NIH Maintains Murky Opioid Partnerships Despite Law, Policy, and Scandals

In 2018, CrossFit HQ discovered a disturbing but unsurprising fact: The pharmaceutical and food/beverage industries have for years made shadowy payments to the CDC Foundation (FCDC) and the Foundation for the NIH (FNIH). These entities filter money to their parent agencies, the Centers for Disease Control and Prevention and the National Institutes of Health, both of which have failed to address the chronic disease epidemic.

When Congress established both foundations in the 1990s, it required that they publicly report each year the source and amount of each payment they received, along with any restrictions placed upon it (NIH requirement, CDC requirement). To date, neither foundation has provided all of this information. Although they confirm they have received funding from major opioid manufacturers, soda companies, and other vested interests, neither has disclosed what is legally required, with some reports even including “anonymous” listings.

Last year, CrossFit told Congress about this, and Congress took action. It told the foundations to stop the “anonymous” listings and abide by the law. Both foundations have decided to ignore Congress’ directive, leaving anonymous listings in their 2018 reports (FNIH, FCDC) and thereby not fulfilling their legal obligations.

The FNIH and the FCDC are not the only avenues through which opioid manufacturers influence government entities. In April 2018, the NIH launched the Helping to End Addiction Long-Term (HEAL) Initiative to “speed scientific solutions to stem the national opioid public health crisis.” Under the direction of NIH Director Dr. Francis Collins, the HEAL Initiative aims to repair the damage done by opioid manufacturers, and in doing so, it is supposed to keep them at arm’s length.

Just prior to the launch of the HEAL Initiative, the Advisory Committee to the NIH Director (ACD) presented Collins with clear suggestions about how NIH could avoid conflicts of interest with opioid manufacturers as it attempted to address the opioid crisis. The ACD offered the following recommendation: “For any public-private partnership to address the opioid crisis, NIH should not accept funding from companies involved in litigation of concern related to the crisis.” It also spelled out that “any public-private partnership that NIH undertakes in its response to the opioid crisis should not involve governance participation from companies involved in litigation of concern related to the crisis.”

In a painstakingly crafted statement, Collins shied away from fully embracing the ACD’s recommendations. He acknowledged the recommendations and responded, “It is clear, however, that the opioid crisis is beyond the scope of any one organization or sector. NIH and biopharmaceutical companies bring unique skills and assets to bear on this crisis. NIH will use the ACD guidance as we continue our discussions with biopharmaceutical organizations to advance focused medication development for addiction and pain.”

Despite hedging, Collins did “agree with and appreciate the ACD’s guidance to … tailor the governance structures for each initiative that may be pursued through public-private partnerships to ensure appropriate oversight and guidance.”

He ended with a promise: “Any partnerships that NIH does establish with biopharmaceutical organizations as part of the HEAL Initiative will be done with the utmost transparency.”

On Aug. 26, a judge in Oklahoma issued a ruling in Oklahoma v. Johnson & Johnson, finding “Johnson & Johnson and its subsidiaries helped fuel the state’s opioid crisis.” Johnson & Johnson was ordered to pay $527 million. According to the FNIH’s 2018 report, Johnson & Johnson donated between $2.5 and $5 million, which presumably funded activities at the NIH, though given FNIH’s inadequate reporting we cannot know for sure. If that is not bad enough, the FNIH’s board, riddled with representatives of the pharmaceutical industry, includes among its number Paul Stoffels, Chief Scientific Officer of Johnson & Johnson. Did Johnson & Johnson’s funding for the FNIH go toward activities related to the opioid crisis, which a judge found was caused, in part, by Johnson & Johnson? What was the purpose of the donation? Why does the FNIH’s board include an obviously conflicted member? The FNIH’s analogue, the CDC Foundation, received an undisclosed sum from Johnson & Johnson in 2018, which the foundation presumably distributed to the CDC. What was the purpose of Johnson & Johnson’s donation in 2018? What CDC program or initiative did it support? The CDC publishes guidelines on prescribing opioids for chronic pain; did any of the funds donated by Johnson & Johnson go toward this project?

The HEAL Initiative’s Partnership Committee, which informs the governance of the HEAL Initiative, includes Christopher Flores, a representative from Janssen Pharmaceutical Companies of Johnson & Johnson. Johnson & Johnson is a participant in litigation related to the opioid crisis. Why does it have a voice in this committee? Why should it have the ear of the Director of the NIH? Pfizer is also a participant in similar litigation, and yet Pfizer’s Kenneth Verburg holds a seat on the committee. And in the same vein, why does Richard Moscicki of the Pharmaceutical Researchers and Manufacturers of America (PhRMA) have a seat on the committee? Involving the opioid industry and its representatives in the NIH’s premiere opioid initiative directly violates the policy recommended by NIH’s own Advisory Committee to the Director.

There’s also good reason to suspect the opioid manufacturers’ partnerships with NIH have affected government policy. According to an opinion piece in STAT by Adriane Fugh-Berman, MD, and her colleagues at Georgetown University’s PharmedOut project, “Industry lobbyists orchestrated the creation of a 19-member panel at the National Institutes of Health to coordinate pain research.” Members of the panel aggressively criticized the CDC’s stricter opioid prescription guidelines, labeling them “horrible” and “shocking.” One week after this “industry-friendly” NIH panel was convened, “the CDC said it would delay finalizing its guidelines to allow more public comment and released a list of advisers.” It is impossible to investigate whether the NIH’s partnership with opioid manufacturers caused it to advocate for the industry through its panel, however, since the FNIH has refused to follow its most basic legal transparency requirements. We do not know, therefore, if the NIH’s opioid partnerships caused it to promote the industry’s interests and resist stricter prescription guidelines, or whether the result was merely a fortunate accident for the industry.

It is clear that Director Collins doesn’t care about his advisory committee’s suggestions, nor about fighting conflicts of interest, even if such disregard results in the undermining of CDC guidelines. If anything, his inaction shows he embraces the very companies and industries responsible for epidemics that have killed tens of thousands. On what basis did Collins choose to ignore the ACD’s policies? In what world does “tailor[ing] the governance structures for each initiative that may be pursued through public-private partnerships to ensure appropriate oversight and guidance” mean allowing the companies complicit in the opioid crisis and embroiled in litigation on the same to be active participants in the HEAL Initiative? What does a promise for transparency mean if FNIH does not reveal the purpose of the donations provided by those same companies?

The conflicts of interest don’t end there. Journalist Tim Schwab recently uncovered that one of the presidents of the National Academies of Science, Engineering, and Medicine (NASEM) had “recent links to the drug industry.” Blood money from the Sackler family of Purdue Pharma, to the tune of $14 million, seeped its way into NASEM as well. The Sacklers’ influence is felt across the federal government: Jillian Sackler is a board member of the FNIH.

With conflicts of interest as pervasive as these, should anyone be surprised by the toll of the opioid epidemic?