"A Bit Intemperate"

Not in many years had the much-assaulted pharmaceutical industry heard such an unbridled attack as came last week from the head of the U.S. Food and Drug Administration. About 500 drug-company delegates gathered at Boca Raton, Fla., for the annual convention of the Pharmaceutical Manufacturers Association could have used some of their own tranquilizers after the FDA's new boss, Dr. James Goddard, got up to speak. He accused the industry's executives of slovenliness, deception and dishonesty--and warned them that they had better straighten up or else face much stricter controls.

Matter of Tone. After just ten weeks on the job, Goddard--the first physician in 40 years to chair the FDA--said that he had seen flagrant examples of sloppy research, improper labeling, and misleading advertising. In the area of new drugs still under investigation, he was astounded by "low-quality work" and "conscious withholding of unfavorable animal or clinical data." He had also been "shocked at the clear attempts to slip something by us."

None of them actually did get by, but Goddard cited examples of attempts that might make any physician cringe. One manufacturer of a new drug wanted to label it "effective in a few" cases of cancer. Goddard said that of 127 patients treated in trials, only five had had temporary reductions in the size of tumors; to him this was not at all effective. In another instance, the maker of a long-acting sulfa, which had been clinically proved to be effective only in treating the genitourinary tract, wanted to imply on the label that the drug could be prescribed to treat acne.

Goddard went from labeling to advertising. In the past year, he said, the FDA found fault in ads run by nearly one-third of the members of the Pharmaceutical Manufacturers Association. "Some advertising cases have been quite abusive of regulations. They have trumpeted results of favorable research and have not mentioned unfavorable research; they have puffed up what was insignificant clinical evidence; they have substituted emotional appeals for scientific ones." To Goddard, it was all a matter of tone--professional tone. "For example, no drug categorically 'relaxes both physical and emotional tension' all by itself. But a drug can help to relax these conditions or can often relax these conditions."

Watch Each Other. Then Goddard made an implicit threat: "Every time the pharmaceutical manufacturers see a violation of law made by one of their number--and then look away--the pressure builds up even more for tougher, tighter, more sweeping regulatory action and legislative control over the drug industry."

When they got over the shock, the drugmakers reacted cautiously. Pharmaceutical Manufacturers Association President C. Joseph Stetler regretted that Goddard's reprimand would be interpreted as a blanket indictment, yet conceded that "nobody in that room wanted to be with firms that were responsible for submitting the data mentioned in the speech." On the other hand, a high official of the Health, Education and Welfare Department, which supervises FDA, found the speech "a good first draft--but a bit intemperate."

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