The National Institute on Alcohol Abuse and Alcoholism clinical trial should be halted

The National Institute on Alcohol Abuse and Alcoholism clinical trial should be halted
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At a congressional budget hearing the National Institute of Health (NIH) director Dr. Francis Collins was questioned about an NIH clinical trial on the benefits of drinking that is being funded primarily by alcohol companies, which are contributing $68 million to this $100 million project.

 A former official of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is overseeing the study, admitted that the NIAAA actively solicited funding for the research from the alcohol industry. Dr. Collins stated that he is investigating whether there was a violation of NIH policy, which prohibits NIH officials from soliciting industry donations for research.

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However, there is another violation of NIH policy that has flown under the radar screen, but which actually represents a more significant threat to the scientific integrity of the agency.

 

According to NIH Policy Manual 1135, "the NIH is precluded from accepting a gift to support an activity that would not be conducted but for the gift and thereby reorders the programmatic priorities of the agency and diverts the use of appropriated dollars from activities with higher priorities."

There is a critical reason for this policy. If the NIH begins to accept donations from companies for research that would not otherwise be conducted, then corporations can literally set the agenda for federal research by offering funding for studies that help promote their business agendas. Instead of Congress and the executive branch determining the appropriate scope of federal health research, the nation’s corporations would literally be able to “purchase” the ability to determine the major priorities for medical and scientific research.

Imagine the tobacco industry ponying up $100 million for a clinical trial to see whether nicotine can be beneficial in the treatment of schizophrenia. Or the sugar industry generously offering to fund a study of the benefits of sugar consumption for brain health. This research may be scientifically valid, but the tobacco and sugar corporations should be required to conduct their own studies rather than to co-opt the underlying mission of NIH by essentially controlling the agency’s research agenda.

At the hearing, Dr. Collins emphasized that he is conducting an investigation to determine whether the question of whether moderate drinking has cardiovascular benefits has scientific merit. But that’s begging the question.

The question is not whether there is any merit to this research hypothesis, but whether corporations should be allowed to dictate the NIH research agenda in the first place by funding specific studies that would not otherwise fit into the agency’s research priorities in alignment with their primary mission.

As Dr. Lorraine Gunzerath —  a former senior NIAAA advisor — noted, the NIAAA’s mission is to reduce the harms caused by alcohol, not to design studies intended to produce evidence to convince doctors to recommend alcohol to their patients: “We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly.”

If this study is allowed to continue, it will set a dangerous precedent. The NIH research agenda can be bought off by the highest bidder. The only remedy for this violation of NIH policy is to halt the study.

There are two other reasons why the study should be halted. First, the investigators are hiding from the public (and from potential research subjects) that the study is being funded by alcohol companies. The study website informs the public that the research is sponsored by NIAAA, but nowhere on the site does it disclose that the alcohol industry is footing the bulk of the bill.

A key element of informed consent is that research subjects should be told who is funding the study. Because the main study web site hides the fact that the primary funders of the trial are alcohol companies, this concept of informed consent is being violated.

Second, the scientific and ethical integrity of the research have already been compromised. The principal investigator of the study has apparently lied to the New York Times, as he is quoted as stating that he “had literally no contact with anyone in the alcohol industry in the planning of this.” Yet the truth is that he pitched the trial to alcohol companies in 2014, telling them that the primary purpose for the study was to "convince clinicians, patients, and policymakers that alcohol consumption in moderation is safe and a healthy part of diet... ."

Whether consumption of a drink a day reduces cardiovascular risk is an interesting question, but it is something that the alcohol companies should be funding on their own. The NIH must not allow itself to be co-opted to promote a corporate agenda.

Dr. Michael Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He was a recipient of a grant from the NIAAA for a project to study the effects of brand-specific alcohol advertising on youth alcohol brand consumption (R01 020309 – September 20, 2011 through June 30, 2015).