Most Americans have never heard of Dr. Richard Whitley, an expert in pediatric infectious diseases at the University of Alabama-Birmingham.
Yet as the coronavirus pandemic drags on and the public eagerly awaits a vaccine, he may well be among the most powerful people in the country.
Whitley leads a small, secret panel of experts tasked with reviewing crucial data on the safety and effectiveness of coronavirus vaccines that U.S. taxpayers have helped fund, including products from Moderna, AstraZeneca, Johnson & Johnson, and others. The data and safety monitoring board — known as a DSMB — is supposed to make sure the medicine is safe and it works. It has the power to halt a clinical trial or fast-track it.
Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials, or the public, according to multiple clinical trial experts who have served on such panels. That could be especially important in the pressure-cooker environment of Covid-19 vaccine research, fueled by President Donald Trump’s promises to deliver a vaccine before Election Day.
As pharmaceutical companies work to produce one as quickly as possible, the board’s anonymity has stirred concerns that the cloak of secrecy could, paradoxically, allow undue influence. Whitley, for example, represents the specialized world these experts inhabit — a professor revered in academia who also is paid by the drug industry.
The lack of transparency is exasperating.
Any political pressure to rush pharmaceutical companies or lean on federal regulators to prematurely greenlight a vaccine would undermine a system put in place to ensure public safety. Calls are growing for companies and the government to be more open about who’s involved in reviewing the vaccine trials and whether board members have any conflicts of interest.
“We want to know they’re truly independent,” said Dr. Eric Topol, director of the Scripps Research Translational Institute and a specialist in clinical trials. “The lack of transparency is exasperating.”
Data and safety monitoring boards have existed for decades to vet new drugs and vaccines, acting as a backstop to help ensure unsafe products don’t make their way to the public. Typically, there’s one board for each product.
This time, a joint DSMB with 10 to 15 experts will review unblinded data across trials for multiple coronavirus vaccines whose development the U.S. government has helped fund, according to five people involved in the Trump administration’s Operation Warp Speed or other coronavirus vaccine work. It is run through the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and consists of outside scientists and statistical experts, not federal employees, NIH Director Francis Collins said on a call with reporters.
“Until they are convinced that there’s something there that looks promising, nothing is unblinded and sent to the FDA,” Collins said. “I doubt if there have been very many vaccine trials ever that have been subjected to this size of the trial and the rigor with which it’s being evaluated.”
The NIH safety board oversees trials in the U.S. from Moderna, Johnson & Johnson, and AstraZeneca, U.S. officials and others involved in Operation Warp Speed said, but not Pfizer, which is fully funding its clinical trial work and established its own five-member safety panel. Pfizer has attested that it can conclusively determine by late October the effectiveness of its vaccine, being jointly developed with German company BioNTech. It secured a $1.95 billion purchase agreement with the Department of Health and Human Services for the first 100 million doses produced. The agreement gives HHS the option to buy an additional 500 million doses.
Moderna, Johnson & Johnson, and AstraZeneca, which have either started or are aiming to soon begin large-scale trials in the U.S. involving thousands of patients, collectively have received more than $2 billion in government funds for vaccine development; billions more have been meted out under agreements similar to the HHS contract with Pfizer to buy millions of vaccine doses. Having one safety board oversee multiple trials could allow researchers to better understand the field of products and apply consistency across evaluations, clinical trial experts said in interviews.
One big advantage “could be more standardization,” said Dr. Walter Orenstein, associate director of the Emory Vaccine Center at Emory University and a former senior official at the Centers for Disease Control and Prevention. “They can look at that data and look at all the trials instead of just doing one trial.”
But it also means that one board has an outsize influence to dictate which coronavirus vaccines eventually succeed or come to a halt, all while most of their identities remain secret. The NIH declined to name them, saying they were “confidential” and could be identified only once a study was complete.
Anonymous to shield against pressure
One exception to the mystery is Whitley, who was appointed as chair by Dr. Anthony Fauci, the nation’s top infectious disease official. Fauci said that following a “combination of input from us and from him and other colleagues, the people who had the greatest expertise in a variety of areas, including statistics, clinical trials, vaccinology, immunology, clinical work,” were selected for the panel.
Whitley’s role became public when his university announced it, an unusual move. He is a professor as well as a board member of Gilead Sciences, which recently signed a contract with Pfizer to manufacture remdesivir to treat Covid-19 patients. Whitley, who’s been on Gilead’s board since 2008, conducted research that led to remdesivir’s development.
In 2019, he was paid roughly $430,000 as a Gilead board member, according to documents filed with the Securities and Exchange Commission. That same year, he received more than $7,700 in payments from GlaxoSmithKline for consulting, food, and travel, according to a federal database that tracks drug and device company payments to physicians.
GlaxoSmithKline and Sanofi are jointly developing a vaccine that’s received $2 billion from the U.S. government under Operation Warp Speed. Whitley declined an interview. However, through a university spokesperson, Whitley said his DSMB has not seen any GlaxoSmithKline Covid-19 protocol. The companies have yet to begin phase 3 trials. Although he chairs a separate GSK data and safety monitoring board for a pediatric vaccine, he was vetted and cleared by the NIH conflict-of-interest committee with its knowledge of his involvement, the spokesperson said.
“When handled responsibly, it is appropriate for physicians to collaborate with external entities,” said UAB spokesperson Beena Thannickal, saying the university works with physicians to ensure that industry engagement is appropriate. “It facilitates a critical exchange of knowledge and accelerates and advances clinical treatments and cures, and it fuels discovery.”
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