The American Medical Student Association (AMSA), with a Half-Century History of Medical

American Medical Student Association Statement

IOM Committee on Conflict of Interest in Medical Research, Education, and Practice

Brian Palmer, MD, MPH, Past President

March 13, 2008

The American Medical Student Association (AMSA), with a half-century history of medical student activism and a membership of more than 68,000 medical students, premedical students, interns, residents, and physicians, is the oldest and largest independent association of physicians-in-training in the United States. Our activism is focused around four strategic priorities, all of which deeply impact our nation’s health and our medical training: eliminating health disparities, advocating for diversity in medicine, transforming the culture of medicine, and fighting for universal access to health care. As the largest student-run organization of future physicians, we feel that the presence of conflicts of interest harms our ability to act without bias in the best interest of our patients and the faith the public has in our professional judgment.

AMSA believes that prescribing decisions should be based on the best medical evidence and that threats to this principle should be actively defended against. As patients, we expect no less from our physicians. As physicians, responsible for the health of patients, we should do everything possible to limit influences of outside parties seeking to alter our prescribing practices. The tens of billions of dollars the pharmaceutical industry spends on samples, academic journal ads, detailing, gifts, and so-called CME reflects a coordinated effort to shift the prescribing patterns of doctors -- often away from evidence-based practice and to a culture where we prescribe more and chose more expensive medications. No one doubts the effectiveness of the industry strategy. The question is what should we, as the profession of medicine, do about the obvious conflict between our duty to take the best care of our patients and the coordinated effort to influence us. Colluding with these influences, while financially and psychologically appealing, only deepens their effects. AMSA believes that the only reasonable strategy -- particularly in the setting of medical schools and residencies -- is to draw a bright line between education and influence and to promulgate policies for academic medical centers, professional associations, and individual physicians that insure that prescribing decisions are based on the best medical evidence.

Institutional History

AMSA has been extensively involved in attempts to limit inappropriate influence in medicine through our PharmFree Campaign. Launched in 2002, the campaign is an educational effort targeted at medical students to inform them about relationships between industry and health care professionals and limit the access and influence of industry representatives at medical schools and academic medical centers. Although pharmaceutical and medical device industries provide a valuable resource for research and development of new and potentially life-saving therapies, many of their marketing practices have led to an erosion of medical professionalism through potential bias in medical practice and culture. The PharmFree campaign has been a leader in effecting a cultural shift among medical students and medical centers towards identifying and eliminating these conflicts.

To reduce the influence of industry on medical students, AMSA has banned all pharmaceutical and medical device advertising and sponsorships at regional and national conferences; in The New Physician, AMSA’s national magazine; on the organization’s web site; and as sources of corporate donations. We have partnered with The Medical Letter, to provide members with unbiased information about pharmaceuticals. The PharmFree Scorecard, which evaluates policies regarding access to and relationships between students or professionals and industry representatives at academic medical centers, has been extremely successful in achieving positive change towards more ethical and effective policies regarding industry-physician interactions. AMSA’s National PharmFree Week and local events throughout the year include lectures, physician panels, and policy discussions to educate physicians-in-training about physician and industry relationships and to encourage organizations to adopt policies that deal with conflict of interest.

Principles

AMSA endorses the recommendations published in the Journal of the American Medical

Association (JAMA) by Brennan TA, et al. 1 to encourage academic medical centers to be leaders in the implementation of policies regulating industry-professional interactions. These centers provide influential advice and support to the public and professional community, most of medical student and resident training, and are well organized to take broad and decisive action quickly.

AMSA has developed recommendations to eliminate interactions between physicians and industry that would subvert the fiduciary nature of the physician-patient relationship based on these and other guidelines (see Figure 1 for specific recommendations and criteria by which academic centers and other organizations are evaluated). Critical steps towards reducing industry influence include:

1 Troyen A. Brennan, et al. Health Industry Practices that Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers (JAMA, January 2006).  Industry representatives should not play any role in medical education, whether it be medical

school, residency, or continuing medical education (CME)

 Control of the interactions with the industry within academic medical centers should be

within the hands of an independent body that can provide the proper oversight

 Full disclosure of the nature and extent of industry interactions with physicians should be

made to the public

 Medical school curricula should incorporate teaching on the role of industry interactions and

conflicts of interest, including but not limited to evidence-based medicine and continuing

medical education

 Our professional associations should end the practice of supporting and facilitating industry-

sponsored medical education, and should examine the relationships they have with industry

through the lens of working to insulate themselves from inappropriate influence on medical

practice

Interactions between Pharmaceutical Representatives and Physicians: Reasons for Change

For the purpose of this hearing, I will briefly outline why medical students are concerned with this issue. The extent of contact with industry representatives has become widespread throughout a physician’s career, beginning in medical school. The contacts usually consist of sponsored meals, free samples, and other gifts. In a national survey of third year medical students, 93% had been asked or even required to attend lunch or an event sponsored and hosted by pharmaceutical representatives.2 One recent study reported that medical students have an

2 Frederick S Sierles, et al. Medical students' exposure to and attitudes about drug company interactions: a national survey (JAMA, January 2006). average of 10.6 contacts per month.3 Similarly, a survey of primary care residents found that

98% of them had eaten a meal sponsored by a drug company within the past year, and 97% of them carried at least one item with pharmaceutical insignia.4 As medical students and residents enter practice, the interactions evolve as the frequency of honoraria, conference travel, and research funding increases.5 Pharmaceutical representatives have become so much a part of medical education and practice, it is the norm to interact with them and gain the free benefits they offer.

Why would pharmaceutical companies spend money on giving away free meals and gifts to physicians? As a for-profit business, industry has a fiduciary responsibility to return and add to the investments of their shareholders. Yet, they spent nearly $28 billion in 2004 on promotional spending for their drugs, $23 billion of which went to free samples and detailing to physicians.6 Clearly gift-giving and detailing would violate this responsibility to shareholders if the strategy did not result in financial gain, but in fact, rapid increases in marketing expenses have generally been associated with greater and greater profitability.

Social science research has shown that the impulse to reciprocate for even small gifts is a powerful influence on people’s behavior.7,8 In this case, physicians who receive gifts are unable to remain objective because they carry the expectation of reciprocity from the gift they receive.

Drug sample availability has been shown to alter physician preference towards marketed drugs over generic drugs that are considered the appropriate standard of care.9,10 One study showed

3 Daniella A. Zipkin and Michael A. Steinman. Interactions Between Pharmaceutical Representatives and Doctors in Training (J Gen Intern Med, February 2005). 4 Stephen K. Sigworth, et al. Pharmaceutical Branding of Resident Physicians (JAMA, September, 2005). 5 Ashley Wazana. Physiciancs and the Pharmaceutical Industry: Is a Gift Ever Just a Gift? (JAMA, January 2000). 6 IMS Health, Trends in Promotional Spending for Prescription Drugs, 1996-2004, http://www.imshealth.com 7 Susan L. Coyle. Physician-Industry Relations. Part 1: Individual Physicians (Ann Intern Med, March 2002). 8 Troyen A. Brennan, et al. Health Industry Practices that Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers (JAMA, January 2006). 9 Ashley Wazana. Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift? (JAMA, January 2000). 10 Lisa D. Chew, et al. A Physician Survey of the Effect of Drug Sample Availability on Physicians’ Behavior (J Gen Intern Med, July 2000). how the prescriptions of two new drugs promoted at a symposium increased significantly for ten physicians immediately after they attended the program.11 In addition, physicians were more likely than other physicians to have requested that drugs manufactured by specific companies be added to the formulary if they had met with pharmaceutical representatives or had accepted money from those companies.12 Many newly approved drugs are not new molecular entities and present little or no therapeutic advantage over existing therapies. These changes in prescribing behavior have dramatically increased overall costs while undermining confidence in the patient- physician relationship.

Patients seem to have a better sense of what is going on. In one study, 54% of patients were aware of gift-giving from industry representatives, and 24% of those unaware responded that this knowledge altered their perception of the medical profession.13 Whether or not they were aware of industry-physician relationships, patients considered gifts less appropriate and more influential than physicians did. Physicians and physicians-in-training, on the other hand, perceive gifts to be generally appropriate.14,15 In this survey, 100% of physicians surveyed considered inexpensive gifts like meals, pocket guides, and pens to be appropriate, while 60% still believed that expensive gifts like dinner lectures, travel for continuing medical education, and luggage were appropriate.16 Substantial numbers of physicians-in-training deemed interactions to be “appropriate,” “important,” “beneficial,” or even “ethical.”17 Numerous studies

11 James P. Orlowski and Leon Wateska. The Effect of Pharmaceutical Firm Enticements on Physician Prescribing Patterns: There’s No Such Thing as a Free Lunch (Chest, July 2002). 12 M.M. Chren and C.S. Landefeld. Physicians’ Behavior and Their Interactions with Drug Companies. A Controlled Study of Physicians who Requested Addition to a Hospital Drug Formulary (JAMA, March 1994). 13 Robert V. Gibbons, et al. A Comparison of Physicians’ and Patients’ Attitudes Toward Pharmaceutical Industry Gifts (J Gen Intern Med, March 1998). 14 Ibid. 15 Michael A. Steinman, et al. Of Principles and Pens: Attitudes and Practices of Medicine Housestaff toward Pharmaceutical Industry Promotions (Am J Med, May 2001). 16 Ibid. 17 Daniella A. Zipkin and Michael A. Steinman. Interactions Between Pharmaceutical Representatives and Doctors in Training (J Gen Intern Med, February 2005). have also shown that physicians and physicians-in-training are skeptical of the influence of pharmaceutical representatives on their own prescribing practices while believing that industry significantly influenced their colleagues’ prescribing practices.18,19 This discrepancy shows how, in accordance with cognitive theory, physicians are implicitly aware of the influence, yet deny its effect on themselves because they do not want to believe that their own behavior would be unethical. Interestingly, the number of gifts received has been positively correlated with the belief that representatives have no influence on prescribing behavior.20

Given this evidence, the reality of the conflict of interest induced by industry representatives reveals a need for policy implementation. Some physicians are unaware or unable to see how industry practices undermine the principles of medical professionalism. These practices have become commonplace in the field of medicine even as patients have become more aware of influences on prescribing practices. As a result, the public trust between professionals and patients is in jeopardy. Prudent policy must be introduced to remove these undue distractions from an otherwise professional and patient-centered process and to restore patient confidence in the physician-patient relationship.

Conclusion

While there are substantial challenges remaining, the need for more effective policy is critical to preserve the gains that have been made and protect the quality of treatment to our patients. AMSA’s vision of medical professionalism and the physician-patient relationship does not match the current state of our profession. Pharmaceutical and medical device companies have contributed to immeasurable advances in the nation’s health, and they deserve credit for

18 Michael A. Steinman, et al. Of Principles and Pens: Attitudes and Practices of Medicine Housestaff toward Pharmaceutical Industry Promotions (Am J Med, May 2001). 19 Frederick S Sierles, et al. Medical students' exposure to and attitudes about drug company interactions: a national survey (JAMA, January 2006). 20 Ashley Wazana. Physiciancs and the Pharmaceutical Industry: Is a Gift Ever Just a Gift? (JAMA, January 2000). their role in scientific innovation. However, their marketing practices have created a culture that subverts our fiduciary duty to our patients. We know that the interactions between pharmaceutical representatives and physicians have helped pharmaceutical companies become incredibly financially successful while simultaneously creating biased prescribing practices and potentially altering the medical literature through selective publication and influences on study design. Regulatory policies have shown to affect the attitudes of medical residents towards representatives, taking a more skeptical approach to their interactions.21,22 It is time to implement comprehensive policies in the academic medical centers leading the nation’s medical practice, ethics, and education, that can extricate the medical profession from coercive industry relationships and educate medical students about issues in conflicts of interest. We believe that these steps will move us closer to restoring the public’s trust in the healthcare profession and bringing the balance between patients and profits back towards the ethical, patient-centered standard. Thank you.

21 Daniella A. Zipkin and Michael A. Steinman. Interactions Between Pharmaceutical Representatives and Doctors in Training (J Gen Intern Med, February 2005). 22 Frederick S Sierles, et al. Medical students' exposure to and attitudes about drug company interactions: a national survey (JAMA, January 2006). Figure 1. American Medical Student Association, Conflict of Interest Policy Evaluation,

http://www.amsascorecard.org/policy_evaluation

Issue Policy Gifts (including All gifts funded by industry are prohibited, regardless of nature or value. meals) Pharmaceutical Industry samples are prohibited, except under limited circumstances that Samples protect the interests of patients and prevent the use of samples as a marketing tool (e.g. policies that allow samples under limited circumstances with approval of the Pharmacy and Therapeutics Committee or policies that incorporate samples into a larger program designed to ensure the availability of brand-name and generic medications to under-insured patients.) Site Access Pharmaceutical and device representatives are not allowed to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment, providing visits by appointment and at the request of faculty.) On-site Industry is not permitted to provide support for educational activities Educational directly or through a subsidiary agency. (Companies may contribute Activities unrestricted funds to a central repository at the academic medical center, which, in turn, would disburse funds for CME programs that are independent of any industry input or control.) Off-site Attendance Personnel may not accept payment, gifts or financial support from industry at Lectures & to attend lectures and meetings. (An exception may be made for modest Meetings meals, if part of a larger program.) Industry Support Industry support for scholarships, fellowships, and other trainee activities, for Scholarships & including travel expenses or attendance fees at conferences, may only be Funds for Trainees accepted into a common pool of discretionary funds. Industry may not earmark funds for particular individuals or expenses. Recipients must be chosen by the school or department. Medical School Students are trained to understand institutional conflict-of-interest policies Curriculum and recognize how industry promotion can influence clinician judgment.