Open the books on NIH royalty payments

 Recently, Sen. Rand Paul (R-KY) pressed Dr. Anthony Fauci for details of hidden royalty payments made to the National Institutes of Health, its leadership, and scientists. Once again, Fauci was evasive and misleading in a congressional hearing. If his agency has nothing to hide, he should open the books and share all the information with the public.

For years, the NIH has worked to keep hidden a stream of third-party royalties paid to its scientists by for-profit companies. These payments flow when a medical innovation made as part of NIH research is used by the private sector and government employees are considered “co-inventors” on the patent. There were approximately 55,000 of those payments during the past decade. Each royalty could be a conflict of interest that requires transparency to investigate.

After the agency ignored Freedom of Information Act requests from OpenTheBooks's data capture team, we sued the agency, represented by the group Judicial Watch. Only recently and under court order has the NIH begun disclosing the amount of money changing hands with the private sector for these innovations. As officials slow-walk the royalty data release, we can say that the NIH and its scientists received an estimated $400 million in third-party paid royalties between March 2010 and today and that they dole out around $32 billion a year in research grants across the medical community. Concurrently, decisions inside the NIH, the Food and Drug Administration, and the wider Department of Health and Human Services were made regarding product approvals, public health guidance, and continuing research priorities.

These huge financial stakes make it critical for patients and the public to have full transparency from the NIH. People, the press, pundits, and watchdogs must be able to follow the money.

However, in the production of this information, the NIH is redacting every individual payment amount, the identity of the payer, and the patent license numbers. So we know hundreds of millions of dollars enrich the NIH and its scientists, but the NIH refuses to tell who is paying, at what amounts, and for which innovations. It renders these document dumps effectively useless.

Our OpenTheBooks investigation has thankfully sparked interest and action from Congress, which began last month in a budget hearing in which acting NIH Director Lawrence Tabak answered questions about 2023 funding levels. Rep. John Moolenaar (R-MI) got Tabak to concede that this whole arrangement appeared to be a conflict of interest. But Tabak contended that there are “firewalls” in place to ensure decision-makers were not receiving payments for innovations their subagencies were researching or overseeing. We are meant simply to take their word for it, it seems.

Based on Fauci’s testimony this week, that approach won’t suffice.

When Paul asked whether Fauci ever received royalty payments from entities he later regulated or made funding decisions for, Fauci demurred, saying he didn’t know, “but I doubt it.” In 2005, though, he was sure. Back then, Fauci confirmed that the payments were a conflict of interest because the National Institute of Allergy and Infectious Diseases, the institute where Fauci is the director, was spending $36 million to test his invention on patients — the interleukin-2 experimental AIDS drug.

However, the concern here is much broader than the behavior of the NIH’s most famous scientist.

Take another example, Dr. Doug Lowy, the acting director of the National Cancer Institute, another NIH institute. He is tied for 19th of 1,805 scientists receiving the most royalty payments between 2010 and 2016. Lowy studied papillomaviruses for decades, from how they reproduce to how they encode cancerous cells in the human body. He wrote hundreds of papers on these viruses, and then his laboratory developed and tested the ingredients now used in three HPV vaccines approved for use by the FDA: Gardasil, Gardasil 9, and Cervarix. From his new perch as acting director, Lowy makes all manner of decisions about grant-making priorities and cancer research using tax dollars.

Presciently, in the hearing, Paul asked Fauci a vaccine-related question as well: Has anyone on the vaccine approval committees ever received money from vaccine manufacturers? Fauci’s answer mirrored Tabak’s: Existing statutes and regulations don’t require these disclosures.

Paul is right to be asking for transparency here. He was joined by Sens. Tim Scott (R-FL), Ron Johnson (R-WI), Josh Hawley (R-MO), and Jim Lankford (R-OK) in sending Tabak a letter demanding the answers the NIH had refused to give to OpenTheBooks. They set a deadline of June 17, which has come and gone.

The public deserves the unredacted information because it’s the public's tax dollars being used to fund this revolving door of grants and royalties. If the NIH can hide behind the law, Congress should press forward with its oversight authorities by holding more hearings — and also update relevant statutes to ensure it serves the public’s present-day interests.

Let’s vaccinate our government bureaucracies, leadership, and scientists against these myriad conflicts of interest. Transparency is needed to build back trust.

Adam Andrzejewski is the CEO and founder of OpenTheBooks, the largest private database of public-sector expenditures.

https://www.washingtonexaminer.com/opinion/op-eds/open-the-books-on-nih-royalty-payments