July 30, 1990, Human Gene Therapy Subconmittee 
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 bg revised and Ije reviewed and accented fey 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 intraneritoneal (i.p.l infusions not be utilized without further 
approval by 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 possible to present it for consideration. 
Dr. Walters said this issue was as yet unresolved and the subcommittee would have to 
discuss this further. 
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Recombinant DNA Research, Volume 14 
