To the Editor:
In the outstanding Special Article “Association of Funding and Findings of Pharmaceutical Research at a Meeting of a Medical Professional Society” by Drs. Finucane and Boult, the explanations for potential bias in outcomes favoring pharmaceutical products when research was sponsored by the pharmaceutical industry did not include one seemingly obvious bias.
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While less nefarious, it seems almost intuitive that the pharmaceutical industry would invest, like any other business, in studies that are most likely to have significant findings that favor their products.This explanation is far different from “ …supporting biased study designs …” or “ …controlling access to, and analysis of, study data …,” as elaborated upon in the authors’ “Discussion” section. Preliminary information that indicates a benefit of a medication, either comparatively speaking or as a new finding, would be understandably pursued by the industry. So too, early information that disfavors a formulation may lead to abandonment without further investigation, simply as a cost-effective business decision. Thus, if a company is successful, most often the research and development dollars for legitimate studies will also be consistent with preliminary data that favor the investment into additional, well-designed trials in the first place.
There are, of course, examples in which investigation that clearly focuses on safety is done by industry even though there is little benefit to be gained from a financial perspective. The most recent, and now perhaps most well known, example is the Merck trial of long-term rofecoxib use for prevention of adenomatous polyps, which included as part of its initial study design a safety component assessing cardiovascular risk. This arm was included despite the lack of financial incentive to do so, ie, regardless of the findings, the data would not have been beneficial in promotion of the drug. A negative study would have been dismissed by many as a pharmaceutical industry-sponsored trial of inadequate design or sample size (or as suspect of data suppression, as evidenced by the “Discussion” section of this Special Article). A positive study would, as is now indisputable, have devastating corporate consequences, not only on the drug sales, but on the company portfolio overall.
Reference
- Assocation of funding and findings of pharmaceutical research at a meeting of a medical professional society.Am J Med. 2004; 117: 842-845
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© 2005 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
