Recombinant DNA Advisory Committee - 12/3-4/92 
Royston said that he did not have a written protocol at the time Senator Harkin's letter 
was sent to the NIH Director. 
Dr. Walters proposed a two-part solution. First, the RAC will entertain single patient 
protocols and is prepared to act expeditiously in the review of such protocols. Second, 
the RAC will approve minor modifications to approved protocols in order to 
accommodate a particular patient. Dr. D. Miller explained that relaxation of the 
inclusion/exclusion criteria would allow Dr. Royston's patient to be enrolled in the 
approved glioblastoma protocol conducted by Dr. Edward Oldfield. Dr. Royston said 
that Dr. Oldfield's protocol has not been approved by the FDA; therefore, patients are 
not being accepted into the study. Dr. Anderson said that Dr. Oldfield's protocol has 
been approved by the FDA Dr. Royston said that he would try to convince his patient 
to consider Dr. Oldfield's protocol. 
Dr. McGarrity reminded the RAC that there are thousands of glioblastoma patients in 
the U.S. This disease is incurable. Dr. Oldfield and GTI have already received over 650 
requests for entry into this protocol; many of these requests have been on a 
compassionate use basis. 
Dr. Royston said that he will follow any mechanism that the RAC adopts; but it has to 
be expeditious, not on a 3 month basis. Dr. Murray explained that there are many 
individuals who do not believe that gene therapy has reached a stage that it can be 
granted on a compassionate use basis, especially when the request comes from a 
laboratory that has not received protocol approval. 
Mr. Barton stated that in his view the only option is the submission of a protocol in the 
current time frame (January 4) for review at the March 1-2, 1993, meeting. Dr. Royston 
encouraged the RAC to establish a rapid mechanism of review that can accommodate 
the RAC and NIH Director. Dr. Murray stated that it is unclear that the RAC is ready 
for establishing such a mechanism nor is the public ready for expedited review. 
Dr. Carmen recommended that a working group should be established to propose 
recommendations with specific language that could be presented at the March 1-2, 1993, 
RAC meeting. Dr. Murray appointed Dr. Walters to chair the working group. 
Dr. Royston said that it is his understanding that he RAC will entertain a single patient 
protocol if submitted by January 4, 1993. He said that he would be happy to submit this 
proposal by the deadline. However, he stated that his expectation is that he will submit 
a request to initiate this treatment prior to the March meeting. He will submit the 
protocol, and deal with the government authorities as needed. 
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Recombinant DNA Research, Volume 16 
