Operation Warp Speed’s conflict of interest problem.

A brief complaint tonight.

The most important medical development initiative in recent history is the COVID-19 vaccine development program. Nicknamed “Operation Warp Speed,” this program has provided billions of dollars to private sector companies for the development of multiple vaccines that may protect individuals against COVID-19. 

There has been much concern about the independence of individuals in the FDA who will be reviewing the results from these clinical trials, and the CDC, which will be involved in their implementation. Despite these concerns, the individuals leading these organizations are all federal employees and have complied with the conflict of interest rules of the federal government. Drs. Hahn and Redfield (FDA and CDC Directors) had to divest of many of their personal holdings to meet governmental conflict of interest regulations.

In contrast, the “Warp Speed” leaders and advisors have not agreed to these restrictions and are being considered contractors instead of government employees. As outlined in a recent ProPublica article, this results in inherent conflict of interest issues with these individuals that dwarf any perceived concern with either FDA or CDC employees.

Dr. Moncef Slaoui

This is most apparent with Moncef Slaoui, the top scientist on Warp Speed. He insisted on being a contractor rather than a government employee to avoid the conflict of interest rules. A former head of GSK’s vaccine development program, he agreed to sell stock worth $12 million and resign from the board of Moderna, the developer of a leading potential vaccine. He sold this stock at a substantial profit, in part due to Warp Speed and other government investments in the company.

But Slaoui insisted on keeping his roughly $10 million stake in GlaxoSmithKline, which is also developing a Warp Speed COVID-19 vaccine. “I won’t leave those shares because that’s my retirement,” he has said. GlaxoSmithKline’s coronavirus vaccine is supported by up to $2.1 billion from the U.S. government. This conflict has raised significant concerns throughout government and oversight organizations.

As a concession, Slaoui committed to donating any increase in the value of his holdings to the National Institutes of Health. But according to newly released information, Slaoui’s contract with the government says that the donation “may occur on the last death of the employee and his or her spouse.” Slaoui is 61 and his wife, Kristen Belmonte, is 50. “That means he’s going to live out his life with those profits,” said Craig Holman, a lobbyist with the advocacy group Public Citizen who has filed multiple ethics complaints about Slaoui’s service. “It’s so clearly an all-out evasion” of the law against conflicts of interest, Holman said.

Everyone who has worked in the pharmaceutical industry, myself included, has equity in companies that would be painful to give up if they were to enter government service. While I’m sure Dr. Slaoui has a 401K from GSK as his formal retirement program, it is probably of less value than his stock holdings.

However, no matter how qualified Dr. Slaoui is for this position, with the very integrity of the COVID-19 vaccine programs on the line it might be better they have an individual without a conflict of interest leading “Operation Warp Speed.” 

Published by jbakerjrblog

Immunologist, former Army MD, former head of allergy and clinical immunology at University of Michigan, vaccine developer and opinionated guy.

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