On the menu today: Your family is coming over for Christmas in a few days, you’d prefer to have a few Covid-19 tests done to make sure nobody’s walking around asymptomatic . . . and in most of the U.S., you’re screwed because no one can find any tests. Welcome to the pandemic mess of the 2021 holidays, brought to you by a tone-deaf, oblivious administration and a federal bureaucracy that is still dragging its feet in approving tests, even more than two years into this pandemic. Also, a somewhat surprising endorsement of vaccines and boosters.
The FDA’s Covid-Test Failure
This week, tens of millions of Americans are preparing to visit relatives for the Christmas holiday. With 496 million Covid-vaccination shots administered so far and roughly 52 million Americans having been infected and having some degree of natural immunity, we’re much more protected against the virus than we were at this time last year. But as families gather, Grandma and Grandpa are getting up there in years, maybe Aunt Edna had cancer treatments earlier this year, maybe Uncle Louie is immunocompromised, and all around the dinner table, family members live with various comorbidities. So while a run-in with Covid-19 probably wouldn’t be fatal at this point . . . lots of Americans have good reasons to avoid encountering it or minimizing exposure to an infected person if they can.
Having a lot of fast, easy-to-use Covid-19 tests around right now sure would make things easier and put a lot of minds at ease. Forewarned is forearmed. In fact, the CDC specifically recommends: “Testing can give you information about your risk of spreading COVID-19. Consider using a self-test before joining indoor gatherings with others who are not in your household.” Last Friday, CDC director Rochelle Walensky urged, “For that extra reassurance as we have more disease in this country right now, do a test and make sure that you’re negative before you mix and gather in different households.”
But in large swaths of the country, if you’ve tried to find a Covid-19 test at your local drugstore in the past few weeks, you’ve been out of luck. The Biden administration spent the past weeks urging Americans to take Covid-19 tests, without bothering to check to see if regions had adequate supplies of those tests.
The Philadelphia Department of Health is giving out free at-home test kits at nine pop-up clinics throughout the city this week, with a goal of handing out 24,000 before Christmas. Hundreds of people stood in line outside libraries and recreation centers Monday for the kits, which each contain two COVID tests, and supplies quickly ran out, leaving dozens standing out in the cold, empty-handed. City officials encouraged anyone who had waited for a test without getting one Monday to try again another day this week.
And most Big Apple pharmacies visited by The Post on Monday were completely out of stock, with one Brooklyn location saying it sold its entire inventory — 2,000 kits — in just two days. At one Brooklyn pharmacy, the tests were going for $39 — with the store saying it’s paying more just to be able to get its hands on them as the highly transmissible Omicron variant rages with Christmas approaching. Some other stores had their prices for the tests marked up to as much as double the usual cost. Still, most retailers seemed to keep true to the suggested retail price, if they even had kits to peddle.
Finding a rapid, at-home COVID-19 test has become nearly impossible in the DMV [District of Columbia, Maryland, and Virginia. Regionally, the sought-after test kits have sold out, leaving store shelves empty, but that hasn’t dampened demand. The shortage is hitting both small neighborhood pharmacies and national chains alike. As appointments for testing have filled up, many people have tried to turn to rapid tests at home to test themselves.
Columbus, Ohio: “Columbus Public Health announced Monday that it won’t be able to receive another shipment of free COVID-19 tests from the Ohio Department of Health until January.”
And trying to get a test at the “minute clinic” at your local drugstore probably won’t work either, according to the Wall Street Journal: “Websites for CVS and Walgreens showed some parts of the country with no available testing appointments until later next week or more than a week out. CVS said people might need to wait a couple of days to get a test appointment in places where demand is high. A Walgreens spokeswoman said availability varies by region.”
It’s a similar story in Connecticut, Saint Louis, the Pittsburgh area, Dallas . . . you get the idea.
As noted, this is technically Year Three of this pandemic. This administration keeps telling us how focused it is on resolving the pandemic, but then keeps getting blindsided by new problems. (As Kamala Harris put it, “We didn’t see Delta coming. I think most scientists did not — upon whose advice and direction we have relied — didn’t see Delta coming. We didn’t see Omicron coming.”)
Today, the White House announced that, “The President is announcing his Administration will purchase a half-billion at-home, rapid tests this winter to be distributed for free to Americans who want them, with the initial delivery starting in January 2022. The Administration will stand up a website where Americans can go to get at-home tests delivered to their home — for free.”
(Recall that two weeks ago, Jen Psaki scoffed at a version of this proposal when a reporter suggested it. “Should we just send one to every American? Then what — then what happens if you — if every American has one test? How much does that cost, and then what happens after that?”)
This mess was entirely predictable. In early September, the CDC sent out an official notice warning that, “There is currently a temporary shortage in point-of-care and over-the-counter test supplies. To help preserve rapid test kits and supplies and meet the current test demand, CDC recommends the use of laboratory-based testing whenever possible.” A few days later, the New York Times’ David Leonhardt wrote about the shortage of test supplies. In October, Reuters wrote about the shortage of test supplies. In November, ProPublica wrote about the shortage of test supplies. Do you notice a pattern here?
Having a lot of tests available starting sometime in January is better than nothing, but the Omicron wave is already here — that variant made up 73 percent of new infections last week. At the start of November, the country was averaging about 71,000 new cases per day. Yesterday, the seven-day average hit more than 145,000. Based upon the quick rise and quick decline in cases in South Africa, it’s possible that the Omicron wave will come and go by the time the new orders of tests get delivered.
This appears to once again be a story of bureaucratic failure:
While developing a rapid test that detects the coronavirus in someone’s saliva, Blink Science, a Florida-based startup, heard something startling: The Food and Drug Administration had more than 3,000 emergency use authorization applications and didn’t have the resources to get through them.
Some experts say the FDA’s approach to clearing rapid tests has been onerous and overly focused on exceptional accuracy to detect positive results, rather than on what would really benefit people en masse: speedy results. The main use of rapid tests is to screen people so they can safely attend work, school, meetings or gatherings. This screening can then be followed up with a more sensitive, lab-based polymerase chain reaction (PCR) test for diagnosis.
The FDA has authorized just 12 over-the-counter options for rapid tests.
ProPublica offered a horror story of a medical company that developed what it believes is an inexpensive, fast, accurate testing system . . . and has run into a brick wall of unresponsive federal bureaucracy in trying to get its test approved:
After the FDA put out a call for more rapid tests in the summer of 2020, Los Angeles-based biotech company WHPM, Inc. began working on one. They did a peer-reviewed trial following the agency’s directions, then submitted the results this past March.
In late May, WHPM head of international sales Chris Patterson said, the company got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies, and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be “deprioritized,” or moved to the back of the line.
“We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,” said Patterson. Meanwhile, the WHPM rapid test has been approved in Mexico and the European Union, where the company has received large orders.
An FDA scientist who vetted COVID-19 test applications told ProPublica he became so frustrated by delays that he quit the agency earlier this year. “They’re neither denying the bad ones or approving the good ones,” he said, asking to remain anonymous because his current work requires dealing with the agency.
There is little indication that the FDA recognizes that time is of the essence when it comes to products attempting to mitigate an ongoing pandemic: “An outside review of the [Emergency Use Authorization] process conducted by the consulting firm Booz Allen Hamilton, which found that the median number of days it took the FDA to issue a decision on original applications rose to 99 in November 2020 from 29 the previous April, with denials taking substantially longer than authorizations.” If the agency is going to reject a product, it should do so quickly so that the applicant can get back to the drawing board and make adjustments!
You may have noticed that whenever this administration runs into a serious problem, it prefers to blame some corner of the private sector.
President Biden blames oil companies for high gas prices. Jen Psaki argues that your higher grocery bills are caused by “the greed of meat conglomerates.” Pete Buttigieg says our supply-chain issues can be partially blamed on companies’ not offering employees enough child-care options.
You notice that this administration never says, “The federal government has failed to fulfill its duties” or “Policies we enacted are having some unforeseen bad consequences.” To hear Team Biden tell it, the U.S. is blessed with a nimble, efficient, wise, speedy, and astute federal government and is just beset by all kinds of wicked, selfish, and bumbling forces in the private sector.
I doubt this is the case in many circumstances at all, but this is particularly not the case in the circumstances of Covid-19 testing. Medical companies came up with hundreds of proposals, but the FDA took its time in approving only a handful. And that’s why Americans have twelve kinds of self-administered antigen tests for Covid-19 available, while Europeans have 39.
ADDENDUM: Thank you, President Trump:
“Both the president and I are vaxxed, and, did you get the booster?” O’Reilly asked.
“Yes,” Trump replied.
O’Reilly then said, “I got it, too.”
When some in the Dallas crowd started hooting about that, Trump told them to stop. He then claimed that the negative noise only came “from a very tiny group over there,” as he pointed to his left.
Trump also said during the same show, “We saved tens of millions worldwide by creating the vaccine.”
“It would have been like the Spanish flu without it. . . . We should take credit for it, and you play right into their hands” when you question the vaccine’s value, he added.
Don’t play into their hands! Get vaxxed and boosted and tell everyone you did so with pride!