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Brandywine Valley Pain Control Center, Coatesville, PA, DCLARKE780{at}aol.com
To the Editor:
I read with interest the six articles on intrathecal midazolam (1–6) in the June 2004 issue of Anesthesia & Analgesia. Tucker et al. (1) assessed the symptomatology of neurological damage of intrathecal midazolam in 547 patients and found no increased occurrences of neurological or urological symptoms in these patients. Tucker et al. (2) also found that intrathecal midazolam potentiated the analgesic effect of intrathecal fentanyl in laboring parturients. These two clinical studies of intrathecal midazolam by Tucker et al. were performed despite the lack of a systematic study of toxicology of intrathecal midazolam in animals or humans (4,5). These two studies were also conducted despite the toxicity findings of intrathecal midazolam administration in rabbits by Malinovsky et al. (7) and Erdine et al. (8). Therefore an ethical dilemma was created for the Editors of this journal regarding whether to publish the clinical findings of Tucker et al. (6). Having worked in academia, the pharmaceutical industry, and the Food and Drug Administration (FDA), I would like to offer my fair and objective assessment of the above dilemma:
Academicians spend a great deal of time researching the literature and writing grant proposals for possible research projects. They then spend a great deal of time, and frequently for a lengthy period, to carry out their studies. The main hope of doing all of this is to be able to publish the findings of their studies and, hopefully, to contribute to the advancement of science. Therefore, I really have a lot of sympathy for academicians in their endeavor to publish their research findings.
I do not believe that it is the duty of the editor of a journal to ensure that a drug is safe and efficacious. The editor can ascertain that a manuscript be reviewed by the experts to ensure that the study design is scientifically sound and that the conclusion reflects the study findings. The editor can also encourage the publications of articles that can stimulate further research in the subject of interest. It is the responsibility of the Institutional Review Board to ensure that the human trials undertaken in their institution are safe and ethical. It is the responsibility of the FDA to ensure that a drug is safe and efficacious. The FDA has a relatively large staff to review the new drug applications of a drug submitted by the pharmaceutical companies to determine if a drug is safe and efficacious. In addition, they have the option of assembling an advisory panel consisting of experts to help them determine of the safety and efficacy of a drug. Therefore, Tucker et al. are entitled to publish their findings. However, I believe it might be prudent for them to include in the conclusion of those two studies that the systemic studies of toxicology of intrathecal midazolam have not been performed on animals or human beings. They may also indicate that the lack of neurological symptoms in their patients does not rule out long-term tissue toxicity of intrathecal midazolam administration in humans. It is then up to the readers or the clinicians to draw their own conclusion regarding the safety and efficacy of the intrathecal administration of midazolam in humans.
References
This article has been cited by other articles:
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  S. L. Shafer Anesthesia & Analgesia's Policy on Off-Label Drug Administration in Clinical Trials Anesth. Analg., July 1, 2007; 105(1): 13 - 15. [Full Text] [PDF]
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