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DrugReporter

So Much for Big Pharma's 'Anti-Pot' Pill

By Paul Armentano, AlterNet. Posted June 15, 2007.


The FDA has rejected a controversial diet aid that is supposed to counteract the effects of pot and has been linked to suicidal thoughts and depression.
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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 Acomplia

As 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?


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See more stories tagged with: rimonabant, anti-pot

Paul Armentano is the senior policy analyst for the NORML Foundation in Washington, D.C.

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View:
No surprises here:
Posted by: Obijuan on Jun 15, 2007 2:34 AM   
Current rating: 5    [1 = poor; 5 = excellent]
Rather than probing the possible medical benefits of naturally occurring cannabinoids, we are allow big-pharma to waste gov't RnD money engineering new ones...with the sole desire to make a profit from them, rather than public health.

There is a disconnect between neuroscience and big-pharma which is the root cause of this problem. The usual short-cuts used by drug companies don't work anymore. This is just a particularly striking example.

obi

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» RE: No surprises here: Posted by: LMNOP
» RE: No surprises here: Posted by: aussidawg
» RE: No surprises here: Posted by: somegirl
» RE: No surprises here: Posted by: aussidawg
useless
Posted by: JoshuaLudd on Jun 15, 2007 6:13 AM   
Current rating: 5    [1 = poor; 5 = excellent]
This drug seems useless to me in the first place... a new diet pill.. as if we don't have enough of them.... and it counteracts a relatively harmless drug.. though it has side effects that may cause suicide.

Anyone else notice how utterly FUCKED UP the priorities this drug caters to are????

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Story is Illustrative of BIG TROUBLE for BIG PhRMA
Posted by: drricklippin on Jun 15, 2007 7:06 AM   
Current rating: 5    [1 = poor; 5 = excellent]
Thanks Paul Armentano and AlterNet for publishing this.
If you dissect this story therin lies the huge fiasco-now criminal- Big PhRMA has become

I predicted this meltdown 5 years ago, in 2002. but now I am forecasting indictments and jail time for some Big PhRMA CEOS

Here is my 2002 forecast

“Major Trouble ahead for Pharmaceutical firms”

1)Classical example of how greed and arrogance and the excesses of the free market takes something that is truly miraculous (life saving drugs/vaccines) and moves it to excess which then "backfires" See Teller -"When Technology Bites Back" or Dutton “ Worse Than The Disease"

2)Direct marketing to consumers on TV is a real debacle- the pharm companies come across as bone-fide drug pushers which they have become!

3)Science will show an increasing number of pharm products do more harm than good. They may be "efficacious" BUT THEY ARE NOT SAFE- grossly underestimated as contributing to cancer for example-see prempro story recently


4)Polypharmacy is running rampant- too many drugs for too many conditions in an individual- will get MUCH WORSE as naive boomers age and take more and more mixed meds

5)Psychotropics, analgesics and sedating antihistamines are contributing to serious safety problems on America’s highways and workplaces and who knows what other errors in judgment by leaders with this stuff swirling around their brains

6)Medications, especially psychotropics and analgesics are migrating in alarmingly large quantities to illicit market (eg. Oxycotin)


7)Yet politically, denying NEEDED drugs to elderly is hottest political issue going-another one is denying affordable drugs to millions dying of aids especially in Africa. So some populations are UNDERMEDICATED. Many in US are OVERMEDICATED

8)In high density populations there is the issue of ultimate ENVIRONMENTAL FATE in soil and water of human excreted medicines and/or their metabolites

9)Congressional Hearings ahead with tone of Tobacco and Asbestos

Richard A. Lippin, MD
Health Sector forecaster-July 2002
http://medicalcrises.blogspot.com

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Amazed the FDA had that much sense
Posted by: Gravitas on Jun 15, 2007 8:23 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
I am actually amazed the FDA had that much sense given their history. This pill must have had some really awful side effects. Or the company already had way too many law suits. I would also like to point out that Dr. Sidney Wolfe has said there has NEVER been a diet drug that did not cause harm in at least some part of the population that used it. But guess what? In all those large scale epidemological studies, any harm from risky weight loss practices gets attributed to obesity. Usually, they only control for age, weight, and smoking! I would also like to point out that there are some very well done studies that have found that exercise and fitness level is far more important than weight! Fit fat people are healthier than thin, sedentary ones. Forget about what Hollywood tells you! And certainly forget about what the government tells you, they are the most corrupt of all. Walk or bike!!! If Mother Nature wants you to be round, you will be round, but both your body and the earth will be better off!!!!

"Weight obsession is a social disease. If we cared more about CO2 than BMI there MIGHT still be time."

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Big Pharma supports "Medicinal Methamphetamine"...but not Medicinal Cannabis
Posted by: thoughtcriminal on Jun 15, 2007 9:17 AM   
Current rating: 4    [1 = poor; 5 = excellent]
Ritalin, Adderall, Wellbutrin, Desoxyn - all are knockoffs of the 'worst street drug that we know of' - meth - also known as ice, crank or speed. Desoxyn is actually pure meth - for use only in cases when the kids don't respond well to the weaker meth mimics like Adderall and Ritalin.

However, as a lot of kids and adults know, you just need to take more Ritalin and Adderall to get the full meth effect - and if you crush the pills up and snort them, they work even better.

Guess how many studies there are in the US of whether or not Ritalin et al lead to meth abuse in adults? What do you think happens when the meth prescription wears off? People rush out to their nearest crank dealer to get their supply!

So, why is this? Why is medical meth broadly supported by the FDA, HHS and Big Pharma, while medical cannabis is roundly condemned by all of the above, as well as by the DEA and the local sherrifs, police and DAs?

Two reasons, folks:

1) Medical meth is under patent protection, meaning that Big Pharma can make huge profits off the sales. Meth costs next to nothing to produce (which is why there are so many clandestine street producers), but under patent protection, only a few Big Pharma corps can sell it - Pfizer, etc. Medical cannabis is a plant and cannot be patented, any more than coffee or caffeine could be patented (or sugar, for that matter). If medical cannabis is allowed, Big Pharma will lose billions in profits as people switch to this cheap pain/nausea medication - it works better than the heroin knockoffs as well. You'd see a massive loss in Big Pharma's market share.

2) The DEA, the local DA, and the police and sherrifs departments make millions of dollars every year by seizing property from cannabis users. It's a racket - they go after people who are growing cannabis for personal use, but only if they have seizable assets - cars, money and houses. If you look into this, you'll find a huge amount of corruption. Cops prefer to target cannabis users over meth users because the meth types tend to be crazy, violent and armed to the teeth with guns of all kinds. They'd rather bust a stoned college kid and seize the nice car his parents gave him than try and bust in on some psychotic freak in a trailer park who has no assets other than a pit bull, an assault weapon and a kilo of crank.

Remarkable, isn't it? How do they get away with it? It's called propaganda, public relations - a massive effort to mislead the public, which is heavily promoted by the corporate media.

Notice, for example, how the drugs used by the Virginia Tech shooter were never made public? How is autopsy was never made public? How the whole story was buried? The guy was under pharmaceutical outpatient treatment, and we don;'t even know what he was taking! The same is true for the Columbine shooters.

Big Pharma is the most powerful lobby in Washington, by far.

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side effects
Posted by: Lauren on Jun 16, 2007 10:16 AM   
Current rating: 5    [1 = poor; 5 = excellent]
nausea, anxiety and depression

Wow!

That is exactly what I am treating, and very well - thank you, with my medical marijuana.

The symptoms I know very well having always experienced them as stress reactions. (I can even feel the levels of cortizole in my body, chronically high at this point, it is aging me rapidly.)

I wish my husband would realize pot is an excellent medicine for me, he calls it an addiction. I find this very offensive to my religion, I knew what it was like to play in Shiva's garden well before I ever toked. It's funny, I remember one dead concert where this guy was saying whatever I was on, he wanted some of that. I just laughed, I wasn't on anything, I am a natural.

Krishna consciousness is something I just do naturally from time to time, so I really resent it that he tries so hard to keep me from using a medicine that, one, helps me keep balanced, two, cope with life's difficulties and three, live in a more spiritual, even religious state.

It is a completion thing with him, he is jealous of my attention.

I want to defend myself from that witch down at city hall. She thinks I am a dazed and stupid pot-head. You know, the tie-dye kind you can see a mile away, she's right about that and she has good reason.

I really could not understand how the process worked in her office. This was not because she didn't explain it well or because I couldn't understand what she was saying. It was because I couldn't understand.
It didn't match what the boy scout had told me. I could not believe he had lied to me.

You see, I had to trust him. It was a choice I was forced to make and once made, I could not believe he could not be trustworthy. Therefore, I could not understand how the permit filing process worked. It was contrary to what he had told me, I knew the clerk was not lying to me, thus the process was overwhelmingly confusing.

It was a moral disconnect that I just could not accept at that point. Later the boy scout turned out to be very untrustworthy, and the clerk thinks I am a total fool.

My neighbor, a REAL Indian, and I were down there yesterday talking to the staff again. They've allowed our mutual neighbor to employ a man full time to grind metal for nearly a year. The noise is nasty. We both have complained about it a lot, with tax payer funded visits from our city officials, only to be repeatedly told to live with it.

Yesterday I went armed with the ordinances that are being violated. I am trying to convince my neighbor it is ethnic/religious discrimination against us because of my project. The city and I have some history on that. She thinks it is just the good 'ole boys network sticking it to some women. Either way, the ordinance is going to have to be enforced at some point. I love the sport, like I tell her that I know what I am doing, just as the guy actually reading the ordinance is realizing the city has been acting in the wrong.

I let him hang there for a while with that uncomfortable thought, before asking what our next step should be.

You always want to give the institution discriminating against you an opportunity to make amends and start doing the right thing. When that fails get them to make some act, as in this case, tell us to write a letter.

I think they are being stupid down there. It is a very small town, they have a reputation to project. My friend and I have been talking to all kinds of people, asking them what is wrong with our city government. Calling other cities for advice and my favorite, asking Real Estate agents what they think.

Oh yeah, I'll write a letter.

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» THAT IS TO FUNNY - LOL Posted by: gellero
» RE: side effects Posted by: Ian MacLeod
*counteract* the effect of *POT*... ?!
Posted by: BlueBerry PickN on Jun 16, 2007 1:31 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
BUT WHY???

okay, its official.
Euro BigPharm has officially jumped the shark in trying to appeal to the US drug market:
vanity
sloth
fear

Sadly, I suspect the only reason it was rejected by the US Drug Administration is because it wasn't made in the USA...

...which co-incidentally was Chris Rock's theory on why pot is the bête noir of US Federal Policies.
xenophobic US BigPharm & secret services are terrified of a FREE, wild, mind-altering compound that competes with the highly profitable, domestic addictive compounds & services...
What are the characteristics of *socially networked* drug users... by the very traits of the chronic (punny, its not) users:
Cocaine = "narcissistic, socially-engaged, turbo-charged, paranoid & ruthless"
Morphine = "isolated, apathetic or wild-eyed & desperate addiction"
Booze = "social, invincible, slower & extroverted..."

etc... etc... etc... everybody recognizes the argument... but think about the *personal characteristics* of a social circle's dynamics...

pot = "a detachment of Thought from physical responses, succeptibility to noodling on Theory or Ideas, reduced anxiety responses to new paradigms or philosophies, social, relaxed, gregarious, increased patience... "

gee, which do you think Busheviks prefer in a controlled social experiment 'labelled' "Democratic Republic"?

My suspicion is that BigPharm product is probably flawed, but I imagine that its isn't because the US would not love to have a domestic product that could achieve the same ends.

Oh, that's Right... they've got FauxNooze & the distinguished, Compliant Members of the APA.
In the meantime, it makes a great means to remove Progressive voters with a fauxcrime, doesn't it?
Spread Love...
... but wear the Glove!


BlueBerry Pick'n
can be found @
ThisCanadian
"Silent Freedom is Freedom Silenced"

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It's not all about pot or anti pot ...
Posted by: ataran on Jun 19, 2007 12:45 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
1. I wonder if there would have been a different outcome at the FDA if this new drug had been presented by an American pharm as opposed to a French one.
2. What are the statistics? How many people thought about or tried to commit suicide? Two or 95%? I only heard about 1 instance of MS that could be POSSIBLY be connected.
3. If this were, indeed, an "anti pot" pill, don't you think the USA would jump on approval since pot seems to be so evil in the governments eyes?

My conclusion is that the adverse effects of Zimullti/Acomplia are, indeed, clinically manageable, and that obese people still suffer because of the mentality that they just need to diet and exercise. Unfortunately for the USA, people who will take it in spite of the FDA, will just spend their money buying it online in the many other countries where it is available.

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WHY I SMOKE MARIJUANA
Posted by: gellero on Jun 21, 2007 1:13 AM   
Current rating: 5    [1 = poor; 5 = excellent]
I smoke pot to stay off drugs & make other people normal.

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» ... reduces FauxNooze anxiety, too... Posted by: BlueBerry PickN
So, logic would indicate.....
Posted by: hRIOR on Jun 21, 2007 7:53 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
If blocking the cannabinoid receptors leads to the various unpleasant symptoms (nausea, anxiety, depression, etc.), and various types of neurological damage and deterioration, then flooding them with their agonist/activator (cannabinoids, ie. pot) will treat those symptoms, and may even protect and preserve the nervous system!

Sounds dangerous to me!

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