Jack Lewin, MD
I was a speaker at the futuristic annual meeting of the International Society for Cardiovascular Translational Research (ISCTR) in Washington DC recently, and participated thereafter on a panel during which a fascinating discussion ensued between Alain Cribier, the iconic French interventional cardiologist and pioneer in the transcatheter aortic valve replacement procedure, and the respected FDA official Dr. Bram Zuckerman. Cribier asked why FDA was going to require a new three-year clinical trial process to approve the Sapien XT transcatheter valve, an improved version of the original Sapien valve (these valves can miraculously replace ailing heart valves though catheters and without requiring surgery). Sapien was only approved in the US after it was already available in Europe, Canada, and dozens of countries. Now version #2, Sapien XT, appears measurably superior to the original valve, after being used in thousands of patients outside of the US with scientifically reported fewer side effects in terms of strokes and better functionality. US patients who want this new valve have to travel outside the US to get it.
Dr. Cribier clearly has the bias of working closely with the California-based Edwards company that created the Sapien valves, but his question was nonetheless interesting. I believe Dr. Cribier was simply asking why is the US so cautious in introducing new products when an impressive amount of respected, unbiased scientific information in Europe, the UK, Canada and elsewhere suggests adequate safety and effectiveness. Americans too often do not receive the safest and most successful products for years after their regulatory approval elsewhere. We won’t see access to Sapien XT, for example, for at least 3 more years, when a Version #3 of the valve will already be in widespread use outside the US. This isn’t just about Sapien and Edwards. The same thing is true in terms of the long and expensive delays other US companies are experiencing getting to market with their parallel products.
At the same time, I believe the FDA, under the leadership of Dr. Peggy Hamburg and her highly respected team, is sincerely committed to streamlining the regulatory approval process without threatening patient safety. They may likely be lacking the resources and support they need to effectively do this. And, the media and many public advocates in this country make the FDA understandably nervous about patient safety—without seeming to recognize that no new drug or device can be risk-free. Patients who agree to use such new technology must be meticulously and ethically counseled about any known risks. Also, we are a more litigious society than other OECD nations, which discourages US innovation.
Further, we now live in an era of ‘big data’ and analytics, and could be partnering with many high quality registries and research institutions in other countries in order to enrich and speed up the regulatory process in the US, again without compromising patient safety. Michael Porter at Harvard Business School, through his ICHOM project (International Consortium on Health Outcomes Measurement), has been working with me and many others on promoting such international collaboration on research and registries.
All said, there’s a lot at stake here beyond the unquestioned importance of patient safety. America has been the absolute leader among nations in medical innovation throughout the modern era—it is a huge and important part of our economy. We are threatening to push that precious resource away, and to delay bringing the best medical care to our own citizens, if we don’t modernize and invest further in our regulatory processes.
About the Author of this Post: Jack Lewin, MD is President and Chief Executive Officer of the Cardiovascular Research Foundation. Dr. Lewin served as CEO of the American College of Cardiology (ACC) from 2006 through April 2012. Prior to ACC, Lewin was CEO of the 35,000 member California Medical Association for eight years. Hawaii’s Director of Health from 1986-1994, overseeing 6,500 employees, 12 hospitals, and a billion-dollar budget. Before that, as a Commissioned Officer in the US Public Health Service, Dr. Lewin was the founder and first Director of the Navajo Nation Department of Health, serving the needs of America’s largest American Indian tribe. He currently serves as the voluntary Chairman of the Board for the National Coalition on Health Care. In 2011, he was named as one of Modern Healthcare’s 100 Most Influential People in Healthcare. Dr. Lewin received his BA in Biological Sciences from the University of California, Irvine, and his MD from the University of Southern California.
Reprinted with permission from www.LewinReport.wordpress.com