Word: transplanter
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Dates: during 1990-1999
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...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...
While Najarian may not have been greedy, he was certainly ambitious. He saw himself, says a former colleague, as a pacesetter who was moving the field of transplant surgery forward, someone who couldn't be bothered with the details of the rules because he was changing the rules. And while Najarian is a personable man who enjoys chatting with patients, he's also an opinionated, imposing figure who can intimidate friends and foes without even trying. University president Hasselmo sees Najarian's situation as "a tragedy in the classic sense. It's the story of a hero who is destroyed...
Just wait for the trial, says Najarian, who believes he will be vindicated. In the meantime, his downfall has already produced heavy casualties. Transplant patients have lost a good drug, the University of Minnesota has lost millions of dollars in annual income, and the field of transplant surgery has lost a charismatic leader...
...Transplanting a pig's heart into a human being sounds like an experiment only a mad scientist would dream up. But researchers at Duke University Medical Center in North Carolina believe they are quite sane -- and getting closer to making such a bizarre operation possible. In the journal Nature Medicine last week, they reported overcoming some of the obstacles that Mother Nature has put in the way of transplanting organs between species. By altering the genetic makeup of a strain of pigs, Duke's team, led by Dr. Jeffrey Platt, was able to fool the immune systems of three baboons...