Preserving Public Trust in Scientific Studies

Last week, the National Institutes of Health, the primary agency of the U.S. government responsible for biomedical and public health research, outlined a series of steps aimed at preventing conflicts of interest in research and at safeguarding the integrity of its studies.

The impetus for the undertaking was a revelation last summer of a possibly compromised 10-year, $100 million study of the effects of moderate alcohol consumption. The NIH canceled that study after determining that officials had possibly affected the research by soliciting over $60 million from beer and liquor companies to underwrite the effort.

The study was supposed to measure the effect of moderate drinking on rates of nonfatal heart attacks, nonfatal strokes, hospitalizations for angina, coronary or carotid revascularization and death from any cause.

It was discovered that members of the staff at a nongovernmental institute overseen by the NIH met with representatives of five liquor companies, in violation of existing rules that required them to report any such contacts. In a statement, NIH said that “a small number” of employees at the National Institute of Alcohol Abuse and Alcoholism (NIAAA) were at fault and that “appropriate personnel actions” would be taken. The report included a lengthy appendix with emails between staff and industry representatives.

In the summer, NIH Director Francis S. Collins said that the study’s results would not be acceptable because of the secretive way in which the NIAAA staff members met with major liquor companies, talked to them about the trial’s design and convinced them to underwrite a large share of its funding. And so, he explained, there was no point in allowing the study to proceed.

Scrutiny of the proposed research began the previous March after the New York Times reported on the solicitation of corporate support for the study, and the routing of donations through the NIH’s nongovernmental foundation.

The study participants, it was found, not only shared details of the design of the trial with alcohol industry representatives but had even suggested to them that the results would reflect well on moderate drinking, possibly leading to official government-endorsed advice touting a daily alcoholic drink to prevent heart disease.

In fact, though, the issue of whether moderate alcohol consumption is healthful remains a complicated one. Several studies over the years have seemed to yield results indicating that a daily drink can indeed have health benefits. But more recently, such connections have been called into question. A 2016 meta-analysis of 87 long-term studies on alcohol and death rates, for instance, found that many of the seeming health benefits likely stemmed from flaws in the studies’ designs.

After correcting for these perceived biases, the meta-analysis study’s authors found no evidence that moderate drinking had protective health benefits.

In its recent announcement, NIH officials said the 27 institutes that operate under its umbrella must evaluate all current research projects that receive private donor support, to ferret out any conflicts of interest of the kind that compromised the alcohol trial.

The report also called for NIH officials to examine the motives of all private donors offering funding for research projects, to ensure that donations are given unconditionally and without any expectation of desired results from any scientific studies.

The NIH is also seeking to ensure that the NIH itself, and not private donors, make final decisions about trial design and data analysis.

Dr. Lawrence A. Tabak, the principal deputy director of the NIH, said that the new rules will buttress the agency’s standards and provide uniform enforcement across the institutes. “We want to make sure we’re doing it completely consistently across the agency,” he said.

The NIH report said the problems that came to light in the alcohol trial “threaten public trust,” which is crucial to the agency’s mandate.

The 27 institutes’ directors who were charged with evaluating all current research projects receiving private donor support are to report their findings to NIH director Dr. Francis Collins early next year.

The NIH has a well-deserved reputation for sound, impartial research; and information about health, disease and epidemiology is important to all Americans. We Torah Jews, in particular, have an abiding need for up-to-date and accurate information to factor into our halachic mandate to guard our health and make decisions accordingly.

And so, it is heartening that the governmental agency not only canceled the compromised study even on the mere possibility that it might have yielded tainted results, but saw its exposure as a spur to issue guidelines aimed at preventing the possibility of commercial influence on other scientific research.