DOI: 10.1097/01.BONEJ.0000342262.40670.00
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Issn Print: 1938-8659
Publication Date: 2008/12/01
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Excerpt
“In recent years,” says former New England Journal of Medicine editor Marcia Angell, MD, in a commentary in JAMA, “sponsoring companies have become intimately involved in all aspects of research on their products. They often design the studies; perform the analysis; write the papers; and decide whether, when, and in what form to publish the results. In some multicenter trials, authors may not even have access to all their own data.”
Angell uses the pharmaceutical industry as an example. However, many of the same points apply to medical device companies as well.
“Given the conflicts that permeate the clinical research enterprise, it is not surprising that industry-sponsored research has consistently been shown to favor the sponsor's drug—partly be-cause negative results are often not published, partly because positive results are repeatedly published in slightly different forms, and partly because a positive spin is put on even negative studies,” says Angell.
Commercially sponsored trials can be biased in both subtle and not-so-subtle ways: through the selection of inferior comparison treatments, inappropriate outcome measures, unrealistic endpoints, and incomplete reporting of results.
Angell suggests—and this is a damning criticism—that the medical literature on commercially sponsored products isn't believable. “Physicians can no longer rely on the medical literature for valid and reliable information,” she points out bluntly.
The current research system needs to be redesigned to protect the interests of both patients and providers. “It is more than a matter of perception or appearances,” says Angell. “It is a matter of public health.” (See JAMA, 2008; 300:1069–71.
