Am Heart Hosp J. 2011;9(1):7
Lozenge Reference
Five Years On Overview
The Future was Here and Now, and has Passed You by
Thomas J Fogarty, MD
Unfortunately regulatory and reimbursement agencies do not place a high priority on the urgent need for improved technology. This continues to be the case and its negative impact on patient care continues.
S
ome predictions made five years ago have come to pass, some have not. An ever-increasing demand by patients for less invasive procedures continues.
Unfortunately in the US, we have not been able to respond to or deliver on many of these new and appropriate procedures and technologies. In the cardiovascular field, there are two examples of procedures that are less invasive. Transcatheter aortic valve replacement has been available in Europe for ten years but is still unavailable in the US. There are two other less invasive valvular technologies that have been in use abroad for five years. It is projected that both of these technologies will be released in the US this year. Both companies independently are concerned that this will not come to pass in the timeframe indicated.
A unique technology for the treatment of atrial fibrillation has been under study for five years. The Phase I study with a total of 60 animals has been completed, with positive results. The US Food and Drug Administration (FDA) was involved in discussions as to the appropriate pre-clinical study that would be
necessary. They are now questioning what the animal model should be and what length of follow-up should be, in the animal. They have talked of at least two and perhaps five years of follow-up in these animals.
The late arrival of medical devices and drugs in the US is multi-factorial and not all fault can be placed on the FDA or Centers for Medicare and Medicaid Services (CMS). However, when one compares the cost of getting safe and effective products to the marketplace; Europe versus the US, the US almost always loses. The impact of this state of affairs on future predictions of the availability of new clinical technology is almost impossible. The problem of prediction has been the unpredictability of the FDA and CMS.
Let us hope that the future is much more positive for our patients. Oversight and regulations should not be abandoned but should be reasonable and doable. Currently the cost of innovation in the US is not sustainable. Safe and effective technology should not be compromised by unfounded fears, a statistically insignificant incidence of adverse events, and a total lack of consideration for cost surrounding developing drugs and devices. n
• Correspondence: Thomas J Fogarty, MD, 3270 Alpine Road, Portola Valley, CA 94028. E:
tjf@fogartybusiness.com Summer 2011 The Future was Here and Now, and has Passed You by 7
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