There's a bill pending in California, called the Access, Compassion, Care, and Ethics for Seriously Ill Patients Act, that would allow the marketing of drugs based on Phase I trial results and nonhuman studies for seriously ill patients. In a letter in the current issue of Science, (subscription req'd) people from a number of scientific and medical organizations come out against this bill, saying that "The vast majority of drugs that enter Phase I testing turn out to be either ineffective or toxic," and that instead of helping these seriously ill patients, it could just open them up to being marketed drugs that won't help them (for more on this point of view, see the position paper on this from the Society for Clinical Trials).
Obviously, were this to pass, it could have implications for CME. Thanks to Deb for making me aware of it.
