Ann: Response to media article, page-37

Let us consider the medicine and medical device argument a little further:

The Vivagel BV treatment was approved as a medical device with its active ingredient astodrimer sodium being included as a Schedule 3 entry on the Poisons Standard. This was supported by several clinical trials of patients who had been diagnosed with bacterial vaginosis. It is also able to be advertised for treatment and prevention of BV . The approval process did not occur all at once, with BV tretament being first followed by prevention.

Astodrimer sodium as a condom lubricant is specifically excluded from the Poisons Standard entry which means that usage is permitted for this purpose.

Now Viraleze nasal spray is not being considered as a treatment but a prophylactic. It helps prevent virus invasion through the nasal cavity by forming a barrier on the mucous membrane. Clinical trial success is therefore based on a reduction in rates of infection. This is much harder to manage because not only must the application of Viraleze be monitored and recorded but possible exposure to the virus. There are obviously serious ethical issues about deliberately exposing trial participants to the virus.

There are statistical ways in which one could measure the effectiveness of the prophylactic by enrolling very large number of participants and comparing their infection rate against the community in general, this was the sort of approach adopted for vaccines. However it would be much harder to manage a Viraleze trial involving application every 4 to 6 hours than a single vaccination.

So SPL resorted to the WHO mouse model trial and, for good measure, a safety trial in healthy humans.

There is absolutely no question on safety or transport into the blood stream. For both BV and Coronavirus astodrimer sodium forms a barrier on a mucous membrane. Is a barrier a "device" like barrirr hand creams or is it a medicine. There is compelling evidence it is a device. Not only the spray bottle but the spray itself.

The TGA is being officious as bureaucracies often are with matters which do not quite fit their processes. This position has probably cost lives and contributed to the massive disruptions to our health services caused by isolation requirements (which governments eventually gave up on because they had no option).

It is perhaps time for the government to offer guidance in this matter, and avoid the very public fall-out when this becomes more public than it is today.

And it a great pity that SPL management will not put this picture publicly, as I just have.