with Paulina Firozi
Hydroxychloroquine — President Trump’s pet remedy for the novel coronavirus — may be the most-politicized prescription drug ever.
But now the drug has officially fallen from favor. Yesterday the Food and Drug Administration revoked emergency use authorization for it to be used on covid-19 patients.
Because of the decision, patients hospitalized with covid-19, the disease caused by the coronavirus, will no longer be given hydroxychloroquine distributed from the Strategic National Stockpile. The FDA is encouraging hospitals to phase out providing the drug to their patients. And stockpiles of the drug created by more than 20 states are now in limbo.
Hydroxychloroquine can still be used to treat lupus and arthritis. But the FDA said it’s “no longer reasonable” to believe the drug the president called a “game-changer” is effective in treating covid-19 or that its benefits outweigh its potential risks. The agency said it’s reversing the emergency use it had granted back in March — a time when coronavirus cases were mounting and public health experts were grasping for any treatments that showed promise.
“Clinical trials have failed to show hydroxychloroquine is effective in preventing or treating covid-19,” The Post’s Laurie McGinley and Carolyn Y. Johnson report. “A United Kingdom trial was halted in early June because of the lack of evidence that it helped hospitalized patients.”
Health experts and Democrats, long dismayed by Trump’s allegiance to the drug, gave a thumbs-up to the FDA decision.
The Infectious Diseases Society of America said it supports the move. “Our nation must remain committed to following the science,” its president, Thomas File Jr., said in a statement.
Sen. Ron Wyden (D-Ore.), top Democrat on the Senate Finance Committee, said the FDA never should have issued the emergency use authorization in the first place. He urged the Government Accountability Office, which is planning to examine the FDA’s issuance of emergency use authorizations, to make hydroxychloroquine a top priority.
“By ignoring science and caving to political pressure from the White House, the FDA stoked false hope and put American lives in danger, while damaging the agency’s reputation in the process,” Wyden said.
Senate Minority Leader Charles E. Schumer (D-N.Y.):
America: Do not listen to President Trump on any medical advice.— Chuck Schumer (@SenSchumer) June 15, 2020
His own FDA is rejecting his advice on hydroxychloroquine.
On medical issues like on so much else, he doesn’t know what he’s talking about.https://t.co/9CXZWnyV5f
Andrew Weinstein, chair of the lawyers council for the Democratic National Committee:
David Axelrod, former adviser to President Barack Obama:
It’s a blow to a medication the president had latched onto early in the pandemic.
Trump told Americans he had a “good feeling” about it, despite a lack of evidence the ant-malarial was effective against the virus, and even said he took a two-week course of the medication to try to protect himself from getting covid-19. He invited Fox News host Laura Ingraham and two doctors who are regular on-air guests to the White House to talk up the drug.
In April, Trump's coronavirus task force rush-delivered hydroxychloroquine to hospitals and pharmacies in the New York area, as well as to Detroit, New Orleans and other places where virus cases and hospitalizations were spiking.
The president also repeatedly praised the drug on Twitter and in White House meetings and briefings. One time, he asked recovered covid-19 patients if they’d tried it, saying that if a different president was promoting it, “People would say ‘Gee, isn’t that smart?’ ” Retail sales of the drug have soared.
HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents).....— Donald J. Trump (@realDonaldTrump) March 21, 2020
Trump’s wholehearted embrace of the unproven treatment even convinced Florida Gov. Ron DeSantis (R) to purchase 1 million doses of the drug, which have mostly gone unused, Politico reported.
And Rick Bright, former director of the Biomedical Advanced Research and Development Authority, said he was removed from his post because he resisted pressure from the administration to make hydroxychloroquine and other unproven drugs widely available.
Bright, who testified before Congress on the matter, alleged in an 89-page complaint released last month he was pressured to buy drugs and medical products for the nation’s stockpile of emergency medical equipment from companies linked politically to the administration.
Two medical journals recently retracted research claiming poor results from hydroxychloroquine — but that doesn’t mean the drug works.
Both the Lancet and the New England Journal of Medicine published retractions of two studies using data and analysis provided by a private company, Chicago-based Surgisphere. In both cases, the researchers said they couldn’t vouch for the underlying data.
The Lancet-published study found that hospitalized patients treated with the drug had a higher risk of death and heart problems, but it used observational data, which is less rigorous than a randomized, placebo-controlled clinical trial, Laurie reported at the time.
“The retractions raised concerns in the medical and scientific community that researchers and even prestigious medical journals are lowering their standards in a rush to publish during the pandemic,” Laurie wrote.
And now the FDA’s shift away from hydroxychloroquine boosts persistent suspicions it was all politicized to begin with.
“The initial FDA decision was fraught,” The Post’s Aaron Blake writes. “Health officials questioned its speed and raised suspicions that the agency had bent to pressure from a president who was keen on finding a quick fix — whether it was this or anything else — for the country’s coronavirus outbreak.”
“The recent issuance of the chloroquine/hydroxychloroquine EUA, in the midst of political pressure and with scant and conflicting supporting evidence, should be of serious concern,” former FDA chief scientists Luciana Borio and Jesse Goodman wrote.
Ahh, oof and ouch
AHH: People have signed up to be exposed to the coronavirus to help researchers develop a vaccine more quickly.
Many have signed up for what’s called a human challenge trial, in which researchers would inject healthy people with an experimental vaccine and then expose them to a pathogen. If it prevents these people getting sick, the study can push the development of that vaccine candidate forward, Ben Guarino and Carolyn Y. Johnson report.
There are preliminary discussions about whether to use such an approach in the rush to find a coronavirus vaccine. It’s a process fraught with ethical, scientific and philosophical questions.
“Exposure to pathogens in challenge trials is usually permitted only for diseases that aren’t fatal or that have treatments available. No such assurances exist for the coronavirus, which has killed more than 435,000 people worldwide,” they write. “ … Large-scale trials of coronavirus vaccine candidates are slated to begin this summer and fall, but they involve more conventional approaches.”
National Institutes of Health Director Francis Collins said such trials are “on the table for discussion — not on the table to start designing a plan.”
Here’s one reason they're under discussion: In a typical Phase 3 vaccine trial, participants would receive an experimental vaccine or placebo, and then researchers would wait until they had been exposed to a virus naturally in their communities. That could take some time, now that cases are declining in some hard-hit areas. But in a challenge trial, exposure is guaranteed, and there is a shorter wait time.
OOF: Public health departments say their efforts to protect Americans from the coronavirus are being severely undermined.
Two associations of local health officials released a statement warning that “public health department officials and staff have been physically threatened and politically scapegoated,” and “the vital work of public health departments is also being challenged," Lenny Bernstein, Rachel Weiner and Joel Achenbach report.
“Public health departments are facing lawsuits over their authority to close businesses, schools, and places of worship in order to protect the community at large — the very action that is credited with saving hundreds of thousands of American lives from this virus,” the National Association of County and City Health Officials and the Big Cities Health Coalition said.
Hospitalizations of covid-19 patients have reached new highs in 10 states, yet there's widespread quarantine fatigue.
“Even as the number of infections rose and hospital beds filled in some places, voices clamored for an end to mandatory mask-wearing. And relaxation of restrictions designed to curb the novel coronavirus continued,” our colleagues write.
Collins, the NIH director, acknowledged people’s quarantine fatigue but added that “the virus doesn’t care that we’re tired. The virus is still out there.”
“They’re either just over it, or they’ve come to believe it’s a phony pandemic because their own personal grandmother hasn’t been affected yet,” Andrew Noymer, an epidemiologist at the University of California at Irvine, told The Post. “People just think this is a nothingburger. So they think the risk is exaggerated.”
Vin Gupta, an assistant professor at the same University of Washington institute, pointed to political leaders that haven’t given a consistent message about mask-wearing and social distancing. “It’s as though they’re actively trying to oppose their public health professionals,” he said.
OUCH: Coronavirus patients with underlying medical conditions are 12 times more likely to die and six times more likely to be hospitalized.
The Centers for Disease Control and Prevention released data on more than 1.7 million cases and 103,700 deaths from the first four months of the pandemic. The data is consistent with initial reports that people with underlying conditions, such as heart disease and diabetes, were hit harder, Lena H. Sun reports.
The report also highlights the disparities in the impact of covid-19 between white and nonwhite people.
“Among nearly 600,000 people who were sickened and for whom the CDC has race and ethnicity information, 33 percent of patients were Hispanic, although they make up 18 percent of the U.S. population; 22 percent were black, while they constitute 13 percent of the population; and 1.3 percent were Native American or Alaskan Natives, nearly double their representation in the overall population,” Lena reports.
The CDC’s report offers a better understanding about what groups may be vulnerable, especially as states continue to reopen and some areas see surges of new cases.
The CDC found the most common underlying conditions “were heart disease (32 percent), diabetes (30 percent) and chronic lung disease (18 percent). Other preexisting conditions included liver disease, kidney disease, neurodevelopmental or intellectual disability, and immunocompromised conditions,” Lena adds.
In the states
Numerous states, including Arizona and Texas, that were among the first to reopen are seeing spikes in coronavirus cases.
On Sunday, 27 states reported a seven-day case average higher than the average the week prior, Meryl Kornfield writes for The Post’s live blog.
- Arizona reported 1,014 new cases Monday, continuing a two-week trend of record case counts, deaths and hospitalizations. The state has the third-highest rate of transmission in the country as of Monday. The state has tallied 36,705 coronavirus cases and 1,194 covid-19 deaths.
- Texas reported 2,326 covid-19 hospitalizations Sunday, a new high. The state’s Monday numbers weren’t public as of the afternoon. Texas has totaled 87,854 coronavirus cases and 1,976 deaths.”
Neither Arizona nor Texas's governor has announced plans to bring back any restrictions that have already been lifted.
Trump's take, per Rebecca Ballhaus, White House reporter for the Wall Street Journal:
Trump on the number of coronavirus cases, per pool: “If we stop testing right now, we’d have very few cases, if any.”— Rebecca Ballhaus (@rebeccaballhaus) June 15, 2020
California Gov. Gavin Newsom (D) defended his move to reopen the state even as case numbers continue to increase.
“There’s a certain point where you have to recognize you can’t be in a permanent state where people are locked away for months and months and months on end,” Newsom said.
He cited stabilizing infection numbers and the state health system’s capacity for new cases as justification for the reopening, Politico’s Jeremy B. White reports.
Newsom allowed counties across the state to resume operations, including at dine-in restaurants and nail salons “after facing weeks of rising pushback from local officials who argued the economic fallout was eclipsing public health risks,” Jeremy writes. “While business owners and many residents have cheered the reopening, some county health officers and public health experts have voiced skepticism about moving ahead as caseloads continue to rise, especially in dense urban epicenters.”
Massachusetts announced it will offer free coronavirus testing at dozens of locations for people who have recently participated in protests.
Testing will be available at more than 50 pop-up locations on Wednesday and Thursday, the Boston Globe's Matt Stout reports.
“Please, if you were at a large gathering in the last couple of weeks . . . find a testing site near you,” Baker said. “If you’re healthy and feeling fine, you should consider getting tested anyway. Preventing the spread of COVID-19 is also about protecting other people around you: moms, dads, grandparents, aunts, uncles, brothers, sisters.”
“Baker said there have been nearly 300 protests across the state where more than 100 people had gathered, a stretch that included events across Boston this past weekend,” Matt reports. “He said officials began discussing last week about ‘creating some mechanism’ to gauge whether the disease has spread amid the demonstrations, even though many people took precautions, such as wearing face coverings.”
Contact tracers in New York City won’t ask people whether they attended a protest over police violence.
“No person will be asked proactively if they attended a protest,” Avery Cohen, a spokesperson for Mayor Bill de Blasio (D), told the City.
Tens of thousands of people have protested in New York over the past few weeks — including a rally on Sunday focused on black transgender people, where participants stood closely packed together. De Blasio and other officials have voiced concerns the protests could enable the virus to spread more quickly, although some, including D.C. Mayor Muriel E. Bowser (D), have participated anyway.
“The hundreds of contact tracing workers hired by the city under de Blasio’s new ‘test and trace’ campaign have been instructed not to ask anyone who’s tested positive for covid-19 whether they recently attended a demonstration,” the City writes.
Congress on coronavirus
Top Federal Reserve officials wants lawmakers to spend more on education, health care and digital infrastructure to aid the economic recovery.
“We can’t wait 10 years for an economic recovery to reach everyone,” San Francisco Fed President Mary C. Daly said at a National Press Club event. “Inclusive growth is faster growth — and it will pay for itself in the long run.”
“Fed leaders are making two big requests of Congress: First, to be prepared to deliver more emergency aid this summer if there’s a second wave of coronavirus cases and deaths. And second, to make long-term investments that can help the nation grow faster after the covid-19 threat passes,” Heather Long reports.
In a blog post, Richmond Fed President Thomas Barkin urged further spending on child care and elderly care, as well as on community college and digital workforce training to help people find work again.
“The job losses have been the most severe for low-income black and Hispanic Americans, especially women who are the most likely to hold many of the restaurant, retail and hospitality jobs that were affected by stay-at-home orders,” Heather adds.
Here are a few more stories to catch up on this morning:
The Trump administration’s response:
- The White House push to quickly develop a coronavirus vaccine has left some public health experts worried regulators will be pressured to greenlight a vaccine candidate without evidence it’s effective, Politico’s Sarah Owermohle reports.
- The increase in new coronavirus cases is not just because of more testing, as Trump suggested yesterday, Philip Bump reports.
- Oklahoma state Rep. Jason Lowe (D), who had covid-19 early in the outbreak, called the president’s planned rally in Tulsa “reckless.” "When I confronted covid, I felt like a truck hit me. To have a rally in an enclosed stadium, it’s dangerous. It puts the campaign over the citizens of Oklahoma,” Lowe told The Post’s Steven Goff.
The price tag for coronavirus treatment:
- After three weeks in the hospital and surviving the coronavirus, Janet Mendez received an invoice for more than $400,000, the New York Times’s Joseph Goldstein reports. A hospital spokesperson said the patient received the bill in error, and that it should have instead gone straight to her insurer or to the government. “Coronavirus patients, through a series of federal aid packages, are supposed to be largely exempt from paying for the bulk of their care,” Joseph adds.
A return to normal programming… sort of:
- The 93rd Academy Awards will be delayed two months to April 25, 2021. The Academy of Motion Picture Arts and Sciences said the move is “to provide the flexibility filmmakers need to finish and release their films without being penalized for something beyond anyone’s control,” Sonia Rao writes.
- U.S. Open officials are set to announce this week the tennis tournament will begin in New York as scheduled on Aug. 31, but there will be changes, including no spectators and required rules and precautions, Liz Clarke reports.