Baclofen Petition

[Otter]

Baclofen Petition

I just want to offer this as at once a peace offering if I have offended anyone and show of the best of Canadian entertainment. You can't watch this and seriously say that we don't know how to have fun: http://www.youtube.com/watch?v=HFKKZStEH8Y[/video]]Marg & Charlie - YouTube

[Otter]

Baclofen Petition

Hey JackieClaire. This is for you to show you the Canadian culture that made me the "gentleman" I am today: http://www.youtube.com/watch?v=Dw7rzpvDvS0[/video]]Stompin' Tom Connors - Sudbury Saturday Night (Live 2005) - YouTube

Happy New Year everyone!

[Cassander]

Baclofen Petition

Hey Otter

I love Stompin Tom. We were a hockey family when the kids were growing up and Stompin Tom did the best hockey song ever. Still gives me goose bumps to listen to it.
Here's a link: http://www.youtube.com/watch?v=wmimLBSTEUw[/video]]Stompin Tom Connors: The Hockey Song - YouTube. Enjoy!

Of course you are right about baclofen. I support you 100%. I only wish I could do more.

I literally want to cry when the conversation on this board turns from what's really important (information and mutual support) to petty argument over tangential (at best) matters. If I understand JackieClaire's snit she believes medical professionals in England are better trained than you think they are. So what? Medical training in the old country may not be quite as bad as you describe. Or it may be. Its irrelevant (as I know you well appreciate). What is relevant is that lives are still being ruined and lost when promising treatments have been found.

It is disgraceful (or worse) that the medical profession, the "rehab" community, the pharmaceutical industry and the governmental health agencies with responsibility for alcoholism and addiction are not more aggressively pursuing the promise of baclofen in treating -- in fact, in curing -- alcoholism. It is disgraceful that the medical profession has basically abdicated its responsibility to treat the disease of alcoholism and has left it to self-help groups, no matter how well-intentioned.

There is no question that alcoholism can be medically treated. I am sure numerous compounds will ultimately be confirmed as effective in treating alcoholism. I am sure baclofen (and related compounds) will be one of them.

The shame of it is that lives are still being lost and billions of dollars wasted by reason of untreated alcoholism.

I don't know that a petition will work but I absolutely applaud your efforts to get the word out. I believe that the best thing each one of us can do is to write to government health authorities and media outlets telling and retelling the story of baclofen and demanding to know why GPs, addiction specialists and psychiatrists aren't more familiar with the success of baclofen treatment, why government health agencies haven't pursued more clinical testing and approval given the relatively small cost, and why baclofen treatment isn't more widespread (and in many places, still unknown).

We still have numerous problems at home and around the globe that seem intractable and insoluble. Alcoholism is a problem for which there is hope and promise. My New Year's prayer is that there is real progress in making knowledge and treatment available to those who need it in 2013.

In addition to your many helpful efforts this year, Otter, not the least of which was your excellent translation of the French physicians' excellent protocol, I also want to give New Year's props to a handful of members here who get it and who provide both support and good information to those in need. I would single out Ne and Lo0p and when they are here Murph and bleep and terryk. For newbies, I would recommend you read everything they have written and everything they recommend reading. I know I am inadvertantly leaving others out. I also would send New Year's greetings to Pete, Rudy, LL, dose, Isolde, suneelca and all the others whose honesty, openness, intelligence, sense of humor and thoughtfullness make this a very special place.

I wish you all the best for 2013.

Cassander

[Otter]

Baclofen Petition

Thanks for the hockey song, I grew up on that stuff.

Of course I was generalizing about doctors. Our GP is very good.

Here is the latest: Baclofen for Treating Anxiety and Alcoholism - Full Text View - ClinicalTrials.gov

At last, a US study on anxiety and alcoholism. I expect if this gets any decent result at all it will lead to some push to have doctors prescribe off licence pending further full trials.

This illustrates what I was talking about. Why do they need to do this study in the US? What is wrong with the French study? It suggests to me that if this is positive, in a year of so, then the US will need to have a US double blind trial which will put this whole thing back even further. It is what I have found so frustrating with this. You explain the treatment to a doctor or other professional, get him on side and then he goes away, moves to another office and you have to explain it to someone else.

[I am editing this: I read the link more carefully and it looks like it is a very short study of a few weeks. I find that interesting. I wonder if the other studies are so powerful that the NIAAA is simply doing this very simple study to add support to the other studies rather than drawing this out over weeks and months. It goes back to what I have said before. 1. Medicine knows no borders. It makes no difference that a study takes place in France or the US if it is done properly. 2. There is already sufficient evidence for governments to put out health alerts to doctors to prescribe on a case by case basis prescribing off-licence. That is what happened in France after a study of 1500 patients as per the Prescribing Guide. 3. The only impediment to this is lack of knowledge in the medical profession. It is the professional, legal responsibility of medical professionals to keep up to date with research and developments in the treatment of illnesses. 4. It is the duty, ethically and legally (in negligence law and according to rules of professional conduct), of medical professionals to prescribe off licence in consultation with their patients and taking into account the benefits and risks of medications, regardless of whether a particular medication is off licence.]

Perhaps, though, it is a sign that this has now become a "must do" for those in organizations whose duty is to deal with this issue.

I did write to Obama and did get a very long response not mentioning this. When I wrote to my MP his office got in touch with the NHS to find out what the score was which is how I found out about our local hospital doing trails. I'll repost that one for newbies: http://www.rcpsych.ac.uk/pdf/Baclofe...0Masson_A0.pdf

[Otter]

Baclofen Petition

Thinking about this, it would be crazy, would it not, if people like the doctors in France who did the study, and Ameisen were not in contact with the NIAAA? Surely they must contact each other. There must be someone in the NIAAA who keeps on top of these sorts of developments, keeps his ear to the ground. The NIAAA is the US equivalent of the French institution which advised doctors to prescribe baclofen last year, 2012.

[Otter]

Baclofen Petition

Hey! I just had a thought.

I should add that this version of the Prescribing Guide has been adopted as the authorized English language version by the authors of the guide who were looking to get it published. Here it is for anyone needing it: https://dl.dropbox.com/u/59463672/Prescribing-Guide-for-Baclofen-in-the-Treatment-of-Alcoholism-Don.pdf

[Otter]

Baclofen Petition

September 27, 2012


Dear David:

Thank you for writing. I have heard from many Americans whose lives have been affected by a wide range of health conditions and diseases. Whether they are common, preventable ailments or rare, life-threatening illnesses, we must do more to find cures and improve treatments for patients.

I have always been a strong supporter of medical research because of its power to lead to discoveries that save lives, relieve suffering, and improve quality of life for those afflicted. Medical miracles do not happen by accident. They often result from painstaking and costly research, as well as years of trial and error. From the sequencing of the human genome to life-saving vaccines and pioneering cancer treatment, Federally-funded research has led to scientific progress and improved health care for countless Americans.

To advance medical research, the American Recovery and Reinvestment Act made over $10 billion available to the National Institutes of Health for scientific research grants. This money has helped fund an array of research projects in labs and hospitals across our country. I also lifted the ban on Federal funding for embryonic stem cell research, which has the unique potential to help us better understand—and possibly cure—some of the most devastating diseases and conditions. To explore the steps my Administration is taking, please visit National Institutes of Health (NIH).

At times, our pride in discovery of innovative drugs is tempered by shortages of vital medications, including some used for the treatment of cancer. That is why in October 2011, I signed an Executive Order directing the Food and Drug Administration (FDA) to take action to help reduce and prevent drug shortages, protect consumers, and prevent price gouging. Since then, over 100 drug shortages have been averted. Additionally, the FDA has taken action to increase drug companies’ notifications of potential drug shortages so they can work to prevent or mitigate a shortage before it becomes a crisis. Through these and other aggressive efforts, we will continue working to protect the health of Americans and ensure patients have access to the lifesaving medicines they need.

Thank you, again, for writing. Together, we can keep America at the forefront of medical research and disease treatments. This work is essential not only for our health and well-being, but also for the progress of all humanity.

Sincerely,

Barack Obama

[Otter]

Baclofen Petition

I thought initially it was a letter sort of dismissing what I had to say but now I see the NIAAA doing something, maybe someone in his office contacted the NIH.

Well, he knows about Baclofen! Let's see what happens.

[Cassander]

Baclofen Petition

Hello Otter

I'm not sure what to make of the President's reply. It kind of looks like a form letter to me, but that doesn't mean that your letter wasn't passed on to the NIAAA. Good work!

FWIW, I have emailed the NIAAA three times over the past two years to ask what is their position on baclofen and have never received even the courtesy of a reply. So you are making some progress!

Would you be willing to share your letter to the President? Perhaps we could all (those of us who are interested) then share comments and come up with a form which could be sent to politicians and health authorities and media outlets around the world...

At your prompting, I went to the NIAAA website this morning to look (again) at what (if anything) the NIAAA has to say about baclofen. I was surprised to see a new (2013!) clinical study led by Lorenzo Leggio which I was not aware of entitled "A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics". The study is in the recruitment phase and is apparently sponsored by the National Institute on Alcohol Abuse and Alcoholism.

A summary of the study states: "Baclofen is a drug used to control muscle stiffness in people with neurological diseases. Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels."

The objective of the trial is stated to be "To see if baclofen is safe and helpful for people who have alcoholism and high anxiety levels."

The lead investigator is Lorenzo Leggio. Baclofans will be reminded that Dr. Leggio has been a co-author of most (if not all) of the Addolorato studies that have found a causal connection between baclofen and relief from alcoholism.

For those who are interested, here's a link to the NIH page: NIH Clinical Center Search the Studies: Study Number, Study Title.

I can't help but also take some personal satisfaction in the fact that the study is finally probing the relationship between anxiety, alcoholism and baclofen. This is a subject which numerous of us have commented on.

In 2011 I surveyed the forum for evidence of the efficacy of baclofen in treating anxiety and alcoholism and started the following thread here on mwo: https://www.mywayout.org/community/f2...ety-50827.html.

While anxiety is a tricky condition which doesn't always respond directly to baclofen, the evidence (at least here on mwo) seems to strongly correlate relief of anxiety with suppression of craving following appropriate baclofen administration. It will be wonderful to see if Dr Leggio can prove this out in a way that leads to wider-spread adoption of baclofen treatment for alcoholics.

Thanks again, Otter, for your efforts. Let's see what we can accomplish in 2013!

Best,

Cassander

EDIT: Otter, somehow I missed your post earlier today on the Leggio/anxiety trial and wrote my screed (above) unaware of your post. Yes, it seems a short trial. We'll see what develops. Best, C.

[Otter]

Baclofen Petition

I cannot find the outgoing email which I sent via the Whitehouse website. I wonder if you have looked at the informed consent form attached to the prescribing guide and could say whether it is good enough. What stands in the way of doctors prescribing is lack of a titration schedule and the worry of being sued, which the guide hopefully takes care of.

[RedThread12]

Baclofen Petition

I haven't read back since your post following mine, Otter. But you're right about there being "something;" but I'm not so sure it's about alcoholism. What I keep banging into are the professionals who are not willing to consider a new paradigm. And, in my experience, the "higher-up" they are in the traditional models, the more close-minded they are. My former yoga student who is about 2 years out of medical school read Dr. Ameisen's book, all of the stuff I printed off the "Consolidated Bac Info" thread, and prescribed 80 mg/day.

I know 2 psychiatrists who head two different hospital detx/treatment facilities in this city. One of them has been a client in my astrological consultation practice. The other dated my best friend, for a long time. So fairly warm and friendly relationships that I thought would be fully on-board regarding baclofen. Un unh. Same response I got from Dr. Mate. "Oh, that's nice."

This is just a single case study. But I'm really wondering . . . what's up with that?

I'll probably give it a go again, once I've updated myself on research. I can even report 3 successful collaborations with my physician, when she referred patients to me to guide them. But it's not top on my list. I'm doing it one drunk at a time, just now.

[Otter]

Baclofen Petition

It is about a paradigm shift from psychological, will based view of alcoholism to a neurological one.

The NIH are the equivalent body in the US to the French body which advised prescribing on a case by case basis in France.

I worry that they get people taking baclofen who say they feel no difference but then I remember taking it for the first time and spending one Friday evening on the sofa feeling...well...fantastic.

[Otter]

Baclofen Petition

Seems there is another clinical trial of baclofen ongoing at Brown University: A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking - No Study Results Posted - ClinicalTrials.gov

It appears no results are in yet. It is Leggio doing the study and he is also doing the NIH study. I would not think that the NIH study would try to replicate the Brown study. I suspect that Leggio set up the NIH study knowing what he was looking for, ie., that he could get the results he needed within the timeframe and dosages he chose. In other words, the NIH study will likely have a positive result.

I don't get it. There are no US studies on Baclofen? Look at the studies cited by Leggio, many in US publications:

Leggio L, Garbutt JC, Addolorato G. Effectiveness and safety of baclofen in the treatment of alcohol dependent patients. CNS Neurol Disord Drug Targets. 2010 Mar;9(1):33-44. Review.
Evans SM, Bisaga A. Acute interaction of baclofen in combination with alcohol in heavy social drinkers. Alcohol Clin Exp Res. 2009 Jan;33(1):19-30. Epub 2008 Oct 6.
Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D'Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. Lancet. 2007 Dec 8;370(9603):1915-22.
Addolorato G, Leggio L, Abenavoli L, Agabio R, Caputo F, Capristo E, Colombo G, Gessa GL, Gasbarrini G. Baclofen in the treatment of alcohol withdrawal syndrome: a comparative study vs diazepam. Am J Med. 2006 Mar;119(3):276.e13-8.
Addolorato G, Leggio L, Abenavoli L, DeLorenzi G, Parente A, Caputo F, Janiri L, Capristo E, Rapaccini GL, Gasbarrini G. Suppression of alcohol delirium tremens by baclofen administration: a case report. Clin Neuropharmacol. 2003 Sep-Oct;26(5):258-62.
Addolorato G, Leggio L, Abenavoli L, Caputo F, Gasbarrini G. Tolerance to baclofen's sedative effect in alcohol-addicted patients: no dissipation after a period of abstinence. Psychopharmacology (Berl). 2005 Mar;178(2-3):351-2. Epub 2004 Sep 30. No abstract available.
Colombo G, Addolorato G, Agabio R, Carai MA, Pibiri F, Serra S, Vacca G, Gessa GL. Role of GABA(B) receptor in alcohol dependence: reducing effect of baclofen on alcohol intake and alcohol motivational properties in rats and amelioration of alcohol withdrawal syndrome and alcohol craving in human alcoholics. Neurotox Res. 2004;6(5):403-14. Review.
Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8.

Lorenzo Leggio, Assistant Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT01076283 History of Changes
Other Study ID Numbers: 0906000002
Study First Received: February 25, 2010
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board