Ann: VIRALEZE relaunched by LloydsPharmacy in the UK, page-251

As to your first question, the TGA's performance in this matter has been, in my opinion, seriously flawed. It follows their approach to the BV indication for which they placed astodrimer sodium on the Poisons Schedule as a pharmacy only medicine, when Europe did not. The consultant who did this gave the reason of not wanting women to self medicate. One would have to be blind Freddy to not realise the dozens of remedies being promoted using everything from yoghurt to apple cider vinegar. The consultant was, I would be fairly sure a person with a medical degree who saw the financial danger to his colleagues of not having a steady stream of women wanting metronidazole prescriptions. Perhaps I am being unkind here but that is what it looks like.

When the same active ingredient was proposed as a prophylactic against nasal infections, the TGA had a problem with the substance already on the poisons standard except where used as a condom coating. They had already accepted that the substance does not cross into the bloodstream and the evidence of its action against various viruses was clear from the various Scripp's test results and the earlier one undertaken in Australia. So the dear old TGA had a dilemma, if they approved astodrimer sodium for application to a mucous membrane in the nose how could they maintain their stance for its application to a mucous membrane elsewhere. I suspect they are still puzzling what do despite my suggestion to them that they should remove astodrimer sodium from the poisons standard altogether.

In Europe Viralese is approved and in the UK as a barrier (do I suspect there are emails between the TGA and MHRA on this?), you bet I do. Perhaps an FOI request would work!

The Viraleze web site is OK, I think, and the issue now is to tell the story to the public. This requires appropriate advertising. The approaches for BV and nasal protection should be quite different. The former is very specific and the latter very broad. There are many ways to advertise and the company should seek expert advice as to what works best.

In the meantime they should sack Mundipharma.