Synthetic Pot Pill Gets FDA Approval

[hippiechick]

Of course, if big pharma can make a profit off a chemical ripoff, it's ok.
If you grow the safe stuff in your own backyard, you're going to jail forever. :eyes:

http://www.theindychannel.com/health/9225519/detail.html

WASHINGTON -- Seventeen years after it was withdrawn from U.S. markets, a synthetic version of the active ingredient in marijuana is going back on sale as a prescription treatment for the vomiting and nausea that often accompanies chemotherapy, its manufacturer said Tuesday. Valeant Pharmaceuticals International hopes to begin selling Cesamet in the next two to three weeks, company president Wes Wheeler said.

The Costa Mesa, Calif. company received Food and Drug Administration approval Monday to resume sales of the drug, which it bought from Eli Lilly and Co. <BFEE ALERT!> in 2004. Valeant currently sells the drug, also called nabilone, in Canada. Lilly originally received FDA approval for nabilone in 1985 but withdrew it from the market in 1989, Wheeler said. Valeant, since purchasing the drug, has revised its label and updated its manufacturing process, he added.

The drug will compete with Marinol, made by Belgium-based Solvay SA. Marinol, another synthetic version of tetrahydrocannabinol, the active ingredient in marijuana that's more commonly known as THC. It also received FDA approval in 1985.

Synthetic THC acts on the brain like the THC in smoked marijuana, but eliminates having to inhale the otherwise harmful smoke contained in the illegal drug, Valeant said.


... more at link ...

[arcane1]

1. eating a brownie, or using a vaporizor, also eliminates inhaling

but where's the profit in that??

[CottonBear]

2. Oh, the hypocrisy of big Pharma and the wingnut drug war people!

:grr:

[Gregorian]

10. Absolutely. They all need to be fired.

And half of the bullshit laws repealed.

Utter bullshit.

[stepnw1f]

3. CONTROL

I always knew it was about controling profit.

[shadowknows69]

6. Didn't they just come out with some BS report

that pot has no medicinal purposes at all? The why is the FDA approving a synthetic version of it?

[stepnw1f]

12. Yes I Do Remember Reading That Article Here

Incredible isn't it? And yet, MSM is silently standing by with a leash around it's useless neck.

[jayfish]

16. GMTA! Here's The Proclamation Right From The FDA.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html

FOR IMMEDIATE RELEASE
April 20, 2006


Media Inquiries:
FDA Press Office, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine

Claims have been advanced asserting smoked marijuana has a value in treating various medical conditions. Some have argued that herbal marijuana is a safe and effective medication and that it should be made available to people who suffer from a number of ailments upon a doctor's recommendation, even though it is not an approved drug.

Marijuana is listed in schedule I of the Controlled Substances Act (CSA), the most restrictive schedule. The Drug Enforcement Administration (DEA), which administers the CSA, continues to support that placement and FDA concurred because marijuana met the three criteria for placement in Schedule I under 21 U.S.C. 812(b)(1) (e.g., marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision). Furthermore, there is currently sound evidence that smoked marijuana is harmful. A past evaluation by several Department of Health and Human Services (HHS) agencies, including the Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and National Institute for Drug Abuse (NIDA), concluded that 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. There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana.

FDA is the sole Federal agency that approves drug products as safe and effective for intended indications. The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in this country. FDA's drug approval process requires well-controlled clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions. If a drug product is to be marketed, disciplined, systematic, scientifically conducted trials are the best means to obtain data to ensure that drug is safe and effective when used as indicated. Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products. FDA has not approved smoked marijuana for any condition or disease indication.

A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor's recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the CSA, and the Office of National Drug Control Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.

They get around this by including the adjective "smoked". Sounds like they have been smoking too much money.

Jay

[Arkansas Granny]

19. What they really meant was that pot has no monetary value to

the big pharma companies.

[shadowknows69]

20. So give them the rights to the farms

It would be the biggest cash crop in the nation.

[Arkansas Granny]

21. At one time, it was the biggest cash crop in this part of the country.

[panader0]

4. I think I'll stick with the real thing........

[William769]

5. My partner was on Marinol for 3 years

It was a Godsend for him.

[pinerow]

7. Very difficult to roll a pill...on the serious side...

I wonder what other chemicals one would be ingesting when using the synthetic...

[endarkenment]

8. This is a prime example of systemic corruption.

"Pot has no medicinal value." - recent government report.

Pot users who are taking pot for 'medicinal purposes' should be persecuted and prosecuted. State laws permitting such use should be ignored and overridden by federal laws. Thousands are in jail for the victimless crime of buying/selling/growing marijuana.

Synthetic pot has medicinal value. Big Pharma is granted a government monopoly to provide medical marijuana (synthetic of course), a monopoly backed by the force of the state and guaranteed by cash payments to the ruling political parties.

This is government by and for the wealthy elites, government intended to rent out us peasants for use as consumers to various huge corporations. We are serfs in their little system, and their system is rotten to the core.

[Telly Savalas]

32. Valeant is not Big Pharma

The are numerous factors involved in keeping our totally irrational marijuana laws in place, but it's a stretch to say that appeasing a bit-player in the pharmaceutical industry is one of them.

[daleo]

9. It sounds rather like pot

"The 1-milligram tablets are meant to be taken twice daily before cancer patients undergo chemotherapy and up to 48 hours following treatment. Side effects include euphoria, drowsiness, vertigo and dry mouth."

I don't know about vertigo - I don't recall anyone ever mentioning that. After all, it's called getting high. I wonder if music sounds better after popping a few of these pills.

More seriously, I'll bet this is a lot more expensive than pot (especially considering how easy it is to grow).

[Nickster]

14. That's what I was wondering, how much more is this stuff going to cost

than the real stuff. Will cancer patients on Medicare Part D be able to have this covered? Somehow I doubt it.

[crikkett]

26. That's what I'm sayin! This is HUGH!!!1!!

$6/pill versus what... having a plant that grows like a WEED.
I hope it puts us on a SLIPPERY SLOPE!!!!!!!!!!!!!!!!!!!!!!!!

[jayfish]

11. Strange, If MJ Has, According To Our Government, No...

medicinal value, why would a derivative? As an aside, I recently tore the rotator-cuff in my right shoulder and have since run out of my prescriptions for Vicodin. I tried a bit of rope over the weekend and was amazed by the pain killing value. 100% better than any pharma I've ever had.

Jay

[crikkett]

27. I read that it was used by early Christians

as a curative for anything - and Moses' recipe for holy oil (Exodus 30:22-33) contains a great amount of it.

I mean, the stuff grows wild, for crying out loud. What's the big deal?

[Gregorian]

13. You've come a long way, baby.

If this isn't the most obvious piece of shit.

Let me guess, it has contraindications. Where real cannibis has none.

Our government is so obviously against the people, it's pathetic. Wake the fuck up, Americans.

[RUMMYisFROSTED]

30. It's main side-effect is going broke.

Much like the original.

[zara]

15. how can this be? fda just said pot has no medicinal value..?

[benburch]

17. Marinol cannot be an effective anti-emetic if you cannot keep it down.

THAT is why an inhaled form of the drug is mandatory in chemotherapy treatment, and neither of these closely similar drugs is an inhaled form.

[antonialee839]

18. It's approved because the "right" people get to make a buck

off of it.

[hippiechick]

22. Bingo.

:evilfrown:

[killbotfactory]

23. Wow, they found a way to patent pot

and surprise! It got FDA approval!

[adriennui]

24. do you get a buzz?

[Up2Late]

25. So typical, I've been saying this would happen for years. Here's more

From BBC News about a Canadian Company that did this almost a year ago:

<http://news.bbc.co.uk/1/hi/health/4338634.stm>

Thursday, 13 October 2005, 22:58 GMT 23:58 UK

'Cannabis' acts as antidepressant

<http://news.bbc.co.uk/1/hi/health/4606475.stm>

Friday, 3 June, 2005, 14:03 GMT 15:03 UK

'Cannabis' may help mentally ill

<http://news.bbc.co.uk/1/hi/health/4286435.stm>
Tuesday, 22 February, 2005, 23:52 GMT

Marijuana may block Alzheimer's

[Miss Chybil]

28. If the synthetic is ok, what's wrong with the organic version? nt

[NorthernSpy]

29. it took the Great Depression to rid us of alcohol Prohibition...

What calamity will it take for us to finally rid ourselves of pot prohibition?

[boobooday]

31. Buy Organic!

They hate pot for its freedom!