Association of Clinical Researchers and Educators: Academic Physicians Confront a Hostile World: The Creation of ACRE

 

Michael A. Weber, M.D., a founder of the Association of Clinical Researchers and Educators (ACRE), recently published an editorial titled: Academic Physicians Confront a Hostile World the Creation of ACRE to address the concerns about relationships between academic physicians and the pharmaceutical and device industries.

 

He noted that today, a large part of medical research and education is based on this relationship. In fact, even Dr. Jeffrey Flier, Dean of Harvard Medical School, acknowledged at ACRE’s inaugural meeting this past July that his school’s mission to promote medical education and research requires interaction with industry.

 

This interaction in recent decades has created significant breakthroughs in treating conditions such as cancer and heart disease, and their incorporation into medical practice have resulted from this partnering between academia and industry.

 

Another reason for such collaboration is “because academic physicians are uniquely qualified to identify unmet medical needs and, working collaboratively with industry colleagues, to devise and conduct the types of basic research and clinical trials that lead to therapeutic breakthroughs.”

 

Critics of such collaboration want to preserve the independence of academic physicians by pointing to the negativity associated with the costs of new developments in patient care.

 

Such a concern however, is misguided because while industry and its academic advisors develop and make new tests, procedures, and therapies available to help save lives, government agencies are left with limited budgets, and commercial health plans with financial obligations to investors. These problems for agencies and health plans are made worse when academic physicians begin teaching their practicing colleagues about the attributes of these new developments because the government does not have the resources necessary to ensure the widespread use of such breakthroughs.

 

To solve such a problem of limited resources does not require the government to start yelling “conflict,” when the reality is, agencies cannot keep up with industry.

 

As nationally recognized medical ethicist, Lance Stell, explained at ACRE’s inaugural meeting, “occurrences of conflicts are extraordinarily rare in the conduct of medical research and education activities” because empirical proof is needed to accuse a physician of such conflict.

 

Instead of conflict, Dr. Weber advocated for the use of “duality, concordance, or alignment of interests.” He even pointed to the irony of how commercial health plans offer practitioners direct monetary rewards for switching their patients from more expensive to less expensive drugs, or, possibly, for reducing their use of tests, referrals, and therapies so as to minimize the insurers’ outlays. Yet these are not considered conflicts.

 

THE CHALLENGE OF EDUCATION

 

Dr. Weber also indicated in his article that because industry has the responsibility as well as the resources to provide ongoing education in the clinical sciences, it should be no surprise that much of the information received by practicing clinicians comes from events that are funded, directly or indirectly, by industry. The idea that industry is providing promotional activities or CME for reasons other than advancing science and helping patients are misguided.

 

The promotional education programs that take place in hospitals, medical offices and other venues to provide information directly about a company’s product are regulated by the FDA. These regulations guarantee that information presented must be balanced, providing information about risks as well as benefits, and must conform largely to what is stated about the drug in its approved product label.

 

Although some pharmaceutical companies have pushed to use company-provided slides, this requirement obviously creates fundamental problems for academic physicians invited to present at such events. In response to such demands, major medical schools have now instructed their faculty members not to give such lectures unless they have meaningful control over the content. For community practitioners who attend such events, this is an unfortunate development, for it deprives them of beneficial teaching interactions with true medical leaders.

 

Instead of preventing physicians access to such education, negotiations between industry, academia, and regulatory agencies is needed to “re-create the collegial educational experiences.”

 

RE-EVALUATING CME

 

The contents of CME programs usually are created by academic faculty and are subjected to peer review (similar to an article submitted to a journal) to ensure their objectivity. Such an indication is evidence that industry has a “hands off” involvement in such events, merely serving as a provider of grants. Moreover, industry now goes to considerable pains to ensure that its grant decision processes are kept entirely separate from marketing activities.

 

Critics who believe industry support for CME results in increased sales of its products underscore the significance of these programs. Even if this were true, it is a not unreasonable proposition that if well-balanced data, presented in an unbiased fashion, affects the subsequent utilization of drugs or devices, this will very likely be to the benefit of patients.

 

What critics should consider is a report conducted by the Royal College of Physicians in Great Britain about four years ago, which “stated that the interests of patients and their clinicians are best served by close cooperation between academia, industry, and the health services.”

 

ACRE’s Role in CME

 

The responsibility of ACRE is to re-establish the partnership of academia, industry, clinicians, and patients in the United States. Among its initial goals is educating the lay public as well as the medical community about the value to patients of the research and educational collaborations between academia and industry. Another of ACRE’s main tasks will be to set up codes of conduct or guidelines designed to ensure that relationships between academic physicians and industry are ethical and clearly targeted at improving outcomes for our patients. ACRE will also develop a public voice that gets heard and quoted when these industry-academia relationships are attacked, as they have been in the past.

 

There already has been one such success: Dr Thomas Stossel, one of ACRE’s leaders and the chair of the Harvard meeting, was invited to testify at a high-profile US Senate hearing on CME in late July.

 

Dr. Weber concluded his support for academic-industry partnership by noting the dramatic improvements in cardiovascular medicine and patient care that have resulted in reducing mortality rates, hypertension, lipid disorders, diabetes, heart failure, acute coronary syndromes and chronic kidney disease by this collaboration.

 

Consequently, from the perspective of academic clinicians, rigorously conducted CME events in which they are free to select the content and ideas represent ideal opportunities to enhance practitioner knowledge and patient care. Any attempt by legislators (and others who regard medical education as a health–care cost driver) to prevent or limit industry support of CME could have the effect of diminishing the quality of medical practice.

 

ACRE’s members, in common with most physicians, no longer find it acceptable to let others unilaterally set up the rules by which we are expected to function in performing these vital tasks. It is the responsibility of physicians and organizations like ACRE to argue the value to patients of cooperation between academia and industry in medical education as well as in research.

 

More information about ACRE can be found on its Web site: http:// www.acreonline.org. The site also has information about how to become a member.