Shortly after arriving as chair of the surgery department, Najarian and his team performed the first successful kidney transplant in a patient with diabetes, a feat that many clinicians felt was too risky to attempt.
Najarian’s team took on these cases because diabetes was a major cause of kidney failure, and without a transplant, patients would be tethered to costly regular dialysis sessions for the rest of their lives.
Central to Najarian’s surgical success, and eventual downfall, was a drug he pioneered called anti-lymphocyte globulin, or ALG. The medication helped patients survive a post-surgical phase called acute rejection. ALG tamped
down the immune system’s attack on a donor organ.
On the strength of that success, the U of M launched kidney, heart, liver, pancreas and bone marrow transplant programs that were the envy of medical centers throughout the world.
But it was an 11-month-old girl with a failing liver who made Najarian a household name in 1982 and cemented his reputation as a medical hero.
Other transplant centers had declined to take on Jamie Fiske’s case.
At the time, a successful liver transplant had never been done on a baby. As the operation unfolded, Najarian recalled how crowds descended on the hospital:
“It was one of the most staggering things that ever happened to me. We were doing her [surgery] in the middle of the night and we kept getting reports that there were people accumulating in our hospital lobby and they came from all over. And that’s kind of a hard position to be put in when you’re right in the middle of an operation which has not been done before and is likely to be unsuccessful.”
But Jamie did survive. She grew up and did well. Media coverage followed every time she returned to the university for a checkup.
During one such visit, her father Charles Fiske recalled his family’s ordeal.
“For us, there was no place else to go. And I think that’s the one thing he really offered us was hope,” Fiske said. “There was hope that we could take this very ill, dying, 11-month-old baby home and begin celebrating birthdays and put the word ‘tomorrow’ and ‘the future’ into her vocabulary and into ours.”
The publicity surrounding the Fiskes helped persuade Congress to pass the National Transplant Act of 1984. The law created a national database to match donors to people in need of a transplant.
Former medical school Dean Frank Cerra said Najarian’s success in the case also transformed liver transplantation.
“And out of that came, not only whole organ transplantation, but partial transplantation of livers,” said Cerra. “And out of that came the advancement of new technologies of immune suppression.”
The Fiske case also made Najarian arguably the most famous physician in Minnesota. It was a role he embraced.
Medical ethicist Art Caplan worked with Najarian starting in the late 1980s. Caplan said the surgeon was a larger than life figure, whose towering height matched his outsized persona.
“On the good side, he really was empathetic to patients. He wanted to help,” he said.
But Najarian was also a risk-taker, and Caplan said he didn’t like being held back, whether it was in the surgical suite or in his research program.
Najarian didn’t like to be hindered by bureaucracy or regulation, said Caplan, and that eventually got him into trouble.
Najarian had a limited license for ALG that barred him from selling it at a profit.
But he thought his transplant peers should have access to it anyway because ALG greatly improved patient survival.
So he sold it to dozens of centers around the world. Over an 18-year period sales totaled $79 million.
Federal officials began investigating the ALG program in 1989. Three years later the Food and Drug Administration shut down the program and accused Najarian of illegally selling the drug.
Najarian said the FDA knew all along what he was doing, but stepped in only after the drug industry complained about the competition. Najarian put it this way in 2010: “The FDA and drug houses were in bed together, enjoying the bed together. And so, when the drug houses called the FDA and said, you got to stop them, they looked for a way to stop us.”
But amid a massive, damaging federal investigation, the university painted Najarian as a rogue employee profiting from an illegal drug operation.
Then-President Nils Hasselmo moved to strip Najarian of tenure and fire the faculty member who had been the human face of the U’s most prestigious department. He would eventually lose his position as head of surgery, but continued to perform transplants there for years.
“What went wrong, two things: lack of oversight, lack of systems in the university to ensure that when things are not working, it would be discovered,” Hasselmo said. “And mismanagement within the program.”
Najarian was eventually indicted on 21 federal charges including fraud, tax evasion and obstruction of justice.
The judge in the case, Richard Kyle, threw out the six most-serious charges against Najarian and later sided with the defense saying the FDA had been looking at the ALG program for 15 to 20 years. A jury cleared Najarian of the remaining 15 counts, but the damage to his career was extensive.
The university also paid a steep price — $32 million in settlements. Nearly 90 faculty members left the medical school. The U also fell out of the top 20 in National Institutes of Health funding recipients.
Caplan said it was a disaster Najarian could have avoided.
“If he had been just a little bit more willing to collaborate with the authorities I think he could have probably survived that whole situation and basically put his drug through the approval process.”
However, Caplan says it’s interesting to think of Najarian’s dispute with the FDA in light of the current drug approval environment. He says legislation passed over the years to speed up the FDA’s process shows that Najarian’s frustrations resonated with others.
“He would probably smile and say, ‘Yep, that exactly what I was fighting all those many years ago.'”
With time, hard feelings at the University of Minnesota faded and in 2007, the school created a $2 million endowed surgical chair in Najarian’s name.