Any which way you can

For companies frustrated by the need to prove efficacy and safety in clinical trials before receiving FDA approval for a drug, there is sometimes the possibility of marketing the same compound to the public without agency approval. Shaman Pharmaceuticals Inc. plans to take that route after Phase III data for its Provir SP-303 extract of the Croton lechleri tree were insufficient to support FDA approval of the product as a prescription pharmaceutical to treat AIDS-related diarrhea (see BioCentury, Feb. 1).

SHMN, through its ShamanBotanicals.com web site, is marketing SP-303 as a dietary supplement to promote normal stool formation, under the name SB-Normal Stool Formula. According to the company's advertising, "clinical studies demonstrated that this compound normalizes excess water flow in the intestinal tract and promotes normal stool formation, without causing constipation."...