“The F.D.A. and the Drug Houses Were in Bed Together”

(p. A22) Dr. John S. Najarian, a groundbreaking transplant surgeon who made headlines for taking on difficult cases, and who weathered a different type of headline when he was accused, and then exonerated, of improprieties related to a drug he had developed, died on Aug. 31 in Stillwater, Minn., east of Minneapolis.

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In November 1982, Dr. Najarian performed what may have been his highest-profile surgery. The patient was Jamie Fiske, who became the youngest successful liver transplant recipient when Dr. Najarian performed the operation a few weeks before her first birthday. Her parents had made a widely publicized appeal for a donor.

“They were told that she wouldn’t survive that kind of an operation,” Dr. Najarian said in an oral history recorded in 2011 for the University of Minnesota’s Academic Health Center. “I’m not the kind of guy that takes that lightly. So I told them, ‘If a liver becomes available, we’ll transplant it, and it will work’ — a pretty brash statement, but it did.”

Dr. Najarian’s success with transplants was aided by a drug he developed in 1970, a type of antilymphocyte globulin known as Minnesota ALG, which addressed the biggest problem with early transplants: the rejection of the new organ. He said the drug, which he began using around 1970, gave the Minnesota transplant teams notably better results than other surgical centers were getting with a product offered by a pharmaceutical company.

“Everybody thought we were lying,” Dr. Najarian said, “because we could take patients and we could transplant them, and 65 to 70 percent of them did extremely well, whereas they were lucky to have 50 percent with the commercially available product from Upjohn.”

Other transplant centers began asking for the product, and it turned into a multimillion-dollar business for the university. But in 1992, the Food and Drug Administration, which had approved ALG as an investigational drug but not for interstate sale, stopped the program, and the federal authorities began an investigation. The university turned on Dr. Najarian, pressuring him to resign, and in 1995 he was charged with violating drug safety laws and other crimes.

Dr. Najarian maintained that the case was an attempt by the pharmaceutical industry and its friends in the F.D.A. to squash a successful treatment that was costing drug companies money by besting their products.

“The F.D.A. and the drug houses were in bed together,” he said bluntly in the oral history.

His trial in federal court in St. Paul, Minn., in 1996 provided vindication. Judge Richard Kyle threw out six of the charges, and a jury acquitted him of the other 15. The judge then took the extraordinary step of blasting the F.D.A. and the prosecutors.

“I have some questions as to why we were here at all,” Judge Kyle said.

The F.D.A., he added, “was certainly aware of what was going on, and yet they came in here as a witness to testify that somehow they were hoodwinked by this defendant and his colleagues and other people at the university.”

“We had a program here in Minnesota,” the judge added, “which, for all its problems and shortcomings, was a good program, literally saved thousands of lives.”