A world-famous transplant surgeon who led the University of Minnesota surgery department for 26 years is scheduled to go on trial this week on charges of illegally selling an experimental drug and lying to federal authorities about his activities.
John Najarian, M.D., faces 21 counts of fraud, embezzlement, tax evasion and obstruction of justice. The charges are related to his oversight of a university program to develop and market a version of antilymphocyte globulin. The drug, known as Minnesota ALG, was being tested for its safety and efficacy in preventing the rejection of transplanted organs.
Jury selection in Najarian's criminal trial was set to begin Jan. 16. The trial in U.S. District Court in St. Paul, Minn., is expected to last through March.
Najarian told regulators that ALG wasn't being sold or producing a profit, although his department collected nearly $80 million from sales of it and related products over two decades, federal officials said. It is illegal to market drugs without approval from the Food and Drug Administration.
Najarian has pleaded innocent to the charges.
"The FDA knew the drug was being sold for cost recovery," said Peter Thompson, Najarian's lawyer. "We intend to prove the ALG drug was safe and efficacious, the patients were treated with great care, and the drug and Dr. Najarian made substantial contributions to the well-being of thousands."
Najarian, 68, is the surgeon who treated former Vice President Hubert Humphrey when he was dying of cancer and saved 11-month-old Jamie Fiske in a 1982 liver transplant case that captured national attention. He was president of the American Society of Transplant Surgeons in 1977.
He resigned under pressure in 1993 as chairman of the University of Minnesota surgery department and abandoned his faculty appointment in February 1995.
Najarian improved ALG and received FDA permission to test it on patients in 1970. Although the drug never was approved for marketing, it probably was used on more than 50,000 patients, according to a university investigation.
The FDA halted sales of the drug in 1992, and the university closed the ALG program in 1994 after failing to find a buyer.
Najarian was indicted in April 1995. He also stands accused of concealing serious adverse reactions to ALG, including nine deaths, defrauding the university and other institutions of thousands of dollars through double-billing for expenses, and failing to obtain informed consent from patients.
Last August, a former subordinate who was named in the indictment pleaded guilty to three counts of conspiracy, embezzlement and income-tax evasion.