Former CDC Director Tom Frieden, president and CEO of Resolve to Save Lives
Biopharmaceutical companies that have received billions of dollars from U.S. taxpayers to support COVID-19 vaccine research and development are not being transparent enough with the American public and should share their full study protocols, the former head of the U.S. Centers for Disease Control and Prevention said.
"I don't see any valid reason for them not to do so," said Tom Frieden, who ran the CDC for eight years during the Obama administration.
Frieden is now president and CEO of Resolve to Save Lives, a nonprofit global public health initiative. He was speaking at a Sept. 15 online briefing hosted by the Infectious Diseases Society of America.
The former CDC chief said he was particularly concerned when one company's CEO — AstraZeneca PLC's Pascal Soriot — provided more details to investors about a serious adverse event in the company's phase 3 COVID-19 vaccine trial than to the U.S. taxpayers who are supporting the study.
Soriot told investors that the study participant who received the company's experimental vaccine in the trial experienced neurological symptoms consistent with transverse myelitis, an inflammation of the spinal cord, Stat News reported Sept. 9. But neither AstraZeneca nor its partner, the University of Oxford, would publicly disclose details about the adverse event.
"That's not acceptable," Frieden said. "We need radical transparency here. We need complete transparency because sunlight is a great disinfectant. Sunlight can shine down and kind of get rid of the shadows of suspicion that are all too present in the current days."
He noted that most of the COVID-19 vaccines are using new technology platforms, such as messenger RNA and DNA, which have never been used in humans before now.
"So there's a lot we don't know," Frieden said. "We don't even know what adverse events to look for in these vaccines. We're not sure of the correlates of protection. We think neutralizing antibodies are going to correlate with protection, but that's just a theory. Until we have a lot more data, we won't know that that's the case. And it's an important question."
Any potential problems with the COVID-19 vaccines should be discussed and assessed openly so companies "can roll out a vaccine being completely honest and open with people about what we know, what we don't know, what we're finding, when we're finding it," Frieden said.
He called on all the COVID-19 vaccine manufacturers to transparently post their study protocols, including those for assessing safety and efficacy signals, and to announce when the independent data and safety monitoring boards are meeting and what criteria they are using to make decisions.
"These are knowable things," Frieden said. "And they should be in the public domain."
Scientific expertise missing
What has been missing in the U.S. COVID-19 response is consistent data-driven, science-based expertise "speaking regularly, daily or multiple times a week, explaining what we know, how we know it, what we're learning, when we'll learn it," Frieden said.
"If that were happening, we would see less division in this country; we would see more unity and understanding," he said.
Frieden said there have been "clear episodes of political interference" at the U.S. Food and Drug Administration and the CDC.
"We've seen the FDA issue approvals in ways that are not based on science," he said. "And we've seen the CDC be forced to put things on its website that are not scientifically defensible, and that's a huge problem. That's a problem regardless of what party you're in. That's a problem because you're undermining Americans' trust in some of our most important institutions."
It also endangers the health of all Americans, he added.
FDA Commissioner Stephen Hahn and CDC Director Robert Redfield have both insisted that their decisions have been guided by science and not politics.
Frieden took issue with reports that Michael Caputo, assistant secretary for public affairs at the U.S. Department of Health and Human Services, had sought to edit and delay CDC reports and had disparaged the agency's scientists, accusing them without evidence of being part of an effort to undermine President Donald Trump's chances for reelection.
"I know the doctors and scientists at CDC well," Frieden said. "They are devoted to stop any disease wherever and whenever it occurs. They're not disloyal to the administration. They are loyal to science."
The House Select Subcommittee on the Coronavirus Crisis opened an investigation into whether there has been political interference with the CDC's reports. Democratic leaders of the Energy and Commerce Committee asked HHS Secretary Alex Azar to meet with them on the matter.
Senate Minority Leader Chuck Schumer, D-N.Y., went further, calling for Azar to resign Sept. 15.
Caputo apologized to some HHS staff on Sept. 15 and was considering taking a medical leave, Politico reported, citing unnamed sources.
Azar told the Tennessean newspaper on Sept. 15 that Caputo's claim of "sedition" about CDC scientists was "concerning," but he has not otherwise commented publicly on the matter.