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How money colors Operation Warp Speed's quest to defeat COVID-19

By Rachana Pradhan, Kaiser Health News on

Published in News & Features

After leaving the FDA in 2019, Gottlieb joined Pfizer's board and has bought 4,000 of its shares, at the time worth more than $141,000, according to SEC filings. As of April, he had additional stock units worth nearly $352,000 that will be cashed out should he leave the board, according to corporate filings. As a board member, Gottlieb is required to own a certain number of Pfizer shares.

McClellan has been on Johnson & Johnson's board since 2013 and earned $1.2 million in shares under a deferred-compensation arrangement, corporate filings show.

The two also receive thousands of dollars in cash fees annually as board members. Gottlieb and McClellan frequently disclose their corporate affiliations, but not always. Their Sept. 13 Wall Street Journal op-ed on how the FDA could grant emergency authorization of a vaccine identified their FDA roles and said they were on the boards of companies developing COVID-19 vaccines but failed to name Pfizer and Johnson & Johnson. Both companies would benefit financially from such a move by the FDA.

"It isn't a lower standard for FDA approval," they wrote in the piece. "It's a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine."

About the inconsistency, Gottlieb wrote in an email to KHN: "My affiliation to Pfizer is widely, prominently, and specifically disclosed in dozens of articles and television appearances, on my Twitter profile, and in many other places. I mention it routinely when I discuss Covid vaccines and I am proud of my affiliation to the company."

A spokesperson for the Duke-Margolis Center for Health Policy, which McClellan founded, noted that other Wall Street Journal op-eds cited his Johnson & Johnson role and that his affiliations are mentioned elsewhere. "Mark has consistently informed the WSJ about his board service with Johnson & Johnson, as well as other organizations," Patricia Shea Green said.

Johnson & Johnson's vaccine is in phase 3 clinical trials and could be available in early 2021.

 

Still, while they worked for the FDA, Gottlieb and McClellan were subject to federal restrictions on investments and protections against conflicts of interest that aren't in place for Warp Speed advisers.

According to the financial disclosure statements they signed with HHS, the advisers are required to donate certain stock profits to the NIH — but can do so after the stockholder dies. They can keep investments in drug companies, and the restrictions don't apply to stock options, which give executives the right to buy company shares in the future.

"This is a poorly drafted agreement," said Jacob Frenkel, an attorney at Dickinson Wright and former SEC lawyer, referring to the conflict-of-interest statement included in the NIH contract with Advanced Decision Vectors, the Warp Speed advisers' employing consulting firm. He said documents could have been "tighter and clearer in many respects," including prohibiting the advisers from exercising their options to buy shares while they are contractors.

De Notaristefani stepped down as Teva's executive vice president of global operations in October 2019, but according to corporate filings he would remain with the company until the end of June 2020 in order to "ensure an orderly transition." He's been working with Warp Speed since at least May overseeing manufacturing, according to an HHS spokesperson.

When Erhardt left Pfizer in May, U.S. COVID-19 infections were climbing and the company was beginning vaccine clinical trials. Erhardt and Harrigan, whose LinkedIn profile says she left Pfizer in 2010, have worked as drug industry consultants.

"Ultimately, conflicts of interest in ethics turn on the mindset behavior of the responsible persons," said Frenkel, the former SEC attorney. "The public wants to know that it can rely on the effectiveness of the therapeutic or diagnostic product without wondering if a recommendation or decision was motivated for even the slightest reason other than product effectiveness and public interest."

(c)2020 Kaiser Health News Distributed by Tribune Content Agency, LLC