By: M Hammer; Wayne B Jonas
Publication Name: Integr Cancer Ther
Year: 2004
From December 1991 to December 1995, the National Cancer Institute (NCI) initiated phase II clinical trials of A10 and AS2-1 (antineoplastons) infusions in patients with diagnosed primary malignant brain tumors. Four years and more than a million dollars later, these studies were stopped before it was possible to determine the effectiveness of antineoplastons. Both NCI and Dr Burzynski, the developer of antineoplastons, accused one another of attempting to undermine the project. In an effort to determine why this study failed to be completed, the director of the National Institutes of Health Office of Alternative Medicine (OAM), who sponsored the study, commissioned a detailed analysis of the conflicts that led to the study's closure. The intent was to understand the social dynamics surrounding this failed study and to develop a method for managing and possibly preventing such failures in the future. This clinical trial was extremely complex and comprehensive. It involved hundreds of memoranda, letters, and telephone and fax correspondence among a wide number of parties over a 4-year period. All correspondence and other documents from the OAM as well as documentation from NCI were thoroughly examined. In addition, in-depth interviews with key individuals involved in the antineoplaston study were completed and incorporated into the analysis. At least 10 areas of conflict emerged from the analysis including issues around production, quality, and delivery of antineoplastons; commencement of the trial; the role of Dr Burzynski in the trial; types and combinations of cancers; choice of clinical investigators; need for communication; criteria for patient selection and treatment; and evaluation. Each of these issues clearly represented a difference of opinion between the 2 main parties around scientific protocols. Yet contention around these substantive, ""scientific"" disagreements reflected conflict in attunement (trust, power, and affiliation) between Dr Burzynski and NCI. This article summarizes the findings from this case study.
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