Ann: Landmark Study- FGF5 Critical Regulator of Human Hair Growth, page-19

Shortly after commercial release of the Evolis product a detailed formal complaint was registered with the Australian Therapeutics Products agency (presumably by a worried competitor) challenging the scientific basis for claims included in the product’s promotion. The complaint rested largely on the fact that the claimed FGF-5 mechanism of action for human hair re-growth was derived from non-human research studies.  In February 2013 the Review Panel found in favour of much of the complainant’s case, which then necessitated all Evolis advertising to be appropriately modified. Relevant sections of the basis for the Panel’s findings are shown here.

“The table summarising evidence was not, in the absence of full copies of the cited material, evidence that could support the use of representations in advertisements directed to consumers.

Moreover, even if the summaries were regarded as authoritative, they did not summarise evidence that could support the representations used in the advertisement. On the basis of the summaries, it appeared that almost all of the evidence was from in vitroresearch or research involving mice. One study apparently related to the inhibition of FGF-5 appeared to involve human subjects but almost no information was provided as to the methodology of the study or the number of subjects involved. None of the summaries appeared to describe clear and robust evidence that the products could offer benefits such as those described in the advertisement….”

The research now reported in the National Academy of Sciences article vindicates the Company’s claim that it truly has a proven medicinal product capable of controlling human hair re-growth via a known scientific mechanism, thereby providing a major advantage in product promotion battles against its many Disallowed selling competitors.

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