Cannabis/Hemp Products/Medicinal/Legal

jh79

K.Flyer wrote: »

Nail on head..
Not only regarding this matter, but almost anything huge where it has been done successfully elsewhere, the Irish powers that be try to do it their own way and invariably go and royally fcuk it up.
Examples include;
Irish Water.
Port Tunnel.
M 50.
Luas.
etc.

Gino and the PBP could of presented a better bill too.

K.Flyer

jh79 wrote: »

But it is not GW products but weed you want available.

No, I want a cure, or at least something that stops any advance of my sons cancer. And if cannabis extract turns out to be that, then I am good with it. I am not naive to say it will most definitely work, but there is enough evidence, anecdotal or otherwise, to suggest that there is hope.
I really don't care who crosses the line first as long as it works.
I have no interest in recreational use.

The success of GW 's products does not strenghten the argument for other varients of natural cannabis.

Successful trials and studies will be the proving ground. The range of varieties is immense, and two of the same plant can give differing cbd / thc results depending on their growing conditions. This is why GW are setting up clean rooms with soil and light consistencies to produce a uniform product.

jh79

K.Flyer wrote: »

No, I want a cure or at least something that stops any advance of my sons cancer. And if cannabis extract turns out to bev that, then I am good with it. I am not naive to say it will most definitely work, but there is enough evidence, anecdotal or otherwise, to suggest that there is hope.
I really don't care who crosses the line first as long as it works.
I have no interest in recreational use.



Successful trials and studies will be the proving ground. The range of varieties is immense, and two of the same plant can give differing cbd / thc results depending on their growing conditions. This is why GW are setting up clean rooms with soil and light consistencies to produce a uniform product.

Sorry to hear about your son.

My post grad was in cancer research. I had compounds that "killed cancer" much like those articles and videos keeflar likes to post and the same as those papers linked to here as a reason for medical marijuana. But they weren't potent enough so that was the end of it. These compounds came from a family of drugs with known anti-tumour activity, a fairly well understood mechanism of action too. But it still wasn't enough.

Now cannabinoids on the other hand have a possible but not proven mechanism of action for anti tumour activity, have no real history in cancer treatment and are not potent at all requiring huge doses in the one clinical trial.

Can you see why i am cynical about how keen people are to catapult it from pre-clincal studies to the market. Some PhD students in an Irish University / IT probably "killed cancer" today.

.

I don't honestly believe normal weed would help. No way someone would acidentally breed the perfect strain and then do it consistently.Most pharma drugs would only have about a 5-10% variation in active ingredient concentration and would have to prove this variation does not affect efficacy.

GW are doing it properly and have a product for glioma i believe. Access to GW products will be pretty easy in the new system.

mulbot

jh79 wrote: »

Sorry to hear about your son.

My post grad was in cancer research. I had compounds that "killed cancer" much like those articles and videos keeflar likes to post and the same as those papers linked to here as a reason for medical marijuana. But they weren't potent enough so that was the end of it. These compounds came from a family of drugs with known anti-tumour activity, a fairly well understood mechanism of action too. But it still wasn't enough.

Now cannabinoids on the other hand have a possible but not proven mechanism of action for anti tumour activity, have no real history in cancer treatment and are not potent at all requiring huge doses in the one clinical trial.

Can you see why i am cynical about how keen people are to catapult it from pre-clincal studies to the market. Some PhD students in an Irish University / IT probably "killed cancer" today.

.

I don't honestly believe normal weed would help. No way someone would acidentally breed the perfect strain and then do it consistently.Most pharma drugs would only have about a 5-10% variation in active ingredient concentration and would have to prove this variation does not affect efficacy.

GW are doing it properly and have a product for glioma i believe. Access to GW products will be pretty easy in the new system.

What do you mean accidently breed? Once you have the genetics of the plant(male and female) you can breed the same strain for as long as you want.

jh79

mulbot wrote: »

What do you mean accidently breed? Once you have the genetics of the plant(male and female) you can breed the same strain for as long as you want.

A breed that consistenly delivers the correct therapeutic dose.

mulbot

jh79 wrote: »

A breed that consistenly delivers the correct therapeutic dose.

Easily done once you have the genetics.

jh79

mulbot wrote: »

Easily done once you have the genetics.

Well GW pharma must of done it. But each new strain that claims to have a partcular benefit needs to prove it, do you realise the logistics of doing this to the level expected for medicine?

mulbot

jh79 wrote: »

Well GW pharma must of done it. But each new strain that claims to have a partcular benefit needs to prove it, do you realise the logistics of doing this to the level expected for medicine?

No,do you?

jh79

mulbot wrote: »

No,do you?

Yes, I work in the pharma industry.

mulbot

jh79 wrote: »

Yes, I work in the pharma industry.

So maybe you'll explain then?

jh79

mulbot wrote: »

So maybe you'll explain then?

It is a huge undertaking and expensive to meet GMP. They would need Formulation , Method Development, QC, QA, Reg Affairs and Manufacturing departments.

Assuming the formulation is already decided upon, they would need to show a probable shelf life. It would be stored at normal and accelerated storage conditions and analysed weekly/monthly to see if the active ingredients stay within the therapeutic range. Any degradants would need to be isolated and shown to be safe or not to affect performance.

It is method development team's job to invent these methods of analysis and these methods have to be proven to work and these are also assessed by the FDA.

QA design the systems used to record all data to ensure a clear paper trail. No erasing of data is allowed, even a spelling mistake needs to be crossed out and signed and dated.

Reg Affair ensure the submission meet legal requirements and advise on what other data might be needed for approval.

Post approval , the product would be put on stability to prove that the accelerated studies were correct. So these would be analysed monthly at first and less frequently as time goes on.

Once in manufacturing SOP would be needed for the grower to document the process, the analytical methods have to be transferred to the QC lab to prove they work in that lab.

Each harvest would be tested to ensure it meets the spec.

The FDA will come for a week about every 2 years and go through some of this data to ensure standards are maintained.

They go through bins etc to make sure nothing is being hidden.

A Scottish scientist was even sent to prison for falsification of data

The average person has no idea how regulated this industry is.

drunkmonkey

As there's no killer dose of cannabis wouldn't logic dictate that if you use the strongest dose possible it should kill cancer if cannabis really does cure cancer.
I haven't seen anywhere it does though, it has some benefits as increasing appatiet and lifting mood, that's from THC (the stone) though.

The oil is pretty potent, this is the effect a tiny bit has on someone taking it for recreation and not medicine even though it's medicinal.

https://www.youtube.com/watch?v=TzqDZA6EVDI

Her's a girl in remission, I'm not sure cannabis is responsible or they needed to keep giving the kids cannabis, one thing they seem to be saying is it the kids we're hungry, as a stoner and not a doctor it just seems obivious, if someone won't eat or has no appetite get them stoned so they'll get the munchies. You don't need medicinal cannabis for that.

https://www.youtube.com/watch?v=TXKjRkkoIOU

drunkmonkey

jh79 wrote: »

It is a huge undertaking and expensive to meet GMP. They would need Formulation , Method Development, QC, QA, Reg Affairs and Manufacturing departments.

Assuming the formulation is already decided upon, they would need to show a probable shelf life. It would be stored at normal and accelerated storage conditions and analysed weekly/monthly to see if the active ingredients stay within the therapeutic range. Any degradants would need to be isolated and shown to be safe or not to affect performance.

It is method development team's job to invent these methods of analysis and these methods have to be proven to work and these are also assessed by the FDA.

QA design the systems used to record all data to ensure a clear paper trail. No erasing of data is allowed, even a spelling mistake needs to be crossed out and signed and dated.

Reg Affair ensure the submission meet legal requirements and advise on what other data might be needed for approval.

Post approval , the product would be put on stability to prove that the accelerated studies were correct. So these would be analysed monthly at first and less frequently as time goes on.

Once in manufacturing SOP would be needed for the grower to document the process, the analytical methods have to be transferred to the QC lab to prove they work in that lab.

Each harvest would be tested to ensure it meets the spec.

The FDA will come for a week about every 2 years and go through some of this data to ensure standards are maintained.

They go through bins etc to make sure nothing is being hidden.

A Scottish scientist was even sent to prison for falsification of data

The average person has no idea how regulated this industry is.

It's a plant it can be grown by farmers. To try and regulate the whole market as you would a manufactured drug is absolute insanity. That's not how it's going to work when it's legalised, you'll have to be allowed grow it. Look at what's happening in the states.
If we agree White Widow for example can be used medicinal, we don't need to apply gmp to it. We just need licenced commercial growers and an allowance for home growers.
I know what your saying but your thinking of a drug not a plant. What your talking about will apply to manufactured cannabis drugs.

evolving_doors

jh79 wrote: »

It is a huge undertaking and expensive to meet GMP. They would need Formulation , Method Development, QC, QA, Reg Affairs and Manufacturing departments.

Assuming the formulation is already decided upon, they would need to show a probable shelf life. It would be stored at normal and accelerated storage conditions and analysed weekly/monthly to see if the active ingredients stay within the therapeutic range. Any degradants would need to be isolated and shown to be safe or not to affect performance.

It is method development team's job to invent these methods of analysis and these methods have to be proven to work and these are also assessed by the FDA.

QA design the systems used to record all data to ensure a clear paper trail. No erasing of data is allowed, even a spelling mistake needs to be crossed out and signed and dated.

Reg Affair ensure the submission meet legal requirements and advise on what other data might be needed for approval.

Post approval , the product would be put on stability to prove that the accelerated studies were correct. So these would be analysed monthly at first and less frequently as time goes on.

Once in manufacturing SOP would be needed for the grower to document the process, the analytical methods have to be transferred to the QC lab to prove they work in that lab.

Each harvest would be tested to ensure it meets the spec.

The FDA will come for a week about every 2 years and go through some of this data to ensure standards are maintained.

They go through bins etc to make sure nothing is being hidden.

A Scottish scientist was even sent to prison for falsification of data

The average person has no idea how regulated this industry is

But some companies already use GMP so all the above is moot no?

jh79

drunkmonkey wrote: »

As there's no killer dose of cannabis wouldn't logic dictate that if you use the strongest dose possible it should kill cancer if cannabis really does cure cancer.
I haven't seen anywhere it does though, it has some benefits as increasing appatiet and lifting mood, that's from THC (the stone) though.

The oil is pretty potent, this is the effect a tiny bit has on someone taking it for recreation and not medicine even though it's medicinal.

https://www.youtube.com/watch?v=TzqDZA6EVDI

Her's a girl in remission, I'm not sure cannabis is responsible or they needed to keep giving the kids cannabis, one thing they seem to be saying is it the kids we're hungry, as a stoner and not a doctor it just seems obivious, if someone won't eat or has no appetite get them stoned so they'll get the munchies. You don't need medicinal cannabis for that.

https://www.youtube.com/watch?v=TXKjRkkoIOU

Whatever causes the munchies in a healthy person may not work in a sick person. Studies were done in this for AIDS sufferers but without success.

Regarding dose, we are talking about blood plasma levels and how much of it gets to the tumour.

For glioma, potency was such an issue it required brain surgery to insert a stent in the brain so the equivalent of 100'S of joint could be directly injected to the tumour.

At these high levels the experience of a heavy smoker is not equivalent enough to say it won't do harm.

Also cancer cells and healthy cells share very similar biology. Something that disrupts the cancer cell cycle could also affect the healthy cells, that is why chemo is an horrible experience.

I don't know how weed works for cancer so this might not be an issue but it still needs to be shown that this is the case.

Receptors do different things depending on location and could be a source of adverse effects.

For example tamoxifen is the best treatment for hormone dependent breast cancer but because the estrogen receptor is expressed differently in the uterus it actually can cause uterine cancer as a side effect!

jh79

drunkmonkey wrote: »

It's a plant it can be grown by farmers. To try and regulate the whole market as you would a manufactured drug is absolute insanity. That's not how it's going to work when it's legalised, you'll have to be allowed grow it. Look at what's happening in the states.
If we agree White Widow for example can be used medicinal, we don't need to apply gmp to it. We just need licenced commercial growers and an allowance for home growers.
I know what your saying but your thinking of a drug not a plant. What your talking about will apply to manufactured cannabis drugs.

No it applies to plants too, Bedrocan is weed grown to GMP standards.

Gino et al want it licensed as medicine and these are the requirements.

As I posted earlier the PBP bill was poorly conceived.

jh79

Gebgbegb wrote: »

But some companies already use GMP so all the above is moot no?

But this would have to be done for each strain claiming particular benefits.

The thing to take from this is that the regulators are not making it difficult for weed they are applying the normal standards.

As the HPRA say in their report there is a major gap between what the public think the regulatory requirements are and what they actually are.

If you want safe and effective medicine then these standards need to be maintained and improved on not diluted to suit populist opinion.

kleefarr

As a lot of us are aware, politics gets in the way, either intentionally or unintentionally, you decide.

https://www.endoca.com/blog/discovery/why-whole-plant-cannabis-matters/

jh79

kleefarr wrote: »

As a lot of us are aware, politics gets in the way, either intentionally or unintentionally, you decide.

https://www.endoca.com/blog/discovery/why-whole-plant-cannabis-matters/

The legal issues with research in the US are an hindrance alright. But this is not a justification for the HPRA to lower standards.

In terms of GMP, being difficult is not an excuse, GW pharma managed it. This industry needs to adapt to these requirements not the other way round.

It is wrong to say Pharma only goes for synthetic versions because they can patent them. The other reason is because history has shown that natural products have poor bio-availability and that synthetic versions offer opportunities to improve on this and potency based on understanding how the molecule reacts with the receptor.

Too Tough To Die

This might be of interest to some.

http://www.news24.com/SouthAfrica/News/dagga-can-be-used-in-the-home-western-cape-high-court-rules-20170331

drunkmonkey

Too Tough To Die wrote: »

This might be of interest to some.

http://www.news24.com/SouthAfrica/News/dagga-can-be-used-in-the-home-western-cape-high-court-rules-20170331

First sensible thing I read today..

It is an infringement of people’s rights to ban the use of dagga by adults in private homes, WC High court rules...

What we need is a High court.

evolving_doors

jh79 wrote: »

But this would have to be done for each strain claiming particular benefits.

The thing to take from this is that the regulators are not making it difficult for weed they are applying the normal standards.

As the HPRA say in their report there is a major gap between what the public think the regulatory requirements are and what they actually are.

If you want safe and effective medicine then these standards need to be maintained and improved on not diluted to suit populist opinion.

Indeed it would, but I'm sure they would be working with more than one strain at the moment so it's not that big a deal to apply GMP to yet another strain.... once the time is put aside to do so.

ScumLord

scamalert wrote: »

how come this thread is still alive ? jh79 must of posted 1000 times now on single thread, someone says why not, he says research needed,back and forth useless discussion.

The problem I have with this "more research needed" thing is that they've been saying that for decades, they've been doing research for decades. The fact is the research has been done and they didn't get the answers they wanted to hear, that cannabis is dangerous and bad, what happened was they found the exact opposite, that it could actually be a helpful drug.

There are too many vested interests from pharma companies and moral crusaders for us to get a straight answer.

Even if the jury is still out of the medical benefits of cannabis the fact remains there is no reason to deny people access to cannabis. It should be completely legal.

jh79

ScumLord wrote: »

The problem I have with this "more research needed" thing is that they've been saying that for decades, they've been doing research for decades. The fact is the research has been done and they didn't get the answers they wanted to hear, that cannabis is dangerous and bad, what happened was they found the exact opposite, that it could actually be a helpful drug.

There are too many vested interests from pharma companies and moral crusaders for us to get a straight answer.

Even if the jury is still out of the medical benefits of cannabis the fact remains there is no reason to deny people access to cannabis. It should be completely legal.

This is not the case at all.

The slow progress is due to poor study design not the regulator changing requirements.

The success of GW pharma shows it is possible. It is up to the medical marijuana companies to meet the standards they are already aware of.

I'm sure GW would have an ex regulator as an employee to help them.

jh79

Natural weed biggest obstacle isn't adverse effects but proving it is more effective than a placebo unfortunately the high prevents this.

Jayop

jh79 wrote: »

Yes, I work in the pharma industry.

That explains a lot. What department? PR??

scamalert

jh79 wrote: »

This is not the case at all.

The slow progress is due to poor study design not the regulator changing requirements.

The success of GW pharma shows it is possible. It is up to the medical marijuana companies to meet the standards they are already aware of.

I'm sure GW would have an ex regulator as an employee to help them.

can you stop with gw campaigns, they are barely making over 20mill year to year, that's crumbles to likes of pfizer and they dont even touch cannabis field.

there should be no companies for the plant only licensed growers, rest should be sent to labs to analyze and sold otc like done in states, this crap with perfect strain isolating single cannabinoids when full plant does same job, as i said is recreating wheel, since you somehow imply that likes of Canada have low standards and its like they dont know what they are doing but at the same time it works perfectly where its legal to generate revenue and let people choose it as medical/recreational option.

Since seems only thing here is politicians who are from 60-70s who seem weed as still war on drugs, that's major issue, instead working towards laws implementing it and making actual revenue, somehow Colorado is blooming, LA didn't collapse and kids in Canada get treated but not here, total bummer when in 21st century goverment cant hire external advisers who use it as treatment for decades, rather blame that there's no certified people to treat with it, when its banned substance irony .

ScumLord

jh79 wrote: »

This is not the case at all.

The slow progress is due to poor study design not the regulator changing requirements.

I'm sure you're right up to a point but I definitely think there's interference that is based on morals over science. Especially when it comes to harm, I'll accept that you're right on medical benefits, it's hard to get a definitive answer, but there's still no reason to deny access to cannabis on the grounds of harm. I don't think it should be taking this long to get an answer, and pro cannabis lobbies are as much to blame for misinformation as anybody else.

jh79 wrote: »

Natural weed biggest obstacle isn't adverse effects but proving it is more effective than a placebo unfortunately the high prevents this.

I don't think that's true, now maybe this means cannabis isn't a daily drug for most people but the high could be feeding into the medical benefits, ignoring that side of it could be where science keeps running into walls trying to prove the anecdotal evidence. The relief it can bring shouldn't be overlooked.

jh79

Jayop wrote: »

That explains a lot. What department? PR??

I wish pay would certainly be better.

It's a revelation alright that a scientist would believe in evidence based medicine!

jh79

scamalert wrote: »

can you stop with gw campaigns, they are barely making over 20mill year to year, that's crumbles to likes of pfizer and they dont even touch cannabis field.

there should be no companies for the plant only licensed growers, rest should be sent to labs to analyze and sold otc like done in states, this crap with perfect strain isolating single cannabinoids when full plant does same job, as i said is recreating wheel, since you somehow imply that likes of Canada have low standards and its like they dont know what they are doing but at the same time it works perfectly where its legal to generate revenue and let people choose it as medical/recreational option.

Since seems only thing here is politicians who are from 60-70s who seem weed as still war on drugs, that's major issue, instead working towards laws implementing it and making actual revenue, somehow Colorado is blooming, LA didn't collapse and kids in Canada get treated but not here, total bummer when in 21st century goverment cant hire external advisers who use it as treatment for decades, rather blame that there's no certified people to treat with it, when its banned substance irony .

Canada didn't lower their standards for medicine at all. Like American a seperate entity was set up that controls it. It is treated more like a supplement and is just called medical marijuana.