Human Gene Therapy Subcommittee - 7/30/90 
precarious position relative to making his data public. 
Dr. Leventhal said that The New England Journal of Medicine had 
previously had a similar policy, but that they were becoming less 
stringent in this regard. Dr. Mulligan added that there should 
be an appreciation of the fact that the data were not developed 
and the Milan experiments were not designed with this protocol in 
mind. He said it may appear to people that criticisms are being 
raised about the human gene therapy protocol that do not pertain 
in any way to the Milan study. 
Dr. Epstein suggested that the list of provisos be reiterated 
with a current summary as to the status of each, so that issues 
can be narrowed. 
Dr. Walters went through the issues one at a time: 
1. That the consent form be revised and be reviewed and 
accepted bv the RAC at its next meeting ; 
Dr. Walters said all issues had been taken care with the 
exception of the questions posed by Drs. Childress, Zallen and 
Ms. Meyers, which left only minor matters for the investigators 
to respond to. 
2 . That a stronger warning with regard to the potential 
for malignancy be inserted into the consent form : 
Dr. Childress said this issue has been satisfied. 
3 . That a stop criterion of two therapy-related deaths be 
inserted ; 
Dr. Parkman said the investigators had adequately addressed this 
on page 62 of the revised protocol. 
4. That intraperitoneal (i.p.) infusions not be utilized 
without further approval bv this committee ; 
Dr. Parkman said there were still references in the protocol to 
i.p. administration that were a result of administrative 
oversight and should be removed. 
Dr. Anderson said this reference to i.p. administration was an 
issue which the investigators wanted to retain as a compromise 
position. He said this had been worded so that if the 
investigators can provide data to the Institutional Review Board 
(IRB) that i.p. injection would be appropriate, it would be 
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Recombinant DNA Research, Volume 14 ;| 
