With all the turmoil and craziness, too much is flying under the radar

I didn ' t even know thatit appears a truly horrible version of so-called " right to try " is about to become federal law. I have written about this before, but when legislation was only being passed at the state level it didn ' t really matter. The FDA still controls access to experimental drugs and state law can ' t preempt it, so state legislation was purely symbolic.The link is to an essay by the notoriously long-winded David Gorski. Do read it if you want all the details, but I ' ll try to give a succinct version.For background, the drug approval process has several stages. First, trials in animals have to show some evidence that a chemical may be promising to treat human disease and establish evidence about safety. People are not mice, however, and unfortunately most agents that show promise in animals turn out not to be useful for human health care, due to lack of efficacy, safety, or both.So, the next step is a so-called Phase One trial. This involves giving the agent to a small number of human volunteers, starting with very small doses and increasing them until adverse effects are observed. This is not intended to show anything about efficacy, just to get an idea of how much of the drug can be administered safely in a larger study.Phase Two trials are relatively small trials which are not powered (i.e. do not have a large enough sample size) to really prove efficacy, but do have at least one control arm (a placebo or existing standard treatment) and produce more info...
Source: Stayin' Alive - Category: American Health Source Type: blogs