Sativex® approved in Germany for treatment of MS spasticity

A cannabis derived drug which has been approved in some countries to treat muscle spasticity.

Postby willowford » Fri May 27, 2011 11:46 am

THEGREEKFROMTHED wrote:my neuro is all about major drugs and thats about it..Not sure of a neuro in the area that would prescribe me the sativex....


You're very close to Windsor! But given that you're not a Canadian resident, it's highly unlikely that a Canadian doctor would prescribe a long-term drug to you (I don't even know if they're allowed). Same thing for any long-term drug like barbiturates, codeine etc. The situation would be similar to going to a walk-in clinic in Canada - they never prescribe these substances because they are not your primary, long-term family physician.

They would give you these "controlled" drugs in emergency situations (like morphine in emerg) but would not be allowed to prescribe it to a visitor from another country long-term (rare exceptions might exist, but this isn't one of them).

Finding someone where you are is still your best bet.

You said you already got a prescription for marijuana but the "supply" is out right? Whoever prescribed marijuana normally should be even more willing to prescribe Sativex (which is cannabis-based medicine and not smoked). Family docs can prescribe too, not just neurologists.
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Postby HarryZ » Fri May 27, 2011 12:44 pm

THEGREEKFROMTHED wrote:30 MINUTES FROM WINDSOR...


I'd probably try to get the phone number of a Walk-In clinic in Windsor and call them to explain your situation. You'd probably be wasting your time finding a doc's office which would accept you as a patient since most of them normally don't accept new patients these days. Anybody can use a Walk-In clinic and of course you would have to pay up front since you aren't part of the Health Care system in Canada. But discuss the possibility of Sativex first before you spend the time and effort to cross the border.

If you are successful, ensure that you find a pharmacy that has Sativex in stock. They likely all don't have it readily available and may have to order it in. That's what happened when my wife first used it and it was quite new.

If you have problems finding a Walk-in clinic, let me know. I grew up in Windsor and could likely locate one for you.

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Postby willowford » Fri May 27, 2011 12:59 pm

HarryZ wrote:
THEGREEKFROMTHED wrote:30 MINUTES FROM WINDSOR...


I'd probably try to get the phone number of a Walk-In clinic in Windsor and call them to explain your situation.

Harry


Definitely the pre-planning is great advice. But I can assure you that walk-in clinics in Canada would be the last place to prescribe controlled drugs (which this one is in addition to others). I'm familiar with the current system- walk in docs without a long-term relationship with the patient will never prescribe certain classes of drugs. Most clinics also don't prescribe anti-depressants for those who are on long-term anti-deps and have ran out and are experiencing the terrible side-effects - I'm not saying they don't care - but that that's their policy. They have signs all over the clinics indicating that they will not prescribe stimulants, sedatives... psychotropics...
Sativex and other cannabis-based medicines are not included in the lists since they are an even higher schedule (more controlled), so they're out of the question. Even if you have already been taking them, they would not write you a new script; so they certainly aren't likely to prescribe a brand new controlled drug.

I just wanna make sure noone gets their hopes too high with this. Canadian residents, it's a diff scenario.

Family docs in Detroit can also prescribe. That's why I suggested it.
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Postby THEGREEKFROMTHED » Fri May 27, 2011 1:06 pm

Let me understand this...it is available through my family doc and could be obtained in the detroit area?! I appreciate everyones help sincerely but thought the US FDA had not approved this!
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Postby willowford » Fri May 27, 2011 1:19 pm

THEGREEKFROMTHED wrote:Let me understand this...it is available through my family doc and could be obtained in the detroit area?! I appreciate everyones help sincerely but thought the US FDA had not approved this!


To my knowledge, there are cannabis-based medicines in US available through prescription. Sativex is relatively new so it may still be in the works in US. But Marinol *should* be available. It has shown efficacy in MS related symptoms (pain mostly).
Cesamet in US is mainly for cancer chemo symptoms. Off label use in MS also.
Cannador is another one (more similar to Sativex in content but still pill form). Not sure about its availability in the US but still worth a look into (it's older than Sativex so it might have made it there already).

There is always clinical trials on Sativex - not sure if there are any in your area. But always worth looking into.
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Postby HarryZ » Fri May 27, 2011 5:44 pm

THEGREEKFROMTHED wrote:Let me understand this...it is available through my family doc and could be obtained in the detroit area?! I appreciate everyones help sincerely but thought the US FDA had not approved this!


To my knowledge, Sativex has not been approved anywhere in the US.

It is not a new drug like Willowford stated but has been available in Canada for over 6 years. From what I have read on the net, Marinol has been stated pretty much as useless by MS patients who have tried it. It uses a synthetic substance and thus the poor results.

My suggestion still stands to call a Walk-In clinic in Windsor and ask about the possibility of getting Sativex. If they won't prescribe to you under any circumstances, then ask them to offer a suggestion on how you might go about getting it prescribed to you under your situation. You won't know unless you ask.

I do know that there was a Canadian doctor working in Marysville MI (I think at the Marysville Clinic near I 94). He thad the ability to rx both in the MI and Ontario. We crossed the border to see him in order to get LDN when no doc here would rx it for my wife. I wish I could remember his name and don't even know if he still works there. It would certainly be easier for you to see someone like that and if he would rx Sativex, you could cross the border to get it.

It won't be easy regardless of what route you take.

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Postby willowford » Fri May 27, 2011 6:09 pm

HarryZ wrote:It is not a new drug like Willowford stated but has been available in Canada for over 6 years. From what I have read on the net, Marinol has been stated pretty much as useless by MS patients who have tried it. It uses a synthetic substance and thus the poor results.


As always HarryZ, I enjoy how anything I say, regardless of its accuracy, you disagree with.

I deal with these issues every single day and have done so for the past 3 years (only), albeit in Canada. But given that medicinal cannabis is directly within my area of expertise, I feel qualified to comment on it - otherwise, I would not. The only reason I take the time to do this is because I believe that people should receive accurate, reliable information that is free of personal bias and emotion.

Sativex IS new... 6 years IS absolutely a new drug in the actual medical world (perhaps not to all patients, but we're referring to prescription practices in the medical world). In all countries, it is still under intense investigation to continue to discover its various properties as well as short- and long-term effects (the latter are not known, which makes this a new drug all the more).

Many drugs are synthetic! And they work just fine. All depends on the compound and its mode of delivery. So the criticism that a drug is synthetic does not hold true when it comes to efficacy/ side-effects. STUDIES suggest that Marinol has some efficacy in treating various symptoms related to MS. Research has been done in all of the 4 compounds that I noted.

The active ingredient of cannabis is THC; synthetic THC = Marinol.
This is why it was developed; because it was believed that the psychoactive component of cannabis can be beneficial in treating symptoms without the exposure to smoke inhalation.

Sativex is derised from the C. Sativa (plant) directly; which means it contains all of the ingredients; however, most of these do nothing to the human body in terms of symptom alleviation. The only notable one is CBD (the latter is not a psychoactive ingredient and does not induce any of the effects typically associated with "high" as THC does). The benefits of the addition of CBD are unclear (it is not known IF there are any effects to having CBD but it may be involved in dampening the effects of the THC somewhat, producing less effect, good or bad, at a given dose of THC).

While I respect opinions on "the net", individual opinions are not generalizable to everyone (many people find Sativex undesirable and ineffective as well; this too does not apply to all).

I have never seen the actual evidence based on the majority of patients studies objectively that suggests that Marinol is "useless". The weight of the evidence suggests that Marinol can be beneficial for some, not all, individuals; Sativex also may be beneficial for some, not all, individuals.

While many studies have noted benefits of one over the other, the only consistent benefit noted in favour of Sativex is that it can be self-titrated via additional sprays. However, the issue is that more effective results requiring much higher dosages are associated with increased risks of side-effects that are undesirable. So it's all a balancing act, as with any drug, but more so here because the psychoactive ingredients may lead to undesirable effects in naive users.

If Sativex is unavailable for use given that it is new (from the perspective of medical science), keep in mind that Marinol, Cannador, and Cesamet are all cannabis-based medicines also. Their immediate risks have been studies (not the long-term ones) and suggest that risks of severe adverse effects are low and therefore they are safe to try.
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Postby HarryZ » Fri May 27, 2011 7:36 pm

As always HarryZ, I enjoy how anything I say, regardless of its accuracy, you disagree with.


It's too bad that you took one small comment and sort of blown it out of proportion. But if that's the way you feel, then that's the way you feel.

I deal with these issues every single day and have done so for the past 3 years (only), albeit in Canada. But given that medicinal cannabis is directly within my area of expertise, I feel qualified to comment on it - otherwise, I would not. The only reason I take the time to do this is because I believe that people should receive accurate, reliable information that is free of personal bias and emotion.


You can comment all you want but I have had actual experience in obtaining this drug and have done so through an expert pain neuro in Canada.And this is what I am basing my comments on.

Sativex IS new... 6 years IS absolutely a new drug in the actual medical world (perhaps not to all patients, but we're referring to prescription practices in the medical world). In all countries, it is still under intense investigation to continue to discover its various properties as well as short- and long-term effects (the latter are not known, which makes this a new drug all the more).


Depending on a docs experience with Sativex, it can be totally new or a drug that he/she has been using for 6 years. The same goes for rx actual MJ. Docs who have been rx Sativex or MJ for a number of years are quite comfortable with it. New ones are likely scared to death.

Many drugs are synthetic! And they work just fine. All depends on the compound and its mode of delivery. So the criticism that a drug is synthetic does not hold true when it comes to efficacy/ side-effects. STUDIES suggest that Marinol has some efficacy in treating various symptoms related to MS. Research has been done in all of the 4 compounds that I noted.


I stated that my comment on Marinol came from the net from MS patients who actually used it. They said it was all but useless for them. It very well might help some patients but that wasn't the case on those who commented.

The active ingredient of cannabis is THC; synthetic THC = Marinol.
This is why it was developed; because it was believed that the psychoactive component of cannabis can be beneficial in treating symptoms without the exposure to smoke inhalation.


The neuro who I got my information from stated that ingesting MJ provided the same kind of MS symptom relief albeit not as fast as smoking it. Many of his patients who used MJ preferred this method because they did not want the smoke inhalation problem. He has spent years studying MJ for pain use and has conducted several trials in this area.

Sativex is derised from the C. Sativa (plant) directly; which means it contains all of the ingredients; however, most of these do nothing to the human body in terms of symptom alleviation. The only notable one is CBD (the latter is not a psychoactive ingredient and does not induce any of the effects typically associated with "high" as THC does). The benefits of the addition of CBD are unclear (it is not known IF there are any effects to having CBD but it may be involved in dampening the effects of the THC somewhat, producing less effect, good or bad, at a given dose of THC).


My wife used Sativex for a number of months and she experienced relief from her MS symptoms without ANY side effects. So far, from what I have read about Sativex, there doesn't appear to be any major problems that have been found. As you are aware, it is being approved by a number of countries, albeit very slowly.

While I respect opinions on "the net", individual opinions are not generalizable to everyone (many people find Sativex undesirable and ineffective as well; this too does not apply to all).


Just like ANY drug that is used.

I have never seen the actual evidence based on the majority of patients studies objectively that suggests that Marinol is "useless". The weight of the evidence suggests that Marinol can be beneficial for some, not all, individuals; Sativex also may be beneficial for some, not all, individuals.


Again, it's what I read about Marinol by those who used it. And again, what works for some people won't for others.

While many studies have noted benefits of one over the other, the only consistent benefit noted in favour of Sativex is that it can be self-titrated via additional sprays. However, the issue is that more effective results requiring much higher dosages are associated with increased risks of side-effects that are undesirable. So it's all a balancing act, as with any drug, but more so here because the psychoactive ingredients may lead to undesirable effects in naive users.


Agreed.

If Sativex is unavailable for use given that it is new (from the perspective of medical science), keep in mind that Marinol, Cannador, and Cesamet are all cannabis-based medicines also. Their immediate risks have been studies (not the long-term ones) and suggest that risks of severe
adverse effects are low and therefore they are safe to try.


Of course the patient can choose which medication he/she feels is right for them. But the person in this thread wanted to obtain Sativex and I was only tyring to help him attain his goal.
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Postby willowford » Fri May 27, 2011 7:53 pm

@harryz

Your experiences are valuable and important. And I'm sure many people appreciate them. As you know, the only way to get true answers is from objective controlled trials of every medication to observe the effects in a large number of patients. That is the only way the results can be generalized.

So while individual people's experiences are great to read about, it should not deter people from trying out what may very well work for them.

I'm glad your wife has had a good experience with Sativex and no side effects.

I have met hundreds of patients with MS with variable experiences. I never discuss these because I have no data to sort out the varying experiences. This is why I never rely on individual experiences and relay them to others.

Remember that side-effects of any medication do not affect everyone. This is why they need to be studied also in large populations and conclusions about side effects cannot be made on a basis of individual experiences. There is evidence that Sativex can lead to side-effects. While it's great that your wife and many others have not experienced these, all patients should be aware of these as by definition (statistically) they will arise in a certain proportion of those using the drug. This applies to all meds. I may take a drug and experience no side effects. You may take the same drug and experience severe side effects, because our bodies metabolize each drug differently (clinical pharmacologists study these differences which are quite complex and beyond our ability to comment on in detail).

Sativex is new by any standard - compared to other meds of the same type. This is why there is still hesitancy in some docs in prescribing them routinely, even if they occasionally prescribe them. The long-term effects are NOT known, because it is a new med... no trial has been conducted of individuals who use these meds for several years, therefore it is difficult to know. Again, as more research is done and the drug is well-established in long-term trials, doctors usually feel more comfortable prescribing them more routinely.
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Postby HarryZ » Sat May 28, 2011 6:23 am

Willowford,

I don't think this thread is the place to continue another verbal debate between us. I initially responded in order to help a person who wanted to try Sativex but because of his circumstances wasn't able to do so. I offered a possible yet knowingly difficult route for him because of his situation. And all of a sudden I find myself debating with you again over the principles of science and how they may apply to Sativex.

I agree with a lot you have to say about this but I don't think our differences should interfere with the MS patient who wants to try Sativex. If you want to continue our discussion perhaps you may want to send me a private message. In the meantime I will help the person who wants to try Sativex as much as I can. My wife (and I) were in a very similar situation a few years ago and I know the frustration that he is feeling.

Take care.

Harry
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Postby HarryZ » Sat May 28, 2011 6:32 am

THEGREEKFROMTHED wrote:Let me understand this...it is available through my family doc and could be obtained in the detroit area?! I appreciate everyones help sincerely but thought the US FDA had not approved this!


Hi "Greek",

There is another possible approach you may try but it could be as difficult as the Walk In clinic in Windsor.

And that is getting referred to a Pain Clinic in Canada. There is one here in London, ON, a couple of hours from Windsor (closer through Port Huron/Sarnia if you are closer to that area. This clinic has done a lot of research on MJ and related drugs and is very familiar with their use. But it would take the referral of your doctor to get in and I don't know how difficult it would be to do that. Of course there is a cost association since you live out of Province. Just a thought.

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Sativex

Postby Moom9335 » Sat May 28, 2011 2:52 pm

It's not bad enough to suffer from MS, but it seems so many have to jump through legal and medical hoops just to get some help. Why is Sativex not available in the US? If it is legal in CAnada, it should be legal here. There is certainly an arrogance factor in thinking that other countries cannot make good decisions regarding meds as we do. And, the FDA has not been looking "clean" for a very long time. It sure is hard not to get disgusted and jaded.
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Postby willowford » Mon May 30, 2011 10:01 am

HarryZ wrote:Willowford,

I don't think this thread is the place to continue another verbal debate between us. I initially responded in order to help a person who wanted to try Sativex but because of his circumstances wasn't able to do so. I offered a possible yet knowingly difficult route for him because of his situation. And all of a sudden I find myself debating with you again over the principles of science and how they may apply to Sativex.

I agree with a lot you have to say about this but I don't think our differences should interfere with the MS patient who wants to try Sativex. If you want to continue our discussion perhaps you may want to send me a private message. In the meantime I will help the person who wants to try Sativex as much as I can. My wife (and I) were in a very similar situation a few years ago and I know the frustration that he is feeling.

Take care.

Harry


I will note for the sake of others who have read any of my posts that NONE of the posts I wrote here represent my personal opinion about Sativex or any other treatment.
Having a "medical debate" that is based on personal experiences and opinions has no meaning to me.
Unless otherwise stated, whatever I have written is based on objective studies of cannabis and cannabis-based medicines, which is what I study. The evidence can be debated by providing other evidence, but no one's opinion will change the objective data out there.
I have no differences in "opinion" with anyone, given that I have not expressed nor would I ever express my personal opinions about other people's decisions.
Health care decisions should not be based other people's opinions but based on objective data and facts, to the extent that these are available as well as an individual's (not other people's) preferences and values etc.

I too was trying to help the original poster. I did not have a name of a doctor to give him (especially since the poster is in the US). Despite that, my providing information on this forum was only meant to provide the poster and any others with bias-free information from larger populations with samples greater than 1.
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Postby HarryZ » Mon May 30, 2011 10:51 am

Having a "medical debate" that is based on personal experiences and opinions has no meaning to me.


Then participating on this board may be difficult for you since a lot of posts are based on personal experiences and opinions.

Harry
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Postby willowford » Mon May 30, 2011 11:27 am

HarryZ wrote:
Having a "medical debate" that is based on personal experiences and opinions has no meaning to me.


Then participating on this board may be difficult for you since a lot of posts are based on personal experiences and opinions.

Harry


I never suggested they were not based on personal experiences and opinions.
I said the information that *I* give does not reflect my opinion or that of others. It's based on extensive studies that have been done on certain topics/ objective literature. Therefore, a debate is impossible. Two opinions can be debated, but I haven't mentioned mine so that's not possible. The debate you suggested, as interesting as it would be, would never get anywhere because it will be opinion versus evidence... can't be compared.
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