Sunday, April 08, 2018

Principal Investigator of Alcohol Clinical Trial is Hiding its Industry Funding from the Public and Potential Research Subjects

I have already explained why I think the Moderate Alcohol and Cardiovascular Health (MACH15) clinical trial should be immediately halted because of both scientific and ethical breaches in the way the research was planned. Today, I reveal what I believe is misconduct in the actual conduct of the trial: namely, in the communication of the research sponsors to the public.

I believe that the public -- and especially research subjects -- have the right to know who is funding a clinical trial that is seeking their participation. In fact, there are rules requiring the sponsors of such studies to be revealed to the public. However, I believe the MACH15 study is violating these principles by hiding its true sponsors from the public.

The Rest of the Story

On the study web site, the study sponsor is reported as being the "National Institute on Alcohol Abuse and Alcoholism (NIAAA)." However, nowhere on the site does it disclose that the real sponsor behind the research are alcohol companies, which have ponied up to cover two-thirds of the cost of the entire research project. The alcohol money is being funneled through a "middle man" (the NIH Foundation) on its way to NIAAA, but the source of the money is clear: this is an alcohol industry-funded study. In violation of ethical principles for the conduct of research, this critical information is not being disclosed to the public on the project web site.

Therefore, I am calling both the Department of Health and Human Services (through the Inspector General) and Congressional oversight committees to require the study researchers to disclose to the public and potential participants that this study is being funded by the alcohol industry.

This is too reminiscent of the unethical behavior of tobacco-funded researchers in the past who failed to disclose the industry funding of their research. In fact, it was this behavior that contributed heavily to the implementation of conflict of interest disclosure rules.

The rest of the story is that the principal investigator of the MACH15 trial is hiding from the public the fact that this is an industry-funded study. I believe the trial should be halted, but if it is allowed to continue, the researchers should be forced to disclose the industry funding to the public and to any potential research participants.

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