(2021-12-23) The Biden Administration Rejected An October Proposal For Free Rapid Tests For The Holidays

The Biden Administration Rejected an October Proposal for “Free Rapid Tests for the Holidays”. On October 22, a group of COVID-19 testing experts joined a Zoom call with officials from the Biden administration and presented a strategy for overhauling America’s approach to testing.

The plan called for an estimated 732 million tests per month, a number that would require a major ramp-up of manufacturing capacity

The antigen rapid tests at the center of the plan can detect the virus when patients are at their most contagious. Though less sensitive than polymerase chain reaction (PCR) laboratory tests, which can detect the virus’s genetic material at any stage of infection, antigen tests provide a quick snapshot in time for those seeking assurance that they are safe to travel or won’t accidentally infect vulnerable relatives.

Yesterday, President Joe Biden told David Muir of ABC News, “I wish I had thought about ordering” 500 million at-home tests “two months ago.” But the proposal shared at the meeting in October, disclosed here for the first time, included a “Bold Plan for Impact” and a provision for “Every American Household to Receive Free Rapid Tests for the Holidays/New Year.

Three days after the meeting, on October 25, the COVID-19 testing experts received a back channel communication from a White House official. Their big, bold idea for free home tests for all Americans to avoid a holiday surge, they were told, was dead.

“We did not have capacity to manufacture over-the-counter tests at that scale.” The problem, in essence, was twofold: The FDA had authorized only a handful of different home tests, and those it had authorized could not increase manufacturing fast enough.

Four days after that, White House press secretary Jen Psaki seemed to deride the very idea of free nationwide home tests

The fury with which public-health experts greeted Psaki’s comments reflected their longstanding frustration with an administration that, in their view, has put almost all its focus on vaccinating the American public, at the expense of other critical aspects of the response, from getting shots into arms overseas to making high-quality masks (N-95) widely available

“It’s undeniable that [the administration] took a vaccine-only approach,” said Dr. Michael Mina, a vocal advocate for rapid testing who attended the October White House meeting.

On Tuesday, faced with a terrifying omicron surge, a stampede of holiday travel, and images of Americans waiting in hours-long testing lines from Brooklyn to Miami, Biden finally announced that his administration would do what many experts had been urging since the earliest days of the COVID-19 pandemic: Give Americans the ability to diagnose themselves

the president’s announcement on Tuesday struck many experts as “an exemplar of too little, too late,” as Dr. Eric Topol.

Three experts who interacted with the White House came to believe that the Biden administration had deprioritized rapid testing, partly out of concern that people would opt for that instead of getting vaccinated

It has fallen to a small but determined group of advocates to argue that rapid testing is an essential strategic tool, and should be pursued as aggressively as vaccinations. Chief among them is Dr. Michael Mina

He is now chief science officer at a Miami-based diagnostic company, eMed.

His journey began as early as January 2020, when he saw clearly that Boston was going to need COVID tests it didn’t have. He sought funding from Brigham and Women’s Hospital to build a test. “They thought it was a joke,” he said of some of the hospital’s pathology officials

Once Mina began to advocate for rapid home tests, he encountered the same mindset: doctors “trying to guard their domain.” Some doctors had long opposed home testing, even for pregnancy and HIV, arguing that patients who learned on their own about a given condition would not be able to act on the information effectively.

A similar view prevailed within the FDA. The agency had approved PCR tests with perfect sensitivity that could tell people for certain whether they were infected with SARS-CoV-2. Those tests, while crucial, were expensive, hard to access, and tended to take days to yield results, meaning that they had little mitigating effect on spread. By contrast, low-cost antigen tests, which patients could administer themselves at home, were less sensitive.

Ultra-accurate tests that take a long time to process have a clinical benefit for treating patients, but they are of no help in deciding if you should go to work or get on a plane that day.

Doctors and regulators weren’t the only ones with qualms about rapid tests, which have been generally viewed as unreliable thanks to shaky reviews, bad press over recalls, and widespread confusion over what they can and cannot measure

Many Americans also recall that the Trump White House relied heavily on rapid tests in order to avoid canceling events or making them virtual, only to wind up swarmed with COVID cases. Only later did it turn out that Trump himself had ignored a positive test result and may well have sparked a September 2020 superspreader event in the Rose Garden himself. “That Rose Garden event created so much uncertainty around rapid tests,” says Mina. “It was the worst publicity.” But lost in the uproar was the fact that “the Trump administration tested every day before work and managed to go a full six months without having outbreaks,” he says. “No reporter ever writes about the outbreak that doesn’t happen. It’s not interesting.”

As the FDA lumbered along, rejecting antigen tests that inevitably failed to compete for accuracy with PCR tests, rapid home tests became ubiquitous in Europe

With roughly 200 different home tests approved in Europe, the price is as low as $1.50 a test, said Schatz.

By contrast, some of the biggest testing companies, from Siemens to Roche, have not had rapid tests authorized by the FDA yet.

*Once the Biden administration came into office, Mina, like many experts, saw an opportunity to transform the nation’s testing infrastructure.

In January, Mina and Dr. Steven Phillips of the COVID Collaborative sent the new administration a 23-page document outlining a national rapid-testing strategy*

But the Biden administration, said Phillips, lacked “the imagination to have an Operation Warp Speed-level program for testing.”

So far, the FDA has authorized only 13 rapid antigen tests.