Conflicts of Interest In Science
Catherine DeAngelis, MD, Editor of the Journal of the American Medical Association, gave a keynote speech entitled "Conflicts of Interest In Science" at the 44th annual meeting of the American Society Of Therapeutic Radiology and Oncology. Her experiences as editor of the most circulated medical journal have given her a unique perspective on this hotly contested issue. She began by reminding the audience, consisting of mostly physicians, that they are afforded a certain level of respect from the public, whether or not it is deserved.
The pharmaceutical industry has long been a partner with physicians involved in clinical research. This partnership is a necessary one, with over 50 billion dollars in research funding coming from the pharmaceutical industry in 2001. This compares with 27 billion from government funding, 7.5 billion from foundations, and 12 billion from biotech companies. Over 90% of all clinical trials in this country are funded by the pharmaceutical industry. Obviously, without this partnership, numerous advances in treatments would not be possible, but this is not without concerns.
Industry has increased its promotional funding from 6.54 billion in 1996 to 12 billion in 2002. Direct-to-consumer advertising has risen most substantially from 700 million to 2.8 billion. Funding for events (i.e., dinners, sporting events, etc.) has increased from 0.9 billion to 1.9 billion over the same time frame. In addition, the pharmaceutical industry is the largest lobbying effort in Washington, with over 221 million in political spending in 2001. Dr. DeAngelis stated, "This spending arouses public concerns and threatens the credibility of biomedical research and ultimately our practice". In addition, the financial interests of academic institutions may raise concerns. Academic institutions have more patents pending than the top 25 firms and the biotech industries combined, and are highly involved in genomic research and patents.
Dr. DeAngelis used the phrase "you see it when you believe it" to describe the possibility for biases in research. She referred to a survey published in JAMA (Blumenthal, JAMA, 1997), including 2167 faculty members, of which 19.8% reported delaying publication of a study for more than six months for proprietary needs. She also referred to a study comparing synthroid to its generic counterpart (Dong, JAMA, 1997), whose publication was delayed more than three years, allowing the company to gain millions of dollars in sales. Dr. DeAngelis reported several other cases in which she was deceived or threatened with law suits for refusing to publish a study, or publishing unfavorable data, as the editor of JAMA. Dr. DeAngelis reminded the group that even sophisticated, apparently well-done trials are open to the perception of unacceptable influences by the for-profit funder.
In response to these incidents, the International Committee of Medical Journal Editors, which includes 150 editors, put together the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. This document has undergone multiple revisions over the years to address ongoing concerns. Over 500 journals use the guidelines, and state in their instructions to authors that their requirements are in accordance with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals.
Recent additions to the guidelines include a statement, to be signed by authors, requiring that they have full access to the data, and that they accept responsibility for the integrity of the data and the accuracy of the data analysis. In addition, authors provide financial disclosure.
When held to ethical standards, the partnerships between the pharmaceutical industry and researchers can provide amazing advances in the care of our patients. Dr. DeAngelis concluded by stating "we must work together to assure that our patients are best served", a goal that must be kept in mind by both partners.
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