Regarding FDA complaints about baclofen, I would check to see how many of these are for intrathecal baclofen which is continuous injection into the spinal column, typically used for severely disabled patients who need much higher doses than can be taken orally. The injection localizes baclofen's distribution so that high concentrations are kept out of the rest of the body. There is plenty of literature on problems and pitfalls with this risky but necessary method of delivery.
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GQ article about Dr. Ameisen and baclofen
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GQ article about Dr. Ameisen and baclofen
Regarding FDA complaints about baclofen, I would check to see how many of these are for intrathecal baclofen which is continuous injection into the spinal column, typically used for severely disabled patients who need much higher doses than can be taken orally. The injection localizes baclofen's distribution so that high concentrations are kept out of the rest of the body. There is plenty of literature on problems and pitfalls with this risky but necessary method of delivery.
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GQ article about Dr. Ameisen and baclofen
I'd also like to say great work Nate. Unfortunately not everyone is going to benefit from a particular medical treatment, and baclofen is no exception. Fortunately it does seem to work for many who try it at a high dose.
A new extended-release formulation may help reduce a common problem with normal baclofen, which is the huge daily doses usually needed to help alcoholics. My own doctor is an experienced addiction specialist who is interested in trying new ideas, but he has constantly baulked at the daily doses of baclofen I have mentioned. Not only is the drug itself being used off-label but the doses are WAY off-label...in some cases 2-3 times the recommended maximum daily oral dose or even higher. For most alcoholics this is a tiny issue compared to an addiction that is destroying their lives, but for doctors it is a very real issue. Opponents of baclofen could easily latch onto this as a scare tactic, and they are likely to be able to dig up more adverse reactions to baclofen simply because of the higher than normal doses used in alcoholism treatment.
As others have said, normal baclofen won't be banned since it is still needed as a muscle relaxant for other serious illnesses.
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GQ article about Dr. Ameisen and baclofen
Great job Nate! Any chance you could write about the Sinclair Method too? Me and many others on this forum have had success with it and it allows people to continue to drink socially (and thus avoid the stigma of being teetotal) without over doing it.
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GQ article about Dr. Ameisen and baclofen
Bernard has a good point about the "adverse event" reports on baclofen. The intrathecal method of delivery is notorious for causing very serious, often life-threatening consequences. The surgically-implanted pumps seem to fail at an alarmingly high rate, which causes very abrupt withdrawal. Since the doses aren't metabolized (and therefore much more potent), abrupt withdrawal is often very serious. It's compounded by the fact that patients often don't realize the pump stopped working until the withdrawal symptoms start hitting them hard.
In the medical literature, there are only a few scattered reports of serious withdrawal on oral baclofen, but there are tons of reports about terrible withdrawal caused by malfunctioning intrathecal pumps (seizures, psychosis, and so on, up to and including systemic organ failure - pretty scary stuff....)
So, the number of "adverse events" (which in the article seems to mean serious, life-threatening emergencies) can almost certainly be attributed to intrathecal pump malfunctions, which is completely different from taking baclofen in pill form.
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GQ article about Dr. Ameisen and baclofen
One other thing. It's ironic that an executive from Alkermes is the one disparaging baclofen in Nate's article.
As Nate mentioned, there is indeed one company making an extended release version of baclofen combined with naltrexone.
The company? Alkermes.
In fact, there are a couple other companies making extended release versions too, one as a pro-drug (a different formulation that the body metabolizes into baclofen), and one as a straight extended release version. Neither of these companies are testing the drugs for anti-addiction properties, but if Ameisen releases that clinical study in a high-profile journal, I'm sure they will start the process for getting FDA approval for addiction. Although I wouldn't be surprised if Alkermes would beat both of them to the punch, since they're running trials of the baclofen component of the drug separately from the naltrexone component, so they are already well on their way should they decide to develop a baclofen-only version.
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GQ article about Dr. Ameisen and baclofen
Nate's Baclofen article
Yeah, this could be truly scary. If you look up the Alkermes press release on Fierce Biotech and scroll a bit down and look to the right you see an ad for a Webinar titled: How to Land a Deal: Partnering with Big Pharma. My cynical mind makes all kinds of connections.
Here's how I got my MD to prescribe Baclofen for me.....he knew I had a problem with AL and all he could do was tell me to cut down. This month I gave him some abstracts to read and he had time to read one. He probably doesnt have time to read the current issue of JAMA! He said he didnt want to be brought up before the state medical board, but if I had 'muscle spasms' he could prescribe Baclofen up to 80mg. Conveniently, I have 'neck spasms'. So I got the Rx.
Now if he had glossed his current issue of GQ while sitting on the crapper in the morning, he may have scanned Mr. Penn's article and read about the sorry state of story's protagonist. I think my doctor would like to help but he doesnt have the time or courage to carry the ball.
I say courage because the real research is being done by Dr. Ameisen and members on this forum by using themselves. Yes Bill, isnt it ironic that Alkermes disparages generic Baclofen in a off handed way? I have no faith in the Establishment when stocks are involved. Adverse events.....easy to find if you are looking for them. Administration of baclofen for alcoholism/other addictions will only take place inside a treatment center staffed with professionals 'partnered with Big Pharma' Yikes!!
azuldog
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GQ article about Dr. Ameisen and baclofen
OnTheWagon;820331 wrote: Personally, I'm thrilled "big Pharma" is getting involved. Thanks to AA, we are 75 years behind schedule on a legitimate treatment for addiction. Of course their in it for the money, as are all the caring "professionals" working at these revolving-door laundromats around the country.
Pharmaceutical companies bear the enormous cost of bringing drugs to market and take on all the risk. As far as I'm concerned, they deserve the reward too.
When taking Baclofen, I was already aware of the situation, and I would have thought it would have been a more odd feeling for me to go and buy my Baclofen directly without doctor. I simply knew nobody will help me, if I do not help myself.
We are living in a such sad world. The people being down the most, are kicked with shoes and used like cows to get their milk ("money"). :upset: If I was to go into a rehab I would wish that they give me Baclofen. It is more compatible to the idea of going abstinent than TSM is. You can administrate it like Naltrexone (that they use anyways wrong with forcing people not to drink!) - and still have an total abstinent station at the clinic.
but if people find out that they just need to take Baclofen, and actually do not need the rehab, then the rehab will have to close sooner or later. So that is their only motivation - money.since 23. Apr 2009 : TSM - failed to reduce units
since 08. Jan 2010 : Naltrexone + Baclofen combination therapy
reborn since 16. Jan 2010 : Alcohol Free (AF) - only taking Baclofen
since 22. May 2010 : Baclofen against anxiety/fear
since 14. Mar 2011 : off Baclofen - taking 25mg Topamax/day
My stats :
http://www.baclofen-forum.com/stats/craving/
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GQ article about Dr. Ameisen and baclofen
The role for big Pharma and professionals
As an ex-substance abuse therapist in a State Facility I can tell you the last thing doctors, nurses, and therapists will give up is their authority. The last thing they will do is use Naltrexone the way it is supposed to be used. Would they serve red wine with supper? Will they Rx Baclofen at possibly high doses needed to meet individual 'switch' levels? If patients were cured, the rehabs wouldnt have any 're-treads ' (as returnees are called in the business). No profession or brewing company for that matter is going to knowingly put themselves out of business. 10% of the people drink 90% of the alcohol in this country. And 10% of (different kind) of people make 90% of the money in this country.
If aspirin hadnt been discovered yet, but touted by the tomorrow night's 7:00 news as The New Found Wonder Drug, who do you think would have proprietary rights on the sale of such a drug that has so many 'side effects'? Nobody would ever get it OTC.
There will always be a need for medically supervised detox. There will always be a need for addicts to learn new life skills. There will always be a need for AA to meet the needs of the quasi-religiously inclined. And there will ALWAYS be a need for medical and pharmacological institutions to make their bottom line greener.
Im stocking up now my friends..............azuldog
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GQ article about Dr. Ameisen and baclofen
azuldog;820389 wrote:
If aspirin hadnt been discovered yet, but touted by the tomorrow night's 7:00 news as The New Found Wonder Drug, who do you think would have proprietary rights on the sale of such a drug that has so many 'side effects'? Nobody would ever get it OTC.
Or like Ameisen said - there have been people taking 2000mg Baclofen and they did not die. this respresents 25 times the recommended dose.
if you would take a such significant overdose of aspirin you would be dead. The people who tried to kill themselves with Baclofen failed. :H:H:Hsince 23. Apr 2009 : TSM - failed to reduce units
since 08. Jan 2010 : Naltrexone + Baclofen combination therapy
reborn since 16. Jan 2010 : Alcohol Free (AF) - only taking Baclofen
since 22. May 2010 : Baclofen against anxiety/fear
since 14. Mar 2011 : off Baclofen - taking 25mg Topamax/day
My stats :
http://www.baclofen-forum.com/stats/craving/
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GQ article about Dr. Ameisen and baclofen
Good article on Bac in GQ.
I have been cured. Simple as that. Bac works and works well with some of us it seems. Not a magic bullet but a very strong weapon in the armoury.
I have now been AF for months on end and dont even think about AL . This is a complete turn around for me as I would obsess about getting my first drink in just the same way as the guy in the article did - every waking minute. I would crave and crave and crave.
I am now comfortable having a coke in a bar with work buddies (45 minutes and I am out of there when the beer talk gets boring)
I dont mind people having wine with their meal at my home. I just dont drink. BAC has given me this complete indifference to Alcohol.
My anxiety levels have dropped as a side benefit also.Andy R:
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GQ article about Dr. Ameisen and baclofen
I'm surprised that no one has replied to the skeptical comment posted after the story. Great article/story. Although I tried BAC and was one of the few that could not tolerate the side effects only at 100mgs (and due to excessive driving for work), I still believe in the drug and believe that it has helped many on this board and world wide. And....even though Martin is not "cured", look at his alternative....he would probably not be alive right now. He's even back to a somewhat productive state. Tig and Andy...you guys are my Bac hero's and I know there are many more out there!
I am currently on NAL and TSM. It's nine weeks and I am seeing improvement. I can see the benefits of a combination therapy and there are a few on this board that have had huge success with the combination. Loop for one.
Nate, great story...maybe you should write a follow up piece on the many successes here at MWO.
Everything I need is within me!
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GQ article about Dr. Ameisen and baclofen
brightlite;821564 wrote: I'm surprised that no one has replied to the skeptical comment posted after the story.
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GQ article about Dr. Ameisen and baclofen
Thanks bernard. I read the comments (one by you, I assume). I'm a little confused-- what is the "skeptical comment"?
Maybe it is:
"Like I said -- nice idea, lotsa luck." ?
Jeff's experience and comments reflect my own experience and thoughts. I don't know what that last bit was about.
Am I missing something?Your time is limited, so don't waste it living someone else's life... And most important, have the courage to follow your heart and intuition. They somehow already know what you truly want to become. Everything else is secondary.
Steve Jobs, Stanford Commencement Adress, 2005
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GQ article about Dr. Ameisen and baclofen
Beatle,
Take another look. Jeff's writing is suffused with skepticism. All the same, he has earned the right to be skeptical, even though he is wrong, and even though he has found his way out (so far anyway) through some means that even he can't explain. Vallient's work suggests that this disease is probably not done with him. Maybe then he'll try baclofen.
Bernard
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