A guest post in Forbes by Dr.Tom Yates, a UK-based physician, challenges the disclosure statements in two review articles on anticoagulant therapies published in the September 2011 edition of the Quarterly Journal of Medicine. Dr. Yates also seems to dismiss peer-review as a safeguard and essentially suggests that despite disclosure statements and the peer-review process, any funding by sponsors (pharmaceutical companies in this case) of authors or for editorial assistance for review articles will bias the information presented and will result in an unbalanced assessment of the therapies being evaluated. He doesn’t critique the papers or their conclusions, admitting that that he is “not an anticoagulant expert.”
In the Forbes blog published letter response to the journal, Dr. Yates’ expectations regarding conflict of interest and the potential for bias are reflected in the following statements:
“In answer to Prof Hobbs’ question , I believe it is important that clinicians are able to access review articles on this topic. However, they should be written by authors who have no financial relationship with the companies who make the products under discussion.”
I don’t believe Dr. Yates is alone in his thinking. I do wonder, however, if Dr. Yates and his like-minded colleagues have considered the practicalties of completely eliminating the potential for financial conflict of interest.
- There are few therapeutic area relevant clinical experts (not just those who are self proclaimed) who could meet his expectations for independence. As suggested in his statement above, the only people who could publish review articles are those who have never received any financial support from a pharmaceutical company that has a product in the therapeutic category being reviewed. That would have to include pharmaceutical company sponsored clinical study investigators, consultants, and advisers.
- Only clinical studies that have been independently funded (self funded, government funded, or funded by an advocacy group that accepts no pharmaceutical industry support) could be included in the publication of therapeutic reviews. To accept results from pharmaceutical industry funded studies done by investigators supported by the pharmaceutical company in a review would further propagate the conflicts of interest and biases inherent in the original publications.
- Only unconflicted, qualified authors (no potentially biasing financial support from any benefiting organization, be it pharmaceutical companies or therapeutic area advocacy group) could initiate the drafting and publishing of reviews and they would have to seek their own editorial support (including graphics and formatting) at their own personal expense.
- Peer reviewers for journals would have to be held to the same independence and conflict of interest standards as they have the potential to introduce their personal biases in their feedback and commentary during the peer review process. Perhaps then these conflicts would also have to be disclosed in the review article as well.
Here are some things to think about in the context of espousing Dr. Yates’ position:
- There are probably too few independently funded clinical studies that are large enough to adequately provide data to do a meaningful review for any therapeutic category or class of drugs.
- “… authors who have no financial relationship with the companies who make the products under discussion” probably don’t have sufficient, statistically relevant, independently funded, personally developed “controlled clinical data” to support their “independent conclusions.” Peer-review would have to eliminate any inferences or conclusions that reflect personal biases or opinions from their anecdotal clinical experience that are not supported by statistically relevant clinical data.
- As a result of points 1 and 2, very few review articles could be published. In fact, I’m not sure there has ever been a clinically helpful therapeutic class review article that is completely void of financial conflict of interest and bias as suggested by Dr. Yates.
Unfortunately, history has demonstrated that we can no longer rely on the integrity of investigators, authors, peer reviewers, and editors to assure us that the implications and conclusions in a review article are valid and were not financially influenced. Therefore, we have to depend on the disclosure statements and rigorous peer-review to mitigate the potential for financial conflict of interest and bias in scientific and medical publications.
Completely eliminating financial conflict of interest might be impossible and even if achieved has its own negative consequences. You would get reviews done by unconflicted experts who have little or no personal, controlled clinical experience with the products discussed. This being the case you really have to wonder “are the experts really experts?” Their conclusions could only be based on their personal interpretation of financially biased industry supported clinical studies, perhaps some small self funded statistically meaningless studies, or worse, their own anecdotal clinical experience. Where else would they get the data to support their conclusions?
As a result, I still believe that honest, full disclosure and rigorous peer review are better solutions than trying to completely eliminate financial conflict of interest. firstname.lastname@example.org