Thursday, August 6, 2020

Coronavirus – clinical trials #3

Yesterday’s post was about a clinical trial for a coronavirus vaccine and Mill’s Method of Difference. In this post I consider a clinical trial for a Covid-19 cure and Mill’s Method of Difference.

A clinical trial for a cure for Covid-19 would enroll patients who already have Covid-19. There is no contingency analogous to becoming infected like there is for a coronavirus vaccine clinical trial. On the other hand, there are a lot more variables – a variety of patients’ ages, each patient’s health status, degree of infection, and so forth. Dosage amounts may also differ, for which the logic is also Mill’s Method of Concomitant Variation.

Dr. Anthony Fauci often invokes the “gold standard” for clinical trials (randomized double blind placebo control studies) when he comments on any drug doctors might prescribe to treat patients. This standard is mainly for new drugs, but may also be used for already FDA approved medications for treating medical conditions outside the scope of prior approval, e.g. remdesivir for Covid-19. These are often called “off label” uses. It is also called repurposing. The FDA has relaxed its standards for drugs to treat Covid-19 patients. The FDA has made emergency use authorizations (EUA). The FDA may grant Investigational New Drug (IND) permission to test a drug. To my knowledge no drugs – even Remdesivir, which Fauci personally approves -- have passed the “gold standard” for treating Covid-19.

The following are the NIH guidelines for the treatment of Covid-19 with four different drug therapies.  Remdesivir.  Chloroquine and Hydroxychloroquine.  Hydroxychloroquine Plus AzithromycinDexamethasone.

Conspicuously non-existent are web-pages for (1) Hydroxychloroquine (HCQ) Plus Zinc and (2) HCQ Plus Zinc Plus Azithromycin, especially with outpatients. Several doctors who recommend using HCQ for Covid-19, mainly with outpatients, have said zinc is a necessary enabler and without zinc the HCQ is minimally effective. Note that the NIH's web-page for HCQ + Azithromycin page concerns only trials with inpatients (hospitalized).

Dr. Anthony Fauci still approves using remdesivir. Regardless, it falls far short of a cure for Covid-19. Like the above web-page shows, some clinical trials have shown at best that remdesivir reduced  recovery time compared to a placebo. Other trials have shown no observed improvement or the data is insufficient. I would not call that passing the “gold standard.”

Dr. Fauci and the NIH recommend dexamethasone for some patients. The web-page above says clinical trials have shown significant mortality reduction in patients requiring supplemental oxygen, with or without a ventilator. On the other hand, no benefit of dexamethasone was observed in patients who did not require supplemental oxygen. Does this mean that dexamethasone passed the “gold standard”? Arguably 'yes' in some cases, but a cure? Many who got the drug still died during the trial.

Despite the many unknowns about the coronavirus and Covid-19 and the long time frame of clinical trials, Dr. Fauci often appeals to the “gold standard” as an argument against anything that doesn’t meet his or the FDA’s approval. In effect, he has little regard for individual judgments of practicing physicians to prescribe drugs absent his or the FDA’s approval, despite the lack of “gold standard” drugs for curing Covid-19 or halting its progress.

Dr. Fauci also consequently has shown little regard for giving placebos to patients who are seriously ill with Covid-19. Assume such patients participate in a clinical trial hoping to be cured and they later learn – if they survive – they were given a placebo and other patients in the trial who got the drug benefited. I suspect they would not be content.

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