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Clearly, if there were some way to prevent GVHD, the prospects for transplant patients would be greatly enhanced. In 1981, three doctors at The Hutch thought they had come up with the answer. They believed that if they could kill the T-cells – the cells that fight off disease – in the donor marrow, they could avoid GVHD. The researchers claimed that the process had been successful in several studies using mice and in the only known study that used dogs. This second bit of information was important. If a procedure worked successfully in more than one animal species, the odds that it would also work in humans were greatly improved.

The only trouble was that the statement wasn’t true. In another study using dogs the treatment failed and several of the test subjects died. Although the research results from that study had not been published, they were widely known among specialists in bone marrow transplants – including Dr. Ranier Storb who was actually the resident expert on GVHD at The Hutch. He was not, however, a member of the Human Subjects Review Committee that was considering the T-cell proposal. Other Hutch employees, who were, however, had similar concerns. Among the problems identified by the HSRC were:

The lack of sufficient animal testing – especially the lack of testing on higher species.

The intent to use relatively healthy patients – many were in remission – instead of sicker patients as test subjects.

The selection of subjects who were receiving marrow from siblings – the least likely individuals to get GVHD.

The concern that removal of T-cells from the donor marrow might actually increase the likelihood of rejection.

Deficiencies in the “informed consent” document. Of particular concern was the document’s statement that in the event of rejection or graft failure a second transplant could be required. The problem with this statement was that it left an impression that a second transplant would entail minimal risk, when in fact 95% of the time second transplants were fatal.

In addition to the deficiencies identified by the HRSC, there was another factor that might have entered into their deliberations, except it was kept from them: the researchers had a financial interest in the experiment. It would employ a number of monoclonal antibodies owned by a company they had founded. They wanted federal dollars from The Hutch to underwrite the research that would make their product marketable.

The HSRC rejected the proposal, and that should have been the end of Protocol 126 – but it wasn’t.

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