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FDA finds that FDA is not biased
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Following a year-long in-house investi gation of employee allegations that the Food & Drug Administration is biased toward the drug industry, Commission er Alexander M. Schmidt has conclud ed that not only is there "no evidence to support such charges," but that "there is evidence to refute them." In a 906-page report issued earlier this month, Dr. Schmidt documented alle gations made by each individual, ques tions he posed and answers he received from them during the course of the "open" investigation, and all other rel evant agency materials. The investiga tion took about 16,670 man-hours and cost about $196,000. Last year 11 current or former FDA employees, as well as three agency con sultants, told Sen. Edward M. Kenne dy (D.-Mass.), who chaired joint hear ings held by the Subcommittee on Health and the Subcommittee on Ad ministrative Practice & Procedure, that their recommendations to approve drugs were never questioned, but their recommendations to disapprove drugs were almost always questioned. They also testified that their efforts to disap prove drugs resulted in repeated ha rassment from FDA officials, in their files being altered, and—in some cases —in transfers out of their divisions. And they cited episodes to support their allegations. (The hearings were part of a continuing series of probes by the committees into the drug industry and its practices, and drug regulation by FDA). In his report, Schmidt admits that there were problems. But he points out that they stemmed from "faulty com munication" and sometimes "very clumsy administration . . . understand able, but sad occurrences in any large organization." These problems, he says, certainly were not of "malicious behavior" supporting any of the charg es of improper drug approvals, bias towards drug approvals, industry dom ination of the Bureau of Drugs, im proper attempts to change agency doc uments, or patterns of harassment. The employees who made the charg es are all medical doctors, with the exception of Dr. Burton L. Appleton, who is a chemist. Appleton had charged at the hearings that, among other things, "my reviews of new drug applications and of investigational new drugs (IND) were altered unbeknownst to me, which I found only by inadver tence much later than the actual oc currence." In response to Schmidt's in quiry, he listed several specific inci dences. One incidence concerned Appleton's review of IND 4643. Appleton claimed that his immediate supervisor and the director of the division made changes in his review that he discovered only later. But, according to Schmidt, the
Schmidt: no evidence to support charges
changes were of an editorial nature, and did not alter the technical content of the review. For instance, "gratui tous" remarks, such as "fallible phar macists and physicians," were deleted because it was felt that such terms didn't belong in a drug review docu ment. Schmidt blasted the manner in which Kennedy held the hearings. In the report, he points out that although the two subcommittees were obligated to get at the whole truth, they were merely satisfied in knowing that "those testifying were indeed agency employees." As a result, the implica tion was created that there was no cre dence to the agency's currently existing drug review process, or to the integrity of the bureau's managers. Hence, he says, one is left with the impression that "unsafe drugs had been approved for the American market." And that is far from the truth, Schmidt asserts. Nevertheless, Sen. Kennedy, in a prepared statement, says that Schmidt's report still does not "remove doubts about FDA's capability to pro tect the health and safety of the Amer ican people. . . . Volume cannot be equated with accuracy or complete ness." Kennedy says he is going to withhold further judgment until an in vestigation by an outside panel of ex perts is completed. The panel, headed by Dr. Thomas C. Chalmers of Mount Sinai Medical Center in New York City, was appointed by the Secretary of Health, Education & Welfare at the request of Schmidt. Ling-yee Gibney, C&EN Washington
NSF science course program criticized The National Science Foundation's precollege science curriculum develop ment activities have been criticized sharply in two reports released recently by the House Committee on Science & Technology. Although both reports in dicate that NSF erred more by omis sion than by commission in its man agement of curriculum development programs, they recommend extensive
