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Francis Collins testifying before Congress in 2017

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NIH will examine whether director of alcoholism institute improperly stopped funding policy studies

An investigation into whether staff at the National Institutes of Health’s (NIH’s) alcoholism institute broke ethics rules by wooing beverage industry funding will also examine new allegations that Director George Koob later improperly declined to fund certain studies critical of industry advertising, NIH Director Francis Collins revealed after a congressional hearing today.

“We are looking into this in a very aggressive way,” Collins said in response to questions raised about the National Institute on Alcohol Abuse and Alcoholism (NIAAA) at a hearing before the House of Representatives spending panel that oversees NIH’s budget. Collins later told ScienceInsider that the scope of these reviews will go beyond what had previously been announced: “We’re looking at the whole spectrum, going back to before Dr. Koob came when there were questions about how this interaction with the beverage industry happened, going right up to the present.”

Since last year, NIAAA in Bethesda, Maryland, has been embroiled in controversy over a study funded largely with $70 million from the beverage industry. It will enroll 7800 volunteers and follow their health for years to determine whether one drink a day has health benefits. Last month, The New York Times reported that two NIAAA officials met with beverage industry officials in late 2013 and early 2014 to urge them to support such a study by directing funding through a nonprofit called the Foundation for the NIH. That is an apparent violation of a policy that bars NIH staff from soliciting contributions to NIH.

Collins soon announced two reviews: the NIH Office of Management Assessment (OMA) would look at whether NIH employees broke ethics rules, and a working group of his Advisory Committee to the Director (ACD) would review the scientific merits of the study.

The controversy has since escalated. Last week, STAT reported that after becoming NIAAA director in 2014, Koob summoned to his office two investigators with an NIAAA grant to study the impact of alcohol advertising on underage drinking to tell them he didn’t support their work. In an email quoted in STAT’s story, Koob told an industry official that NIAAA would no longer fund these kinds of studies. One of the researchers later submitted a proposal for a similar study that was not funded, despite receiving a high score from peer reviewers.

In another article, STAT documented a decline in grants on alcohol advertising since Koob came to NIAAA.

At today’s hearing, Representative Lucille Roybal-Allard (D–CA) brought up the controversy over the moderate drinking study and called the reports that Koob halted the studies of advertising and underage drinking “even more disturbing.”

“I’m also very concerned,” Collins replied and described the working group’s planned review of the moderate drinking study’s scientific merits. Although some researchers argue there is evidence that one drink a day can have cardiovascular benefits, suggesting the study is “useful and appropriate,” Collins noted “others are quite concerned about what this might say in terms of NIH’s stance about a substance, namely alcohol, that is clearly capable of doing a lot of harm.”

The OMA review of whether employees broke ethics rules will pass along “anything we find that seems truly inappropriate” to the Department of Health and Human Services’s inspector general, Collins added.

The moderate drinking study is already enrolling volunteers, which is adding urgency to the probes, Collins added later while talking to reporters. The project could be stopped “if the working group says that it’s flawed,” Collins says.

He said the two reviews have also been “extended” to look at Koob’s apparent decision to fund fewer studies of alcohol advertising. At any NIH institute, a director deciding to give less attention to studies in one area and more to other areas “isn’t unusual,” he said. “It’s their responsibility to decide what are the priorities for research.” In Koob’s case, he added, “The question is: What was the context, was there a conflict of interest?”

The working group will also look at the process that resulted in the grant for the study of moderate drinking going to an investigator who was also part of the funding discussions with the beverage industry. “We're leaving no stone unturned here to see if anything is irregular,” Collins said.

The working group will deliver its report at the 14–15 June meeting of the ACD. The OMA review will likely take longer, NIH officials say.