Series on COVID Therapy Studies – Considering Studies for COVID 19 Therapy

Series on COVID Therapy Studies – Considering Studies for COVID 19 Therapy

Current national headlines ramble constantly concerning studies and models for COVID.  Those outside of medicine or the world of research either scratch their heads or lob verbal hand grenades at one another. One side shouts “give us the medicine even it is not tested”.  The other side swears “you are killing people if you don’t test it first”.  Who do we believe?  If you end up COVID infected, what are you going to do?

We desperately need discernment based on facts and reasoned out by logic. Discernment means weighing our assessment of reality and distinguishing bad from good and good from the best.  If we start with a faulty assessment of the situation, we can get a faulty conclusion, maybe even dangerous.  If we use bad reasoning, we can turn a great assessment into another faulty conclusion.  No room for skipping a step exists.

In the case of COVID, one side wants medications like hydroxychloroquine to be studied.  The other side wants it available yesterday for anyone with COVID.  Who is right?

What is a medical study anyway?  Well, there are different types of medical studies.  A few examples include a double-blind placebo-controlled trial of a new therapy or simple case reports of a small number of individual patients or a metanalysis combining multiple studies.  Most consider the first double blind type or the metanalysis to provide the most trustworthy answers.  They look at case reports as anecdotes or clinical experience, helpful but not something to hang a guideline on.

Anyone conducting a study desires to answer some scientific question.  Maybe they want to determine the cause of a disease or its mechanism.  Maybe they want to know if a particular therapy will cure or treat the disease.  They design a test model and run some number of patients or subjects through it.  To produce a confident answer requires some combination of a good design, enough test subjects, and…. time.  For therapies, they want to know “did it help”, “did it hurt”, or “did it do nothing”.

While the desire to cure a disease like cancer does put a rush on finding successful therapies, there is no panic for society as a whole.  In the case of COVID, the intensity and society wide pressure for a cure is palpable.  No one really wants to wait, but neither does anyone want to harm a critically ill COVID patient with a toxic therapy.  So, what do we do when we are facing a brand new enemy without either tried and true weapons against it nor time to run year-long trials?

We discern and act on what we have available.

First, what information, not just gold standard studies do we have available?  In the case of hydroxychloroquine, we have years of use for other diseases providing relatively good knowledge of its safety profile. However, we don’t have years of its use against COVID or other coronaviruses.  We do have some understanding of the basic mechanisms of how the antibiotic works.  We are learning in the lab daily how it interacts with COVID infected cells.  We are learning about the effects of cytokine storm causing severe disease and death in COVID.  AND… we have early case reports and small series of cases in which hydroxychloroquine appears to treat COVID in combination with Azithromycin, another antibiotic which we know a great deal about.

Second, how much time do we have and what is at risk?  We have weeks in terms of society.  For patients in the ICU with COVID we have hours to days before they may die.  Lives are at risk.  We need therapies now.

Third, do we have enough information to act in light of the urgency?  Those supporting hydroxychloroquine claim that we have enough information to move forward.  Those opposing claim we don’t have enough information.  We don’t have time to test 1,000 or 10,000 patients over a 1 month or more time span.  We know that if we use a placebo to compare against those who get the medicine that many will die on the placebo therapy.  (The placebo is a fake therapy so that both the clinician or scientist and the patient will not know if they are getting the real therapy or a fake.)  To give anyone a placebo would be unethical in my opinion in this case.  You may disagree.

Fourth, if we move forward with therapy, how do we apply this potential success?  Do we restrict it only to a small number of experts in a small study?  Do we let anyone prescribe it without tracking the results?  Do we let governors outlaw its prescribing after they stir up a hysteria?  We should set up registry for any clinician to write the prescription, documenting the patient’s condition, and reporting the outcome.  Crowdsource what we learn so we not only save lives, but get even better at responding to this enemy.  No one needs nor should write an excessive supply for others or for themselves.  But… no one should be penalized (doctor or patient) for trying to help those who are suffering.  By criminalizing its use, we are attacking the good Samaritan doctor, the very ones we need in this crisis.

One final point, for all those complaining that we should NOT treat “off label”… we do it all the time already.  A recent physician lecture I reviewed, sponsored by the American Academy of Pediatrics, stated that 75% of what we do in pediatrics is off label anyway.  Maybe he is overstating the frequency, but I don’t believe he is far off.

Put on your boots, strap on your hydroxychloroquine guns, and start shooting judiciously.  Stop penalizing the ones trying to save us.  We can beat this together but not if we attack each other in the process.

If you agree, share this with others and send to our leaders.

 

Appendix and Disclaimer

With the onslaught by COVID and its coinciding onslaught of self-proclaimed experts with every opinion under the sun, I choose to respond with a series of research study reports so you can choose for yourself.  Each edition will bring a few studies describing possible therapies for COVID under investigation or reported in past research.  As my recent Facebook Live video noted, we do not know enough about this virus to be definite at this time.  I am not claiming any of these are the preventive or curative answer for you or your family’s safety.  I just want you to be aware of these studies and have knowledge so that you can grow in wisdom rather than stumble about in panic.

 

One huge challenge in identifying effective therapies for COVID lies in the novelty of it all. Research requires time, something of which we have little in an emerging pandemic.  We don’t have the luxury of studying 100 years of research or 10,000 past experiments.  This battle requires a great deal of extrapolation.  Extrapolation means that we take the little information we do have and attempt to use it in predicting what we don’t know.  This process takes place every time an experiment proceeds in science, but the urgency in this case makes it more frustrating than usual.  As we walk through a different possible therapy each post, keep this paragraph in mind.

 


Sanctuary Functional Medicine, under the direction of Dr Eric Potter, IFMCP MD, provides functional medicine services to Nashville, Middle Tennessee and beyond. We frequently treat patients from Kentucky, Alabama, Mississippi, Georgia, Ohio, Indiana, and more... offering the hope of healthier more abundant lives to those with chronic illness.

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7 Comments

  1. Avatar
    pam

    It’s been three weeks since I read about the success doctors in India were having with hydroxycholorquine. They had used it in conjunction with some other drugs (not azithrimycin) to save a couple in their 60s who were vacationing from ITALY. Speaking of Italy, a lot of people still don’t know that northern Italy , which was hit so hard, has a very large Chinese population who moved over to work in the leather factories when Chinese buyers started acquiring them. The Italian government had a ‘hug a Chinese’ person promotion, where even the mayor of Florence is on video encouraging people to hug Chinese people. There are videos on youtube (until they figure it out and censor them) where people (both male and female) are standing in a piazza holding up a sign that says, “I’m not a flu, I’m Chinese. Please hug me.” Now, this is not to say that every Chinese person in that area of Italy (about 100,000 of them) had the flu, but all of this happened right before this whole thing broke wide open. The media seems to be suppressing this very significant info.

    Also, I have seen studies of doctors having great success with the hydroxychloroquine, azithrimycin, and zinc combo from around the world. There is a Dr. in NY claiming to have had 100% success with over 500 patients. One of the many things I appreciate about President Trump is the “right to try” legislation he pushed for which gave terminally ill patients the right to choose if they would like to try drugs that had not yet been approved by the FDA because they were still undergoing testing. A number of people have already been saved by that right to try. It seems to me this is a similar situation and only evil people would prevent a person from having the right to try something that already has proven highly successful.

  2. Avatar
    Jill

    I have the utmost respect for your balanced and Biblical perspective. Thank you for your blog. One question that has been intriguing me though: we are told that antibiotics are of no use for viruses. In paragraph seven above you reference hydroxychloroquine as being an antibiotic, used with azithromycin, another antibiotic. Why are antibiotics being found to be successful? Does the disease in fact share characteristics of tuberculosis?

    1. Dr. Potter
      Dr. Potter

      Yes, we normally think of antibiotics as being ineffective for viruses. The intriguing aspect of hydroxychloroquine appears to be its mechanism of action. Researchers suspect that it interferes with a protein necessary for the virus to fuse with our cell membranes. Without the protein’s cooperation, the virus cannot enter the cell to replicate. I have not seen any explanation for azithromycin, but I do not it works as an anti-inflammatory besides its antibiotic effects. The disease appears to share similarities to malaria in that the virus appears to displace iron from hemoglobin (malaria ingests red cells with hemoglobin). I am looking forward to a fuller understanding of these mechanisms as research unfolds.
      Thanks for your question, Dr. Potter

    2. Dr. Potter
      Dr. Potter

      Therapies work through various mechanisms. This “antibiotic” appears to hinder viral entry into the cell.
      Dr. Potter

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