MONASH'S School of Public Health and Preventive Medicine Associate Professor Ken Harvey has once again blasted the Therapeutic Goods Administration (TGA), this time over the approval of a restricted advertising representation by The Tomato Pill Company for Ateronon XY Pro (pictured).
The product is promoted as a treatment "traditionally used in herbal medicine to help relieve the urologic symptoms (e.g. weak urine flow, incomplete voiding, frequent daytime and night time urination) associated with mild to moderate benign prostatic hyperplasia".
Harvey highlights that this "conflates the 'traditional use' of a herb with a 'scientific medical diagnosis' (benign prostatic hypertrophy (BPH))" while scientific studies including a Cochrane review and a 2011 NIH-funded study have shown the herb is "no more effective than a placebo" in relieving these stated symptoms, even in doses up to three times the usual, he said.
The pharmaceutical watchdog said this sort of "traditional use" permitted indication is applicable to more than 1,000 other products, calling on the TGA to follow its own "Evidence Guidelines" which state that when there is conflicting evidence between the history of traditional use and contemporary scientific evidence for a medicine, this must be stated.
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