US Needs Plan to Coordinate Research Before Next Pandemic, Officials Say

Melva Mlambo, right, and Puseletso Lesofi, both medical scientists prepare to sequence COVID-19 omicron samples at the Ndlovu Research Center in Elandsdoorn, South Africa, on Dec. 8, 2021. Jerome Delay/AP Photo, File

Public health officials say the United States needs a plan and infrastructure to avoid the fragmented response to a new disease that marked its response to the COVID pandemic.

“We don’t have a systemic approach to medical product testing,” said Dr. Janet Woodcock, principal deputy commissioner for the U.S. Food and Drug Administration (FDA).

Dr. Mark McClellan, director of the Margolis Center at Duke University and a former FDA commissioner, agreed. He said public health officials should work with state and local offices to devise strategies and set up systems to streamline necessary research for the next virus.

“We didn’t have, and still don’t have, a unitized response,” McClellan said.

The pair participated in a forum hosted by the American Enterprise Institute (AEI) think tank on June 30. The forum moderator, Dr. Brian Miller of AEI, believes such discussions are the first step toward solving the problem. He said public and private health care entities need to communicate more.

Janet Woodcock, Principal Deputy Commissioner of the U.S. Food and Drug Administration, said the United States needs to implement a better system for public and private health care agencies to share information. Here she is shown at a Senate Health, Education, Labor, and Pensions Committee on July 20, 2021. Stefani Reynolds/POOL/AFP via Getty Images

“Public health infrastructure operated largely in a silo [during the pandemic],” Miller said.

Woodcock said the development of therapeutics and vaccines for COVID was hampered by a system that prevents centralization.

She said the United Kingdom, with its National Health Service, could gather and evaluate data and implement what was learned more quickly than the United States. She said the FDA was criticized for using research from Sweden and Israel, but they had the data available sooner than American researchers.

“We celebrate our federated approach, but sometimes we’re a victim of it,” Woodcock said.

Miller agreed.

“We are a country of countries in many ways,” he said.

McClellan said the problem is rooted in federal health care agencies with separate missions and funding. They don’t regularly communicate. So, they had to scramble to get the data when the pandemic came along. He said the problem was worse in the early days of the pandemic.

Chief clinical officer John Corman MD at Virginia Mason administers a dose of the Pfizer Covid-19 vaccine at the Amazon Meeting Center in downtown Seattle, Washington, on Jan. 24, 2021. GRANT HINDSLEY/AFP via Getty Images

“This one didn’t quite come together,” he said.

According to McClellan, the Centers for Disease Control and Prevention (CDC), FDA, and the National Institutes for Health (NIH) have similar but distinct missions. With the CDC focused on communicable diseases, the FDA regulating medicines and food, and the NIH doing research, it’s understandable that they don’t always know what information the others have.

For example, he said the CDC’s mission to protect Americans from diseases that may present a health, safety, or security threat is very broad. So, it works with various research facilities, scientists, and others who can help with that mission.

He said the agency often oversees state and local agencies that receive federal funding. Gathering and organizing data from so many disparate sources is difficult.

“It’s understandable that it’s hard for them to put that all together. It’s a very broad mission,” McClellan said.

Agencies Need Answers

Woodcock added that there can be hundreds of studies at any time. She said they need a system for getting information to answer health officials’ questions when dealing with a new challenge. The lack of open lines of communication hampered that work.

“We had tens of thousands of people involved in trials (during the pandemic) that couldn’t answer the questions,” she said.

She said the pharmaceutical industry has such research infrastructure and provided much of the data her agency used to evaluate various tests, treatments, and vaccines.

She said part of the solution would be to coordinate existing efforts so that the data can be gathered and assessed quickly. Then, the information must be provided to local communities. She said the best way to do that will differ depending on the community.

For example, Woodcock said that in one community, the FDA found that emergency medical personnel were able to connect federal officials with local health care providers. She said the ambulance crews knew the community and who were the best conduits for passing and receiving information.

Pragmatism, Flexibility are A Must

She agreed with McClellan’s suggestion that agricultural extension services might be an effective means of communication in rural areas.

“We need to be pragmatic, flexible, and ready to go,” she said. “That’s creativity. We’ve got to think of who’s capable.”

Ultimately, they agreed that a framework needs to be developed before the next pandemic.

Woodcock said the system must produce reliable, evidence-based information in a timely manner. It is something that can and should be done as soon as possible, she said.

Like the European countries, McClellan said that the United States already has the information and means of coordinating the work. He said separate agencies are already doing some of the work. The United States needs a plan to bring it all together, he said.

“We do things like this now. We just haven’t done it intentionally,” he said.