Journal of the National Cancer Institute Advance Access originally published online on July 24, 2007
JNCI Journal of the National Cancer Institute 2007 99(15):1148-1150; doi:10.1093/jnci/djm097
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© Oxford University Press 2007.
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Study Affirms Pharma's Influence on Physicians
Physicians are under more intense financial pressure than ever to prescribe pharmaceutical manufacturers’ expensive new drugs even when cheaper, more established drugs may be at least as effective. Coupled with psychological or social pressure that may distort a doctor's judgment, the influence of free gifts and subtle economic incentives may have financial costs, according to several recent studies on the interactions between doctors and drug company representatives.
In 2004, pharmaceutical companies spent an average of $10,000 per practicing American physician on free meals, free continuing medical education (CME) training, free trips to conferences, and payments for various services, according to data compiled by IMS Health, a company monitoring the industry's finances. Those drug representatives also gave the average doctor an extra $21,000 in free drug samples. The total 2004 tab for drug representative strategies: $23.7 billion.
That's twice as much money as drug manufacturers spent influencing physicians just 6 years earlier, in 1998. This unprecedented increase has spawned considerable resistance to the drug-representative system among a minority of doctors and medical organizations, causing both drug manufacturers and the American Medical Association to make small changes in the way they operate. The influences may be subtle, like small gifts that unconsciously bias doctors toward new drugs over cheaper, established ones. Or they may be more obvious, like drug company–funded CME training that provides information that is self-serving and sometimes inaccurate.
The increased financial pressure was verified earlier this year in a survey of almost 3,200 American physicians in six specialties published in the New England Journal of Medicine (NEJM). The study showed that drug companies’ influence is more ubiquitous than previous studies had found. Almost all (94%) of the family practitioners, internists, pediatricians, cardiologists, general surgeons, and anesthesiologists surveyed said they accepted drug company money or gifts. Of those, 83% accepted free food, and 78% accepted free drugs. More than one-third (35%) accepted reimbursements for the cost of conferences or CME, and 28% took money for consulting, giving speeches to persuade other doctors to use companies’ drugs, or steering their patients into companies’ clinical trials.
Eric Campbell, Ph.D., lead author of the study and a professor at Harvard Medical School in Boston, believes that the free food drug representatives often provide doctors and students belies the industry's claim that representatives’ mission is simply to educate doctors about new drugs. "The key is realizing they do things for a reason," he said. "Drug companies are there to sell drugs." He compares the situation to letting umpires in the World Series accept free meals from the American League team but not the National League team. "If we wouldn’t accept it in our referees," he said, "why would we accept it in our doctors?"
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The Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry's powerful lobbying group, responded to the article by claiming that drug representatives are indispensable to American medicine and that the ubiquitous free food does not influence doctors. When the NEJM survey was released in April, Scott Lassman, J.D., the group's senior assistant general counsel, told the Associated Press, "A modest meal is not going to affect 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 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 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.
Why Drug Reps Court Doctors
One thing that is certain to Campbell and other experts is that all the money and attention drug representatives shower on doctors has its intended effect: building relationships with doctors and ultimately changing how they prescribe.
For example, a 2003 article in Quality and Safety in Health Care investigated why some general practitioners in the British National Health Service write prescriptions worth more than twice as much money as others. The general practitioners running up the highest drug costs were statistically significantly more likely both to see drug representatives more often and to prescribe newly available drugs more freely than those with lower drug costs.
Another study has shown that physicians sometimes prescribe a drug because they have free samples of it, not because it's the best choice for patients. A 2002 report in Family Medicine looked at changes in the prescribing pattern of high blood pressure drugs before and after free samples of new drugs were prohibited at the Medical Center of Central Georgia in Macon. When free samples were still available, only 38% of the antihypertensive drugs physicians prescribed were on the list of safest and most effective drugs for particular ailments compiled by a national panel. 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 in-house 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 new drugs faster, and not prescribe generics.
The central issue is not about whether doctors are prescribing expensive drugs but whether patients receive better care if their doctors have these relationships with drug companies. No study has ever assessed that, Campbell said, probably because collecting several years of health and drug data from thousands of patients and their physicians would be expensive.
However, drug companies already have much of that information on what doctors prescribe, in part through a collaboration with the American Medical Association (AMA). Drug companies match information from the AMA's databases of doctors with data from drug stores to construct a profile of how much of every available drug each American physician prescribes. The AMA earns approximately $44 million annually from this arrangement.
In response to criticism that it profits from selling physicians’ personal information, including the two-thirds of them who aren’t even members, the AMA has created the physician data restriction program, which claims to allow every physician to withhold his or her profiling data from pharmaceutical companies (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 information 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 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 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.
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 representative's preferred drug seem more attractive than it really was. The remaining 89% of statements were accurate and even-handed, half favoring their drug and half opposing it.
The problem is that, historically, industry-funded 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.
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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 drug-representative 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.
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