Recombinant DNA Advisory Committee - 06/1-2/92 
rescue have been answered with Dr. Deisseroth's presentation. 
Dr. Geiduschek asked Dr. Dunbar to distinguish the three clinical protocols included as 
part of the submission from the gene marking protocol. Dr. Geiduschek stated that 
there is significant risk to the patient in these protocols relating to the rigorous 
chemotherapy/radiation regimen that they must undergo in preparation for the bone 
marrow grafts. He noted that there is also additional pain and suffering to the patients 
enrolled in this protocol attributable to the drug and radiotherapy treatments that they 
must undergo. If there is increased suffering attributable to the gene marking portion of 
the protocol, than the RAC should consider this issue. 
Dr. Geiduschek stated that he is inclined to approve the breast cancer protocol at this 
time but not the CML or myeloma protocols without further discussion. 
Review--Dr. Dronamraju 
Dr. Murray called on Dr. Dronamraju to present his review of the protocols. Dr. 
Dronamraju stated that he was in general agreement with Dr. Geiduschek's comments, 
and suggested that the informed consent document be revised using nontechnical 
language. 
Dr. Dronamraju stated that Dr. Dunbar had responded to his previous questions and 
comments in a timely manner. Dr. Dunbar was asked to expand on the primate animal 
data that is now available since the rationale behind this proposal is derived from a 
murine model. 
Dr. Dronamraju asked for clarification regarding the ratio of transduced cells that were 
administered in the murine model. How will this ratio translate to the human 
experiments? What will be the age distribution for the patient population? What is the 
life expectancy of these patients? 
With regard to life expectancy, Dr. Dronamraju stated that if the expected survival of 
these patients is only a few months, the RAC should receive a report from the 
investigators more often than once a year. He asked Dr. Dunbar if the goals of the 
protocol are achieved, how will she proceed next. 
Review-Mr. Barton 
Mr. Barton stated that the majority of the concerns that he had regarding the protocol 
were accurately addressed previously by Dr. Dunbar. There still is a concern that the 
number of transduced cells being returned to the patients will be so small that there is 
only a remote probability that the marker gene will be detected. A negative result will 
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