MARCH 22, 2007 | The editor-in-chief of the Journal of the American Medical Association (JAMA) urged researchers always to offer full disclosure of funding sources for their work, during a March 1 lecture at the University of Arkansas for Medical Sciences (UAMS).
Catherine DeAngelis, M.D., expressed concern over what she called a blurring of the line between science and marketing that has threatened the credibility of biomedical research. DeAngelis, also a professor of pediatrics at
She pointed to instances where research support by pharmaceutical companies was not fully disclosed by the researcher upon publishing research results, and sometimes, disclosed only after the research proved suspect.
“There has to be a relationship between pharmaceutical companies and researchers, but it’s time for the physicians to take back medicine and do it right,” DeAngelis said while standing in front of an image of two porcupines hugging.
A conflict of interest, DeAngelis said, can be real or perceived, inconsequential or harmful. The conflict comes when anything interferes with what she called the basic point of all medical research: that it ultimately results in better patient care.
Pharmaceutical companies provide two-thirds of the funding for biomedical research, including almost all of the support for clinical trials, she noted. The industry as a whole leads all others in political spending through both lobbying and campaign contributions, she said.
The support is critical, she said, but there is concern about how the funding influences researchers. She displayed a magazine cover with a headline posing the question “Science and Profit: Are they partners or enemies?”
Adding to the perception problem have been the high profile ethical lapses, she said.
“Why does it matter? Bias can affect what authors publish, when, how and why they publish,” DeAngelis said.
DeAngelis cited instances in recent years when publication of research was delayed to lessen the impact of negative results, incomplete data was provided to show a particular drug did work, some results were fabricated or researchers deliberately lied about having additional data showing problems with a drug, she said.
One example concerned Vioxx, an anti-inflammatory drug used to treat osteoarthritis and acute pain. When the New England Journal of Medicine (NEJM) published a study in 2000, “it looked like a great drug,” she said.
Data showing an increased risk of heart attack, though, was not made available to the NEJM editors prior to publication. The drug was ultimately pulled from the market in 2004 because of the risk.
DeAngelis said the drug was still effective for most and many would’ve chosen to accept the increased heart attack risk.
“If they had just been honest and up front about the risk,” she said. “That’s where the trouble started.”
She traced the trend back about 15 years, saying pharmaceutical companies apparently made a decision to blur the line between science, where the goal is to find the truth, and marketing, where the goal is to sell a product.
The conflicts of interest “threaten the credibility of biomedical research, the researchers and the care given to patients,” she said.
Financial disclosure is essential to maintaining the public trust in the work as well as the publication in which the research is published. </SPAN>
Financial disclosures should:
- Be complete and detailed
- Cover the entire study from inception to publication
- Adopt a “when in doubt, disclose” philosophy
- Report all sources of funding
- Report all individual financial interests
Publications also should have similar disclosure policies that are transparent to readers, she said.
The lectureship was created in honor of Annie Lea Shuster, who administered the Robert Wood Johnson Clinical Scholars Program for 25 years. Seven of those years were spent at UAMS directing the program, which is the premiere training program for physicians in health services research.
DeAngelis has served for more than six years on the program’s national advisory committee. With Shuster in the audience, DeAngelis noted: “Annie Lea is one of the most wonderful mentors I have had in my life. If she asked me to jump off the
JAMA, published continuously since 1883, is an international peer-reviewed general medical journal published 48 times per year. JAMA is the most widely circulated medical journal in the world.
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Journal of the American Medical Association: http://jama.ama-assn.org/
UAMS Psychiatric Research Institute: http://www.uams.edu/psych/default.asp