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In the French study, the experimental antibody was compared to treatment with a standard antibody, antilymphocyte globulin, among 100 kidney transplant recipients.
Medical therapy of aplastic anemia often includes a short course of antithymocyte globulin (ATG) or antilymphocyte globulin (ALG) and several months of treatment with a cyclosporin to modulate the immune system.
Dr. Najarian, who is also president of the international Transplantation Society, is accused of conspiring to violate F.D.A. rules, including requirements that deaths and serious reactions to the experimental drug antilymphocyte globulin, or ALG, be reported to the Federal agency.
The core of the prosecution's case was the charge that Dr. Najarian and a co-defendant, Richard Condie, conspired to hide deaths and serious reactions associated with the drug, antilymphocyte globulin, or ALG, an anti-rejection drug once widely used after organ transplant surgery.
Dr. Jean-Paul Soulillou's team, from the National Institute of Health and Medical Research in Nantes, found that almost all those receiving the experimental antibody tolerated it well, while one-third of those receiving the antilymphocyte globulin suffered major side effects like chills, diarrhea and rashes.