a pharmaceutical consulting firm in Newtown, Pa., in 1999 pharmaceutical firms spent $6.2 billion on "detailing" (sales calls to doctors offices) and $1.6 billion to exhibit their products at medical meetingsincreases of 8% and 29%, respectively, over the previous year. And despite the growth in alternative strategies such as direct-to-consumer advertising, Scott-Levin reports that in 2000, the number of sales representatives grew by an average of 16% among the top 40 drugmakers.
The new code was written to replace guidelines that were developed with the American Medical Association and introduced in 1990. The earlier guidelines, Trewhitt said, prompted complaints that they were too vague to offer useful guidance and "occasionally, periodically, there were violations of the existing guidelines." For sports and entertainment especially, he said, the old guidelines lack of specificity encouraged practices that are explicitly prohibited under the new guidelines.
"Anything that distracts from a meaningful conversation is considered inappropriate," Trewhitt said. "So sitting on the third-base line at Camden Yards watching the Baltimore Orioles is inappropriate, because youre watching baseball and not talking about the medicine."
The new guidelines are voluntary, but Trewhitt said that because they are far more specific, and because the impetus for the new code came "from the top down"from PhRMAs board of directors, many of whom are chief executive officers of major drug companiesthe organization expects broad compliance.
The code includes answers to frequently asked questions about what kinds of gifts are acceptable. An example: "May golf balls and sports bags be provided if they bear a company or product name?" The answer: "No. Golf [balls] and sports bags, even if of minimal value, do not primarily entail a benefit to patients and are not primarily associated with the health care professionals practice, even if they bear the name of a company or product."
One thing that seems unlikely to change is the ubiquitous presence in medical offices of pens, sticky pads, and other office paraphernalia adorned with drug names and company logos. These continue to be permitted because they are of modest value and are used in medical practice, or at least in its clerical support.
But some critics, most visibly the grassroots group No Free Lunch (www.nofreelunch.org), believe that even such apparently trivial items can compromise physician autonomy. No Free Lunch wants to persuade doctors to proclaim their independence by refusing all drug company freebies. The group even has a "pen amnesty" program in which doctors can exchange their promotional ball-points for plain ones. Founder Bob Goodman, M.D., a general internist in New York, coined the term "bagel bias" to highlight his contention that even that humble breakfast staple can influence prescribing decisions.
PhRMAs Trewhitt responded that "I cant fathom how a pen with the name Pfizer or Merck or Bristol-Myers Squibb on it is going to make a doctor write a prescription for their products. That belief is an insult to most doctors."
But Dana Katz, a bioethicist at the University of Pennsylvanias Center for Bioethics, Philadelphia, said such reasoning is flawed because it ignores deeply ingrained human values that hold sway even in professional interactions.
"Gift-giving is an extremely effective marketing tool because it triggers in the recipient the basic human tendency to reciprocate whether the recipient is conscious of it or not," Katz wrote in an article for the Center for Bioethics (http://bioethics.net/er_bioethics.php). This "reciprocity rule" plays out in a wide range of social relationships, such as mutual birthday gifts and party invitations.
Summarizing the work of psychologist Robert Cialdini, Ph.D., Katz wrote, "Regardless of the size of a gesture, it is widely considered distasteful to take and make no effort to give in return. It tends not to matter whether we like the person giving the gift. Therefore, people who are ordinarily dislikeddisagreeable acquaintances, beggars, sales peoplecan influence our behavior simply by imposing an unsolicited gift."
Critics also question whether today, with up-to-date, unbiased information on drugs and medical practice easily accessible on the Internet, sales representatives are truly an important information source for physicians.
"I dont think any doctor would defend using [drug sales] reps if the reps werent coming with food and other gifts," Goodman said. "It would be a nice experiment to take away these sorts of things and see if doctors are still defending them."
Trewhitt countered that sales reps provide one-to-one interactions not available online. "If the doctor has a question, who do you talk to?" he asked.
Goodman acknowledged that the PhRMA guidelines are "a big step" in the right direction.
"The industry does not need any bad publicity on this issue, so I think theyll probably follow the guidelines," he said. "I think the most egregious stuff will disappear."
In the March 5 Annals of Internal Medicine, the American College of Physicians and American Society of Internal Medicine published a position statement that covers industry gifts. It states that "the acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged," and that "the dictates of professionalism require the physician to decline any industry gift or service that might be perceived to bias their judgment, regardless of whether a bias actually materializes."
The article cites research showing that patients tend to view industry gifts as inappropriately influencing medical practice and to believe that such gifts bias their physicians prescription practices and increase the cost of drugs.
The ACP/ASIM "did a great job stating the case, and the research and rationale behind it," Goodman said, "and then came to the totally wrong conclusionthat doctors need to decide for themselves whats acceptable. Doctors downplay or deny the influence this stuff has on them; they dont recognize the bias. So to leave it up to the individual is probably not the wisest thing."
Some states are taking action, if not to stem drug company giving, at least to make it public. Vermont passed a law in June that requires pharmaceutical companies to disclose all gifts worth over $25 given to physicians. The information will be published by the state Attorney Generals Office, and failure to disclose gifts is punishable by a $10,000 fine. Several other state legislatures have proposed similar legislation.
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