Sunday, December 6, 2009

Peeling the onion of financial conflicts of interest - Publishing research


Financial conflicts of interest in research bias towards results, conclusions and recommendations that favour the interests of the sources of the money.  Even though those receiving the money or financial support for their projects 

{Photo Credit - Darwin Bell}
always claim theywere not biased, abundant hard evidence shows just the contrary.

Knowing this, health sciences journals have played a leading role in helping to reveal the conflicts: Initially by providing general guidance for authors about disclosure and then, when that didn’t work, by asking explicit questions about financial relationships with individuals or institutions that might benefit or lose or otherwise be affected by the research, review or opinions expressed.  Editors hoped (without any evidence and indeed with little probability) that published revelations would help readers detect biases or at least increase levels of skepticism.

There have been, however multiple loopholes in the process of revealing and reporting conflict of interest the least of which was addressed by a recent proclamation of the prestigious International Committee of Medical Journal Editors (ICMJE).<1> 

Many authors claimed not to know that their relationship with such and such an institution, company, product or patent etc., was a financial one and therefore did not disclose it. Or they believed they needed to reveal the relationship only if they thought it influenced their research. The most recent ICMJE remedy is a set of definitions of what constitutes a financial conflict of interest along with a prototype for reporting such conflicts.

This timid step is not entirely unhelpful. We should see more honest reporting of the type that Author X owns shares in company Y making product Z that is mentioned in their research, review or commentary.  Medical journals, scarred by multiple humiliations of failure to detect and report authors with financial conflicts of interest to their readers ought to have an easier time of it. Their journals will be less likely to hear, after publication, that a particular author failed to understand that he or she had an unreported conflict of interest.

But will this help the readers, patients or other researchers? Knowing that authors of published research have conflicted financial relationships does not mean that the research is flawed. So how should we, the readers,  interpret such statements as;  author X’s study was funded by company Y or that author X, writing a commentary in a journal, receives speaker fees from company Y?  Given that research, reviews and commentary articles by authors with financial conflicts are more likely to be biased does not explain how these conflicts get translated into results, opinions and conclusions and from there to influencing the reader, often a prescribing physician.

For research articles, which form the basis of knew knowledge, this is especially important. Readers and journal editors need to know more about financial relationships between researchers and their sponsors: Not just that they exist.

We know many of the mechanisms embedded in financial conflicts of interest that result in biased studies and biased study reporting in journals.  The recent revelations made public in the class action law suit pitting Pfizer Inc., the maker of Neurontin (gabapentin), against patients who received the drug show that financial conflicts influence and are directly related to  biases in study design, analysis, interpretation, write-up and publication of research. (an in depth review of some of this is here) A summary article of part of the problem was recently published. (article here)<2> 

The law suit and discovery documents associated with it reveal the many ways that researchers lose control of their studies by relinquishing study design, execution, data collection and analysis, interpretation and even writing up of the study and subsequent publication to company sponsors of the research.

We and others have found that in random samples of researchers these sources of real bias are highly prevalent. For example in our study (in press)  only 11% of over 700 Canadian investigators of randomized trials registered in the clinical trials data base had control over 11 key aspects of their research: study design, data collection, analysis, writing up their papers, deciding when and were to publish and so on. (abstract here - then dig into program abstracts) <3> Most had very little control over multiple aspects of the research.

It is important, that ICMJE and journal editors further peel the onion of financial conflict of interest. In situations where there are declared conflicts of interest authors need to report and journals publish details of the research sponsors' roles in the research and in the write up of the manuscript and decision to publish. Editors need to know who had ultimate responsibility for study design, data collection, analysis, write-up and decision to publish.

Some will argue that supplying such detail is unnecessary, time consuming and bureaucratic. These same individuals will also argue that although they may have competing financial interests, these are not conflicts and their presence did not (and does not) influence their integrity as researchers; contrary, however, to a widening body of research that proves the opposite.

Certainly supplying more detail on the relationships between researchers and sponsors will require additional effort and a bit of time. The process can be simplified. In our work, led by Dr. Paula Rochon at the University of Toronto, we have designed an easily-used electronic reporting template that takes about 10 minutes to complete. The ICMJE should consider adopting this template. For randomized controlled trials, trial registries should insist that these key aspects of human research be revealed when studies are first registered. The financial conflicts could be published along with the other aspects of trial design and recruitment.  Research ethics boards should not approve research on human subjects that is shackled by sponsor control over critical aspects of the research. REBs should have ready access to detailed information on conflict of interest and its effects on research they are evaluating. 

The Canadian Institutes of Heath Research (CIHR) is expected to  adopted a checklist based on the one we developed for use in their grant proposal evaluations.  We urge ICMJE and clinical trials registries to push harder at conflict of interest and adopt a similar template as well.  Fuller disclosure can only be helpful.

1.Drazen JL et al.  Uniform format for disclosure of competing interests in ICMJE journals. N Engl J Med 2009;361:1896-7 (full text here)

2. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label ues. N Engl J Med 2009;361(20):1963=71 (free abstract here)

3. Investigator Experiences With Financial Conflicts of Interest in Clinical Trials. Paula A. Rochon, Melanie Sekeres, John Hoey, Joel Lexchin, Lorraine E. Ferris, David Moher, Wei Wu, Sunila R. Kalkar, Marleen Van Laethem, Andrea Gruneir, Jennifer Gold, M. James Maskalyk, David L. Streiner, An-Wen Chan. Peer Review Congress, Vancouver, 2009 (full abstract here - pdf of conference abstracts)

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