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October 2007 | Volume 43, Issue 10

Drug companies go too far to influence doctors, critics say

Allison Torres Burtka, Associate Editor

In doctors’ offices, free drug samples and pens bearing the name of a drug are familiar sights. But doctors, legislators, public-interest groups, and attorneys are expressing concern that pharmaceutical companies’ gifts to doctors affect what they prescribe. And the problem extends to medical education and research, they say.

Drug companies pay doctors for consulting, speaking, and research, with some payments in the hundreds of thousands of dollars. Critics say these arrangements allow big pharma to inject biased information into purportedly neutral arenas, and that doctors—let alone their patients—may be unaware of how deeply drug companies are involved.

To address some of these problems, Rep. Peter DeFazio (D-Or.) introduced the Drug and Medical Device Company Gift Disclosure Act on July 12. The bill would require drug and medical device companies to publicly disclose payments to doctors by registering them in a national database. Some states have similar registries.

In a recent survey of 3,167 physicians published in the New England Journal of Medicine, 94 percent reported some type of relationship with the pharmaceutical industry, most saying they received food and samples. Thirty-five percent were reimbursed for professional meetings or continuing medical education; 28 percent were paid for consulting, giving lectures, or enrolling patients in trials.

“The drug companies target leading experts with grants, gifts, and trips in order to sway their opinions regarding treatment regimens,” said Christopher McCoy, a physician and member of the National Physicians Alliance, a Reston, Virginia-based group that supports registries. “As a result, our patients are paying more for their medications and are often prescribed brand-name drugs when other medications are just as effective.”

“The drug industry is failing in its social contract with society,” said Shahram Ahari, a former drug company representative who now works for the University of California San Francisco School of Pharmacy. “There needs to be a greater sense of understanding that pharmaceutical marketing is less about science and more about relationships and just plain sales. And that’s incompatible with the idea of medical practice and public health.”

People should know whether doctors are potentially biased, said lawyer Gerald Jowers of Columbia, South Carolina, who handles pharmaceutical cases. For example, he pointed out that the learned-intermediary rule can make a patient’s prescribing physician central to a failure-to-warn case, so “any evidence to suggest the doctor is influenced is important.”

Details of ‘detailing’

Drug reps visit doctors to “detail” specific drugs—often their newest and most expensive—with gifts, free samples, and “educational” materials in tow.

The industry’s gift-giving guidelines have tightened in recent years, so drug companies no longer pay for doctors’ lavish resort stays. Doctors are now uncomfortable with expensive gifts, which was not the case 10 or 15 years ago, said Stephen Kaufman, a retinal surgeon and founding member of Physicians for Clinical Responsibility, a Cleveland-based group concerned about drug companies’ growing influence over doctors.

But drug companies still give smaller gifts in the form of meals and items like notepads, and even these create a sense of obligation, according to No Free Lunch, a New York-based group of doctors that discourages all gifts. Because drug companies give away samples of new, typically more expensive drugs, and because a patient who has been given a free sample is likely to continue taking that drug, free samples drive up health care costs, doctors say.

Bob Goodman, a general internist and director of No Free Lunch, noted that samples make up more than half of the companies’ promotional budget. Some doctors and hospitals have stopped accepting them.

Peter Lurie, a physician and deputy director of Public Citizen’s Health Research Group, based in Washington, D.C., said samples are pushing people away from drugs that have proved to be safe over the long term. “The net impact is to drive people away from the nonmedical and the unprofitable, such as diet, exercise, and generics,” he said.

The educational materials that drug reps provide are of dubious value, some doctors say. The industry line is that reps provide useful information because doctors are busy and can’t keep up with the literature, but access to information has become much easier—such as through the Internet—so doctors don’t need to get it from drug reps, Goodman said.

In interactions between drug reps and doctors, “any exchange of information is incidental,” said Lurie. Relying on industry materials is taking the easy way out, he said: “People find it easier to get information that’s already been digested—by pretty people, with pretty food. It’s easier than reading the Lancet.”

It’s not a coincidence that reps are pretty people, Ahari said. Drug companies recruit charismatic, attractive people because they can best influence doctors, he said. “They’re looking for people who are iconic—the blond bombshell, the guy with rugged features and broad shoulders.”

Ahari suggested that drug reps should have some scientific education. “As it is now, drug reps are pretty smart people, but that’s not their outstanding characteristic,” he said. “Their outstanding characteristic is that they’re all very charismatic. Science is not even secondary—it doesn’t even register.”

When drug reps visit doctors, they often know what the doctor has prescribed. Reps’ access to individual doctors’ prescription records was at issue in IMS Health, Inc. v. Ayotte earlier this year. (490 F. Supp. 2d 163 (D.N.H. 2007).) A federal court struck down a New Hampshire law protecting doctors’ prescription data from being sold to drug companies. (See Allison Torres Burtka, Court Strikes Down Law Protecting Doctors’ Prescription Data, TRIAL 84 (July 2007).)

Drug companies say they need to know what individual doctors are prescribing to tailor their marketing efforts, but critics say drug reps may use the information to pressure them. Ahari, who testified in IMS Health, said it’s still generally taboo to confront doctors with this data directly, but company reps do use it to influence doctors in more subtle ways.

For example, Ahari said that if he was detailing drug A and knew a doctor was prescribing a lot of competing drug B, which does not last as long, he would emphasize drug A’s long half-life and point out that if a patient misses a dose, he or she won’t have to worry about withdrawal effects—knowing that doctors fear such outcomes. This way, he said, he juxtaposes the two drugs without even mentioning drug B.

“As drug reps, we’re taught to cultivate this sense of illusion that doctors can’t be swayed,” Ahari said. He added that many doctors think their colleagues are susceptible to influence—but that they themselves are not.

In an article about marketing tactics, Ahari and a Georgetown University Medical Center professor explained that reps try to learn about physicians’ families and interests, entering children’s names and birthdays into databases after visits to establish personal connections with the doctor. They wrote, “Every word, every courtesy, every gift, and every piece of information provided is carefully crafted, not to assist doctors or patients, but to increase market share for targeted drugs.”

Ahari wrote that, when working as a rep, he would befriend doctors and, when necessary, “lean on my ‘friendship’ to leverage more patients to my drugs.”

They explained that reps rank physicians from 1 to 10 based on how many prescriptions they write: “Some reps said their 10s might receive unrestricted ‘educational’ grants so loosely restricted that they were the equivalent of a cash gift.” (Adriane Fugh-Berman & Shahram Ahari, Following the Script: How Drug Reps Make Friends and Influence Doctors, 4 PLoS Med. 621 (2007).)

Thought leaders

Industry tactics go beyond the doctor’s office. In offering doctors speaking engagements and consulting fees, drug companies target “thought leaders” who can influence other doctors. Drug companies are “looking for ideal speakers, which are those that have the same charisma that a drug rep has but also the credentials and respect of other physicians,” Ahari said.

Although some of these speakers’ presentations are more biased than others, Ahari said, “at the end of the day, you’re still getting a skewed presentation. No one gets paid to speak negatively about a product.”

Continuing medical education used to be funded mostly by universities and associations, but now it’s half funded by pharmaceutical companies, said psychiatrist Daniel Carlat, who once served as a paid speaker himself. “They’ve essentially co-opted accredited medical education,” he said.

Carlat said that despite the disclosures made about company sponsorship at these programs, most attendees don’t realize the extent of the companies’ involvement. “It can be very difficult to really perceive the more subtle forms of bias—such as not mentioning or downplaying certain side effects” and choosing which studies to mention and which to omit, he said.

To gauge bias, attendees would find it useful to know how much a presenter is being paid, Carlat said.

Kaufman agreed. “As a clinician, I’d like to know if a colleague has made $100,000 as a consultant,” he said.

Registries

Several states are attempting to track drug companies’ payments to doctors. California, Maine, Minnesota, Vermont, West Virginia, and the District of Columbia have disclosure laws, but they each have problems, Public Citizen’s Lurie said. Some registries do not require the physician’s name to be reported; exempt free samples, research, and payments that companies say relate to trade secrets; lack enforcement mechanisms; do not require each payment to be reported separately, so data can be aggregated by payment type or by doctor; and do not include medical device or biologic companies.

In some states, the registries are public but not easily accessible, Lurie said. To obtain Vermont’s physician-specific data that had been designated trade secrets, Public Citizen sued the state attorney general and numerous drug companies. Some of the companies settled and provided their data. (Public Citizen, Inc. v. Sorrell, No. 513-8-05 Wncv (Vt., Washington Co. Super. filed Aug. 19, 2005).)

Minnesota recently made its registry available online. Using that data, a New York Times report revealed that more than 100 doctors who had been disciplined or criticized by the state medical board were later paid by drug companies for research and marketing. The reasons for sanctions included inappropriate prescribing practices, substance abuse, substandard care, and mismanaging drug studies; two had even been convicted of criminal fraud. (Gardiner Harris & Janet Roberts, After Sanctions, Doctors Get Drug Company Pay, N.Y. Times (June 3, 2007).)

Similarly, a publicly available national registry would allow for public health analysis, Lurie said. Although disclosure is not a panacea, he noted, it is the most practical solution at the moment.

“Unfortunately, instead of eliminating the conflict of interest—as is the case in law—in medicine, the approach has been disclosure,” he said.

The House bill calls for the data to be posted on the Internet, but Lurie said he’s concerned that it might allow the companies to report combined payments, such as one amount that includes several payments to one doctor, rather than describing each payment separately. He also faulted the bill for exempting free samples and payments for conducting clinical trials.

“There’s a difference between going out to a string of $100 meals and conducting a clinical trial,” but that’s why it’s important for gifts to be appropriately labeled, Lurie said. “The public, the media, and health care providers can decide whether it’s appropriate.”

Lawyer Jason Mark of Uniondale, New York, noted that plaintiff lawyers in pharmaceutical litigation sometimes seek information—on doctors paid for speaking engagements, for example—from the companies’ own databases, so a public registry would increase transparency and benefit the public.

“What is it about these payments that should be entitled to secrecy or confidentiality?” Mark asked. A public national registry would facilitate increased drug safety, he said.

A national registry is a step in the right direction, Ahari said, but “it’s a Band-Aid on a shotgun wound.”