Sunday, March 25, 2018

Congressional Investigation Needed into Scientific and Ethical Corruption at NIAAA

I used to think of the National Institutes of Alcohol Abuse and Alcoholism (NIAAA) as a highly-reputed, objective, science-based agency whose primary goal was to reduce alcohol consumption to improve the public’s health. The scientific integrity of the NIAAA is critical, as it describes itself as “the largest funder of alcohol research in the world.” The agency is funded by taxpayers to the tune of $480 million a year.

But then one day, all of that changed. On January 16, 2015, I was called into the office of the Director of NIAAA and was essentially reprimanded for conducting NIAAA-funded research that was detrimental to the alcohol industry. My NIAAA grant was focused on studying alcohol marketing and its possible link to underage youth drinking behavior. We identified the brands of alcohol that underage youth are consuming and found that their brand choices were related to their brand-specific advertising exposure. At the meeting, I was told that I would never again be funded to conduct research on alcohol marketing, regardless of how highly my research proposal was scored by the scientific review panel.

I later found out that the NIAAA director had extensive contact with the alcohol industry and that he promised the Distilled Spirits Council that this type of research would never be funded again: “For the record. This will NOT happen again. … I will NOT be funding this type of work under my tenure.”

Not only had the NIAAA director privately told an alcohol lobbying group that his agency would never fund research on alcohol marketing, but he then went on to participate in the industry’s marketing activities himself by appearing in a promotional video (at 3:17) for Anheuser-Busch InBev, creating the impression that the NIAAA is endorsing the alcohol company and its programs, which is a violation of NIH policy. The true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."

Finally, the truth about the relationship between the NIAAA and the alcohol industry has come out. In a New York Times article published last Saturday, Roni Caryn Rabin revealed that the NIAAA actually solicited funding from alcohol companies to conduct a study to demonstrate the “benefits” of alcohol consumption and industry officials were essentially promised positive results.

The Times reported having obtained slides from a presentation by a Harvard researcher to alcohol executives in which he makes a pitch for funding to study the health benefits of alcohol. The NIAAA apparently facilitated the meeting, at which a senior agency official was present. In the slides, the researcher suggests that the study could result in newspaper headlines reporting that alcohol is now part of a healthy diet. Promising positive results before even initiating a study and pitching the study based on its potential economic benefits to the industry violate standards of scientific integrity.

The NIAAA’s solicitation of donations for this research from the alcohol industry was a clear violation of NIH policy, not only because NIH officials are not allowed to solicit donations, but also because they are not allowed to accept funding for a study unless the agency would conduct the research even without the donation. However, a former NIAAA official apparently admitted to telling alcohol industry executives that “the research could not be done without their support.”

The story gets worse. The principal investigator of the study apparently lied about having met with the alcohol industry. In a July 2017 New York Times article, he was quoted as stating: “We have had literally no contact with anyone in the alcohol industry in the planning of this.” However, his name is on a presentation delivered directly to alcohol companies to convince them that they had “a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases.”

Apparently, the director of NIAAA was also dishonest, as he appears to have told the New York Times that the NIAAA did not solicit alcohol industry funds. This conflicts with the testimony of at least two high-level NIAAA officials—one of whom was the former director—who admitted that the meetings between NIAAA and the alcohol companies were “to determine if they had interest in taking part” as funders.

In fact, the advisor to the former NIAAA director apparently recognized that studying the benefits of alcohol was not even within the scope of legitimate NIAAA research: “We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly.” This is why it was so essential for the agency to convince the alcohol industry to fund the clinical trial.

The solicitation was successful. The NIAAA is now funding a $100 million clinical trial—largely funded by alcohol companies— designed to demonstrate the health benefits of alcohol, and the principal investigator is the researcher who gave the presentation.

Even if the study were a legitimate use of agency funds, it would still be inappropriate because many of its primary investigators have substantial financial conflicts of interest with the alcohol industry. At my institution, such researchers would not even be allowed to be involved in a clinical trial in which they have a significant conflict of interest. Our general policy is that an investigator with a significant conflict of interest cannot conduct a clinical trial on a product made by the relevant company. We do allow conflicted investigators to conduct pre-clinical studies, such as laboratory research; however, the line is drawn definitively at the level of a clinical trial. Thus, the NIAAA also appears to be violating the NIH conflict of interest policy.

Finally, the study itself is misguided and a waste of money. Even if it were to find that moderate drinking can reduce heart disease risk, it would still not be clear that recommending that people who don’t drink start to drink is warranted. Alcohol is a known carcinogen that causes breast cancer even when consumed in extreme moderation. Recommending that people consume a known carcinogen is not something that we do in public health.

In short, the NIAAA is assisting the alcohol industry in a marketing ploy to increase the sales of its products. The research has no scientific integrity and is tainted from the start. Its principal investigator solicited money from the industry and boasted of a positive outcome before the research was even started. Multiple NIH policies have been violated in the planning of the research alone.

That the NIAAA was involved in this corruption is inexcusable. This behavior risks damaging not only the reputation of the alcohol institute, but of the entire NIH. Congress should initiate an investigation immediately to protect the scientific integrity of federal health research. Further, it is imperative that this clinical trial be immediately halted on both scientific and ethical grounds.

Disclosure: I was a recipient of a grant from the NIAAA for a project to study the effects of brand-specific alcohol advertising on youth alcohol brand consumption (R01 020309 – September 20, 2011 through June 30, 2015).

4 comments:

Robert Lipton said...

wow! I did not know all this, I've had a bunch of PI, co-PI and co-I research with NIAAA and I'm continually wary of science corrupted by industry regarding "moderate alcohol" although I investigated moderate alcohol and mental health early in my career. The part where you were actually reprimanded?! Seriously! Thanks for getting this out Prof. Siegel. I would like to be involved with any efforts to daylight any corruption.

Robert Lipton said...

btw, I'm also involved with a lot of tobacco related research too.

Jon Nelson said...

The Poison Pen letter referred to here is on page 121 of the 132 page attached document (email dated 30 July 2014). Not a fan of Jernigan and Siegel's research -- What goes around, comes around.

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