by Karl Denninger
Market-Ticker.org
FACT: It is illegal in the United States to sell, offer for sale or promote via any means that touches interstate commerce (which would include any communications form that crosses a state line) any drug or device intended to treat, prevent or cure any disease or disorder of the human body without proof in the form of random clinical trials which are then submitted and analyzed by the FDA. This is controlled under the Food, Drug and Cosmetic Act (Title 21 USC.) The government goes after sellers of supplements and devices on this basis all the time. The law is crystal clear in this regard; both safety and efficacy must be scientifically proved, reviewed and then formally approved by the FDA.
FACT: There are protocols for “compassionate use” and similar for drugs and devices in the pipeline for approval, or approved in other nations, but such are specific to an individual person and circumstance (e.g. in the event of a terminal illness) and cannot be ordered as either a “standard of care” nor ordered against someone’s expressed desires.