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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...
Fellow transplant surgeons speculate that the FDA crackdown may have been triggered by complaints from commercial drug companies. These companies, the thinking goes, were annoyed that their university-based competitor was selling an experimental drug as if it had been approved for full marketing. Or it may be that regulators, who sent letters to Najarian complaining of infractions, were unwilling to cut off the supply of a drug that filled such a desperate need. Whatever the reason, by the time the fda barred ALG production in 1992, two drugs capable of taking its place had come on the market...