Issues pertaining to the critiques of the SAINT-I Trial.

welcomes Letters to the Editor and will publish them, if suitable, as space permits. They should not exceed 750 words (including references) and may be subject to editing or abridgment. Please submit letters in duplicate, typed double-spaced. Include a fax number for the corresponding author and a completed copyright transfer agreement form (available online at In the recent article by Ginsberg, 1 the author advances several statements that are clearly incorrect. Additionally, the author impugns the critique written by one of us, the editorial by another one of us and aspects of the SAINT clinical trial program. We feel it appropriate to respond to these allegations and mis-statements. The author states that the critique by Hess and editorial by Fisher appeared in a section of Stroke coedited by Dr Lees, the first author of the SAINT-I article that was the subject of these 2 articles, implying impropriety. 2,3 In fact, on the page preceding the article submitted by Hess in April 2006, the Editor-in-Chief of Stroke, Dr Hachinski, clearly states that Dr Lees' appointment as section coeditor for Emerging Therapies began on July 1, 2006 and that " Dr Lees had nothing to do with the choice or editing of these articles. " 4 No impropriety occurred. Another mis-statement by Dr Ginsberg is " Given the marginal findings and questionable methods of SAINT I, it is natural to question the wisdom of the rationale for proceeding to invest the tens of millions of dollars and thousands of medical-personnel hours needed to conduct SAINT II. " The 2 SAINT trials were designed as concurrent trials and initiated within a short time of each other. The sample size and National Institutes of Health Stroke Scale (NIHSS) outcome assessment of SAINT II were adjusted using appropriate trial methodology after the results of SAINT I became available to enhance the ability of SAINT II to evaluate the therapeutic efficacy of NXY-059. Recruitment to SAINT II was complete before publication of the articles cited by Dr Ginsberg. The suggested " unnatural exuberance " of the stroke community had no role in the performance of the 2 SAINT trials. Dr Ginsberg suggested that one of us " waxed enthusiastic " (Dr Hess) and the other one of us (Dr Fisher) was " insufficiently critical " in our critique and editorial. 2,3 We strongly dispute these allegations and the convenient out-of-context quotations used to support them. For …