Gas vap worth it ?

[Karol]

So ...as thousands of beekeepers currently use pure but unlicensed OA to illegally treat their bees by sublimation ... and the success was proved, if I recall correctly, by a study at Sussex university who stated (again as I recall) that treatment with pure OA by sublimation in a brood free period was 97% effective..

The study may have been done but unless it is considered within the context of a licensing application then the study is irrelevant. It may well be used to support expert opinion written in support of a licence application but the study would have to stand up to a high level of scientific scrutiny.

Why has someone not attempted to licence pure OA as a treatment for varroa?

Commercial risks too high. Amount of supplementary work required to corroborate the Sussex study too great. Not as effective as combo product when brood is present...….. There may be a myriad of reasons.

Are you saying that if I got VMD approval for PPOA (Phil's Pure OA) then nobody else could sell pure OA for treatment of varroa by sublimation of OA without a licence ?

Yep!

Indeed ... if they wanted one assumes that as pure OA had already been approved ... a licence would be automatic ?

Nope! The second entity would have to go through the same licencing process obtaining the same data and assurances for their product and the ingredient they use, its production, packaging, purity, stability, bioequivalence, etc etc, compiling a dossier to support the application before grant of licence would happen. All of which is far more complicated than it sounds.

If that's the case it would be an immense market opportunity - yet nobody has done it ?

Because licencing products is a challenging undertaking prone to the risk of commercial failure.

Makes little sense...

Not an easy concept to grasp I freely admit.

 

[Repwoc]

So there are two hurdles:

1. Get OA established as a Licensed Medicine; and
2. Obtain a marketing licence for OA.

I guess neither of these processes is cheap to do and both carry a risk of failure.

 

[Erichalfbee]

Why are you disrespectful of the only way we will ever find bees that can manage varroa?

Not at all
"non treaters" especially in parentheses means people who treat with generic oxalic but keep quiet about it.
Of course the only way in the end is for bees to manage the pest themselves.
I just don't have the time or the inclination any more to try.
Not all of us are Giants.....some climb happily on their shoulders
So.................you completely misunderstood my joke.

 

[B+.]

Not at all
"non treaters" especially in parentheses means people who treat with generic oxalic but keep quiet about it.
Of course the only way in the end is for bees to manage the pest themselves.
I just don't have the time or the inclination any more to try.
Not all of us are Giants.....some climb happily on their shoulders
So.................you completely misunderstood my joke.

Yes, but there are those of us who are genuine non-treaters and do it, not out of some cynical delusion but, out of a genuine desire to improve the bees.

 

[Karol]

So there are two hurdles:

1. Get OA established as a Licensed Medicine; and
2. Obtain a marketing licence for OA.

I guess neither of these processes is cheap to do and both carry a risk of failure.

Succinctly put.

Getting hold of 'medicine' grade ingredients is notoriously difficult. So for example, how do you prove you are using BSE/TSE free OA? OA manufactured as a wood treatment doesn't have to be produced in a manner to exclude prions. OA used to treat hives does. I very much doubt that there are many beekeepers who have even considered the risk of causing CJD in consumers of their honey as a consequence of their OA treatment?

 

[Beefriendly]

Splutters coffee over market stall.
Wonders if coffee is prion free...

 

[Walrus]

I may have got this wrong and would be happy to be corrected by somebody who understands this better but...

The approved products containing just OA as the "active substance" are either a powder with added things (one product) or in some kind of solution (the rest).

Presumably if somebody got pure OA in powder form licensed for bee treatment then nobody would be able to tell the difference between the licensed product and the identical stuff already sold at places like (admin edit to unlicensed product link). I don't see how they could make any money.

I don't know if the government could license OA dihydrate for bees if it was proven to be beneficial but that no private company would go there as it's not going to make them any money? It seems odd that the only way something will get licensed is if there is money to be made, rather than what works?

 

[iann41]

It seems odd that the only way something will get licensed is if there is money to be made, rather than what works?

Nail and Head

 

[Karol]

Splutters coffee over market stall.
Wonders if coffee is prion free...

To put this into context. When our MHRA inspector last inspected our pharmaceutical manufacturing facility they made it crystal clear that if we opened and sampled an ingredient even without actually using it and we could not establish that it was BSE/TSE free then the expectation was that we would have to shut down the facility until we could categorically prove we had not contaminated the facility with prions.

 

[Erichalfbee]

Yes, but there are those of us who are genuine non-treaters and do it, not out of some cynical delusion but, out of a genuine desire to improve the bees.

Of course and I know how dedicated you are. The future of treatment free beekeeping lies in the hands of people like you who make the effort. Let’s hope in generations to come the rewards will be there for everyone. I didn’t mean any disrespect at all.

 

[masterBK]

we had not contaminated the facility with prions.[/QUOTE]

Unless you use sheep products in your process or have a family history of CJD then what are the odds of contamination with prions?

 

[Karol]

I don't make the rules. The MHRA do. They do so because several hundred patients have died from man made mad cow disease and you might be surprised how many chemicals come from bovine sources where there's a risk of prion contamination.

https://tinyurl.com/y57g6alo

 

[Karol]

<snip>.

I don't know if the government could license OA dihydrate for bees if it was proven to be beneficial but that no private company would go there as it's not going to make them any money? It seems odd that the only way something will get licensed is if there is money to be made, rather than what works?

Welcome to my world.

The Government would not be excused from doing all of the work to satisfy the requirements of licencing so it would be just as expensive only it would have to be paid for by the tax payer which in this instance might be nice but I don't think you could argue that it would be equitable.

There are mechanisms that exist that allow unlicensed medicines to be used where it is not economically viable to licence them. That situation does not apply to OA because a licensed product does exist albeit in combination with other ingredients. As previously mentioned I suspect that the commercial risk of pursuing a licensed pure OA is too great because the pure OA would be at least as expensive as the licensed combination product and would have to show better efficacy which doesn't appear to be borne out in some of the research out there.

 

[Beefriendly]

We must be like a third world country. OA vaporization appears to be an accepted treatment in most of the rest of the EU.

 

[philipm]

We must be like a third world country. OA vaporization appears to be an accepted treatment in most of the rest of the EU.

No I think it is the rest of Europe don't blindly follow the rules like we do.

 

[Beefriendly]

No, it's an accepted form of varroa treatment.
Apart from UK.

 

[B+.]

No, it's an accepted form of varroa treatment.
Apart from UK.

Accepted or legal?

 

[Beefriendly]

Legally accepted..an approved method of varroa control. I'd copy and paste the links but on mobile and hard to do.

 

[Ian123]

That situation was the same with apivar that then became available at first in the U.K. if signed off by a vet. If my memory serves me right!!

 

[pargyle]

The study may have been done but unless it is considered within the context of a licensing application then the study is irrelevant. It may well be used to support expert opinion written in support of a licence application but the study would have to stand up to a high level of scientific scrutiny.



Commercial risks too high. Amount of supplementary work required to corroborate the Sussex study too great. Not as effective as combo product when brood is present...….. There may be a myriad of reasons.



Yep!



Nope! The second entity would have to go through the same licencing process obtaining the same data and assurances for their product and the ingredient they use, its production, packaging, purity, stability, bioequivalence, etc etc, compiling a dossier to support the application before grant of licence would happen. All of which is far more complicated than it sounds.



Because licencing products is a challenging undertaking prone to the risk of commercial failure.



Not an easy concept to grasp I freely admit.

Thanks Karol, great reply. More or less as I suspected ..

If I win the lottery one of my philathropic gestures will be set up a non-profit organisation to market pure OA with the sole objective of spending whatever it takes to get pure OA licensed for treatment of varroa ... and then to sell pure OA at cost plus packaging to UK beekeepers.. Perhaps even invest in machinery to create 1.5 gm tablets to make it easy.