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DR. FREDRICKSON: The Committee will come to order. The next invited 
witness is Ms. Pfund. Do you have something to say at this point, Ms. 
Pfund? 
MS. PFUND: I would just like to say that while I found the previous 
discussion interesting, I was a little disturbed by the tone I perceived, 
which seemed to me that people are chomping at the bit a little to get 
these other host-vector systems approved as rapidly as possible, but still 
insuring safety. And I think that really if we take the certification of 
EK12 systems as an example, we should be sobered by the fact that even 
though we know so much about that organism and we have studied it for so 
many years, it still requires an enormous effort to develop studies and 
tests before we can make any claims about the safety of this host-vector 
system. 
I think Dr. Sinsheimer raised some points questioning the legitimacy 
of claiming the EK12 system as safe at this time. I don't think he is alone. 
I, for one, agree with him. I know other scientists that do. So I would 
urge that instead of acting like we have to catch up with the Europeans as 
far as approving all these other host-vector systems, that we should certify 
systems with deliberate caution and with real attention to the special 
problems created when we are dealing with new vectors or new hosts. 
I think Mr. Helms brought up a good point when he asked if the cri- 
teria and the instructions to investigators developing these systems are 
matters of public record. I would urge that they not only be matters 
of public record, but be distributed, and that the NIH make a policy of 
garnering comment on the data itself, and the level of specificity in 
the criteria. I think in the Guidelines at this point it is not specific 
enough. Not only the criteria, but the process used to evaluate the cri- 
teria. It describes making a subcommittee of the Advisory Committee, 
and putting other people on it chosen because of their expertise in eval- 
uating such data. I think that ought to be made more clear, what this 
expertise is, what is the range? I mean, does it include epidemiologists, 
infectious disease people, microbial ecologists. I think it is important 
to really be explicit about what level of review you are going to have, and 
who is going to have input into the review process. I think by creating 
vaguely constituted, vaguely constructed subcommittees, the NIH skirts 
important issues of who determines what will be sufficient data to merit 
certification, and on what grounds such decisions should be made. 
I think the NIH should make an aggressive effort to disseminate all 
such information to the public and to relevant professionals before any 
decisions are made as co certification. One way to do this is to require, 
not merely encourage, that investigators publish their data on these systems 
before these decisions are made, and by circulating the data and by eliciting 
comments I think we will have more of a chance of really critical review of 
these systems rather than just in-house review of the systems. 
[ 307 ] 
