In the summer of 1992 the Food and Drug Administration, having discovered paperwork violations at Bunnell, Inc., ordered the company to recall its Life Pulse High Frequency Jet Ventilator and tell hospitals to stop using it. Doctors protested that without the device, for which no effective substitute existed, many tiny premature infants would be unable to breathe and would die.
Some sixty hospitals refused to comply with the order, but others did comply, and babies did die. According to Dr. Joel Nobel, head of the independent testing organization ECRI, the FDAs action caused "anywhere from 10 to several hundred infant deaths."
One might have though that FDA head Dr. David Kessler would concentrate on trying to prevent a recurrence of this sort of lethal agency mistake. But FDA officials say that instead Kessler spent much of his time focusing on an issue where his agency had no jurisdiction whatever, the regulation of tobacco products. Getting more power took precedence over the responsible exercise of the vast power already possessed.
Recently, after years of maneuvering in which Kessler characterized smoking by youths as a "pediatric disease" and criticized the promotion of tobacco products, the FDA revealed that it plans to regulate tobacco products on the grounds that nicotine is a drug. This initiative has stirred a hornets nest in Congress, where the Republican leadership is already disposed to rein in the FDA. The FDAs timing seems politically ill-chosen. Whats going on?
Perhaps Kessler is simply obsessed with the tobacco issue and determined to push it regardless of the political repercussions.
Another possibility is that he has decided the best defense is a good offense. An attack on youth smoking will elicit widespread support and divert attention from criticisms of other agency actions.
Most likely, however, FDA regulation to keep cigarettes away from kids will be an entering wedge for much more extensive regulation. Even those of us who do not smoke should pause to consider the risks of a more powerful FDA, in view of how grossly the agency has misused its powers in the past.
In fiscal years 1991-94 the FDA approved, on average, only half as many new medical devices annually as it had in the preceding eight years. Waiting times quadrupled for marketing approval for new devices, and doubled for improved versions of old devices.
Manufacturers of life-saving devices complained that under Kessler the FDA treated them as suspected felons. Scores of device companies have moved operations to Europe to escape the suffocating rules and administrative abuses.
After systematically weighing the good and bad effects of the FDAs drug regulations, Dr. Dale H. Gieringer concluded that "the FDA fails its own criterion [safety and effectiveness] for public health," generating far greater harm than benefit. Many studies by economists have confirmed that the huge expense and years of delay associated with the agencys product approval process discourage pharmaceutical research and development.
As a result thousands of people have suffered unnecessarily and died prematurely, unaware that their plight might have been relieved if not for the FDA.
Grandstanding enforcement actions also cost lives. A defibrillator is a device for restoring the normal heart rhythm of a heart attack victim. Physio-Control Corp. is a leading manufacturer of defibrillators, with sales in more than 70 countries. In 1992 the FDA forced Physio-Control to shut down, largely for paperwork infractions. The company was not permitted to operate fully until two years later. According to Dr. Richard Cummins of the University of Washington School of Medicine, this FDA action caused at least 1,000 deaths.
Thousands of the people who die each year from heart attacks could avoid these attacks by taking aspirin daily as a preventive, yet the FDA forbids aspirin sellers to promote this life-saving use of the product except for consumers who have already had a heart attack.
The FDA forbids the dissemination of information by sellers of nutritional supplements about many of the potential health benefits of vitamins and minerals. The probable harm of this censorship is immense -- comparable perhaps to the harm caused by the FDA during the decades, ending only in the early 1970s, when it prevented sellers from touting the benefits of foods low in fats and cholesterol.
Besides health and life itself, personal liberties are always jeopardized when the FDA gains more authority. Whether people smoke or not, they have much at stake as the most powerful -- and lethal -- federal regulatory agency maneuvers to widen its jurisdiction even further.