Recombinant DNA Advisory Committee - 12/S4/92 
compromised patients. These patients already have a 10% risk of developing lymphoma. 
If this risk is increased by .0000001%, is it worth spending tens of thousands of dollars 
and expending many person years to expand the testing criteria? The lower-limit of risk 
in non-severely immune compromised patients is unknown. Dr. D. Miller said that he 
was in complete agreement with Dr. Anderson's conclusions. Testing of an entire 
production run could cost as much as $100,000, which would be prohibitive. 
Dr. D. Miller explained that the same concerns exist with adenoviruses. The 
investigators who received approval for the use of adenovirus vectors indicated that they 
could detect less than 1 particle per patient dose. If these investigators find that they 
cannot achieve this level of sensitivity, what criteria will the RAC establish? Perhaps the 
normal exposure to adenovirus in the environment should be considered. 
Dr. Geiduschek stated that what needs to be determined is the slope of the line that 
gives the rise of the breakout in terms of how fast that slope increases per day, then 
decide how many days rise is needed in order to detect a break out. In turn, the 
production run should be cultured for twice that number of days. The number of days or 
weeks is unknown because these reconstruction experiments have not been performed. 
It is unlikely that a non-productive extension in the incubation period will increase costs 
by a factor of 10. 
Dr. Murray suggested that the FDA should comment on the criteria they have 
established for testing RCR. Dr. Henry Miller stated that the agenda for this meeting 
was moved up, and that the FDA representative regarding this issue is not present. Dr. 
Murray agreed to postpone the discussion until the FDA representative arrived. 
DISCUSSION REGARDING COSTS ASSOCIATED WITH TREATMENT OF NON- 
NEGLIGENT RESEARCH-RELATED INJURY/(CONTINUED) 
Dr. Murray recalled the RAC's attention to the revised letter to the NIH Director 
regarding costs associated with the treatment of non-negligent research-related injury. 
This letter was revised by Drs. Walters, Zallen, Geiduschek, and Ms. Meyers; and 
distributed to the committee for comments. 
Dr. Parkman stated that he still has great difficulty with this issue. He said that he 
would only support a position that did not focus solely on gene therapy or research 
funded by the NIH. He would endorse a letter to the NIH Director that would 
recommend that a proposal should be sent to the administration recommending that this 
issue be considered in the formulation of a reformed health care policy. The 
recommendation of the RAC should be very broad. 
Recombinant DNA Research, Volume 16 
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