The research, supported in part by grants from the Association of Clinical Research Organizations (ACRO), The Association of Clinical Researchers and Educators (ACRE) and from the Searle Freedom Trust, was written by ACRE Co-Founder Thomas Stossel, MD, and authors Roman Lesko, and Samuel Scott.
After reviewing over one-hundred articles, the authors concluded that the “discussion of academic-industry relationships in top-tier medical journals has been unbalanced.”
Economists have concluded that extensive interaction between academic researchers and practicing physicians with industry has facilitated the development and dissemination of biomedical diagnostics, devices and therapies. Despite the significant improvements in healthcare, including increased lifespan, decreases in death rates for cancer and cardiovascular disease, and better management of diabetes and hypertension, critics persist.
This has led academic health centers, states and the federal government to institute regulations designed to monitor, limit or eliminate such interactions based on concerns that such relationships may degrade the performance and reporting of biomedical research and also induce physicians to behave in a manner inconsistent with cost-effective or ethical patient care—which are loosely defined under the operational term ‘financial conflicts of interest’ (COIs).
Study and Findings
The authors analyzed papers published in four journals selected on the basis of their high (>20) impact factors: The Journal of the American Medical Association (JAMA), The Lancet, Lancet Neurology and The New England Journal of Medicine (NEJM). They identified articles by performing keyword searches on the websites of the selected journals and on PubMed. Overall, 17% of the articles contained original data and were classified as research papers or else as ‘special articles’ by the journals in which they were published. The rest were editorials or commentaries. These two types of articles were analyzed separately.
The preponderance of articles (n = 96, or 89% of the sample) unambiguously emphasized the risks of physician-industry relationships. In many cases, the risk emphasis was obvious from the paper’s title (e.g., “Just how tainted has medicine become?” or “Impugning the integrity of medical science: the adverse effects of industry influence”). These articles either did not discuss or only briefly mentioned benefits of physician-industry or academic-industry relationships, and all of them recommended more stringent regulation of such relationships
For example, one commentary published in Lancet asserted that there is… “grave danger because of the nature of its dealings with the pharmaceutical industry, the medical profession is forfeiting public confidence.”
Half of the risk-emphasizing research articles and over two-thirds of the non-research articles included a statement to the effect that relationships to industry negatively affected patient care outcomes or caused public distress, without objective evidence to substantiate the supposedly negative effects. Of the total set of risk-emphasizing articles, nearly two-thirds contained no mention of an opposing point of view and only 5% critically analyzed it.
Ultimately, this analysis reveals that the discussion of academic-industry relationships in top-tier medical journals has been unbalanced. The authors wondered whether this imbalance has in turn negatively influenced policymaking, resulting in more restrictive policies than the evidence supports, particularly in terms of how COIs relate to patient outcomes or public attitudes. It also points to the need for editors of top-tier journals to be open to a broader and more inclusive diversity of voices when considering articles on academic-industry relationships. The authors recommended further research into this area.
The Association of Clinical Researchers and Educators (ACRE), founded in 2008, is a non-profit organization of medical professionals who recognize that appropriate physician-industry collaborations and relationships benefit patients and advance science. ACRE provides a forum for like-minded physicians and industry partners to further such collaborations, and to advocate on behalf of better patient care. ACRE is lead by a steering committee of physicians from major medical institutions including Harvard Medical School, SUNY Downstate Medical Center, Stanford University, New York University School of Medicine, The Mayo Clinic Cancer Center and others.
ACRE members seek to define and promote balanced policies at academic medical centers and within government, to enhance positive, well-managed partnerships. They also recognize that industry-physician relationships are critical to educating practitioners about new treatments and therapies. There is much evidence to support the social good provided by industry, as well as many unique and successful collaborations between industry and the medical community. By informing public debate and professional understanding, ACRE encourages new investigators and clinical trials that benefit patients by advancing medical knowledge.