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).
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.
ReplyDeletebtw, I'm also involved with a lot of tobacco related research too.
ReplyDeleteThe 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.
ReplyDelete