Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.
FDA Drowned in ‘Junk Science’
Journalist Katherine Eban’s latest piece for Vanity Fair charts the trajectory of FDA Commissioner Stephen Hahn, MD, from being beaten down by President Trump to eventually standing up for science — and all the odd requests he endured in between, staining the agency’s once-sterling international reputation.
Hahn came to the helm of the FDA in mid-December 2019, just before the coronavirus pandemic broke out. Early in the pandemic, the agency was forced to entertain a “tsunami of randoms” when it came to pitches for COVID therapy — which was made easier by a new White House email address created for the express purpose of routing “VIP” COVID pitches to the FDA and other agencies.
It became a direct line for “hawkers of dubious COVID-19 nostrums and tests,” one FDA official said. Trump’s ex-wife Marla Maples was promoting a rapid antibody test on behalf of a North Carolina doctor. A ventilator company with ties to Ivanka Trump was “willing and WANTS to help produce ventilators for adults ASAP but needs FDA-expedited assistance,” according to an email from a White House special assistant.
And who could forget the agency’s hydroxychloroquine debacle?
Meanwhile, Hahn was battling Health and Human Services Secretary Alex Azar, MD, who was determined to win Trump’s support at all costs. One senior HHS official described Azar as having a “triple black belt” in bureaucratic infighting. Azar had insisted that Hahn retain Keagan Lenihan as his chief of staff, though she turned out to be a “spy,” said one HHS official. “At the end of the day, she was working for Azar.”
Hahn confidentially described the administration as “evil” to colleagues, according to Eban, best known for her generic drug industry exposé, Bottle of Lies.
Sorting Out COVID Variants
Correspondent Kai Kupferschmidt sorts through the latest on coronavirus variants of concern in an article for Science.
While the B.1.1.7 variant first identified in England is spreading rapidly around the world, researchers are also monitoring others including 501Y.V2 in South Africa and P.1 in Brazil.
All three variants share a mutation called N501Y in the viral spike protein — the key it uses to unlock host cells. However, this mutation also occurs in some variants that don’t spread faster, suggesting it doesn’t operate in isolation. Kristian Andersen, PhD, of Scripps Research in La Jolla, California, said N501Y “might be innocent, except maybe when she’s hanging with her bad friends.”
The 501Y.V2 variant in South Africa has additional mutations, E484K and K417N, both of which also alter the spike protein. This variant has been shown in lab studies to reduce the effectiveness of monoclonal antibodies, and possibly convalescent plasma, against the virus.
The P.1 variant detected in Manaus, Brazil (it’s also been detected in travelers arriving in Japan from Brazil) has a similar constellation of mutations and emerged in a city with high levels of immunity. An earlier paper in Science estimated that three-quarters of Manaus’s inhabitants had been infected with the virus — yet recently, its hospitals have been filling up once again.
The new variant may have nothing to do with the new surge in infections, Kupferschmidt wrote. It could just be that immunity is waning, or that there have been other changes in behavior that led to spread. More study to determine the variant’s effects is ongoing, he wrote.
There’s no evidence yet that these variants will resist COVID-19 vaccines, said Philip Krause, MD, who chairs a World Health Organization working group on COVID-19 vaccines. “The not-so-good news is that the rapid evolution of these variants suggests that if it is possible for the virus to evolve into a vaccine-resistant phenotype, this may happen sooner than we like.”
Vaccine Distribution Chaos
States only learn how many doses of COVID-19 vaccines they’ll receive one week at a time, leading to cancelled appointments and other problems, ProPublica reports.
That decision was made by Operation Warp Speed’s distribution chief, Gen. Gustave Perna, who was hesitant to count on supplies before they were ready. “Every week I get an update, I know exactly what has been approved by the FDA for final distribution,” Perna said in a Dec. 12 briefing. “I will not allow those estimates to go forward for speculation because I want people to focus on what is actually available.”
State health officials told ProPublica that the policy has led to chaos. Sometimes, they can’t use all the doses sent to them. Sometimes they need to cancel appointments. It’s also difficult to plan for the second doses that are needed three to four weeks after the first dose.
For example, for this coming week, Michigan was initially told on Tuesday it would get 62,400 doses of the Pfizer vaccine, but on Wednesday it was told it would get 60,000 doses of the Moderna vaccine that were initially supposed to go to long-term care facilities. That left the Michigan health department with just one day to decide where to send the extra doses.
On the opposite end of the spectrum, Mount Sinai Health System in New York had to cancel scores of appointments last week because shipments fell short.
Companies are supposed to give weekly or daily updates on vaccine supply to the federal government, which then divides the total supply between states based on population of residents 18 or older. For each of the past 3 weeks, regulators have received about 4.3 million shots.
Pfizer and Moderna are each contracted to deliver 100 million doses each by the end of March. Just 31.2 million in total were delivered as of Jan. 15.
Source: MedicalNewsToday.com
