I just want to point out the obtuse guidelines of the FDA on what they consider effective drugs so that they can approve them, see below. I listened to a doctor in a conference one time and he stated that a drug only has to be 7% effective in treating a condition to be approved, along with the other guidelines. BTW they changed the definition to be more murky on efficacy in 1997.
So when I see this word "promising results" by doctors and scientists, when it comes to the Hydroxychloroquine & Zpac, when a majority of people are getting well, that pisses me off. Pharma is behind this because there's no way on the planet studies were not done before on this, and probably other flues. I wouldn't be surprised if the info was intentionally repressed. So Trumps right, it's a "game changer"
In 1997, the Act was amended via passage of the Food and Drug Administration Modernization Act (FDAMA). The FDAMA introduced a number of important changes into the Act, but for our purposes here the important revision included a revised definition of substantial evidence of effectiveness.
Under FDAMA, the definition of substantial evidence of effectiveness was amended to include a single adequate and well-controlled study and “confirmatory evidence,” if the Agency determines, “based on relevant science,” that the data establish effectiveness. While Congress gave no guidance about when such a standard should be applied, or what could constitute confirmatory evidence, the Agency has produced a document (Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products)1 that provides a detailed discussion of the regulatory and scientific considerations that are involved in the decision to approve an application on the basis of a single adequate and well-controlled clinical trial.
This document describes two categories of trials in which a single study might serve as substantial evidence of effectiveness; those cases in which a single study may receive substantiation from related data, and those cases in which there is no independent data outside the trial that can provide substantiation. In the former category, examples would include studies of new dosage regimens or forms (e.g., controlled-release products when a drug is only approved as an immediate release formulation) for treatments already approved, studies in related populations (e.g., studies in pediatric patients when the drug is approved in adults), studies performed under related conditions of use (e.g., use in monotherapy when the drug is approved as adjunctive therapy), and studies in different severity strata (e.g., studies in severely ill patients in which the drug is approved only in mildly ill patients).