Tony DeMaria, M.A.C.C., our JACC editor in chief, recently used his May 19 Editor’s Page to discuss the alarming frequency with which initial clinical trials for novel devices and therapies are being performed outside of the U.S. According to Dr. DeMaria, the situation "clearly raise[s] a question as to whether we in America are exploiting the rest of the world to prematurely test potentially hazardous therapies, or conversely, whether our regulatory and financial environment is stifling access to important new innovations for patients and investigators."

The piece has generated a high volume of responses. “It seems to have struck a chord,” Dr. DeMaria says. One reader notes, “Over the past two decades I have seen an unfortunate gap develop between U.S. and overseas investigations, making us in effect second-tier investigators within the international community. Devices we have invented end up being evaluated, approved and used in general practice well ahead of us ... Percutaneous valves are one the latest example of this dangerous trend/gap!”

I applaud his message. We need to turn this around. Read Dr. DeMaria’s Editor’s Page here. But having just returned from India this week, and after visiting a most amazing 1000 bed CV hospital in Bangalore that produces outcomes comparable to the US (be ready to be stunned) for about 10 % of the cost, I think we need to be aware of the astounding and frankly positive growth of research outside the US that is developing exponentially. One thing the emerging world has going for them is that in environments with no insurance or health care coverage, experimental and novel therapies can be tested in willing patients far more prevalently that in the US or Europe. This will result in a great deal more relevant manuscripts, and in application of new therapies in early stages of illness, that will be considered here only as “compassionate use” therapy in late stages of disease, and only after traditional therapy fails. They will be able to see if new therapy works when started before the patient is near terminal. We won’t. And, as health reform in the US ratchets down the screws on PHARMA, they will go abroad to innovate, taking jobs with them. I’m just trying to cheer everybody up here…

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