“To continue to advance the agency’s mission, and promote its independent role, we urge you to prioritize securing its leadership team, including through seeking the formal nomination and confirmation of an FDA Commissioner,” the letter says.
The letter, signed by Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, Mark McClellan and Andrew von Eschenbach, points to several key jobs the agency is facing, including modernizing vaccines, drugs and tests to keep up with coronavirus variants and implementing new tobacco regulations.
The commissioners praised acting commissioner Janet Woodcock.
They didn’t explicitly endorse a candidate in their letter, but they did describe Woodcock as “a highly effective advocate for advancing the FDA’s mission.”
“We are also grateful for Dr. Janet Woodcock’s willingness to take on the role of acting commissioner, and her commitment to FDA’s scientific mission and its career staff,” the letter says.
Woodcock, named in January to serve as acting commissioner, has been endorsed for the permanent post by many of the nation’s leading cancer doctors — including the physician who treated Biden’s son, Beau, for brain cancer.
“In broad terms, Woodcock, 72, is known for her deep experience in drug regulation and safety, and for prizing innovation, including in clinical trials, and regulatory flexibility,” my colleague Laurie McGinley reported, adding that Woodcock has strong support among patient groups because of her determination to try new treatments for devastating and rare diseases.
Yet some anti-opioid advocates have opposed Woodcock.
Activists say the agency has approved too many opioids over the years she has been there. Senators Maggie Hassan (D-N.H.), Ed Markey (D-Mass.) and Joe Manchin (D-W.V.) have been critical of how the agency approached opioid painkiller approvals under her leadership.
Josh Sharfstein, a former FDA and Maryland state official who is currently at Johns Hopkins University, has also been vetted by the administration, although multiple sources said he is no longer in the running. Sharfstein declined to comment to The Health 202. The Department of Health and Human Services didn't respond to a question about whether Sharfstein is still being considered.
Team Biden doesn’t seem to be in a huge rush to nominate an FDA chief.
Some health-care leaders and experts have expressed frustration that the process is moving so slowly amid the pandemic.
“Every month is a crucial month in the pandemic,” Scott Becker, president of the Association of Public Health Laboratories, told the New York Times. “There is so much going on regarding the vaccine, and new drugs and diagnostics. The time to have permanent leadership is now.”
Science writer Laurie Garrett:
But at least so far, the timeline mirrors that of the previous administration. Scott Gottlieb was sworn in as Trump’s first FDA commissioner in May 2017, two months after the president nominated him.
Whoever Biden eventually nominates would have to be confirmed by the Senate.
And right now, senators are in the process of trying to confirm Xavier Becerra, Biden’s nominee for HHS secretary. A floor vote on Becerra could be held next week, although a spokesman for Senate Majority Leader Chuck Schumer (D-N.Y.) said yesterday the schedule hasn’t yet been decided.
The position of health secretary is one of 18 Senate-confirmable positions at HHS. So far, Biden has named nominees for six of the 18 positions. The Senate has yet to confirm any of them.
Ahh, oof and ouch
AHH: Tomorrow marks one year since the World Health Organization declared the coronavirus a pandemic.
The Post's Health and Science team takes a look back at the early days of the pandemic, tracing how a cluster of cases in China morphed into a viral tsunami that took over the world.
As initial reports of cases emerged during the first weeks, many scientists thought that it would be relatively straightforward to isolate symptomatic cases and contain the spread. They underestimated the stealth of a virus that turned out to spread widely through asymptomatic transmission, The Post’s Joel Achenbach, Ariana Eunjung Cha and Frances Stead Sellers report.
We now know more about the virus, which has been described in more than 13,700 research papers published on the online servers medRxiv and bioRxiv, the gateway to peer-reviewed journals. That research has spurred therapeutics and successful vaccines. But there are still unanswered questions about transmission, disease severity and even the origins of the virus.
“Now a year has passed,” our colleagues write. “The pandemic continues. For how long? At this point, anyone giving a confident answer is guilty of hubris.”
OOF: Brazil’s failure to control the coronavirus poses an international threat.
Brazil has suffered more coronavirus deaths than any country outside the United States, and it has now become a breeding ground for a concerning new variant of the virus, known as P.1. The variant, which emerged in the Amazonian city of Manaus, appears to be more transmissible and possibly capable of reinfecting people who have already recovered from covid-19, The Post's Terrence McCoy reports.
The situation in Brazil is dire: ICU occupancy level in most Brazilian states is over 80 percent. And in some hospitals and clinics, nurses have had to pump patients' lungs manually because of a lack of ventilators. Brazilian President Jair Bolsonaro has repeatedly downplayed the virus, promoted fringe treatments for covid-19, and expressed skepticism about vaccines and other public health measures.
Some scientists worry that the country's failure to control the virus could breed more dangerous mutations of the virus. “The situation is unpredictable for both Brazil and the world. As viruses course through a population, they inevitably mutate,” Terrence writes. “But uncontrolled outbreaks in communities with mounting immunity, scientists say, can give rise to more dangerous variants. It’s not by coincidence that one of the world’s most virulent variants emerged in Manaus, one of the world’s hardest-hit cities.”
“If Brazil is not serious, then it will continue to affect all of the neighborhood there — and beyond,” Tedros Adhanom Ghebreyesus, director general of the World Health Organization, said last week. “This is not just about Brazil. It’s about the whole Latin America, and even beyond.”
OUCH: Four scientists say the CDC misinterpreted their research on reopening schools.
“Keeping schools closed or even partially closed, based on what we know now is unwarranted, is harming children, and has become a human rights issue,” a group of four physicians write in a USA Today op-ed objecting to new guidance from the CDC on school reopenings. The authors say the rules, which recommend hybrid elementary schools and remote high schools in areas with high transmission, have delayed a return to classrooms.
One of the authors, Tracy Beth Hoeg, is the co-author of a study on school transmission in Wisconsin, which looked at 4,876 K-12 students and 654 staff members during the pandemic. The study found that no staff members and only seven students contracted the virus in schools, even in the midst of high community coronavirus rates. Although the CDC guidance cites the Wisconsin study, the authors write, it did not “take that data and new analyses from that data into account.”
The CDC is struggling to report race and ethnicity data related to covid-19.
The inspector general for the Department of Health and Human Services is examining how the Centers for Disease Control and Prevention can better collect data on the toll of coronavirus by race and ethnicity, Politico’s Erin Banco and Darius Tahir report.
Health officials are focused on gathering more-accurate race and ethnicity data on coronavirus cases, hospitalizations and deaths, as well as demographic information on who is receiving vaccinations. This data could be helpful for understanding the impact of the virus, which has disproportionately affected communities of color (although age is a far greater risk factor for serious illness and death from covid-19).
But federal health officials are limited by data systems that rely on reporting from state and local jurisdictions. And gathering accurate race and ethnicity data has been a long-standing challenge in public health. Attention to the problem has led to some limited improvement: At the beginning of the pandemic, data was missing in three-quarters of cases. Now that number is down to about half of cases.
Some European countries frown on collecting racial data. France doesn't compile racial statistics, the New York Times recently reported, describing it as part of its commitment to universalism and treating all citizens equally under the law.
More in coronavirus news
- Alaska became the first state to open vaccine eligibility to anyone over the age of 16 who lives in or works in the state. At least a quarter of Alaska's total population is at least partially vaccinated — the highest proportion of any state. But even as the state has progressively expanded eligibility, health officials have struggled to fill thousands of open vaccine slots, the Anchorage Daily News's Morgan Krakow reports.
- Children and young people have experienced a far lesser toll from covid-19, the disease caused by the coronavirus, compared to older adults. But school closures, rigid restrictions on colleges and the disruption of normal life have exacted their own costs. Researchers have documented a fall-off in academic performance, an uptick in visits to the emergency room for mental health crises, and, in many cities, a sharp rise in crimes involving juveniles, ProPublica’s Alec MacGillis reports.
- Post Style reporters reflected on what it meant to live during a shutdown. Beyond the stories of “profound grief and heroic resolve” are countless personal and emotional losses: “The almost-9-year-old who never felt like she got to be 8. The 102-year-old who lives in mandated isolation. The massage therapist and her customers who simply crave touch.”
Elsewhere in health care
A federal task force called for expanded screenings for lung cancer for smokers and ex-smokers.
“The U.S. Preventive Services Task Force, an independent group of 16 physicians and scientists who evaluate preventive tests and medications, said people with a long history of smoking should begin getting annual low-dose CT scans at age 50, five years earlier than the group recommended in 2013. The group also broadened the definition of people it considers at high risk for the disease,” The Post’s Laurie McGinley reports.
At least 15 million people, nearly twice the current number, will be eligible for the screenings, which will be fully covered by most insurance plans with no cost-sharing for the patient. The new recommendations lower the age threshold for screening and the number of years that someone must have smoked to be eligible. The changes are likely to result in more women and Black Americans becoming eligible for screening.
Lung cancer is the No. 1 cancer killer in the United States, killing more than 135,000 people last year alone. Smoking and increasing age are the biggest risk factors, although nonsmokers can also develop the disease.
While the new recommendations were largely welcomed by lung-cancer specialists, some physicians have raised concerns that the screenings could result in more false positives, which can lead to costly and invasive follow-up procedures.