The American Journal of Medicine
Volume 121, Issue 4 , Pages 253-255, April 2008

Doctors and the Drug Industry: Further Thoughts for Dealing with Potential Conflicts of Interest?

Robert S. and Irene P. Flinn Professor of Medicine, University of Arizona, College of Medicine, Tucson, Editor-in-Chief, The American Journal of Medicine

Article Outline

 

In February, 2005, The American Journal of Medicine published my commentary concerning the relationship between physicians and the pharmaceutical industry.1 The subject of satire for centuries, the close economic connections between doctors and druggists or apothecaries has taken a new form in the 21st century. Contemporary global discussions involve attempts to define ethically appropriate behavior involving physicians and the pharmaceutical and/or device companies. The question is repeatedly asked: Should physicians have any dealings at all with these industrial giants? In the US, Congress and the media have taken a great interest in these relationships and their potential for abuse. There is expressed societal concern that the current high cost of pharmaceutical agents is the result of connections between doctors and industry that are fraught with potential for conflict of interest. As a result of the debate surrounding this possibly conflicted relationship, some medical schools and medical centers have recently banned industry representatives from their campuses.

As noted in my earlier commentary, a great deal has been written about this subject both from the point of view of the “truly ethical physician” and from the perspective of the “truly ethical pharmaceutical company.”1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Cogent arguments have been advanced for complete separation of doctors and industry representatives. If such a scenario were to occur, then no truly ethical doctor would accept gifts or inducements of any size or value from industry. Using this model, all physicians also would avoid watching or reading industry advertisements in the public media or in scientific journals, and there would be absolutely no contact whatsoever between physicians and company representatives. Physicians would prescribe drugs based only on a full understanding of drug benefit, cost, and potential for adverse reactions. Doctors would base therapeutic decisions on information gleaned from objective, controlled, and blinded studies published in peer-reviewed journals. Finally, physicians would not attend any lecture or obtain any consultation from a colleague who had any economic relationship with industry, no matter how trivial.

The same rules would apply to ethical behavior on the part of the pharmaceutical industry: there would be no contact between industry employees and physicians. Moreover, industry would never seek to influence physicians or patients with advertising or other inducements. Industry would never consider giving gifts of any kind to physicians. And finally, direct-to-consumer advertisements of any type involving pharmaceutical products or devices would be banned from all forms of public media including television, newspapers, magazines, and controlled circulation letters or cards.

Certainly, such a scenario seems highly unlikely given our capitalist society in which no product is produced or sold without a considerable amount of overt and hidden media advertising and promotion extolling the specific company’s product. In our society, it is normal and usual for companies to try and influence lay and professional consumers. Marketing of products is an accepted business practice in modern society as long as certain bounds of honesty and ethical behavior are maintained.

However, a potential conflict of interest exists in any relationship between doctors and drug and device companies. Patients are a captive audience, almost never able to judge for themselves if the prescription that they have just received is really cost effective and appropriate for their condition. Despite intensive industry advertising campaigns that seek to influence public desire for a specific therapeutic agent or procedure,12 in the end, patients have to depend on ethical, honest, and hopefully, objective reasoning by the physician. This is the sort of attitude that US medical schools and post-graduate educational programs try to foster.

Despite such medical school efforts to inculcate a skeptical attitude towards industry advertising claims, research has demonstrated that even small gifts and modest meals provided by industry to physicians-in-training have a measurable influence on the prescribing habits of these young physicians.13, 14, 15, 16, 17, 18 These habits, once fostered, presumably continue following training. Unfortunately, even some academic physicians are involved in highly lucrative consulting arrangements with industry. Moreover, pharmacists and drug stores also are rewarded in a variety of ways for assisting in the sale of specific products.10 The objectivity of a variety of health professionals would thus seem to be compromised, despite 1 study suggesting that pharmaceutical representatives actually had minimal influence on physician prescribing behavior.19

Nevertheless, the pharmaceutical and device industries would seem to be satisfied with their large expenditures made in an effort to influence decision-making by physicians.20, 21

Doctors are thus placed in a very difficult situation. Complete separation of doctors and industry will almost certainly never happen in our entrepreneurial, capitalist society, despite the fact that the relationship between them can apparently color the doctor’s medical practices and thereby benefit doctors and industry, but not necessarily patients.

Are there potential solutions to the difficult ethical, philosophical, and social problems just described? In essence, I think that there are potential solutions that do not entail a complete separation of doctors and pharmaceutical representatives—something that I believe to be impossible in our country. I would like to suggest 3 approaches to loosening this Gordian knot. First, there needs to be complete transparency in all relationships between doctors and industry. I would like to suggest a Congressional mandate requiring monthly industry reports to a national public Internet registry detailing all but the most trivial financial transactions between doctors and industry. I would probably exclude the value of drug samples placed in a doctor’s office from this registration process because such samples usually benefit patients as well as physicians’ practices. This registry would be publicly accessible with a simple, user-friendly index so that locating a specific physician would be straightforward. From the point of view of industry, documentation could be easily done electronically by the pharmaceutical or device representative following contact with a physician.

A second intervention should be employed during undergraduate and post-graduate medical education. This intervention would consist of regular seminars for all students, residents, fellows, and faculty. The content of these seminars would be scientific skepticism. They might be entitled “Industry and the Need for Maintaining a Skeptical Attitude.” The topics covered would describe industry practices aimed at influencing medical students and physicians. Additionally, there would be a discussion of the importance of maintaining a scientifically skeptical attitude towards various claims involving efficacy and safety of various healthcare products.

A third and final intervention would be to establish a non-governmental oversight committee consisting of representatives from academic medicine, for example, the American Association of Medical Colleges, the Institute of Medicine, etc, and the pharmaceutical and device companies. This committee would be charged with preparing a set of expectations for appropriate, ethical behavior on the part of both industry and physicians. I could even envision a role for this committee in the review of public media advertisements for drugs and devices in order to control the degree to which such ads create artificially inflated expectations.

In conclusion, I believe that complete transparency with respect to industry inducements given to physicians, combined with an augmented educational program on skepticism and an oversight committee to determine ethically appropriate behavior on the part of both parties would be major corrective factors for a number of the current problems. Indeed, when potentially conflicting financial relationships exist that are unknown to all but the 2 principals involved in such agreements, possible abuse is fostered. I would welcome letters responding to the suggestions included in this commentary.

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References 

  1. Alpert JS. Doctors and the drug industry: How can we handle potential conflicts of interest?. Am J Med. 2005;118:99–100
  2. Morin K, Rakatansky H, Riddick FA, et al. Managing conflicts of interest in the conduct of clinical trials. JAMA. 2002;287:78–84
  3. Korn D. Conflicts of interest in biomedical research. JAMA. 2000;284:2234–2238
  4. Cech TR, Leonard JS. Conflicts of interest—moving beyond disclosure. Science. 2001;291:989
  5. Lo B, Wolf LE, Berkeley A. Conflict of interest policies for investigators in clinical trials. N Eng J Med. 2000;343:1616–1620
  6. La Puma J. Physicians’ conflict of interest in post-marketing research: What the public should know, and why industry should tell them. Research Ethics and Human Subjects: Facing the 21st Century. Frederick, MD: University Publishing Group; 1995;
  7. Federman DD, Hanna KE, Rodriguez LL, et al. Responsible Research—A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press; 2003;
  8. Levinsky NG. Non financial conflicts of interest in research. N Engl J Med. 2002;347:759–761
  9. Committee on Assessing the System for Protecting Human Research Subjects. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: National Academy Press; 2001;
  10. Alpert JS, Furman S, Smaha L. Conflicts of interest. Arch Intern Med. 2002;162:635–637
  11. Blumenthal D. Doctors and drug companies. N Engl J Med. 2004;351:1885–1890
  12. Mitka M. Researchers critical of TV drug ads. JAMA. 2007;297:939–940
  13. Studdert DM, Mello MM, Brennan TA. Financial conflicts of interest in physicians’ relationship with the pharmaceutical industry—Self regulation in the shadow of federal prosecution. N Engl J Med. 2004;351:1891–1900
  14. Wazana A. Physicians and the pharmaceutical industry: Is a gift ever just a gift?. JAMA. 2000;283:373–380
  15. Keim SM, Mays MZ, Grant D. Interactions between emergency medicine programs and the pharmaceutical industry. Acad Emerg Med. 2004;11:19–26
  16. Komesaroff PA, Kerridge IH. Ethical issues concerning the relationships between medical practitioners and the pharmaceutical industry. Med J Aust. 2002;176:118–121
  17. Chren M. Interactions between physicians and drug company representatives. Am J Med. 1999;107:182–183
  18. Brett AS, Burr W, Moloo J. Are gifts from pharmaceutical companies ethically problematic? (A survey of physicians). Arch Intern Med. 2003;163:2213–2218
  19. Mizik N, Jacobson R. Are physicians “easy marks”? (Quantifying the effects of detailing and sampling on new prescriptions). Management Science. 2004;December
  20. Relman AS, Angell M. America’s other drug problem. The New Republic. 2002;27–41December 16
  21. Reinhardt UE. An information infrastructure for the pharmaceutical market. Health Aff (Millwood). 2004;23(1):107–112

PII: S0002-9343(08)00053-3

doi:10.1016/j.amjmed.2008.01.010

The American Journal of Medicine
Volume 121, Issue 4 , Pages 253-255, April 2008

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