cannabisnews.com: So Much for Big Pharma's 'Anti-Pot' Pill





So Much for Big Pharma's 'Anti-Pot' Pill
Posted by CN Staff on June 15, 2007 at 10:01:56 PT
By Paul Armentano, AlterNet
Source: AlterNet 
USA -- An independent U.S. Food and Drug Administration advisory committee determined yesterday that the controversial "anti-pot" pill Rimonabant is unsafe for human consumption in the United States. Sanofi-Aventis' would-be diet aid -- which has been linked to suicidal thoughts, depression and even multiple sclerosis -- counteracts the effects of marijuana and similar naturally occurring chemicals in the body (so-called endocannabinoids), causing users to lose their appetites and, according to the warnings of experts, a host of other unwanted and dangerous side effects.
Rimonabant does not possess a "favorable risk-benefit profile" to warrant U.S. market approval, members of the FDA's Endocrinologic and Metabolic Drug advisory panel determined in a 14-0 vote. Panelists reported that patients prescribed Rimonabant experienced increased incidences of depression, nausea, vomiting, and suicidal tendencies. Adverse neurological symptoms in some patients were also reported.The expert panel's rejection sent shares of Sanofi stock plummeting and may have worldwide implications. Last summer European regulators gave preliminary approval to the pill, which has now been prescribed to some 100,000 patients under the trade name Acomplia. However, following Wednesday's unanimous decision, representatives of the European Medicines Agency immediately announced that they will begin hearings to consider recalling the drug.For Sanofi stockholders and analysts, who had predicted that pharmaceutical giant's "anti-pot" pill could one day rake in some $3 billion in annual profits, the news is a disappointing financial setback. But to health experts familiar with the workings of Rimonabant and similar drugs, the FDA panel's decision comes as little surprise and is long overdue. The Dark Side of AcompliaAs a weight loss drug, Rimonabant is far from a miracle cure. In controlled studies, patients who ceased taking Rimonabant typically gained their weight back -- implying that the drug may have to be prescribed indefinitely. It's that likelihood, coupled with the drug's reported and potential side effects, that have raised eyebrows among the scientific community.Because the endocannabinoid system is involved in the regulation of a broad range of primary biological functions -- including appetite, mood regulation, blood pressure, bone density, reproduction, learning capacity, and motor coordination -- some experts are concerned that the long-term use of Rimonabant and/or similar drugs to counteract it could contribute to a host of significant adverse health effects. Animal data appears to substantiate this concern. Newborn mice injected with Rimonabant refuse feeding and often die days after birth. Mice genetically bred to lack certain cannabinoid receptors also suffer from numerous health defects such as cognitive decline, hypoalgesia, decreased locomotor activity and increased mortality compared to healthy controls. Could similar risks await long-term users of Rimonabant?Dr. Franjo Grotenhermen, director of the Association for Cannabis as Medicine (ACM) in Germany, states, "One of the major functions of the endocannabinoid system is the protection of nerve cells from damage by overactivation of neurotransmitters," Grotenhermen says. "The long-term use of [endocannabinoid] receptor antagonists may impair this neuroprotective effect with an accelerated loss of nerve cells and negative consequences on brain functions such as memory."Investigators at Amsterdam's Vrije University (the Netherlands) express a similar viewpoint. Writing recently in the journal Multiple Sclerosis, they report of a 46-year-old woman who was diagnosed with the disease after taking Rimonabant daily for seven months. They note that the woman had no prior history of neurological symptoms before taking the drug and that the patient recovered to "near normal" several weeks after discontinuing the medication. "It does not seem implausible that [endocannabinoid] antagonism may cause [central nervous system damage] in susceptible subjects," they concluded.Among patients administered Rimonabant in clinical trials, many report experiencing adverse effects such as nausea, anxiety and depression. According to published data, more than 15 percent of subjects who try the drug discontinue its use because of intolerable side effects. In addition, at least one study of the drug reported a 2.7-fold increased risk of psychiatric disorders in Acomplia users. Dr. Mitch Earleywine, author of Understanding Marijuana: A New Look at the Scientific Evidence (Oxford University Press, 2002), isn't surprised. "Given what we are now learning about the endocannabinoid system, one would think that any blocking of its receptors, especially long-term, would be an invitation for a host of negative health consequences involving pain, brain function, and mood -- particularly depression," he says.At yesterday's hearing, FDA experts voiced similar concerns and recommended the agency shelve the drug when it makes its official determination next month. If so, it will be the second time the FDA has refused to grant market approval to Rimonabant, which Sanofi initially tried to sell in the United States as a prescription smoking-cessation agent. Ultimately, in the eyes of the FDA, a healthy body needs all the "pot" it can get. Paul Armentano is the senior policy analyst for the NORML Foundation in Washington, D.C. Source: AlterNet (US)Author: Paul Armentano, AlterNetPublished: June 15, 2007Copyright: 2007 Independent Media InstituteContact: letters alternet.org Website: http://www.alternet.org/DL: http://www.alternet.org/story/54191/Related Articles & Web Site:NORMLhttp://www.norml.org/Anti-Obesity Pill Might Fight Drug Abusehttp://cannabisnews.com/news/thread19822.shtmlStraight Dope on the Munchies http://cannabisnews.com/news/thread9338.shtml 
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Comment #11 posted by Hope on June 18, 2007 at 13:26:48 PT
Schmeff 
:0)Sounds good to me.
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Comment #10 posted by schmeff on June 18, 2007 at 12:05:42 PT
Endocannabinoid Supplements
With the endocannabinoid system being so "involved in the regulation of a broad range of primary biological functions -- including appetite, mood regulation, blood pressure, bone density, reproduction, learning capacity, and motor coordination", one would be a fool not to keep one's "E" system in good health.I take endocannabinoid supplements daily. They make me the opposite of depressed.If you seek an endocannabinoid system in tip-top health, it is my understanding that the tip-tops have the highest concentration of supplemental endocannabinoids...and a minty-fresh flavor.
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Comment #9 posted by mykeyb420 on June 17, 2007 at 08:39:57 PT:
safer
just rememeber that pot is safer than spinach, peanut butter, toothpaste, cat and dog food,,and yes, even water. Why dont the TV ads tell you that VIAGRA could make you butthole bleed. 
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Comment #8 posted by Hope on June 16, 2007 at 09:35:08 PT
Rimonabant 
Rimonabant and other cannabanoid blockers were a really bad idea from the start. The drug sounds like a bad thing, to me, for anyone, or certainly most people. I think the FDA did something right by blocking it.My Mom has gotten overweight and she was told that a new "diet pill" was to be released soon and I've been so afraid that it was Rimonabant. I sure didn't want her any more miserable than she already was (widowhood). As a cannabinoid fan, I could see the misery making potential of a cannabinoid blocker...of any kind.Blocking cannabinoid function seems detrimental and stupid from the get-go. 
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Comment #7 posted by mayan on June 16, 2007 at 04:11:20 PT
What A Read...
How the FDA is Becoming a Drug Company: Consumer Safety and Access to Natural Health Options Threatened:
http://www.newstarget.com/021900.htmlDon't forget...Vancouver 9/11 Truth Conference - June 22-24:
http://www.v911truth.org/conference2007.htmlSPREAD THE WORD!!!
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Comment #6 posted by Dankhank on June 16, 2007 at 04:11:16 PT
Compassion deficiency
new at Alternet ...http://alternet.org/story/54183/
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Comment #5 posted by afterburner on June 15, 2007 at 20:45:52 PT
Is Endocannabinoid Deficiency Responsible for MS?
This is huge!{
Investigators at Amsterdam's Vrije University (the Netherlands) express a similar viewpoint. Writing recently in the journal Multiple Sclerosis, they report of a 46-year-old woman who was diagnosed with the disease after taking Rimonabant daily for seven months. They note that the woman had no prior history of neurological symptoms before taking the drug and that the patient recovered to "near normal" several weeks after discontinuing the medication. "It does not seem implausible that [endocannabinoid] antagonism may cause [central nervous system damage] in susceptible subjects," they concluded.
}
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Comment #4 posted by FoM on June 15, 2007 at 20:03:08 PT
Rolling With Lester Grinspoon
June 15, 2007http://www.getunderground.com/underground/features/article.cfm?Article_ID=2232
[ Post Comment ]


Comment #3 posted by mayan on June 15, 2007 at 18:15:49 PT
"Disappointing"
For Sanofi stockholders and analysts, who had predicted that pharmaceutical giant's "anti-pot" pill could one day rake in some $3 billion in annual profits, the news is a disappointing financial setback.Who cares about people? Profits are where it's at! THE WAY OUT IS THE WAY IN...9/11 Political Prisoner Michael Cook's Medication Hearing Set for July 3rd: 
http://mujca.com/cookhearing.htm9/11 Truth Group Protest At Parliament: 
http://www.indymedia.org.uk/en/2007/06/373546.htmlWebster Tarpley's "Truth Squad" speech - Chandler, Arizona, February, 2007:
http://911blogger.com/node/9363ABC NEWS BLOG CAUGHT CENSORING 9/11 TRUTHERS:
http://www.whatreallyhappened.com/abccensors.php9/11 WAS AN INSIDE JOB - OUR NATION IS IN PERIL:
http://www.911sharethetruth.com/
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Comment #2 posted by FoM on June 15, 2007 at 16:34:41 PT
Are Pharmas Addicted to Lifestyle Drugs?
June 15, 2007Drugmakers are eager to spiff up your sex life and hairline, even as their lucrative products face mounting safety questions. Business Week: http://tinyurl.com/ytq9xh
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Comment #1 posted by josephlacerenza on June 15, 2007 at 11:00:07 PT:
Pot pill for dopes
It just goes to show the real necessity of cannabis and other endogenous cannabinoids for general health and well being. If people commit suicide when the good feelings, even the ones produced by the body, are blocked by some pharm. product, how is the pill even seen as beneficial? Oh, I get it. If your teenager “Sue” comes home stoned out of her mind, then you can giver this pill that one of the side effects is a deep sense of depression only death seems to be the way out of. This is much better than “Sue” having the munchies and going upstairs and passing out. I love were this countries priorities are!!!!! 
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