DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20892 
Building : 126 
Room : 0433 
(301) 496- 
November 25, 1988 
Dr. Arnold S. Reiman 
Editor-in-Chief 
The New England Journal of Medicine 
10 Shattuck Street 
Boston, MA 02115-6094 
Dear Dr. Reiman: 
Your letter clarifying for the record The New England Journal of 
Medicine’ s publication policy is appreciated. It is my 
understanding that confusion arose regarding the distinction 
between providing unpublished data in an open public meeting as 
opposed to the confidential deliberations of a study section or 
internal review committee. Clearly this issue is of great 
concern to the National Institutes of Health and to the 
scientific community in general. 
Since its inception, the Recombinant DNA Advisory Committee has 
maintained a long tradition of supporting public discussion of 
proposals to exercise new forms of recombinant DNA technology. 
Such applications are scrutinized and debated extensively, often 
finding an audience in the lay press as well as scientific 
journals. With the exception of a few instances when research 
proposals contained information of a proprietary nature, we have 
encouraged broad participation at these meetings by announcing 
the agenda in the Federal Register and by allowing time for 
public comment. Frequently, the debate is lively and receives 
national coverage. This serves to inform the public about 
advances in basic biomedical research and may be responsible for 
some degree of the growing acceptance of biotechnology and the 
recognition of its benefits. 
Naturally, the first proposal to insert a foreign gene into human 
patients has focused much attention on the RAC. Therefore, we 
have been made acutely aware of the need for openness and full 
cooperation of the investigators who are submitting their 
applications to the RAC. In the case of the proposal from 
Drs. Anderson, Blaese, and Rosenberg, data that were not given to 
the RAC Human Gene Therapy Subcommittee for its meeting on 
September 29 were presented in slide format at a meeting of the 
full RAC on October 3. For this reason, I felt that it was 
appropriate to ask that this information be reviewed, in writing, 
by the subcommittee prior to my decision to approve or nor to 
approve. This process is under way, and additional material will 
be provided to the subcommittee. 
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Recombinant DNA Research, Volume 13 
