Red tape is once again preventing the deployment of tests that could get our economy back up and running. Action Alert!
The COVID-19 pandemic has had a profound impact on the American economy, but innovation may offer a way out: simple to use, at-home COVID-19 tests could allow businesses and schools to resume normal operations. Unfortunately, the FDA is standing in the way, insisting that a certain threshold of accuracy be attained. This reliance on bureaucratic red tape is what marred the agency’s early response to COVID-19 testing, and it seems as though the agency has not learned its lesson. The FDA needs to get out of the way so these rapid tests can be deployed.
Writing in The New York Times, Professor Laurence Koltikoff of Boston University and Michael Mina of Harvard’s T.H. Chan School of Public Health describe new testing being developed by several companies (credit also to John Goodman of the Goodman Institute for alerting us to this story). One is a paper-strip test that is inexpensive and can be used every day. You simply spit into a tube, insert a small piece of paper embedded with a protein, and if you’re infected, the strip of paper will change color within 15 minutes. The price per person would be between $1 and $5 dollars a day. Infections could then be confirmed with the polymerase chain-reaction (PCR) swab test, and infected individuals would quarantine until the daily test turned negative.
Individuals could take time-stamped photos of daily negative tests to return to work or school, or for admission into movie theaters, restaurants, or other businesses.
These daily tests are not as accurate as the PCR nasal swab tests currently being used. The rapid tests catch an infection at its peak, but they may not be sensitive enough to detect the virus in a person who is in the early or late stages of infection, when viral loads are lower and the chance for spreading the virus is smaller. According to Mina, “As long as you’re using the test on a pretty frequent basis, you will be more likely than not to catch the person on the day they might go out and transmit. And they’ll know to stay home.”
But the FDA is blocking the widespread deployment of these tests. Recently, the agency released approval criteria for at-home COVID tests, noting that, “While the recommended sensitivity for these non-lab tests is lower than lab-based tests, the tremendous benefits of broader access to simple and fast testing options generally outweighs this risk.” It is an interesting assertion, given the guidelines provided by the FDA are a mere five percent lower than the sensitivity required by PCR and other molecular tests. According to Michael Mina, these new standards will still block innovation: “The software [required by the FDA guidelines] alone will pose an incredibly large hurdle for many. Unfortunately the template does not offer this type of ‘new’ avenue that I think is going to be necessary if we want to see truly $1 daily tests become a reality.”
To us it seems like the FDA made superficial changes to the requirements for at-home tests so the agency could boast that it is allowing for innovation, when it is doing anything but.
The PCR test may be more accurate, but it has many other problems. The test is expensive ($50-$150), it causes discomfort, you need to go to a lab or other location for a technician to perform the test, and then you need to wait five days to a week or longer for results—during which time you might be spreading the virus if infected or you may even contract the virus, rendering the test results useless. All of this explains why few people are actually getting tested: the CDC has reported that nine of ten infected Americans never get tested.
In short, the FDA has overseen the creation of a fairly accurate COVID-19 test that few people are using. New rapid tests could allow us to test large numbers of people cheaply and safely so we can begin to reopen the economy. Why is the FDA standing in the way?
This isn’t the first time the FDA, charged with protecting and promoting public health, has bungled the response to COVID-19 by inflexibly applying bureaucratic rules and preventing companies from innovating. This has to stop.
The FDA’s mismanagement of the COVID testing situation follows a pattern of ineptitude:
- FDA is actively attempting to ban bioidentical estriol and other hormones critical for women.
- FDA is working to destroy homeopathic treatments.
- The FDA and their partner in crime, the FTC, are gagging doctors and clinics from telling their patients and the public about natural methods of treating and preventing COVID-19, for which there are no effective pharmaceutical treatments.
We need to reform a healthcare system that not only bars the use, but even the mention, of natural remedies like compounded bioidentical hormones that have not been, and never can be, put through the multi-billion dollar FDA approval process, because as natural substances they cannot be fully patented.
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