The Honorable Alex M. Azar II
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
RE: NIH Officials Allegedly Violated the Agency’s Policy by Soliciting Donations from
Alcoholic Beverage Manufacturers to Fund Study on Health Effects of Moderate Alcohol
Consumption
Dear Secretary Azar:
The undersigned consumer advocacy, science, and public health organizations respectfully urge
you to request that the Department of Health and Human Services (HHS) Inspector General
immediately launch a formal investigation into the conduct of National Institutes of Health
(NIH) officials who, according to an article published by The New York Times (The Times) on
March 17,[1] were directly involved in soliciting donations from alcoholic beverage manufacturers
to fund a $100 million study that is intended to assess the cardiovascular health effects of
moderate alcohol consumption. The conduct described by The Times, if confirmed, represents a
serious violation of the NIH’s policy prohibiting solicitations of gifts by NIH employees and
clearly undermines public trust in the integrity of the study and in the NIH.
The NIH study in question — the “Moderate Alcohol and Cardiovascular Health Trial” — is a
randomized trial comparing the effects of consuming one standard serving of alcohol daily with
alcohol abstention on the risk of cardiovascular disease, diabetes, and death among 7,800 adults
age 50 or older worldwide.[2]
On July 3, 2017, 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 $67.7 million to the Foundation for the National Institutes
of Health to fund the alcohol study.3 According to the July 3, 2017, article, the lead researcher
for the alcohol study claimed he was not aware that alcohol companies were supporting the trial
financially. He also 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.”
However, 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 that university-based scientists, including the alcohol study’s lead
researcher, and senior National Institute on Alcohol Abuse and Alcoholism (NIAAA) officials
“waged a concerted campaign to obtain funding from the alcohol industry” 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.”[4]
Importantly, section 1135 (Gifts Administration) of the NIH Policy Manual, which was last
updated on October 5, 2011, explicitly “prohibits employees, either directly or through another
party, from requesting or suggesting donations to the NIH or to any of its components, of funds
or other resources intended to support activities.”[5]
Moreover, according to The Times, the NIAAA signed an agreement with the Foundation for the
National Institutes of Health (FNIH) for the alcohol study “that said, ‘Under no circumstances
shall [NIAAA] or its representatives communicate directly with any Donor in order to raise
funds for the project or to disclose to any Donor any information’ about ‘the name and affiliation
of the awardee’ or ‘details and information relevant to the award.’”[6]
According to The Washington Post (The Post), on March 20, NIH Director Dr. Francis Collins
announced at an unrelated briefing to reporters that he had assigned a group of advisers to
examine whether any improprieties were committed with respect to the alcohol study.[7]
In a letter to the editor published by The Post on March 30, NIH Principal Deputy Director Dr. Lawrence
Tabak clarified that the Office of Management Assessment — a component of the NIH Office of
the Director — will be conducting an internal investigation into “any process irregularities in the
identification of funding sources” for the alcohol study.[8]
Such an internal NIH investigation into the allegations of serious misconduct by senior agency
officials cannot be credible. Indeed, among the key unanswered questions is whether anyone
within the NIH Office of the Director was aware of this campaign or played a significant role in
the alleged solicitation of industry funds. There is ample reason to be concerned about the
involvement of the NIH Office of the Director in this matter: According to The Times, the
“request for collaboration” from NIAAA, which initiated the process of obtaining funding from the alcohol industry through the FNIH, was submitted to a joint NIH-FNIH steering committee,
which is based in the NIH Office of the Director.[9]
Thus, the NIH, especially in light of what is already known, has conflicts of interest that would
preclude a thorough and unbiased internal investigation into this matter.
An independent investigation by the HHS Inspector General is necessary to ensure public
confidence in the integrity of the investigation and that all culpable NIH officials are held
accountable.
Thank you for your prompt attention to this important matter.
Sincerely,
Public Citizen
Annie Appleseed Project
Campaign for a Commercial-Free Childhood
Center for Science in the Public Interest
Franciscan Action Network
Government Accountability Project
Jacobs Institute of Women’s Health
National Center for Health Research
National Women’s Health Network
PharmedOut, Georgetown University Medical Center
Project On Government Oversight
Union of Concerned Scientists
US Alcohol Policy Alliance
Woodymatters
cc: The Honorable Francis S. Collins, M.D., Ph.D., Director, National Institutes of Health
References:
1. Rabin RC. Federal agency courted alcohol industry to fund study on benefits of moderate drinking. March 17,
2018. New York Times. https://nyti.ms/2GAG6Xi. Accessed April 9, 2018.
2. National Institutes of Health. NIH Research Portfolio Online Reporting Tools (RePORT). Project information:
1U10AA025286-01. https://projectreporter.nih.gov/project_info_description.cfm?aid=9197811&icde=38618230.
Accessed April 9, 2018.
3. Rabin RC. Is alcohol good for you? An industry-backed study seeks answers. July 3, 2017. The New York Times.
https://nyti.ms/2uDkXEF. Accessed April 9, 2018.
4. Rabin RC. Federal agency courted alcohol industry to fund study on benefits of moderate drinking. March 17,
2018. The New York Times. https://nyti.ms/2GAG6Xi. Accessed April 9, 2018.
5. National Institutes of Health, Office of Management. NIH Policy Manual: 1135 – Gifts Administration. October 5,
2011. https://policymanual.nih.gov/1135#F20C5206. Accessed April 9, 2018.
6. Rabin RC. Federal agency courted alcohol industry to fund study on benefits of moderate drinking. March 17,
2018. The New York Times. https://nyti.ms/2GAG6Xi. Accessed April 9, 2018.
7. Goldstein A. NIH will examine ethics of its study on the health effects of a daily glass of wine. April 3, 2018. The Washington Post. https://www.washingtonpost.com/national/health-science/nih-will-examine-ethics-of-its-study-on-the-health-effects-of-a-daily-glass-of-wine/2018/03/20/db8f2806-2c78-11e8-b0b0-f706877db618_story.html?utm_term=.6c21902753e1. Accessed April 9, 2018.
8. Tabak LA. The NIH is taking its liquor investigation completely seriously. March 30, 2018. The Washington Post. https://www.washingtonpost.com/opinions/the-nih-is-taking-its-liquor-investigation-completely-seriously/2018/03/29/99d7cd68-32cd-11e8-b6bd-0084a1666987_story.html?utm_term=.0f955b8801c1. Accessed April 9, 2018.
9. Rabin RC. Federal agency courted alcohol industry to fund study on benefits of moderate drinking. March 17,