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Study Affirms Pharma’s Influence on Physicians By John Dudley Miller hysicians are under more intense almost 3,200 American physicians in six financial pressure than ever to pre- specialties published in the New England scribe pharmaceutical manufactur- Journal of Medicine (NEJM). The study ers’ expensive new drugs even when showed that drug companies’ influence is cheaper, more established drugs may be more ubiquitous than previous studies at least as effective. Coupled with psycho- had found. Almost all (94%) of the family logical or social pressure that may distort practitioners, internists, pediatricians, cara doctor’s judgment, the influence of diologists, general surgeons, and anesthesifree gifts and subtle economic incentives ologists surveyed said they accepted drug may have financial costs, according to company money or gifts. Of those, 83% several recent studies on the interactions accepted free food, and 78% accepted free be tween doctors and drug company drugs. More than one-third (35%) accepted reimbursements for the cost of conferrepresentatives. In 2004, pharmaceutical companies ences or CME, and 28% took money for spent an average of $10,000 per practicing consulting, giving speeches to persuade American physician on free meals, free other doctors to use companies’ drugs, or continuing medical education (CME) steering their patients into companies’ clinical trials. training, free trips “The key is realizing they Eric Campbell, to conferences, and Ph.D. , lead author of payments for various do things for a reason. the study and a proservices, according to Drug companies are there fessor at Harvard data compiled by Medical School in IMS Health, a comto sell drugs.” Boston, believes that pany monitoring the industry’s finances. Those drug representa- the free food drug representatives often tives also gave the average doctor an extra provide doctors and students belies the $21,000 in free drug samples. The total industry’s claim that representatives’ mis2004 tab for drug representative strategies: sion is simply to educate doctors about new drugs. “The key is realizing they do $23.7 billion. That’s twice as much money as drug things for a reason,” he said. “Drug commanufacturers spent influencing phy- panies are there to sell drugs.” He comsicians just 6 years earlier, in 1998. This pares the situation to letting umpires in unprecedented increase has spawned con- the World Series accept free meals from siderable resistance to the drug-represent- the American League team but not the ative system among a minority of doctors National League team. “If we wouldn’t and medical organizations, causing both accept it in our referees,” he said, “why drug manufacturers and the American would we accept it in our doctors?” The Pharmaceutical Research and Medical Association to make small changes in the way they operate. The influences Manufacturers of America (PhRMA), the may be subtle, like small gifts that uncon- drug industry’s powerful lobbying group, sciously bias doctors toward new drugs responded to the article by claiming that over cheaper, established ones. Or they drug representatives are indispensable to may be more obvious, like drug company– American medicine and that the ubiquitous funded CME training that provides infor- free food does not influence doctors. When mation that is self-serving and sometimes the NEJM survey was released in April, Scott Lassman, J.D., the group’s senior inaccurate. The increased financial pressure was assistant general counsel, told the Associated verified earlier this year in a survey of Press, “A modest meal is not going to affect

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the independence of the health care practitioner.” Campbell said that whether pharmaceutical company pressure on doctors is more intense now than before is not clear because, for most questions asked in the study, “we simply have no data from previous studies” to compare. “I don’t think it’s worse” than it has been for the past several years, said Arthur Caplan, Ph.D., a professor of bioethics at the University of Pennsylvania in Philadelphia. “I just think it’s been documented in its full glory for the first time.” There are historical data in one area: the frequency of drug representatives’ visits to physicians. A 2000 study in the Journal of the American Medical Association (JAMA) reported that from 1982 through 1997, 16 surveys of doctors from a variety Eric Campbell, Ph.D. of specialties showed that drug company representatives visited them an average of 4.4 times per month. But by early 2004, when the NEJM survey concluded, company representatives were visiting family practitioners 16 times a month, internists 10 times a month, cardiologists nine times a month, and pediatricians eight times (the study did not look at meetings with oncologists). They can visit that often because an army of approximately 100,000 drug industry representatives work to influence around 700,000 active physicians, according to data from industry and the Health Resources and Services Administration. But even so, Campbell said, it’s not certain that total face time with doctors has increased because meetings now might be shorter than in the past. “Back in the day, meetings could have been 10 minutes, and now maybe they’re 2 minutes or 4 minutes,” he said. Some anecdotal evidence Vol. 99, Issue 15

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Once free samples were banned, many of which hadn’t been on the list, the percentage of the best and safest drugs prescribed rose to 61%. The JAMA article echoed these findings. The more interaction there was between physicians and drug representatives, the more likely hospital-based doctors were to request that the company’s drugs be added to the institution’s inhouse pharmacy, even though most of the requested drugs presented little or no therapeutic advantage over drugs already available. Moreover, doctors with the most interaction were the most likely to write more expensive prescriptions, prescribe Why Drug Reps Court Doctors One thing that is certain to Campbell new drugs faster, and not prescribe and other experts is that all the money generics. The central issue is not about whether and attention drug representatives shower doctors are prescribon doctors has its intended effect: buildIndustry-funded events have ing expensive drugs but whether patients ing relationships with made up nearly all CME in receive better care if doctors and ultimately changing how the United States. “When they their doctors have these relationships they prescribe. For example, a take that over, they’re actually with drug companies. No study has ever 2003 article in Quality taking over the practice of assessed that, and Safety in Health medicine.” Campbell said, probCare investigated why ably because collectsome general practitioners in the British National Health ing several years of health and drug data Service write prescriptions worth more from thousands of patients and their physithan twice as much money as others. The cians would be expensive. However, drug companies already general practitioners running up the highest drug costs were statistically significantly have much of that information on what more likely both to see drug representa- doctors prescribe, in part through a coltives more often and to prescribe newly laboration with the American Medical available drugs more freely than those with Association (AMA). Drug companies match information from the AMA’s datalower drug costs. Another study has shown that physi- bases of doctors with data from drug cians sometimes prescribe a drug because stores to construct a profile of how much they have free samples of it, not because it’s of every available drug each American the best choice for patients. A 2002 report physician prescribes. The AMA earns in Family Medicine looked at changes in the approximately $44 million annually from prescribing pattern of high blood pressure this arrangement. In response to criticism that it profits drugs before and after free samples of new drugs were prohibited at the Medical from selling physicians’ personal inforCenter of Central Georgia in Macon. mation, including the two-thirds of them When free samples were still available, who aren’t even members, the AMA has only 38% of the antihypertensive drugs created the physician data restriction physicians prescribed were on the list of program, which claims to allow every safest and most effective drugs for particu- physician to withhold his or her profiling lar ailments compiled by a national panel. data from pharmaceutical companies he’s heard indicates that they may be even shorter. Although drug representatives focus most of their attention on doctors, they put pressure on American medical students as well. In a survey of more than 1,100 students conducted in 2003 and published in 2005 in JAMA, the average student received one gift or attended one sponsored activity a week from drug companies. Also, the students’ supervisors asked or required 93% of them to attend lunch sponsored by a drug representative at least once.

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( http://www.ama-assn.org/ama/pub/ category/12054.html ). Eight thousand doctors have signed up so far, just 1.1%. What the AMA Web site does not explain, however, is that the program withholds the data only from employees in sales: drug representatives and their supervisors. Drug companies still receive the data. And although they are not supposed to show it to their sales forces, nothing prevents them from doing so except AMA’s threat to cut off their data access if a physician somehow learns about it and complains. An AMA spokesperson said that companies need the data to identify patients to contact in case of a recall, but a proposal to ban them from receiving the in formation will be discussed at the AMA’s next delegate assembly. While considerable evidence shows that drug representatives’ gifts to doctors can cause them to prescribe expensive drugs unnecessarily, no evidence has been collected to show that Merrill Goozner those drugs actually harm patients’ health or take longer to heal them. But Ross Upshur, M.D., director of the Joint Centre for Bioethics at the University of Toronto, says it can. “I think that aggressive marketing of new medicines for which the full safety profile is not available could lead and has led in the past to harm.” Company Culture

Physicians often resent the presumption that taking gifts from pharmaceutical representatives is unethical. When Jason Dana, Ph.D., an assistant professor of social psychology at the University of Pennsylvania in Philadelphia, lectures to doctors about their interactions with drug representatives, the question he always gets is, “How dare you question my integrity? I can’t be bought.” In survey after survey, most physicians say they don’t think the food, gifts, and payments they accept from drug representatives make JNCI

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them more likely to prescribe a company’s new drugs. But in an April article in PLoS Medicine, two former drug representatives presented a starkly different picture. “The essence of pharmaceutical gifting is ‘bribes that aren’t considered bribes,’” Michael Oldani, a former drug representative who quit to become a medical anthropologist, said in the article. “It’s my job to figure out what a physician’s price is,” Shahram Ahari, a former Eli Lilly representative, said in the article. “For some it’s dinner at the finest restaurants, for others it’s enough convincing data to let them prescribe confidently, and for others it’s my attention and friendship.” But at the most basic level, he said, “everything is for sale and everything is an exchange.” Dana coauthored a 2003 article in JAMA outlining the social science research that indicates that the former drug representatives and other critics are missing the point. The problem is not unethical behavior but rather an unconscious, self-serving bias that distorts the judgments of doctors and anybody else who is offered a gift, he said. Experiments show that most people are unaware that they constantly use this bias and have little control over it. So when physicians say they don’t think gifts influence them, they may well be telling the truth as they see it. Unfortunately, this evidence has barely made a ripple in the national debate over the ethics of doctors’ accepting drug representatives’ gifts. And even though physicians may honestly not realize that such gifts change how they prescribe, the drug industry does. For both those reasons, indignation over the industry’s practices has spawned a backlash over the past decade. Several medical organizations, like the American College of Physicians and the National Physicians Alliance, have called for further reform. Several universities have also restricted gifts, and the University of Michigan has banned meetings with company representatives. A New York City internist created NoFreeLunch.org, a Web site where physicians can publicly pledge not to accept meals from drug representatives. 1150 News

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States are getting in the mix too. Recent legislation in five states and the District of Columbia requires that drug industry payments to physicians be reported, and in two of them, Vermont and Minnesota, those reports are supposed to be publicly available. Last year New Hampshire passed a prescription restraint law that forbids pharmaceutical companies from using profiling data to identify what drugs individual physicians prescribe. But a federal district court has since ruled the law unconstitutional, arguing that it restricts commercial speech protected under the First Amendment. In response to the backlash against its practices, PhRMA issued a voluntary code for drug representative–doctor interactions in July 2002. According to the NEJM article, it has curtailed one of the most egregious practices: paying for travel, food, and entertainment for physicians on trips that include no medical training. However, the code still lets drug companies pay big fees to consultants and pick up all the expenses for sending doctors to multiday speaker-training sessions at national golf resorts. It also allows an unlimited number of small gifts and larger gifts up to $100. “I think it has been effective,” Lori Reilly, PhRMA’s vice president for policy and research said, noting that the $100 gifts must be something educational, like a stethoscope or a book, and representatives cannot simply drop off free lunches and leave. Moreover, she said, drug representatives cannot be as influential as critics claim, because generic drugs now make up 60% of all drugs prescribed in the United States and 63% in the Medicare population. Ethicists and industry watchers may be more concerned that companies often pay for educational sessions about their drugs— and often don’t tell the whole truth. A 1995 JAMA study conducted at the University of California at San Diego School of Medicine analyzed the accuracy of statements drug representatives gave in 13 presentations about their products. Eleven percent of the statements were false, researchers later determined, and all of them made the rep-

resentative’s preferred drug seem more attractive than it really was. The remaining 89% of statements were accurate and evenhanded, half favoring their drug and half opposing it. The problem is that, historically, industryfunded events have made up nearly all CME in the United States, including conferences, said Merrill Goozner, director of the integrity in science project at the Center for Science in the Public Interest in Washington, D.C. “When they take that over, they’re actually taking over the practice of medicine,” he said. A few organizations are trying to do something to change how doctors learn. The Pew Charitable Trusts has given the activist group Community Catalyst and the Boston-based Institute for Medicine as a Profession $6 million to try to change medicine by restricting drug representatives’ access to all academic medical centers, promoting the use of evidence-based prescribing as an alternative, and conducting more research into the effects of the doctor–representative interaction. In another educational effort, a series of $400,000 grants will fund projects to teach physicians and consumers how to recognize and resist drug representatives’ influence. The project is funded through a $21 million settlement between the 50 state attorneys general and a division of Pfizer that allegedly paid doctors to use its drug in ways that the U.S. Food and Drug Administration hadn’t approved. These programs may be among the first to give medical schools the assistance they need to take charge of educating physicians about new drugs in an unbiased way. And that’s where Upshur thinks the responsibility should be: “I think it’s up to the faculties of medicine.” But for all the problems the drugrepresentative system causes, Campbell thinks that banning it outright at this point would be a terrible idea. “We don’t have any system in place to replace what we have,” he said. © Oxford University Press 2007. DOI: 10.1093/jnci/djm097

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