Monday, May. 15, 1995
ONCE A HERO
By J. MADELEINE NASH/MINNEAPOLIS
Patients think of him as a guardian angel. Nurses call him a god. Virtually every week for the past three decades, pioneering trans-plant surgeon John Najarian -- an Olympian figure with the physique of a football player and the self-confidence to match -- has ventured into the operating room at the University of Minnesota Hospital to battle death. And more often than not, he has won. Patients he has saved can vividly recall the surge of hope they felt when Najarian gave them his simple vow: "I can do it."
His vision and skill have opened new frontiers for transplant surgery. Thanks to Najarian's work, diabetics are no longer told that transplants are too risky for them. And it was Najarian who proved that patients could safely receive kidneys donat-ed by living relatives. "We're not talking about just any doctor," says ethicist Arthur Caplan of the University of Pennsylvania, "but a giant of 20th century medicine."
So the shock and sorrow were profound last month when Najarian was indicted by a U.S. federal grand jury on 18 felony counts related to his work. Najarian, 67, who has pleaded not guilty, is accused of offenses ranging from embezzlement and income-tax evasion to conspiring to deceive the Food and Drug Administration. "When I heard the news," said Beverly Massegee of Ranger, Texas, who credits Najarian with saving her daughter's life, "I sobbed."
Najarian's trial, scheduled to begin later this year, is already shaping up to be a compelling courtroom drama. Prosecutors will seek evidence of duplicity from uni-versity administrators and government officials, while the defense is expected to summon an army of patients to portray a man motivated by nothing but the Hippocratic oath. "I'd go to the ends of the earth for him,'' says Charles Fiske of Bridgewater, Massachusetts, whose 11-month-old daughter Jamie in 1982 became the world's youngest recipient of a successful liver transplant performed by Najarian. Scott Jameson of Minneapolis, Minnesota, who recently marked the 25th anniversary of his kidney transplant, is already considering what he'd like to tell the jury. "I've seen one side of the man," he says, "and he's been nothing but good."
Najarian's life had seemed the very model of an American success story. The son of Armenian immigrants, he attended the University of California, Berkeley, on a football scholarship and later turned down an offer to play for the Chicago Bears in favor of going to medical school at the University of California at San Francisco. He stayed there for a residency in surgery, joined the faculty and soon became one of the first practitioners in a glamorous new field of medicine: organ transplantation.
First in San Francisco and later as chief of surgery at the University of Minnesota, Najarian focused on kidney transplants, struggling to improve the dismal success rate. Early on, only a third of patients survived more than three years. They were dying, Najarian knew, mainly because of tissue rejection. Their immune systems targeted transplanted organs as foreign and marshaled white blood cells to destroy the invaders. But Najarian saw a solution. With a colleague, he worked out a method for purifying a new drug called antilymphocyte globulin, or ALG, a potent cocktail of antibodies capable of countering the lethal reaction.
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's St. Paul campus.
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 by a desire to enhance Najarian's power and prestige. The surgeon denounces that allegation as ludicrous. "I didn't need to enhance my power and prestige. I was one of the original transplant surgeons in the U.S. and, in fact, the world!"
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 a grand-jury probe that subpoenaed 22 years' worth of records kept by Condie and Najarian.
As the 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.
Now awaiting trial, Najarian has retreated into his private practice. At the University of Minnesota Hospital, where he still performs two or three transplants a week, the embattled physician can often be seen striding down corridors in his white coat and surgical greens or sitting behind his desk in his out-of-the-way office, musing quietly amid pictures of his adult sons. On the advice of his lawyers, Najarian is saying little about the charges he faces, but he makes no secret of his anger and sense of betrayal. "The university," he says, "turned on me because they were afraid they might be held culpable."
If 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 have to be deaf and blind not to know what was going on."
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. "We're using the alternatives now," says Sutherland, "and it's a good thing they're there."
As 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 a similar amount.
The surgeon's defenders argue that whatever mistakes he made, they were not the product of greed. Though Najarian earned as much as $600,000 a year and liked to fly first class, he shunned ostentatious cars and sent all his children to Minneapolis public schools. "My father could have made millions of dollars a year as a surgeon for the rich and famous," observes Jon Najarian, the eldest of four sons. "But it was never his goal to make millions of dollars. It was his goal to help people."
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 by arrogance."
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.
One larger lesson is that medical-school departments should not be allowed to operate as independent fiefdoms with little external oversight. At the University of Minnesota, at least, the lax administrative system that let Najarian get in such serious trouble is belatedly undergoing a radical overhaul-in hopes that none of the school's other stars will fall so far so fast.