NIH to Beef Up Private Donor Controls After Alcohol Study Scandal

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By Jeannie Baumann

The NIH will tighten the screws on research underwritten by the private sector in the aftermath of an alcohol study scandal that cost $4 million in taxpayer money and three agency staffers their jobs.

Allegations arose earlier this year of improper influence by the alcohol industry over a clinical trial it was helping to fund on the benefits of moderate drinking. “The integrity of the NIH grants administrative process, peer review, and quality of NIH-supported research must always be above reproach,” NIH Director Francis S. Collins said in a response to an inquiry from Sen. Chuck Grassley (R-Iowa).

Collins shut down that study, but his letter to Grassley follows up on an inquiry about what the agency is doing in the aftermath. “I am determined to make sure that violations of policies are not happening in other parts of the agency,” the NIH director said.

Collins’s letter makes clear he wants to take additional steps to ensure no industry or company can bend the results of taxpayer-supported research in its favor. More than 80 percent of the NIH’s $39 billion annual appropriation funds research grants, which generate evidence for new medicines, approaches to medical care, and policy.

Details on specific agency steps will be unveiled at the NIH Advisory Committee to the Director’s meeting Dec. 13-14, Collins said. An agency official will present a report on the results of a recently concluded NIH investigation into its management of public-private partnerships.

“Transparency and accountability are critical in maintaining public trust in the federal government,” Grassley said in an Oct. 30 statement.

Study Terminated in June

Collins decided in June to terminate the study on the benefits of moderate drinking because apparent alcohol industry influence and improper behavior by agency staff compromised the trial’s credibility.

At issue was whether a now-retired employee violated a ban on fundraising by persuading the alcohol industry to pay for the study known as the Moderate Alcohol and Cardiovascular Health Trial.

Both the National Institute on Alcohol Abuse and Alcoholism, part of the NIH, and donations from beverage companies helped fund the study. The NIH spent about $4 million of its own money on the study, which includes funding from fiscal years 2016 and 2017, as well as close-out costs.

The decision to end the study stemmed from an NIH investigation that focused on the scientific merits of the research.

Collins also directed the NIH’s Office of Management Assessment (OMA) to conduct a separate investigation to determine if the alcohol study scandal was a one-time incident or if it indicated there were systemic problems that needed fixing.

As a result of that assessment, which recently ended, three individuals “are no longer employed at NIH or anywhere within the Department of Health and Human Services.”

The OMA investigation is driving the additional scrutiny of public-private partnerships across the agency. The NIH is developing additional questions and documentation requests for these partnerships, Collins’s letter said. The agency is also identifying further considerations for risk analysis as part of the evaluation.

Public-private partnerships are used by the NIH fairly commonly to spur new solutions to pressing health problems.

Congress established the Foundation for the NIH more than two decades ago to establish public-private partnerships, including fundraising.

Foundation spokeswoman Abbey Meltzer told Bloomberg Law the foundation’s total research program revenue in calendar year 2017 was approximately $57 million. The total research program spending was around $49.9 million, of which the foundation sent approximately $21 million to the NIH for 21 research projects.

At the same time, she noted, the NIH engages in public-private partnerships beyond the foundation.

The foundation has firewalls in place to prevent industry influence on the study results. But allegations emerged that before the foundation finalized an agreement on the alcohol study, discussions between NIH staff and the beverage industry aimed to tilt those results in favor of the alcohol industry. The controversy was first reported by the New York Times.

Senator OK With Response

Grassley appeared to be satisfied by Collins’s response.

“The questionable activities related to this study were alarming to me and all taxpayers and should have never happened in the first place. NIH’s timely response and willingness to hold responsible parties accountable is what taxpayers expect and deserve from their federal government,” Grassley said.

The Iowa senator has opened up a number of inquiries into allegations of improper industry payments to physicians, such as allegations in 2011 that doctors conducting clinical trials for device maker Medtronic may have hidden serious side effects.

He’s also the main architect of the law that led to the open payments program at the Centers for Medicare & Medicaid Services.

Under open payments, drug and device manufacturers are required to report all payments they make to physicians and teaching hospitals, which can include lunches, consulting fees, research funding, and plane tickets.

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