Word: alge
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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...
...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 have to be deaf and blind not to know what was going...
...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. "We're using the alternatives now," says Sutherland, "and it's a good thing they're there...
...long as ALG remained the central issue, Najarian's defenders could claim he had done nothing more immoral than run afoul of federal bureaucrats. But earlier this year, university officials disclosed irregularities in the surgery department's handling of federal grant money, including apparent diversions of funds to support the ALG program. Investigators also released documents suggesting that Najarian sometimes cheated on his expense accounts. Seven years ago, for instance, he allegedly asked the corporate sponsor of a conference held in Stockholm to reimburse him for $4,122 in travel charges after submitting a bill to the university claiming...