Physician–Industry Relationships

For the love of money is the root of all evil: which while some coveted after, they have erred from the faith, and pierced themselves through with many sorrows.
—1 Timothy 6:10 (KJV)

Almost everywhere you turn these days, there’s talk of increasing transparency and eliminating conflicts of interest with regard to relationships between healthcare professionals and the pharmaceutical industry and medical device manufacturers. Whether it’s the news, Congress, patients, hospitals or academic institutions, or even pharmaceutical representatives, conversations flourish about the implications (real or perceived) of physicians’ financial ties with industry. The basic premise of these conversations is that any financial association creates a potential bias, a perceived lack of self-determination by the physician. More recently, concerns have been raised about the potential for partiality when industry provides funding for the activities of professional medical associations. No matter what your perspective, all agree that we will be navigating a future environment where relationships between physicians, professional medical associations, and the pharmaceutical and medical device industries are heavily scrutinized and discussed. Because of the ACR’s commitment to transparency, we welcome these discussions.

Many Opinions on Conflict of Interest

Fueled by the fervent interest on the part of both patients and the public, several trade publications have recently made headlines in the public press, including the revised “PhRMA Code on Interactions with Healthcare Professionals,”¹ which took effect January 1, 2009, and the “AdvaMed Code of Ethics on Interactions with Health Care Professionals,”² taking effect on July 1, 2009. These codes, instituted by the industries themselves, guide pharmaceutical and medical device–manufacturer relationships with medical professionals. They are voluntary codes of conduct, and as such are subject to interpretation and are not otherwise regulated. The standards set out in these documents call for increasing transparency, eliminating non-educational gifts to physicians, limiting the costs of educational items given physicians, and distinctly separating medical education activities from promotional activities. In addition, meals provided to healthcare professionals must be modest and incidental and provided in a workplace setting combined with an educational component. Overall, the revised codes are intended to increase the transparency of physician–industry interactions by focusing these interactions on education rather than promotions.

The federally proposed “Physician Payments Sunshine Act” would require companies to report a variety of payments made to healthcare professionals or businesses owned by these professionals that exceed $100 annually. Payments that are to be reported include those in the areas of consulting fees, charitable contributions, grants, honoraria, and research. The bill outlines how the reporting is to be implemented via electronic submission to the Department of Health and Human Services, and there are penalties—steep ones if the omission is found to be intentional—for failure to report. Additionally, the language of preemption enables states to add any regulatory laws they deem suitable. Several states, including California, Maine, Massachusetts, Vermont, and Washington, D.C., have requirements for the annual reporting of gifts to healthcare professionals that exceed dollar amounts anywhere from $25 to $100. I believe that these regulations are the first wave of a movement that will permanently change the landscape for physician–industry relationships.

The article, “Professional Medical Associations and Their Relationships with Industry,” published in the Journal of the American Medical Association, specifically addresses interactions between professional medical associations and industry.³ The authors suggest that it is inappropriate for professional medical associations to receive industry funding for their educational and other activities, and recommend that associations work towards the eventual goal of eliminating such support altogether. The article also discusses the conflict-of-interest policies of medical associations, suggesting that any relationship with pharmaceutical or device manufacturers creates potential conflict and should be avoided. The authors offer suggestions for procedures that medical associations can adopt in order to ensure that they effectively resolve any potential, real, or perceived industry conflicts of interest, noting that simply identifying conflicts is not enough.

A 400-page report from the Institute of Medicine, “Conflict of Interest in Medical Research, Education, and Practice,” follows suit by tackling broad-based conflict-of-interest issues in medicine and calling for a new method for accredited providers to deliver high-quality continuing medical education that is free of commercial support.⁴

Industry and the ACR

It appears clear that the general consensus demands a re-examination of all relationships with industry. So what does all of this mean for educational and other programs offered by the ACR? Where does the ACR stand on these issues? How do these changes affect you, as individual members?

The ACR continually strives for fair, conflict-free programs and acknowledges that the identification and resolution of conflicts of interest is necessary to ensure the validity and balance of medical education. In fact, ensuring the autonomy of medical education is not only a best practice, it is a necessary requirement articulated by the Accreditation Council for Continuing Medical Education (ACCME). The ACCME Standards for Commercial Support outline criteria to ensure the independence of continuing medical education. In addition to fully abiding by the ACCME standards, the ACR follows a strict code of ethical conduct, the ACR Policy on Corporate Relationships, which governs the ACR’s interactions with all external corporate supporters. This code has allowed us to develop meaningful collaborations with industry to achieve our organizational mission without compromising our values or principles and while maintaining our independence. These policies are reviewed annually or more frequently, as needed. Among other things, the policies prohibit the acceptance of support for certain activities, including position statements, patient fact sheets, practice management guidelines, advocacy, response criteria, and quality indicators. When compared with other similar policies in other organizations, the ACR Policy on Corporate Relationships is consistently described as among the most conservative.

Recently, the ACR was approached by the American College of Cardiology, which was mobilizing a small coalition of medical specialty societies to respond to the aforementioned Institute of Medicine report by coauthoring “Medical Professional Society Relationships with Industry: A Joint Statement.”⁵ This statement argues that such relationships should be allowed when governed by a strict ethical professional policy and code of conduct. The ACR agreed to sign onto the statement because we firmly believe that our policies do allow us to manage relationships with pharmaceutical and medical device manufacturers in a productive, transparent, and highly ethical manner.

The ACR, ARHP, and Research and Education Foundation (REF) have a long history of corporate support for educational and career development programs. One such example is the REF Core Awards and Grants program supported by the REF Industry Roundtable. These programs include the Rheumatology Scientist Development, Rheumatology Investigator, Career Development Bridge Funding, and Clinician Scholar Educator Awards. On average, 88 cents out of every dollar donated to the REF directly supports recipients of the REF’s Core Awards and Grants Program. Moreover, in accordance with established policies and procedures, funders have no knowledge of who the recipients will be and are not involved in the review process.

The ACR Fellows Education Fund, a scholarship program for rheumatology fellows, is also supported by corporate donors. The fund provides fellows-in-training (who may not have other sources of funding) with the opportunity to attend the most comprehensive scientific meeting in rheumatology, the ACR/ARHP Annual Scientific Meeting, as well as other key ACR educational meetings throughout the year. Fellows benefit from the opportunity to learn firsthand from internationally known rheumatology experts and to expand their professional network. Additionally, the corporate support the ACR receives for the annual meeting helps to offset the rising costs of hosting the meeting. This support allows the ACR to keep the meeting registration fees low (far lower than those of similar non-ACR meetings) thus making it possible for more rheumatologists and rheumatology health professionals to attend. The collective impact of these programs on rheumatology is tremendous. Taken together, these programs ensure that current and future rheumatologists will be available and optimally prepared to address the needs of patients with rheumatologic diseases.

While the ACR stands behind all of our relationships, we also understand the rapidly changing environment. As a result, the ACR is actively working to diversify our sources of revenue. However, until such time as alternative sources of funding for education and research are identified, relationships with industry will remain a vital element of our activities.

The passage at the beginning of this column is often misquoted as: “money is the root of all evil.” The accurate interpretation is that it is the “love of money” and “erring from the faith” that gets people into trouble, not the money itself. The ACR believes that our strong ethical principles, our strict policies and procedures, our commitment to transparency, and our unwavering focus on the needs of our members and their patients will continue to keep us from erring from the faith.

Dr. Gabriel is president of the ACR. Contact her via e-mail at [email protected].

References

1. Pharmaceutical Research and Manufacturers of America. PhRMA Code on Interactions with Healthcare Professionals. www.phrma.org/code_on_interactions_with_ healthcare_professionals. Revised July 2008. Accessed June 8, 2009.
2. AdvaMed Code of Ethics on Interactions with Health Care Professionals. www.advamed.org/MemberPortal/About/code. Revised December 18, 2008. Accessed June 8, 2009.
3. Rothman DJ, McDonald WJ, Berkowitz CD, et al. Professional medical associations and their relationships with industry: A proposal for controlling conflict of interest. JAMA. 2009;301:1367-72.
4. Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press, 2009.
5. Medical Professional Society Relationships with Industry: A Joint Statement. www.rheumatology.org/about/pma.pdf. Published April 28, 2009. Accessed June 8, 2009.