May 15, 1996
Development of the coronary stent, a wire-mesh tube placed in an artery to increase heart-muscle blood flow, has revolutionized treatment of certain heart conditions. The Gianturo-Roubin coronary stent reduces the need for coronary-bypass surgery and is especially valuable during angioplasty when a coronary artery collapses and prevents blood flow to the heart. According to a report, “The Human Cost of Regulation,” by David C. Murray, a scholar at the Indianapolis-based Hudson Institute, the Gianturo-Roubin coronary stent was developed in 1986 but the Food and Drug Administration didn't approve its use until May 28,1993.
We want medical device manufacturers to demonstrate safety and effectiveness. We don't want FDA arrogance, delays, and bureaucratic bungling that's responsible for the United States’ lagging eleven months or more behind Europe's device-approval rate. FDA ineptitude doesn't simply impose time-wasting, costly procedures on device manufacturers; each year it kills thousands of Americans.
Approximately 15 percent of patients die undergoing emergency bypass surgery made necessary due to coronary-artery collapse during angioplasty. During clinical trials of the Gianturo-Roubin stent, far fewer patients needed bypass surgery after a collapsed coronary artery, and of those who did, only 5 percent died. Murray says roughly 1,230 American lives a year were lost in angioplasty procedures because of FDA-delayed approval of the Gianturo-Roubin stent.
If your loved one died during the early 90s during an angioplasty procedure, Dr. David Kessler, the head of the FDA, is in part responsible. The tragedy is you and your loved one are part of the many invisible victims of FDA policy. Here's the modus operandi. If FDA officials mistakenly approve a device that has unanticipated harmful effects, their necks are on the chopping block because the victims are highly visible. Career-minded FDA officials don't like that kind of exposure. They prefer the hidden mistake, erring on the side of overcaution by needlessly delaying approval. When FDA officials err on the side of overcaution, their victims are invisible. After all, you didn't know there was a device available that could have saved a loved one's life, as would have been the case had the angioplasty procedure occurred in Belgium or some other European country.
FDA delays in approval of the Omnicarbon heart valve contributed to the suffering or death of as many as eight thousand of the sixteen thousand Americans who experience either a thromboembolic event or bleeding complication with their artificial heart valves each year. Again, these people are the invisible victims of Dr. Kessler's FDA.
There are many medical devices, or improvements to existing medical devices, introduced each year and needlessly held up because of FDA self-serving Byzantine procedures. The medical profession shares some of the blame. Doctors are at least partially aware of the introduction of new tools in their profession. I think they have an ethical duty to inform patients about life-saving and suffering-sparing devices and useful drugs being needlessly held up by the FDA.
The problem is not resources. In 1988, the FDA's budget was $482 million and it was staffed by 6,869 people. That year, they approved forty-six applications for premarket approval of medical devices. By 1994, with a budget of $877 million and a staff of 8,539, they managed to approve only twenty-six applications for premarket approval of medical devices. The FDA is long overdue for over-hauling. In the process, Congress should allow for private medical-device certification. After all, Underwriter's Laboratory does an excellent job assuring electrical-device safety.