Recombinant DNA Advisory Committee - 01/14/93 
to reach anyone at the NIH. He said that he is not suggesting that RAC meetings 
should not be open to the public. However, the RAC does not have to have the 
responsibility for compassionate plea exemptions if it does not choose to entertain these 
requests. Even if the RAC chooses to review compassionate plea requests, that authority 
can be taken away from the RAC. 
Under the Federal Advisory Committee Act (as interpreted by Dabney vs. Reagan in 
1992, in the Federal District Court of New York) the head of the agency who appoints 
an administrator does not have to call meetings. Therefore, the head of an agency that 
has an advisory committee does not have to call, listen, nor have put before that advisory 
committee, any matter of any kind whatsoever. He stated that his wife's request has 
turned into a turf battle. 
There is one matter that he found particularly reprehensible; namely, the suggestion that 
there has been political interference with the RAC and its decision making process. For 
the record, he explained how Senator Harkin became involved in his wife's 
compassionate plea for gene therapy. He contacted a former friend and client asking for 
assistance. This friend said that he knew Senator Harkin from Iowa. The patient's 
husband informed his friend that his wife is from Iowa and that her family still lives in 
Iowa. In fact, his wife's sister-in-law worked on several of Senator Harkin's campaigns. 
After the appropriate contacts were made, Senator Harkin sent a letter to Dr. Healy on 
October 8, 1992, requesting that his wife be considered for the compassionate use of 
gene therapy. This letter had been misconstrued as a threat to Dr. Healy that Senator 
Harkin would introduce pertinent legislation if the request was not acted upon. The 
patient's husband assured the RAC that Senator Harkin had not intended this letter as a 
threat; the Senator had merely offered his assistance. On October 20, 1992, Dr. Healy 
responded to Senator Harkin's letter stating that the RAC does not have a mechanism 
by which to consider individual compassionate plea exemption requests. The patient's 
husband stated that at this point there was insufficient time to submit a protocol within 
the 8-week time frame. Throughout this entire period, the FDA was extremely 
cooperative. He will always be grateful to the FDA for their cooperation. These are the 
facts surrounding any political involvement. He has never talked to Senator Harkin 
directly and, to the best of his knowledge, no one else with political influence has been 
involved in his wife's case. 
He explained that between himself and his wife's doctors, contacts were made in Canada, 
England, Germany, France, Italy, and Japan. He has talked to individuals at 31 cancer 
centers and has spent over $18,000 of his own money seeking treatment for his wife. His 
wife's tumor was identified on January 10, 1992. Her first resection was on January 14, 
1992. She has received 36 radiation treatments, 16 magnetic resonance imagings, 5 
computerized tomography scans, etc. On August 10, 1992, she had her entire right 
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Recombinant DNA Research, Volume 17 
