Recombinant DNA Advisory Committee - 12/S4/92 
provided regarding the proposed testing aliquot. Dr. McGarrity noted that his 
calculations indicated that 2% of the lot would be tested. Dr. Kahn said that 0.5% refers 
to the number of cells, not the volume of supernatant. 
Dr. McGarrity said that there has been a lot of discussion regarding the lack of data 
regarding co-cultivation and amplification. He would like to include the viral 
immunofluorescence in this list of non-validated tests. Dr. Kahn said that the 
immunofluorescence test was proposed as an additional test, but the FDA is not 
requiring investigators to perform this assay; it is one of 4 tests that can be performed to 
detect retroviruses. Dr. McGarrity added that TEM, even in the mouse producer cell 
lines, is a very inefficient test. Dr. Wivel agreed with Dr. McGarrity's assessment of the 
TEM assay. Dr. Wivel noted that the level of sensitivity is extremely low, and that this 
technique will not detect viral replication unless there is budding. Dr. McGarrity said 
that GTI is in the process of trying to validate a number of new assays; however, the 
data is not conclusive at this stage. Additional data will be forthcoming. 
Dr. Murray stated that since there is no further discussion, Dr. Anderson will revise the 
report and submit it to the RAC at a future date. 
XIV. DISCUSSION REGARDING PROPOSED REVIEW OF EUROPEAN HUMAN GENE 
THERAPY PROTOCOL (CONTINUED) 
Presentation-Dr. Blaese 
Dr. Murray called on Dr. Blaese to start the continued discussion regarding the review of 
a European human gene therapy protocol. Dr. Blaese provided additional background 
information regarding the European request for RAC review of a human gene therapy 
protocol. A group of European scientists have inquired about the possibility that the 
RAC would assist them in establishing an acceptable review format. These scientists are 
concerned that if individual European countries develop their own guidelines and 
legislation, than cooperation between international boundaries will be impossible. The 
EC is considering the adoption of the RAC model of review. 
In an effort to establish a set of standards that is similar to the RAC, The EC has 
proposed the dual review of several protocols. The European committee may actually 
establish a working group to participate in the RAC review of these proposals. This 
process will provide structure and legitimacy to European scientists' proposal that the EC 
establish a multinational review committee. This request has come from the president of 
this organization. 
Dr. Dronamraju asked Dr. Blaese to be more specific regarding the origin of this 
request. Dr. Blaese said that this committee, the Working Group for Gene Therapy and 
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