By Glenn Ellis
(Trice Edney Wire) – In the spirit of doing my best to keep you informed on important aspects of this COVID-19 pandemic, I wanted to continue to write about things we all will have to think more and more about moving forward.
Yes indeed, we must start doing a lot of thinking. Most of it is thinking about things that we otherwise wouldn’t pay any attention to: clinical trials; antibody testing; vaccine candidates; experimental treatments.
You see folks, COVID is going to be with us for a long, long time, and it is important to get in the habit of learning as much as you can about these topics, and others. In this column, I will offer you a starting point by giving some general facts.
Clinical trials are required in order to have an FDA approved treatment or vaccine. Since the coronavirus was first identified in China in December 2019, over 1100 registered clinical trials, registered globally. Of those, 170 are solely devoted to looking for a vaccine. The rest are looking at other treatments, including antibody plasma therapy.
Out of the 170 companies, the Trump administration chose five companies to work on the development of a vaccine at “Warp Speed” (whatever that is). Even though, as of June 30th, the FDA issued guidelines calling for the inclusion of diverse populations, many of the studies are already underway, as well as, under these pandemic circumstances, we can rest assured that there will be little, or no, oversight to ensure compliance with including Blacks, and other ethnic groups. Don’t let anyone fool you, this is important. Your health status is determined 80% by the social determinants of health in the community in which you live. That is why it is good science to make sure that clinical trials for any medication or treatment includes research participants who reflect the general population that the drug or treatment is intended for. You want to look into this to inform any decision you make for yourself or you family.
Antibody testing is done following a person being infected with COVID-19. The test shows whether the person’s immune system is producing antibodies. This would be the normal response of the immune system. If virus shows up again, there are already antibodies ready to attack. With over 200 antibody tests, either in development or on the market, only 12 have been approved emergency use authorization. So, what about the other 188? Another concern is that no one knows, at this point, if the antibodies actually offer any protection, and if so, for how long? In addition, the analysis of results shows a great range of accuracy for these tests.
Vaccines are steadily advancing in the process of development. As mentioned earlier, “warp speed” is not your typical approach to vaccine development. I worry about this, in particular, because of the sensitive, and sometimes political, nature of the word. The development of the polio vaccine was the last time we had a vaccine to prevent an pandemic like this. Remember that we still don’t have an HIV/AIDS vaccine after 40 years, and the flu vaccine last season was only 45% effective following the previous year when it was only 29 percent. Still, even a vaccine that’s not 100% effective could be good enough. At the very least, vaccines do significantly reduce the severity a viral infection. With the horrible way COVID takes over the body and destroys it, a reduction in the severity of that is not a bad deal. So, you have to consider your own health status, risk factors, etc., and make the best decision.
Even for those who would previously consider themselves as “anti-vaxxers”, COVID-19 has made it necessary for all of us to think in ways, and about thongs, that haven’t had to before.
Experimental treatments are standard of care in the absence of an approved treatment. Remember the drug that President Trump touted hydroxychloroquine, and it turned out to be a dud? Well, seems like he wasn’t the went for it. There were hundreds of trials around the world trying find out if it would work. Remdesivir is another experimental medication designed to stop a virus from replicating in the body. the In times when there is no pandemic, carefully done clinical trials tell us drug’s effectiveness against an illness. Or disease. Now, there are so many “work-arounds” in clinical care: compassionate-use programs permit the use of untested treatments; older drugs are considered by doctors in never-before-seen situations; research is being rushed into publication without being peer-reviewed; and not to mention a constant stream of media reports jump on any research study result, often barely vetted, and typically, reported to us almost word-for-word from the company’s press release.
By now, whether we like it or not, we all have come to accept that things are going to be different; really different. We have to begin to get information and learn more about these things. Come on, y’all. Let’s do what we have done for so long; use good, common sense, make decisions based on the best information, and look out for each other.
Remember, I’m not a doctor. I just sound like one! Take good care of yourself and live the best life possible!
The information included in this column is for educational purposes only. I do not dispense medical advice or prescribe the use of any technique as a replacement form of treatment for physical, mental or medical problems by your doctor either directly or indirectly. Glenn Ellis, MPH is Visiting Scholar at The National Bioethics Center at Tuskegee University and a Harvard Medical School Research Bioethics Fellow.