Gabapentin gets half billion dollar criminal fine for Pfizer for off-licence use

[Otter]

In 2004 manufacturers of Neurontin were fined nearly half a billion dollars for promoting gabapentin, marketed as Neurontin, for off-licence uses such as for alcoholism. Warner-Lambert "admitted that it aggressively marketed the epilepsy drug by illicit means for unrelated conditions including bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal." That is according to this article: http://www.sfgate.com/business/artic...es-2759293.php

This was the second largest fine for fraud in the promoting of drugs in the USA.

OUCH!

I have said on this forum and elsewhere that it is illegal to promote the use of an off-licence medication. The purpose of this forum is for users of drugs to talk about their own experiences and get support and help, not to be pushing for one particular drug which they haven't used themselves.

People here are not being supported by any medical professionals and there is no network of doctors sharing information about the use of baclofen. I came here in 2010 and my concern has been that people are giving medical advice about the use of a drug which acts on the brain. This is not an acne cream we are talking about. It is a serious matter that people are relying on advice given by non-professionals rather than seeking medical attention.

That is why I set up my web site, to try to get doctors and government to take this situation seriously. If baclofen works, which it does, then the medical profession and the governments need to take it seriously and help people.

Because of FDA and similar drugs laws elsewhere, baclofen is not going to be marketed by drug companies for alcoholism. It can be used off-licence by doctors now, and should be. What stands in the way of that is lack of information about it, but that can't be spread by the manufacturers. Until the drug is licensed that means people can be made aware by private individuals actively sharing their experiences and calling for change.

I am involved in both of those activities through my websites, calling for changes in the medical profession and government approval, and by lending my support to the doctors in France who are actively seeking approval of baclofen. After it is approved in France, that should make other governments and the medical profession take similar actions elsewhere so I have agreed to help with this outside of France.

This is the only way forward for drugs like baclofen. Gabapentin may also be used off-license but it is extremely unlikely in view of what happened in the USA that anyone will be taking this drug forward, primarily because its trial results are not very good at all.

Nalmafene has now been approved in the UK but the recommendations for use issued by the government health bodies urge doctors to use it in conjunction with other 12-step type approaches, including counselling. The trial results of Nalmafene show that it reduces heavy drinking days by only a few days over a 12 week period and only in a minority of those involved in the trials. It is required, as part of TSM, that users continue to drink. It is highly unlikely, in my opinion, that any doctor will use this treatment. I have spoken to one doctor who has told me about the reaction from the medical profession in the UK on the doctors' net forum. The response has been entirely negative to the point that doctors are expressing disbelief that the government has even approved this. Generally, they are refusing to get involved. The other aspect is that there simply are no social workers in the UK who counsel people on this drug and it is highly unlikely this will change.

Nalmafene has been promoted by Roy Escapa who has engaged the services of an actress who says she took it and recovered from alcoholism. She has written a book about her journey. In conjunction with that there has been a media campaign involving the release of a film which she narrates and which also mentions the use of it in criminal cases. They even interview a Chicago prosecutor and one person in the film says that doctors would be negligent "not" to prescribe it.

The purpose of this is that Roy Escapa intends opening private clinics in Europe and the USA to promote the TSM. They already have a website and are actively pursuing licenses for the drug across Europe and in the USA.

Not that I am cynical, but this seems to be an entirely commercial venture and I am skeptical of it. I have seen very little said about Naltrexone or Nalmafene which would suggest it is the "answer" to alcoholism or even much of a hope. I followed the TSM forum for a while and there was virtually no one posting. The few that did appeared to be cheer leaders for the TSM site but were still drinking heavily on Naltrexone. I believe it is also expensive, however, in the UK, the cost will be met by the NHS. The problem with that, however, is that this means disclosing one's alcoholism to one's doctor which I think most people won't want to do, for obvious reasons. It could, then, have a knock on effect in employment with people having to disclose medical conditions in certain jobs...and having to say they are continuing to drink regularly. Their doctors will also insist that they take counselling. This could also effect one's ability to drive a car as one is obliged to report medical conditions to the vehicle licensing authorities, as are doctors. I seriously wonder whether the DVLA would be happy to let a person continue to drive who has been told by his doctor or a private clinic, that he is an alcoholic, needs to take a drug which makes him feel slightly tipsy and to take this daily before embarking on a drinking session.

I hardly think one would want to disclose this treatment to one's priest let alone one's doctor, employer, insurance company and driving license authority.

[spiritwolf333]

Hi Otter -the lawsuits brought against Pfizer and their off label marketing were for headaches -not for treatment of alcoholism.

Otter, if Gabapentin works (in reducing or eliminating alcoholism) for one person while Baclofen works for another, is it not important for a person to have access to information regarding both?

There is not a one-pill solution for everyone regarding the treatment of the symptoms for alcoholism. And yes, alcoholism is only a symptom -but it is, in and of itself, a mental disorder.

[cureforalcoholics]

Hi Otter,

I'm really glad that baclofen worked for you and that you are helping to spread the word about it -- people suffering from addictions need to know these things are out there and that there is hope beyond AA.

I was a little sad to see how much you knocked Naltrexone and Nalfamene in your post though and cast so much doubt on it. I would hate for someone whose life it could potentially save to see your post and not have an open mind to it as an option. I believe strongly that while it is not a 'cure' for everyone that it does help some people and for some people it does save their lives. After doing my own research I do not believe that Eskapa and Claudia Christian (the actress) have much of a profit motive for what they are doing.

Instead of knocking drugs that we haven't tried, I hope we can be encouraging to others that there are some medical/pharmaceutical options that are worth learning more about. As I am learning, one size does not fit all when it comes to addiction treatment.

I hope that anyone reading this will do their own research and come to their own conclusions about whether to try it or not.

I have seen the movie Otter mentions and I recommend it strongly for anyone considering Naltrexone or who just wants to learn more about the disease of alcoholism. It is very well done. You can rent it on vimeo here -- http://www.onelittlepillmovie.com/

Claudia Christian is in the documentary (and is the actress Otter mentioned). I have great respect for her and when she says it cured her of her alcoholism I believe her 100%. Watch it and make your own mind up about that.

There is also an article and a couple of videos on the CNN site that you can read. There is a video of a man interviewed by Dr. Sanjay Gupta who also found sobriety with Naltrexone. The article and videos can be found here -- http://www.cnn.com/2009/HEALTH/04/15...ill/index.html

I also recommend reading Roy Eskapa's book. I built a website called Cureforalcoholics.com (i will eventually change it to 'http://www.NaltrexoneDrug.com' as I do think that naltreone is not a CURE for everyone... but it is for some.) I built it to provide links to information about Naltrexone.

smiles,
Cure

[guapo]

Good work, Cure. Reasonable helpful sane comments are always welcome. Thanks for your efforts.

[Otter]

I don't have any problem with Naltrexone or Nalmafene being used by anyone and I have even written to them saying so. I think it is a step in the right direction that governments like the UK are now approving drugs. Baclofen was referred to a committee of the UK national institute for clinical excellence over a year ago for consideration of whether guidelines should be drafted for off-licence use of the drug. The consideration of baclofen was delayed, however, until after Nalmafene was dealt with, and it was approved for use. That was a month ago so by rights, baclofen should be back on the agenda.

The problem I have with some posters on this site is not that they are promoting other drug per se, but that some of them simply don't know what they are talking about. If you have a condition which someone has found responds to a particular drug for a particular and very clearly explained scientific reason, then it is only right to set out why this is the case, and why other drugs don't work in the same way, otherwise they would be that drug.

Ameisen describes how Naltrexone works very clearly and carefully in his book. It was approved by the FDA in 1984 for addiction. It is what Ameisen calls a "craving reduction agent" because it only reduces craving. It works on particular receptors, gabba A, I think, in the brain as an antagonist so it reduces craving by deadening some pleasure receptors.

Baclofen, Ameisen says, works as a "craving suppressing agent" in that it is an agonist of the Gabba B receptors. So, instead of deadening pleasure receptors so that we get less pleasure from alcohol, baclofen as an agonist, gives the receptor what it wants. Bacofen does not deaden the receptor. It gives the receptor what it needs to get rid of the anxiety which results from the lack of a chemical which the alcoholic lacks, GHB. This makes it a completely different "trip" from Nalmafene. The problem with Naltrexone/Nalmafene, is that it's effects are time limited. I have bought some and done research into it. It is primarily a drug used to maintain abstinence in those who are already abstinent and in addiction, it gives a person a three month window of opportunity before the pleasure receptors it is deadening are regenerated elsewhere in the brain. After that, it becomes useless. In TSM, this effect is avoided by continuing to drink while taking the drug. That may work for a certain type of "drinker". My experience is that it doesn't touch the illness of someone with a serious alcohol problem whose physical and mental health are already badly effected. That is my personal experience.

Not all drugs are equal. Trials show that some are more effective than others. Baclofen trial results are better than Nal both in quality, by suppressing craving, not just reducing it, and quantitatively, by working in a majority of those taking it. So, instead of getting a minority of people reducing their heavy drinking days on Nal, with Baclofen you get a majority of people taking it becoming abstinent.

Gabapentin is in a whole different place. I and others here have been pointing out, as Ameisen did, that baclofen, and a lot of other drugs can be used now, off licence. They don't need to be licenced so the issue becomes one of getting information out. Against this, we have people making points that doctors won't prescribe because of the doctors fear of a law suit for going over 80mg per day, for instance.

So, if the delay and opposition to baclofen being used is all about concerns over law suits and disciplinary actions against doctors, what on earth would a doctor say to someone asking him to prescribe gabapentin off licence if he knew about the massive criminal fine imposed in relation to off licence use? I am not trying to scare monger, I just think it is unrealistic to think that doctors are going to stick their necks out and prescribe a drug which doesn't have great trial results for use in alcoholism when it has this kind of history. I also think drug companies like Warner Lambert are probably a bit shell shocked and not that anxious to start pushing for approval of gabapentin for use in alcoholism. Seems to me like trying to stir up interest in gabapentin on this forum is a pointless exercise. It's not as though people haven't come here and discussed their use of gabapentin. They have, and there hasn't been much to say about it.

There has been some comment here that different alcoholics need to be looked at differently. I don't think that categorizng everyone who drinks and has a bit of trouble stopping as an "alcoholic" is a useful diagnostic tool. It is in keeping with 12 Step ideas but in in this age of brain scanning and changes in understanding of neurological issues, it is, IMHO, essential to focus on the biochemistry of the brain rather than on worn out diagnoses which are tied to outdated talking therapies.

[Otter]

Hi Otter,

I'm really glad that baclofen worked for you and that you are helping to spread the word about it -- people suffering from addictions need to know these things are out there and that there is hope beyond AA.

I was a little sad to see how much you knocked Naltrexone and Nalfamene in your post though and cast so much doubt on it. I would hate for someone whose life it could potentially save to see your post and not have an open mind to it as an option. I believe strongly that while it is not a 'cure' for everyone that it does help some people and for some people it does save their lives. After doing my own research I do not believe that Eskapa and Claudia Christian (the actress) have much of a profit motive for what they are doing.

Instead of knocking drugs that we haven't tried, I hope we can be encouraging to others that there are some medical/pharmaceutical options that are worth learning more about. As I am learning, one size does not fit all when it comes to addiction treatment.

I hope that anyone reading this will do their own research and come to their own conclusions about whether to try it or not.

I have seen the movie Otter mentions and I recommend it strongly for anyone considering Naltrexone or who just wants to learn more about the disease of alcoholism. It is very well done. You can rent it on vimeo here -- http://www.onelittlepillmovie.com/

Claudia Christian is in the documentary (and is the actress Otter mentioned). I have great respect for her and when she says it cured her of her alcoholism I believe her 100%. Watch it and make your own mind up about that.

There is also an article and a couple of videos on the CNN site that you can read. There is a video of a man interviewed by Dr. Sanjay Gupta who also found sobriety with Naltrexone. The article and videos can be found here -- http://www.cnn.com/2009/HEALTH/04/15...ill/index.html

I also recommend reading Roy Eskapa's book. I built a website called Cureforalcoholics.com (i will eventually change it to 'http://www.NaltrexoneDrug.com' as I do think that naltreone is not a CURE for everyone... but it is for some.) I built it to provide links to information about Naltrexone.

smiles,
Cure

I just went to your site. Here are a couple of quotes from it:

What is TSM?
Read This:
“I’m not trying to eliminate AA,” says Dodes, the former director of substance abuse treatment at Harvard’s McLean Hospital. “I’m just saying it should be prescribed to that tiny group who can make use of it. It’s terribly harmful when you send 90 per cent of the people for the wrong treatment advice.”
- 2014 Toronto Star Article

More Quotes.
"We are not encouraging patients to drink very large quantities at one time. Large volumes of alcohol do not help... but drinking frequently while on naltrexone is beneficial since each time drinking is an extinction session."
- Dr. Sinclair


I dunno...?? I am puzzled.

How can anyone call this a "cure"? Maybe I'm misreading this but one doctor appears to calls it a treatment for a "tiny" number of people while another says they do encourage people to drink frequently. So, is this not exactly what I have been saying? Doctors are going to be telling patients on this treatment to drink frequently. That sounds like a really bad mixed message that it is ok to drink because a doctor has said so. A lot of doctors are afraid of claims against them arising from side effects of baclofen, even though they don't know much about them. Here we have a situation where a doctor tells a patient to drink frequently, and these are going to be heavy drinkers. So, a patient drinks, loses his disinhibition, isn't thinking clearly, because he is drinking and then gets behind the wheel of a car, safe, he thinks, from prosecution because in his alcohol impaired mind he is under a legal, medical treatment.

As a lawyer this scenario fills me with terror!

ps. apologies for the typos in the previous post.

[Otter]

You see, Guapo, and CFA baclofen immediately suppresses the desire to drink within minutes of taking it. The problem with going in "Big" as some have done on this forum is that it immediately sobers a person up and can send them into DTs. Alcohol becomes the sole source of nutrition for many serious alcoholics as well so they end up in a heck of a mess if this method is tried and it should only be done in a hospital.

However, the best advice a doctor would give in relation to alcohol would be to try to stop drinking and to use baclofen to stop the craving and to refrain from driving, even working while achieving sobriety, and even to check into hospital, not to continue drinking so as to see if the drug worked for that patient's level of alcohol dependence. Baclofen even in low doses can suppress craving so it stops drinking and reduces the risk of driving while drunk. There is no mixed message. All the advice and drug treatment is aimed at stopping a person from drinking, not having them continue drinking to experience so called "extinction" sessions where you are supposed to experience drinking which doesn't give you pleasure because you have previously deadened your pleasure receptors.

My experience is that in chronic, serious alcoholism, Nal doesn't work. So, if someone tries to downplay their drinking habit (most alcoholics do) and TSM is not going to work for them, you have a very dangerous situation for a doctor. He is relying on unreliable information being supplied to him by an alcoholic patient and his advice is to keep on drinking frequently. If the patient is in the very large group of people for whom TSM doesn't work, as opposed to the smaller group for whom it does work, then the only thing that will come from the doctors advice is the patient continuing to drink frequently.

The doctor is, in my opinion, playing Russian roulette on this one, with more bullets than empty chambers. And, he is playing roulette with his own career, his patient and anyone within the ambit of the alcoholic's activities while continuing to drink...on doctor's orders.

[frogdog]

QUOTE=Otter;1578715] Gabapentin may also be used off-license but it is extremely unlikely in view of what happened in the USA that anyone will be taking this drug forward, primarily because its trial results are not very good at all.
[/QUOTE]


Actually, I am a doctor in psychiatry and I use gabapentin often for help with alcohol and opiate withdrawal and craving. A study published in JAMA (N=150) this past January supports its use. It was a relatively large study in comparison with the study of Kudzu root (n=17) which showed reduction of use in NON treatment seeking men (I think the NON part is quite significant if you think about study design).

I often use drugs off label to help with addiction as it seems most psychiatrist just don't go there. I have a problem myself with binge drinking and have been wanting out for years and years, but only the past five years have I started to treat myself. I cannot seek treatment because of my position. How can I get openly treated without risking impact to my insurance or job or licensing board? I never work impaired, and I never drink and drive, and I don't drink daily. That does not mean I don't need help.

So, I treat myself by telling my GP what I need and making up some reason. Even when I got naltrexone, I told my GP that I was using it to see the effects prior to recommending sinclair method. All this being said, this is what I have seen from both personal experience and patient responses:

1. Topomax: off label, helps some. However, the new FDA warning about sudden angle closure glaucoma (which can lead to sudden blindness) and my concerns about hyponatremia AND because it causes such cognitive dulling, cause me to use this as second or third pick. I have not tried this myself because of these potential side effects.

2. Gabapentin: off label, helps more. The effective dose for alcohol that was supported by the study is 600 mg three times daily. I have not tried this myself largely because it is hard for me to find a reason to tell my GP that I need it and largely due to the tid dosing schedule (short half life). It is an anticonvulsant, so large doses taken here and there can potentiate (theoretically) seizure. I do not use it with people who are not able to abstain for a few days as drinking on the med can make side effects worse and potentiate the alcohol effects. I have found it very helpful for people who are able to have some days of abstinence prior to starting treatment and who are motivated.

3. Acamprosate / campral: FDA approved, helps some but it is not covered by a number of insurances. Further, because it is FDA approved solely for alcohol dependence, it is extremely difficult to prescribe and use without everyone knowing why it is being prescribed and used. So, if you don't mind a black mark on your insurance (for rates, preexisting, etc) or your job (if you have a career which is monitored by a licensing board), and you can afford to pay for it, then go for it. I think Gabapentin works equally effectively.

4. Antabuse: FDA approved; I don't ever prescribe it simply because I am doing outpatient work and cannot assure that a patient won't drink when on it. It is very dangerous to drink while taking. I also don't think a motivating factor of being extremely sick or dying is a good approach (aversion therapy). The med does not target craving by soothing.

5. Naltrexone: FDA approved only when abstinent, works for some. I have prescribed this (both via sinclair and abstinence method) and tried it via Sinclair method. I could not tolerate taking it even at 1/4 of the beginning dose. I am not sure if it is because I don't drink as heavily as the people who are taking it successfully via sinclair. At higher doses it made me feel dissociated, sick, dizzy, nauseated and overall horrible, though lower doses did very oddly make anything alcoholic not attractive when I drank on it. I found myself at the lower dose being able to easily get past the first beer and head to the second at which point it didn't stop my desire. On higher doses I just felt like dog poop. When I have prescribed via sinclair to patients they did not stay on it. I have found that the people who have been abstinent for long enough to use it via FDA method did not want to take it. The side effects are really something. One guy who came out of treatment on Revia went back to drinking once he was no longer court ordered to the injection. So, not the greatest experience. A MAJOR issue with naltrexone is also that it blocks opiate receptors, so can be dangerous in cases where opiates are later administered after dosing (such as a car accident or opiate abuse). So, the patient has to be extremely able to understand risk and self-advocate.

Baclofen: off label, and haven't prescribed yet, but started last night. I particularly like this because I have scoliosis and am able to justify its use. As for prescribing it, the only study I am finding that doesn't recommend using over the FDA guidelines for dosing is one that showed 30 mg daily helped. Here is the BIGGEST problem I have with prescribing it: it has no upper bounds with dosing effectiveness for alcohol dependence. However, coma has occurred at doses higher than 200 mg day. FDA dosing for its approved use is 80 mg max daily. I am seeing where some people feel they need doses higher than 200 mg day. This creates a huge problem in that if I am prescribing it off label, I am certainly not then going to prescribe it beyond dosing recommendations. Even prescribing an on-lable drug beyond dosing recommendations is problematic. I am also questioning its potential for abuse since it seems to have a level of tolerability that may require higher and then higher dosing. The same is a concern for gabapentin, but the major study supporting it published in JAMA shows it works best at a mid-dose level. The wide fluctuation in dosing is the big issue here with Baclofen. However, I am willing to take it up to 30 mg per day, but that's it. I am willing to prescribe it up to 80 mg per day as that is the top FDA approved dose.

So, those are the drugs I use specifically for alcohol dependence (and often use them for other dependences as well as the same pathway is thought to mediate all substance abuse).

Treating underlying disorders such as bipolar can be enough as well. Also, meds such as seroquel and lithium and depakote which are generally used for bipolar have some efficacy in alcohol dependence. I just don't use them as primary anti addiction agents.

I also recommend that patients read this website, and HAMS network.org which is a harm reduction website. And, I recommend the kudzu root (especially works if you have it in your system for a few hours prior to drinking), multi B, magnesium and Thiamine (extra B 100 on top of the multi b), and l-glutamine.

The key it seems to me is that we support anyone who is trying to improve his/ her life regardless of method used. We all know that the drugs that get FDA approval have pharm companies backing them to fund the research. So, if a drug has lost its patent, who is going to fund the research for using it off label?

[Spiritfree]

Hi FrogDog -thanks for the information. You provide some really good-hands-on information. Gabapentin certainly does seem to be the current drug of choice to study and confirm its legitimacy with AUD.

FD, a helpful source of information for prescribing Baclofen can be found at:
***http://www.sciencedomain.org/abstrac...9#.UxCmCYc5koA
(If I am not mistaken, member Otter assisted in the translation of this document and might be a useful source of further information for you.

I am interested to know more about Baclofen's potential for abuse as it relates to tolerability. I can not imagine it being abused in a recreational way.

[Otter]

Thanks for the post, FD.

Your comments about baclofen are all dealt with in Olivier Ameisen's book. Doctors in France who put together the prescribing guidelines for baclofen go well over 80mg per day. That limit is set in relation to conditions, such as spasticity in which 80 mg per day is a helpful dosage and takes into account the side effects at that dose in relation to the condition being treated. What we have found is that baclofen is entirely safe at much higher doses, as confirmed by the doctors in France, and that the side effects of the drug are manageable and far preferable than the alternative of severe, life threatening alcoholic disease. Your views are the same as those which Dr. Ameisen, and others, have lamented for years as stopping this drug being used to stop preventable deaths from alcoholism.

I posted about Gabapentin simply to illustrate a problem we have encountered in this community for some years, namely the reluctance of doctors and others in the medical profession and regulatory field to take up baclofen as a treatment despite its science and success.

The issue seems to come down simply to mindset, that it is extremely difficult to break through the wall of reluctance to accept that there just might be a sceintific basis for looking at addiction which might yield a pharmaceutical response.

Ameisen is revolutionary. He sets out the science behind addictive craving and shows how baclofen is the key which fits the keyhole. That done, we, here, have seen this drug work almost magically to stop alcoholic craving and many here have now recovered and moved on to new lives.

So, why is it so hard to get this across to doctors and the government regulatory agencies? Well, there is no drug company out there needing to get approval of it since it is already approved. Moreover, it is perfectly legal and advisable for doctors to prescribe this now, on an off licence basis so there is, in reality, no need for anyone to spend huge amounts of money to get it licensed. The French are getting it licensed, probably because they realize that this is necessary to break through the barrier and get doctors prescribing and it helps that Olivier Ameisen's brother is head of the medical ethics section of the French doctor's medical association.

Outside of France it is a hard job moving this forward. Doctors coming here and generally are simply refusing to move forward and use this drug claiming that the side effects are such that they might get sued etc for prescribing it.

Because of this, and the length of time it is taking to make headway, there is an emerging view on this website that maybe Baclofen is not such a wonder drug after all and there are those who are saying that gabapentin is just the same, maybe better etc etc.

However, that isn't the case. These drugs have different pharmacologies and the trial results are simply not as good for gabapentin as they are with baclofen. I have read the trial result for gabapentin and I have to question the whole basis on which it proceeded because the participants in it were chosen with reference to their having two characterstics which suggest they were "alcoholics" ie., the paticipants in the trial may have had as little as a drink drive conviction, lost a job and severe difficulties stopping drinking. All were abstinent at the beginning of the trail for, I think, 3 days so they were a group of people who were not serious alcoholics with a life threatening condition.

I have seen baclofen work for people with liter a day of spirit consumption levels and baclofen works to halt alcohol consumption dead in its tracks in these people whereas for the "lighter" drinkers in the gabapentin trials, it acted to help in abstinence and reduce heavy drinking.

Anyway, the point is that if doctors are so paranoid about medical claims from baclofen prescription, I would think that the massive fine imposed in relation to Pfizer's marketing of gabapentin would horrify doctors. However, for those who are able to manage their live and have careers, yes, gabapentin may be a useful tool. It is not baclofen though and it doesn't work the same way.

Baclofen does work for binge drinking and it should be used in varying dosages, depending on stress levels. The continuous use of it over a period and the resultant reduction in drinking allows for brain repair to take place and I would recommend reading the work of Dr. Susan Mosher Ruiz at Boston University Medical School. She has done considerable work in the field of white matter damage and repair in alcoholics which shows that the brain does recover from alcoholism over time.

I've also made the point, until I am blue in the face, about exactly the issues that you are talking about. It is extremely difficult for those with jobs etc to start getting prescribed anything for alcoholism for all sorts of reasons. I took baclofen in low doses while working and it make me feel great while under stress but high levels of it can make you feel and look doped and not function properly. It deadens response time and affects memory.

That said, it is extremely important that we all understand the pharmacology of baclofen precisely because it illustrates what alcoholism is and that it is a treatable neurological condition. That is important because if it becomes accepted that this is the case, then getting treatment, which is effective, will not be something which you cannot discuss with your GP or employers, anymore than discussing getting treatment for a cancer cannot be discussed.

The government and medical profession needs to get to grips with baclofen treatment and how the pharmacology of it shows that alcoholism is a treatable neurological condition which can be effectively treated and "cured" so people in your position can get the help they need, whether it is with baclofen or with any other drug. I think, however, it is unlikely that gabapetin will be taken forward by the medical profession in cases other than those where a less potent drug is needed than baclofen and I expect those doctors using it will only use it because they have also educated themselves about the anxiety basis of alcoholism and they feel that they should prescribe a "softer" drug for those with a less acute problem.

Maybe I haven't go this entirely right but that is how I see it at the moment. Taking the very manageable side effects of baclofen and using them as a reason for ignoring the underlying science of baclofen treatment risks losing site of what alcoholism is.

[Spiritfree]

Hi Otter -thank you for providing more informative information about Baclofen. For those that don't you, I would like to comment that I consider Otter one of (if not the most) the most knowledgeable people around the forum in regards to Baclofen. Please correct me if I am wrong Otter, but you were one of the 'ones' if not the only one who translated the physicians baclofen prescribing guide to English?

In my view and quick summary, here is what we are faced with here in the USA regarding medications for alcoholism. The current -FDA- approved medications for alcoholism only address the blocking of 'euphoric feelings' when one drinks (except for Antabuse which only makes you sick if you drink). These medications do nothing to help rewire the brain or address anxiety. Thus, relapse is always the alternative. The primary benefit to one taking the approved medications will be the temporary relief from not drinking -which does help the brain to calm -to an extent. But that is it. The brain's so called wiring essentially remains the same -most always remembering the euphoric calming effect of alcohol. At some point, or at many points, this leads the AUD patient back to alcohol -the cure.

Moving forward, we introduce drugs such as Baclofen and Gabapentin. Both of these drugs seem to not only help reduce or eliminate alcohol consumption, but they help the brain to begin repairing itself. From what Otter says and other areas of research indicate, Baclofen tends to be much more effective than Gabapentin or other newer medications in more quickly transforming the brain to a non-alcohol thinking state. I certainly am not scientifically or medically knowledgeable enough to even come close to discussing the positives or negatives of these drugs.

But here is what I do know: These more advanced medications for the treatment of AUD have a real chance of becoming approved for use in the USA -now. It just so happens that the National Institute of Health is pushing for Gabapentin as a primary medication for the treatment. I also believe that the NIH believes that Baclofen will eventually be approved as a medical treatment as well. Here is a response that I received back from Dr. George Koob, the director of the National Institute of Health -Alcohol Abuse division (a few months ago):

"SF: Sorry for the delay in responding but I was hosting our NIAAA National Advisory Council last week. NIAAA is supporting basic and clinical research on both baclofen and gabapentin but we just signed an agreement with Xenoport to do a major clinical trial with gabapentin. There is a press release that you can find on the web. Gabapentin has many advantages one of which is that it is not metabolized by the liver, it appears to improve sleep and the Xenoport product is a long acting preparation. Scientific colleagues in France are just completing a major clinical trial on baclofen so I would keep an eye on that in the literature. Please keep an eye on the NIAAA web site for new developments in our medications development program and thanks so much for your support of our work in research to develop evidence-based treatments. Best wishes George Koob"

So, it is my belief that if you combine the current -more advanced- medications with the current genetic research, we are not far from seeing almost immediate cures for AUD. I further believe that our children, grandchildren, ......, will have a much greater chance of arresting their AUD than ever before -and to me, this is the most important reason to keep trying to get information out to others -now.

[Otter]

Yes, that sums it up very well.

I translated the guidelines for Dr. Renaud de Beaurepaire and his colleagues and I met with him in Paris last February.

I think you are right in what you say about the way these drugs work and what is happening in the US. Dr. Koob is mentioned in Dr. Ameisen's book as someone who was interested in baclofen back in 2006 and earlier but I expect that Dr. Koob is not engaged now in baclofen research because the French are very advanced in getting the drug approved so I would expect the French situation, ie., licencing, likely next year, will motivate other countries to do the same. Koob was engaged in private research so needed to do research which paid and Gabapentin is marketed by Pfizer so there is big money involved there if it is approved, I guess.

I understand Gabapentin works on neurotransmission, something called calcium channels. Here is what wiki says: Pharmacology[edit]
Gabapentin was initially synthesized to mimic the chemical structure of the neurotransmitter gamma-aminobutyric acid (GABA), but is believed to act on different brain receptors.[citation needed]

Some of its activity may involve interaction with voltage-gated calcium channels. Gabapentin binds to the α2δ subunit (1 and 2) and has been found to reduce calcium currents after chronic but not acute application via an effect on trafficking[46] of voltage-dependent calcium channels in the central nervous system.[47] Another possible mechanism of action is that gabapentin halts the formation of new synapses.[48]

Baclofen actually replaces GHB which is the brain chemical which is mimicked by alcohol, hence its use as a date rape drug, because it is indistinguishable in the system from a natural brain chemical. Baclofen is an analog of GHB so taking it supplements or replaces the missing brain chemical, with the result that the brain no longer crave alcohol.

So, the problem I have, is that one shouldn't get side tracked because Dr. Koob is researching Gabapentin rather than baclofen. That doesn't mean anything. You have to look at the results and it pharmacology.

Of course, it's all very well to talk about this, but if there are no doctors prescribing either of them to any large degree, then the real issue is to get information out there which is correct about the science behind this because people are coming here and relying on what is being said here, some of it by doctors who aren't familiar with how baclofen works. It worries me because there isn't anywhere else at the moment for people to get good advice and a lot of people have left this site. I think the feeling among some old timers is that we have had such a hard time getting acceptance of this treatment even on this forum, then finding doctors and we continue to get people hammering away at us and overlooking the revolution in alcohol treatment that Ameisen started. It's very discouraging and I find myself throwing my hands up in despair when I get into discussions or arguments with people who say things about Ameisen and baclofen but haven't read his book and have no idea of the science behind what he said in it.

Oh well, onwards and upwards, hopefully.

[Spiritfree]

Hi Otter - if your true ambition is to get information out to people about Baclofen (and or other medications for AUD), then you can not worry about "ole timers not posting" or arguments, etc. And again, Otter, this is only my opinion, but at the stage that we are still at with medications for AUD, just even having a chance to get information out to people regarding medications for AUD is a huge step forward.

And yes Otter, you are correct about the money and Gabapentin. The new-long lasting version of Gabapentin will/is patentable, thus the pharmas and government will make their money. That is ok by me because, at this same time, people will start looking at Baclofen as well. Otter, initially, Baclofen and Ameisen may have to play second fiddle at first, but when all is said and done, Baclofen and Ameisen will end up first in the poles.

[Otter]

SF, you are right about Gabapentin. It is because it is supported by a drug company which needs to get a return for its investment. I read somewhere that taking a drug through licencing costs many millions of dollars. No one will do that for baclofen. It was being pushed through for a license for autism as "arbaclofen" and they spent $500,000,000 and stopped half way through.

Recently, Nalmafene has been approved for acoholism in the UK but it is also a new patent. It doesn't really matter how effective the drug is. If it helps a small percentage of people and is safe and someone wants to pay for it to be licensed, it will get its license.

Baclofen development is one of those "head-messingly" unpleasant issues because it falls between the cracks. It exposes the hypocrisy of the "system".

What annoys me the most is people who go on about doctors being sued if they prescribe at high levels because of side effects. It just demonstrates how some people just can't get it, that the side effects are bad in comparison to what baclofen is now used for, ie., muscle tremors, hiccups. They don't do the proper analysis of risk of DRINKING ie., death, versus the side effects of baclofen ie., transitory sleepiness and forgetfulness.

So, all these drugs that are approved, like Campral, have had some successful trials where they have shown "some" benefit for some aspect of alcoholism. Some helped a small percentage of abstinent drinkers to stay abstinent, so they got a license. All these drugs share a very significant characteristic, none of them actually suppresses alcoholic craving, so it is very important to recognize that getting a license from the FDA does not make a drug a treatment which you can take to "stop" drinking. Baclofen does stop drinking but by a complete fluke, it has this ridiculous 80mg or 100 mg limit on daily dose and it is out of a patent. If it was a game of horse shoes and I missed twice, I would just say "Dang" and move on, but this is a crazy situation in such an important field of public health...

[Otter]

It's not really a question playing second fiddle. There are two different routes here, one for new patents and one for old out of patent drugs. That is just the reality of it.

I am involved in this because it is a condition which affects me personally and I have had a long career dealing with the wreckages of addiction related "train crashes". I have had clients who have killed four people over the years while drunk and it brings it home to you to be "defending" that sort of person and seeing what they are going through and what "treatment" there is. I have been a witness to an endless parade of people through courts who have serious addiction and alcohol problems and the response from those in the "system" has been dismissive, many involved in the process are heavy drinkers themselves.