Jacob Sullum | January 5, 2006
Yesterday GW Pharmaceuticals announced that it has received FDA approval for Phase III clinical trials of its cannabis extract spray, Sativex, which the Canadian government last year approved as a treatment for neuropathic pain in patients with multiple sclerosis. The U.S. study will test Sativex's effectiveness in treating the pain of cancer patients who do not get adequate relief from narcotics--an application that has shown promise in a European study. GW, which is based in the U.K., reports that the FDA let it skip Phase I and Phase II trials, which focus on establishing safety and appropriate dosage, because it had already conducted substantial research on Sativex in Europe.
GW's success with Sativex, which is sprayed into the mouth, once again contradicts American drug warriors' repeated denials of marijuana's therapeutic utility. At the same time, it's another step toward a future in which legal alternatives to smoked, vaporized, or ingested whole cannabis will render the medical marijuana debate moot.
Another such step is Philip Morris' medical inhaler, which is based on technology developed for its unsuccessful smokeless cigarette. The device delivers aerosol medicine to the lungs for quick absorption. If used with THC and/or other useful cannabinoids, it would have all the medical advantages of smoked marijuana (immediate action, patient control over dosage, no capsules to swallow and keep down) without the drawbacks (variable strength, combustion products). Such a product would be more expensive than homegrown or club-dispensed marijuana, but presumably it would be covered by insurance.
These developments, while a boon to patients, will pose a challenge to the drug policy reform movement, which has gotten a lot of mileage out of the federal government's cruel, know-nothing intransigence on the issue of medical marijuana. Once legal, equally effective aternatives to marijuana are readily available, reformers will be forced to switch their focus back to recreational use (which is, after all, the main form of marijuana consumption), seemingly confirming the accusation that all their talk about the drug's medical virtues was just a cover. And having emphasized the sympathetic claims of suffering patients for so long, they will be in a weak position to argue that people shouldn't need a special excuse to smoke pot.
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Whatever the other implications may be, an effective, fast acting product with easily controllable dosage and no combustion products is something to be happy about. If it helps sick people, that is A Good Thing.
Mother Jones had a very good
article on Sativex, including a discussion of the possible
political ramifications.
Personally, I've always been hesitant about the Medical Marijuana
issue because it carries an "illegal drugs are bad, except..."
undercurrent. Because the MPP is typically unable to segregate
contributions between Medical Marijuana activism and drug
legalization activism (like they are pushing in NV), I only make a
token contribution to their effort. I've never made the effort to
find an anti-drug war non-profit that I should more fervently
support. Suggestions?
But if they legalize medications made from marijuana, wouldn't they have to remove it from the Schedule I list? If I understand correctly, "Schedule I" means "no medical value whatsoever."
The reason marijuana is illegal is because the pharma complex and government cannot make money from it. Now that they have been forced to admit to safety and effacacy they've engineered a way to make money off of it. Next step will be to fenetically modify hemp to reduce/remove the canabanoids so that the commercial fiber value can also be exploited.
And having emphasized the sympathetic claims of suffering
patients for so long, they will be in a weak position to argue that
people shouldn't need a special excuse to smoke pot.
Which is why the argument should have been about recreational use
all along. I have long thought support for "medical marijuana" was
a wasted effort, and now we're about to see why.
Once legal, equally effective alternatives to marijuana are
readily available...
Of course there is no reason to think that Sativex will be either
equally effective or readily available (read affordable).
Jacob is right that the drug warriors could do real damage the
anti-prohibitionist movement (such as it is) by not opposing
marijuana based medicine to come to market. I still find it obscene
that safe and effective medicine should be available to sick people
solely from the hands of big pharma, but that is a more general
criticism of our medical establishment than it is of the WOD.
I was never really excited over medical marijuana for this very
reason. But I did think it useful for two reasons. One, it
dramatically illustrated the moral bankruptcy of the WOD. The
absolute insistence that if anyone, anywhere, ever, smokes a joint,
someone needs to be hauled off to jail, by flack jacketed federal
agents, if necessary. Even if that someone is weak frail and dying,
we can afford no sympathy (or presumably all our children will
start smoking crack). The second thing I think medical MJ might do
is get some sanity into the debate. I can't understand how so many
people line up against legalizing. This is marijuana we're talking
about, the evils people like drug czar John Walters ascribes to it
are just ludicrous, and yet he is able to say them in broad
daylight without being laughed out of the room. I thought that the
only way that was possible was if most people refused to ever be in
the same room with it. I thought that maybe if people saw that
grandma was much more alert and coherent on dope than on say
Oxycontin, and also that it wasn't interfering with her other drug
treatments, the refer madness stigma would subside.
Don't get too excited. The BBC reports today that Britain is
discussing taking a step backwards on marijuana laws.
[quote]But John Henry, a clinical toxicologist at St Mary's
Hospital in London, told BBC News there was a "strong link" between
cannabis and schizophrenia.[/quote]
From this link:
http://news.bbc.co.uk/1/hi/uk_politics/4582818.stm
Jennifer, bless you, you're thinking too reasonably. Stop trying to apply consistent judgement to the window dressing that is the Schedule I issue. Instead, think as as the FDA and the government do, with your focus on marketing and propaganda.
Some (many?) people who advocate for medical cannabis are pretty
clearly recreational users in disguise. I spoke with some medical
pot advocates at a recent California gathering and I was encouraged
to get a medical pot recommendation, despite my clearly stating
that I was not sick.
Besides, if sativex becomes widely available, maybe recreational
users could get prescriptions for it in the same way current
California users get medical marijuana recommendations.
Imagine that. A British company is beating us to the punch with
this R&D. From what I understand, it's generally understood
that R&D in Europe is less onerous than R&D in the U.S.,
but the fact that there is one and only
one source of marijuana - and garbage marijuana at that - in
the U.S. surely can't be helping.
Getting this into a form that doctors and patients can control and
trust is a good step for medicine in general, and a defeat for
blind anti-THC zealotry. Incidentally, it may pose a stronger
challenge to the problem that Jacob noted here earlier this week of
discrimination by employers against patients who use legal
THC-based products to relieve pain.
As for the drug reform movement, there's been plenty of mileage to
squeeze out of arresting medical marijuana patients, and it will
still be a good platform to point out the evils of the shitbags at
the DEA for a few years to come. But the drug reform movement can't
ride it forever, and making the case for legalization for personal
use - like the SAFER folks did out in Denver - might as well start
sooner rather than later. Nevada will certainly be interesting this
year, and Vermont is one to watch as well in the coming couple of
years. Slooooow but sure, I suppose.
MP - I think you can make donations straight to the Nevada
initiative if you want to support a strictly-legalization for
personal use push...check out regulatemarijuana.org.
But if they legalize medications made from marijuana,
wouldn't they have to remove it from the Schedule I list? If I
understand correctly, "Schedule I" means "no medical value
whatsoever."
Logical as that may seem, there is plenty of precident to keep
things as they are. Heroin (Schedule I) is nothing more than
acetylated morphine (Schedule II), and codiene (Schedule III) is
nothing more than methylated morphine. Though delta-9 THC in a
medicalized formulation is the same molecule as the primary active
ingredient in cannibis, the argument can (and would) be made that
the presence of other substances makes it a different formulation
and therefore a different drug.
Jen - "no medical value whatsoever." should be read as "no
profitable value to the pharmaceutical industry." Which can then be
read as no profit value to the government if they can't tax the
billions that pharma makes.
It works the same as all other things in DC. Pharma gives huge
(some of the biggest) campaign donations to the pols. For this the
pols insure they get the profit margins they want which the pols
have have no problem with because they profit off the corp tax of
those companies. This also enables the pols to make big benefit
giveaways to voters who just can't seem to afford their meds for
some reason and ensures those people benefiting never think about
voting for anyone else.
If marijuana were legal there is no mechanism for anyone to profit
from it, after all it is a plant most anyone could grow themselves.
Always follow the money. Same goes with Budweiser and others who
cringe to think about all their customers who now drink only
because they can't legally smoke pot leaving the alcohol alone for
a doobie at night. Once again no profit. Think of the insane tax
rate the government has on alcohol and its not that hard to see the
big picture.
I found this amusing
"The U.S. study will test Sativex's effectiveness in treating the
pain of cancer patients who do not get adequate relief from
narcotics."
It pretty much states outright that they really don't care that
your on narcotics or not. They just want to make sure you are you
on a narcotic that they provided and profit from. That old saying
speed kills is only applicable to black market or self prescribed
speed. The speed made by the pharma's however is just fine to be
taken daily. As are the opiates, and benzos and sleeping pills they
all peddle.
Ask your doctor if its right for you!
I once took a email from our CEO about the new medicare giveaways
and re-worded it to mean what he actually was saying maybe I will
post the original and the edited version together.
Unfortunately I don't believe any schedule change will make any
difference on the legality of MJ. In fact, I would say that Sativex
will make it even harder for MJ to become legalized. The argument
will compare (not legitimately, of course) Sativex to morphine.
Sativex is a powerful drug which helps people with some of the most
debilitating conditions on the planet: AIDS, Cancer, MS, among many
others. Morphine, too, is a powerful drug which helps people in
extreme pain. Both are extracted from crude plant material. Sativex
is proven a powerful drug through research, which shows why it's
even more important to keep the crude plant form illegal. Just
because morphine works doesn't mean opium should be legal. It will
be a major setback.
It is important to note who is lobbing for Sativex
http://blogs.salon.com/0002762/stories/2005/04/20/andreaBarthwellSnakeOilSal.html
Luckily, I believe there is "moral" ground to stand on (beyond the
"I think it's fine to get stoned when I want to" argument), with
the prison costs and overcrowding. But the MMJ argument was a nice
pedestal to stand on.
However, the moveing to schedule II might (I am unsure of this)
allow true independant scientific testing of the negative effects
of MJ, which would demonstrate the few real side effects of MJ use
(especially when compared to booze). This could greatly help the
relaxing of MJ laws.
By the way, the "no medical value whatsoever" thing is determined entirely by the definitions set by the FDA and congress. Heroin would be an exceptionally good pain killer--especially for the terminally ill--so the fact that it is deemed to have "no medical value" shows that these definitions are not grounded in actual science.
It's been clear from the start that Drug Policy Reformers and
Drug Warriors alike have been using medical marijuana.
The difference is that the Reformers knew that medical marijuana
was important on its own, but was ALSO a step toward getting past
the demonization. However, the Warriors knew that medical marijuana
worked, but were willing to promote the suffering of patients to
prevent people from seeing through the thin anti-marijuana
propaganda.
Even if Sativex is accepted and the government shuts down smoked
(or home vaporized, or cooked in brownies) medical marijuana in
favor of the more expensive pharmaceutical version, it will still
end up a victory for long-term marijuana legalization, for the
simple fact that more and more people will start to wonder what the
big fuss was about.
Heroin would be an exceptionally good pain
killer--especially for the terminally ill--so the fact that it is
deemed to have "no medical value" shows that these definitions are
not grounded in actual science.
You don't have to even rely on conjecture. In the 80s, the DEA
rescheduled Methaqualone from II to I.
I've never understood why Heroin is illegal, but morphine is A-Okay, frankly.
This won't change the medical marijuana argument. Rather, it will reinforce the hypocricy of the federal position.
Robert Cote wrote:
"The reason marijuana is illegal is because the pharma complex
and government cannot make money from it. Now that they have been
forced to admit to safety and effacacy they've engineered a way to
make money off of it. Next step will be to fenetically modify hemp
to reduce/remove the canabanoids so that the commercial fiber value
can also be exploited."
Say what? There is an ocean of government money to be made from
cannabis legalization. I think its fair to say that if the gov
stopped spending money prosecuting cannabis offenses, and taxed
sales of cannabis, there would be billions to be made. The
government would certainly make a shitload more money from legal
regulated cannabis than it ever will from sativex.
Secondly, strains of cannabis that have been bred for fiber are
already so exceedingly low in cannabinoids that there is no need to
genetically engineer a cannabinoid-free strain.
Um Patrick my friend if you think I am going to pay the
government tax and buy my weed from them you must really be smoking
the good shit.
Who in their right mind would pay for something you can grow damn
near anywhere. People do brew their own beer and distill their own
alcohol legally now. It is not easy to do well and obtain a quality
product that passes taste testing so most people buy what they
drink. With weed its just that a weed once you find the flavor you
like the DNA will reproduce the same results over and over no brew
master needed. Damn sure no government tax collecter needed. Not to
mention I will be dead and cold before I start paying this
government to profit off what they spent so long ruining peoples
lives over.
No one I know would buy much of anything except gardening supplies
and rolling papers that I know.
Let me go try to dig up this piece about a cannibis knock off drug
that is claimed to be used for the exact opposite of what the gov
has claimed it does to you thats bad all these years.
Hypocrisy!!!
Patrick,
You are absolutely right. The problem is that the establishment is
always invested in the status quo. Moneys resulting from the sale
of pot and industrial hemp are hypothetical and not anybody's
current rice bowl.
Dar,
As one who brews his own beer and grows his own pot, I can tell you
that growing quality dope is much more difficult. If pot were put
in the same legal boat with booze, I predict the dope market would
look a lot like the beer market does now. RJR and Phillip Morris
would grab the lions share, specialty microsmokes would also be
plentiful, pasty white geeks that can't get dates would grow their
own.
Who in their right mind would pay for something you can grow
damn near anywhere
Why do people still pay money for vegetables when they could just
grow their own? Why is Jiffy Lube still in business when it's
cheaper to change your oil yourself? Why do people buy bread when
baking it yourself costs less?
Jen- I don't really need 1000 pounds of pot to satisfy my monkey
so whether ADM and Phillip Morris start plowing every field they
have with pot or not I am still growing my own. This type of
mentality is what has the US turning into a service and retail
economy. I personally would rather do something I can on my own
versus paying someone else to do it for me. Sure you can't do
everything for yourself but damn come on planting some seeds and
watering it is not that hard is it. Mother nature will do all the
work.
Warren- as one who brews and grows his own you must be a pasty
white geek that can't get a date. For you to say growing a weed is
hard makes me question what you consider easy. On further thought
for you to say its hard to grow weed makes me wonder what your beer
must taste like. And yes I have grown it. The shit will grow all by
itself after all its a weed and was growing just fine long before
we started using it. If your having problems that make you think
its hard perhaps your the one trying to hard and killing them with
all your love.
No doubt that people would buy the weed and pay the tax. Just not
anyone I know.
Here is the piece about the new pot knock off drug they can't
wait to sell you.
New drug acts as marijuana in the brain
MONTREAL, Dec. 13 (UPI) -- A McGill University study suggests a new
anti-depressant drug works by raising levels of endocannabinoids --
similar to a substance found in marijuana.
The study suggests the new drug, called URB597, might represent a
safer alternative to use of marijuana for treatment of pain and
depression, and open the door to new and improved treatments for
clinical depression.
In pre-clinical laboratory tests researchers found URB597 increased
the production of endocannabinoids by blocking their degradation,
resulting in measurable antidepressant effects.
"This is the first time it has been shown a drug that increases
endocannabinoids in the brain can improve your mood," said lead
investigator Dr. Gabriella Gobbi, a researcher at Montreal and
McGill Universities.
The researchers, including scientists from the University of
California-Irvine, were able to measure serotonin and noradrenaline
activity as a result of the increased endocannabinoids.
"The results were similar to the effect we might expect from the
use of commonly prescribed antidepressants, which are effective on
only around 30 percent of the population," said Gobbi. "Our
discovery strengthens the case for URB597 as a safer,
non-addictive, non-psychotropic alternative to cannabis for the
treatment of pain and depression."
So now after decades of propaganda BS financed by us for us the
medical world has a drug based on cannabis that treats depression.
The very same depression the government and medical community has
claimed is a result of using the drug directly.
This is such exciting news!
Do you think it will also help with us regain long and short term
memory and allow us to focus better on tasks. It must since now it
appears weed does exactly the opposite of what government has
claimed.
I think the only way to legalization is through constant bombarding
of politicians about their hypocrisy and point out over and over
all the lies they told as straight faced truths over the years.
Remind them at every turn of the money wasted on telling lies and
lives hurt. That is one of the only things a politician seems to
mind being labeled as these days.
Dar,
You missed the part where I said quallity dope. And before
that gets your fingers moving, let me try and head you off a
bit.
Yes you can just throw the seeds on the ground and water it like
tomatoes. In fact Jennifer makes a good point, that you can grow
your own tomatoes too but few people do. Indoor growing (which is
what I was thinking of) is more complicated, but produces better
and more reliable results. Growing outdoors yields only one crop a
year, and it's subject to a variety of perils. So yes, if you have
good soil and good weather, and if you take due diligence with
water, pests, fertilizer, and if you avoid frost, flood, those damn
kids, you can, grow good bud right next to the rhododendrons.
However, most stuff grown that way is going to come out as seedy
schwag weed. Growing quality herb takes knowledge (albeit no more
than growing quality anything, tomatoes e.g.) and effort. Then
there's the matter of harvesting, drying, and curing, which is more
than enough trouble to convince most folks that over-priced
over-taxed by-the-pack with a tank of gas is still the better
deal.
As to some other points;
I am a pasty-faced, over weight, middle aged, white guy, with
chronic flatulence. And while I am brilliant, charming and oh so
witty, attractive women almost never accept my invitations. This is
a deep mystery to me, I have no clue as to why this is so.
My home brew I'll stack up against anything you can find in the
supermarket.
Having enjoyed pot virtually every day since 1968, I was almost
grateful for my glaucoma diagnosis five years ago, because of the
profound relief being immune from state/local prosecution
brings.
I find the concept of cannabis prohibition absolutely unacceptable
in a nation with thriving tobacco and alcohol industries.
NO ONE should suffer due to cannabis prohibition, LEAST of all the
ill who can benefit from its theraputic effects.
Marinol should have been sufficient to repudiate the Schedule I
status of the herb; Sativex simply adds more proof of its
efficacy.
Cannabis & THC per se will remain in schedule 1 while
dronabinol & Sativex will be "exempt preparations" of them,
respectively, in higher-numbered schedules.
And yes, of course some people will wind up using Sativex
recreationally, just as some people do with oxycodone, for
example.
Methaqualone's placement in schedule 1 was based on "lack of
accepted medical use in the USA", which does not mean lack of
medical utility! It's a circular judgement that does not rest
primarily on biology but the social meaning of "accepted". The mfr.
voluntarily withdrew their marketing license, which withdrawal was
taken as a reflection of the use of methaqualone's being newly
deemed not to be "accepted". Nobody claimed that the facts of its
safety and efficacy had changed. Someone could enter the business
to re-establish its medical use, and it's not clear what evidence
would be taken to deem its use again "accepted", but apparently it
would seem to be simply the will of a drug firm to market it. FDA
would apparently require a new new drug application; an abbreviated
NDA probably wouldn't work, because the eauivalency claimed would
not be to a currently marketed product. Possibly however a petition
to declare it "generally recognized as safe and effective" based on
its history of use would be in order, but someone would have to pry
open the trade secrets of its mfr. to ensure identity to the
historic product.
Jennifer, No. just as currently Ritalin/Adderal prescribed for
ADHD in kids IS METHAMPHETAMINE!
Adderall Chemical name: Amphetamine-Dextroamphetamine
Figure that one out.
:)
>>But if they legalize medications made from marijuana,
wouldn't they have to remove it from the >>Schedule I list?
If I understand correctly, "Schedule I" means "no medical value
whatsoever."
>>Comment by: Jennifer at January 5, 2006 11:28 AM
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