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The FDA's Marijuana Problem
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| Cowboy 2006-08-20, 8:25 am |
| http://www.tcsdaily.com/article.aspx?id=3D081806D
The FDA's Marijuana Problem
By Charles L. Hooper : BIO| 18 Aug 2006
The U.S. Food and Drug Administration has a marijuana problem. On April
20 of this year, the FDA rejected marijuana for medical uses. The FDA
said, "no sound scientific studies supported medical use of marijuana
for treatment in the United States, and no animal or human data
supported the safety or efficacy of marijuana for general medical use."
This conclusion contradicts a lot of other scientific research and
expert conclusions, including that of the National Academy of Sciences
and the FDA itself. In 1985, the FDA was so convinced of marijuana's
medical benefits that it approved Marinol and Cesamet, both synthetic
versions of delta-9-tetrahydrocannabinol (THC), the main active
ingredient in marijuana.
Here's what the FDA has to say about Marinol. "MARINOL=AE (Dronabinol)
Capsules is indicated for the treatment of: (1) anorexia associated
with weight loss in patients with AIDS; and (2) nausea and vomiting
associated with cancer chemotherapy in patents who have failed to
respond adequately to conventional antiemetic treatments."
The FDA obviously thinks that Marinol and Cesamet are safe and
efficacious drugs or else it wouldn't have approved them. If the
synthetic versions are so good, why hasn't the FDA embraced the natural
version? After all, in the Marinol statements above, the FDA is
basically agreeing with marijuana advocates.
Two reasons that might come to mind are dosing and delivery mechanism.
Although it may seem that an inability to pin down the ideal dose is a
problem, the FDA is fully aware that the gold standard of analgesia in
hospitals is patient-controlled analgesia (PCA), in which the patient
pushes a button as often as desired to get I.V. doses of morphine. In
other words, there is no one-size-fits-all dose with PCA. Empirical
evidence shows that PCA produces better pain control with less morphine
consumed. Marijuana can be used in much the same way as PCA.
The delivery mechanism of marijuana is usually smoke, which can
irritate soft tissues and perhaps precipitate cancer. While certainly a
problem, I estimate that marijuana smokers consume about one-percent as
much per day as do tobacco smokers. Marijuana smokers take a few puffs
("hits") while tobacco smokers may smoke 20 or 40 entire cigarettes per
day. Also, many AIDS and chemotherapy patients will be on short-term
therapy or won't live long enough to worry about marijuana-induced lung
cancer. Many of them would love to live long enough to have such a
problem.
Look at the FDA's statements critically. The FDA isn't saying that
marijuana doesn't have health benefits; it's saying that no good
studies exist to prove that conclusion. In 2004, the FDA stated, "FDA
will continue to be receptive to sound, scientifically based research
into the medicinal uses of botanical marijuana and other cannabinoids."
The key term is "sound research." The FDA recognizes only medicines
that have gone through its long, expensive, and exhaustive
investigational new drug (IND) application process -- its idea of
"sound research."
The FDA is blind to anything that hasn't been through its process.
What's worse, marijuana is highly unlikely ever to clear such hurdles.
Why? The FDA requires controlled and consistent production batches and
it wants to inspect each manufacturing facility. This would be very
difficult for a dried weed that is grown in thousands of different
places under thousands of different conditions. The FDA also requires
placebo-controlled clinical trials with thousands or tens of thousands
of patients. What placebo could possibly be used? I doubt that any
other safe and medically inactive plant would smell and taste like
smoked marijuana. Last, these clinical trials, I estimate, would cost
tens if not hundreds of millions of dollars. Who would pay for them?
Not the FDA. Not drug companies. Not self-medicating AIDS and cancer
patients.
Drugs like marijuana almost certainly do have some health benefits for
certain patients. But to put marijuana through the IND process would
involve paying for clinical trials, manufacturing facilities, data
analysis, legal fees, administrative staff, and FDA face-time, which
are all private costs that someone must bear. Marinol's and Cesamet's
manufacturers were willing to bear these costs due to the prospect of
profits that accrue to the patent holder. For a widespread weed that's
been around for millennia, how would anyone garner and enforce such
patent protection?
Some say this is a weakness of the private enterprise system. The
proponents of government spending on medical research use cases like
this as an argument for the role of government. They shouldn't be too
optimistic about their solution because that's what we have right now
and it has failed miserably. Why? Certain parts of the federal
government haven't allowed this scientific process to happen. Remember
that, above all else, the government is a political organization and
the U.S. government is fighting a war against the production, sale, and
usage of marijuana.
The federal government maintains marijuana's status as a Schedule I
controlled substance, keeping company with infamous drugs like heroin
and PCP. A Schedule I drug is defined as having a very high potential
for abuse, no accepted medical use in the United States, and a lack of
accepted safety data for use under medical supervision. Interestingly,
Marinol is rated as only Schedule III (less dangerous), just like, for
example, Tylenol with Codeine.
Just recently, the FDA has landed in more hot water over its marijuana
ruling. In 2000, Congress passed what is known as the Data Quality Act
to help ensure that regulations are based on solid science. The
two-paragraph Data Quality Act wasn't written by a member of Congress,
but by James J. Tozzi, and included in a longer appropriations bill.
Now Tozzi, who is founder of the Center for Regulatory Effectiveness,
is suing the government because the FDA's marijuana ruling has ignored
data showing that marijuana is helpful to some patients.
Should we pity the FDA? In some ways, yes, we should. The FDA behaves
as a bureaucratic scientist. The FDA will always to be too slow and
conservative and require too much data.
I am happy that there are such careful and plodding people in the
world. I am not happy that they have the power to prohibit drugs like
marijuana. In some cases, like this one, the FDA is the wrong tool for
the job. Americans shouldn't rely on the FDA to control widely used and
naturally occurring botanicals such as marijuana. The FDA is simply
unable to effectively assess the medical value of natural plants like
marijuana in any reasonable timeframe. AIDS and cancer are deadly
serious diseases and the FDA's approach is fatally flawed. AIDS and
cancer patients deserve a better path to useful medicines and than
through the FDA's benediction.
Charles L. Hooper is president of Objective Insights, a company that
consults for pharmaceutical and biotech companies. He is a visiting
fellow with the Hoover Institution and coauthor of Making Great
Decisions in Business and Life (Chicago Park Press, 2006).
| |
| Marilyn Bachmann 2006-08-20, 4:25 pm |
| http://seattletimes.nwsource.com/ht...empfest20m.html
"Cowboy" <msbuckaroo@hotmail.com> wrote in message
news:1156071979.751984.191160@h48g2000cwc.googlegroups.com...
http://www.tcsdaily.com/article.aspx?id=081806D
The FDA's Marijuana Problem
By Charles L. Hooper : BIO| 18 Aug 2006
The U.S. Food and Drug Administration has a marijuana problem. On April
20 of this year, the FDA rejected marijuana for medical uses. The FDA
said, "no sound scientific studies supported medical use of marijuana
for treatment in the United States, and no animal or human data
supported the safety or efficacy of marijuana for general medical use."
This conclusion contradicts a lot of other scientific research and
expert conclusions, including that of the National Academy of Sciences
and the FDA itself. In 1985, the FDA was so convinced of marijuana's
medical benefits that it approved Marinol and Cesamet, both synthetic
versions of delta-9-tetrahydrocannabinol (THC), the main active
ingredient in marijuana.
Here's what the FDA has to say about Marinol. "MARINOL® (Dronabinol)
Capsules is indicated for the treatment of: (1) anorexia associated
with weight loss in patients with AIDS; and (2) nausea and vomiting
associated with cancer chemotherapy in patents who have failed to
respond adequately to conventional antiemetic treatments."
The FDA obviously thinks that Marinol and Cesamet are safe and
efficacious drugs or else it wouldn't have approved them. If the
synthetic versions are so good, why hasn't the FDA embraced the natural
version? After all, in the Marinol statements above, the FDA is
basically agreeing with marijuana advocates.
Two reasons that might come to mind are dosing and delivery mechanism.
Although it may seem that an inability to pin down the ideal dose is a
problem, the FDA is fully aware that the gold standard of analgesia in
hospitals is patient-controlled analgesia (PCA), in which the patient
pushes a button as often as desired to get I.V. doses of morphine. In
other words, there is no one-size-fits-all dose with PCA. Empirical
evidence shows that PCA produces better pain control with less morphine
consumed. Marijuana can be used in much the same way as PCA.
The delivery mechanism of marijuana is usually smoke, which can
irritate soft tissues and perhaps precipitate cancer. While certainly a
problem, I estimate that marijuana smokers consume about one-percent as
much per day as do tobacco smokers. Marijuana smokers take a few puffs
("hits") while tobacco smokers may smoke 20 or 40 entire cigarettes per
day. Also, many AIDS and chemotherapy patients will be on short-term
therapy or won't live long enough to worry about marijuana-induced lung
cancer. Many of them would love to live long enough to have such a
problem.
Look at the FDA's statements critically. The FDA isn't saying that
marijuana doesn't have health benefits; it's saying that no good
studies exist to prove that conclusion. In 2004, the FDA stated, "FDA
will continue to be receptive to sound, scientifically based research
into the medicinal uses of botanical marijuana and other cannabinoids."
The key term is "sound research." The FDA recognizes only medicines
that have gone through its long, expensive, and exhaustive
investigational new drug (IND) application process -- its idea of
"sound research."
The FDA is blind to anything that hasn't been through its process.
What's worse, marijuana is highly unlikely ever to clear such hurdles.
Why? The FDA requires controlled and consistent production batches and
it wants to inspect each manufacturing facility. This would be very
difficult for a dried weed that is grown in thousands of different
places under thousands of different conditions. The FDA also requires
placebo-controlled clinical trials with thousands or tens of thousands
of patients. What placebo could possibly be used? I doubt that any
other safe and medically inactive plant would smell and taste like
smoked marijuana. Last, these clinical trials, I estimate, would cost
tens if not hundreds of millions of dollars. Who would pay for them?
Not the FDA. Not drug companies. Not self-medicating AIDS and cancer
patients.
Drugs like marijuana almost certainly do have some health benefits for
certain patients. But to put marijuana through the IND process would
involve paying for clinical trials, manufacturing facilities, data
analysis, legal fees, administrative staff, and FDA face-time, which
are all private costs that someone must bear. Marinol's and Cesamet's
manufacturers were willing to bear these costs due to the prospect of
profits that accrue to the patent holder. For a widespread weed that's
been around for millennia, how would anyone garner and enforce such
patent protection?
Some say this is a weakness of the private enterprise system. The
proponents of government spending on medical research use cases like
this as an argument for the role of government. They shouldn't be too
optimistic about their solution because that's what we have right now
and it has failed miserably. Why? Certain parts of the federal
government haven't allowed this scientific process to happen. Remember
that, above all else, the government is a political organization and
the U.S. government is fighting a war against the production, sale, and
usage of marijuana.
The federal government maintains marijuana's status as a Schedule I
controlled substance, keeping company with infamous drugs like heroin
and PCP. A Schedule I drug is defined as having a very high potential
for abuse, no accepted medical use in the United States, and a lack of
accepted safety data for use under medical supervision. Interestingly,
Marinol is rated as only Schedule III (less dangerous), just like, for
example, Tylenol with Codeine.
Just recently, the FDA has landed in more hot water over its marijuana
ruling. In 2000, Congress passed what is known as the Data Quality Act
to help ensure that regulations are based on solid science. The
two-paragraph Data Quality Act wasn't written by a member of Congress,
but by James J. Tozzi, and included in a longer appropriations bill.
Now Tozzi, who is founder of the Center for Regulatory Effectiveness,
is suing the government because the FDA's marijuana ruling has ignored
data showing that marijuana is helpful to some patients.
Should we pity the FDA? In some ways, yes, we should. The FDA behaves
as a bureaucratic scientist. The FDA will always to be too slow and
conservative and require too much data.
I am happy that there are such careful and plodding people in the
world. I am not happy that they have the power to prohibit drugs like
marijuana. In some cases, like this one, the FDA is the wrong tool for
the job. Americans shouldn't rely on the FDA to control widely used and
naturally occurring botanicals such as marijuana. The FDA is simply
unable to effectively assess the medical value of natural plants like
marijuana in any reasonable timeframe. AIDS and cancer are deadly
serious diseases and the FDA's approach is fatally flawed. AIDS and
cancer patients deserve a better path to useful medicines and than
through the FDA's benediction.
Charles L. Hooper is president of Objective Insights, a company that
consults for pharmaceutical and biotech companies. He is a visiting
fellow with the Hoover Institution and coauthor of Making Great
Decisions in Business and Life (Chicago Park Press, 2006).
| |
|
|
Cowboy wrote:
> http://www.tcsdaily.com/article.aspx?id=081806D
>
> The FDA's Marijuana Problem
> By Charles L. Hooper : BIO| 18 Aug 2006
<snip>
> The delivery mechanism of marijuana is usually smoke, which can
> irritate soft tissues and perhaps precipitate cancer.
Marijuana can be eaten; brownies are the usual vehicle for drug
delivery.
This would also solve the "placebo" problem in tests stated further
down in this article.
Sylvia
| |
| steve@tropheus.demon.co.uk 2006-08-20, 4:25 pm |
| On 20 Aug 2006 10:51:25 -0700, "Sylv" <Sylv772003@yahoo.com> wrote:
>Marijuana can be eaten; brownies are the usual vehicle for drug
>delivery.
>
Yes, but it doesn't work quickly and its not so predictable.
>This would also solve the "placebo" problem in tests stated further
>down in this article.
>
What's wrong with placebo smoke?
AAMOI smoking just a pinch of bush cannabis works very well without
all the dangers of mixing it with tobacco.
| |
|
|
Sylv wrote:
> Cowboy wrote:
>
> <snip>
>
>
> Marijuana can be eaten; brownies are the usual vehicle for drug
> delivery.
What's interesting is that recent studies, that weren't politically
driven, couldn't find any link between heavy cannabis smoking and lung
cancer. In fact, there appeared to be a slight protective effect, which
makes sense given the other studies showing it suppresses a number of
different tumor types.
However, it can definitely irritate tissue and can cause bronchitis, so
smoking is probably not the best method of administration for a
long-term medical user.
Vaporizers can deliver the active ingredients with almost none of the
tars and nasty gases. With the same rapidity of onset, and the same
degree of tritration, as smoking.
> This would also solve the "placebo" problem in tests stated further
> down in this article.
>
A vaporizer would work for this, too, as there's nothing coming out but
a faint mist. However, I think most people in a trial would quickly
figure out if they were getting the placebo. Unless the famous "high"
of cannabis is mostly placebo?
| |
| John Husvar 2006-08-21, 4:27 pm |
| In article <1156071979.751984.191160@h48g2000cwc.googlegroups.com>,
"Cowboy" <msbuckaroo@hotmail.com> wrote:
> http://www.tcsdaily.com/article.aspx?id=081806D
>
> The FDA's Marijuana Problem
> By Charles L. Hooper : BIO| 18 Aug 2006
>
>
> The U.S. Food and Drug Administration has a marijuana problem. On April
> 20 of this year, the FDA rejected marijuana for medical uses. The FDA
> said, "no sound scientific studies supported medical use of marijuana
> for treatment in the United States, and no animal or human data
> supported the safety or efficacy of marijuana for general medical use."
>
From a libertarian (Note the lowercase "l."/conservative POV:
What damn business of the government's is what citizens choose to ingest
anyway?
Sure, I appreciate FDA's oversight of the _purity_ of what one ingests,
and the efficacy and safety of the medicines that are sold. Beyond that,
however, it goes to deciding _what_ we can consume. Pizzondat! 
I really have a hard time seeing that power granted the Federal
Government by the Constitution, but, of course, I'm by no means a legal
scholar.
Oh, well, the citizenry have so far abdicated their rights and
responsibilities to government that there's no recovery short of a
voters' revolution -- and that ain't gonna happen unless folks start
losing their personal peace and affluence in a big way.
Might not happen even then.
I'm to the point where I just figure if Da Gubmint is going to become
totally nanny-ized, it should do a complete job of it for what we pay
and have paid.
We sure as Hell deserve it!
Speaking of Hell, I attended the last Hell Party at the Pennsic War last
week. The hosts gave me another Pentwyvern Goes To Hell T-shirt. Now I
have one from the first Hell Party and one from the last Hell Party.
I fixed their flaming "HELL" sign for the first party 13 years ago.
So now I'm the only blacksmith in the world who has gone to Hell,
repaired the sign at the gate, attended a party there, received a Writ
of Appreciation from Satan, watched Hell freeze over (snow machine this
year) -- and got the T-shirts.
--
Bring back, Oh bring back
Oh, bring back that old continuity.
Bring back, oh, bring back
Oh, bring back Clerk Maxwell to me.
| |
|
| Cowboy wrote:
> http://www.tcsdaily.com/article.aspx?id=081806D
>
> The FDA's Marijuana Problem
> By Charles L. Hooper : BIO| 18 Aug 2006
(SNIP)
> The FDA also requires
> placebo-controlled clinical trials with thousands or tens of thousands
> of patients. What placebo could possibly be used? I doubt that any
> other safe and medically inactive plant would smell and taste like
> smoked marijuana. Last, these clinical trials, I estimate, would cost
> tens if not hundreds of millions of dollars. Who would pay for them?
> Not the FDA. Not drug companies. Not self-medicating AIDS and cancer
> patients.
A couple-three years back (memory fog), I participated in a clinical
trial supported by UCSD and the UCSD M.S. Clinic, a *smoked marijuana*
trial. They used a placebo -- male plants.
The research was sponsored by UCSD and its affiliated M.S. Clinic (it
was an M.S.-specific trial). I'd assume UCSD paid for it?
Totally put the lie to the assertion that *anyone* would participate in
a smoked marijuana trial because they were "stoners who want a free
high." It was friggin' BRUTAL.
They did a urine test every visit, and we were told that the test they
used was *the* most sensitive of its kind, even moreso than those used
to test gov't employees, cops, firefighters, etc. During the test, no
one was permitted to take anti-spasticity, or prescription pain meds --
they tested for the presence of benzos and opiates and such, as well as
for the MJ.
Everyone enrolled had to complete both phases of the test -- the one
with the real herb, and the one with the placebo. They said, and I
believed, that the test was sensitive enough to be able to tell if
you'd been smoking more MJ than you'd been supplied during the tests,
so no smoking either. They'd keep you there and run bunches of tests,
and by the time it was time to leave again, I was exhausted, in pain,
and stiff as a board. Then I had he dubious pleasure of taking 4
different busses to get home.
After everyone had completed both phases, pot/placebo, the researchers
said their prelminary results had been promising. Then they "ran into
problems" and the WHOLE DAMNED STUDY WAS SCRAPPED. Now, theyre
recruiting again -- or possibly the recruitment is finished, and
they're running another study.
Everyone was told up front that this study involved *smoked* MJ, and
that they'd have to agree to inhale smoke into their lungs. No further
info was given about what the purported "problems" were -- my suspicion
is that the FDA or other government branch pulled something out of
its...hat....to object to, because the results were promising.
But the article is wrong -- placebo-controlled studies have already
taken place, are taking place, and will take place. They use buds from
male plants for the "placebo." And it was a cubic ton more rigorous
than any other clinical trial I've ever participated in. Rather than
going "Oooh, a free high!" it was more like "Ugh, I'm taking one for
the team," to me.
I think there was a different Catch-22 in play heere, tho: folks with
severe spasticity and pain may be more likely to drop out before
completing the trial, as no spasticity or pain meds = lots of
spasticity and pain, at ALL OTHER TIMES than those you actually send
*in* the M.S. Clinic. The folks most likely to complete the entire
thing, pot/placebo, no similarly-effective meds permitted, *might* be
those whose spasticity and pain problems are less incapacitating, and
therefore, the measurable results might be lower than they are for
those whose problems are more severe (but who are less likely to be
able to complete the trial, just *because* of its rigor).
I feel like I honestly endured 6 weeks of purgatory for no reason,
completing that trial and then seeing the whole thing and its positive
preliminary results thrown in the toilet.
Anyone who's considering entering a placebo-controlled trial of smoked
marijuana needs to be aware that it's not going to be fun, it's not
going to be comfortable, the only positive is that it leads to medical
MJ being taken more seriously -- but if the studies are *all* scrapped,
then _cui bono_?
RD
| |
|
|
CQ wrote:
> A vaporizer would work for this, too, as there's nothing coming out but
> a faint mist. However, I think most people in a trial would quickly
> figure out if they were getting the placebo. Unless the famous "high"
> of cannabis is mostly placebo?
hi CQ,
Yup, I did a placebo-controlled smoked marijuana trial sponsored by
UCSD and the UCSD M.S. Center. The placebo was male plants. I could
tell right away, got the tingly-mouth and an annoying headache from it,
and that was all.
I was (lucky? enough to) assigned to the real deal *first*, but still
had to complete the placebo phase -- everyone enrolled had to do both.
The study did include people who had never smoked MJ before, mostly
tobacco smokers, as the study required actual smoking, and those folks
all seemed to "guess" correctly as well, although their guesses were
due to the symptom relief or lack thereof, while those of us who'd
smoked MJ previously "guessed" correctly due to a combo of symptom
relief and high vs. cottonmouth/tingle-tongue/headache. ;->
in any case, the entire trial, although initially approved by the
D.E.A. *and* the F.D.A., was scrapped *after* it was completed. The
damned thing was *so* rigorous, that I just can't see what reason,
other than political, it could be considered "problematic."
If you (general 'you) live in a medical MJ state, chances are that
there are trials of some sort re MJ and its various medical uses going
on. They're kind of hidden -- I found out about the one I participated
in through my enrollment in the NARCOMS program, which is a
longitudinal study in itself, and also maintains a database of patients
available for trials and trials in search of patients.
For more info, go to http://www.narcoms.com
best,
RD
| |
|
| John Husvar wrote:
> What damn business of the government's is what citizens choose to ingest
> anyway?
>
> Sure, I appreciate FDA's oversight of the _purity_ of what one ingests,
> and the efficacy and safety of the medicines that are sold. Beyond that,
> however, it goes to deciding _what_ we can consume. Pizzondat!
>
> I really have a hard time seeing that power granted the Federal
> Government by the Constitution, but, of course, I'm by no means a legal
> scholar.
Well, the way I understand it, is that for some reason, our founding
fathers chose to insert the part about congress having the power to
regulate trade among the states, the so-called commerce clause.
Now, my (limited) understanding of the reasoning behind that clause, is
that it was put there to prevent the individual states from charging
duties, or tariffs or whatever, on goods from another state, an "import
tax".
Of course, along the way, the courts & congress have chosen to use that
clause for everything under the sun and then some. If it crosses state
lines at any point in the transaction, they claim the right to regulate it.
I don't think the original framers of the constitution had enough
experience with loopholes & weasel-words to realize the effect that
clause would have. How could they? They didn't have a congress yet to
interpret the constitution *their* way yet.
> Oh, well, the citizenry have so far abdicated their rights and
> responsibilities to government that there's no recovery short of a
> voters' revolution -- and that ain't gonna happen unless folks start
> losing their personal peace and affluence in a big way.
>
> Might not happen even then.
Of course not. We have become sheep. Follow the party line, don't ask
questions. Whatever they decide, its good for us. "Momma knows best".
> I'm to the point where I just figure if Da Gubmint is going to become
> totally nanny-ized, it should do a complete job of it for what we pay
> and have paid.
And will keep paying more & more & more ....
> We sure as Hell deserve it!
As long as we keep accepting their actions, we deserve everything we get.
> Speaking of Hell, I attended the last Hell Party at the Pennsic War last
> week. The hosts gave me another Pentwyvern Goes To Hell T-shirt. Now I
> have one from the first Hell Party and one from the last Hell Party.
>
> I fixed their flaming "HELL" sign for the first party 13 years ago.
>
> So now I'm the only blacksmith in the world who has gone to Hell,
> repaired the sign at the gate, attended a party there, received a Writ
> of Appreciation from Satan, watched Hell freeze over (snow machine this
> year) -- and got the T-shirts.
>
Hehehe, cool! Errr, should that be hot? ;-)
Alex
| |
|
|
Rose - my hat is off to you for putting yourself through that to
advance the cause of medicine. Even though they said "there was
something wrong" and the trial needed repeating, the results could
still be used in a metastudy ( I think!)
I had to opportunity to participate in an "inhaled dronabinol" trial in
my state. I already use Marinol to treat my condtion. It helps with my
spasticity and significantly reduces the incapacitating migraines I
get. But Marinol has two problems for me: it is VERY slow acting; and
it causes me anxiety. Because it's slow acting, I never know if I'm
going to react badly to it until it's too late. I think the anxiety is
due to the lack of CBD in Marinol.
But the inhaled approach would at least overcome the slow action and
allow better titration. I could do a small dose, make sure I was OK,
and then increase the dose in steps to the necessary level. So I think
it would be a major improvement.
But the trial required me to give up all my medications for the
duration - 6 weeks. Your're suppose to wait until you are getting a
severe migraine, call them, and they pick you up, give you a dose of
either placebo or active spray, and then send you home after 6 hours.
So not only no medications, but a full day off work missed each time I
participated. Plus I probably would have missed at least 10 days of
work during this period if I didn't take medications.
I just couldn't do it. My employer would probably have been OK with it,
but it was just too much missed work for me. Not to mention pain and
suffering. That's why I'm impressed with your sacrifices. You're a
better man ( or lady) than I!
| |
| bobbyD 2006-08-22, 4:27 pm |
| awesome info!!!!
i have also tried the synthetic pills- Cesamet or Nabilone in Canada,,,
they totally sucked for me,,, as i am used to potent high grade marijuana ,
which contains all the ingrediants the fake synthetic crap doesnt,,,
i then tried Sativex last summer,,, it also sucked,, but for a couple
different reasons,, first-
it is whole plant extract,, but i dont ever smoke Sativa strains,, they make
me vibrate and cause bad bad anxiety,,, i grind my teeth.
Sativex is made from all marijuana strains,, which is kinda stupid since
they are very individual in their abilities and effects on your body,,, if
you prefer sleepy couch potatoe pot,, Sativas are opposite what you need,,,
oppositely,, if you need a morning energy buzz or up energetic effects,,
some insane indicas are not for you,,,
outting both in one med is contrary to what i need or want,,, or get myself,
also most importantly- the main problem with Sativex, is its VERY LOW
medication content,
to put it in regular person terms,,,
the ENTIRE BOTTLE - 1 weeks medication contains the total amount of only 1
GRAM of 13.5% thc pot,,
well i roll 2 big bhats per gram of marijuana!
so the entire weeks meds are equivalent to only 2 joints of medication,,
for me that is just totally USELESS,,,
to back up my statement!!!!! -
recently, GW Pharmaceuticals,, the makers of Sativex, did another research
study on MS neuropathic pain and marijuana,
the daily dose for patients, was up to an ENTIRe BOTTLE, or a full 48 sprays
during their daytime awake period,, aauming they sleep 8 hopurs a day- thats
48 sprays for every 16 hours,,, as needed,, 12 sprays every 4 hours,,,
after this amt.was used the study concluded that it DID benfit Ms
neuropathic pain!!!!!
i gave this info my doctor ,, who was disgusted when i told him the amt
inside sativex,, and how patients actually needed 8 times the amt,,, to get
any relief,,,
also- the cost is 134 dollars per bottle,, and it is NOT COVERED in BC,,,
for Ms, even though that is what is has been spproved for treating in
Canada,,,
a great example of government ineffectiveness,, medical retardedness,
uselessness to the Nth degreeeeeeee.
the cost of using Sativex instead of actual marijuana per week is unreal,,
i go thru 2 ounces,, 250 dollars,,,worth of pot,,,
the sativex is approx 1,000 dollars a week,, 4 grand a month,,, 48 grand a
year,,,,
48 grand will buy you 25 pounds of marijuana!!!!!!!!!!!!!!!!!!!!!
i could never smoke 25 pounds of buds in a year!!!!! nor could 2 people,,,
Sativex also causes mouth infections, from the 50% ethanol alcohol in it,,,
yuck!!! it tastes rude, it burns too,,, WTF???
so in conclusion,, real marijuana has NO EQUAL in the medical world today,,,
cheers
bobbyD
"CQ" <charmed_quark@n2mail.com> wrote in message
news:1156255638.514134.271170@74g2000cwt.googlegroups.com...
>
> Rose - my hat is off to you for putting yourself through that to
> advance the cause of medicine. Even though they said "there was
> something wrong" and the trial needed repeating, the results could
> still be used in a metastudy ( I think!)
>
> I had to opportunity to participate in an "inhaled dronabinol" trial in
> my state. I already use Marinol to treat my condtion. It helps with my
> spasticity and significantly reduces the incapacitating migraines I
> get. But Marinol has two problems for me: it is VERY slow acting; and
> it causes me anxiety. Because it's slow acting, I never know if I'm
> going to react badly to it until it's too late. I think the anxiety is
> due to the lack of CBD in Marinol.
>
> But the inhaled approach would at least overcome the slow action and
> allow better titration. I could do a small dose, make sure I was OK,
> and then increase the dose in steps to the necessary level. So I think
> it would be a major improvement.
>
> But the trial required me to give up all my medications for the
> duration - 6 weeks. Your're suppose to wait until you are getting a
> severe migraine, call them, and they pick you up, give you a dose of
> either placebo or active spray, and then send you home after 6 hours.
>
> So not only no medications, but a full day off work missed each time I
> participated. Plus I probably would have missed at least 10 days of
> work during this period if I didn't take medications.
>
> I just couldn't do it. My employer would probably have been OK with it,
> but it was just too much missed work for me. Not to mention pain and
> suffering. That's why I'm impressed with your sacrifices. You're a
> better man ( or lady) than I!
>
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| Michael 2006-08-25, 9:25 pm |
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"rose" <rosedawn_scott@yahoo.com> wrote in message
news:1156175687.123973.276020@74g2000cwt.googlegroups.com...
> if the studies are *all* scrapped, then _cui bono_?
The pharmaceutical, law enforcement and organized crime industries.
Everyone else - especially the taxpayer - suffers in one way or another...
and some of them suffer terribly in many different ways, all at the same
time.
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