Pot-based prescription drug looks for FDA OK (first pharmaceutical developed from raw marijuana)

[kpete]

Pot-based prescription drug looks for FDA OK

By LISA LEFF, Associated Press – Sun Jan 22, 4:39 pm ET
SAN FRANCISCO – A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists.

A British company, GW Pharma, is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents_ a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013.

Sativex contains marijuana's two best known components — delta 9-THC and cannabidiol — and already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis.

FDA approval would represent an important milestone in the nation's often uneasy relationship with marijuana, which 16 states and the District of Columbia already allow residents to use legally with doctors' recommendations. The U.S. Drug Enforcement Administration categorizes pot as a dangerous drug with no medical value, but the availability of a chemically similar prescription drug could increase pressure on the federal government to revisit its position and encourage other drug companies to follow in GW Pharma's footsteps.

http://old.news.yahoo.com/s/ap/20120122/ap_on_bi_ge/us_marijuana_drug_development

[AlecBGreen]

1. here's to a saner approach to MM

[RainDog]

9. unfortunately, it's likely not that at all

it's an attempt to segregate pharm cannabis and pretend it's diff. than mm.

[Cooley Hurd]

11. Yes, quite sane to pay for something that you can grow naturally for viturally nothing

...because Big Pharma doesn't make much in the way of profits.

[Snake Alchemist]

15. I thought the taxes on it were going to save us?

If it can be grown for virtually nothing, then what?

[RainDog]

16. taxes can move profits from drug cartels to states

just as we tax alcohol and tobacco.

No one knows what the market cost would be - no doubt there would be a temporary steep drop in price as a lot of diff. growers flood the market - but regulations can make sure that cannabis provided by dispensaries meets certain standards for chemicals (i.e. flushing soil before harvest) and lack of mold, etc.

Rand did one study that indicated prices for the plant itself would drop drastically. But, again, as with other substances, a regulated market can include taxes to keep something expensive enough to gain revenue but not so expensive it would encourage an illegal market.

just as now, there can also be compassionate providers for people with illnesses to provide non-profit medicine for cancer patients, etc. No one has to smoke cannabis to get the benefit of it, either, with vaporizers or edibles.

The real issue is the hypocrisy of this attempt to create a "class-based" system of legality.

[Snake Alchemist]

17. I think the taxes on it would be nil.

I'm for total decriminalization, but I think the tax argument is just now well thought out.

[RainDog]

19. 2010 Estimate: California Already Collects $50 Million in Cannabis Sales Taxes

that's the low-end estimate.

While the State of California begins to debate the consequences of taxing and regulating cannabis for personal use, it's important to note the state is already taxing and regulating the agricultural product used by 2.9 million Californians monthly. California Board of Equalization official Anita Gore told the Express this week that the board estimates it collects anywhere from $50 million to more than $100 million in sales taxes per year from medical cannabis dispensaries.

That's on top of the millions of dollars municipalities like Oakland have begun collecting in local sales taxes and fees. Gore said the board doesn't have more precise figures because dispensaries are not required to report the exact business they are in. Their taxes come in under several categories of business like “retail” and “pharmacy,” Gore said.

The board estimates the state can make $1.4 billion annually from fully integrating the vibrant cannabis market into the economy.

http://www.eastbayexpress.com/LegalizationNation/archives/2010/05/05/california-to-collect-100-million-in-cannabis-taxes-this-year

[Snake Alchemist]

22. Yes, but I think decriminalization would eliminate that.

I would be growing my own. I assume the majority of people would be.

[RainDog]

23. well, people can grow their own tomatoes, but a lot of them don't

cannabis is already decriminalized in CA and, with a medical card, people can grow their own. same in many other states. yet those states still have dispensaries and still collect revenues.

people who are sick are less likely to grow their own anyway - esp. someone dealing with cancer.

so, we already see that, in places in which it is possible to legally, at the state level, grow cannabis, many prefer to buy from growers.

as far as cannabis for recreational use - I think craft beer vs home brewing is about the closest analogy.

[stevedeshazer]

2. Just another way for Big Pharma to cash in.

For shame.

Just legalize it instead of altering it and making obscene profits from it.

Marinol revisited, IMHO.

[DCKit]

3. Shameful, ain't it?

This is exactly what we expected, and were afraid of happening.

The biggest drug dealers sit in boardrooms and collect HUGE salaries.

[sakabatou]

4. Here, here

[Guy Montag]

5. I agree, screw big Pharma

The Goddess gave cannabis to us so we might grow and prosper.

Let the pretty green plants grow. Smoke them or bake food with them as they were meant to be used.

Regulate the use of cannabis perhaps, but never again should we ever make such destructive war on people who use cannabis ever again once we inevitably see the light and end it.

One of the most myopic things President Obama's administration has done is intensify the war against cannabis to the point where they even thumb their noses at the right of states to declare it medicine and regulate it.

We all need to get a grip and to finally use some common sense here in regard to this sacred herb.

[Fokker Trip]

20. Great post Guy, You read my mind.

It is natures greatest gift to us humans. A pharmacy, a food source(seeds...perfect balanced efa profile for humans), a building material, etc. Its prohibition is a crime against humanity.

We are full of cannabinoid receptors, and there is growing evidence that some people are naturally deficient in their own endo-cannabinoids, thus the plant acts to top up those levels in an individual.

The substitution of stimulants and depressants as coping substances(nicotine, alcohol, etc.) is devastating to society. Cannabis re-regulates human systems that are out of regulation. Issues like PTSD are being treated with cannabis as it helps the mind to forget the repetitive and destructively traumatic memories.

[tridim]

25. The prevailing theory is that endocannabinoids in modern humans often need supplementation..

Because our bodies have to constantly do battle with new toxins and pollution as our civilization "advances". The endocannabinoid system is VITAL to maintaining good health. If it is out of balance, health will suffer.

It is a crime to deny cannabinoid supplementation, especially since we now know how the EC system works and why some people choose to self-medicate. Self-medication is nothing new, it has been going on for thousands of years. It is as natural as eating an orange for vitamin C.

[waddirum]

26. Dr. William Courtney doesn't view cannabis as "medicine"...

but rather as an essential dietary nutrient. He recommends juicing the raw leaf and bud.

[RawHemp]

38. Spam deleted by azurnoir (MIR Team)

[awoke_in_2003]

29. +1. nt

[RainDog]

6. The Big Switch-a-roo

Last edited Sat Jan 28, 2012, 09:54 AM - Edit history (2)

http://www.democraticunderground.com/1170125

Dr. Lester Grinspoon "On The Pharmaceuticalization of Marijuana" a decade ago.

Given the very limited toxicity of marijuana and the growing appreciation of its therapeutic value, it will undoubtedly find increasing application as a medicine in the coming years. But there is uncertainty about the forms in which it will be made available. Governments are hesitant to approve it because of concern about its use for nonmedical purposes and the difficulties of distributing as a medicine a substance that is already easily available. An alternative is the development of commercial cannabis pharmaceuticals that can be regulated and controlled. But pharmaceutical firms will be reluctant to invest the necessary money if they believe they cannot compete successfully with marijuana. Some of these products may have advantages over whole smoked or ingested marijuana, but most will not, and they will all be quite expensive. Ultimately, we can anticipate two medical distribution networks, a legal one for cannabinoid pharmaceuticals and an illegal one for street or homegrown marijuana

http://www.democraticunderground.com/?com=view_post&forum=1170&pid=123

Andrea Barthwell: Deputy Drug Czar turned lobbyist for Bayer/GW Pharma/Sativex

Drug Czarina in the palace:

...You won’t find any commercial development of plant-based marijuana medicines being pursued in the United States. Andrea Barthwell, a deputy director in the White House Office of National Drug Control Policy and President Bush’s point person on medical marijuana, says cannabis medicines aren’t compatible with modern science. They do not constitute “a serious line of research,” she says.

“The people who are advancing marijuana as a medicine are perpetuating a cruel hoax that exploits our compassion for the sick,” Barthwell says. “They are using patients’ pain and suffering in an attempt to change America’s drug control policy. Marijuana is a crude plant product that most definitely is not a medicine.”

Former Drug Czarina turned lobbyist:

Barthwell showed up at a conference sponsored by Americans for Safe Access and claimed that Sativex is not cannabis...and she's a doctor? An advocate from ASA noted her appearance.

After I pointed out to the few reporters that she was not JUST a private citizen, but the ex-Deputy Drug Czar, a representative of GW, and the failed Republican nominee for IL Senate, she told the press that rescheduling marijuana would not make it available to patients. I concurred. Then she asked me how I could say that Sativex was marijuana. I asked her if it was not marijuana, what was it? She rattled off her sound byte "If your grandmother was in pain would you give her opium?"

I am writing this list because I have major concern for the future of Sativex. Barthwell looked ridiculous. All the reporters kept asking her "They are here in support of Sativex, what is your problem?" And she just kept giving her sound bytes about how Sativex was not marijuana. Luckily Matt Atwood, Executive Director of IDEALReform, also a chemist was present and challenged her on the "compound level" to which her only response was "What are you a scientists?"

Directly after the press conference, I received a "Cease and Desist" order from the Bayer attorneys over a domain name ASA purchased but had yet put up the content www.SativexInfo.org , www.SativexInfo.com, and www.SativexInfo.net which is a pro-Sativex website they also found out about from Don Wirtshafter's e-mail. We have kindly told them we will not be giving over the domains and we will end up in court in the next 20 days or so.

So, we see that, yes, indeed, drug warriors like this woman are working with Bayer and GW to pull some slick shit and make Sativex legal while keeping the cannabis plant illegal by pretending that a medicine made from WHOLE-PLANT CANNABIS, not a synthetic, is not WHOLE PLANT CANNABIS.

So, basically, if the DEA and the office of the Drug Czar make claims that Sativex is substantially different than cannabis that they oppose as medicine at the state level, the only difference between being a drug dealer and someone in the Fed. govt who sets cannabis policy is that dealers get paid more money. Both don't give a shit about human life if there is money to be made for a few at the expense of the many.

Gil Kerlikowske spoke in Fresno in July of 2009. He said: "Marijuana is dangerous and has no medicinal benefit," regarding Operation SOS -- Save Our Sierra -- a multiagency effort to eradicate marijuana in eastern Fresno County, according to the Fresno Bee.

He rephrased his statement soon afterward on a program on KOMO news in Seattle to say: “I certainly said that legalization is not in the president’s vocabulary nor is it in mine. But the other question was in reference to smoked marijuana. And as we know, the FDA has not determined that smoked marijuana has a value, and this is clearly a medical question that should be answered by the medical community.”

https://wwws.whitehouse.gov/petitions/!/petition/stop-interfering-state-marijuana-legalization-efforts/hvcsS8pC

In response to one of the many petitions to the White House web site to stop the war on cannabis, including this one from LEAP (Law Enforcement Against Prohibition) that noted:

Taking a noncriminal, regulatory approach to marijuana would enable states to pass their own laws, regulations and taxes to control marijuana and would end the Justice Department's intimidation tactics in medical marijuana states. One or more states will likely legalize adult use of marijuana in 2012, and the Obama administration should stop wasting scarce federal resources and uphold the president’s campaign pledge to respect states’ rights when it comes to marijuana.

Kerlikowske responded:

Like many, we are interested in the potential marijuana may have in providing relief to individuals diagnosed with certain serious illnesses. That is why we ardently support ongoing research into determining what components of the marijuana plant can be used as medicine. To date, however, neither the FDA nor the Institute of Medicine have found smoked marijuana to meet the modern standard for safe or effective medicine for any condition.

Kerlikowske obviously "got the memo" to continue to treat average American citizens like criminals regarding cannabis UNLESS Bayer, etc. can profit from it. As Grinspoon explains in the first link, above, cannabis WILL NEVER be approved as medicine in the U.S. based upon current regulatory demands - just as ASPIRIN would never be approved as medicine in the U.S. at this time based upon current regulatory demands - b/c no pharma co could profit from the same with the amount of money required to bring a substance onto the market - unless that substance has NO COMPETITION from natural substances and can be a FALSE scarce market.

Because of this reality, the truth is that the Federal govt. simply needs to decriminalize and then legalize cannabis - or simply legalize it if Sativex is going to be on the market here - otherwise, what a bunch of elitist, citizen-despising crony capitalists. I wonder how much money GW Pharma is using to grease the backsides of the pigs in various federal offices and Congress to achieve this stunningly anti-democratic level of perfidy against the American people? I wonder if Bayer contributes to Lamar Smith's campaign since he's holding up the Decriminalization Bill in the House?

I hear it pays well to be a prostitute among the monied class in DC.

Kerlikowske and the President need to take some vocabulary lessons. The Drug Czar said it's not in the administration's vocabulary to say the word "legalization." They need to learn that one. They already know "hypocrisy" very well, it seems. I don't care if Obama said he opposed legalization. If Sativex is going to be marketed in the U.S., American-grown cannabis should be regulated as a product like alcohol and made available to the millions who cannot afford to pay for the pharmaceutical elixir of cannabis (which is, btw, nearly the exact same product that was sold in the U.S. throughout the 19th and first half of the 20th century!) The science indicates that anything else is breathtakingly corrupt.

[Trillo]

7. "The science indicates that anything else is breathtakingly corrupt."

And there you have it. Free market vs rigged market.

Remember, there's 147 firms controlling and influencing every other company worldwide. There's a dollar to be made. Squeeze. Hard.

[RainDog]

8. This just makes my head want to explode

Again, as I noted in further detail in one of the links in the post above - Sativex is Cannabis sativa and ruderalis, two species of cannabis that easily grow in the wild. They are claiming they're different b/c they create a 50/50 THC/CBD tincture that is delivered via a spray that goes under the tongue.

There is NO DIFFERENCE between this product and something sold in a dispensary in CA, other than the reality that the legal status of Sativex in Great Britain allows the grower to test and maintain standard levels - which could also occur here for American-grown cannabis given the proper regulatory and legal environment.

Well, there is one other difference - GW Pharma does what Rick Simpson does. Simpson is a guy in Canada who started touting his cannabis oil (he calls it hemp, but it should be called cannabis oil) that is suspended in alcohol and boiled down to a concentrated viscous substance. Given the proper equipment and safety procedures, anyone could make their own version of Sativex if so motivated. Or they could buy a version in a cannabis dispensary in any of the states with medical marijuana laws if the Federal Govt. would stop pretending the current law has any relationship to anything other than pigheaded intransigence.

When the U.S. had cannabis tincture legally available here before the prohibition of cannabis in the 1930s, at least half a dozen different pharma cos marketed it here. At that time, the tinctures that were made were often labeled Cannabis indica, a subspecies of sativa that differs from the subspecies C. sativa (ssp sativa v. ssp indica) more in terms of the natural habitat and growing habits of the plant - although there are differences based upon effects of the two, with indica generally identified as having more soporific effects.

[Fokker Trip]

21. Great posts here RainDog.

Your posts are excellent info for those who might doubt the evil that is cannabis prohibition.

[RainDog]

24. thanks for those kind words

because others here have accused me of all sorts of things simply because I have taken the time to learn as much as I can about this subject - they assume I'm something that I'm not and attack me on that basis. so it's nice to hear encouraging words. but this issue intersects with many of my interests (the history of botany, racism, music...) and mainstream news outlets simply do not provide enough factual information to people in the U.S. Most people don't seek out and try to sift through information from sites that are geared toward growers or scientists - so I thought, hey, I can use my geek librarian training to help widen the knowledge base on this subject, maybe. At least that's my hope.

I've archived a lot of info in the drug policy forum for anyone who wants to read up on this issue.

cannabis prohibition is, without doubt, one of the most racist and most class-based forms of institutional malfeasance practiced by our govt. at this time and in the history of this prohibition.

[Tripod]

10. Many States, such as mine are trying.

Last edited Mon Jan 23, 2012, 06:42 AM - Edit history (1)

In our country nothing will be legalized, unless it can be taxed, and controlled. I believe this is the right step in the right direction, against my personal believe which is " live and let die" Anyway, so many of us can benifit from this. I have depression, and anxiety now that I never had before when I quit using pot 4 years ago. So If I could use it to help me sleep, and stay out of depression, I would consider it. Maybe my eyes would get better again...LOL Here in NY if you have an ounce or less, it's only a 75$ fine, unless it's packeged for re-sale. In my county anyway.

[existentialist]

12. Can we see an agenda here boys and girls?

How can we legalize marijuana and let people self medicate when there's money to be made off patenting and selling its medical properties?

[Le Taz Hot]

13. This explains the Obama Administration's

reversal on MM. There are large donations to be made from Big Pharma as was evidenced by the Health Care "Reform" Bill which was written by lobbyists from Big Pharma and major insurance companies.

[radhika]

27. That's It - same with Los Angeles

Out here, our City Council is doing its level best to restrict, eliminate and otherwise squash the right to medical marijuana that state voters granted. So many routine and NON-PATENTABLE substances are being funneled to the control and profits of Big Pharma.

Vitamins, herbs, and now virtually free-to-grow marijuana is set to roll into their overpriced product line. Individual MM dispensaries and herbalists are being stripped of their rights to do business.

On the plus-side, they will help fill up the for-profit private prisons. A win-win corporate result.

[evilhime]

14. Let me get this right

Marijuana which is available, even for free if you grow it yourself is illegal, but coming from a company that would score big money on it, that might get approval. What am I missing here?

[Uncle Joe]

18. Legalize cannabis and be done with it.

Thanks for the thread, kpete.

[Smilo]

28. Amazing

we can't grow Marijuana or hemp but by God the pharmaceutical industry can do what the hell they like just as long as there are profits to be made and people exploited.

[Tutankhamun]

30. I have not heard of this "marijuana" of which you speak.

It sounds quite interesting. Maybe I will venture to the public library and find more information regarding this curious subject.

[Monk06]

31. I am in Canada and have MS and Emphysema, and Avascular Necrosis in both hips. This sounds good.

I may actually be covered by MSP so would be free.

[RainDog]

32. Sativex has been available in Canada since 2005

specifically for MS.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_fs_fd_091289-eng.php

[Monk06]

33. My specialist never even mentioned it to me. I think we need to have a talk he and I.

[RainDog]

34. Studies also indicate cannabinoids may be able to halt the progression of MS

http://www.ncbi.nlm.nih.gov/pubmed/18781983

CB(1) and CB(2) cannabinoid receptor stimulation may also have anti-inflammatory and neuroprotective potential as the endocannabinoid system controls the level of neurodegeneration that occurs as a result of the inflammatory insults. Therefore cannabinoids may not only offer symptom control but may also slow the neurodegenerative disease progression that ultimately leads to the accumulation of disability.

Best of health to you!

Let us know what happens. It would also be great if you keep a daily journal to track your symptoms and kept us posted from time to time - useful for yourself and to share your experience with others.

[RainDog]

35. here's more info

http://www.newscientist.com/article/dn6387-cannabis-truly-helps-multiple-sclerosis-sufferers.html

Cannabis truly helps multiple sclerosis sufferers

Compared with those on placebos, patients who received active compounds said they both felt less pain and less muscle spasticity - the spasms characteristic of this neurodegenerative disease.

the researchers worried that some who received the active compound and not the placebo were aware and elevated mood would cause them to report based upon that rather than spasticity. so...

...When the short-term study ended....the researchers gave all subjects the opportunity to continue their treatment for a full year. The team wanted to extend the study to gather information on the safety of long-term cannabinoid use.

More than 500 patients agreed to stay on their original treatment. One group took pills of D9-tetrahydrocannabinol (THC), the active ingredient in cannabis. The second group received natural cannabis extract, and the third group took a placebo.

At the end of the 12 month period, the patients were evaluated again using the same measures as in the first study. But this time, physiotherapists saw a marked improvement for subjects on active drugs. They had reduced muscle spasticity and an improved overall score for their level of disability.

A meta-analysis of the safety and efficacy of Sativex for patients using it for MS indicated it did reduce spasms
http://msj.sagepub.com/content/16/6/707.abstract

[mariematt]

36. Just Legalize Marijuana!!!

Just legalize it already. It is no different than having a beer, liquor or smoking. OH wait, THE BIG THREE would lose money and they give a ton of money to politicians. Police and lawyers would lose defendants. Legalize it, tax it and watch the deficit slowly disappear with all the revenue.
Vote Stephen Colbert for President of the United States of Medical Marijuana!!

[RainDog]

37. Sativex is being touted as a "cure" for marijuana "addiction" in New Zealand.

http://www.globalpost.com/dispatch/news/health/120108/cannabis-medical-marijuana-addicts-pot-weed

honestly, we have crossed over into bizarro world.

so, cannabis that's sold by a pharmaceutical company is being promoted as a cure for cannabis addiction that is less dangerous or addictive than coffee.

This is like offering Starbucks as a cure for Folgers.

The argument is that current whole plant cannabis is generally very THC concentrated. As Michael Pollan wrote about
http://www.democraticunderground.com/117042

and as Judge Gray testified to - http://www.democraticunderground.com/1170156

the reason for this higher-grade THC cannabis is because of prohibition!!!

If this were not such a tragedy for so many people - this would be one of the most hysterically funny attempts to bullshit the American people since Orson Welles' War of the Worlds.

But the reality is that people go to jail for doing something less harmful than drinking a glass of wine in this nation. The real criminals seem to be in DC, however.