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EDITORIAL: Impotent and Indecisive

I disagree with the premise of the editorial. The FDA is within its mission granting such permits. Compassionate Special Permits are not licensees nor emergency use authorizations. There are requirements for granting CSPs with the important one being that there are no other treatments that work for the particular medical condition.

Consider it a permit to conduct a clinical trial but in clinical trials, the FDA is not responsible for any outcome (favorable or adverse) precisely because the data is still to be collected. The patient has to agree in writing to basically absolve the doctor or anyone connected to such a trial. The attending doctor has the duty to fully explain what the trial is all about and the possibility of severe outcomes, even death. This is a common practice even in other westernized countries.

The permit also allows the pharmaceutical company to formulate and issue such investigational drugs (that otherwise will be illegal for them to formulate) and be absolved from any criminal prosecution in the event of an adverse outcome, including death.

Ivermectin is an approved veterinary drug but not suitable for human use. A special formulation is specially made for the clinical trial.

CSPs are necessary for the advancement of medicine (that benefits mankind) without unnecessarily burdening the government and doctors for any adverse outcomes. The FDA is not passing the buck to the doctor. As a matter of fact, the doctor better understands that. CSPs are granted as a routine matter but never make the news until a clinical trial is completed that shows a significant breakthrough or severe or worse, fatal outcomes.

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Have a Nice Day!

Al Villamora