Clinical Ethics in Anesthesiology. A Case-Based Textbook

5. Practice issues

41. Conflicts of interest - industry gifts to physicians

Murali Sivarajan

The Case

Dr. Daniel Carlat, a practicing psychiatrist, published an article entitled, ‘Dr. Drug Rep’ in the New York Times Sunday Magazine in November, 2007.*1 In it, he wrote of his experience acting more or less as a drug company detail man going to physicians’ offices and giving lunch-time talks to primary care physicians and psychiatrists extolling the virtues of Effexor®an antidepressant, while the audience feasted on gourmet luncheons supplied by the maker of Effexor®Wyeth Pharmaceuticals had recruited him to do this by inviting him and his wife to attend a conference in New York City, plying them with expensive dinners and theater tickets and, in addition, paying him an honorarium of $750.00. He was given a set of slides on Effexor® prepared by Wyeth to use for his talks and he was promised a fee for each talk that he delivered. He admits to being somewhat uneasy about this arrangement but nevertheless decided to participate.

In his talks, Dr. Carlat pitched Effexor® as a better antidepressant than other drugs on the market. This was based on a meta-analysis presented at the conference by an esteemed academic psychiatrist who was a paid consultant to Wyeth. The co-authors were Wyeth employees. As the year went by, new data emerged showing that Effexor® was only marginally better than other drugs in improving depression. It also had a significant side effect – a 50% greater incidence of hypertension than with other antidepressants – and serious withdrawal effects as well. Dr. Carlat realized that these undesirable properties of Effexor® had been downplayed at the conference but he still continued to pitch the drug to his audiences because he was “concerned that the reps would not invite him to give talks if he divulged any negative information.” He came to the realization that he was just a “drug rep with an MD” when he was challenged by one of the psychiatrists in the audience on the incidence of hypertension with Effexor®After a year of giving an average of one talk a week, earning him a supplemental income of $30 000.00, he quit being a drug rep. At the end of the article, he raised several questions:

Did I contribute to faulty medical decision-making? Did my advice lead doctors to make inappropriate drug choices, and did their patients suffer needlessly?

And he provides his own answers

Maybe. I’m sure I persuaded many physicians to prescribe Effexor®, potentially contributing to blood-pressure problems and withdrawal symptoms.

Dr. Carlat’s ethical lapses are obvious; misrepresenting and evading the truth, prevarication if not outright lying. One could argue that there was no conflict of interest because Dr. Carlat did not misrepresent himself as any one other than a speaker for Wyeth paid to promote its product. However, a conflict resides in a general sense because the payments he accepted from the drug company to sustain or increase its market share were against the interests of patients he is sworn to protect as a physician. In his confessional, Dr. Carlat acknowledges his own ethical lapse in “dancing around the truth…,” but he ignored the larger problem of drug companies trying to influence physicians by plying them with gifts.

As part of promotion aimed at physicians, drug companies have always given out gifts. In 1985, this author observed that these gifts were “no longer cheap ball-point pens but something moderately priced, such as a document case, with the name of the company emblazoned on it.”*2 Subsequently, the gifts became even more extravagant. Expensive dinners at local restaurants, all-expenses-paid trips to resorts to attend quasi-scientific meetings where the company’s products were heavily promoted, and cash offerings to sit through promotional presentations became commonplace. In response to concern expressed in the peer-reviewed literature about drug companies’ influences on physician practice and behavior, the American College of Physicians*3 and The American Medical Association*4 published position papers that sought to limit, but not eliminate, drug companies’ gifts to physicians. They found trivial gifts such as pens and calendars, modest dinners, drinks and hospitality related to an educational event, even trips to educational meetings chosen for their convenience and not for recreation still acceptable. It was suggested that whether a gift is acceptable or not may be guided by the answer to the question, “would you be willing to have these gifts generally known?”3

In spite of position papers and guidelines, the practice of feting physicians with expensive gifts continued unabated. The print media began to take note. Numerous articles, editorials and Op-Ed commentaries in major newspapers and magazines led the Pharmaceutical Research and Manufacturers of America (PhRMA) to publish a voluntary code of conduct for interactions with health professionals in July 2008.5 It prohibits small gifts (e.g., logo-embossed pens and coffee mugs), and recreational and entertainment gifts, (e.g., tickets to shows and sporting events that have no educational value). But it does not prohibit drug reps from providing office-based and hospital-based meals and educational material less than $100.00 in value. Does the acceptance of these gifts, such as the office-based meals that Dr. Carlat presided over, constitute conflicts of interest? Do these gifts influence physicians’ practices and potentially harm patients?

The obligation of gifts

Most physicians who accept gifts from drug companies deny that they are influenced to prescribe that company’s drug over other, or generic, drugs of equal merit. But to expect them to admit being influenced by gifts is unrealistic. Their natural and instinctive response is denial because admission reflects poorly on their character or professionalism. In behavioral psychology this response is attributed to “self-serving bias” that tends to favor one’s own self interests:6 an individual’s judgments of appropriate behavior are biased in favor of their own actions. Yet, in fact, both philosophical reasoning and empirical evidence do implicate drug company gifts in influencing the prescribing behavior of physicians.

A reasonable body of enquiry in moral philosophy has defined the obligation that gifts impose.7 In some Native American tribes, gifts entail no reciprocal obligation on the part of the recipient. However, gifts in our society have a more personal meaning. The giver offers a personal relationship and the receiver in accepting the gift, accepts the relationship that carries an obligation to reciprocate. Camenisch also describes the tension between the giver and the receiver if the gift is not reciprocated; the recipient in accepting the gift without reciprocating assumes an inferior or dependent relationship.7The desire to reciprocate is a powerful emotional response to maintain an equal relationship with the giver. Partaking of food in the company of others is a social event that most enjoy; therefore gifts of food, in particular are more entangling because of the camaraderie and the good feelings that accompany it. It has been said that food is “the most commonly used technique to derail the judgment aspect of decision making.”8 Obviously, the doctor who accepts a drug company gift is not expected to respond by giving a gift to the drug rep. Physicians’ desire to reciprocate results in their favoring the company’s product when prescribing from a bewildering formulary of similar, equally effective drugs.

Empirical evidence supports the contention that physicians favor the products of the company that provided gifts to them. One study examined the prescribing patterns of 20 physicians before and after their attendance at a drug company sponsored seminar. They found that prescription for the index drug increased after the drug company sponsored event compared with that before the event and also compared with national trend at the same time. All but one of the physicians denied that the seminar would affect their behavior.9 A critical analysis of the studies on the influence of drug company interactions with physicians on their practice patterns demonstrated that: (1) physicians’ meetings with drug company representatives are associated with increased requests for adding the drugs promoted by the drug reps to the hospital formulary; (2) continuing medical education (CME) programs sponsored by a drug company preferentially promoted the sponsor’s drug compared to non-sponsored CME programs; (3) physicians who attended drug company sponsored CME programs and accepted travel funds from sponsors were more likely to write prescriptions for the drug(s) made by the sponsor and less likely to prescribe generic drugs; and (4) resident physicians attending drug company sponsored luncheon lectures were more likely to have inaccurate information about the sponsor’s and the competitor’s products.10

Social science and marketing research support the view that the insidious obligation that gifts impose is not related to the size and cost of gifts. Studies show that even trinkets with brand names etched on them, such as key chains, ball-point pens, refrigerator magnets and coffee mugs, increase sales of the brand products.6 A simple indication of their effectiveness is the fact that the drug companies would not be doing it if the resulting increase in sales did not warrant the cost of these promotions. From a behavioral perspective, small gifts with brand logos create brand-awareness and implicit associations in memory. This results in their name being recalled when purchasing a product or writing a prescription. Another study demonstrated that two small pharmaceutical promotional items, namely a clipboard and a notepad with brand logos, skewed the treatment preferences of medical students who were exposed to them when compared to students who were not.11

The cost of the obligation created by accepting gifts

The financial costs of these obligations are impressive. Annual marketing expenditures by pharmaceutical companies are approximately $ 20 billion, 90% of which is directed at physicians.12 In 2004, Blumenthal reported that drug companies spent $8 000 to $15 000 per physician every year to promote their products.13 The money to pay for such promotions comes from the sale of products, paid for by patients in one way or the other. During this decade, when inflation was approximately 1%–3%, drug company profits increased by double-digit percentages every year, and over 30% of their budgets were spent on marketing. Inevitably, this adds to the cost of healthcare overall.

The moral cost of the obligation of gifts is the erosion of the physician’s professional image. The drug companies declare these expenses as legitimate marketing, but there is a crucial moral difference between the marketing of pharmaceuticals to physicians and the marketing of consumer products such soaps, cosmetics and cars directly to consumers. In pharmaceutical marketing to physicians, gifts are given to physicians to influence their practices while the patients, who are the consumers, pick up the tab. In stark mercenary terms, physicians decide the medicine or treatment for which the patients pay and then receive tax free gifts for those decisions. There is the injustice of redistribution of wealth from the patients, some of whom are least able to afford it, to doctors, who are considerably better off.

Anesthesiologists are less likely to write prescriptions than other physicians but are still the target of drug companies and medical equipment manufacturers. A survey of physicians in the US revealed that, on the average, anesthesiologists met with drug and equipment sales representatives about two times a month. They were as likely to have received gifts  such as free meals and entertainment tickets as surgeons, internists, pediatricians, family practitioners, and cardiologists. In general, anesthesiologists were less likely to have received travel reimbursement and payment for consulting than cardiologists, internists, and family practitioners.14

Physician obligations to the profession

Voluntary guidelines and policy statements published over the last 15 years have had some effect in curbing some of the practices, such as all-expenses paid vacation in luxury resorts, that could be seen as blatant bribes. But, by pharmaceutical industry’s own guidelines, gifts will continue to be given especially in professional meetings in which the company’s products are promoted. Because voluntary guidelines have had only limited success, a group of academic physicians and representatives from the Association of American Medical Colleges have called on academic medical centers to take a leadership role in abolishing potential sources of unwanted influence by drug companies.12 The hope is that academic medical centers, which have responsibility for educating and training physicians, will have an influence in shaping the attitude of future physicians toward these conflicts of interests. There is some validity to this assumption. A recent study reported that students at a medical school that had policies prohibiting gifts from drug companies were less likely to be influenced by drug company promotional items than students from medical schools that had no restriction on gifts from drug companies.11

Some years ago, the Marketing Executive of a large drug company was invited by the author’s institution to debate their promotional activities. He declined the invitation but confided that there were two reasons for their gift program: (1) that the rival companies were doing it in a fierce competitive market, and (2) that without some gifts to catch their attention, doctors would not give them their time of day. Surveys of resident physicians confirm the view that without meals as inducement they were less likely to attend drug company sponsored CME meetings.13 Physicians are therefore at least somewhat complicit with the drug companies in perpetuating these activities. But physicians’ obligations to the medical profession demand that they put patients’ interest ahead of material gain outside of regular remuneration. If physicians rejected the overtures of commercial medical companies with as much indignation as they display when accused of being influenced by them, then these practices and conflicts of interest would probably cease. In the words of Goldfinger, “In this world of medical commerce, it still takes two to tango”.15

Key points

• Drug companies exert influence on physicians’ practice behaviors by bestowing a wide variety of gifts on them, from trinkets to gourmet dinners and travel reimbursements to attend company sponsored meetings.

• Even inexpensive gifts influence physician behavior by creating “brand awareness” and implicit associations with the products of the companies that provide the gifts.

• Accepting gifts creates obligations for physicians that are in direct conflict with their obligations to patients.

• Company gifts are funded from the sale of companies’ products to patients. Hence patients suffer additionally by having to pay for these gifts.

• Voluntary guidelines by professional medical organizations have had very little effect in curbing drug companies’ influences on physician practices.

• Academic medical centers might have a role in shaping the attitudes of future physicians to drug industry influence on physician behavior.

• Individual resolve is essential if physicians are to preserve their professional image and dignity.

References

1* Carlat D. (2007). Dr. Drug Rep. New York Times, November 25. http://www.nytimes.com/2007/11/25/magazine/25memo-t.html?_r=1&emc=etal Accessed October 27, 2009.

2* Sivarajan, M. (1985). Tarnishing the medical profession’s image. N Engl J Med312, 1132.

3* Physicians and the pharmaceutical industry: A position paper of the American College of Physicians. (1990). Ann Intern Med, 112, 624–6.

4* Gifts to physicians from industry (editorial). (1991). JAMA, 265, 501.

5* Pharmaceutical Research and Manufacturers of America. (2008). Code on interactions with healthcare professionals. http://www.phrma.org/files/PhRMA%20Marketing%20Code%202008.pdf Accessed October 27, 2009.

6* Dana, J. and Lowenstein, G.A. (2003). Social science perspectives on gifts to physicians from industry. JAMA290, 252–5.

7* Camenisch, P.F. (1981). Gift and gratitude in ethics. J Religious Ethics9, 1–33.

8* Katz, D.Caplan, A.L. and Merz, J.F. (2003). All gifts large and small: towards an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth3, 39–46.

9* Orlowski, J.P. and Wateska, L. (1992). The effects of pharmaceutical firm enticements on physician prescribing patterns: there is no such thing as a free lunch. Chest102, 270–3.

10* Wazana, A. (2000). Physicians and the pharmaceutical industry: is the gift ever a gift? JAMA283, 373–80.

11* Grande, D.Frosch, D.L.Perkins, A.W., and Kahn, B.E. (2009). Effect of exposure to small pharmaceutical promotional items on treatment preferences. Arch Intern Med169, 887–93.

12* Brennan, T.A.Rothman, D.J.Blank, L., et al. (2006). Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA295, 429–33.

13* Blumenthal, D. (2004). Doctors and drug companies. N Engl J Med351, 1885–9.

14* Campbell, E.G.Gruen, R.L.Mountford, J., et al. (2007). A national survey of physician-industry relationships. N Engl J Med356, 1742–50.

15* Goldfinger, S.E. A matter of influence. (1987). N Engl J Med316, 1408–9.

Further reading

Brody, H. (2010). Drug detailers, professionalism, and prudence. Am J Bioeth10(1), 9–10.