AHA, ACC applaud IOM for its new report on clinical practice guidelines

Few issues are more important to the American College of Cardiology and the American Heart Association than translating scientific evidence into guidelines and performance measures for healthcare providers, a process we have been engaged in for several decades.  The use of these evidence-based guidelines has been proven to improve the quality of care and actual outcomes for patients. We applaud the IOM for its new report and share its position that it is critical that no commercial or any other bias can be allowed to influence the development of clinical practice guidelines.

The new Institutes of Medicine report, "Clinical Practice Guidelines We Can Trust," published March 23, 2011, cites the American College of Cardiology and American Heart Association's standards for guideline development as being almost perfectly aligned with their recommendations.

Both the AHA and ACC also appreciate the focus on the issue in the Archives of Internal Medicine article by Mendelson et al, which analyzes the disclosure of relationships with industry in joint guidelines developed by the American College of Cardiology and American Heart Association between 2004 and 2008.

Both the American College of Cardiology and the American Heart Association have long had strict policies for preventing any undue influence of industry.  In 2004-2008, these policies relating to practice guidelines included the requirements that:

• All writing panel members must verbally disclose all relevant relationships with industry at every meeting and conference call.
• Individual panelists with a relationship with industry were held responsible to recuse themselves from any matter relevant to their relationship.
• All disclosures would be published as an appendix to each guideline.
• Multiple tiers of reviewers assured the lack of bias of each guideline document.

As the Archives article states, the American College of Cardiology and the American Heart Association refined their policies in 2010 to require even more stringent management of relationships with industry, to align with the Council of Medical Specialty Societies (CMSS). Thus the data within and the conclusions drawn by the article do not reflect the reality of the guidelines development process today.

Updated practices include these additions:

• The Chair of the guidelines writing panel may not have any relevant relationships with industry.
• In addition to the Chair, a majority (at least 50 percent) of guidelines writing committee members must not have any relevant relationships with industry.
• A writing committee member may not draft a recommendation nor any text nor vote on any recommendation that is relevant to any of their industry relationships.
• Members of the final approving bodies of both ACC and AHA, Science Advisory Coordinating Committee and the Board of Trust respectively, also must recuse themselves from voting if they have a relevant relationship with industry.

For determining eligibility to serve on a writing committee, a person is considered to have a relevant relationship IF:

• The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or
• The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or
• The person or a member of the person's household has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.

The American College of Cardiology and the American Heart Association remain fully committed to transparency in the development of all our guidelines. We will continue to look closely at our policies regarding relationships with industry and welcome public dialogue that may help us continue to enhance our practices in the future.