Since the early 1990s, concerns about the conflicts of interest in the doctor/drug representative relationship have grown increasingly vocal. Over the past four or five years, these concerns have reached a fever pitch, and have sparked a backlash among many physicians. These physicians, more and more of whom are refusing to meet with sales representatives altogether, resent not only the time demands placed on them, but also the influence these salesman hold over their prescription writing.

While drug companies continue to claim that their sales representatives are a critical component of America’s healthcare system because they provide busy doctors with important information about the latest medications, many physicians and other critics are saying just the opposite: drug representatives are a detriment to our healthcare system.

What’s more, they say, the data now exists to prove it. The website, founded by a New York-based physician in 1999 to protest the promotional efforts of drug representatives, provides links to over 100 major articles and studies published in just the last several years that condemn the relationship between salespeople and physicians.

One of the foremost critics of this relationship has been Dr. Jerome Kassirer, the editor in chief of the New England Journal of Medicine from 1991 until 1999. In a recent interview Kassirer acknowledged the growing criticism, and tied its genesis to the ever-widening scope of the ethical and financial conflicts involved, not just between doctors and drug representatives, but, in a broader sense, between doctors and drug companies.

“I think it’s a long time in coming,” Kassirer said of the growing criticism. “Finally some of the things [the drug companies] are doing have been uncovered. I think finally people have begun to realize how serious the problem is and have begun to write about it.”

Kassirer said he first became concerned with financial conflicts between physicians and drug companies during his very first year at the journal, so much so that it was the subject of one of his initial talks there. In 1993, through his impetus, the journal decided not to publish review articles or editorials by authors with financial ties to drug companies if that company or its drugs were featured prominently in the article. Throughout his tenure, however, these conflicts grew to such an extent that authors without them became harder and harder to find. In 2001, in fact, Kassirer’s successor changed the journal’s policy and began allowing these authors to write articles providing they disclose their conflict(s).

Two of Kassirer’s recent studies—his 2004 book, On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health; and a 2005 article—to be published as a chapter in an upcoming book—called “Physicians’ Ties With The Pharmaceutical Industry: A Critical Element Of a Wildly Successful Marketing Network”—have examined these conflicts, with the aim being, as he said in On The Take, to “distill the benefits of these collaborations and fully explore the risks.”

There are five main ways, Kassirer found, in which drug companies entangle physicians in financial and ethical conflicts of interest. They are:

Giving physicians gifts, free meals, and drug samples

Paying physicians to lend their names to articles ghost written by drug companies

Sponsoring continuing medical education (CME) courses for physicians that are often biased in favor of the sponsoring company’s medications

Employing physicians to help write literature and brochures advocating their products

Paying physicians to make presentations at drug-company sponsored conferences, which place a favorable slant on the sponsoring manufacturer’s medications.

Drug representatives play a role in three of these. They are, of course, the main purveyors of free meals, drug samples, and promotional gifts. They also help recruit physicians for CME courses and as speakers at drug-company sponsored conferences. While pharmaceutical companies, as well as many physicians, maintain that the small gifts and meals drug representatives lavish on doctors are trivial and don’t influence prescribing habits, recent studies show otherwise.

Evidence suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize.

A 2000 study published in the European Journal of Clinical Pharmacology, for example, found that increased interaction with drug representatives—whether in the form of accepting gifts, sharing meals, or discussing medications—was associated with prescribing habits less beneficial to the patient (“low prescribing quality”). Other recent studies have shown that while most physicians don’t see themselves as influenced by promotions and small gifts, basic social science contradicts them. A 2003 study by Dana Katz, Arthur Kaplan and Jon Merz for the American Journal of Bioethics found that “Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize.”

And that when a person accepts a gift, no matter how small, “the obligation to directly reciprocate, whether or not the recipient is conscious of it, tends to influence behavior.”

Kassirer, who dedicated an entire chapter in On The Take to physicians’ mistaken beliefs that small gifts don’t influence them, tied these misconceptions to medical training, which is designed to give doctors a strong sense of objectivity. This training, he wrote, causes “many physicians to believe that they have no difficulty separating the facts from the hyped information given to them by industry representatives.” Kassirer goes on to dispute these beliefs, citing evidence from a 1994 study in the Journal of the American Medical Association. In the study, 40 physicians who requested additions to their hospital drug formularies (drugs approved by their hospital) were compared to 80 physicians who had not requested additions. The study found that doctors who requested additions were over nine times more likely to have eaten free meals from drug representatives, or to have had accepted drug-company money—either to speak at conferences or for research support.

Along with the giving of gifts and free meals, the issue of drug-company sponsored education is viewed by many critics as being rife with conflicts of interest. Pharmaceutical companies currently spend between half-a-billion and several billion dollars annually educating physicians. This education is delivered through various channels, including industry-sponsored CME events, for-profit medical education centers (of which approximately three-quarters are funded by drug companies), academic and medical society-sponsored education, and face-to-face visits by sales representatives.

The issue, of course, is the extent of bias in drug-company sponsored education. If Pfizer, for instance, sponsors a CME course about the latest treatments for depression, the natural question would be whether Pfizer’s own medications were advocated over others. While Kassirer declined to speculate on just how much bias is involved in drug-company-sponsored education, he said that there is indeed evidence of it.

When some of the Merck-paid speakers began to talk about the risks of Vioxx, they were threatened by one of the Merck vice-presidents. Speakers know what they say is being monitored. If they talk about the risks of these drugs, they know they’re not going to be speakers anymore.

“A perfect example of what goes on at these CME situations is what happened recently with Merck,” he said. “When some of the Merck-paid speakers began to talk about the risks of Vioxx, they were threatened by one of the Merck vice-presidents. So speakers are being watched by the drug companies, and they know that. They know that what they say is being monitored. And if they start talking about the risks of these drugs, they know they’re not going to be speakers anymore.”

Dr. John Westfall, associate dean for rural health at the University of Colorado Medical School, said the drug industry should play only a limited role in educating physicians. While he is opposed to all “informal CME”—pharmaceutical education provided by drug representatives during office visits—as well as CME lectures and symposia involving drug-company paid speakers, he believes that there is value in the “unrestricted” grants the drug industry provides. These grants, Westfall said, do not facilitate bias because the drug companies that bequest them do not set the agenda for the program being funded.

Kassirer, however, cites a case that may dispute this. In “Physicians’ Ties With The Pharmaceutical Industry” Kassirer offers the example of the National Initiative in Sepsis Education (NISE), an organization founded in 2000 in part to deliver information on new therapies for severe sepsis. NISE’s programs were supported by an “unrestricted” educational grant from Eli Lilly & Company, yet most of the treatment information on the NISE Web site “dealt with information critical to the use of Eli Lilly’s very expensive product, Drotrecogin Alfa (activated), or Xigris.”

Many physicians who are otherwise hostile to the role pharmaceutical representatives play in the healthcare system justify time spent with them by citing one main reason: drug samples. The argument often made by these physicians is that the only way to effectively treat their indigent patients is with the free samples drug representatives continuously hand out.

Westfall disagrees. He said the use of samples in treating indigent patients is a “stop-gap approach” which leads us “farther away from a just healthcare system.”

“A just healthcare system would be one where patients had access regardless of their ability to pay,” he said. “Using drug samples doesn’t really help us get to that place because a lot of patients don’t have access to them. Either their clinic is out (of samples), their clinic doesn’t use them, or the clinic doesn’t have the particular samples the patient needs. Also, if it’s a chronic medication, what happens when you run out of samples? Do you have the patient bop from medication to medication, using whatever happens to be available?”

Another factor in using samples to treat patients, Westfall said, is that drug representatives almost always provide doctors with the newest, most expensive drugs, which are not necessarily the most effective. “In (treating) hypertension the two most studied drugs are diuretics and beta-blockers. Those are rarely in physicians’ sample cabinets. And hydrochlorothiazide, which is the cheapest and most studied and has the best outcome data of any drug for hypertension, there are no samples of it, ever. The samples are always of the newer drugs that (drug companies) are trying to get out there.”

Just how often drug samples are taken for personal use, not just by physicians and nurses, but also by drug representatives themselves, is another issue. Westfall, in fact, conducted his own study in 1997 on the personal use of drug samples. Entitled “Personal Use of Drug Samples by Physicians and Office Staff” and published in the Journal of the American Medical Association, Westfall’s study found that out of 53 family practices surveyed over a one-year period, 96 percent reported at least one staff member having taken samples for personal use. (In all, 230 separate drug samples were reported taken, in amounts ranging from one dose to more than one-month’s supply.)

Use of samples by pharmaceutical representatives might be just as widespread. In Hard Sell, Reidy writes of self-medicating with samples of Zithromax, an expensive Pfizer antibiotic, for symptoms as innocuous as a mild cough. He also frequently handed out samples to family and friends. In one episode from his book, Reidy tells of what amounted to conducting his own test on the efficacy of Zyrtec, a new Pfizer antihistamine, on a friend who was suffering from intense allergies.

With all of these sample medications being used in ways for which they weren’t intended, one might wonder why drug companies don’t make it harder to do so.

The above cases suggest that the dollar value of sample medications used in personal ways by doctors, their staff, and drug salespeople, could be staggering. Reidy, for his part, declined to give a dollar estimate on the amount he himself used in this manner, though his response indicated that the amount could be very large. The reason, he said, that he didn’t want to attach a dollar figure was because Pfizer had been “surprisingly cool” in its reaction to his book (he didn’t elaborate on this) and that giving a dollar estimate might “rub it in their face a little bit.”

With all of these sample medications being used in ways for which they weren’t intended, one might wonder why drug companies don’t make it harder to do so. An answer might be that the industry does not mind when doctors and office staff members use samples for themselves because it gives pharmaceutical representatives an opportunity to return to their offices, restock their shelves, and engage in more drug pitches.

Indeed, as a marketing tool, drug samples cannot be overestimated. A Wyeth salesman interviewed recently said that samples were his absolute key in getting face time with physicians, and that he brought them along on most sales calls.

While the pens and pads and trinkets usually went over well enough with the office staff, he said, restocking the samples’ cabinet was the best way to get past the “gatekeeper” (person at the front desk) and into the back.

Once in the back, he said, he would linger, looking for doctors.

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