What You See Is What You Get: Transparency in Industry relationships

As a healthcare professional, it’s almost impossible to keep abreast of the ever-changing rules, regulations, and guidelines that relate to industry, professional medical associations, physicians, medical education, and issues of conflict of interest. The same is true for professional medical associations, such as the ACR.

In the last 12 months, the number of proposals to dramatically reduce or eliminate industry support for the activities of professional medical associations has increased. In response to an article published in JAMA¹ suggesting that professional societies strive to end their use of financial support from industry, the ACR released a joint statement with five other like-minded associations, stating that, “Medical professional societies can and do have ethical, positive relationships with industry, as do others in federal and state government and the foundation community. Without continued external support from industry, our associations will be unable to provide the same level of outstanding education and cutting-edge science that has advanced the quality of patient care in this country. Moreover, as funding and reimbursements tighten, medical practices and practitioners are likely to fall further behind in offering the most current, evidence-based care to patients as the pace of scientific progress accelerates. We would welcome more public support, however unlikely, for advancing quality, evidence-based care, and translation of science into clinical care guidelines. But, in the absence of public funding, industry funding can be separated from product bias and be firewall protected to support continuing medical education as a means to improve quality of care and outcomes… .” (Read the full statement online at www.rheumatology.org/ref/industry/PMA_Joint_Letter.pdf.)

Since releasing this statement, we have continued to track the changes in environmental opinions and policies to ensure that we remain compliant. However, as a professional medical association, we believe it is our responsibility to provide a venue where primary data can be openly presented and discussed by those closest to the science. Accordingly, the road to the 2010 ACR/ARHP Annual Scientific Meeting has not been without debate.

Industry in CME

This spring, the Committee on Education further discussed the Accreditation Council for Continuing Medication Education’s (ACCME) March 2009 statement that precludes industry employees from serving as speakers at accredited CME activities. This stance was problematic to associations such as ours that consider this an important step in the translation of discovery to practice through the dissemination of the results of scientific research conducted by ACCME-defined commercial interests. In fact, just prior to ACCME’s issuance of guidance, we had taken a position on “ghost presenting” that now appeared to be going against the spirit of ACCME’s guidance. Our policy on abstract presentation states that those closest to the science (whether employees of commercial interests or not) are the best suited to deliver content to learners. The ACR took an observational approach and asserted that the mechanisms we already had in place to resolve potential conflicts of interest did result in achieving a balanced and bias-free CME activity.

This approach paid off as discontentment among other CME providers grew. In June, the American Heart Association approached ACCME to make its case for the involvement of industry presenters at its annual meeting. ACCME responded by issuing further guidance, which reaffirmed the ACR’s opinion that, through rigorous peer review and conflict of interest management, employees of commercial interest can play a critical role in certified CME. Mechanisms for managing this conflict of interest in order to safeguard the independence of the CME include peer review of content, asking that the presenters teach about the scientific or discovery process itself, or reporting research results that are at the level of biology but not discussing products, among other approaches. As a clinical trialist for 30 years, my interaction with the industry research community has been positive and rewarding, and it is clear that industry rheumatologists have significant expertise that could be of value to the ACR. I feel strongly that our rheumatologic colleagues in industry should have the opportunity to present the results of new, innovative research going on at their companies that has the potential to change the therapeutic landscape for our patients.

New Approaches at the Annual Meeting and Beyond

For the 2010 annual meeting, the ACR is piloting a program allowing Industry Roundtable members to support either CME-accredited symposia or company-directed promotional symposia. Industry Roundtable members requested this option due to the increasingly stringent environment surrounding CME activities and the firewalls between commercial supporters and CME. Several companies cited experiences where company medical education staff attended their own CME symposium to find that data had been presented incorrectly. Five of the eight Industry Roundtable members will be hosting non-CME symposia during the meeting, which are considered promotional presentations and fall under the guidance of the Food and Drug Administration and PhRMA Code on Interactions with Healthcare Professionals. Symposia will be clearly identified and the ACR will reevaluate these activities after the annual meeting to determine whether to continue them in 2011.

We would be naive if we did not acknowledge that perception plays a major role in evaluating interactions between industry, physicians, and societies. The ACR recently determined it will no longer be offering noneducational items such as tote bags, lanyards, or luggage tags as support opportunities. Beginning in 2011, the ACR will also make publicly available on our website the annual financial contributions each company makes. It is the intent of the ACR to continue to manage and cultivate responsible relationships with industry and we will continue to evaluate our interactions on a regular basis to ensure we comply not only with those relevant to the industry but also with our internal standards.

Since the revised PhRMA Code took effect in January 2009, companies have sought new and different ways to have effective and engaging interactions with physicians. At this year’s annual meeting, you will notice that some companies are modifying their approach to exhibiting. Like last year, you will not be able to pick up a pen in the exhibit hall and you will see more medical liaison staff and fewer marketing staff. Since the focus will be on education, expect more interactive booth exchanges to educate attendees about products and the science behind them. Based on the feedback from 2009 attendees that the Innovation Theater was a convenient place to learn about new products, we will offer more sessions there this year.

As part of a broader initiative, the Council of Medical Specialty Societies (CMSS), which represents 32 leading specialty societies, released a voluntary Code for Interaction with Companies in April. Among other things, the code reinforces the integrity that CME providers are required to demonstrate by adopting policies and procedures for managing the relationships of individuals who plan, carry out, or contribute to the content of CME activities. The ACR recently applied to become a CMSS member so that we could have input into policies established by external groups. In an effort to unify the diverse ACR policies touching on issues of industry relationship, and in an effort to be transparent in these matters, the ACR has developed its own ACR Guiding Principles for Interactions with External Entities. In addition to making available to the public a listing of commercial support, individual disclosures of the 2011 ACR Board of Directors will also be publicly available.

As the landscape surrounding the annual meeting, CME, and industry remains in flux, the ACR is committed to transparency and ensuring its educational activities continue to the offer outstanding education. We will also continue to explore appropriate opportunities for our rheumatology members in industry to contribute their talent and expertise to our organization.

We believe we can continue to work with industry and other external entities to support our ever-growing effort to achieve our mission: Advancing Rheumatology.

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

Reference

1. 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;301:1367-1372.