American Enterprise Institute (AEI) scholar Scott Gottlieb, MD a former senior adviser to the Center for Medicare and Medicaid Services (CMS) warns that a new ruling by CMS will force people to get open-heart surgeries that might have been avoidable.

For grant-winners whose studies will involve human volunteers, another big hurdle remains: federal ethics regulations.

Company funded trials are valuable, but more needs to be done.

Successfully translating scientific discoveries requires a sense of urgency, which some disease foundations seem to have, and many big pharmas appear to need. Patients waiting expectantly for medical research to produce important new cures are finding bad news almost everywhere they turn.

The crisis in financing is having a chilling effect on biomedical innovation. As discussed in my last column, the main problem in our industry is that the sheer cost of drug development has become almost prohibitively expensive, effectively pricing almost everyone but the largest companies out of the market.

This is an all too familiar story, the FDA impeding useful innovations in the US entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials. In response, American device makers are moving their business overseas.

Drug makers aren't chasing blockbusters like Lipitor anymore, or uncovering compounds the same way.