Several members of a panel that will be advising the Food and Drug Administration (FDA) on whether to approve potential vaccines for coronavirus have a history of financial relationships with companies developing the vaccines.
The FDA advisors’ ties to the drug companies have taken a variety of forms, including consulting fees and compensation for travel and lodging, according to records reviewed by the Project On Government Oversight (POGO). In some cases, companies have paid them directly. In other cases, companies have paid their organizations for medical studies in which they played a principal role, records show.
The FDA panel, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet tomorrow to discuss for the first time “in general, the development, authorization and/or licensure of vaccines to prevent COVID-19,” according to the meeting agenda.
A federal database shows that, in 2019, advisory committee member Dr. Archana Chatterjee, for instance, received $23,904 from Pfizer (including Pfizer International LLC), $11,738 from Merck, and $11,480 from Sanofi, each of which is in the race for a coronavirus vaccine. Since 2013, she has received more than $200,000 in consulting fees, travel and lodging, and other payments from those companies and others working on coronavirus vaccines, according to the database.
The newly named acting chairman of the committee, Dr. Arnold Monto, received $54,114 from 2013 through 2019 from vaccine contenders Sanofi, GlaxoSmithKline, Pfizer, and Shionogi, according to the database. He also received $10,657 from Novartis, which has a deal to manufacture a coronavirus vaccine.
Monto’s curriculum vitae says he served as principal investigator from 2007 to 2016 on a study of influenza vaccines funded by Sanofi Pasteur, a unit of Sanofi. He is a professor of epidemiology at the University of Michigan, which has announced that it is partnering with pharmaceutical company AstraZeneca on a clinical trial of a potential COVID-19 vaccine.
Meanwhile, the FDA has indicated that it has granted or is preparing to grant waivers from conflict of interest prohibitions to two new temporary appointees to the committee. One is the president of Meharry Medical College, the approved site for a clinical trial of a potential coronavirus vaccine, an FDA memo says. Meharry, which is in Nashville, will be receiving between $500,000 and $750,000 for conducting the clinical trial, the memo says.
The second waiver recipient, a professor of biostatistics, holds stock valued at $25,000 to $50,000 in Philip Morris, which has a one-third stake in a company “which can be affected by the particular matters before the committee,” another FDA memo says.
The need for the two temporary appointees’ expertise outweighs the potential conflicts, an FDA official asserted in the memos.
The chair of the FDA committee, who specializes in vaccines and infectious diseases at Baylor College of Medicine in Houston, has been recused from the panel’s review of COVID-19 vaccines because she is co-chairing Moderna’s vaccine trial, Baylor spokesperson Dipali Pathak said by email, confirming a September report by Reuters.
The committee enters the picture as the FDA is trying to reassure the public that it will not cut corners or bow to political pressure—and against a backdrop of the White House trying to bend agencies such as the FDA and the Centers for Disease Control and Prevention to its public relations agenda.
In March, for instance, the FDA granted an emergency use authorization for hydroxychloroquine, which President Donald Trump was touting as a remedy for COVID-19. In June, the FDA withdrew the authorization, saying the benefits no longer outweighed the risks of serious side effects.
In a June 30 news release, FDA Commissioner Dr. Stephen M. Hahn declared: “We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data.”
Weeks later, the FDA was giving the public new reason to doubt that commitment. The agency issued an emergency use authorization for a COVID-19 treatment called convalescent plasma despite objections from officials at the National Institutes of Health that the treatment was unproven. Hahn was soon apologizing for overstating the benefits.
To head the federal push for a coronavirus vaccine, dubbed Operation Warp Speed, Trump chose Moncef Slaoui, former chair of GlaxoSmithKline’s vaccine division. Slaoui has declined to liquidate GlaxoSmithKline stock worth about $10 million, ProPublica recently reported.
The stakes in the FDA’s vaccine reviews are huge—in terms of politics, potential corporate profits, and the public’s health and safety. However, at this point, it seems clear that no coronavirus vaccine will be approved before Election Day.
In an interview with 60 Minutes aired Sunday night, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, cited the involvement of the advisory committee as a source of confidence. “We have an advisory committee to the FDA who are made up of independent people who I trust,” Fauci said.
The advisory committee on vaccines is one of many specialized committees of doctors, scientists, and others from outside the FDA appointed by the agency to help it evaluate medical products. Their recommendations are not binding, but they generally carry great weight at the FDA.
After reviewing the results of clinical trials—studies in which vaccines and drugs are tested over time on human subjects—the advisory committees can give experimental products influential endorsements. Through their public hearings, they can also spotlight flaws in the way the trials were conducted, weaknesses in the data, and dangerous side effects.
Advisory committees are supposed to provide independent advice, the FDA says. “To protect the credibility and integrity” of that advice, the FDA says, it screens committee members for “potentially disqualifying interests or relationships.”
Under federal ethics law, some conflicts of interest clearly disqualify advisors from participating in particular regulatory proceedings—for example, personal investments that could be directly affected by the regulatory decision at hand. Others relationships fall in a gray zone.
The law “gives FDA and other agencies significant flexibility and discretion in deciding whether a member with an appearance issue should participate in a particular matter,” an FDA draft “guidance” document from 2016 says.
A key question, the FDA has said, is whether a reasonable person would doubt the committee member’s impartiality.
“Although interests or relationships more than a year old do not generally give rise to appearance issues, there may be exceptions when these involvements suggest close ties,” the FDA has said.
Even if it concludes that an advisory committee member has an actual financial conflict or questionable impartiality, the FDA has the power to waive recusal requirements and allow the member to participate.
Members’ corporate connections reflect the fact that much medical research is funded by industry, and many of the most accomplished medical researchers have relationships with pharmaceutical companies. That doesn’t mean the experts put corporate interests ahead of humanitarian concerns. But medical experts and drug companies are often part of the same system and can become dependent on each other, even if only to advance science from the lab to the patient.
The information POGO reviewed comes mainly from committee members’ curriculum vitae—which are essentially detailed résumés—and from the federal Open Payments database, which tracks payments by pharmaceutical companies to doctors.
Since 2017, when a lawsuit by the consumer advocacy group Public Citizen prompted the FDA to be more transparent, the agency has posted unredacted curriculum vitae of committee members.
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Some advisory committee members are not physicians and, as a result, Open Payments would not show any payments they might have received from pharmaceutical companies. Committee members are required to submit financial disclosures to the FDA, but those documents are not publicly disclosed. When the FDA issues waivers allowing members to participate despite conflicts of interest, it discloses the waivers and its grounds for issuing them.
If the FDA determines that a waiver is unnecessary because a financial interest or relationship does not pose a conflict of interest, the public can be left in the dark about it.
POGO emailed Monto, the committee’s acting chair, and a spokesperson for the University of Michigan, where he is a professor in the School of Public Health. We have not heard back.
Committee member Archana Chatterjee is dean of Chicago Medical School at Rosalind Franklin University of Medicine and Science. According to Open Payments, the tens of thousands of dollars she received from Pfizer, Merck, and Sanofi in 2019 were in categories labeled travel and lodging, food and beverage, consulting, and services other than consulting.
The database lists similar payments in varying amounts over earlier years. In 2018, they included two other vaccine contenders: $12,222 from AstraZeneca Pharmaceuticals and $3,235 from GlaxoSmithKline.
In addition, the database lists more than $140,000 from Pfizer, GlaxoSmithKline, Merck Sharp & Dohme, Sanofi Pasteur, and AstraZeneca since 2013 in “associated research funding,” which included payments to organizations for research in which Chatterjee played a principal role.
As recently as this year, she was working on studies sponsored by Pfizer and GlaxoSmithKline, according to her curriculum vitae.
Chatterjee’s curriculum vitae says she was invited to serve on advisory boards for Merck, GlaxoSmithKline, Sanofi Pasteur, and MedImmune (now part of AstraZeneca), among others. In 2008, it says, she received a Merck Vaccination Service Award.
In an interview with POGO, Chatterjee said she has no current conflicts of interest.
Asked if past matters raise an appearance issue, Chatterjee said, “It’s hard for me to judge that. … I think, you know, appearance is in the eye of the beholder.”
“Certainly someone may feel that that has an appearance of conflict of interest,” she said. “I rely on the FDA to judge whether they believe that there is a conflict of interest or not and let me know accordingly.”
“I would say that it’s important for the public to be made aware of the relationships that the members of a committee that serves the FDA have. I believe that is public information, and in my opinion the public can make its own judgment.”
Chatterjee said she declined an invitation to play a role in a COVID-19 vaccine trial so that she could continue to serve on the FDA advisory committee, “given what a critical need there is for assuring the public that the COVID-19 vaccines that are in development are safe and effective.”
Committee member Dr. Steven Pergam is medical director for infection prevention at Seattle Cancer Care Alliance. His Open Payments profile shows $140,311 of associated research funding from Merck Sharp & Dohme in 2013 through 2016. That involved payments to one or more research centers for work in which he was listed as principal investigator.
The database shows he received $4,083 from Merck in 2013 in the form of a consulting fee, food and beverage, and travel and lodging.
POGO emailed Pergam for comment but did not receive a response.
The draft roster for Thursday’s web-based advisory committee meeting shows that several committee members will not be attending.
One of those is Dr. Geeta K. Swamy, an associate professor of obstetrics and gynecology who plays a clinical research oversight role at Duke University Medical Center. Swamy is working on a clinical trial for a Pfizer COVID-19 vaccine, according to a Duke web posting from July.
Since 2013, according to Open Payments, Swamy has received “general payments” such as consulting fees and travel and lodging totaling $56,832 from GlaxoSmithKline, Sanofi Pasteur, Pfizer, and Merck. In addition, from 2013 through 2019, GlaxoSmithKline and Regeneron Pharmaceuticals, maker of an experimental COVID-19 treatment that was administered to Trump when he got sick, have paid $121,771 to Duke for research in which she played a principal role, according to Open Payments.
Another committee member listed as not attending tomorrow’s meeting is Dr. Myron M. Levine, associate dean for global health, vaccinology, and infectious diseases at the University of Maryland School of Medicine. The school is participating in a clinical trial of a COVID-19 vaccine being developed by Moderna and the National Institute of Allergy and Infectious Diseases.
Since 2013, for research in which Levine played a principal role, GlaxoSmithKline has paid the University of Maryland Baltimore Foundation Inc. and another institution more than $2.3 million, according to the federal database.
According to Open Payments, Levine received $30,199 in general payments in 2019 from Sanofi Pasteur, Merck Sharp & Dohme, and Emergent BioSolutions Inc., which is working on a COVID-19 vaccine with AstraZeneca.
POGO emailed Swamy and Levine and did not receive responses.
The roster for Thursday’s meeting does not say whether committee members slated as not attending have recused themselves, whether they’ve been disqualified, or whether they will be absent for other reasons. In response to questions from POGO, the FDA did not say.
POGO also asked whether those committee members might participate in future committee meetings on COVID-19 vaccines. “The roster we posted yesterday is the roster for the Oct 22 meeting and, for any future meetings, FDA will post the meeting materials no later than 48 hours before the meeting,” an FDA spokesperson said by email Wednesday.
POGO also asked the FDA spokesperson where the agency draws the line on committee members’ relationships with vaccine developers. The spokesperson pointed to a document generally describing agency procedures and added, “The FDA makes these determinations on a case-by-case basis.”