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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Source 2
4 comments:
To clear up some confusion, I believe antibody tests determine whether the body of the person tested has created antibodies for the Covid-19 virus specifically, and if it has, that means that it has been exposed to the virus and is either in the process of fighting it or has already beaten the virus but is keeping some antibodies around in case it needs to fight that strain of virus again. That being said, antibody tests have proven to be more difficult to produce than other tests that test for the current presence of the actual virus (which would give a negative result if the person has recovered, since they would no longer have the virus in their body). From the articles I've read, vaccines will probably be cleared to use by late 2021, and will still need to be rolled out to the general population much like tests are being now, so it is imperative that tests are widely available so people with the virus can quarantine and also possibly so people who have recovered can start to return to normal. However, this does not give the FDA an excuse to rush the production of tests without properly testing (ha) their effectiveness, and I find it rather ironic that private and state level tests were blocked for "safety" reasons which appear to have gone out the window now that coronavirus is an undeniable danger.
Personally, I think tests that check if someone has antibodies to the coronavirus are just as important because that shows that that person was exposed to the virus somehow and their body developed antibodies to protect itself. Although it does give “false positives”, it is still important to know if someone has antibodies against coronavirus. Maybe those kinds of tests should be labeled differently and it should specifically say that it is not a test for whether or not the person currently has the virus but rather that it is a test for if the person has antibodies. In regards to question 2, I do think testing experimental drugs without the approval from drug approval companies is dangerous but times are desperate right now and drugs and vaccines are urgently needed if we want life to go back to normal, or somewhat normal.
Adding on to Nick, another aspect to this is that these antibody tests are being used as an emergency cure - meaning that health care workers, people on the frontline, elderly people, and (if extended) essential workers would be the ones who would receive this. This would be a temporary fix until a vaccine is found. Moreover, something that could cause a drawback is that blood transfusion might not work all the time - it depends on blood type. Some people are having some sort of reaction or rejection of the transfusion.
I think this article is quite interesting, and the fact the the FDA has allowed the situation to fester to the point of states outright banning the test illustrates how the so called "flexibility" the FDA allowed was abused. Also, if what Nick stated above is accurate, I'm not certain that these tests would have been the best method to test if someone has been exposed to the virus. If I remember correctly, there is a chance that this virus can induce an autoimmune response in infected people. Using that information, a test that just tests for presence of disease fighting antibodies would be less useful because it might be too late for the people infected. It would be useful to scientist who might need the antibodies to study to make a cure. However, the other corona virus test method seems to have a lot of false negatives because of testing error, so it seems that no test method it truly a baseline as of yet.
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