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14 Reasons the new NIH/industry-funded moderate alcohol & health study could be a $100 Million CREDIBILITY flop

EDITORIAL: Alcohol science versus public credibility: Why MACH15 must correct its protocol in order to be worthwhile

 

The new $100-million-dollar, government/industry-funded study on moderate alcohol consumption — first reported on by Wine Industry Insight almost three years ago and expanded upon this year by the NY Times — could set a record as one of the most flawed, least relevant, and least credible studies ever to be supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) — part of the National Institutes of Health (NIH).

 

Key Problems

  1. Healthy participants are specifically excluded.

  2. Only people with diagnosed cardiovascular conditions and risks (including previous strokes and heart attacks) are allowed.

  3. No one below the age of 50 is allowed. That minimizes the relevance to most of the population.

  4. Industry funding and previous industry support of study investigators will deal a blow to credibility

  5. The drug treatments for CVD will vary from subject to subject. No way to separate effects of alcohol consumption/abstention from CVD pharmaceuticals and treatment.

  6. Women are mistakenly treated as men for alcohol dosage.

  7. Tobacco smokers are allowed.

  8. Cannabis use is not addressed despite the fact that 24% of the test demographic are users and the health effects of combined alcohol and marijuana use is unknown.

  9. Fails to consider the effects of lifelong moderate consumption.

  10. Vague or no requirements or controls regarding time or circumstances of consumption, diet, or exercise.

  11. Industry funding offers an appearance of conflicts of interest that assures the study will not be accepted as a valid, unbiased study by a large number of the general public, along with physicians, public policy makers and regulators.

  12. Potential compliance issues with smokers or reformed smokers.

  13. No provision for test subject bias or placebo effect.

  14. The study leaves a huge amount of science undone

  15. No data sharing with outside researchers: thwarts transparency, no reproducibility, damages credibility. (Protocol on government website very recently corrected. See full text with screen capture and Principal Investigator Comments)

According to the study’s 92-page protocol filed with the NIAAA, the six-year “Moderate Alcohol and Cardiovascular Health Trial” (MACH15) (premium, annotated document), is scheduled to begin moving forward tomorrow (Dec. 1) and is designed to follow approximately 7,800 non-healthy people who have consumed at least one alcoholic beverage in the previous five years. The study is restricted to participants aged 50 years or older who have been diagnosed with cardiovascular disease (CVD) or above-average risk.

 

InclusionCriteriaMACH15

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Also In This Article:

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  • People aged 50 years and older with cardiovascular issue only —  Healthy people excluded.

  • Limited relevance: Sick people only

  • Sick people are good from a practical standpoint: They get sicker faster and die quicker (high background rate of events)

  • Study & industry funding first reported by Wine Industry Insight.

  • Industry funding delivers a credibility blow from the beginning.

  • Americans have a dim view of industry-financed studies

  • Drug and treatments regimes for CVD will vary and confound results

  • Fails to consider the effects of lifelong moderate consumption

  • Fails to recognize that men and women are not physiologically identical

  • Tobacco smokers welcome

  • Potential compliance issues with smokers or reformed smokers

  • No consideration of cannabis

  • No provision for bias or placebo effect

  • Moderate consumer subject randomization & compliance issues

  • Failure to share data with other researchers damages credibility

  • Social Interaction Effects

  • Failure to assess/correct effects of BAC and gender

  • No protocol for when or how  the “dose” is administered

  • Inadequate control and consideration of diet

  • Inadequate control and consideration of exercise

  • Study protocol wastes golden opportunity, leaves a huge amount of science on the table

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