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ResourcesHuman Research EthicsA Major Industry-Funded Alcohol Study Was Compromised. How Many Others Are Out There? – UnDark (Jeremy Samuel Faust | July 2018)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

A Major Industry-Funded Alcohol Study Was Compromised. How Many Others Are Out There? – UnDark (Jeremy Samuel Faust | July 2018)

Published/Released on July 13, 2018 | Posted by Admin on October 2, 2018 / , , , , ,
 


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The most salient takeaway from the collapse of the MACH15 trial is that the conflicts of interest at its core are probably not as rare as we think.

LAST YEAR, the National Institute on Alcohol Abuse and Alcoholism, part of the federal National Institutes of Health, laid out plans for what is a rarity in the realm of public health: a high quality clinical trial. The “Moderate Alcohol and Cardiovascular Health Trial,” known as MACH15, was to be randomized so that some subjects would be selected to drink and some would not. It would follow participants “prospectively,” over time, not retrospectively. And in the end, the results were to be adjudicated by evaluators blinded to which subjects had been instructed to drink and which to abstain. The goal was an assessment of the effect of alcohol consumption on cardiovascular health.

This discussion piece highlights how unmanaged conflicts of interest can easily creep into work, even when it’s a banner project of a peak research funding and oversight body. Taken in retrospect you might wonder how they couldn’t see the mistakes they were making and how inevitable the consequences were, but it’s a ‘good’ case for highlighting that even enthusiastic correspondence can slide into a compromised space.

But last month, the National Institutes of Health took the unusual step of shutting down one of its own clinical trials — a $100 million dollar experiment gone wrong. The announcement followed an internal investigation, prompted by a dogged New York Times report, that uncovered inappropriate interactions between the alcohol industry (Anheuser-Busch InBev, Heineken, and others) and the NIAAA in the execution of MACH15.
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By law, federal health agencies can receive funding from for-profit industry. But direct courting of funding, coordination, and collaboration on research design, and excessive communications are not permitted, and according to The Times and the findings of the NIH’s subsequent internal investigation, these violations occurred early and often during the development of the MACH15 trial. The NIH report concluded that the actions uncovered “calls into question the impartiality of the process and thus casts doubt that the scientific knowledge gained from the study would be actionable or believable.”
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Read the rest of this discussion piece



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