The Cost of Innovation in Cardiac Surgery

Medical devices go through a rigorous clinical trial and approval process before they can be used widely used in patients.

But what if that process sometimes misses serious long-term implications?

That was the focus of a presentation by Dr. Joanna Chickwe, professor and chair of cardiac surgery at the Smidt Heart Institute at Cedars-Sinai Medical Center. For National Press Foundation fellows, she detailed the experiences of some devices that show favorable results early in a clinical trial but unfavorable ones later.

One example is the MitraClip, used to repair a leaky mitral valve. Two different trials were at odds – one favorable, one not.

“Why do two randomized trials show two completely different results?” Chikwe said. “Often you have to wait two years, four years, to see a difference.”

One explanation is that clinical trials are funded by industry firms with a vested interest in success, Chikwe said, noting that industry-sponsored trials have more favorable efficacy results and more favorable conclusions.

She also detailed the many ways that randomized clinical trials – generally the gold standard of medical evidence – can be biased, as well as why prestigious medical journals sometimes publish flawed studies. Among the reasons is that journals get revenue from reprints of those favorable studies.

This program is funded by Bayer. NPF is solely responsible for the content.

Dr. Joanna Chikwe
Professor and chair of cardiac surgery, Smidt Heart Institute, Cedars-Sinai Medical Center
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