They showed 503 internists fake abstracts that they had manipulated according to the study variables. The good news was that these internists knew quality when they saw it; they were less willing to prescribe a new drug as the rigor of the study design diminished. The part of the study that forms the remainder of our discussion was that independent of study quality, the internists were less likely to prescribe a new drug (by a factor of about half) if the study was labeled as industry-funded compared to NIH-funded.
This latter finding unloosed an editorial from NEJM Editor-in-Chief Dr. Jeffrey M. Drazen, somewhat ominously titled,"Believe the Data" (http://www.nejm.org/doi/full/10.1056/NEJMe1207121). Dr. Drazen took serious issue with the idea that one should judge an article based on who funded the study: "A trial's validity should ride on the study design, the quality of data-accrual and analytic processes, and the fairness of results reporting. Ideally, these factors — not the funding source — should be the criteria for deciding the clinical utility." Just in case we were not sufficiently impressed, he then pulled out the moral trump card: "Patients who put themselves at risk to provide these data earn our respect for their participation; we owe them the courtesy of believing the data produced from their efforts and acting on the findings so as to benefit other patients." That is: If you decide to question the results of a study because it's industry-funded, you're being disrespectful of the patients who agreed to participate in the research.
All of which shows that Dr. Drazen is not a regular reader of this blog. Let us take just a sampling of past posts, starting with the most recent one:
http://brodyhooked.blogspot.com/2012/09/more-on-tamiflu-challenges-of-getting.html
http://brodyhooked.blogspot.com/2012/06/those-persistent-ghosts-key-loophole.html
http://brodyhooked.blogspot.com/2012/04/yet-more-ways-literature-can-mislead-us.html
http://brodyhooked.blogspot.com/2011/11/some-capsules-of-recent-pharma-related.html
(In the last-mentioned post, see the sub-entry, "Data Dredging: Which Studies Do It the Most?")
I could have listed a lot more, but 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.)
Now--let's address Dr. Drazen's moral trump card. The issue he raises about respect for research subjects is indeed an important issue. It just has nothing to do with whether the reader should be suspicious of a company-sponsored study. The real question is: when are we going to demand that truly "informed consent" for research subjects in industry-sponsored trials include disclosure of when the trial is not designed for scientific purposes and is instead designed for drug marketing purposes?
6 comments:
Remember when Merck failed to report a few heart attacks which occurred during a clinical trial... in an article published in NEJM? Drazen was not the editor then, but still this incidence of covering up negative data is well-known.
Howard,
Thanks for an excellent post. Human subjects are not being well informed and I suspect that at least some would be more wary of participating if they knew a study was industry sponsored.
You asked: “The real question is: when are we going to demand that truly "informed consent" for research subjects in industry-sponsored trials include disclosure of when the trial is not designed for scientific purposes and is instead designed for drug marketing purposes?” The term for such a study is experimercial.
A trial's validity should ride on the study design, the quality of data-accrual and analytic processes, and the fairness of results reporting. Ideally, these factors — not the funding source. There are lot of things which will undergo in hospital.
"Sildenafil Citrate" is obviously just trying to sell erection drugs, so normally I'd have deleted that comment, but I left it up as it gives me a chance to reinforce the main point. That blogger notes that one of the criteria that should guide assessment of the trial's validity is "fairness of results reporting"-- not funding source. That's exactly the issue. How do we know whether results are reported fairly unless we could see the trial's raw data, which no journal reader ever can? This blog is full of examples of industry-funded studies where reported results are skewed toward the marketing message, in ways the average journal reader could never find out.
We could not afford to make mistakes especially if it deals about life and how serious it is. There are certain circumstances here in our planet that we need to practice perfection even though there is no such thing like perfect, but at least strive to have it. Lesser mistakes is better.
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