Saturday, July 08, 2006

Before researchers can conduct clinical drug research in the United States, they must file an Investigational New Drug (IND) application with the FDA

Before researchers can conduct clinical drug research in the United States, they must file an Investigational New Drug (IND) application with the FDA. IND approval is also required for clinical investigation of homeopathic drugs. The FDA does not disclose information about IND applications or approvals; this information can be released only by the applicants. At present, at least 2 U.S. investigators have IND approval to study mistletoe as a treatment for cancer.[96,97] In this summary, the mistletoe extract or product used in each study will be specified wherever possible.ReferencesStirpe F, Sandvig K, Olsnes S, et al.: Action of viscumin, a toxic lectin from mistletoe, on cells in culture. J Biol Chem 257 (22): 13271-7, 1982. [PUBMED Abstract]Khwaja TA, Dias CB, Pentecost S: Recent studies on the anticancer activities of mistletoe (Viscum album) and its alkaloids. Oncology 43 (Suppl 1): 42-50, 1986. [PUBMED Abstract]Ribéreau-Gayon G, Jung ML, Baudino S, et al.: Effects of mistletoe (Viscum album L.) extracts on cultured tumor cells. Experientia 42 (6): 594-9, 1986. [PUBMED Abstract]

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