The crime of saving lives. The FDA, John Najarian, and Minnesota ALG
L. G. Wilson
Department of History of Medicine, University of Minnesota, Minneapolis, USA.
The indictment of John Najarian, MD, and Richard Condie at Minneapolis,
Minn, on April 10, 1995, was a defining episode in the prolonged agony that
has ensued since August 1992, when the federal Food and Drug Administration
(FDA) placed Minnesota Anti-Lymphocyte Globulin (MALG) on clinical hold,
bringing to an end its use as an immunosuppressive agent for patients
undergoing transplantation. The principal charge in the indictment is that
from about 1968 until 1992--the whole period of the development and use of
MALG--Dr Najarian and Mr Condie conspired to defraud the United States by
impeding the FDA in its oversight of biological drugs and that they did so
for the purpose of financial gain. If the charges can be considered
seriously, they mean that Dr Najarian's purpose in the development and
manufacture of MALG was to make money, presumably for himself, and that the
possible benefit of MALG to the patients was of secondary concern to him.
Several difficulties arise immediately. In 1968, MALG offered a promising
new approach to immunosuppression. In a relatively crude form, it had been
used at the University of Colorado with striking improvement in the
survival of patients undergoing transplantation and transplanted organs,
but it was painful to administer by intramuscular injections and, in
addition to other side effects, produced muscular spasms. Dr Najarian and
his colleagues succeeded in purifying MALG so that the pure globulin could
be injected into a central vein. The process of purification was
complicated and expensive, so it was hardly practical for each transplant
center to produce MALG for itself. Thus, in 1969, when Dr Najarian
submitted an investigational new drug application (IND) to the FDA, he
stated that his purpose was to manufacture MALG not only for patients at
the University of Minnesota Hospital but also for patients at other
transplant centers, which were not in a position to make it for themselves.
He asked the FDA to approve recovery of the cost of providing MALG to other
institutions. The FDA approved Dr Najarian's IND application early in 1970
but did not respond to his request for cost recovery--then, or for the next
15 years. Dr Najarian was free to manufacture MALG and to distribute it to
other transplant centers for investigational use, but as for paying for it,
that was his problem. The FDA offered no suggestion.
