The Mess in FDA

There was no lack of problems in the Department of Health, Education and Welfare when John W. Gardner took over last August. But the biggest mess facing the new Secretary was in the Food and Drug Administration, the agency responsible for the purity and safety of the food, medicines and cosmetics that Americans buy. The mess had been building for decades while the agency rocked along, a cozy bureau for career men whose ambitions were as limited as their powers. Though there have been marked improvements since World War II, what Gardner inherited was an agency that had lagged far behind its fast-growing responsibilities.

Growth Spurts. In 1938, at the start of the wonder-drug era, FDA was given broader powers after a sloppy preparation of sulfanilamide killed 107 people. But the sulfas were only the first of several families of potent drugs developed by inventive chemists working with imaginative physicians. And the high tide of new drugs was arriving at a time when the food industry, which gives FDA 70% of its work, had begun its own technical revolution with new preservatives, additives, and other chemicals. The agency did not have nearly enough manpower to do a thorough job, nor was its prestige enough to attract men of the necessary scientific skill. Meanwhile, both the drug industry and organized medicine, which had resources and skills, felt that they could shoulder the principal responsibility for policing drugs and drug dispensing and should be regulated as little as possible. But in both the industry and the profession there was a minority of careless, unethical operators from whom the public had to be guarded.

FDA got a shot of growth hormone in 1962 with the Kefauver-Harris law, which made the agency responsible for the efficacy as well as the safety of new drugs. But growth (from 800 employees and a $5,000,000 budget in 1955 to 4,400 and $53 million today) also meant growing pains. FDA was ill organized and ill housed--some of its most vital scientific work had to be done in a made-over garage. Worse, many of its difficulties were homemade.

Its officials could not get along with those in the National Institutes of Health, though they clearly had many interests in common. They could not even get along among themselves. Things looked up for a while after Dr. Frances O. Kelsey became a heroine for keeping thalidomide off the U.S. market, and after Dr. Joseph F. Sadusk Jr., with a good record as a medical educator and a practicing physician, took over as head of FDA's Bureau of Medicine (TIME, March 13, 1964). But now the Kelsey faction is warring on Sadusk, who is also the target of Representative Lawrence H. Fountain's Intergovernmental Relations Subcommittee.

Last winter, Commissioner George P. Larrick, an up-through-the-ranks man, decided that he had had enough and asked to be retired (a year before he needed to). Soon, so did two other top officials; six key spots are now vacant.

Law & Duty. Personalities and minor issues aside, the crucial debate in and around FDA centers on the question: How shall it discharge its duty to protect the public against useless or dangerous drugs? There can be no simple answer because the law, and therefore the duty, have changed almost as fast as drugs have changed.

The sharpest division is over how hard FDA should bear down on drug safety. Dr. Sadusk was at first expected to favor strict enforcement. But he is convinced that practicing physicians should be free to make their own choices from among many available drugs, all of which have some degree of danger. His opponents now accuse him of betraying the public interest in favor of protecting the pharmaceutical manufacturers. Some recent examples of action, inaction and disputed decisions: >> SULFAS. FDA last week announced that it was requiring new labeling on two long-acting sulfa drugs marketed by three firms,* "to warn against rare cases of a severe and sometimes fatal side effect," a blistering and ulceration known as the Stevens-Johnson syndrome. There have been 81 reported U.S. cases "associated" with the drugs, with 16 deaths, eleven among children. There have been relatively fewer such cases and no U.S. deaths ascribed to the short-acting sulfas, which have to be taken four, to six times a day. FDA "hawks," who favor drastic action, wanted to pull the long-acting sulfas off the market on the grounds that the short-acting drugs are equally effective and are safer. Congressional committee spokesmen and other Sadusk foes, who have been leaking confidential FDA documents to selected newsmen, accuse Sadusk of a) having dragged his feet for at least a year before taking any action, and b) having watered down the final action to a mere label warning that use of shorter-acting sulfas "should be considered" before the long-acting are employed.

>> ANTI-NAUSEA PILLS. Meclizine (Pfizer's Bonine) "is highly effective," says its manufacturer, "for the control of nausea and vomiting of pregnancy," as well as for motion sickness. Cyclizine (Burroughs Wellcome's Marezine) is widely prescribed for pregnant women, though the company does not specifically recommend it for them. European doctors said that some women who took the pills later bore malformed babies. Last January, Dr. Sadusk agreed that pregnant women should not take these drugs, then promptly reversed himself. Not until October did he approve a label warning: "Not for use by women who are pregnant or who may possibly become pregnant"--even though he is not convinced that they are effective against nausea.

>> CHLORAMPHENICOL. For 15 years FDA has struggled with the problem of how to label and whether to restrict the use of this antibiotic (Parke, Davis' Chloromycetin). It is unquestionably the best drug against half a dozen uncommon diseases and a few medical conditions that should be treated in hospitals. But it is often prescribed to avert the aftereffects of a common cold, for which it is useless and also dangerous, because it may cause death from anemia.

New Life. It took Secretary Gardner a long time to find a man with the right credentials to attack such problems as these and try to put FDA's house in order. Last week he announced his choice:

Dr. James Lee Goddard, 42, whose most recent duty has been as an assistant surgeon general of the U.S. Public Health Service and chief of its famed disease detective branch, the Communicable Disease Center. Earlier he did a good job while on loan as surgeon to the Federal Aviation Agency. What he wants of Goddard, said Gardner, is to "give this agency a new burst of life."

It needs it, and Dr. Goddard will need all the administrative skill he has already shown--and more--to fulfill his assignment.

* Sulfadimethoxine (Roche's Madribon) and sulfamethoxypyridazine (Lederle's Kynex and Parke, Davis' Midicel).

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