A recent editorial proposes that commercial interests are producing an increasing opacity in the field of human gene therapy (1). The grounds offered for this pessimistic assertion are the recent revelation of patient deaths and a growing awareness of morbidity in a number of gene therapy clinical trials, a perceived loosening of public scrutiny over clinical gene therapy studies, and a growing presence of commercial interests in those studies. However, just the opposite is true. It has been all too easy for some observers recently to ascribe these problems to the role of industry in current gene therapy studies. It is, of course, far more complex than that. Although the field of human gene therapy grows vastly more complex as a result of rapid technical advances, expanded clinical trials, and burgeoning interactions between academic and commercial centers, we are coming to appreciate more clearly than ever, perhaps slowly and sometimes through misfortune, the many technical hurdles and the difficult ethical and public policy issues that still face human gene therapy, including the factors that influence the relationship between academic investigators and corporate partners.

During the initial phase of the development of human gene therapy, translation of basic concepts into clinical reality seemed relatively straightforward and largely within the basic and clinical research capabilities of academic gene therapy centers. Even when the logistical difficulties of vector production emerged in early clinical studies, it seemed likely that a division of labor between academia and industry would eventually develop. Academia would innovate and provide the basic underpinnings for the technologies of gene transfer and gene delivery while industry would implement and translate basic knowledge into clinical reality, largely through the production and distribution of gene transfer vectors. This model appeared to have support during the late 1980s to mid 1990s, when academic centers in several institutions established programs not only to develop the basic molecular genetic and cell biology infrastructure required for human application but also to design and carry out clinical studies. However, with the beginning of active human clinical studies in the late 1980s and early 1990s, it became increasingly clear that this emerging field of medicine would not fit easily into this simplistic model. Of course, because of the scientific groundwork being laid out in academia and the existence in academic medical centers of the clinical resources necessary for clinical studies, it was obvious that implementation of clinical studies would require the very heavy participation of the aca-