Letter
Authors: RICHARD L. HURWITZ
Journal: Molecular Therapy (2001)

To the Editor— I read with interest and then surprise the Commentary by Ira Carmen entitled “A Death in the Laboratory: The Politics of the Gelsinger Aftermath,” which was published in the April 2001 issue of Molecular Therapy [1Carmen I.H. A death in the laboratory: the politics of the Gelsinger aftermath.Mol. Ther. 2001; 3: 425-428Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar]. I was surprised that he used our Gene Therapy for Retinoblastoma clinical trial as an example of how clinical investigators are trying to circumvent the oversight of the Recombinant DNA Advisory Committee (RAC). The author's premise is that we had no intent to submit our protocol to the RAC. He implies that we had no respect for the committee's expertise or authority. How ironic that a co-PI on our protocol was at that time a member of the RAC and this individual helped write the RAC application and advised us throughout the application process. There were no regulations at the time of our application concerning the exact timing of applications to the Food and Drug Administration (FDA) and the RAC. After receiving FDA approval, we waited for the RAC to advise us on the protocol. After receiving this advice, we complied with every suggestion the RAC had to offer. After revising our protocol we submitted the amendments to our Institutional Review Board (IRB), the FDA, and the RAC. After receiving the go-ahead from all of these agencies, we then opened our trial for patient accrual. The approval process occurred during the first 6 months of 1999. We treated our first patient in April 2000. We sought the advice not only of members of the RAC and FDA but also of leading ophthalmologists who treat retinoblastoma around the world. We felt that it was imperative to be thorough in our preparation for the trial before rushing into treatment. Ira Carmen made some important points in his commentary. When he used false statements to support his thesis, however, he weakened his entire argument. I was never asked by anyone at Molecular Therapy for a response to Ira Carmen's allegations, even though reputable journalism requires this as an essential part of the fact-checking process before any accusatory article is published. Dr. Carmen refers to an article written in the journal Science about our clinical trial and our response to this article [2Garber K. RAC nixes plan to treat retinobastoma.Science. 1999; 284: 2066Crossref PubMed Google Scholar, 3Hurwitz R.L. Brenner M.K. Poplack D.G. Horowitz M.C. Science. 1999; 285: 663-664Crossref PubMed Google Scholar]. In fact, Science readily acknowledged the error in their article and invited a response from us, which they published. In addition, although it was too late to change the title in the hard-copy version, the editors of Science changed the headline in their on-line version of the journal (the reference to “RAC nixes retinoblastoma protocol” made by Ira Carmen). In my response, I acknowledged the importance of the RAC and the advice their members gave. My displeasure was with the inaccurate reporting of the journal staff that jeopardized our patient recruitment, not with the RAC or the advice they gave. I believe Molecular Therapy as a publication has a responsibility to its readers to get the facts right just as they have a responsibility to ensure that the scientific articles published in the journal are scientifically sound. When accusations are made against an individual, I believe that the journal staff has a responsibility to give the accused a chance to respond concurrently, not months later. Scientific journals cannot afford to be known as purveyors of information that is hostile and inaccurate. We agree entirely with Dr. Hurwitz that science journals cannot be “purveyors” of “hostile and inaccurate” information. However, it is also important to emphasize that editorials and commentaries in Molecular Therapy reflect the opinions and understandings of the authors, not those of the journal nor of the Society. Nevertheless, the Editors regret this interpretation of a section of an otherwise thoughtful and interesting commentary, and will redouble efforts to provide an appropriate forum for response without censoring the opinions of authors.