NIH abruptly changes course on industry opioids partnership after ethics flags raised

WASHINGTON — It’s been touted by health officials for almost a year: a planned opioids research partnership worth roughly $400 million. Ideally, the National Institutes of Health and the pharmaceutical industry would each pick up half the tab, NIH Director Francis Collins has said, to fund research aimed at addressing the opioid epidemic.

Collins reiterated last month: Dozens of drug companies were on the verge of teaming up with the agency, which researchers hope will lead to the discovery of new medicines to treat addiction or serve as alternatives to opioids.

But in an abrupt shift, the agency announced late last week that it won’t accept funds from drug makers after all. Citing recommendations issued earlier this month by an NIH advisory panel, Collins said the agency will exclusively use taxpayer money to fund a comprehensive research initiative on pain and substance use disorder treatment.

“I fully embrace [the] recommendation that NIH should vigorously address the national opioid crisis with government funds and decline cash contributions through partnerships from the private sector,” Collins said in a statement.

Instead of accepting cash from drug companies interested in teaming up, Collins said the NIH would lean on industry only for help in setting up a clinical trial network, establishing common biomarkers for drug development, and sharing data.

“The biopharmaceutical industry remains committed to working with NIH, NIDA, and others to advance innovative solutions to address the opioid crisis,” a spokeswoman for PhRMA, the drug industry lobbying group, said in a statement to STAT. “Toward those aims, we are working to identify in-kind contributions that will help improve our approach to pain management, while minimizing the risk for addiction and better treating overdose.”

The move was a major shift for Collins, who has publicly expressed excitement about the partnership, specifically pointing to the prospect of drug companies chipping in funds to leverage agency dollars. The agency has long pursued such partnerships on disease-specific research via the Accelerating Medicines Partnership, a framework for similar industry collaborations. Last year, the NIH announced a separate partnership on cancer immunotherapy, which relies on $55 million in funding from drug companies.

On the issue of opioids, however, attitudes appear to be dramatically different — largely due to the role many pharma companies are seen to have played in the opioid crisis. In its recommendations, the NIH advisory committee specifically cited Purdue Pharma and Mallinckrodt, two opioid manufacturers currently being sued for their opioid marketing tactics.

“There’s so much controversy swirling around pharmaceuticals on the opioid issue,” said Rep. Tom Cole (R-Okla.), who chairs the House appropriations subcommittee on health, adding that he understood Collins’s rationale for declining industry funds. “[Collins] called me to give me a heads-up, and I said I concur. It’s too dangerous.”

Cole and others close to Collins also cited the ongoing controversy involving Dr. George Koob, the director of the National Institute on Alcohol Abuse and Alcoholism, a unit within the NIH. STAT reported this month that Koob had discouraged research on the impact of alcohol marketing after working with beverage industry lobbyists to fund research promoting the benefits of moderate alcohol consumption.

NIH has become wary, Cole and others close to the agency told STAT, of the perception that the private sector wields too much influence over the direction of taxpayer-funded research. Collins said last week the agency was aggressively investigating the reports regarding Koob and NIAAA.

“In making our recommendations, the committee considered the expert advice of our members as well as information available to us both in the press and from NIH officials,” Dr. Geoffrey Ginsburg, a genomics researcher at Duke University who co-chaired the advisory panel, told STAT in an email.

Cole said Collins had initially spoken of a “200-200” split in agency and industry money to fund a roughly $400 million partnership, but his enthusiasm for receiving cash contributions dampened over the course of the past year.

The prospect of a funding agreement with the drug industry was first alluded to in May. Collins, PhRMA CEO Stephen Ubl, and former New Jersey Gov. Chris Christie — who chaired a White House commission on combating the opioid crisis — made a more formal announcement in September. Capitol Hill figures overseeing the NIH largely appeared enthusiastic at the prospect of industry’s plan to chip in. Ubl said at one meeting that industry was “prepared to do its share.”

Read more: NIH director: Agency is looking at alcohol industry influence ‘in a very aggressive way’

“I think there could have been an opportunity there for the private sector to invest to help solve a problem that they should want to help solve,” said Sen. Roy Blunt (R-Mo.), who chairs the Senate subcommittee overseeing NIH funding, in response to NIH’s change of course. “I’ll look forward to following up with Dr. Collins and hearing the reasons he had as to why that might be a problem.”

Another complication, counterintuitively, was how well NIH made out in a recent spending agreement in Congress. Lawmakers, beyond a broader increase in NIH funding, allocated $500 million to the agency for opioids research alone, half to the National Institute on Drug Abuse and half to the National Institute of Neurological Disorders and Stroke.

“It would have been difficult to move forward at an optimal pace prior to the Congressional allocation of funds for opioid and pain research,” an NIH spokeswoman said. “We are grateful to the Congress for their vision.”

But, the spokeswoman added, the decision to decline cash contributions from industry was based only on recommendations from the NIH working group and Foundation for the NIH, an external organization that serves as a go-between for industry and government on similar partnerships.

Cole said the congressional funding allocation “relieved them of all moral dilemmas.”

Read more: Racing to replace opioids, biopharma is betting on pain drugs with a checkered past

Staff at the Foundation for the NIH said they had submitted a scientific plan for the partnership to the agency in February, and that the scientific goals of research into addiction treatment and painkiller alternatives were unchanged.

Even the FNIH, however, has taken steps to avoid perceived conflicts. A spokeswoman said Jillian Sackler, an FNIH board member and relative of the family who owned Purdue, recused herself from work involving the partnership to avoid even the perception of undue influence.

While FNIH said Sackler had not benefited from her extended family’s increasingly notorious role in marketing OxyContin, ProPublica reported last week that Jillian Sackler receives an income from a trust containing money paid by Purdue to the estate of Arthur Sackler, once a partial owner of the company.