NIH Panel Advocates Harsh Price for Cline

From the Archives of GEN, May/June 1981

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EDITOR’S NOTE: In one of the first issues of GEN, we published an article about the so-called Cline affair. Martin J. Cline, MD, a professor of medicine at UCLA, achieved notoriety in 1980 when he performed the first gene therapy experiments on human subjects. Cline said the experiments were carried out in Italy and Israel while a request to perform similar experiments at UCLA was still being considered. UCLA eventually denied Cline permission and, amid the controversy surrounding the experiments, forced him to resign his chairmanship at UCLA Medical School. He also lost several research grants. The results of the experiments were reportedly inconclusive.

May/June 1981 GEN ArchiveA special staff committee at the National Institutes of Health (NIH) has recommended a severe penalty against blood researcher Martin Cline for his gene replacement experiments involving human subjects. Cline, a UCLA professor of oncology, was charged with violating two sets of rules for gene experiments through his use of human subjects. The NIH report said that he violated federal rules against research with humans, as well as a federal ban on some kinds of research with recombinant DNA.

During July 1980, Cline conducted experiments on two young women: a 21-year-old Israeli and a 16-year-old Italian. Both were suffering from b-thalassemia major, an ultimately fatal genetic disorder in which one of the polypeptide chains of the hemoglobin molecule is missing.

Bernard Talbot, special assistant to the director of the NIH and the official who directed the initial investigation, said that the committee had found that Cline had obtained normal hemoglobin genes from a human donor and used recombinant DNA techniques to splice them into bacterial plasmids.

Gene replacement therapy for this disease involves extracting blood-producing bone marrow cells from the patient, inserting plasmids bearing the genes which produce the missing polypeptides, and reintroducing the cells back into the patient’s bone marrow.

As a result of the charges, Cline could lose all or part of the $650,000 in annual NIH grants that he uses or supervises at UCLA. The charges also could lead to restrictions on his experimental work. However, the sanctions depend on further reviews.

Reports have been conflicting as to whether or not Cline received permission to conduct the experiments. Recently, he told GEN that in 1979 he applied simultaneously to Israel, Italy, and UCLA, and that Italy and Israel gave permission to attempt this experimental therapy, while UCLA deliberated for 15 months before eventually denying permission.

A report in late May in the Washington Post, however, claimed that Cline “did not ask for permission from UCLA, Israel, or Italy to use the products of gene splicing (recombinant DNA) in his work on humans.” Cline has pointed out that he was acting as both a researcher and a physician, and so had to consider the best interests of his patients.

The ethical issues raised by his decision are at the core of the intense professional criticism and investigation. His scientific abilities are generally held in high repute. This penalty is the second that Cline has received for his experiments. The first came in March when he was asked to resign as head of the hematology and oncology department at the UCLA Medical School after a university investigation raised questions about the procedures he used.

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