Outrage of the Month: Scathing Internal Report Finds Serious Misconduct That Undermined the Integrity of NIH Alcohol Study

Health Letter, July 2018

By Michael Carome, M.D.

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On June 15, the National Institutes of Health (NIH) released a scathing report that detailed serious misconduct by senior officials at the National Institute on Alcohol Abuse and Alcoholism (NIAAA) who orchestrated an intensive campaign to obtain funding from the alcoholic beverage industry for a $100 million clinical trial that was intended to assess the cardiovascular health effects of moderate alcohol consumption in nearly 8,000 people around the world.

The report — which was authored by a working group of the NIH Advisory Committee to the Director, Dr. Francis Collins — concluded that the “nature of the engagement with [alcohol] industry representatives…casts doubt that the scientific knowledge gained from the study would be actionable or believable.” The working group therefore recommended that the NIAAA-sponsored alcohol study be terminated. Within minutes of the advisory committee endorsing the working group’s recommendation at its June 15 meeting, the NIH announced that it was ending funding for the study because of “concerns about the study design that cast doubt on its ultimate credibility.”

On July 3, 2017, the New York Times (The Times) first reported the troubling revelation that five of the world’s largest alcoholic beverage manufacturers — Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg — had pledged at least $68 million to the Foundation for the National Institutes of Health to fund the planned 10-year alcohol study, which was called the “Moderate Alcohol and Cardiovascular Health Trial.”

According to The Times, Dr. Kenneth Mukamal, the lead researcher for the study, denied being aware that alcohol companies were supporting the trial financially. In fact, he was quoted by The Times as having said, “We have had literally no contact with anyone in the alcohol industry in the planning of this.” But that claim is belied by subsequent investigative reporting by The Times and by the working group report of the NIH Advisory Committee to the Director.

Based on documents — including emails and travel vouchers — obtained from the NIH under the Freedom of Information Act and interviews with former NIH officials, The Times reported on March 17, 2018, that university-based scientists, including Dr. Mukamal, and senior NIAAA officials waged a concerted campaign to solicit funding from the alcoholic beverage companies for the alcohol study and paid “for scientists to travel to meetings with [alcohol industry] executives, where they gave talks strongly suggesting that the study’s results would endorse moderate drinking as healthy.” Such solicitations of donations from private industry are explicitly prohibited by long-standing NIH policies.

On March 19, Public Citizen called on the U.S. Department of Health and Human Services (HHS) Inspector General (IG) to conduct an independent investigation of the conduct of those NIH officials. On April 11, Public Citizen and 13 other consumer-advocacy, science and public-health groups also urged HHS Secretary Alex Azar to request an IG investigation into this matter.

The June 2018 NIH working group report disclosed new disturbing details about the lengths to which Dr. Mukamal and senior NIAAA officials went to promote the study to alcohol industry executives in order to secure funding from them. The report documented frequent email exchanges between NIAAA senior officials; university-based researchers, including Dr. Mukamal; and alcohol industry representatives, which appear to indicate attempts to persuade the industry to fund the study while it was being planned and before NIH solicited grant applications from university-based researchers to carry out the study.

In one series of emails between NIAAA senior staff, Dr. Mukamal and the International Center for Alcohol Policies (IACP) — a nonprofit group sponsored by alcohol producers — Dr. Mukamal provided responses to address “methodological issues” about the alcohol study that had been raised by Diageo; Anheuser-Busch InBev; the Distilled Spirits Council, the leading alcohol industry trade group; and IACP. According to the working group report, these and other interactions between NIAAA senior officials, Dr. Mukamal and alcohol industry representatives “would undermine the perception of study objectivity and would call into question any potential findings that may show a beneficial effect of moderate drinking on cardiovascular health.”

The senior NIAAA officials engaged in these efforts appear to have been fully aware that soliciting donations for the study from industry was prohibited. For example, one of them wrote the following in an email to another agency colleague:

I really am very concerned about anything being presented to industry from NIAAA directly. That could constitute “solicitation” of a gift, which we absolutely cannot do. …We have to be very careful not to be seen as driving this process.

Moreover, the same senior NIAAA staff appear to have deliberately kept other key NIAAA staff in the dark about their efforts to solicit industry funding.

Importantly, Dr. Collins selected the members of the working group that investigated the allegations regarding the alcohol study and appointed his deputy to be chair of the group. In addition, the NIH Office of Management Assessment, which conducted a separate internal investigation into these allegations and “determined that a small number of NIAAA employees violated NIH policies in soliciting gift funding and circumvented standard operating procedures designed to ensure a fair competition for NIH funding,” is a component of the NIH Office of the Director, and reports directly to Dr. Collins.

The shocking revelations about senior NIH officials orchestrating an aggressive campaign to solicit such industry funding for the alcohol study still require an independent investigation by the HHS IG. These disclosures severely damaged public trust in the NIH. Restoring that trust and holding all culpable NIH officials accountable can be accomplished only by such an investigation.

The NIH has conflicts of interest that preclude a thorough and unbiased internal investigation into this matter. Among the still-unanswered key questions are whether anyone within the NIH Office of the Director was aware of, or played a significant role in, the alleged campaign to solicit industry funding for the alcohol study and whether any similar misconduct has occurred for other NIH research studies. The HHS IG must seek the answers to these questions.

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