Big Alcohol Behind Major Health Study (Additional Coverage)
A decade-long study into the health effects of drinking is expected to produce favorable results.
Source: https://www.wine-searcher.com/
By Liza B. Zimmerman
02-Apr-2018
It has long been a Catch-22. Few, in-depth medical studies can be conducted without the help of well-financed industry support within their fields.
Many cures – and other technological innovations – wouldn’t even exist without this type of funding. However the way in which these same research projects are funded can also create some serious ethical issues.
Major Study Endorses French Paradox
As research expands into the drinks arena to determine if moderate consumption of alcoholic beverages is good for the health, the ethical questions have also multiplied in our field. A decade-long drinks study, currently taking place at the United States’ venerated Bethesda, Maryland-based National Institutes of Health (NIH), is currently being questioned for its ethics as it is largely being funded by drinks industry dollars.
According to John Bowersox, a Washington, DC-based science writer and editor at the NIH’s Institute on National Alcohol Abuse and Alcoholism (NIAAA), the study was funded in part by the NIAAA, which is contributing $20 million. It was also, in part, driven by private donations of $67.7m through the Foundation for the National Institutes of Health (FNIH), according to Bowersox. He adds that the study was started in September of 2016 and is expected to conclude at the end of July in 2026.
However, according to a number of doctors in the public healthcare sector, there are a handful of serious ethical issues with the study. “The main problem with this research is that the NIAAA appears to have violated NIH policy by soliciting funding from alcohol companies to conduct this study. In doing so, they essentially promised industry officials positive results,” claims Michael Siegel, a doctor who holds a master’s degree in public health, who is a professor at the department of Community Health Sciences at the Boston University School of Public Health.
“Industry-funded trials tend to find industry-friendly results. Partnering with NIH gives biased research an ethical gloss. And this is biased research. It’s a cherry-picked population,” adds Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center project that educates healthcare professionals about pharmaceutical marketing practices. Fugh-Berman is also a professor at the department of pharmacology and physiology at Georgetown University Medical Center.
Surprisingly, several major attorneys who focus on the drinks industry weren’t as critical about source of funding for this study as several of the doctors. “The studies are the work of reputable physicians and researchers, the money comes from the industry trade associations [all of them; wine, beer and spirits] and are funneled through academic grants. Questioning the integrity of researchers based on funding sources denigrates the integrity of the academics and is a scurrilous attack technique,” said the notoriously litigious John Hinman, a San Francisco-based partner in the drinks law-focused firm of Hinman & Carmichael.
The key players
The reported almost $70 million dollars was invested in the research – with leading drinks players, including Anheuser-Busch, Heineken, Carlsberg, wine and spirits giant Pernod Ricard, and the Distilled Spirits Council (DISCUS) among the top investment names. None of these companies – with the exception of Pernod Ricard – responded to requests for comments.
“Together with other companies, we are helping to fund a National Institute of Health’s study, which is a 10-year randomized trial focused on the health effects of alcohol through evidence-based studies approach. As the foundation for the NIH has stated, Pernod Ricard and the other companies’ role is limited entirely to the funding,” shared a spokesperson at Pernod’s New York office. “We have had no role in the design of the study and will only learn of the outcome of it when released to the public.”
Doctors Adriane Fugh-Berman (L) and Michael Siegel both believe there are serious flaws in allowing alcohol money to fund the study
“My personal view is that the scientific and medical question of whether moderate consumption of distilled spirits, wine, or beer has health benefits for the consumers who decide to drink is a valid and major public health policy question that needs to be answered conclusively,” said Robert Tobiassen, a Virginia-based attorney and consultant, who was the chief consul for the Alcohol and Tobacco Tax and Trade Bureau (TTB) from 2003 to 2012.
“So we find ourselves today in a situation where the alcohol industry and the federal government has put this health benefits question out there for consumers of alcohol beverages. It is only fair for the federal government [and the industry through its funding] to provide an objective answer to that question.”
He goes on to note that “because many temperate taxpayers would likely object to spending public funds on this question, then it behooves the federal government to accept the private funding for this research and ensure that a sufficient firewall is in place between NIH and the funding sources to maintain the objectivity and ethical standards so that the conclusions of the study can be accepted without challenge.”
The medical establishment’s response
In a time when the efficacy and trustworthiness of medical care and research in the US is up for debate more than ever, it is not surprising that many in the medical establishment expressed greater shock about this study than drinks industry attorneys.
Professor Siegel adds: “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.” He went on to note that “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.”
In response to professor Siegel’s comments, the NIH has provided the following statement attributable to NIH director and medical doctor Francis Collins regarding the study: “The scientific goals of the Moderate Alcohol and Cardiovascular Health Trial are worth pursuing . Mechanisms are in place to protect the integrity of the science supported by donations to the NIH.”
By excluding “anyone with a history of addiction, psychiatric, liver or kidney problems, certain cancers or a family history of breast cancer, and by limiting alcohol intake to one drink a day, potential harms of alcohol will be minimized; any results may not apply to a real-world population. If the alcohol industry wants to fund its own trials, they are welcome to do so. If they want to donate strings-free money to NIH, there is a mechanism for doing [so]. But NIH should not be partnering with industry, especially on studies designed to showcase purported benefits of that industry’s products,” says Fugh-Berman.
Doctor Siegel went on to share his belief that the findings of the current NIF/NIAFF study is questionable, not only because of its funding but because “substantial financial conflicts of interest with the alcohol industry”. He concludes: “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.”
NIH director Collins adds that the”NIH will be looking into this matter. [and] prohibits employees from soliciting donations of funds or other resources to the NIH or any of its components.”
We have another eight years to go before anyone can really determine the value of this research.