Author + information
- Ralph Brindis, MD, MPH, FACC, ACC President⁎ ( and )
- Robert Harrington, MD, FACC, Chair, ACC's Clinical Quality Committee's Science and Clinical Policy Subcommittee
- ↵⁎Address correspondence to:
Ralph Brindis, MD, MPH, FACC, American College of Cardiology, 2400 N Street NW, Washington, DC 20037
Much has been made over the last few years about conflicts of interest in the medical community's relationships with industry. This includes both relationships with individual physicians as well as those with academic medical centers and professional organizations.
The American College of Cardiology (ACC) is committed to professionalism and to a transparent relationship with all of our industry sources of funding. We have among the most stringent policies in place in the medical community to ensure that support from industry has no influence on any of our clinical documents, such as practice guidelines and appropriate use criteria, or the content of the medical education we sponsor.
Our “Principles for Relationships With Industry” (1) serve as the organization's guide in nine key areas of operation: 1) advertising; 2) charitable donations; 3) clinical document development; 4) continuing medical education; 5) exposition; 6) governance; 7) government grants and foundation support; 8) registries; and 9) sponsorships. As the ACC President and the Chair of the Science and Clinical Policy Subcommittee, we are proud of this commitment to full transparency and the very highest ethical standards.
When it comes to industry, properly managed partnerships are absolutely critical to maintaining scientific progress in cardiology and other specialties. While some in Congress, the medical community, the lay press, and elsewhere have suggested that there should be absolutely no use of industry funds for any medical school or organization activity, given the scarcity of public funding for research and publications and the relatively high cost of education, this position would make it very difficult for medical societies to carry out their missions and enhance quality of care. In fact, we believe that industry, in addition to its role in developing new drugs and devices that advance the treatment of cardiovascular disease, has an obligation and expectation to provide funding for the education of practitioners as part of its social contract with patients, clinicians, and society as a whole.
In the case of the ACC, we rely on industry funding to advance cardiovascular research as well as cardiovascular workforce training, practitioner diversity, medical education, and lifelong learning. Without this funding, our efforts to provide meaningful, unbiased education and to improve quality of care would be far more limited than what we currently offer to members and ultimately our patients. Rather than restricting industry funding for such activities, we should instead focus on transparency and actively and appropriately managing industry relationships.
Disclosure is critical. The College has strict organizational firewalls between the development and fundraising related to commercial support and the College's programmatic activities and personnel. These firewalls are designed to ensure that the ACC's relationships with drug and device companies would never influence the scientific or educational content the College produces. In addition, the ACC adheres to both internal and external policies that prohibit the companies providing support from exercising any influence or control over programmatic content, speaker/faculty selection, program format, planning, partnering arrangements, program evaluation methods, and related matters.
Most recently, the College reaffirmed its commitment to transparency by signing the “Code for Interactions with Companies,” released by the Council of Medical Specialty Societies (2). The code is meant to increase transparency and set a universal standard for independent program development and independent leadership. The ACC made significant contributions to the final code, based on our own relationships with industry principles.
In addition, the College has developed new principles related to the development of clinical documents, such as guidelines, scientific advisories, and appropriate use criteria. We consider guideline and clinical document development critical to our mission, and these new principles are designed to ensure that authors involved in the development of clinical documents fully disclose all relationships with industry and other entities to eliminate the possibility of undue bias. The breadth of disclosures include research funding, consulting relationships, stock ownership, advisory boards, data safety monitoring boards, and uncompensated potential “intellectual conflicts.” We have worked collaboratively with the American Heart Association (AHA) to ensure our relationships with industry policies on document creation are identical.
Under the new principles, all clinical document authors, including organizational representatives of American College of Cardiology Foundation (ACCF) document writing committees (e.g., guidelines, performance measures, clinical alerts, scientific statements, and expert consensus documents), must annually disclose all relationships with industry and other entities using the ACC's Electronic Disclosure Database. In addition, all ACCF writing committees must have a chair without any relationships that are relevant to the document under development. The respective ACCF parent task forces responsible for overseeing clinical practice guidelines, expert consensus documents, appropriate use criteria, and so on, must review and approve all writing committee appointments and adjudicate questions or concerns relating to relationships with industry.
The ACC's Clinical Quality Committee's Science and Clinical Policy Subcommittee has taken on the central role of addressing broad conflicts of interest issues. When it comes to writing committees, each committee must have at least 50% of its members (excluding the chair) without relevant industry relationships. This means that the responsibility for identifying members without relevant relationships is distributed (as evenly and fairly as possible) to all partnering organizations. Partners or collaborating organizations are asked to recommend several alternate representatives to facilitate the implementation of this policy. If there is difficulty in reaching the 50/50 distribution of members with and without relationships, organizations are asked for alternative names until even distribution is reached.
It is important to note that there may be times during the document generation process where it is advisable to have writing group members with relevant industry relationships in order to ensure the scientific rigor related to certain areas of content. In these situations, the ACC and the AHA have strict policies in place related to recusing an individual or individuals with industry relationships from any text drafting of relevant document sections and/or from voting on any recommendation relevant to their relationship(s). Finally, relevant industry relationships for all writing committees are published with the document and “comprehensive” documentation is also available electronically.
The College recognizes that the new principles governing development of clinical policy documents are controversial. While some view these policies as too constricting, making ideal document creation quite challenging, others view these policies as not strict enough. We do know that these new policies have added time and complexity to the already difficult process of commissioning writing committees and have potential impacts on partnering/collaborating organizations. It also means that the distribution of members with and without relationships with industry may not always be evenly distributed among partner/collaborating organizations. That being said, we are committed to these new principles and believe that these changes will not dilute the rigor and science behind the clinical document development process. Rather, transparency and a rigorous process to manage relationships with industry is the best policy for everyone involved in the development of organizational documents and standards.
Industry relationships, when managed properly, are crucial in terms of advancing the quality of care for patients. We need to help the media, the public, and policymakers better understand the beneficial role of industry in promoting research, education, and innovation in medicine. We also need to be out in front advising them when their words or actions related to relationships with industry issues may be misguided and/or potentially counterproductive to the creation of the best possible evidence-based documents. It is the College's hope that by developing rigorous and transparent standards that we can create a culture of openness in order to rebuild trust in our health care system and avoid pressing threats to physician autonomy. Our ultimate job is to make sure that any relationship is managed in a way that ensures unbiased, evidence-based, and balanced reviews of science, regardless of funding sources.
More information on the ACC's relationships with industry principles, as well as the disclosures of trustees, state chapter governors, and committee chairs, is available on the ACC's web site (CardioSource.org).
- American College of Cardiology Foundation
- American College of Cardiology Principles for Relationships With Industry
- Council of Medical Specialty Societies