The National Institutes of Health, perhaps the world’s leading medical research institution, has moved fast to try to fix self-inflicted damage to its reputation caused by a controversial $100-million study on alcohol and its harms.
NIH Director Francis Collins halted the study, and an advisory group backed his action, lambasting researchers for soliciting funding and counsel from the alcohol industry for a work that purported to answer key and fundamental questions about booze but from its outset leaned toward seeing benefit in moderate drinking.
The New York Times deserves credit for digging into the dubious actions by researchers supported by the National Institute on Alcohol Abuse and Alcoholism, an arm of NIH.
An NIH advisory panel, at Collins’ request, looked into conduct by the alcohol institute and Dr. Kenneth J. Mukamal, an associate professor of medicine at Harvard Medical School, who served as a key advocate and then lead investigator of a planned, major research initiative about drinking and its health effects.
The advisory panel found Mukamal (photo above, left) and others were in frequent email and other contact with Big Alcohol interests about paying for and shaping the NIH study, even before a nonprofit foundation that aims to raise funds for agency research got involved. The foundation exists, in part, to protect NIH’s objectivity, giving greater distance between NIH researchers and those who might donate to fund them.
In Mukamal’s case, he and colleagues met with industry trade groups as well as officials from five Big Alcohol companies that decided to pay for the NIH study on drinking: Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg.
The advisory panel chastised Mukamal and colleagues not only for failing to fully disclose to NIH colleagues information about their contacts and how alcohol industry officials had shaped the research plan but also the alcohol institute for how it awarded funding for the eventual study. The agency crafted its grant requirements to give Mukamal and colleagues clear advantage to win the research, though NIH routinely seeks to avoid such situations by requiring multiple and competitive applicants and funding requests.
The New York Times reported that the group advising Collins (photo above, right) did not discuss if Mukamal and colleagues violated agency conflict-of-interest policies. But the newspaper repeatedly said: “NIH policy prohibits employees from soliciting, suggesting or requesting donations, funds or other resources to support the institutes’ activities. “
NIH advisors quoted by the newspaper described multiple flaws with the way the planned alcohol study was designed, including its follow-up time and how it had gender imbalances and exemptions that would skew its results to be more favorable to drinking, especially moderate consumption.
Mukamal, the New York Times said, denied any wrongdoing and stands by and defends the drinking study, planned as a 10-year-long randomized clinical trial that aimed to recruit 7,800 participants at 16 sites around the world. Researchers had spent a few million dollars of their grant to start the study. But recruitment of volunteer study subjects was halted weeks ago. Anheuser-Busch InBev recently pulled its planned $15 million for the study, saying the research project’s credibility had been damaged.
In my practice, I see the harms that patients suffer while seeking medical services, and their challenges in finding reputable, reliable, and accurate information to protect and advance their medical and health care. It’s unacceptable that NIH allowed its integrity to be compromised by avarice or cost-saving or what partisans may term public-sector efficiency in reducing expenses by seeking private sector support.
NIH long has put in extensive systems and protections on research it conducts and funds for the public good, and it’s baffling how glaring lapses occurred with the alcohol study. The agency has eroded its standing and increased its conflict risk with its foundation fund-raising and industry partnerships, purportedly to benefit taxpayers by easing their funding burdens. But letting the Big Alcohol fund research it shapes to diminish public perceptions about drinking’s harm, as one study critic emphasized, isn’t science, it’s advertising and marketing bunk ── and it would have come from an elite and respected information source, the NIH, which is Uncle Sam.
The federal Centers for Disease Control and Prevention, a separate agency, says that “excessive alcohol use, including underage drinking and binge drinking (drinking five or more drinks on an occasion for men or four or more drinks on an occasion for women), can lead to increased risk of health problems such as injuries, violence, liver diseases, and cancer. The CDC recently warned that alcohol abuse is on the upswing and poses major risks for millions of Americans.
For consumers, this is another blow, as we, as patients, discover the industry mendacity behind supposedly scientific studies that play significant roles in determining how our medical care gets positioned and delivered. Providing undisclosed financial support and technical meddling in medical research has been a key and sadly effective tactic for Big Tobacco, Big Sugar, and major sports leagues, academic and media investigators have discovered.
Collins ── who already has come under fire for management problems in his agency that put researchers’ interests ahead of patients’ care ── needs to go far and deep to ensure NIH doesn’t join these too-often unsavory players in pushing medical hype and nonsense. He should oust the nickel-and-dime thinkers in the agency who would, for relatively small budget benefits, destroy the high standing that so many distinguished medical scientists have labored for decades to build with their blood, sweat, and tears ── and taxpayers’ hard-won support and confidence.