Word: fda
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Dates: during 1990-1999
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Minnesota ALG, as it became known, turned out to be highly effective. As patient survival rates improved, other surgeons clamored to get hold of the potion. Between 1970, when Najarian obtained permis-sion from the FDA to produce and use the compound on an experimental basis, and 1992, when the FDA shut down the operation, Minnesota ALG was shipped to 175 transplant centers around the world and was used by more than 50,000 patients. Along the way, it generated an estimated $80 million in revenues, enough to finance a $13 million production facility on the University of Minnesota...
Still widely regarded as one of the safest and most effective antirejection agents, Minnesota ALG is now Exhibit A in the controversy surrounding Najarian and his former colleague and co-defendant Richard Condie, who also pleaded not guilty. They stand accused of failing to tell the FDA about adverse reactions associated with ALG (including nine deaths); neglecting to recall one lot suspected of causing bad reactions; and concealing the fact that ALG, an experimental drug that was supposed to be sold at cost, was making a handsome profit. According to the indictment, the two co-conspirators were driven...
Najarian's celebrated career began to implode on Aug. 13, 1992, when FDA officials marched into the office of University of Minnesota president Nils Hasselmo to announce that the agency had imposed a hold on clinical use of Minnesota ALG. The following month university auditors uncovered evidence suggesting that Condie, director of the ALG program, had been selling a by-product of the production process and pocketing the proceeds. In November the university hired two law firms and accountants Coopers & Lybrand to delve into the ALG program. And in December 1992 the U.S. Attorney's office in Minneapolis launched...
...investigations have proceeded, Najarian has suffered one blow after another. In 1993 he was forced out as chairman of Minnesota's surgery department. Last year he signed a consent decree with the FDA that prohibits him from conducting trials of experimental drugs. Then last February, shortly after a faculty panel found him guilty of academic misconduct, Najarian abruptly resigned his faculty post...
...what Najarian was doing was so wrong, his supporters ask, why did the FDA and the university wait so long to act? "The paper work [required by the FDA] didn't get done," observes transplant surgeon David Sutherland, Najarian's longtime colleague. "But the paper work hadn't been getting done for more than 20 years." Moreover, the sale and success of alg were never a secret. From the beginning, says University of Minnesota medical historian Leonard Wilson, Najarian told the FDA that he intended to produce the drug for more than his own use. Says Wilson: "The FDA would...