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Earlier I posted three posts about the various therapies being used to treat COVID-19 and the battle over hydroxychloroquine (HCL) — Day 115: COVID-19 How Are Treatments Coming?, Day 130: COVID-19 The clash in scientific worldviews, and Day 141: COVID-19 The HCQ+ Wars Continue. This week the HCQ wars continued with a video from the America’s Frontline Doctors summit in Washington DC being pulled down by YouTube, et al. They covered a lot of topics about the epidemic but the primary sin was to tout HCQ+ as a treatment for certain COVID-19 patients.
Ohio got into the story this week as well when the State of Ohio Board of Pharmacy prohibited the dispensing of HCQ even with a doctor’s prescription. The Republican governor urged that the order be rescinded, and it was, letting the doctor and the patient make health care decisions and not the pharmacist.
The reason HCQ has become a battleground at all is because of how we regulate drugs in America. The Food and Drug Administration sensibly has a mission of assuring that drugs sold in this country are safe for consumption. But more than that, FDA also sees its role as assuring the drug is efficacious for the purpose it is being prescribed. There is an overlap between these two because drugs have side effects to which different people are susceptible. Through trials the drugs not only are measured for efficacy but for the way in which a population is likely to react to side effects. Literally the FDA is asking the drug manufacturer to prove that “the cure is not worse than the disease.”
Once the trials are complete and the data is compiled, the FDA approves the drug for use in accordance with the data collected. This is known as “on label use”. The “label” being the literature that accompanies the drug describing the diseases for which the drug has been demonstrated as efficacious in treating and the known side effects and prevalence that a patient might experience.
Drug manufacturers publish information about their drugs and the mechanism employed to treat the disease. From this published information medical practitioners sometimes see opportunity to use the drug for a different disease or condition. When prescribed for this purpose, the drug is being used “off label” — that is, for a disease or condition for which no formal trial has been conducted and the measured results documented.
When you are dealing with a novel virus and resulting illness, all drugs applied start out “off label.” There have been no controlled trials and tests involving the disease before, so medical clinicians are relying on their understanding of how a particular drug works to anticipate how it will affect the disease process. So long as the documented side effects do not include death, the expectation is that the drug may or may not help, but it will not do more harm than good. Over time, evidence is gained about the efficacy of a drug for the treatment of a new disease and the FDA may eventually add that treatment to the “label.” The significance of adding a disease to the “label” (as I understand it) is that the manufacturer of the drug is authorized to actively market that drug as a treatment for that disease.
The FDA can ban drugs that it believes are demonstrably harmful. More often it “controls” drugs that represent a life risk if the use thereof is not supervised by a medical practitioner. And it authorizes “compassionate use” of drugs not yet demonstrated to be efficacious and safe pending trials when there is some level of evidence supporting its use and the need is great. That is where some drugs such as Remdesivir are now. But technically Remdesivir’s use in treating COVID-19 is also “off label” today.
Use of HCQ in treating COVID-19 is “off label.” It is a drug that has been around for a long time. Originally developed to treat malaria, it has been used for treating lupus and other auto-immune disorders. The reason HCQ is used by some physicians to treat COVID-19 is that what kills some patients is the body’s reaction to the virus rather than the virus itself. This is referred to as a cytokine storm. HCQ retards the reaction. The idea is that over time the body will fight off the virus even if you retard the body’s reaction to the virus. You add supplements such as zinc and antibiotics to help the body deal with conditions created by the virus even as it is more slowly responding to the virus.
This slow going process is why HCQ is generally not believed to be effective for those whose disease has progressed to ventilation or other critical care. There are some anecdotes about patients being a death’s door and coming back with the aid of HCQ. But that has not been at all routine, and biologic processes are both complex and individualistic so it will likely never be known whether, how, and why HCQ caused a positive result in those cases. The practice of clinicians such as the Frontline Doctors group in administering HCQ to patients just presenting symptoms or newly confirmed as infected through PCR testing makes more sense because it is modifying the body’s response early in the disease process.
The question in my mind, since all treatment of a novel virus is “off label”, why would any regulatory body ban the use of HCQ? The reason seems to be the one documented side effect of tachycardia in a few patients. Untreated tachycardia can lead to death or strokes, so clearly something you don’t want to have happen. That is why physicians should understand the health history of a patient to determine whether there are known heart conditions that make the side effect of tachycardia more likely to occur. If it was being suggested that HCQ be put into vending machines I could understand the concern. But prohibiting pharmacists from dispensing it with a doctor’s prescription and supervised use? That makes no sense.
We are in an off label epidemic. All treatments are being applied based on the understandings of how certain drugs affect different aspects of the disease process. The only clinical trial for many treatments is the outcomes recorded in the wards and clinics — they will never qualify as scientifically proved. Some people will respond well, others will not, based on individual factors that must be monitored and assessed. Some people if infected will work through the disease effectively with no medical intervention at all. Some will die no matter what treatment they get.
Is HCQ only a placebo? Maybe, but there is a lot data suggesting that even if it is a placebo, it is doing very little harm, and an awful lot of good. And it is not an expensive placebo, if it is one.
[Links to all my COVID-19 posts can be found here.]Published in