Pharmaceutical Representatives: An Evidence-Based Review with Suggested Guidelines for Clerkships

In recent years, the influx of drug reps into physician offices and hospitals has attracted the attention of both medical journals and the lay press. Recently the British Medical Journal dedicated an entire issue to this topic.1 Newspapers ranging from the New York Times to the Wall Street Journal have also covered this issue, often in the wake of practices that ranged from questionable to bordering on bribery. Much published research has also been conducted in this area, nearly all of it concluding that the interactions between drug reps and physicians are detrimental to doctors and their patients. Below is a brief review of the evidence: Bias and Influence It can hardly come as a surprise that drug reps are biased toward their own products. When they make factually inaccurate statements, they always favor their products.2 Many doctors claim to be able to sort out the bias, but is that actually true? Research indicates that prescribing habits of physicians exposed to pharmaceutical representatives do not follow the therapeutic guidelines established by expert panels.3,4 Further, while resident doctors claim to be immune themselves, they also believe that the other physicians around them are influenced.5 A prospective study tracking the prescribing habits of physicians graphically showed how interactions with drug companies do alter prescribing patterns.6 Reducing contact with drug representatives during residency training has a lasting impact on how the physicians view information provided by pharmaceutical companies.7 Medicine is striving to become evidence-based. While pharmaceutical representatives do often provide published literature, their talks and trinkets appear to have the power to undo the teaching provided by the senior physicians in the educational setting. Commercialization Many doctors claim that they dont even know what trade name is on their pen. However, patients do notice. Patients further believe that doctors are influenced by the

BMJ. 2003;326:1155-1215. Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA. 1995;273:1296-1298. 3 Siegel D, Lopez J.Trends in antihypertensive drug use in the United States: Do the JNC V recommendations affect prescribing? Fifth Joint National Commission on the Detection, Evaluation, and Treatment of High Blood Pressure JAMA. 1997;278:1745-1748. 4 Chew LD, O'Young TS, Hazlet TK, Bradley KA, Maynard C, Lessler DS. A Physician Survey of the Effect of Drug Sample Availability on Physicians' Behavior. JGIM. 2000;15:478. 5 Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical industry promotions. Am J Med 2001 May;110(7):551-7. 6 Orlowski JP and Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns. Chest. 1992;102:270-273. 7 McCormick BB, Tomlinson G, Brill-Edwards P, Detsky AS. Effect of restricting contact between pharmaceutical company representatives and internal medicine residents on posttraining attitudes and behavior. JAMA 2001; 286(16): 1994-1999
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drug company trinkets and trips.8 Regardless of whether the physician is actually influenced, the perception of drug company interference damages the doctor-patient relationship. In an era when building rapport with patients is made more difficult by time constraints, why make it even harder by giving patients the impression that the physician has an established relationship with a drug company? Gifts Gifts, no matter how small, produce a sense of reciprocity in the recipient.9 This is why pharmaceutical companies provide pens, notepads, name badge holders, etc. Social science has documented the way that gift recipients feel impelled to do something in return for the giver. However, this creates a conflict of interest: the desire to cure the patient versus the subconscious need to repay the drug companys generosity. While these two goals can be congruent, they may not be. Entitlement is also an issue: students and resident physicians feel entitled to a good lunch and cool gadgets from the drug companies. Commentators have pointedly observed the feeding-frenzy of physicians at conferences wherein the attendees line up at tables to collect gizmos and gadgets.10 Is that professional behavior? Inefficient Use of Health Care Dollars According to the drug manufacturing industry, each successful drug costs $897 million to develop.11 Drug companies spend $16 billion on promotions to physicians and patients each year $7.2 billion of which is the cost of drug samples. At a glance, doesnt that mean that drug companies fail to develop 10 to 20 new drugs each year because they are spending that money to promote the current drugs instead? Is that a good use of health care dollars? The drug companies have recently been engaged in a rep race each company, fearful of losing market share, has hired more drug representatives in order to contact more physicians. As a result, there are now 90,000 pharmaceutical representatives in the country. However, the flooding of physicians offices has resulted in fewer successful encounters: a representative actually meets with a physician only once in five attempts.12 Reliance on drug representatives has become a high-cost, low-yield method of disseminating information about pharmaceuticals. For more information and a complete review of the published literature on pharmaceutical interactions: http://www.nofreelunch.org/ http://www.amsa.org/prof/PharmFree.cfm

Mainous lll AG, Hueston WJ, Rich EC. Patient perceptions of physician acceptance of gifts from the pharmaceutical industry. Arch Fam Med. 4; 1995:335-9. 9 Dana J, Loewenstein G. A Social Science Perspective on Gifts to Physicians from Industry. JAMA. 2003; 290:252-255. 10 Griffith D. Reasons for not seeing drug representatives. BMJ 1999;319:69-70 11 Tufts Center for the Study of Drug Development. 5/13/2003. http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=29. Accessed on 7/30/2003. 12 Hensley, Scott. As Drug-Sales Teams Multiply, Doctors Start to Tune Them Out. Wall Street Journal 13 June 2003: A1.

Proposals:
Option 1: Remove pharmaceutical representatives entirely.
This solution resolves all of the ethical problems cited above. It is also the easiest policy to codify: Pharmaceutical representatives are not allowed to interact with medical students, residents, physicians or staff of the department during working hours. A policy of this nature typically engenders some concerns. Below are a few answers to these common concerns: Who would educate the medical students and resident physicians about the newest pharmaceuticals? They could educate themselves. An option would be to sponsor pharm lit clubs breakfast or lunch meetings similar to journal club in which a different student or resident each week is asked to discuss new medications in a certain class of drugs. While being more work, it would also be a more durable educational experience. Additionally, the students and residents would learn to refer to non-biased sources such as the Medical Letter, as well as the published literature. What about free samples? Forbidding pharmaceutical representatives would eliminate the supply of free samples. While drug companies do offer programs for low-income patients, those often involve more paperwork for the physician. However, because free samples alter physicians choices of medications for their patients,13 being without them would be beneficial to the patient and the educational experience.

Option 2. Allow Pharmaceutical Representatives, but Educate Students and Residents About Their Role.
This is the solution found in many residency programs. In some programs, medical students and residents are not allowed to meet with drug representatives until they have been educated about the role of pharmaceutical companies.14 Suggested guidelines are found on the next page.15

Chew, LD, et al. A Physician Survey of the Effect of Drug Sample Availability on Physicians' Behavior. J Gen Int Med. 2000;15:478-483. 14 Kupersanin E. Course Teaches Residents How to Have Ethical Dealings With Drug Companies. Psychiatr. News. Jun 2002; 37: 24. 15 These guidelines are adapted from the Society for Teachers of Family Medicine which can be found at: http://www.stfm.org/guidelines.html.

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Guidelines on Pharmaceutical Representatives Pharmaceutical representatives are allowed to provide educational materials and presentations to the resident physicians only if the interaction is approved by the chief resident or residency director. a. Interactions should only involve presentation of published literature and FDA approved indications. Time should be allowed for questions concerning the proper use of the medications. b. The representative may not provide gifts to the medical students or resident physicians, regardless of value. This prohibition includes pens, notepads, name badge holders, etc. These promotional items convey a message of commercialism to patients. c. While medical students and resident physicians cannot be held to these guidelines during non-working hours, they are encouraged to assess the educational value and influential effects of drug-sponsored dinners and social events. d. Medical students and residents are not required to attend pharmaceuticalsponsored events. Mandatory events should not include pharmaceutical promotions. Pharmaceutical representatives should not have access to patient information nor be allowed to observe examinations or therapeutic discussions of patients. Physicians and students are encouraged to ask pharmaceutical representatives general questions concerning patient care and pharmaceutical use (e.g., Are there any special precautions for using this drug in patients with renal failure?) Drug samples must be appropriately logged and stored in a secure location. a. When dispensing drug samples, physicians should be cognizant of the impact free samples have on the choice of pharmacotherapy, especially since many drugs are taken for extended periods of time (i.e., Will free samples now save the patient money in the long run?). b. Drug samples are for patient use only. Faculty members are encouraged to not accept honorarium from pharmaceutical companies. Research grants from pharmaceutical companies are allowed only if: a. the research has genuine value and would have been conducted in absence of the grant money from the company, b. the results are not subject to review or censorship by the funding company, c. the company issuing the grant is publicly acknowledged.16

Research shows that industry sponsorship correlates with positive outcomes in trials, indicating possible bias in the research: Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003 Aug 20;290(7):921-8.

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Addendum: Policy Guidelines From Various Organizations

American College of Physicians-American Society of Internal Medicine. Position Paper: Physician-Industry Relations. Part 1: Individual Physicians. Ann Intern Med. 2002;136:396-402. American College of Physicians-American Society of Internal Medicine. Position Paper: Physician-Industry Relations. Part 2: Organizational Issues. Ann Intern Med. 2002;136:403-406. American College of Physicians: Position Paper. Ethics Manual, 4th edition. April 1, 1998. American Medical Student Association: www.amsa.org/prof/policy.cfm. American Psychiatric Association: Rosack J. Residency Program Addresses Drug Company Influence. Psychiatr. News, Jul 2001; 36: 5 - 40. Canadian Medical Association Policy Summary: Physicians and the pharmaceutical industry. CMAJ, Feb 1, 1992. Council on Ethical and Judicial Affairs, American Medical Association. Gifts to physicians from industry. JAMA, 1991; 261: 501. Council on Ethical and Judicial Affairs, American Medical Association. Guidelines on gifts to physicians from industry: an update. Food and Drug Law Journal, 1992; 47:445-458. Pharmaceutical Research and Manufacturers of America: www.phrma.org/publications/policy/2002-04-19.391.pdf. Royal College of Physicians: The Relationship between physicians and the pharmaceutical industry. Journal of the Royal College of Physicians of London, 1986. 20(4):235-42. Society of Teachers of Family Medicine: http://www.stfm.org/guidelines.html.