WASHINGTON — The National Institutes of Health has hit a series of ethical snags in recent years, with questions about whether work funded by nonprofit groups has come with too many conditions attached or otherwise failed to meet certain ethical standards.
Congress has taken notice.
In what amounts to a written warning from Capitol Hill, a House committee last week included language in a spending agreement that emphasizes existing requirements on funding from the Foundation for the NIH and the CDC Foundation.
The House Appropriations Committee directed the organizations to include in their annual reports “the source and amount of all monetary gifts.” The nonprofits, the committee said, must also identify any donors whose cash contributions came with restrictions on their use in research, even if those donors wished to remain anonymous. And they must detail any restrictions on the use of money that is donated.
The two foundations are run as nonprofits, but are authorized by Congress to serve as ethical clearinghouses between industry and the research agencies on public-private partnerships. Researchers are typically restricted from direct contact with private research funders, allowing the intermediary organizations to negotiate research frameworks and collect money on the agencies’ behalf.
The FNIH, in its 2017 report, listed contributions worth at least $1 million each from 15 pharmaceutical companies. It also listed several anonymous donations, the largest of which it said was worth between $2.5 million and $5 million.
The organization facilitates a number of ongoing partnerships with many of those companies, including a $215 million cancer immunotherapy research initiative launched last year.
An FNIH spokeswoman told STAT that none of the anonymous contributions listed by the group come from corporate interests, and stressed that the FNIH believes it complies with all applicable transparency laws.
The group does not expect the instructions from Congress “to affect our donors’ willingness to support our mission or programs, particularly our corporate donors, none of whom have requested that we list them as anonymous in our reporting,” the spokeswoman, Meghan Amoroso, wrote in an email.
The FNIH — which is governed by a board that includes numerous private-sector executives, many from pharmaceutical companies — in particular has been scrutinized recently following controversy over a study on the long-term effects of alcohol use. The NIH terminated the study, which was funded by nearly $100 million in contributions from the alcohol industry, due to ethical concerns about contact between researchers and industry figures.
Separately, STAT reported in April that George Koob, the director of the National Institute on Alcohol Abuse and Alcoholism, had admonished investigators who had pursued research into the impact of alcohol marketing on youth alcohol consumption as he pursued industry support, and that he had written an alcohol industry lobbyist to promise such research would not be pursued in the future. (Koob denied any wrongdoing, saying he had rejected certain research proposals on the basis of the quality of the proposed work.)
In two other cases, one involving concussion research and another involving research into non-opioids alternatives for pain treatment, the NIH had to alter partnerships or back off plans for new ones because of ethical concerns.
Dr. Geoffrey Ginsburg, who co-chaired the ethics committee that recommended NIH not accept drug manufacturer funding for the opioids partnership, had told STAT that the panel considered “information available to us both in the press and from NIH officials,” responding to a question about whether the alcohol study’s ethical woes contributed to the reluctance to accept funds from drug manufacturers for opioids research.
The Senate did not include any new stipulations on public-private partnerships in its own spending report, released Friday.
Nonetheless, a perhaps-unlikely stakeholder saw the language in the House report as a testament to its own efforts to raise red flags: Crossfit, Inc., a chain of gyms and branded fitness regimen that has fought against the influence of so-called “Big Soda” interests in biomedical research.
“We’ve tracked the soda industry’s donations and use of proxy groups,” Russ Greene, CrossFit director of government relations and research, said in a statement. “We looked over the CDC Foundation’s and FNIH’s disclosures and found they weren’t even close to following the law. Annually reporting the sources, amount and restrictions of each grant they receive — transparency — is the first step in making sure there’s no undue influence on government science and policy.”