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.