Recombinant DNA Advisory Committee - 12/3-4/92 
Larry Thompson, a science writer for Science magazine, urged the RAC to request all 
pertinent information and to demand this data if necessary. Representatives from both 
the New England Journal of Medicine and Science have provided public statements that 
any government body that requests information from a scientist will not prejudice the 
magazine against the results being published in that magazine. Dr. Leventhal 
acknowledged that these statements have been made in a public forum; however, 
investigators have still experienced problems having their data published after it has been 
presented in public. Dr. D. Miller said that he was not convinced that Science would 
publish an investigators data after the information had already been presented. 
Dr. D. Miller suggested that the data reporting form should include any safety issue 
regarding the patient, e.g., did the patient die? What was the cause of death? The form 
should include information regarding any problems that were encountered with 
implementation, i.e., was the investigator able to establish a lower limit of helper virus 
contamination? 
Dr. Leventhal said that she would revise the data reporting form incorporating the 
suggestions offered by the other RAC members. She asked for assistance with regard to 
establishing scales for socio-economic status. Dr. Secundy stated that she would assist 
Dr. Leventhal in the development of these standards. 
Ms. Meyers inquired if the RAC could hold executive meetings, which are closed to the 
public, for the purpose of reviewing confidential information. Dr. Wivel responded that 
closed sessions can be held only for the discussion of proprietary information. Ms. 
Meyers asked if prepublication data is considered proprietary information. Dr. 
Leventhal asked if this information is considered intellectual property. Mr. Barton said 
that the definition of trade secret involves the potential for commercial value. The key 
issue is probably whether the prepublication information comes from an academic 
research institution or a private company. 
Dr. D. Miller said that he did not want access to an investigator's results before 
publication. RAC members should take into account that data could be presented that 
could influence the research of particular committee members. The RAC should not put 
itself in a position to review this prepublication data. In addition, access to this 
preliminary information could influence the RAC's ability to judge future proposed trials 
because a bias may have already been introduced. Dr. Leventhal stated that she feels 
very strongly about this issue. Some patients, particularly cancer patients, will respond to 
any therapy that is administered. If tumor regression is considered too seriously at this 
stage in human gene therapy, the RAC may draw inaccurate conclusions about efficacy if 
the natural history of each particular tumor is unknown. Major difficulties will arise if 
the RAC attempts to evaluate the therapeutic efficacy of any protocol that has been 
approved. 
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Recombinant DNA Research, Volume 16 
