16 
considerations with other therapies. Dr. Motulsky asked vhether current Section 
I-B-4-c (Attachment IV) had addressed this consideration. Dr. Grobstein said 
he was specifically attempting to obtain probabilities on vhether human gene 
therapy raises new public health concerns. 
The working group agreed to incorporate the language proposed by Dr. Grobstein 
for Sections I-B-4-a, I-B-4-b, and I-B-4-c of the points to consider document. 
Dr. Childress said an important public health consideration is vhether hazards 
different from those that exist with other therapies are associated with human 
gene therapy; he suggested transmission of the viral vector might be one novel 
concern. He asked vhether this concern should be spelled out in Section I-B-4-a. 
Dr. Rich thought the pertinent question vas vhether methods exist to mitigate 
risk to public health. 
Mr. Capron preposed a Section I-B-4-d which would read; "Vhat measures will be 
undertaken bo mitigate the risks, if any, to public health?" 
The working group agreed to this proposed modification of Section I-B-4 of 
the points to consider document. 
Dr. Temin noted that one ccmmentor had mentioned possible risk to phlebotomists 
and had suggested subjects of human gene therapy not be accepted as blood 
donors. He asked why these comments had not been incorporated in the points 
to consider document. 
Mr. Capron said the issue is vhether a large enough risk exists to stigrmtize 
human gene therapy patients by including this type of language in the points 
to consider document. The siioworkirg group did not feel such a risk exists. The 
working group agreed. 
Dr. Walters called the attention of the working group to Section I-B-5-b which 
had been modified to include a question on patient fbllcw-up. Dr. Motulsky 
asked if a time period had been set for follow-up. Dr. Walters said the intent 
is to request information on long-term care facilities. Dr. Grobstein said 
the word "reside" indicates the intent of the working group. Dr. Gottesman 
said the section. Reporting Requirements , specifies a three to five year follow- 
up period; she thought that time frame would be adequate. 
Dr. Mahoney said this portion of the document simply informs the investigator 
that the patient should be followed for a period of time. 
Dr. waiters called the attention of the working group to Section I-C-5 which 
deeils with the fair selection of patients. 
Mr. Capron said the points bo consider should ask hew will subjects be selected 
if more patients wish to be included in the study than the study can accommodate. 
He suggested the language read as follows: "Hew will patients be selected if 
it is not possible to include all who desire to participate?" 
[101] 
