Bradley F. Marple, MD, a member of the ENT Today editorial board, is Professor and Vice-Chair, and Matthew W. Ryan, MD, is Assistant Professor, in the Department of Otolaryngology at University of Texas Southwestern Medical Center in Dallas.
By the end of 2008, almost two dozen inquiries had been sent to several major academic institutions requesting financial information on individual physicians involved in federally funded studies. Through this process, Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) intend to work with universities to compare honoraria received from the pharmaceutical and device industry with that reported by these federally funded investigators, while simultaneously sending a firm message regarding the current state of financial conflict of interest in the medical profession.(1)
Sens. Kohl and Grassley, in their ranking roles on the US Senate Special Committee on Aging and Committee on Finance, respectively, share responsibility for 80 million Americans covered by Medicare and Medicaid and the health services that apply to this population. From this perspective, they have launched a series of investigations intended to better understand influences on the cost and delivery of health care, and in so doing, have shed light on the potential that industry is inappropriately influencing medical professionals through monetary inducements.
The recent increase in scrutiny is a direct result of revelations over the past few years suggesting that, in some cases, the line between the role of a physician as a patient advocate and as an agent of industry has been blurred.
One such well-publicized example is that of Charles Nemeroff, MD, PhD. As Chair of the Department of Psychiatry at Emory University School of Medicine, he had become a prominent researcher and educator, and had developed a well-recognized expertise in the area of clinical depression. As the recipient of several large NIH grants and author of nearly 600 peer-reviewed articles, he possessed the credibility and experience that would make him an attractive consultant to the pharmaceutical industry. As such, he became active in several pharmaceutical advisory boards and frequently lectured at the request of the pharmaceutical industry. In a letter to the Emory administration dated July 15, 2004, Dr. Nemeroff claimed receiving no more than $10,000 a year in the form of honoraria from GlaxoSmithKline (GSK).(2) It later became apparent that he had failed to report more than $800,000 that he received from GSK over a period of several years as a part of an estimated $2.6 million he had received from drug companies between 2000 and 2006.(1) Following this revelation by the Senate Finance Committee, the NIH chose to freeze $9 million in funding for a clinical study of depression at Emory.
In a similar incident, Harvard psychiatrists Joseph Biederman, MD, Thomas Spencer, MD, and Timothy Wilens, MD, were similarly identified by Senate investigators for failure to report industry income exceeding $1 million each. These failures of disclosure appeared to violate institutional disclosure requirements, and also raised red flags because of these researchers’ advocacy of unapproved uses of psychiatric medicines in children.(3)
What’s the Problem?
While stories such as these should not be sensationalized, they can serve to provide an opportunity for professional introspection. A simple search of the blogosphere provides a glimpse of public opinion as it relates to the perception of relationships between the medical profession and industry.(4) Further, medical students have become more vocal in expressing misgivings about the potential ill effects of industry influences on medical education.(5,6) So it stands to reason that these revelations should also serve as a signal within the medical community itself. A recent national survey of 3167 US physicians revealed the extent to which physicians and industry are entwined. In this study, 94% of physicians reported at least some type of relationship with industry in the form of receipt of food (83%), drug samples (74%), support for CME or professional meetings (35%), or remuneration for consulting, speaking, or enrollment in clinical trials (28%).(7)
In such an environment, it becomes understandable how the line between the medical profession and industry becomes blurred. In a statement recorded in the Wall Street Journal, Dr. Nemeroff contended that his lectures weren’t product-specific but were limited to general medical topics such as depression and bipolar disorder. As a part of an investigation of Dr. Nemeroff, Emory found that his speaker slides and interviews with attendees at presentations supported that contention.(8) In fact, Dr. Nemeroff crossed no line by receiving payment for working with GSK. The problem arose from failing to disclose financial arrangements that could ultimately affect patient care. In that simple omission, the line that separates professionalism from commercialism became smudged.(9)
Disclosure: Is It Enough?
For years, the medical profession has relied primarily on financial disclosure as a means by which to deal with the issue of conflict of interest. This process of disclosure is intended to provide the necessary information that allows audiences or readers to identify and resolve bias.(10) However, the assumption that the act of disclosure alone eliminates conflict and provides transparency has been challenged. Dana and Loewenstein, in a commentary on the social science of gifts and their impact on bias, cite a large body of evidence linking financial conflict of interest with unintended bias.(11) The authors note ample data that strongly suggests an individual’s judgment of fairness is biased by his or her own self-interest, and that this bias is frequently unrecognized.
The question then arises: How does one manage bias, if it is not recognized? In an early retrospective study examining the impact of sponsored attendance at CME programs provided to residents on prescription writing, Orlowski and Wateska found that an increase in usage of two drugs manufactured by the sponsoring pharmaceutical companies corresponded to resident attendance, despite the fact that the residents could not recall the names of the companies.(12) More recently, the impact of industry support on research outcomes has been studied. In a study by Alasbali, et al.,(13) the outcomes of 39 studies of ocular hypotensive treatments were examined based upon funding from industry versus non-industry sources. The primary outcome of the study was correspondence between the reported statistical significance of each publication’s main outcome measure and the study conclusion. In the 29 industry-sponsored studies, 62% of the abstract conclusions failed to reflect the study outcome, as compared to zero discordance in the non-industry-funded studies (p = 0.0006). Among the industry-sponsored studies, 90% reported pro-industry abstract conclusions.
The Need for Physician-Industry Collaboration
As many of the cases above demonstrate, failure to disclose financial relationships has been the primary concern of the Senate Finance Committee, NIH, and academic medical centers, yet disclosure alone may not be enough to absolve physicians and researchers from the burden imposed by their financial ties. Many have argued vehemently that disclosure is not a panacea, that the medical profession must be reminded that the goals and fiduciary responsibility of physicians and the health care industry are not the same, and that the only way to definitively address these conflicts of interest is for the financial relationship between physicians and industry to disappear.(9) In other words, the fiduciary responsibility of for-profit companies is naturally to generate a profit for the shareholders, whereas a physician’s primary responsibility is to the patient, and that these realms cannot coexist.
However, it may be naïve to believe that these relationships can or should disappear. Between 1980 and 2000, industry funding for internal and academic medical research increased from approximately $1.5 billion to $22.4 billion, and has resulted in important medical treatments and innovative technologies. In fact, most major academic institutions, recognizing the advantages of these collaborations, encourage industry-funded research.(14) It is not hard to recognize the potential synergy that these relationships have created. In essence, industry relies heavily on advice from physicians to develop advances in pharmaceuticals and health-related technologies, and medicine relies on industry to bring treatment innovations to market. Like it or not, an uncomfortable, yet necessary, relationship must exist.
Refocusing on Our Role as Health Care Professionals
Following the tenets of medical ethics, physicians can be guided in appropriate management of these situations:
- Beneficence-the patient’s best interest must always come first.
- Non-maleficence-protect patients from harm.
- Autonomy-respect patients’ right to informed choice.
- Justice-equity in care.
These principles can serve to guide physician-industry interactions. The intent of clinical research and education should be to advance the common goals of improvement of patient care, augmentation of trainee education, and maintenance of research integrity. Secondary interests, such as personal financial gain or personal advancement, must not dominate or appear to dominate over the primary interests.(15)
Given the recent focus on the issue of transparency surrounding physician-industry relationship, a number of additional regulatory steps are rapidly beginning to evolve.
Individual State Policies
Several states, including Maine, West Virginia, Minnesota, and Vermont, as well as the District of Columbia, have created laws that provide for public access to payments made to physicians from pharmaceutical or device companies.
Association of American Medical Colleges (AAMC)
Citing the need for an effective and principled partnership between academic medical centers and various health industries in order to fully realize the benefits of biomedical research and ensure continued advances in the prevention, diagnosis, and treatment of disease, the AAMC published a position statement on industry funding for medical school programs.(16)
Recognizing that many universities fail to adequately address industry marketing, approximately one-third of US medical schools have implemented or are developing policies that offer guidance to faculty and promote disclosure of real and apparent conflicts.(14) Some universities are going even a step further by publicly reporting physicians’ financial ties with industry.(17)
Pharmaceutical Company Disclosure
An increasing number of pharmaceutical and device companies are joining in the spirit of full disclosure with announcements that they, too, will be disclosing on their Web sites payments to physicians.(17)
Physician Payment Sunshine Act
This bill, introduced January 22, would require yearly reporting of all payments to physicians or medical practices over a cumulative value of $100 from manufacturers and group purchasing organizations. Beginning in 2011, all payments that meet the threshold including consulting fees, honoraria, gifts, entertainment, food, travel, education, research grants or funding, and royalties would be included. The information will be made available to consumers, consumer advocates, and other interested parties. Penalties or enforcement actions under the bill will also be made public. Failure to report this information is subject to penalties up to $1 million per year. The bill will preempt state disclosure laws for the payments described in the bill, but states will still be able to establish their own disclosure laws for items such as drug samples or rebates that aren’t included in this bill.(18)
It is hard to avoid noticing that few, if any, of the regulatory measures currently in development are directed by physicians or the medical profession.
There is little doubt that recent high-profile stories revealing the financial relationships between physicians and industry have served as a wake-up call to both medicine and the public at large. Abolishing interaction between physicians and industry might seem to be a simple way to resolve the problem of conflict of interest. But such an approach is not realistic and could short-sightedly limit the benefits of physician interaction with industry. Our challenge is to balance the potential synergies that these interactions can enable, while maintaining the professionalism and independence that is essential to the practice of medicine. Complete disclosure of financial relationships serves as a starting point. Disclosure, however, is not enough. It is the steps taken after disclosure that remain most crucial. Once financial relationships are openly declared, the question remains, What is the appropriate mechanism to adopt in order to minimize the potential for bias? This question should be seriously considered by organized medicine if we intend to remain a viable part of this conversation. In the end, the answer should be simple: The real key to success as we move forward is vigilance on the part of medicine to act selflessly as the advocate for the patient.
- Samson K. Senate probe seeks industry payment data on individual academic researchers. Ann Neurol 2008;64(6): A7-9.
- www.nytimes.com/2008/10/04/health/policy/04drug.html?_r=1&oref=slogin .
- www.nytimes.com/2008/06/08/us/08conflict.html .
- For example, see http://hcrenewal.blogspot.com/2008/10/thoughts-on-charles-nemeroffs-not-so.html and http://blogs.wsj.com/health/woo8/12/23/under-grassleys-glare-emorys-nemeroff-gives-up-psychiatry-chair .
- Opar A. Medical students protest perks from drug companies. Nat Med 2006; 12(10):1104.
- Fitz MM, Homan D, Reddy S, Griffith CH 3rd, Baker E, Simpson KP. The hidden curriculum: medical students’ changing opinions toward the pharmaceutical industry. Acad Med 2007;82(10 Suppl):S1-3.
- Campbell EG, Gruen RL, Mountford J, Miller LG, Cleary PD, Blumenthal D. A national survey of physician-industry relationships. N Engl J Med 2007;356: 1742-50.
- http://online.wsj.com/article/SB123000405102929417.html .
- Liesegang TJ. Commercialism, loss of professionalism, and the effect on journals. Arch Ophthalmol 2008;126(9): 1292-5.
- Lichter PR. Debunking the myths in physician-industry conflicts of interest. Am J Ophthalmol 2008;146(2):159-71.
- Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA 2003;290(2): 252-5.
- Orlowski J, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns. Chest 1992; 102:270-3.
- Alasbali T, Smith M, Geffen N, Trope GE, Flanagan JG, Jin Y, Buys YM. Discrepancy between results and abstract conclusions in industry- vs nonindustry-funded studies comparing topical prostaglandins. Am J Ophthalmol 2009;147:33-8.
- http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2008_11_14/caredit.a0800165 .
- Lewin JS. Industrial-academic research relationships: departmental collaborations. Radiology 2009;250(1):23-7.
- https://services.aamc.org/Publications/index.cfm?fuseaction=Product.displayForm&prd_id=232&prv_id=281 .
- Steinbrook, R. Online disclosure of physician-industry relationships. N Engl J Med 2009;360(4):325-7. 18. www.prescriptionproject.org/tools/solutions_factsheets/files/0008.pdf .
©2009 The Triological Society