American College of Physicians: Internal Medicine — Doctors for Adults ®


Too close for comfort? How some physicians are re-examining their dealings with drug detailers

From the July-August ACP Observer, copyright 2003 by the American College of Physicians.

By Bonnie Darves

A decade ago, many physicians welcomed drug company representatives into their offices with open arms. After all, detailers not only provided valuable information about new medications and therapies, but they often came bearing gifts and samples.

Times have changed. As the relationship between physicians and the drug industry has become a hot topic in the media, there has been a backlash against what some say is doctors' cozy relationship with drug companies.

Physician and industry groups have responded by issuing guidelines to police certain types of drug marketing practices that may produce conflicts of interest. And earlier this spring, the federal government joined the fray when it released final guidelines on interactions between drug makers and doctors.

Individual physicians, however, have shown a much more mixed response to all the attention on doctors' relationship with the drug industry.

Uncomfortable with potential conflicts of interest, some doctors say they have shut their doors to the growing army of drug representatives. Others say they allow reps to stay around only as long as it takes for a physician to sign for samples.

That sentiment, however, is far from universal. Some physicians are changing they way they work with drug detailers because of practical concerns like time. Still others say they see nothing wrong with their relationship with drug detailers and defend their right to talk to drug reps to educate themselves and get samples for their patients.

Cutting back face time

For many practices, time is the single biggest factor forcing physicians to change the way they do business with drug detailers. Yul Ejnes, FACP, for example, one of three physicians with Coastal Medical Inc. in Cranston, R.I., put a no-detailing policy in place two years ago.

"It wasn't because of any moral or ethical issue, just that I needed the time for patients," said Dr. Ejnes, who is Governor for ACP's Rhode Island Chapter. "I spent most of that time picking apart their arguments, so my return on investment for that 15 minutes wasn't great."

He still accepts drug samples, but only reluctantly, and only because he views samples as "a necessary evil" for patients who can't afford essential medications.

Other practices are determined to impose some order on the constant stream of drug detailers' intrusions. Fayetteville Medical Associates, for example, a seven-physician primary care group in Fayetteville, Tenn., recently adopted a strict rule allowing physicians to sign for samples, but not to engage in long discussions with reps if they're seeing patients.

According to J. Fred Ralston Jr., FACP, a general internist and Governor for the College's Tennessee Chapter, drug reps can make brief presentations at the practice during lunch hour. The presentations are allowed only if reps pre-schedule the meetings with a designated staff member. They must also obtain advance approval from physicians.

Drug detailers may not leave information, such as brochures or flyers, in patient areas without permission. The practice has gone so far as to ban drug reps who have violated the policy and left brochures in the waiting room.

(Dr. Ralston noted that the practice does allow literature to be placed in the waiting room for Together Rx, a program that discounts medications. He said that the practice worried that patients would be too embarrassed to mention that they had financial problems and would simply go without their medications.)

Physicians at Diagnostic Clinic of Longview in Longview, Texas, have gone even further. They allow drug reps to see physicians only during lunch hour to provide samples, not detailing, according to general internist James W. Sawyer, FACP. He said that he gives the samples to uninsured and Medicare patients who can't afford expensive medications.

"Over the years, I've been inundated with reps," he explained. "Some are helpful and very nice to deal with, but many have become intrusive and overbearing."

Many physicians claim they're overwhelmed by drug detailers' attempts to get an audience with them-and with good reason. Since 1997, the pharmaceutical industry has more than doubled its sales force from roughly 41,000 in 1997 to 87,000 in 2001, according to a report from the Newtown, Pa.-based consulting firm Scott-Levin. That translates into one rep for every 4.7 office-based physicians.

Along with boosting sales staff, drug companies have also dramatically increased their budgets for direct marketing to physicians, according to the Kaiser Family Foundation. The Washington, D.C.-based organization reported that pharmaceutical companies spent $13.2 billion in 2001 on physician-targeted marketing, eclipsing the $2.5 billion spent that year on direct-to-consumer advertising.

Concerns about conflicts

Practical issues may be driving some physicians to change their ways when it comes to drug detailers, but others see much bigger issues at stake. In a position paper on physician-industry relations published in the March 5, 2002, Annals of Internal Medicine, the College's Ethics and Human Rights Committee pointed to some of the potential problems that can occur when physicians get too close to the drug industry.

The paper took a tough stand against gifts, hospitality, trips and subsidies of all forms. It also spoke out against issues like drug samples that hit closer to home for many internists.

The paper concluded that drug samples mainly serve to encourage physicians to continue prescribing a certain product. Research has shown, it said, that once patients run out of the sample, most physicians write a prescription for the same brand.

The paper also pointed out that physicians frequently do not realize that their decision-making has been affected by industry's influence. Even more importantly, a growing number of patients may now believe that marketing practices lead to physician bias, whether physicians think so or not. (The College's guidelines are online.)

Some physicians are calling for cutting doctors' ties to industry altogether. Robert L. Goodman, MD, who practices general internal medicine at New York-Presbyterian Hospital in New York, argued that the industry's marketing practices—including distributing drug samples—do influence prescribing behavior.

According to Dr. Goodman, the notion that drug detailers provide a valuable source of education is "outdated" in the Internet age. He wants to see an end to all direct pharmaceutical industry-physician interaction, including sponsored CME. And he noted that "drug company dependence" is a two-way street, advising physicians to mend their own ways instead of merely pointing a finger at industry.

To that end, he founded the organization No Free Lunch to oppose drug company marketing practices. He now urges physicians to publicly take the No Free Lunch pledge to become "drug company free."

Mixed response

To date, however, only about 200 physicians have taken the pledge. That relatively small number hints at the mixed response the issue garners among physicians.

Vinod N. Velakaturi, ACP-ASIM Member, for instance, a general internist in Independence, Mo., said that physicians in his group limit their time with drug reps. In addition, he and another physician in his practice take samples to a free clinic where they volunteer once a month.

Even so, Dr. Velakaturi said he doesn't see why all forms of hospitality should be purged from physician-industry interactions. "If other businesses can take their clients out to ballgames and dinners," he asked, "why can't we do that in medicine?"

He also said he doesn't believe interactions with industry representatives affect his prescribing patterns. "Most of my prescribing habits depend on what a managed care plan covers anyway," said Dr. Velakaturi, "not which company took me out to dinner."

Even physicians who acknowledge that industry largesse is abused by some of their colleagues don't necessarily see all contact with industry representatives as wrong.

Jacqueline W. Fincher, FACP, a general internist with McDuffie Medical Associates in Thomson, Ga., said that one drug rep told her that another practice had asked his company to sponsor its office Christmas party. While she characterized the request as an egregious violation of professional conduct, Dr. Fincher said that she does not believe her own clinical judgment is compromised by attending educational meetings sponsored by drug companies.

"I like to go off where I can concentrate, and that's how I learn," she explained. "If they're going to take me somewhere and I can listen to the top people in the field from around the country, I don't see that as a bad thing."

She spends too little time with individual reps in her office to be influenced by their pitches or beholden to them, she argued. And the needs of individual patients—not promotions—dictate what she prescribes.

"All the promotion in the world isn't going to change the patient," Dr. Fincher said. "You pick drugs based on the clinical ramifications for a particular patient. Sometimes it's the drug that sponsored the program you went to last weekend, and sometimes it's that company's competitor."

Some physicians provide an even stronger endorsement. Arthur Silk, FACP, a solo internist in Garden Grove, Calif., for instance, said that he actually enjoys seeing detailers, "especially those well-trained in their product." He noted, however, that he also uses publications like the Prescriber's Letter to learn about new drugs.

"I often learn first of a new medicine like Zetia [ezetimibe] from a detail person, but whether I prescribe the drug depends on what I learn about it later," Dr. Silk said. He added that he rarely prescribes a medication "fresh out of the laboratory," no matter how heavily it is advertised or promoted.

Voluntary guidelines

Even as physicians disagree about how marketing tactics affect their decision-making, the drug industry has been working to come up with standards to police its own marketing practices. In July 2002, the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group whose members produce 90% of the brand-name drugs sold in America, adopted a "code" intended to document the relationship between drug makers and physicians.

Though the code is voluntary, it spells out promotional activities that are appropriate—and those that are considered off limits. The guidelines call for drug makers to discontinue practices like "dine-and-dash" encounters, for example, where drug reps provide meals for physicians or medical office staff but offer no educational content.

The code says that paying for physicians to attend entertainment or sporting events is no longer acceptable, nor are gifts—even items of nominal value—that do not directly or indirectly benefit patients. Any activity that doesn't enhance physicians' practice of medicine or patient treatment, the guidelines contend, should be avoided or discontinued. (The code is online.)

The code was developed at the urging of chief executive officers from several major pharmaceutical companies, said PhRMA spokesman Jeff Trewhitt. "They originated at the top," he explained, "so it should be clear to sales personnel that they have been embraced and endorsed by the boss."

The industry's effort to regulate itself may, however, have been too little, too late. Just months after the PhRMA released its code, the HHS Office of Inspector General (OIG) unveiled its own guidelines. Some say the OIG's rules will herald an era of new government oversight and regulation of physician-industry relations.

The OIG released the final version of its guidelines in May of this year. The 56-page document scrutinizes how marketing and promotional efforts may violate anti-kickback laws by rewarding physician decision-making. (The document is online.)

The guidelines explain how incentives such as entertainment and expensive meals could be viewed as inducements to prescribe a certain drug. The guidelines also say that even marketing activities that serve a legitimate purpose—educating physicians, for example—may violate anti-kickback laws if they are also intended to influence clinical decision-making or change referral patterns.

The guidelines also frown on paying consulting fees to physicians who only passively attend a meeting or conference. And an increasingly popular arrangement where physicians charge drug companies for the time they spend with detailers is also "highly suspect," according to the guidance.

Some drug makers have complained that government intervention in their marketing practices will harm professional education, which depends upon industry support. And they claim that the guidance, once adopted, could disrupt health care delivery systems that rely on encouraging insurers and pharmaceutical benefit managers to use certain drugs.

The new rules have some strong supporters, however. Ron Pollack, executive director of the consumer advocacy organization Families USA, views the growing scrutiny of relationships between physicians and the pharmaceutical industry as good for patients and consumers.

"We're dealing with a culture in the pharmaceutical industry that is pernicious and that creates conflicts of interest," Mr. Pollack said. "If sales people don't go as close to the line as possible" when marketing to physicians, he continued, "it's frowned upon, as if they're not doing their job aggressively enough. The OIG guidelines are a step in the right direction."

Balancing act

The new guidelines are purely voluntary, however, and drug makers and the government will need time to decide how—or whether—to enforce them. For now, physicians will likely find that things haven't changed much, and that they have to continue their own balancing act.

David W. Potts, FACP, chief of infectious diseases at Anmed Health, a hospital in Anderson, S.C., is a good example of someone who takes a deliberate, middle-of-the-road approach. A former vice-chair of the College's Ethics and Human Rights Committee, Dr. Potts refuses to accept drug samples and declines to attend lunches or dinners sponsored by drug companies.

He hasn't, however, completely cut all ties to drug makers. He is willing to talk to detailers, and he is listed on the speakers bureau for three drug companies.

Dr. Potts said that he has found that he can give company-sponsored lectures—on taking a patient's sexual history, for instance—without being biased by pharmaceutical company dollars. He gives the money he earns from lectures to a hospital foundation that offers HIV patient education and care.

For him, what's critically important is keeping a sense of perspective when dealing with drug detailers. "I always try to remember that it's their job to make money and it's my job to provide patient care," Dr. Potts said. "If I keep that clear, I do better in my dealings with them."

Bonnie Darves is a freelance writer in Lake Oswego, Ore.


Prescribing profiles put physicians under the microscope

By Phyllis Maguire

Within the last year or two, R. Scott Hanson, ACP Member, has noticed a new undercurrent in his interactions with drug reps: They seem intimately familiar with every detail of what he prescribes.

"They know my prescribing patterns better than I do, down to exactly how many antibiotics and antihistamines by brand I've prescribed in the last quarter," said Dr. Hanson, a general internist at South County Walk-in and Primary Care in Narragansett, R.I.

Even more disturbing, the reps seem to know whether the samples they drop off lead him to write any new prescriptions.

"It makes me feel like a rat in a maze when they put little nibblets in front of me to see if I'll prescribe their drug," Dr. Hanson said, referring to drug samples. "I think it's unbelievably invasive and wrong."

Welcome to the brave new world of physician prescribing profiles. While drug companies have gathered data on doctors for decades, they have recently gained access to a new cache of prescribing data: patient prescription databases.

While patient names and identifying information have been removed from these files, other details like the prescribing physician's name and dosage often remain intact. The information has become a powerful tool in the hands of drug makers' sales force, one that makes some physicians feel put on the spot when drug detailers come to call.

Good data, bad uses?

For at least 10 years, drug companies have been buying data on physicians' prescribing habits from pharmacies or data clearinghouses. While drug companies originally wanted data to track how well their sales representatives were doing, they soon began using the information in other ways.

Knowing that physicians prescribe a competitor's product, for example, allows drug detailers to push the benefits of their own drug. And knowing which physicians are high-volume prescribers lets sales reps concentrate their profiling efforts.

Drug companies can now get physician prescribing information to their sales force in a matter of weeks instead of months, said E. M. Kolassa, PhD, managing partner of Medical Marketing Economics in Oxford, Miss. (The company provides marketing consulting to drug companies but does not sell prescription data.)

And drug companies can now buy a new type of prescribing data from pharmacies, he continued: patient data. While these databases replace patients' names with individual patient identifiers to protect their privacy, they can potentially give drug makers a wealth of information about physicians' prescribing activities.

(Ironically, technological breakthroughs to meet federal privacy regulations have made patient prescribing data more available than ever, Dr. Kolassa said. As companies devise ways to strip patients' identities from their health care information, more "de-identified" patient information is hitting the market.)

A patient-data product from Verispan, for example, claims it can track a patient's prescribing history over time, including "who wrote the initial prescription and who continued this treatment." Drug makers can also use the data to learn which drugs physicians switch patients to, and which drugs they try first in combination therapies.

According to the May 25, 2003, Boston Globe, drug companies can use this new type of data to see if doctors are switching patients to a competing product that has a higher dosage, for instance. Drug reps can then detail how to use their own product to be just as effective.

Physician prescribing profiles and patient data aren't always used for marketing purposes, Dr. Kolassa pointed out. Criminal investigators, for example, have used prescribing profiles to track physicians who abuse prescribing privileges with drugs such as oxycodone.

And Dr. Kolassa said that prescribing data has helped make sense of prescribing trends. In the 1990s, for example, data showed that most physicians who prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) also prescribed drugs to relieve gastrointestinal symptoms, such as proton pump inhibitors or H2 antagonists.

"That gave us a strong indication that docs were afraid of NSAIDs and what they might do to patients' GI tracks," Dr. Kolassa said. "Understanding that dynamic helped explain why drugs like Celebrex [celecoxib] and Vioxx [rofecoxib] really took off."

While academic researchers may use prescribing data to spot important epidemiological trends, however, analysts say that drug reps put the data to a much different use.

Detailers often use the targeted information to "put more and more pressure on a physician to prescribe medications that might not be that doctor's choice," said Michael R. Cohen, ScD, president of the nonprofit Institute for Safe Medication Practices in Huntingdon Valley, Pa. As a result, he added, drug costs may be driven up while some drugs may be prescribed unnecessarily.

For Dr. Hanson, the fact that detailers don't use profiles to improve prescribing safety or quality just adds to his frustration. Instead, he said, reps seem motivated to visit him more often when his prescribing falls off. And no detailer has ever alerted him to the fact that, according to his profile, he might be prescribing an expensive antibiotic when a generic equivalent exists.

In fact, Dr. Hanson added, reps refuse to share any of his own profiling data with him. "They swear up and down that their supervisors would fire them if they ever showed me what's on their handhelds and laptops," he said. "They make a great effort to not show their hand."

Questions of legality

Physician frustration with prescribing profiles led the Board of Governors to adopt a resolution on the topic last fall. If approved by the Board of Regents, the resolution would commit the College to work toward a legislative or regulatory ban on the sale or exchange of physician prescribing data.

ACP's Medical Services Committee, which is studying the resolution at the Board of Regents' request, has so far determined that prescribing profiles do not violate federal confidentiality rules because patients' identities aren't revealed. In addition, the practice does not appear to violate FDA regulations governing the marketing practices of drug companies.

The FDA's main concern is that marketing information "is accurate and balanced," said Thomas W. Abrams, director of the division of drug marketing, advertising and communication for the FDA's Center for Drug Evaluation and Research. Merely using profiling data does not violate FDA regulations on false or misleading promotional material, he said. The FDA itself purchases prescribing data, he added, to track product marketing and make sure that physicians are not getting "misleading messages."

While critics probe the legality of using prescribing data, some analysts say that physicians need to remember that the practice of capturing commercial interactions in databases is now ubiquitous. They point to the profiles that online vendors like keep for their customers, or the way marketers can scrutinize the spending habits of shoppers who use "preferred customer" cards at supermarkets.

But Paul A. Gitman, FACP, Governor for the New York Downstate II Chapter and Vice-Chair of the Medical Services Committee, said there are crucial differences between physician prescribing profiles—which may be used, he said, to exert "undue influence in order to change practice patterns"—and other commercial databases.

"There's a difference between trying to get someone to buy a car and prescribe a medication," Dr. Gitman said. The standards for medicine are much higher than those for general commerce, he continued. If the public holds physicians to a higher standard and expects them to do only what is best for patients, he said, then "everyone within the whole environment ought to be held to a similar standard."

The use of physician and patient prescription data doesn't adhere to that standard, he said, because drug makers use profiles to influence decisions "that aren't necessarily in the best interest of patients."


ACP Foundation looks at how physicians and drug reps relate

Can internists and the drug industry work together to improve the sometimes-strained relationship between internists and drug detailers?

In February, the College's Foundation hosted a two-day meeting with officials from drug companies, medical device manufacturers and health insurers to discuss ways the groups can work together to improve patient care. While the meeting had a broad agenda and was not attended by drug detailers or salespeople of any kind, the topic of drug representatives was on the minds of several physicians.

In talking about her relationship with drug detailers, one College Regent described a "siege mentality" that affects both drug reps and physicians. She said there are times when as many as 15 drug detailers are sitting in her practice's waiting room to talk to her.

While drug detailers are under the gun to get "face time" with physicians, some internists said they feel just as pressured to pack more patient care into their already busy schedules. The clash of interests can result in both physicians and the drug industry feeling unappreciated and misunderstood.

Some physicians at the meeting, however, acknowledged that drug detailers can serve as a valuable source of information for physicians. The challenge, they said, is to identify ways that drug detailers can better communicate that information to busy practicing physicians.

A former ACP Governor discussed the relationship he has developed with drug companies, one he said has served him and his colleagues well. He sees two or three drug detailers for a half hour once or twice a week. To keep from becoming swamped by drug representatives, however, the internist said he will not see those particular representatives again for four months.

He said a combination of being respectful but forthright with drug detailers has helped lead to longstanding collaboration on some efforts. Drug companies regularly provide speakers to talk about broad topics (not just specific drugs) for the weekly CME meetings at his hospital. Several drug companies have also provided unrestricted grants for other types of educational programs.

Officials from both ACP and the drug industry said they were encouraged by the discussion at the meeting. Some attendees suggested future collaborations between the College and the drug industry to identify models that both physicians and drug detailers could use to better work together.


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