C3 Foundation Europe – Now a Registered Charitable Organisation

I have the utmost pleasure, and pride, to inform you that, with effect from 4th July 2016, C3 Europe became a registered charitable organisation in England and Wales, with acknowledgement that our support services are available worldwide.

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Our full title is C3 Foundation Europe

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Our Registration Number is 1668002

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Information regarding our governing document, activities and charitable purpose are a matter of public record and can be found on the Charities Commission website.

Being a charitable organisation has many advantages, ranging from the financial benefits of free banking, to exemption from capital gains on funds raised, tax relief and Gift Aid.  I am learning more of these benefits and will have them implemented very shortly.

In addition, a registered charity will find it easier to:

  • raise funds from grant-making trusts, local government, lottery funding and the general public
  • represent and help the needs of the community
  • give donors and beneficiaries confidence that the charity is legitimate and working within a regulatory regime

Our Trustees can be found on our ‘Meet The Team’ Page.

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The Trappings Of TSM Success?

Success?  That’s great!  Isn’t it?  Well, it’s complicated.

The Sinclair Method (TSM) has a very high, clinically-demonstrated, long term success rate at almost 80%, and in many respects this is, indeed, great.  It’s certainly great for the people whose lives it turns around, and for their friends and families, and even for society as a whole.  But one of the trappings of this success is that many people who have never tried TSM rush to the conclusion that it’s ‘too good to be true’.

I can understand this reaction.  After all the addiction treatment industry has been sorely lacking in success stories and, is,  instead, saturated with stories of relapses and increasing deaths.  What I would expect, however, is that before rushing to one judgment or the other, people educate themselves about what is involved in TSM… how the science works… and how many people are now documenting how successfully this method has worked for them.  It isn’t always easy, or smooth, and there are often many highs and lows on the way to pharmacological extinction, but for those who have persevered, it has been quite literally a life saver.

This method, like any other form of treatment available, requires a commitment and a willingness from the individual to want to do something constructive about their drinking issues.

But those individual difficulties pale in comparison with the problems caused by the response from the ‘traditionalist’ element of those in recovery.  The venom that is sometimes hurled at those considering using TSM, or already doing so, can be upsetting and disheartening – and on rare occasions, even paralysing to the recovery of someone who is at their most vulnerable.

I hear often that the Big Book of Alcoholics Anonymous, and the 12 Steps, provide a blueprint for a sober, and better, life, and that many within AA accept that their way to recovery may not be the only way.  I am sure this is true for the majority of those who have followed the 12 steps and are now living healthily and well as a result, but my experience shows that there is also a large and very vocal element of AA that hurls abuse at those who do not wish to use AA for their recovery, or who have tried AA and found that it has not worked for them.

To be fair to those following the traditional way of recovery, my experience as a proponent of a non-traditional Alcohol Use Disorder treatment likely skews the response I receive, in that I am more likely to attract the attention of this particular group.  I accept that, and I accept that putting myself ‘out there’ is also making myself a target.  What I cannot accept, however, is that others who are simply trying to find their way out of their personal drinking Hell are also subjected to ridicule and verbal abuse.  Or that this abuse comes from those who have supposedly had a ‘spiritual experience’ and are living a more rewarding and fulfilling life.  It is not productive, nor it is helpful, and frankly it borders on cyber-stalking in some instances.  These people should know that someone in the throes of addiction is incredibly vulnerable, and we should all support them in however they choose to reach their own personal recovery.  After all, it is their recovery… not mine, not yours and not anyone else’s.  Addicts deserve options, period.  It is difficult for me to imagine that someone who has achieved recovery would spend their time cyber bullying those who are desperately seeking a solution to their own addiction, but I see it on a daily basis.  This is cruelty at it’s most heinous.

I also accept that this is unlikely to ever change in my lifetime, and this is why I never take part in the seemingly endless debates that tend to get very quickly, if not immediately, sabotaged, so that any useful help that might be offered is buried deep down on page 28 of the comments.  I would implore those who have recovered in AA to start commenting on the abuse, stating that it is wrong to do this and not in keeping with AA values, but sadly the silence from the majority is deafening.

At both C Three Europe, and the C3 Foundation, we believe that #OptionsSaveLives – it is not one way or the highway.

To quantify that, and to put into the public domain my own personal beliefs on this important issue, I would like to state the following:

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If the long term success rate of Alcoholics Anonymous is approximately 10%, then I am happy for those 10% who find their recovery goal within the rooms, but, at the same time, I am dismayed that the other 90% of those who require help for their drinking remain untreated.

If TSM had a success rate of just another 10%, then by embracing the idea that it is not one way or the highway, we would have doubled our success rate overnight – we are now aiding 20% in need.  That’s a good thing, right?  Surely, no one, regardless of how they personally recovered, would argue that is a bad thing?

But TSM actually has a long term success rate of 78%.

So, if people wish to use the services of AA to achieve their goals, then brilliant.  I’m genuinely happy for them.  And if others wish to utilise TSM to achieve their goals, then that is brilliant, too.

10% + 78% = 88% of those needing help reached, treated, and living happy and productive lives.  How can anyone say that is wrong?

If other methods out there, such as SMART and Moderation Management, for example, make up the other 10-12% of people, then all of a sudden, by working together and helping each other, we reach almost every single person out there requesting the help that can save their lives.

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We must work TOGETHER towards a common overall objective.

Providing options and saving lives is far more important than anyone’s personal agenda.

TEAM

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‘Weak Evidence on Nalmefene’ Report – My comments

The recent news in the press of the ‘weak evidence of nalmefene’ or, as the BBC and other such long-lost quality organisations put it, ‘Alcohol treatment drug nalmefene ‘not effective” has certainly caused some ripples of discontent and concern for those organisations, such the European Medicines Agency (EMA), who licensed it for use in Europe, and NICE, who licensed it for use on the NHS in the UK, AND those either taking nalmefene or considering taking nalmefene.  Be aware of poor journalism and make your own decision based on the information contained in the actual authored report, many of the facts of which I have included as part of this article.  Sensationalist journalism gets views, but does not necessarily provide you with all the facts.  For your information, the report is entitled ‘Weak Evidence on nalmefene creates dilemas for clinicians and poses questions for regulators and researchers’.

It is fair to say, that in my belief and understanding of reading the actual report itself, there may have been short-cuts, bordering on dishonesty, taken by the manufacturer of Selincro, Lundbeck, in order to get the medication licensed.  These short-cuts include the use of post-hoc analysis of the three clinical tests that they, themselves, ran (which leaves them open to accusations of bias at the very least), and the exclusion of certain information that could have influenced the licensing decision negatively.

There have been over 120 clinical trials of opioid-blocking medication, such as naltrexone, nalmefene and naloxone, which show overwhelmingly that The Sinclair Method using either naltrexone or nalmefene is a safe and effective treatment.

For the EMA and NICE approval, Lundbeck chose to rely almost exclusively on the results of their own 3 clinical trials – named Essence 1, Essence 2 and Essence 3.  Other clinical trials were only used by Lundbeck as a supportive tool to show the most effective dosage – they were not presented to the approving committee of either the EMA or NICE to support the efficacy of the medication, when used as per The Sinclair Method way of prescribing.  I am not privy as to why the previous clinical testing was not used, but I can only assume (maybe incorrectly, of course!) that Lundbeck did not want any comparisons to naltrexone showing success in the same prescribing method.

This is absolutely CRITICAL, in my opinion, because the licensing decision of whether this treatment was effective vs. cost effectiveness is at the heart of the issue that these authors are informing the industry about, and is based almost solely on 3 clinical trials.  The decision makers received a ‘picture’ of Selincro from Lundbeck, and that picture did not include the past many, many years of research, but only what Lundbeck wanted them to see.

Based on this limited ‘picture’, then I have studied their evidence and come to my own conclusion that agrees with the authors – if the committee had seen the full picture, then the licensing approval for Selincro to be used in a free-to-access primary care setting across Europe may well have been in doubt, simply because it does not appear to provide either excellent efficacy or value for money for the respective healthcare providers across Europe.  I believe there was the potential for the licensing to have been declined pending further investigations and trial evidence – all of which would have cost Lundbeck money, of course.

It may surprise some of you to hear me say that but please understand what I am saying here….  based on the limited evidence provided by Lundbeck, it appears the licensees made the incorrect decision to license.  They were provided with a ‘snap-shot’ of information on which to base their licensing decision.

The authors are NOT saying that nalmefene is not effective – they are saying that on this particular licensing decision for Selincro, the wrong decision was possibly made to license a new and expensive product because the trials were subject to bias and there was an alternative and cheaper medication available.

It does appear to be true, from the evidence that was investigated by the authors of the report, that:

  • Lundbeck chose to stray away from the normal way of analysing clinical testing in favour of their own style of post-hoc analysis. Post-hoc analysis uses the assumption that an event that occurred was a direct result of some input into it prior.  In this case, it appears that if someone reduced their consumption during the trial period, then it was 100% due to the nalmefene – this way of reporting, therefore, excludes the possibility that the person could have been influenced by something else completely, or perhaps influenced by something else IN ADDITION to taking the nalmefene.
  • Definitions of what constitutes some of the wording were amended by Lundbeck AFTER the publication of the clinical trial papers – e.g. what constitutes a ‘heavy drinking day’.
  • Although NICE noted that there appeared to be higher than expected drop-out rates during the clinical trials, this does not appear to have received further investigation.  Sensitivity analyses were performed by Lundbeck, but not made public.  This information, had it been presented, COULD have influenced the decision to license Selincro.  Many people are showing to be VERY sensitive to the medication, and physicians deserved to have this taken into account before licensing was agreed.  This sensitivity is proving such a barrier that many people do stop taking the medication before pharmacological extinction occurs – they are not being made aware that, though perhaps severe, any sensitivity does eventually reduce considerably, in not completely.
  • Under the Declaration of Helsinki, in order to make an informed decision about licensing, comparisons of the treatment MUST be made if another suitable medication is available.  In the case of the licensing of Selincro, Lundbeck successfully argued that naltrexone and nalmefene have ‘a different biochemical profile’ therefore not a suitable comparison.  The authors of this report, have found this to be a suspect decision.  Again, had the treatment been tested using both naltrexone and nalmefene, then licensing probably wouldn’t have been granted as naltrexone is so much less expensive than Selincro and therefore, offers higher cost effectiveness than Selincro to the healthcare providers.
  • Lundbeck presented the Finnish clinical trials as evidence of the 70%+ success rates BUT they presented this in a fashion that indicated treatment, and therefore the results, were based on treatment undertaken in a Primary Care setting.  Most of the Finnish trials actually took place in a private clinic setting.  Therefore, Lundbeck adversely influenced a decision about where Selincro-based treatment is placed.
  • There was no comparison between different types of psychosocial support to establish whether a different type of support system would provide increased results.

As part of the investigation, the authors of the report only researched the most recent clinical trials involving nalmefene.  They did not research naltrexone clinical trials.

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Conclusion

Based on the ‘massaged’ evidence that Lundbeck presented to the European Medical Agency, and to NICE, it certainly gives the indication that Selincro works better than the actual 3 clinical trials show that it did.  These were their own funded trials, in which they also had an influence on how the results were analysed.

So, we have a situation where it appears that a multi-national company has been economical with the truth in order to get a product onto the market, and make profit.  Those of us that are old enough to understand, know that this is the way of the world now.  I am not surprised at that in the slightest.

However, this reliance on their own clinical testing makes it apparent that the decision to license Selincro does indeed, appear to be the incorrect decision based on this information alone, but it does NOT change the fact that upon further viewing of ALL the clinical trials using opioid-blocking medications such as naltrexone and nalmefene, pharmacological extinction treatment (The Sinclair Method) IS a safe and very effective treatment for Alcohol Use Disorder.

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The Year In Review – 2015

Now that 2015 is almost over, we thought it would be a good idea to review all that C3 Europe has achieved this year – the highs and the lows, how we have helped support those using The Sinclair Method, and the measures we have taken to continue raising awareness of the method throughout the year.

Year In Review

Overall, it’s been a successful year and that is great news.  Slowly but surely, we have been making progress towards our goal of ensuring TSM becomes more widely accepted as a treatment for Alcohol Use Disorder.  It hasn’t been easy and has come with the frustrations that are inevitably attendant on attempting to loosen the ideological stranglehold of a recovery industry that is just that – an industry.  Rejections are just par for the course, but it is disheartening when those rejections come from those who should know better and who should be more open-minded to other options for recovery – including doctors, addiction counsellors, and alcohol and drug treatment specialists.

We are not deterred, though, and don’t want you to be either.  I remember a very good acquaintance of mine instructing me, many years ago, that the way to double the success rate is to double the failure rate.  I looked at him, puzzled, until he explained that if you put your proposal to one person, one person may say ‘no’, but if you ask two people then one person may say ‘yes’…. and if you ask 100 people, then 50 people may say ‘yes’.

I have separated this year’s activities into two categories: the numbers we are currently helping or have helped during 2015, and a breakdown of the work we have done towards raising awareness.  In addition, I have included the running total of numbers that we have helped since C3 Europe officially began in April 2014.

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The Numbers

C3 Europe has experienced a steady increase in the number of people requesting help or information on their drinking, as well as an increase in the number of people seeking help for their loved ones.  Our visitors came from across 122 countries!  This is most likely due not only to the NICE approval in November 2014 of Nalmefene as a medication for treating Alcohol Use Disorder, but also to our greater presence on both the internet and in social media, and we intend to continue working to enhance this presence and visibility in 2016.

Stats

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Raising Awareness

The first quarter of 2015 proved a challenging series of events.

In January, we finally managed to get our C3 Europe bank account approved and opened – a project that we had been working on since the previous August!  Part of the reason for the long drawn out nature of the process was that having one of our three Directors living outside of the UK complicated matters when it came to meeting the bank’s requirements with regard to fraud prevention and identification measures.

On the positive side, we began communicating with Mike from the RecoveringFromRecovery website and blog.  Mikes uses his website to raise awareness of treatment methods that are not based on the 12-step program of Alcoholics Anonymous and he became aware of The Sinclair Method through his own research.  Though he hasn’t used the method in his own recovery, he understands and appreciates the scientific approach of TSM, and is actively working to spread the word.  Mike has now collaborated with C3 Europe, C Three Foundation and Dr Roy Eskapa to produce several articles on TSM during this year, and to conduct interviews for his podcast.  One very worthwhile podcast features a discussion between Dr Eskapa and Gary Bell.  Gary was one of the very first people in the UK to use this method and was, of course, the original founder of “Naltrexone Confidential” – the blog that ultimately led to my involvement, an which was subsequently re-branded to C3 Europe.  It is an excellent interview and one which I would strongly recommend to anyone interested in TSM.

Our plans for 2015 were, however, thrown into chaos late January by a visit to our premises by the Medicines and Healthcare products Regulatory Agency (MHRA).  A thorough search of our premises confirmed that C3 Europe was neither storing nor providing the medication needed for TSM, which would be illegal, as we are not licensed providers of prescription-only medication.  With this visit came notification by the MHRA that our website did not conform with the regulations governing the advertising and promotion of medicines in the UK, as per their 114 page ‘rule’ book, called the Blue Guide.  This guide is non-negotiable and everything we write, or do, or say on any platform, whether the website or social media, HAS to meet the requirements laid down in this guide.

Click to access the MHRA Blue Guide

Click to access the MHRA Blue Guide

We were then served with a 7-day notice to either amend the website to comply fully with the Blue Guide, or to remove it from public view.  With such a complicated set of rules to abide by, we had no option but to temporarily take the website down and work behind the scenes to rewrite every page of it, before submitting the site back to the MHRA for their approval.  Failure to do so could have resulted in the enforced closure of the website, as well as potential prosecution and/or fines for the Directors of C3 Europe.

The rewriting process took around-the-clock dedication and almost six weeks later, on 9th March, we finally received confirmation from the MHRA that the site now met the Guide’s requirements and that we could re-launch it.  The statutory obligation to comply with the requirements of the MHRA’s Blue Guide is, however, an ongoing one, which means that if we are unsure about any additions to the site, we must approach the MHRA for their guidance, before making the additions visible to the public.

We took advantage of the opportunity offered by the rewrite to include several new features, such as the Bing Translate feature, a Paypal Donate button, and the Five Steps to TSM, as featured in Dr Roy Eskapa’s book The Cure For Alcoholism.   Looking at the website now, we feel it is a big improvement on the 2014 version, but it was a very stressful time for us all.

Needless to say, we closed the first quarter of 2015 with Moyra and myself taking a little well-earned personal down time!

April brought us our first on-the-road C3 Europe experience in Leicester, England, at a sci-fi convention that we attended along with Claudia, and during which we discussed TSM  with the convention’s attendees and raised funds.  Sadly, the experience was very much overshadowed by the news of the death of Dr David Sinclair that very same weekend.  I think I speak for us all involved with the C3 group in saying that we very much appreciated your messages of sympathy and support.  Out of our sadness and the strength of your support came a renewed sense of how we must continue to raise awareness of Dr Sinclair’s lifetime of work.  We will be out and about again in April 2016, so we hope to see many of you in Telford…

April also saw us join EasyFundraising, an online fundraising tool for those in the UK to raise funds for free whilst doing their online shopping.  Our Easyfundraising target for April to December 2015 was £100.00 and  I am very pleased to report that your online shopping actually helped us make almost half as much again, with the funds raised totalling £146.68.  Thank you all very much indeed!

Torrential stormy weather stops sponsored cycle ride!

I had also planned to take part in a sponsored cycle ride to raise additional funds but unfortunately the worst torrential downpours that the UK had seen in many, many years, meant it was deemed to dangerous to complete the ride in full.  Your generosity raised an additional £300.00, however, with not one sponsor asking for a refund, despite my non-completion of the course.  A second sponsored cycle ride will most likely take place on 1st May 2016, and we surely cannot be so unlucky as to suffer such tremendously bad weather two years in a row!

We are always very conscious of our duty to use te funds you help us raise sensibly, and after much discussion we felt we could reach more people, and be taken more seriously by medical professionals and other stakeholders, if we had recognised qualifications.  And so in May, we announced our first C3 Europe project – to become accredited alcohol and drug abuse counsellors.  It was an ambitious plan for sure, but one that has since proved essential to providing direct help to those in need of it.

May turned out to be a good month, with Moyra planning and devising a section of the website specifically for the loved ones of those either on, or considering using, TSM.  Alcohol Use Disorder impacts a great many more people than just the drinker, so this was an important addition to the site.  Moyra published her introductory article on 18th May, and has since added to her writings there.

Other Q2 highlights included the addition of an online appointment booking system for those wishing to contact us via Skype, and my own personal experience of using Nalmefene (Selincro), rather than Naltrexone, for TSM.  Interestingly, the series of two articles that accompany that experience is in the top 5 of articles viewed in 2015.

By the end of the quarter, both Claudia and I had become accredited Drug, Alcohol and Substance Abuse counsellors and Moyra will gain her accreditation during 2016.  We were able to fund this accreditation as a direct result of funds raised by YOU.  Thank you!

The third quarter of 2015 began with lots of behind the scenes work during July.  Our second project was also ambitious and involved a lot of additional planning.  By 11th August, we were read to launch our C3 Europe FREE counselling service, with a gradual roll-out across our websites and social media.  To date, this service has been used by twelve people to obtain their prescriptions for nalmefene on the NHS in England, and by two other people to obtain an NHS prescription for naltrexone.  These are people who would otherwise have been unable to obtain their prescriptions.  Four other people are using this counselling service, alongside their prescriptions from private doctors in the UK, and one person from outside the UK has also successfully obtained their prescription for nalmefene with the additional support that we offer.

Being able to speak as accredited alcohol counsellors has enabled us to be much more successful in communicating with doctors and specialists.  The simple fact of the matter is that, following an initial, fact-finding appointment with someone seeking our help, a letter to their doctor confirming their intention of participating in counselling with us, using the medication as approved by NICE, written on headed paper and signed by an accredited alcohol counsellor with the required qualification letters after their name, gains a far more positive reception than would otherwise be the case.  It shows them that their patient has committed to recovery by seeking help from an accredited counsellor, and therefore has a desire to help themselves.  In the majority of cases, no further communication with the doctor has been necessary for the patient to obtain their initial prescription, and monthly updates confirming their patient’s current situation have been sufficient for them to obtain repeat prescriptions.

Housekeeping activities, such as the filing of our first year’s accounts, was also a feature of this quarter, as was the opening of lines of communication with Paul Turner, an independent alcohol home detox specialist.  Paul successfully uses TSM in his practise, and we have since built up a very useful communications framework which ultimately aids those we help in many ways.  We also both answer questions on the alcohol forum of the Patient.info website, and C3 Europe has now joined Paul in being recognised and respected as a source of well-balanced and sensible advice on the site.

With Dr Eskapa’s approval, we also published the Spanish version of his book The Cure For Alcoholism on the Amazon Kindle bookstore during this quarter.

September brought a very special occasion for me, personally.  During a trip to Amsterdam for a birthday celebration that both Moyra and I attended, we had the pleasure of meeting a gentleman who has been using TSM successfully for 9 months under our guidance.  This is the very special part of working for C3 Europe that we wish we could share with you all in person.  Along with the frustrations that operating C3 Europe involves come those moments when you realise that with your help, someone has been able to get their problem drinking under control and is turning their life around.  To witness how TSM is working for them is an amazing thing, but then to meet with them in person takes your breath away and certainly makes it all worthwhile.  What a fantastic way to end our third quarter!

Nat

Nat under the shaver!

In October, whilst I was busy researching exactly what the current situation is in terms of who is actually authorised to prescribe Nalmefene in each area of NHS England (for a future article to be published early in 2016), one of our trusted supporters was busy planning to raise funds for C Three Foundation and C3 Europe by having her head shaved!

Nat Le Brun raised an incredible £438.00 and on 29th October she underwent her head shave, sharing the funds between our two organisations.  A huge “thank you” to you, Nat!

November and December have also seen some small but important successes in continuing to raise awareness of TSM.

Following a submission to the MHRA, we gained their approval to feature two UK-registered companies on our website page “For Those Living In Europe“, each of which will provide an online medical consultation for the medication, Nalmefene.  If deemed suitable for the medication, the client can then obtain a prescription for it from the site’s UK-based doctors.  Though UK-based, this online consultation service is available across the majority of the EU member states.

Many of you will be aware of the website Reddit.com, whose section on alcoholism is, and always has been, very heavily orientated towards the traditional, 12-step approach.  Following negotiations with the moderators, we have been able to announce that TSM, C3 Foundation and C3 Europe are now also featured as a useful resource on their alcoholism sub-reddit page.  Anyone using Reddit will be re-directed to one of our websites if they wish to learn more about TSM.

C3 Europe's Entry in the Patient.info Support Directory

C3 Europe’s Entry in the Patient.info Support Directory

And, lastly for 2015, C3 Europe is now featured on the “useful resources” of the alcohol forum at the Patient.info website, and has also been added to their Support Directory page.  This is a website that, as a whole, has 15 million unique views each month, with over 45 million page views, including over 250,000 views per month from doctors and other medical specialists.

We also have some additional and very exciting news about our inclusion on the Patient.info website, which we will bring you in early January.

So…. all in all, and despite some difficulties throughout the year, I am sure you will agree that 2015 has been very productive and successful for us here at C3 Europe.  It’s included many challenges, some of which were predictable and some of which came out of the blue, but overall, with your continued support, we are most definitely on the right track for continuing the success in 2016.

Onwards and upwards!  Because…

#OptionsSaveLives

 

 

 

 

One Little Pill now Available for Pre-order DVD

What If Everything You’ve Been Told About Alcoholism Is Wrong?

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The C Three Foundation’s documentary “One Little Pill” is now available to purchase as a region-free DVD.

Shipping will begin on August 10th, 2015.

The price is $19.99 (EUR17.90 or £12.70) plus delivery fees for worldwide shipping.

$2.00 from each sale will be donated to the C Three Foundation’s Physician Outreach Program and a further $0.50 will be donated to the Key Chain Program.

The Physician Outreach Program endeavours to educate physicians about The Sinclair Method (TSM).

The Key Chain Program enables both the C Three Foundation and C Three Europe to provide those on The Sinclair Method with key chain pill holders.  Compliance is a vital component of successful TSM treatment and the key chains ensure that a person is never without a couple of tablets on their person.

Please click the image below to place your pre-order.

OLP

Click image to purchase One Little Pill on DVD

One Little Pill is an award-winning documentary film about The Sinclair Method – a method of treating Alcohol Use Disorder.   The Sinclair Method, which has achieved an outstanding success rate in over 100 clinical trials, uses the FDA- and NICE-approved medications, Naltrexone or Selincro (nalmefene), to bring about pharmacological extinction and thereby eliminate the disorder.

The film follows people using The Sinclair Method and interviews those instrumental in the many years of alcohol research that were needed to clinically prove the method is effective for 78% of patients.

One Little Pill not only shows how and why The Sinclair Method works so well, it is also an excellent tool for those considering TSM as a treatment for their Alcohol Use Disorder, and for their loved ones.

The importance of One Little Pill was, to the delight of the C Three Foundation and those involved in making the film, recognised when it was honoured with the Film4Change award at the 2015 Albuquerque Film Festival.

Film4Change Award

Further resources and detailed information about The Sinclair Method are available on this website and at the C Three Foundation Find A Physician page.

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Selincro (Nalmefene) Side Effects – Joanna’s Experience – Part One (of Two)

As many of you are aware, I began The Sinclair Method in October 2013, using naltrexone.  At the time, nalmefene (brand name Selincro) was not available.

During the last 12 months, the makers of Selincro (Lundbeck) have been rolling out the release of this medication across the majority of the European Union states.

Both medications are opioid blockers and are suitable for use with the TSM protocol.  Unlike naltrexone, nalmefene has the advantage of not being processed through the liver, so the release of this medication was a major breakthrough for those drinkers suffering from poor liver function, in addition to those concerned about their drinking levels.  Indeed, Selincro is the first medication of its kind to be indicated for the reduction of alcohol consumption in adult patients.

Selincro

Over the past months of coaching many people taking Selincro, however, it has become apparent to me that nalmefene may well come with an increased risk of side effects that appear to be quite strong in comparison to naltrexone.  In the UK, the medication is subject to the “yellow card scheme” which allows patients to report adverse side effects.  This information is then compared against existing, known side effects for the medication and, if any new issues are raised, the safety profile of the medication may be re-examined, ensuring that all medications are used in a way that minimises risk.  I understand this to be a fairly common procedure for newly-approved medications so, in itself, this is not a cause for concern, and should not be taken as such.

I am not medically qualified, but was naturally quite concerned about the reports I was hearing.  Any side effect issues could potentially mean that someone would stop taking their Selincro (or skip doses) prior to the full course of treatment being completed.  In a worst case scenario, this may lead to the patient reverting back to drinking at dangerous levels.  Another area of concern for me was that the medical industry, and especially those doctors prescribing Selincro and hearing directly back from their patients, may make the decision that pharmacological extinction (the medical term for The Sinclair Method) simply does not work, when in fact all that was happening was that compliance was the issue preventing successful completion of the treatment.  The knock-on effect of this could be that they may stop prescribing – and no one would want that to happen.

Though the Patient Information Leaflet for Selincro does not state The Sinclair Method by name, the instructions to take one tablet 1-2 hours prior to drinking only is TSM in all but name.

The reports I have been hearing from those already taking Selincro include some quite worrying comments about the severity of any side effects.  Below are some quotes taken directly from emails, conversations, or our C3 Options Save Lives community forum;

  • I felt icky, had sleep issues, and generally felt toxic for the whole week.
  • On Selincro I felt anxious, depressed, foggy, nauseaus and irritable.
  • It encourages alcohol-free days just to avoid the Selincro (note: this action will NOT result in pharmacological extinction.  For that to happen, one must repeatedly drink one hour after taking the medication.)
  • The side effects are so bad that I would not be surprised if some people end up not taking it and drinking anyway!
  • I didn’t have one wink of sleep last night due to the nalmefene.  I think I’d rather go teetotal than face all this.
  • After taking my first Selincro tablet, I thought I was going to die, I felt so ill.

This doesn’t make for comfortable reading, does it?  It makes me think that although I have subsequently been told that the side effects have lessened and disappeared, this does seem to be taking much longer to happen than with naltrexone.  Side effects on naltrexone seem to be much milder and lesson much quicker, often within the first 4-6 tablets at most.

It is correct, and fair, to say that some people will experience no side effects whatsoever from Selincro, and others will experience worse side effects using naltrexone – everyone is different.  Believe me, I do not wish to scare anyone or prevent them from considering Selincro as an option.

Only today, I received an email from a lady who began using Selincro a few days ago.  She reported that although she felt a little spaced out, she had no real issues with it.  The next day she felt “flushed out” and experienced some lower back ache, but that was all.  Based on everything I’ve been hearing, however, she is very much in the minority when it comes to experiences of Selincro.

It is certainly not my intention to create alarm.  Everyone should be very glad that Selincro is available because it is a very valuable tool for those suffering from Alcohol Use Disorder.

My intention is only to support those people through TSM, if they wish me to.  If someone is prescribed Selincro, how can I best support them through any side effects and provide them with some gentle support to ensure they get “across the bridge” with any issues they may experience?  I don’t want them to stop taking their tablets – and everything I am being told so far indicates that some may well stop simply because the effects could be so strong.

I’ve always been a believer that our own personal experiences using naltrexone are of great benefit to those who ask for help from either myself here at C Three Europe, or from Claudia at C Three Foundation.  It made sense to me that in order to fully understand what people are going through, and to be in a position to help them as effectively as possible, I needed to experience Selincro for myself – from the first tablet through to whenever any side effects may dissipate.

I sincerely hope that doing this will enable me to help even more people through the early days of The Sinclair Method.

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Note:  This article, along with the my documented Selincro experience that follows in part two of this article, is my own personal experience.  It is NOT intended as medical advice, not should it be taken as such.  Please consult your physician, or other suitably qualified medical professional, before beginning any course of medical treatment.

This article is part 1 of a 2-part series.

Both parts should be read in their entirety, and in conjunction with each other.

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PART TWO

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