Synthetic marijuana drug coming to chemo patients

cnn ^ | 5/17/06

[LouAvul]

Seventeen years after it was withdrawn from U.S. markets, a synthetic version of the active ingredient in marijuana is going back on sale as a prescription treatment for the vomiting and nausea that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 accompany chemotherapy, the drug's 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, California, company received Food and Drug Administration approval Monday to resume sales of the drug, which it bought from Eli Lilly and Co. 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 for commercial reasons, 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.

Cesamet is a Schedule II drug, meaning it has a high potential for abuse. 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.

[mysterio]

Why not just give cancer victims the real thing and save them a whole lot of money? Because that would make sense.

[Wolfie]

Pretzel Logic Ping (I have never met Napolean, But I'd like to find the time...)

[headsonpikes]

A man should no more expect logic and honesty from government than he should expect water to gush from a stone.

[philman_36]

Lilly originally received FDA approval for nabilone in 1985 ...
I've learned something today.

[philman_36]

The Medical Value of Marijuana and Related Substances
Several cannabinoids have been tested as antiemetics, including THC (both 9-THC and 8-THC) and the synthetic cannabinoids nabilone and levonantradol. Smoked marijuana has also been examined.
Snip...As in the THC trials, nabilone and levonantradol reduced emesis but not as well as other available agents in moderately to highly emetogenic settings. Neither is commercially available in the United States.
Snip...Neither study showed a clear advantage for smoked marijuana over oral THC, but neither reported data on the time course of antiemetic control, possible advantages of self-titration with the smoked marijuana, or the degree to which patients were able to swallow the pills. Patients with severe vomiting would have been unlikely to be able to swallow or keep the pills down long enough for them to take effect. The onset of drug effect is much faster with inhaled or injected THC than it is for oral delivery.87,112,141
Although many marijuana users have claimed that smoked marijuana is a more effective antiemetic than oral THC, no controlled studies have yet been published that analyze this in sufficient detail to estimate the extent to which this is the case.
An important and unexpected problem encountered in the New York state open trial with marijuana was the inability of nearly one-fourth of the patients to tolerate the administration of marijuana by smoking.188 The intolerance could have been due to inexperience with smoking marijuana and is an important consideration.

And to be "fair"...Although marijuana smoke delivers THC and other cannabinoids to the body, it also delivers harmful substances, including most of those found in tobacco smoke. In addition, plants contain a variable mixture of biologically active compounds and cannot be expected to provide a precisely defined drug effect. For those reasons there is little future in smoked marijuana as a medically approved medication.
Guess what! Coffee delivers harmful substances to the body. So does alcohol. So does a myriad number of other things.
They don't even know if those other active compounds cancel out or counter the effects of the "harmful substances" inhaled. They're sooooo sure.

[antiRepublicrat]

Grandma always said the old herbal remedies were the best.

She's right. We use a lot of them in our family -- except for pot, of course. I wouldn't touch it even if it were legal, although I can't say what my stance would be if I had cancer.

[jmc813]

But the FDA just said marijuana has no medicinal value. But synthetic marijuana does? Pretzel logic.

I'd be interested in your take on this Robert.

[dljordan]

"I'm not in favor of recreational pot, but, goodness, cancer? They should give them whatever drug the patient desires."

If the drug companies market it, it's OK.

[Smokin' Joe]

A friend of mine who underwent chemo for Hodgkins' said that the (then $5.00/pill, 4 pills per day) were not as effective as an appetite enhancer and were much more expensive than the herbal 'medication'.

That was in the 1980's and he could get several day's 'medication' to self-administer for the price of a single day worth of pills.

[mysterio]

Hodgekins? That's awful. Did he come out of it ok?

Who even knows how expensive the medicine is now. You could probably self medicate for two weeks on what it costs to buy "legitimate" medicine for a day.

I understand some zealots not wanting people to use pot. But I have not ever understood the ones that are such extreme zealots that they want to prevent sick people from using it.

[vin-one]

exactly what I was thinking, if MJ has no value, why promote the synthetic use of it...Jeez, I wish they could decide.....

[Supernatural]

The rules are whatever they say they are and they make them up as they go along. Subject to change without notice.

Give toxic substances like morphine to sick people but not a harmless herb? Might make sense to an idiot but it doesn't make sense to me.

Synthetic, yet!

[vin-one]

Jeez there you two go again talking logic,

WEED is bad mkay,,,,,it will make you want to rape white women....or is that black musicians........stay cool.

[LIConFem]

"Pretzel logic."

Coming from a government agency, are you really surprised?

[Supernatural]

I am only surprised when the government gets something right. They rarely surprise me.

[robertpaulsen]

"But the FDA just said marijuana has no medicinal value. But synthetic marijuana does? Pretzel logic."

Marijuana has no medicinal use. Cannabinoids do. Isolate the cannabinoids, and the FDA will approve it.

[sono]

http://www.slate.com/id/2140503/

[Supernatural]

Duh!

If marijuana contains cannabinoids and cannabinoids have medicinal use, then marijuana has medicinal use.

Two plus two equals four, RP.

It is what it is, not what you want it to be.

Another lame argument from you.

[headsonpikes]

Isolate the Cannabinoids!

Sounds like an aitch of a slogan for the JBTs and their enablers!

[Smokin' Joe]

Yes, he recovered fully and has been cancer free for nearly 20 years.

He had a theory that other ingredients worked in concert with the THC to increase the efficacy of the natural substance versus the synthetic, and made a good point about being able to self-dose at levels which worked for him as opposed to working with the more rigid framework of the tablet dosage.

I have no idea of current prices of either, myself, but I would bet they have kept pace with inflation...

The bottom line, though, is that you can patent a pill, but not the plant.