Clarification regarding novel Clostridium botulinum toxin.

TO THE EDITOR—I write on behalf of the Department of Health and Human Services to clarify some matters addressed in the editorial commentary [1] accompanying the recently published article by Barash and Arnon [2]. In the Notes section , the commentary states, " A committee representing various branches of the US government reviewed and approved submissions of the manuscripts " [1] authored by Barash and Arnon [2, 3]. Most readers of this statement would logically conclude that the US government had read a draft or prepublica-tion version of the manuscript that was ultimately published, but this is not correct. Representatives of the US government were not provided with and, hence, did not review these manuscripts. Furthermore, the US government had no authority in this case to grant or withhold approval of submission of the manuscripts , and, thus, the government did not " approve " the submission of the manuscript. In addition, the commentary states, " Because no antitoxins as yet have been developed to counteract the novel C. botulinum toxin, the authors had detailed consultations with representatives from numerous appropriate US government agencies (see Notes), as well as the JID editors, and received approval to publish both manuscripts, while withholding the key gene sequences until appropriate countermeasures were developed " [1]. Again, while members of the US government had occasion to speak with Amon regarding his work, the US government did not approve or disapprove publication of the manuscript, did not recommend withholding the gene sequence, and did not place any conditions on the publication of the manuscript.