WASHINGTON — The National Institutes of Health received $7.5 billion in funding in 1990 — an amount that was seen as so paltry that Congress decided the country’s biomedical researchers needed help.
So lawmakers found a way to aid the NIH in a delicate ethical dance: They created a nonprofit that could turn to pharmaceutical manufacturers and soda companies to fund research into their fields, all while attempting to prevent the science from being compromised by the big-money interests picking up the tab.
Even as the NIH budget has climbed to $39 billion next year alone, such public-private partnerships have funded dozens of popular initiatives into specific areas like autoimmune diseases and cancer immunotherapy.
But recent projects have put the NIH in the spotlight for the wrong reasons. The most controversial was a much-publicized partnership with alcohol manufacturers, which was canceled in June after the NIH concluded scientists had so thoroughly involved alcohol industry figures in planning as to render the science untrustworthy.
Now, the NIH is seeking to bounce back from the hit to its reputation — and to demonstrate that the failures of recent years are isolated incidents and not emblematic of a broader cultural problem. At the same time, some congressional aides have hinted at more aggressive oversight of the foundation through which the NIH takes on many of its partnerships.
NIH officials told STAT this week the agency is completing a plan to ensure better ethical compliance and better delineate the actual process for private-sector collaboration. The officials said the plan will be presented to an advisory committee in December.
Already, as STAT reported in April, the NIH proactively nixed a long-touted plan to accept roughly $200 million from pharmaceutical manufacturers to pursue research on pain and addiction treatment, with an explicit acknowledgement that involving companies being sued for their role in the crisis could taint the perception of the research.
NIH Director Francis Collins acknowledged the setbacks in an interview with STAT this week, but defended his staff’s efforts.
“If you see the major source of a partnership coming from an entity that has a strong investment in what the outcome of the research needs to be, that ought to be looked at very carefully,” said Collins, who has been director since 2009.
Referring to a failed partnership with the National Football League on concussion research, which STAT in 2016 reported carried more strings than originally disclosed, Collins added: “Obviously the NFL would like it if research showed that head injuries from football are not as damaging as some have thought. Certainly the beverage industry would like it if the outcome was that moderate alcohol intake was not bad for you, and might even be good for you.”
There is a clear throughline in the failed research partnerships, as former NIH officials, congressional staffers, and other experts in federal research told STAT: the low-profile Foundation for the National Institutes of Health.
The foundation, located down the road from the NIH’s campus in Bethesda, Md., is not technically a government entity, despite its congressional mandate. But in the last three decades it has facilitated hundreds of partnerships between the NIH and companies hoping to contribute to research, serving as an ethical clearinghouse between private donors and publicly funded researchers.
The FNIH often develops a scientific plan for research collaborations, in partnership with both private funders and the NIH, before soliciting contributions from the private sector and using the funds for science carried out by NIH staff or grantees. NIH scientists, per ethics requirements, are typically instructed to avoid contact with funders that could influence the direction of grant awards or scientific plans.
The vast majority of FNIH projects remain universally popular, including a recent collaboration in which the NIH put up $160 million, and 11 pharmaceutical companies another $5 million each, to aggressively research cancer immunotherapies. Another ongoing project, the Accelerating Medicines Partnership, funds research into Alzheimer’s, type 2 diabetes, rheumatoid arthritis, and lupus.
Some, however, are skeptical that the nonprofit can facilitate any partnerships without the potential for controversy.
“There’s a veneer of safety when money is given through FNIH,” said a former high-ranking NIH official. “Now it’s pretty clear FNIH has not provided much safety.”
Congress, too, is increasingly interested in the foundation: A House committee chastised FNIH in June, warning it and the parallel CDC Foundation to comply with transparency rules. (Crossfit Inc., the chain of high-intensity gyms that has publicly fought so-called “Big Soda” interests, took credit for the House committee language in a recent lobbying disclosure.)
Democratic aides, in an interview with STAT, suggested further oversight of FNIH was not out of the question, but declined to provide further detail.
Aides and outside groups alike also raised concerns that the composition of the FNIH board, which includes executives from Novartis (NVS), GSK, and Johnson & Johnson, is too corporate-friendly. It also includes the global head of the private equity firm BlackRock and president of the real estate company Beacon Capital Partners — and Jillian Sackler, a member of the family that benefited from sales of OxyContin.
That composition stands in contrast to FNIH’s congressional mandate, which required that board candidates be chosen from a list submitted by the National Academy of Sciences and specifies that a pediatric medicine and a biobehavioral expert should be included.
FNIH maintains the mandate applied only to the board’s original composition and that, going forward, it was free to choose board members as it saw fit. David Wholley, who manages the FNIH’s research partnerships division, also expressed surprise that outside experts viewed FNIH as too close to industry.
“I’ve not heard that before,” Wholley said.
For Adriane Fugh-Berman, a Georgetown professor who studies pharmaceutical marketing and formerly worked at the National Institute of Child Health and Human Development, the missteps are an inevitable outcome when partnering with industry.
“NIH is well-intentioned and home to many ethical, honest scientists,” she said. “But scientists are not trained in persuasive techniques and are not privy to industry’s long-term marketing goals.”
Collins said FNIH “did its job beautifully” in setting up the trial on alcohol use, and voiced full support for its director, Maria Freire, and for Wholley.
Nothing about the setbacks with the NFL and alcohol collaborations reshaped Collins’s view of public-private partnerships, he said, cautioning against conflating two high-profile failures with the agency’s long track record of successfully accepting outside help.
The difference between successful and controversial projects may hinge on a simple question: whether or not the topic at hand is itself controversial. Private support for popular initiatives generates little or no pushback, especially compared to private support for research of controversial topics.
Ned Sharpless, the director of the National Cancer Institute, suggested as much in a recent interview.
“Think about it the other way,” he said. “If I were to say, ‘I really don’t want to accept private support for these efforts because we have some concerns about how we’re going to cure pancreatic cancer,’ it would give the sense that I’m tying one hand behind my back.”
In some cases, NIH has accepted money from private-sector partners without FNIH’s help as the middleman. In the wake of the BP oil spill, for example, the oil company wrote NIH a check for $10 million to study the disaster’s health impacts.
Part of the increased exposure, FNIH officials have said, is the organization’s willingness to attempt higher-risk projects.
“Every time we consider something, we are looking at whether there’s any private benefit to anyone, and how does that balance against the public health benefit that we can create,” Wholley said in an interview. “The risk side of that equation goes way up when you’re talking about things like addiction, and it’s going to be a lot less if you’re creating a public-access database of genes that can be searched to see what causes type 2 diabetes.”
It’s a question of risk-reward, Wholley said — a calculus that he, Collins, and Capitol Hill aides said has not changed even as the NIH budget has increased by nearly $10 billion since 2013.
Wholley and a former NIH official said that FNIH itself planned to vote down a proposal to accept money from drug manufacturers on opioids research, before being beaten to the punch by an NIH advisory committee.
The broader question, another former NIH official said, was whether it was possible to construct ethical walls high enough that they can’t be scaled.
Often, it happens all too easily. Multiple sources confirmed an instance last year in which representatives from Wyeth Nutrition — a company acquired in 2012 by Nestle — asked to film a promotional video as part of a research collaboration with NIH, effectively using NIH’s logo to rubber-stamp a Nestle brand.
While a few NIH staffers didn’t reject the idea out of hand, Wyeth, eventually, was gently told no by NIH higher-ups and FNIH. There was no malice involved, said one official who recalled the incident, but it nonetheless demonstrated that ethical conflicts often come with the territory when accepting private funds.
Others opposed the practice outright.
“The fundamental problem,” a second former high-ranking NIH official said, “is that when someone gives you money, they’re not doing it out of altruism.”