What First Amendment?
A federal judge sentenced the former head of a biotech company to six months of home confinement this spring and fined him $20,000. His offense? Issuing a single press release about a drug […] Civil charges against companies based on similar commercial speech violations are routine, and the feds are bent on targeting individuals […] At the same time government is limiting what private companies can legally communicate about their drugs, it has set a much lower standard for health agencies […] Retrospective studies will be the core occupation of a new “comparative effectiveness” research agency that has $4.1 billion to conduct government studies on medical products. The results will be used to inform federal treatment guidelines, as well as Medicare’s payment policies. At least $100 million of that $4.1 billion is being spent on promoting research results.
Entire Scott Gottlieb article is worth reading.
In health care there has long been this conflict between those who believe in centralized control and those who support market forces. Among the command and control elite, communicating a drug’s benefits before it has been on the market for a couple years is frowned on. Most also believe marketing directly to patients should be banned. At one point in Europe (where direct to patient marketing is banned) patients had to click on a link indicating they were American in order to read drug advertisements on the Internet.
You mean it’s against the law for a drug company to tell me I might benefit from a drug they make? I thought this was supposed to be a free country.
Very interesting dilemma dealing with first amendment rights and the ethics of scientific research. Clinical research has strict guidelines for human subject research (ie drug trials) outlined in the Belmont Report to maintain the legitimacy of the medical practice and protect patients. Unfortunately this increases the cost of drugs. If the CEO marketed his product showing increased survivability compared to routine practice of medicine, based on a retrospective analysis void of clinical equipoise, he could put at risk the lives of patients. Clearly unethical. Keep in mind it’s illegal to yell fire in a crowded theater as that action may cause harm to others in the process of exiting the building. Similarly proclaiming a benefit without actual proof, could lead to harm. However, if the CEO released the study findings suggestive of a possible increase in survivability with a robust limitations section highlighting the fact that results were from retrospective study, the first amendment stands.
Here, choice is not free but severely limited– not what our Founding Fathers had in mind!
This is terrible.