Captains who volunteer to save sinking ships merit a grace period from safely situated critics. Donald Kennedy, a Stanford University biologist of high scientific reputation, is in that role as Commissioner of the Food and Drug Administration. However, after five months in office, during which he has drawn miraculously few barbs from the pharmaceutical industry or FDA's quick-to-fire public-interest critics, a few comments are in order.
The first thing to be said about the FDA is that is was born for trouble. Cast as the regulator or a rapacious industry that promises medical miracles to a gullible public, its day-to-day workload mainly involves the dull routine of screening drug-testing reports from industry and its contractors. This work calls for advanced medical and scientific abilities. But in the postwar boom in science and medicine, FDA has never been a preferred place of employment among talented specialists, which is why Kennedy's acceptance of the job was both a surprise and a source of hope.
Numerous studies of FDA have cited its professional unattractiveness as prominent among its many problems. That was a major point in the latest and grandest of these inquiries, a 2 1/2-year, $900,000 probe completed last May. Conducted by an independent and well-qualified group known as the Review Panel on New Drug Regulation, it acquitted FDA's Bureau of Drugs of the well-worn charge of pro-industry bias, but otherwise concluded that the agency is so riddled with inadequacies that it requires "a wide range of legislative, administrative and procedural reforms . . . . " The panel's final report, covering 765 pages, abounds with tales of bureaucratic chaos, personal vendettas, confusion, perjured testimony, and a lot of other follies that ought not to have been taking up the time of the public servants who screen our pills.
Against this background, it is to be noted that Commissioner Kennedy has so far made no staff changes and only one staff appointment - that of his own personal assistant. He has set up a search committee - always a laborious procedure - to fill a vacant bureau directorship. Otherwise, he's carrying on with the crew he inherited, his explanation being that "There are a lot of talented people here." To which he adds that the troubles of the past mainly stem from fuzzy guidelines for agency-industry sources, and from the traditional ideological uncertainties that afflict the federal regulatory role.
Now, with all due regard for a commissioner who inherited a discredited agency - along with strife over laetrile, saccharin, a scheme for legal adulteration of ice cream - loyalty to the old crew is fetching, but not reassuring. A bit of callousness in the public interest might be in order.
A useful first step toward cleansing the agency's scientific reputation would be the long overdue righting of the outrageous wrongs that the ancien regime visited upon one of the early heroes of the struggle to keep dangerous drugs off the market, Dr. John Nestor. A physician and heart-drug specialist, Nestor was twice commended by the Justic Department in the early 1960s for uncovering fraudulent laboratory reports that permitted the marketing of a drug that was known to cause cataracts and other detrimental side effects. FDA responded by emptying Nestor's office in his absence and transferring him to makework duties related to his specialty. Nestor fought back, and thus began a series of transfers and wrangles that eventually got him back to a drug-review job where, according to the panel report, he waa able to use his "considerable talents."
However, in 1972, as the Nixon administration pressed regulatory agencies to have "less adversarial" relations with industry, Nestor was abruptly transferred to virtual idleness. He instituted an unsuccessful grievance proceeding at which, according to the review panel, "misleading" testimony against him was given by two senior FDA officials, J. Richard Crout, director of the Bureau of Drugs, and Marion Finkel, associate director for new drug evaluation - both still there.
Reviewing this episode, the panel concluded that though Nestor is not a model of tact, and is, in fact, often abrasive and combative, he merits an apology, a vacating of the tainted grievance finding - and useful work.
Kennedy, amidst weightier concerns, has erased the grievance finding, and has been sparing with Nestor about a new job. Nestor, now 64, responded to Kennedy's invitation to suggest three jobs for which he feels qualified. Kennedy then rejected Nestor's list, apparently because the choices involved supervisory duties. Nestor then replied that he wanted his old job in the cardiorenal division. That, too, was turned down by Kennedy, and Nestor has since put the matter in his lawyer's hands.
Meanwhile, the officials, whom the review panel admonished for besmirching him remain in place, as does a remarkable recommendation by the panel:
"To improve further the science environment and raise agency morale, FDA should adopt regulations which bar disruptive conduct, lying and punitive transfers . . . . "
With a recommendation like that, FDA is starting from so far back that it's so-far-untarnished commissioner shouldn't have any illusions about the durability of the honeymoon period.