OK, I am not a Dr. Dr.- just a pharmacist with a Ph.D. in a dept. of pharmacy practice for the past 27 years, so maybe Dr. Oz outguns me. But even though I’m a cripple and 63, I’m fairly sure I can still kick his ass…So I can live with it.
One thing to remember- the FDA is an agency of the executive branch; in other words, the President sets their budget and appoints their people. They are political, because they have to be.
As to Hydroxychloroquine Sulfate;
Off-Label Uses: Coronavirus disease 2019 (COVID-19); Level of Evidence [C]
Level of Evidence Definitions: Level of Evidence Scale (A, B, C & G)
C=“Evidence from observational studies (eg, retrospective case series/reports providing significant impact on patient care), unsystematic clinical experience, or from potentially flawed randomized, controlled trials (eg, when limited options exist for condition). Any estimate of effect is uncertain.”
Or, to paraphrase a post, We don’t know.
What we do know is that this isn’t an over the counter (OTC) medication. As I tell my students , drugs are prescription-only for a very simple reason- they can, somehow or someway, kill you. NO drug therapy is risk free- it is always a cost|benefit assessment.
We don’t have diddly, in my humble opinion, of reliable evidence for this molecule as an antiviral. The size of the studies makes them VERY susceptible to all sorts of bias. Most drugs being tested for being allowed on the market are evaluated in 1-5,000 people, depending on animal toxicity studies. So there’s rather wobbly evidence for this molecule doing anything (I’m skipping null hypothesis, Type I & II errors, Statistical significance and statistical power out of kindness).
But, I know- we don’t KNOW.
Yep, but what we DO know is the drug is not harmless. If you give it to a large enough number of people, some of those people ARE going to die, as a direct result of the drug.
Retinopathy incidence is 10-40% depending on length of therapy, (years) but renal impairment and being thin (you know, things common in the old) increase odds for early occurrence; going blind isn’t dead, but it’s not fun, either.
Severe hypoglycemia- including life-threatening loss of consciousness, Cardiomyopathy resulting in cardiac failure, sometimes fatal, Suicidal behavior/psychosis, Bone marrow suppression (u stop making blood cells), acute hepatic failure, and renal impairment were all identified in clinical trials- these are labeled “frequency not defined” but ,again, clinical trials are usually 1,000-5,000 people, depending on toxicity seen in animal studies. The rule of thumb is, the inverse of the incidence = the number of people needed to detect an effect. So incidence range is 1/10th of a % to 2/100th of a % detected during clinical trials; post-marketing findings: (meaning, only seen when large # of people were taking it, so lower incidence than range above) Renal insufficiency, extrapyramidal reaction, Neutropenia, pancytopenia, Cardiomyopathy, prolonged QT interval, torsades de pointes, and ventricular arrhythmia.
Those #'s aren’t great- a drug like this wouldn’t be OK’ed for morning sickness- but malaria kills- again- cost|benefit analysis.
So we don’t KNOW if this molecule could help with COVID-19, but we DO KNOW, that is if we give it to a million people, 200 (on the low end) will suffer acute hepatic failure- and that’s just one of the ADRs.
Hydroxychloroquine is a good drug, used carefully, in the right patients, by clinicians familiar with its use, for disease states with high “costs”. But it’s not candy, and advocating population-wide administration of this agent in the absence of an over-whelming preponderance of evidence for significant therapeutic benefit is simply not justifiable.
In fact, I’ll be happy to play expert witness in a court of law again, and state that, in my considered opinion, it is more than “not justifiable” - it is criminally actionable. And I’M a stupid conservative!