With the coronavirus pandemic, the FDA has been working to speed up the availability of tests across the US. They have done this by skipping the usual quality checks they do to make sure tests are not faulty. This has, obviously, caused some problems. Many antibody tests used to determine whether a person has been exposed to the virus are being released into the market without being checked for accuracy, and too many false-positives have been the result. The antibody tests do not determine whether or not a person has the COVID-19 virus, but it checks for antibodies that would indicate exposure. The problem with the false positives is that people now want to know whether or not they have the virus, especially if they end up being asymptomatic. This means that more people are now wanting the actual tests for coronavirus, which we all know are in incredibly short supply.
While I understand what the FDA is trying to do, it seems to be having a counter-affect, and causing almost more of a panic. Health providers in New York are actually being warned against using these antibody tests due to their inaccuracy. I think that this kind of approach the FDA is taking may be more beneficial in other areas of working against this pandemic. For example, with the vaccine everyone is hoping will come faster than actually possible. It usually takes up to 7 years to produce a marketable vaccine, so many companies, such as our local Gilead, are working to make and test their experimental vaccines despite not having been approved by any drug companies. I think that in a time like this, it might be advisable to allow well-known and trusted drug companies to pass the time-consuming tests in order to help people all over the world.
How do you feel about the antibody test problems? Should the FDA have waived the tests?
Do you think testing experimental drugs without approval from drug approval companies is too dangerous?
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