Suppose you found out that you had a serious health issue; perhaps one that was life threatening. Then - suppose you found out that a medical device had excellent chances of saving you. You'd be celebrating; correct?
Well; only if you had access to such a device. If you lived in Europe, then you might well avail yourself of such innovation, yet in the United States .... well; too bad for you.
In November, the U.S. Food and Drug Administration (FDA) approved an innovative product called the Sapien Transcatheter Heart Valve, for the treatment of severe aortic valve stenosis. The Sapien valve can be implanted endoscopically, making it a boon for patients who are too sick to endure open-heart surgery. Clinical trials found that almost 70% of patients receiving Sapien valves were alive one year after treatment, while only 50% of those receiving alternative treatments survived that long.
This would be a great story for American patients, but for one frustrating detail: The Sapien valve has been available in Europe since 2007, saving lives there but not here.
Unfortunately, this delay was not exceptional. American patients used to be the first to benefit from their country's enormous investments in basic medical research. Today, Americans wait as much as 60% longer than they did in 2005 for new lifesaving and life-enhancing medical devices—such as stents that keep arteries open and defibrillators—to reach the market, according to a recent Government Accountability Office report. During that wait, many remain sick or disabled. Some die.
With assets like the National Institutes of Health, cutting-edge academic medical centers, vibrant venture-capital networks, and a vast industrial infrastructure, the U.S. has no excuse not to lead the world in providing new medical devices. American workers should be employed in this vital industry; American investors should profit from it; and most of all, American patients should benefit from it, in the form of better health and longer life. But that won't happen if we saddle the industry with regulations that are slow, costly and ineffective.
The medical-device industry is valuable. If the U.S. doesn't want it, someone else will. For patients, meanwhile, the only alternative to improving the regulatory process is the current system of withholding products, when delay can mean death, disability or "just" a diminished quality of life.
Please remember; I am not anti-regulation. But I am against regulation that is cost ineffective and takes away rational choice from our citizens and their medical professionals.
If you had health issues that severely impacted your quality of life - or your life itself - and there were products that could aid you, wouldn't you at least wish to have the option of using such a device? Or would you prefer that government bureaucrats could hold it up for years - years that you won't have?
Put me down for the former option - please.