Dr. Elizabeth Nabel, president of Brigham and Women’s Hospital, said Thursday she was resigning from the Moderna board of directors after the Globe inquired about whether her position at the Cambridge biotech company conflicted with her hospital’s leadership role in a large study of Moderna’s experimental COVID-19 vaccine.
The hospital said in a statement that when Nabel joined Moderna’s board in 2015, Brigham and Women’s parent company put protections in place to prevent a conflict of interest. It said more safeguards were imposed when the hospital was named one of 89 clinical sites for the late-stage trial, which began Monday with the dosing of a healthy volunteer in Georgia. The nationwide study is being led partly by a Brigham infectious diseases specialist.
In addition to sitting on the Moderna board, Nabel also owns stock in the company, whose share price has almost quadrupled this year. On July 15, she sold 73,975 shares worth nearly $6.5 million.
“Despite the management plans that have been put in place to ensure the COVID-19 vaccine study is not compromised due to my connection with Moderna, I have come to realize that those who do not know me, or how such trials are conducted, may perceive a conflict of interest,” Nabel said in a statement. “It is critically important that the public trust the conduct and outcome of the vaccine trials, so in the best interest of the greater good, I have made the difficult decision to resign from the Moderna Board.”
Dr. Roy Poses, a clinical associate professor of medicine at Brown University who writes about medical ethics, commended Nabel for stepping down ― just hours after he mentioned that step as a potential remedy to the potential conflict during an earlier Globe interview.
“She did the right thing,” he said. “It eliminates one issue that could have led to unfounded skepticism about this trial, and this is a trial where people have to trust the results.”
About 30,000 healthy volunteers are expected to participate in the landmark Phase 3 clinical trial of the experimental vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases.
Nabel ― who is also a cardiologist and professor at Harvard Medical School ― last year received $425,000 in stock option awards from Moderna, as well as $62,500 in payment, according to a filing with the Securities and Exchange Commission. The 10-year-old biotech’s share price took off after the company announced in February it had made its first batch of the vaccine candidate.
Nabel still retains 115,131 options to buy Moderna stock at a predetermined price, the hospital said Thursday.
Medical ethics experts said it was worrisome that the head of the Harvard-affiliated teaching hospital had a financial stake in the vaccine, particularly given that many people are already skeptical of vaccines. Recent public opinion polls show up to half of Americans are reluctant to get a COVID-19 vaccine when one is approved.
“Anti-vaxxers, critics, and kooks will use any appearance of financial conflict to undermine trust in vaccines,” said Dr. Arthur Caplan, a professor of bioethics at New York University Langone Medical Center. “It’s just hyper-dangerous now.”
Christopher Robertson, a professor at the Boston University School of Law and expert on conflicts of interest, said it was no surprise that Brigham and Women’s was selected for the vaccine study, given how often the hospital runs clinical trials. And it would be unusual for a hospital head to play a direct role in a trial, he said. There is no evidence that she has a direct role.
Nonetheless, Robertson agreed that Nabel’s roles created a potential conflict and said it would be “much cleaner” if she declined her Moderna stock options or donated them to a charity. The hospital, he said, “can lose trust if it appears to be following one goal rather than the proper goal.”
After Nabel announced her resignation, the Globe asked Brigham and Women’s whether she intended to keep the $6.5 million she collected in the recent sale of her Moderna stock.
Erin McDonough, a hospital spokeswoman, said, “Dr. Nabel is considering a number of options, including charitable contributions.”
Dr. Lindsey Baden, an infectious diseases specialist, is running the trial at Brigham and Women’s and serves as one of three co-principal investigators for the study nationwide. On Thursday morning ― prior to Nabel’s resignation from the board ― he acknowledged that skepticism about vaccines was a significant public health threat and said it was vital to address questions about her role at Moderna.
“She is the hospital president, and she has the ties you alluded to, and so these things absolutely need to be looked into, as you are doing,” said Baden, director of the Center for Clinical Investigation at Brigham and Women’s and director of Infectious Diseases at Dana-Farber Cancer Institute.
Nonetheless, Baden said, Nabel would play no role in the trial, which is expected to start at the hospital in a week. He said he planned to report the results to Moderna, the National Institute of Allergy and Infectious Diseases, and the Biomedical Advanced Research and Development Authority. That federal authority has provided hundreds of millions of dollars to vaccine makers as part Operation Warp Speed, the public-private partnership to speed development of a coronavirus vaccine. Moderna’s experimental vaccine uses a genetic material called messenger RNA to stimulate an immune response to the virus that causes COVID-19.
“There is nothing about the study that gets reported to Dr. Nabel, zero, from where I sit,” said Baden. “That doesn’t mean she’s not going to read your article, and it doesn’t mean she’s not going to know what’s going on, because people do. But she has no part of it.”
The hospital made a similar assurance in a statement that accompanied Nabel’s announcement that she would resign from the Moderna board.
“The Brigham Board,” it wrote, “is confident that the management plans put into place were sufficient to effectively monitor this matter; however, they support Dr. Nabel’s decision to step down from the Moderna board, as they all agree with Dr. Nabel that maintaining the confidence of the public is essential as we all work toward the common goal of defeating COVID-19.”
In a statement issued by Moderna, Noubar Afeyan, cofounder and chairman of the company, thanked Nabel for her five years on the board and said “her experience as a clinician, global healthcare leader and researcher were instrumental in the progress of Moderna’s clinical development.” Her resignation was effective immediately.
Representatives for the NIH did not respond to questions Thursday.
This is not the first time that Nabel’s multiple roles have raised eyebrows.
In 2016, a congressional committee report said she was part of a National Football League effort to “steer funding” for a landmark concussion study away from a group of respected brain researchers at Boston University who have helped to establish a link between football and chronic traumatic encephalopathy, long-term brain damage.
The report found that the NFL “inappropriately attempted to influence” the NIH’s grant selection process through Nabel, a lifelong football fan who was serving as the league’s chief health and medical adviser. Nabel knows NIH well, having directed its National Heart, Lung, and Blood Institute from 2005 to 2009. When the report was issued, she said she “had no intention of influencing” the NIH process. The agency stuck with its decision to award the grant to BU researchers, but ended up using internal funds, not NFL money, to pay for it.
Nabel’s recent sales of Moderna stock weren’t the first by company insiders to draw attention.
A number of corporate executives and board members have sold millions of dollars worth of stock, including Moderna’s chief executive officer Stephane Bancel and chief medical officer Tal Zaks. Some trades were pre-programmed, company officials have said. But critics have questioned whether the insiders may have gained an unfair trading advantage by timing transactions with the release of market-moving data on the experimental vaccine’s progress.
Jonathan Saltzman can be reached at firstname.lastname@example.org