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The Director of the Department of Health and Human Services is appointed by the Governor to lead a staff of more than 6,900 and manage a biennial budget of more than $16 billion in state and federal funds. In addition, the DHHS Director serves in an advisory capacity as a member of the Governor's Cabinet. Richard Whitley. Richard Whitley was ...
Mar 2, 2022 · Nevada Department of Health and Human Services (DHHS) Director Richard Whitley has announced that Robert Thompson has been appointed as Administrator of the Division of Welfare and Supportive Services (DWSS) starting today. Steve Fisher, who has served as Administrator since 2014, is retiring after 24 years of State service. “Robert has been ...
Richard Whitley was born in Elmhurst, Illinois, to Marian and Edward F. Whitley. [3] [4] He had an older half-brother, John Hill, who was a game designer. [5] Whitley began his career by writing the script for Roger Corman 's Rock 'n' Roll High School (1979). [6] His work on Rock 'n' Roll High School led to writing for several TV shows ...
- American
- Elmhurst, Illinois, U.S.
- 1978–present
- Rock 'n' Roll High School
- Overview
- Anonymous to shield against pressure
- Tension between speed and safety
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.
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.”
Multiple experts praised his skill — Dr. Walter Straus, an associate vice president at the drug company Merck & Co., said Whitley is an “éminence grise” in pediatrics whom people trust.
Moderna, AstraZeneca, Johnson & Johnson and Pfizer have each released protocols that include details on when their DSMBs would review unblinded information about trial participants, and at what points they could recommend pausing or stopping trials. The vaccine data and safety board organized by NIAID advises a broader oversight group consisting of the drug companies sponsoring the trial and representatives from NIAID and HHS’ Biomedical Advanced Research and Development Authority that reviews the DSMB recommendations. Ultimately, the drug company has final authority over whether to submit its data to the Food and Drug Administration.
Moderna and Johnson & Johnson are each aiming for their vaccines to have 60 percent efficacy, which means there would need to be 60 percent fewer Covid-19 cases among vaccinated individuals in their trials. AstraZeneca’s target is 50 percent. The FDA has said any coronavirus vaccine must be at least 50 percent effective to secure approval from regulators. While the parameters of their clinical trials have similarities, there are some differences, including when and how many times the DSMB can conduct interim reviews to assess whether each vaccine works.
Pfizer is similarly aiming for its vaccine to be 60 percent effective. The company allows for four interim reviews of the data starting at 32 cases — a schedule that has been criticized by some researchers who contend it makes it easier for the company to stop the trial prematurely.
Pfizer declined to name the individuals on its monitoring committee, saying only that the group consisted of four people “with extensive experience in pediatric and adult infectious diseases and vaccine safety” and one statistician with a background in vaccine clinical trials. An unblinded team supporting its data-monitoring committee — which includes a medical monitor and statistician — will review severe cases of Covid-19 as they are received and any adverse events associated with the trial at least weekly.
- 2 min
- Rachana Pradhan
Richard Whitley, M.D. Distinguished Professor. Co-Director, Division of Pediatric Infectious Diseases. Loeb Eminent Scholar Chair in Pediatrics. Vice Chair for Research, UAB Pediatrics. Associate Director, Drug Discovery and Development, Comprehensive Cancer Center.
Jan 15, 2019 · Director of Nevada Department of Health and Human Services, Richard Whitley will continue to serve in the Sisolak administration. “I am pleased to have Director Whitley continue to serve our state at the helm of the Department of Health and Human Services,” said Governor Sisolak.
Richard Whitley, M.D. Senior Advisor for Drug Discovery and Development Richard Whitley, M.D. Richard Whitley, M.D., is a Distinguished Professor of Pediatrics, Professor of Microbiology, Medicine and Neurosurgery; Loeb Eminent Scholar Chair in Pediatrics; Co-Director, Division of Pediatric Infectious Diseases; Vice-Chair, Department of Pediatrics; Senior Scientist, Department of Gene Therapy ...
