Tag: National Institutes of Health

  • Controversial "Moderate Drinking" Study Shut Down By Officials

    Controversial "Moderate Drinking" Study Shut Down By Officials

    The news comes on the heels of Anheuser Busch’s decision to pull millions in funding from the study. 

    A highly controversial National Institutes of Health study is no longer in the works, NIH director Francis Collins announced Friday, June 15. 

    According to STAT News, Collins said the $100 million study would be shut down after a task force discovered “severe ethical and scientific lapses in the study’s planning and execution.” 

    The study, which would examine the possible health benefits of consuming one daily drink, had been in the headlines after a New York Times investigation revealed that the federal agency had courted the alcohol industry for funding, leading to concerns that the results could be skewed.

    Recently, Anheuser Busch decided to pull its own funding out of the study.

    STAT News reported that the task force found that the manner in which the NIH funded the research “casts doubt” as to whether “the scientific knowledge gained from the study would be actionable or believable.”

    The task force also found that beginning in 2013, “there was early and frequent engagement” between NIH officials and those in the alcohol industry. These communications, the task force stated, seemed to be “an attempt to persuade industry to support the project. Several members of NIAAA (National Institute on Alcohol Abuse and Alcoholism) staff kept key facts hidden from other institute staff members.” 

    Michael Siegel, public health scientist of Boston University, says the decision to end the study was the right one.

    “NIAAA undermined its own scientific integrity by soliciting and accepting alcohol industry funding to study the health ‘benefits’ of alcohol,” he told STAT News.  

    The study raised ethical concerns in part due to how it solicited its funding. The New York Times investigation revealed that in 2014, the scientists involved in the study went as far as to tell executives in the alcohol industry that the study “represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases.”

    The Times also reported that they told officials that the study would supply a “level of evidence [that] is necessary if alcohol is to be recommended as part of a healthy diet.”

    Aside from ethical concerns, the study was also found to have other flaws. According to STAT News, the group looking into it found that it didn’t have enough patients and the follow-up time was not sufficient, meaning “the trial could show benefits while missing harms.” 

    Before the study was shut down, 105 participants had enrolled and $4 million had already been spent. 

    Dr. Kenneth Mukamal of Beth Israel Deaconess Medical Center was to lead the study. In a statement, the medical center said it is “deeply committed to ensuring the scientific and ethical integrity of any research study involving our investigators.”

    The statement also noted that Dr. Mukamal “is an experienced researcher who has led dozens of important studies over his career. We take the working group’s findings very seriously and will review the report carefully.”

    View the original article at thefix.com

  • Anheuser Busch Pulls Out Of Federal Drinking Moderation Study

    Anheuser Busch Pulls Out Of Federal Drinking Moderation Study

    The alcohol company was set to contribute $15.4 million over a 10-year period for the study.

    One major backer of a $100 million federal study related to alcohol consumption has pulled out due to surrounding controversy. 

    According to the New York Times, Anheuser-Busch InBev, a Belgian-Brazilian brewing company, was to be one of five alcohol companies financially backing the study, which plans to examine the health benefits of consuming one daily drink. 

    But on Friday, June 8, Anheuser-Busch InBev announced it would be withdrawing funding due to controversy around the study and the sponsorship. The company stated that the controversy would “undermine the study’s credibility,” according to the Times.

    The announcement came via a letter to Dr. Maria C. Freire, who serves as the president and executive director of the Foundation for the National Institutes of Health.

    According to the Times, the Foundation for the National Institutes of Health is “a nongovernmental entity that is authorized to raise money from the private sector for NIH (National Institutes of Health) initiatives and manages the institutes’ public-private partnerships.”

    In May, the NIH discontinued enrollment for the study due to reports that officials and scientists from the NIH met with alcohol companies to seek out funding and gave the impression that the study outcome would support moderate drinking habits. 

    Nearly 25% of the funding for the study had been contributed by Anheuser-Busch InBev, the Times reports. Of the $66 million in funding, the company was contributing $15.4 million in payments over a 10-year period, beginning three years ago.  

    Andrés Peñate, global vice president for regulatory and public policy for Anheuser-Busch InBev, stated in the letter that the company had initially decided to fund the study “because we believed it would yield valuable, science-based insights into the health effects of moderate drinking.”

    He continued, “We had no role in the design or execution of this research; stringent firewalls were put in place with the Foundation for National Institutes of Health to safeguard the objectivity and independence of the science.”

    The letter concluded, “Unfortunately, recent questions raised around the study could undermine its lasting credibility, which is why we have decided to end our funding.”

    The study is expected to examine the potential effects of moderate drinking such as reducing risk of heart disease, diabetes and cognitive impairment. It is seeking out participation from 7,800 men and women with a high risk of heart disease.

    During the study, half the group will be asked to not drink alcohol and the other half will be asked to have a single drink every day of the week. Participants would be followed for an average of six years. 

    View the original article at thefix.com