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Nalmefene does not work - official


Molly78
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Small article on page 14 of The Times today, saying that a study has shown that the clinical trials were flawed in a number of ways.The drug "could be ineffective".

How annoying that Big Pharma has once again sneaked through a useless & expensive drug based on a perfectly good generic (naltrexone). I hope they don't try it with baclofen, Arbaclofen is hugely expensive & there is no  logical reason to think  it will be better than baclofen other than having a longer duration of action. If their trials are equally flawed, it could set us back a long way.

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New York Times? I couldn't find it. Will you link it for me? 

I can't wait for the release of arbaclofen. First of all, it legitimizes the use of baclofen. Second of all, if it's covered by insurance (which it should be) then I'll just be paying my copay. And it would be SO nice to not have to take pills all day, every day. That said, I take your point. 

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3 hours ago, Molly78 said:

I hope they don't try it with baclofen, Arbaclofen is hugely expensive & there is no  logical reason to think  it will be better than baclofen other than having a longer duration of action. If their trials are equally flawed, it could set us back a long way.

Molly, not only does arbaclofen have a longer duration of action, it also has better absorption and bioavailability. The biggest boon, however, may be that because it is effectively only the therapeutically active isomer of Baclofen (R-Baclofen) it will almost certainly have a better side-effect profile than the racemic version that we all take -  50% of which is the S/D isomer that is thought to be the cause of many of the adverse effects: 

"Orally administered R-baclofen is reported to be about 5 times more potent than orally administered racemic baclofen, with an R-baclofen regimen of 2 mg t.i.d being equivalent to racemic baclofen at 10 mg t.i.d. (Fromm et al., Neurology 1987, 37(11), 1725-8). Moreover, the adverse effect profile following administration of R-baclofen is significantly reduced relative to an equally efficacious dose of racemic baclofen." - (I'm still looking for the source for this)

About  Nalmefene - I believe that one of the reasons it was developed  was because of reports of liver toxicity with Naltrexone - I did a cursory search and it appears that the jury is still out on that one (I'm not above believing that it could just be a Big Pharma plot). And something  to consider about the clinical trials for both naltrexone and nalmefene, is that the vast majority of them did not use the Sinclair Method, which I think the majority of the Nal_ success stories we read in these support forums, revolve around.

-tk

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Ne, it was the UK Times I'm afraid, & I can't do a link because they stop you doing that from their website - you can read it on the website if you pay, but you can't send it to others who haven't paid!

terryk, thanks for that, arbaclofen may have fewer SE but the long wait for the trials, which might end up as flawed as the nalmefene ones, means that people who could be benefiting from bac are not going to hear about it if Big Pharma has any say. I guess they want arbaclofen to burst on the world as a miracle cure, & any publications promoting bac will spoil it for them. I'm sure that's one reason why the news about bac just doesn't seem to get the prominence it should.  Yes, I suspect another Big Pharma plot - I'm starting to sound paranoid, aren't I?!!

But Otter has pointed me to some really interesting reports of the extent some pharmaceutical companies will go to to keep their products on the market & making money. I think he has put some of these on MWO a while ago.

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38 minutes ago, Molly78 said:

Ne, it was the UK Times I'm afraid, & I can't do a link because they stop you doing that from their website - you can read it on the website if you pay, but you can't send it to others who haven't paid!

CIMG4884.JPG

That will be the badger

Both the Times and The Telegraph both had high hopes for Nalmefene since its introduction here in 2014 - Seems like early verdicts are not that promising

Regards

 

Bacman

 

 

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2 hours ago, Molly78 said:

...I guess they want arbaclofen to burst on the world as a miracle cure, & any publications promoting bac will spoil it for them. I'm sure that's one reason why the news about bac just doesn't seem to get the prominence it should.  Yes, I suspect another Big Pharma plot - I'm starting to sound paranoid, aren't I?!!

I hear what you're saying about arbaclofen AND about Big Pharma. While I don't buy into the whole conspiracy world--meaning, I don't think individual doctors and researchers are to blame, I'm VERY clear that corporations (of any kind, especially huge global ones) will do just about anything to increase their bottom line profits. I blame the stockholders and the ignorance of the General Public,** more than anyone else. But what're you going to do? My hope is just that arbaclofen gets approved, and that then addiction psychiatrists can be educated about baclofen...A long shot, but I'm generally an optimist when I'm not in the throes of self-pitying depression. 

**I also blame the executives who actually believe that their remuneration is legitimately worth a gazillion dollars. So yeah, I believe in the conspiracy. I just hate to admit it. Or rather, it takes a fucking village full of greedy idiots to make this quagmire we call corporate business. Anyway...Back to the point, I guess?

Bacman, thanks for the article. Will you put it down there in the Nalmefene section under articles? 

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37 minutes ago, Ne1 said:

I hear what you're saying about arbaclofen AND about Big Pharma. While I don't buy into the whole conspiracy world--meaning, I don't think individual doctors and researchers are to blame, I'm VERY clear that corporations (of any kind, especially huge global ones) will do just about anything to increase their bottom line profits. I blame the stockholders and the ignorance of the General Public,** more than anyone else. But what're you going to do? My hope is just that arbaclofen gets approved, and that then addiction psychiatrists can be educated about baclofen...A long shot, but I'm generally an optimist when I'm not in the throes of self-pitying depression. 

**I also blame the executives who actually believe that their remuneration is legitimately worth a gazillion dollars. So yeah, I believe in the conspiracy. I just hate to admit it. Or rather, it takes a fucking village full of greedy idiots to make this quagmire we call corporate business. Anyway...Back to the point, I guess?

Bacman, thanks for the article. Will you put it down there in the Nalmefene section under articles? 

Of course, my sweet

Can we have some clarity as to the whole Big Pharma thing

Is it something to do with Baclofen being out of date as far as research is concerned? - Therefore no more will be done? - I do love a conspiracy, please fill me in

Regards

 

Bacman 

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49 minutes ago, Baclofenman said:

Of course, my sweet

Can we have some clarity as to the whole Big Pharma thing

Is it something to do with Baclofen being out of date as far as research is concerned? - Therefore no more will be done? - I do love a conspiracy, please fill me in

Regards

 

Bacman 

No, it's to do with bac being a generic, therefore off label, cheap, & of no interest to the drug companies to research on because they won't make a profit out of it. They need to produce a "new" drug eg arbaclofen which they can patent & therefore make billions of pounds profit.

No company is going to put money into researching what a generic drug can do. And it's my theory that the news about bac is somehow being suppressed - OK maybe I'm being a bit dramatic here - but it does seem strange that what's happening in France with bac just doesn't seem to  have made the news anywhere elsr.

Am I making sense? Is that what you were asking?

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55 minutes ago, Baclofenman said:

Of course, my sweet

Can we have some clarity as to the whole Big Pharma thing

Is it something to do with Baclofen being out of date as far as research is concerned? - Therefore no more will be done? - I do love a conspiracy, please fill me in

Regards

 

Bacman 

Thank you, sunshine! However, I would request that you change the title of it. Here's my reasoning: The article doesn't say that it doesn't work. It says it might not work, and that the research was shoddy. Two very different things. And I guarantee you that it's worked for some people and I'd hate to just make an assumption and not give people viable options for their own treatment. You know what I'm saying? I mean, there's some research out there that says baclofen doesn't work, but it was based on 30mg, or in some other way was flawed...

I'll add some brief into about big pharma, but if you really want to hear from a conspiracy theorist then you've got to ask Otter, and maybe Terryk. 

Baclofen is generic. There's absolutely no money to be made off of doing any kind of research about baclofen. And there's no money to be had in prescribing it. Big pharma does really evil things to keep things expensive and/or under patent. They'll change a tiny ingredient and call it "better" and then encourage doctors to prescribe the new, better version instead of the older, just as effective, med. But worse than that, they'll skew the research by paying for it, and having the doctors/researchers omit or change or manipulate the data and statistics so it shows that the med is less harmful, or more effective, than it actually is. 

There's a drug, I can't remember much about, but it was to treat...heart something or arthritis? @terryk Do you know what I'm talking about? Turns out that drug was extremely dangerous and killed a bunch of people by causing massive heart attacks in people who had no history of heart disease. 

Gabapentin is actually a really good example of a pharma company messing around with data/information in order to get doctors to prescribe. I think the company that makes gabapentin (Neurontin is the trade name) lost the biggest lawsuit in the history of humankind because they falsified data and pushed doctors to use it for things that it wasn't approved for. In other words, they were pushing it for off-label use, (which is exactly what we want doctors to do with baclofen) without proof of efficacy. The irony is that it IS actually really good for a bunch of things that it was not originally intended for. Like depression and alcoholism and a whole bunch of other things. Gabapentin is actually probably a wonder drug of sorts. But now that it's not patented, (generic) there's no reason for anyone to study it. 

They also jack up prices for things like AIDS drugs, or use people in poorer countries to do shady things. In fact, the only industry worse than big pharma for being completely evil assholes is...Well, I can't think of one. Politicians? Even the insurance industry (at least in the US) which is completely underhanded, isn't as evil as big pharma. They're just baaaaad. 

So I know that's not very specific, and someone who actually reads the news or investigates this stuff will come along and be more clear. But there's the gist of it. 

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Thank you Girls

That was it "out of patent" that I was fumbling for

So Baclofen is out of patent, a generic so it is worth nothing 

Along comes Arbaclofen, a gnats cock of a difference from Baclofen but near patent so could be worth loadsamoney?

So

If Baclofen is out of patent there will be no more research

If Arbaclofen gets patent there will be more science on it, including research on it in the AUD field?

Regards

 

Bacman

 

 

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15 hours ago, Baclofenman said:

a gnats cock of a difference

lolol!

No, as Terryk pointed out above, there are some other differences, too. I know you didn't have any side effects, but I did. Horrendous. Part of it was my fault, but there is no question that the side effects for many people are bad enough to make baclofen worse than being drunk. Or at least it seems like it, to them. I figured there wasn't anything worse than being a drunk, and baclofen was my last shot, so kept at it. But I won't lie. It suuuuuucked. 

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I'm in the uk and have been prescribed Nalmefene by my local addiction centre.Been on it for about 6 weeks and havnt noticed a reduction in my drinking or s desire to drink less,I still get the more more more symptoms

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41 minutes ago, Nicnak said:

I'm in the uk and have been prescribed Nalmefene by my local addiction centre.Been on it for about 6 weeks and havnt noticed a reduction in my drinking or s desire to drink less,I still get the more more more symptoms

Thanks, Nicnak, for your input. Perhaps you can start a thread of your own and we can follow along? Or at least keep us posted as to how things progress. Are you taking it via the Sinclair Method, or was it prescribed for every-single-day use? 

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I've commented on the same topic in the other section.

Nalmefene is a big let down. It was a reformulation intended to be better than naltrexone, reports are that side effects are much worse, GPs don't understand what they are prescribing and it's 3 x the cost.

I know many people that Naltrexone via TSM has helped.  A huge missed opportunity.

By the way TSM with Naltrexone can take over a year (and can take a lot less than that) to work, if you are going to drink anyway my advice would be to take it just in case it does one day work.

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