In 2018, a $100 million clinical trial on how ‘moderate’ alcohol use affects health was cancelled in the US. This was because it was found to be biased towards producing findings that small amounts of alcohol have health benefits. The trial was paid for by both the alcohol industry and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the self-described largest funder of alcohol research globally.
NIAAA leaders have had extensive contacts with alcohol companies, trade associations, and so-called social aspects organizations since 2013. A wide range of highly policy-relevant scientific issues sat at the center of the discussions in email correspondence and telephone and in-person meetings. Four NIAAA senior leaders, including the current Director, and eight other leaders were identified as being involved.
This study suggests that there is an urgent need to better understand the nature and extent of this problem, both within and beyond NIAAA. This includes NIAAA (and industry) interactions with other public bodies, including other federal agencies in the United States, and internationally (e.g., with WHO).

Author

Gemma Mitchell (E-amil: ) and Jim McCambridge

Citation

Mitchell G, McCambridge J. Interactions Between the U.S. National Institute on Alcohol Abuse and Alcoholism and the Alcohol Industry: Evidence From Email Correspondence 2013-2020. J Stud Alcohol Drugs. 2023 Jan;84(1):11-26. doi: 10.15288/jsad.22-00184. PMID: 36799670.


Source
Journal of Studies on Alcohol and Drugs, 84(1), 11–26 (2023)
Release date
19/02/2023

Interactions Between the U.S. National Institute on Alcohol Abuse and Alcoholism and the Alcohol Industry: Evidence From Email Correspondence 2013–2020

Research article

Background

In 2018, a $100 million clinical trial on how ‘moderate’ drinking affects health was cancelled in the US. This was because it was found to be biased towards producing findings that small amounts of alcohol have health benefits, writes Dr Gemma Mitchell in a blog post for the IAS. The trial was paid for by both the alcohol industry and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the self-described largest funder of alcohol research globally. Researchers, industry, and NIAAA officials were found to have worked together to produce this biased trial. If successful, it could have influenced millions of people across the globe to think (wrongly) that good quality science was telling them to drink alcohol for the sake of their health.

This scandal received wide public attention and scrutiny. And it promoted the study that is subject of this Science Digest.

What the researchers did

The researchers sent two Freedom of Information Act requests in 2020 and 2021 to the National Institutes of Health, the parent organisation of the NIAAA. They scientifically analysed the 4784 pages of email correspondence (including attachments) they had received as a result.

What the study found

The study found 43 NIAAA officials interacting with 15 alcohol industry groups between 2013-2020.

  • NIAAA leaders gave the alcohol industry lots of information about science and policy developments.
  • Discussions took place by email, telephone, and in-person.
  • They discussed a lot of different topics, including the US and UK dietary guidelines, which include advice on alcohol.
15
Privileged access for Big Alcohol
43 NIAAA officials interacted with 15 alcohol industry groups between 2013-2020 – giving privileged access to multiple scientific projects of public concern.

Industry interest in the US and UK dietary guidelines

All requests by an alcohol industry trade organisation to discuss the US dietary guidelines with NIAAA leaders were granted, with that trade organisation then involving other industry groups in the discussions. A key concern from this trade association was the standard alcoholic drink model used in the US guidelines, and they tried to build ‘consensus’ with NIAAA leaders on the issue.

A NIAAA senior leader also attended a trade association Annual Meeting and took part in a panel titled ‘Commercial Impact of Health Policy: Dietary Guidelines, Labeling Facts and What Makes Beer Distinct’.

Between 2013 and 2017, a separate alcohol company representative expressed concern with a NIAAA senior leader about both the US and UK Dietary Guidelines. The company was against the removal of content in the US dietary guidelines on alcohol being part of a healthy diet. They also expressed negative views about the UK alcohol use guidelines being changed so that the guide for men and women was the same, and suggested taking action in some way:

Attached is a notice of the new UK guideline on alcohol. It is truly crazy!! They have lowered the guideline for men to be the same as women under the conclusion that there are only potential benefits for women 55 and older and otherwise there is a risk of cancer at any level for any one! [C]an we discuss some people to send comments. This is rockers!!.”

Alcohol company senior executive to NIAAA senior leader, 7th January 2016

The NIAAA leader responded by setting up a telephone call the same day.

There were lots of other interactions between the NIAAA and the alcohol industry on this topic, including attempts to set up a meeting at an international scientific conference to discuss global alcohol use guidelines, although it appears the plans were cancelled by industry.

Why is this important?

As the largest funder of alcohol research globally, what this organisation says about dietary guidelines matters. It also funds the research that influences the content of those guidelines, impacting the health of millions. NIAAA leaders’ willingness to meet with the alcohol industry and discuss this and other topics is therefore hugely concerning.

People have a right to expect that publicly-funded institutions – including the NIAAA – put public health first. The study findings lead the researchers to question whether commercial interests are influencing decision making at the NIAAA, in ways that may have a negative effect on public health.

What needs to happen next?

There is a need for an independent investigation into how much the alcohol industry may be influencing NIAAA activity.

This needs to be done urgently, to protect public health not only in the US, but also globally.

Abstract

Objective

The purpose of this study was to examine the extent and nature of email interactions between National Institute on Alcohol Abuse and Alcoholism (NIAAA) leaders and the alcohol industry from 2013 to 2020.

Method

The researchers performed a thematic content analysis of 4,784 pages of email correspondence obtained from Freedom of Information Act requests to the National Institutes of Health on three senior NIAAA staff members.

Results

A total of 43 NIAAA staff were identified interacting with 15 industry bodies (companies and other organizations). NIAAA leaders provided industry with extensive information about scientific and policy developments. Discussions were facilitated by the willingness of NIAAA leaders to meet with industry and have other informal contacts, as well as NIAAA leadership presence at industry-sponsored and other events. Key industry actors asked NIAAA leaders for help on science and policy issues. At times, NIAAA leaders heavily criticized public health research and researchers in correspondence with industry.

Conclusions

Institutional practices of engagement with the alcohol industry have been sustained by NIAAA leaders’ activity. There is an urgent need to better understand the extent to which commercial rather than public health interests have shaped alcohol research agendas, both within and beyond NIAAA.

Background

A major controversy arose in 2018 regarding the $100 million Moderate Alcohol and Cardiovascular Health (MACH) trial. The study was designed to investigate the possible cardioprotective effects of alcohol. It received two thirds of its funding from the alcohol industry and was supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

The trial was terminated due to a biased trial design co-produced by researchers, NIAAA staff, and alcohol industry representatives (Mitchell et al., 2020).

NIAAA is the largest funder of alcohol research globally.

After funding of the MACH trial by five major companies had been secured, two NIAAA senior leaders took part in a promotional video for an AB InBev corporate social responsibility (CSR) initiative in 2016 (Siegel, 2018). AB InBev is the world’s largest beer producer and was a MACH trial funder.

As part of the MACH trial controversy, email correspondence was released into the public domain that appeared to show an NIAAA Director assuring an industry executive that they would not be funding further research on alcohol marketing by David Jernigan and colleagues.

Based on this information, the researchers sought to identify the extent and nature of NIAAA interactions with the alcohol industry, which parties were most prominent in facilitating and maintaining such connections, the topics discussed, and any industry attempts to influence NIAAA scientific and other decision making.

Results

Four NIAAA senior leaders, including the three named in the FOIA requests, plus the current Deputy Director, had extensive contacts with the alcohol industry about a range of science, policy, and public information topics.

The researchers also identified the involvement of eight other leaders, prominently including senior advisors and directors of sections of the organization. Contacts took place via email, telephone, and in-person meetings across the range of topics discussed.

The key industry groups were the companies AB InBev and Diageo, two trade associations—the Beer Institute and the Distilled Spirits Council of the United States (DISCUS), and the International Alliance for Responsible Drinking (IARD).

Ongoing relationships gave industry privileged access to information

NIAAA leaders provided industry groups with extensive information on science and policy developments. In some instances, they advised industry representatives on how to advance their interests in relation to other agencies or processes (e.g., Organisation for Economic Cooperation and Development [OECD] 2015 report and United Nations Sustainable Development Goals).

For DISCUS, this contact was facilitated by a “revolving-door” individual, who had previously been a senior NIAAA employee. The Beer Institute and DISCUS representatives involved other industry groups by including them in email correspondence and organizing various meetings and events at which alcohol companies, trade associations, and NIAAA senior leaders were in attendance.

NIAAA leaders were active participants in interactions with industry, both initiating and reciprocating contacts. For example, NIAAA leaders and Diageo and DISCUS representatives discussed the appointment of a new NIAAA Director in 2013.

In this instance, the NIAAA leader appears to be encouraging this major company to consider lobbying the political representative whose authorization is required for the appointment of the new Director, if the prospective appointee was not in line with their preferences.

At times, there were discussions between NIAAA leaders about whether to attend particular meetings with industry representatives, and in many cases the meetings did go ahead. For example, one senior leader asked the Director and another senior leader for advice about whether to attend a meeting with the Beer Institute regarding a range of topics, including dietary guidelines and the NIAAA website.

The following response from the Director appears designed to avoid criticism of such contacts, although others had different views and the individual concerned later confirmed they would attend (Supplementary File B, pp. 5–7):

I would stay away. Let’s not beknight this meeting so that our friends can dig it up later and say we met with the beverage industry when it will be nothing but a semantic discussion (as usual).”

[Name]

Substantive discussions of scientific issues

NIAAA leaders shared, received, and discussed peer-reviewed articles on a range of health-related topics with industry representatives, most of which were highly alcohol policy-relevant.

The Beer Institute in particular used in-person meetings with NIAAA senior leaders to discuss several different health-related topics at the same time. Industry representatives were concerned about criticism of the purported cardioprotective effects of alcohol, and NIAAA comments on this and other research areas were requested and provided.

AB InBev gained additional information on NIAAA-funded studies during in-person meetings in 2014 and 2015; the latter itinerary included visiting at least one NIAAA-funded study site and discussing NIAAA-funded work and possible regulatory issues.

Discussions at the science/policy interface: Refuting the “public health model”

NIAAA leaders also engaged in substantive discussions of policy-related issues with industry representatives.

NIAAA senior leaders were highly responsive to key Diageo and DISCUS representatives’ queries, and their own perspectives on key policy-relevant issues were often closely in line with those of industry actors.

This alignment was notable, for example, in the NIAAA organizational response to drafts of the OECD 2015 report on alcohol (Sassi, 2015). This report assessed alcohol consumption, harms, and costs and impacts of key policy options, finding that as public health policies confer important economic and societal benefits, they should be adopted more widely.

Here, analysis of the email correspondence significantly extends existing findings on interactions relating to the OECD report.

  • The NIAAA formal response to an early draft of the report, shared with a Diageo representative in January 2015, criticized the OECD microsimulation model, particularly the underpinning aim of reducing overall consumption; this went as far as claiming there was an “overreaching bias against reduction in heavy episodic drinking”, and recommended more emphasis of “harmful” alcohol use.
  • This key industry argument is contradicted by WHO guidance, both current and that available at the time, which identifies that targeted interventions for harmful alcohol users are complementary to, rather than a substitute for, population-based approaches that seek to reduce overall consumption.
  • Further, the NIAAA position disputed the OECD report and well-established research community consensus that reducing alcohol use across the population can have beneficial health effects. It also criticized one major study (Holmes et al., 2014) that rejected purported cardio-protective effects.

Industry groups had previously shared with NIAAA their critique of this same study and the related scientific issues in a joint Beer Institute, Wine Institute, and DISCUS letter to a U.S. government official regarding the report. There was evidence in this instance that industry representatives had gained information about NIAAA publication intentions and sought to coordinate plans for voicing opposition to this OECD report using NIAAA (Sassi, 2015):

Coordinate media response in the event OECD progress to launch. In this regard, the best would be if NIAAA& would also issue press statements on the same day the report is released to the public. (We also heard from [DISCUS and Diageo named individuals] that NIAAA would plan to summarize their critique in The Lancet whenever the OECD report would be covered by that journal)”

Spirits Europe representative email to other industry groups, forwarded by Diageo representative to NIAAA senior leader, April 7, 2015; Supplementary File C, p. 41

There were other examples of criticism by NIAAA leaders of public health research findings and evidence-informed perspectives that conflict with commercial interests, and an emphasis on individual harm reduction in opposition to reducing overall consumption.

When discussing with Diageo a forum workshop that took place in February 2014, an NIAAA senior leader, who participated in the workshop, apparently positioned themselves as being against a public health framework.

Disagreements about evidence are a key facet of scientific progress, yet there is little by way of refutation of a public health approach in the literature, just a long-running industry campaign to subvert the science, developed in proximity to the tobacco industry (McCambridge et al., 2021).

Language used by NIAAA leaders to characterize opposing views was at times derogatory of both researchers and research (as in the example above), and caricatured in ways long promoted by industry, e.g., conflating aiming to reduce consumption as a policy goal with prohibition.

Health information and advice to the public

NIAAA leaders also discussed several topics relating to health information and advice to the public with industry.

The development of Dietary Guidelines in the United States were of particular interest to industry representatives, and were discussed, alongside other topics, when an NIAAA senior leader participated in a panel at a Beer Institute Annual Meeting in 2014.

Relationship building and consolidation

In-person meetings were key vehicles that enabled opportunities for developing relationships with NIAAA staff.

In addition to the previously cited material where information was available on what was discussed, between 2012 and 2017 NIAAA senior leaders planned and/or confirmed attendance at several Beer Institute events, including a “Beer Freedom Party” to “celebrate the end of prohibition”.

NIAAA staff also planned and/ or confirmed attendance at various DISCUS events; this included the NIAAA Director accepting an invitation to an informal discussion over lunch at a DISCUS event with industry CEOs in 2015.

At least one NIAAA senior leader attended the National Organization on Fetal Alcohol Syndrome (NOFAS) 2015 and 2016 galas; at the 2016 gala, this person, along with other alcohol company representatives, attended as a guest of DISCUS rather than as a guest of NOFAS. The 2016 invitation listed DISCUS as a trustee, the alcohol company Brown-Forman as a patron, and other industry organizations as “champions” and “friends” of the organization.

NOFAS and the industry-funded “social aspects organization” Foundation for Advancing Alcohol Responsibility (FAAR, previously The Century Council until 2014; McCambridge et al., 2021) are listed as members of Friends of NIAAA, a group that has supported NIAAA activities. Friends of NIAAA has a “corporate advisory board” made up of “mainly for-profit” organizations, and it remains active at the time of writing.

Industry representatives used such events to initiate and follow up on discussions, for example after the 2015 gala:

It was great to see you Thursday night. As always, it was an awesome event [referring to NOFAS gala 17th September]. I am hoping that we can set up some time to talk either this afternoon or tomorrow morning re guidelines conference &”

[email from Diageo representative to NIAAA senior leader, September 21, 2015; Supplementary File B, p. 353]

In this case, a call was agreed for the next day.

Industry representatives also attended some NIAAA meetings. Alcoholic Beverage Medical Research Foundation (a now disbanded social aspects organization that funded alcohol research; Babor & Robaina, 2013), Beer Institute, DISCUS, FAAR, and IARD representatives were invited (separately) to various NIAAA Advisory Council Meetings.

The groups usually confirmed their attendance. After the formal advisory council meetings adjourned, they were followed by informal and unrecorded discussions, at which participants had the opportunity to meet the Director and other staff.

  • There were many other examples of calls and in-person meetings where the substantive contents of discussions are unknown, which were often arranged at short notice.
    • These include introductions, checking in, or other informal chats with Diageo, the Beer Institute, Heineken, and FAAR.

In maintaining relationships with industry, NIAAA leaders were asked for help on a range of science and policy issues by key contacts.

NIAAA leaders also supported – by both taking part in, and providing feedback on – alcohol industry–led CSR activity.

  • For example, a Diageo representative sought thoughts and recommendations on the IARD CEO appointment from an NIAAA senior leader;
    • subsequently, that individual was invited to be a member of an IARD advisory group.
  • A fellow senior leader also recommended the same NIAAA colleague for an AB InBev advisory role.
    • Following retirement from NIAAA, the individual concerned joined the AB InBev Technical Advisory Group.
  • NIAAA leaders also connected industry groups with other organizations, for example introducing and endorsing a Heineken CSR leader to a National Association for Children of Alcoholics representative.

Discussion

NIAAA leaders have had extensive contacts with alcohol companies, trade associations, and so-called social aspects organizations since 2013. A wide range of highly policy-relevant scientific issues sat at the center of the discussions in email correspondence and telephone and in-person meetings. Four NIAAA senior leaders, including the current Director, and eight other leaders were identified as being involved.

The most important findings, however, concern not the behavior of individuals but the institutional practices of active engagement with industry. These were sustained by NIAAA leadership and invited the embedding of alcohol industry influence, which likely contributed antipathy toward public health.

Discussions about the MACH trial supported relationship building between NIAAA staff and industry, and enabled the discussion of other science and policy topics, which also pre-dated the MACH trial.

The present findings add to recent studies that identify the long-term effects of industry research funding on alcohol science, with likely profound impacts on the resulting evidence base. Public health science is arguably the most important area of alcohol research, at least in connection with the societal burden and the policies needed to ameliorate it. The study findings here provide examples of alcohol public health science being opposed rather than championed by NIAAA leaders, at least in their direct communications with industry.

These data show that industry attention to alcohol science and policy has involved the targeting of NIAAA, and no doubt other key scientific institutions.

In the case of alcohol, this activity extends also to charities and other issue-based groups, such as on the intergenerational transmission of alcohol harms, where the science is under-developed and industry actors are actively involved, as seen here.

This study suggests that there is an urgent need to better understand the nature and extent of this problem, both within and beyond NIAAA. This includes NIAAA (and industry) interactions with other public bodies, including other federal agencies in the United States, and internationally (e.g., with WHO).

The alcohol industry using NIAAA as a vehicle for influence may not be new; two of the first three Directors of the organization have claimed that they were removed for political reasons, as a result of funding public health–oriented research. The other went on to receive alcohol industry funding and work with the tobacco industry after he stepped down. During the conduct of this study, one of the three senior leaders whose correspondence we requested went on to work for an alcohol industry organization. Another took up a role as Research Director for the Center for Truth in Science, whose funding sources are opaque, but includes on its board Marjana Martinic, formerly Deputy President of the International Center for Alcohol Policies and senior IARD staffer. The third remains in post as NIAAA Director.

After the MACH trial, the Director is reported to have stated that they were “disappointed in what had transpired”. It appears from the present study that there are further lessons to be learned, and these are not to do with individual conduct but with organizational culture and practices and their consequences for scientific and public understanding.

The range of topics discussed between NIAAA senior leaders and industry, and the apparent embedding of industry influence over many years, adds vital context to the examination of the provenance of NIAAA decision-making by the NIH that led to the termination of the trial.

The COVID-19 pandemic has brought into sharp focus the crucial role public trust in science plays in efforts to improve public health; NIAAA and NIH have a job to do in rebuilding credibility and relationships with the alcohol public health community. In so doing, the organization must regard this report not as presenting a public relations challenge to be managed, but as posing a set of major scientific challenges to which it must rise.


Source Website: JSAD