1 Boring Old Man

New England Journal of Medicine
• ^{September 20, 2012:}
  A Randomized Study of How Physicians Interpret Research Funding Disclosures
• ^{September 20, 2012:}
  Believe the Data
Hooked: Ethics, Medicine, and Pharma
• ^{September 27, 2012:}
  NEJM: Overly Defensive, or Just Naive?
• ^{October 12, 2012:}
  More on Sponsorship of Studies in Medical Journals

^{…the ones that I’ve shown basically tell the following story:}

• Research studies paid for by industry commonly distort findings so as to favor their products.
• As a rule, the journal reader cannot tell how the results have been distorted. (As the latest entry showed, to find out what was misleading about a study that occupies 7 pages in a journal might require wading through 8500 pages of data.)
• These distortions occur in all medical journals and if anything are even more prevalent in the top-tier journals. (Probably not because these journals are badly edited, but because it’s so much more of a coup if the company can land their research findings in those top journals.)

^{Bottom line – if the reader is automatically more skeptical of a study because it’s industry sponsored, there is good reason for that skepticism.}

More on Sponsorship of Studies in Medical Journals
Hooked: Ethics, Medicine, and Pharma
by Howard Brodie MD PhD
October 12, 2012

Again tipping my hat to Rick Bukata and Jerry Hoffman’s Primary Care Medical Abstracts, I come across a study by Drs. Michael Hochman of UCLA and Danny McCormick of Harvard:

These guys looked at several ways of reporting results that overestimate benefits:

• Reporting relative vs. absolute risks
• Reporting surrogate endpoints rather than significant changes in health
• Reporting composite endpoints instead of reporting each endpoint of interest separately
• Reporting only disease-specific mortality instead of all-cause mortality

If people write in and request I’ll explain why each of these overestimates benefit from drugs.

Drs. Hochman and McCormick then compared how likely it was that a study would report results in these ways, based on who sponsored the study. They found significant differences in two categories. Exclusively industry-sponsored studies were more likely than studies with at least some non-commercial support to report surrogate endpoints (45% vs. 29%) and disease-specific mortality (27% vs. 16%).

Now, if you wanted to defend the NEJM editorial position, you could say that readers of studies can readily see how the data are reported according to these criteria and can be wary of any study, regardless who funds it, that reports data in the less desirable way. But let’s give the last word to Drs. Hochman and McCormick, in their final recommendations: "These findings highlight the need for educational efforts to ensure that readers understand the complexities of these endpoints and of relative risk reporting. … In addition, Institutional Scientific Review Committees and regulatory agencies (e.g. the FDA) must closely examine the endpoints used in clinical trials and discourage the inappropriate use of surrogate and composite endpoints, and endpoints involving disease-specific mortality. Finally, medical journals may consider instituting editorial policies mandating the reporting of results in absolute numbers."

In other words, rather than asking readers to sift through whether the results are reported in a useful and valid fashion, medical journals like NEJM could simply refuse to publish papers that don’t adhere to the highest standards. Of course, if they did, they might lose revenue as drug companies would not buy so many expensive reprints of papers that are really useful for marketing drugs – which may be one of the roots of the problem.