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The Perils of Delaying Medical Devices

All regulatory agencies are human institutions.  Re-

gardless of motive or enthusiasm, they make mistakes and

produce delays.  When the FDA makes a mistake and allows

unsafe and harmful products on the market, there is a clear

result: people die.  But what is not so clearly seen is that

people also die when the FDA fails to act or acts too slowly

in allowing a life-saving device on the market.  Moreover,

businesses may lose profits, jobs may be destroyed, and

consumers may pay more for the goods they purchase.

One can seldom specify the deaths that occurred because

the FDA was slow to allow a drug or device on the market.

There are, however, some well-known examples:

· Thrombolytic therapy dissolves blood clots in heart

attack victims.  Every year 700,000 people suffer heart

attacks, and 9 percent of them die.  The FDA found the

therapy reduced heart attack fatalities by 18 percent,

but it took two years to approve the new drug applica-

tion.  The result was as many as 22,000 deaths.5

· Based on FDA's own calculations, between November

1988 and May 1992, 3,500 kidney cancer sufferers died

as the FDA deliberated the approval of Interleukin-2,

which was already available in Denmark, France, and

seven other European countries.6

· Misoprostol prevents bleeding ulcers caused by aspi-

rin and other, similar drugs.  These ulcers are common

in arthritis sufferers.  According to the FDA's own

figures, Misoprostol can potentially help 10,000 to

20,000 people every year.  During the nine and one-half

months it took the FDA to approve the new drug applica-

tion no one could use the therapy.  That means 8,000 to

15,000 Americans may have died because Misoprostol was

not available sooner.7

Delays in medical devices also cost lives and prolong

illness.

· Seven thousand Americans die every year because the

AmbuCardioPump, a CPR device used in emergency rooms

and available in most industrialized nations, is not

available in the United States.8

· In 1993 the FDA disallowed the use of a specialized

infant ventilator, a machine that helps very sick in-