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.
The methodologic problems of the MACH15 trial’s design are considerable. How the outcome measures ever passed muster defies logic.
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.
Here’s how it was supposed to have worked: Volunteers aged 50 or older with either substantial cardiac risk factors or existing heart disease were to have been randomly assigned to either abstain from alcohol completely or to consume precisely one alcoholic beverage per day. They were then to be monitored for cardiovascular health. Investigators were interested in whether the patients assigned one drink per day were more, less, or equally likely to experience a heart attack, stroke, or even die in just six years? This was primary goal of the MACH15 trial.
In essence, the NIH was making a $100 million gamble that volunteers would portray their alcohol consumption accurately.
That’s not where the problems ended. In their report, the NIH investigators said they had found that the trial was apparently set up to lean towards “demonstrating a beneficial health effect of moderate alcohol consumption,” and that it was exceedingly unlikely to find that alcohol was harmful, because the trial design ignored some of alcohol’s most notable long-term risks, including cancer and congestive heart failure — the latter of which is linked to alcohol consumption. The eventual study would have under-reported cancer risks simply because, at six years, the trial was too short for those dangers to have caught up to patients who drink. But neglecting to include heart failure as an outcome of interest in a trial assessing cardiovascular health of alcohol is a far more flagrant oversight — akin, perhaps, to a study assessing the health risks of sugar intake in which researchers failed to ask whether patients developed diabetes. How the outcome measures of MACH15 ever passed muster defies logic, but in a statement attributed to Dr. Kenneth Mukamal, the study’s principal investigator, and supplied by his hospital’s public affairs office, he said the protocol was approved by “three external scientific panels and by ten institutional review board.”
“Most trials undertaken today are destined to produce a certain conclusion through designs that are manipulated just enough to almost guarantee a result without losing their integrity.”
Perhaps what sets MACH15 apart is not what it did, but who did it. The alcohol industry, while powerful, is far less experienced in the realm of biomedical research than large pharmaceutical companies who perhaps, by now, know just how to expertly game the research system without breaking the rules outright. Alternatively, it might be that alcohol itself is expected to play by a different set of rules than other would-be medicinal compounds. “Alcohol was never meant to necessarily benefit people, unlike medications,” wrote Florence Bourgeois, an assistant professor of pediatrics and emergency medicine at Harvard Medical School and a faculty member at Boston Children’s Hospital, in an email. “With drugs, pharma can justify their trials and marketing as an attempt to help people in need of medical breakthroughs. But alcohol is generally perceived as harmful to our society, so attempting to promote it on the false grounds of having health benefits doesn’t go over well in the lay media.”
For complete article cited 30/7/18
There are around 38 domestic assaults reported across New South Wales on State of Origin game days.
June 2018 BuzzFeed News
There is a 40.7% average increase in domestic violence and 71.8% increase in non-domestic assaults across New South Wales on State of Origin game days, research released today by the Centre for Alcohol Policy Research (CAPR) at La Trobe University found.
Fans enjoy the pre-match fireworks during Game 1 of the 2018 State of Origin series at the MCG in Melbourne, Wednesday June 6, 2018.
“In the 12-hour window from 6pm to 6am on State of Origin game night, women and children in NSW are almost 40% more likely to become victims of domestic violence," the centre's deputy director Dr Michael Livingston said.
“When we compare those findings with Victoria, a state with less interest in rugby league, the data reveals no statistically significant increase in violent assaults on the dates in question."
Researchers map out a cellular mechanism that offers a biological explanation for alcoholism, and could lead to treatments
You can lead a lab rat to sugar water, but you can’t make him drink—especially if there’s booze around.
New research published Thursday in Science may offer insights into why some humans who drink alcohol develop an addiction whereas most do not. After caffeine, alcohol is the most commonly consumed psychoactive substance in the world. For the majority of people the occasional happy hour beer or Bloody Mary brunch is where it stops. Yet we all know that others will drink compulsively, despite whatever consequence or darkness it brings.
Tom Hardy, who receives a CBE for services to drama, made his name on the big screen with a series of hard man roles.
The 40-year-old actor is known for Inception, Mad Max: Fury Road, Bronson and The Revenant.
The privately-educated star has spoken about how he went off the rails and suffered from alcohol addiction in his youth.
Hardy checked himself into rehab in 2003 and has been clean ever since.
“I went in thinking I’d do it for a little bit until I can go out and drink and people forgive me. But I did my 28 days, and after listening to people who had been through similar circumstances I realised I did have a problem,”
Author: Mark Gold, MD May 2018
Supplying alcohol to their adolescent children is not associated with any reduction of harm. Quite the opposite—parents who allow and support adolescent drinking actually increased their risk of incurring alcohol-related harm. Further, the myth that parental supply of alcohol, or supervision of alcohol consumption will teach adolescents how to drink responsibly is just that—a myth.
Recently, Mattick, et al, conducted a prospective study using data culled from the Australian Parental Supply of Alcohol Longitudinal Study of adolescents to examine correlations between parental supply of alcohol and subsequent drinking outcomes over the 6-year period of adolescence. Children in grade seven and their parents were recruited and surveyed annually. In total, 1927 eligible parents and adolescents were recruited by June of 2011 and were followed until 2016.
The researchers found that the odds of subsequent binge consumption, alcohol-related harm and symptoms of alcohol-use disorder were increased for adolescents who were supplied alcohol only by parents (odds ratios, 2.58, 2.53, and 2.51, respectively) when compared with parents who did not supply alcohol to their children.
In this prospective study, associations between both parental supply of alcohol and supply from other sources, and after adjusting for known covariates, revealed pattern of harm associated with parental supply. By the sixth follow-up (mean age 17·8 years), parental supply of alcohol was found to be associated with binge drinking, alcohol-related harm, and symptoms of alcohol use disorder. The findings also revealed that parental supply not only increases adverse outcomes itself, it also risks increasing obtaining alcohol from other non-parental sources.
Plainly stated, there is no evidence to support the view that parents who supply alcohol to their teens protect them from adverse drinking outcomes. The authors write. “Parents should be advised that this practice is associated with risk, both directly and indirectly through increased access to alcohol from other sources.”