GW Pharmaceuticals boss: Cannabis-based treatments could be used in autism – The Telegraph

Justin Gover says GW’s experimental drug for severe epilepsy also appears to treat symptoms of autism.

GW Pharmaceuticals grows cannabis in a top secret location in the South of England

 

GW Pharmaceuticals is to investigate whether a cannabis-based medicine could treat symptoms of severe autism.

The British drugmaker, which develops medicines using cannabis extracts, is putting together the “building blocks” of a research programme into autism, its chief executive told The Telegraph.

Justin Gover said doctors treating severely epileptic children with GW’s experimental drug Epidiolex had observed improvements in behaviour and brain function in those patients who also had autism.

He cautioned that the observations were “no more scientific at this stage” but that he saw an “important role for GW in researching the use of cannabinoids within autism-like disorders”.

GW has been testing Epidiolex in a few dozen children with debilitating forms of epilepsy in the US for around a year and has already seen “promising” results. It has done so under a so-called “expanded access” programme which allows patients with untreatable conditions to try out experimental drugs.

It recently embarked on a formal clinical trial of the drug across Europe and the US, which includes patients at Great Ormond Street Hospital in London. GW hopes to complete clinical trials by the middle of 2016 and launch Epidiolex in early 2017.

Analysts have previously suggested that Epidiolex could also be used in autism since the two conditions are closely associated. As many as a third of people on the autistic spectrum also have epilepsy. A recent study by scientists at Stanford University in California also suggested that compounds found in cannabis could successfully treat autism.

Mr Gover revealed his new research plans as GW released its full-year results showing losses widened to £14.7m in the year to September 30. These compared with a loss of £4.9m a year earlier and largely due to the company ploughing money into its Epidiolex programme, it said.

GW also posted a 10pc increase in full-year revenues to £30m, driven by a doubling in sales of the company’s single product Sativex, which treats pain in multiple sclerosis, from £2.2m to £4.4m.

The group makes most of its income from fees charged to Japanese drug maker Otsuka, which has secured the exclusive rights to develop and market Sativex in the US. GW said Otsuka paid it £24.3m in the year to September 30 for its work in getting Sativex – which is currently unavailable in the US – approved for use in cancer pain.

Story from The Telegraph

 

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Open Letter to Dr. Sarah Wollaston

Dear Dr Wollaston,

May I begin by thanking you for attending the drug policy debate in Parliament, even if you weren’t planning on attending an event that 130,000 people signed a petition in support of. It was big of you to realise your mistake and change your plans from whatever it was that you had deemed more important.

As you were kind enough to provide me with a transcript of everything you said during the debate I would like to start there, and offer my own opinion, seeing as there seemed to be very little in the way of actual debate going on in the Commons.

In your opening statement you said – “It always surprises me that people who object to buying coffee in Starbucks and who refuse to support Amazon are quite happy to support cartels that cause untold misery to hundreds of thousands of people around the world. Until such time as we have a change in drugs policy, I hope that people who support the drugs industry will reflect on the wider harms that they, personally, are causing.”

Skirting over the issue of whether people should support Starbucks and Amazon (I read your comments regarding tax avoidance with disdain), the callousness of blaming drug users and addicts for the existence of drug cartels is truly staggering in its ignorance and deserves to be addressed.

The existence of cartels cannot be blamed on drug users, but rather government policy which has, for 50-odd years, placed the control of production and supply of drugs squarely in the hands of organised criminals, without a thought to the harm that such a policy causes to society. Placing drugs into a regulated market would not only deprive organised criminals of a hugely lucrative source of income ($321.6 billion worldwide in 2003), but would also create a far safer environment for drug users, allowing them to know exactly what substances they were buying and giving them the chance to seek help should they need it rather than criminalising them and pushing them into committing far more serious crimes to feed their habits.

In addition – no amount of arresting drug users and blighting their lives with criminal records is going to make the cartels go away. The idea that our drug laws are causing even the tiniest of dents in the behemoth that is international drug cartels is laughable – almost all of the tax money spent on fighting a war on drugs is being used to arrest and imprison low-end drug users, not to put an end to the cartels themselves. This is not a lie politicians can hide behind any more.

Nowhere has this been made clearer than in the case of HSBC – fined $1.9 billion for laundering drug money in 2012. The fine covered only a fraction of the amount that was laundered, and was nothing compared to HSBC’s profits that year. What’s more – no one went to jail. Compare that to the fate of the 4000 people behind bars in this country (as of 2011) for drug possession or possession with intent to supply. Many of whom will have been people growing their own cannabis and having no contact whatsoever with the black market. Ruining these people’s lives with prison sentences does nothing to harm the cartels, especially when those directly responsible for allowing those cartels to operate within the banking system are let off with a fine (and in the case of Stephen Green, given a cushy government job advising the Chancellor).

The next point I would like to bring up from your speech in the Commons regards falling use of drugs and your belief that we are in fact winning the war on drugs. Caroline Lucas MP pretty well summed up what my response to that statement would be with her own reply – “The only real model that we can see over time is that there was a 32% increase in respect of some of the most serious drugs, heroin and morphine, last year. Cannabis use has been coming down, but that has happened irrespective of the policy context and of whether it has been class B, class C or anything else.”

Basically what Caroline Lucas is pointing out here is the fact that was backed up by the report issued by the Home Office on the morning of the debate (having been suppressed by your own party for months), namely that punitive drug laws have no impact on the rates of use of drugs. It is disingenuous to claim that our drug laws are responsible for a drop in use of cannabis among young people when the laws themselves and the way in which they have been applied have been in a state of constant flux. Indeed the application of the laws has been changed yet again this week with the abolition of cannabis cautions, supposedly to get rid of the ‘soft option’, despite the findings of the Home Office report you were kind enough to send me.

During the debate you skirted over the point raised by Ian Swales MP regarding legal highs and whether their rise has had anything to do with the decline in cannabis use. You may have been able to dodge the question in the Commons but it is one that deserves serious consideration. There is a clear correlation between the rise in popularity of synthetic cannabinoids and the fall in use of the real thing, particularly among young people. The policy of prohibition has caused the explosion of New Psychoactive Substances, many of which are potentially far more dangerous than the drugs that they imitate. Banning them has only led to ever more complex molecular structures being devised, leading to substances that have never been seen before and whose effects and risks are therefore unknown. This policy is putting people’s lives at risk, the market for these substances simply wouldn’t be nearly as huge if the drugs that we have known about and researched to death did not carry with them the threat of criminalisation.

Next up in your tour of tired government excuses for maintaining the status quo, you moved onto cannabis. Immediately you fall into the trap of so many prohibitionist MPs before you (not to mention the Daily Mail), by falsely assuming that the argument for cannabis law reform has anything whatsoever to do with it being a ‘harmless’ drug. No one is arguing that cannabis cannot cause harm, of course it can. But so can anything, from fast food to alcohol to gambling. The question is how to minimise that harm, and whether or not our methods of dealing with cannabis use causes more harm than they prevent.

In fairness to you, your concern regarding the harms that cannabis can cause to young people are legitimate, and are shared by all sensible thinking people. I would argue however that the criminalisation of young people for the ‘crime’ of simple drug possession is an utterly disproportionate and ineffective way of minimising the potential harms that the use of cannabis could cause them. You have said in previous correspondence with me that in your role as an GP you witnessed young people whose lives had been blighted by cannabis use. I put it to you that this should be a sign to you that the current laws simply are not working to protect young people. From personal experience I can tell you that it is far easier as a young person (under 18) to get hold of cannabis than it is to get hold of alcohol and cigarettes. Indeed this is the very reason that a huge number of people take up cannabis smoking in their teens. And why?

Well it’s simple really – the legal and regulated marketplace for alcohol and tobacco allows us to demand that anyone purchasing either of these products must produce proof of age, as well as allowing quality control and health warnings on packaging. In an unregulated market dealers do not ask for ID, they do not care about the quality of the product (and often cut it with far more dangerous substances) and if someone gets into trouble they have nowhere to turn for fear of criminalisation.

This has led to some tragic stories in the recent past where young people have ended up committing suicide rather than go through the ignominy of a criminal trial and all the harm that such a trial and resulting criminal record would do to their future prospects.

If you really want to protect the children as you claim then the best way to do that would be to take the control away from unscrupulous and dangerous criminals and place it into a framework whereby young people’s access to cannabis could be prevented far more effectively – namely a legal, regulated framework. If we look at other countries that have adopted this idea we can see that it works – The Netherlands decriminalised cannabis 24 years ago and has one of the lowest rates of teen use in Europe. In order to buy cannabis from a coffeeshop you must provide proof of age. Indeed if a coffeeshop is found to not be asking for ID from everyone who purchases cannabis from them they can be shut down by the police, and rightly so.

Similarly, drug use in Portugal has fallen across the board since they decriminalised 12 years ago. I understand that you want to wait and see what happens in Colorado and Washington State, but the evidence from 24 years of various methods of decriminalisation in different countries, not to mention 50 years of failed prohibition, has shown that the current system does far more harm to our young people than good. I fail to understand your obsession with specifically waiting to see what happens in two states that are just the latest in a long line of places to understand that locking people up for drug possession is never going to work.

Perhaps most importantly of all, the prohibition of cannabis and other drugs has led to a situation where the only drug education children get growing up is ‘drugs are bad’. This is dangerous for a number of reasons. For starters we know that telling a young person not to do something is generally a bad idea; it’s pretty much what the whole concept of reverse psychology is based on. When you don’t educate and instead just tell young people that they mustn’t do drugs because if they do they will be arrested, you are pretty much guaranteeing that they will experiment with drugs, only they won’t be armed with the information they need to ensure their own safety. What’s more, once teenagers try cannabis and realise that it isn’t the monster they’ve been warned of they are more likely to think that they have been lied to and mislead about other drugs too. This is a far wider point than just drugs – once that trust is broken it leads to a breakdown in the relationship between the public and the police, as well as MPs such as yourself. You are no longer seen as protectors and instead as aggressors, randomly searching and arresting people for choosing to consume a plant that the people know to be safer than alcohol.

A great example of why education and the dissemination of good information is vitally important can be found by looking at tobacco. Everybody knows that smoking causes cancer and other nasty diseases, and whilst there are still a lot of tobacco smokers in this country, we have been able to bring those numbers way down. Less kids are taking up smoking tobacco now than ever before as a direct result of education programs, regulations banning advertising, a higher legal smoking age and other measures which were able to be implemented thanks to the fact that tobacco sales are legal and not just blanket banned.

I would like to ask you exactly how you think that the current policy of prohibition is protecting children? You are obviously concerned about the possible link to mental illness but I fear you may have been blinded by media propaganda and fear-mongering. The most in depth studies into the link between cannabis and adverse mental health outcomes have shown that despite huge rises in cannabis use and the prevalence of high-THC strains, the rates of schizophrenia and psychosis in this country have remained at the same level or have decreased. Whilst there is probably a greater risk of triggering mental illness for young people who are predisposed to such an illness and who are regular users of cannabis, it has been said that in order to stop one person from developing schizophrenia, we would have to stop 5000 young men or 7000 young women from ever smoking cannabis. These figures come from the Swedish Conscript study – the only study with large enough numbers to determine whether or not there is a risk of schizophrenia as a result of using cannabis. As you can see, that risk is very small, and the criminal records that have been given to over 1 million young people in this country for smoking cannabis are far more dangerous and harmful to their lives than cannabis.

An area of the debate that was hardly touched upon in the commons is the medical uses for cannabis. Medicinal marijuana is available in 23 US states plus the District of Columbia, as well as a huge number of countries around the world. In the UK GW Pharmaceuticals produce tonnes of medical grade cannabis every year which is used to make medicines such as Sativex, an oral spray which has just been blacklisted by NICE due to cost effectiveness worries. This blacklisting has nothing to do with the efficacy of the drugs and everything to do with the fact that GW, being the sole owners of a government license to grow cannabis, are able to charge pretty much whatever they like for them. Cannabis is proven to be massively beneficial for a huge number of medical conditions and the fact that the UK government continues to class it as having no medical value is beyond ludicrous – it is criminal. Allowing cannabis to be prescribed to sick people who need it would be the humane thing to do and would save the NHS millions as patients would literally be able to grow their own medicine. But instead we insist on breaking down the doors of people growing a plant to improve their lives, branding them criminals, and in some cases locking them up and forcing them back onto legal medications which often don’t work and almost always have far greater risks to the individual than cannabis.

I was quite pleasantly surprised to see that you sent me links to the both of the reports that were released by the Home Office on the morning of the debate as I was planning on mentioning them anyway. To me the release of these reports and the subsequent statements from Norman Baker MP and others offers the clearest insight into the absurdity of how the government operates – it is a farce. On one hand the report undertaken into how other countries deal with drug policy and the outcomes they have had in comparison to us came to a pretty clear cut conclusion – that punitive drug laws and harsh sentences for drug users have no impact on the rates of drug use in a country. And yet on the other hand there was a report calling for legal highs to be banned and Norman Baker crowing about wanting to destroy head shops. Politicians like to talk a lot about sending a clear message to children; about not wanting to give them mixed messages about drugs. But here we have the Home Office saying “banning drugs doesn’t work, so we’re going to ban some more”. Einstein’s definition of insanity seems quite appropriate – doing the same thing over and over again and expecting different results.

The final link you sent me was to Professor Wayne Hall’s review into the adverse health effects of recreational cannabis use. I had guessed you would as you quoted it in the Commons debate. Or rather you quoted the Daily Mail’s version of it – that one in six users become dependent, rather than the one in ten that Dr Hall actually wrote in the review. I can only presume that you read about this review in the media and took it at face value, rather than reading it yourself, so I suggest you do so. You may want to bear in mind that Professor Hall has himself said that his review is far from definitive, and that he is in favour of decriminalisation. Even the NHS have had to step in and debunk the Mail’s reporting.

If you have made it this far I am impressed and grateful for you for hearing me out. I will end this letter by reminding you that you are an elected representative of the 69,000 people in your constituency. The people are way ahead of the politicians on this issue and poll after poll shows that the people believe prohibition has had its day and needs to be replaced by a system that puts evidence first. There are thousands in Devon and all over the country who will simply not vote for a party that wants to continue to criminalise non-violent drug users. The UK branch of the oldest cannabis law reform movement in the world, NORML, is based in Totnes, and its numbers are growing daily. If you want to be on the right side of history and to continue to represent us I suggest you start listening.

Yours,
Daryl Sullivan

Source: Open Letter to Dr. Sarah Wollaston.

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The case for decriminalising drugs in the UK is becoming irresistible

Please select ‘Yes’ in the poll!

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Brian Deer: Wakefield ‘MMR mother’ fabricated injury story

An interesting development in the UK. Many have been wondering how some parents are able to get away with inflicting ineffective and often harmful ‘Biomedical’ procedures? It seems they are not able to get away with it, and it’s only a matter of time before these parents are deal with by the courts of law.

However, while cannabis remains illegal, our legal system is a joke. I can’t feel good about this ruling. I know it will galvanise the anti-vaccine contingent. I know it will be their ‘proof’ that even the UK courts are in on the vaccine conspiracy. Oh, and me too. #shillarmy

Left Brain Right Brain

Brian Deer, the reporter who broke the story on Andrew Wakefield’s conflicts of interests, has a new story on his website:

Wakefield ‘MMR mother’ fabricated injury story
In a newly-released judgment from England’s Court of Protection, a prominent anti-vaccine campaigner is branded a manipulative liar. Brian Deer reports

The story is quite sad. And while it presents an extreme case, there are themes here which have been seen elsewhere.

A British “mother warrior”, who claimed that the combined measles, mumps and rubella vaccine is responsible for autism, fabricated accounts of injury to her son and persistently lied about his health, a London court has ruled.

The mother, “E”, who cannot be named so as to protect her son’s identity, concocted a story about how he reacted to an MMR shot in January 1991. She said that he became distressed with fever and then lost speech, eye contact and play immediately…

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Hammering Spilled Milk

From Hammering Spilled Milk.

To understand why we must change prohibition, and how we must change it, we must first know why that needs to happen. The answer is quite simple, it is in the numbers. Drug prohibition on a global scale is an exercise in Einstein’s definition of insanity. It is repeating the same procedure over and over while expecting to produce different results. If it didn’t work for the first century then it isn’t likely to start.

Prohibition is not unlike cleaning up spilled milk with a hammer, or putting out a grease fire with a garden hose. Regardless of the amount of effort you invest you will never accomplish those tasks with the stated tools. Continued hammering will only break up your kitchen tiles while milk is distributed farther and wider. Water on a grease fire will only spread it around, increase the surface area of the fuel and make a bigger fire. How long would you hammer spilled milk before you reached for a paper towel? Would you burn your whole house down rather than admitting you were wrong and putting a lid on the pan?

That sounds a bit tongue-in-cheek, but that is precisely what policy makers have been doing for the better part of eight decades, and continues to reinvest further effort and resources in despite past failures. It’s like destroying your own home to avoid the pain of admitting failure. You don’t have to capitulate to the essentially racist and classist motivations of prohibition when initially implemented to agree to the fact that whatever the reasons for it, drug prohibition doesn’t make anything better for anyone.

With military interventions in dozens of nations, drug enforcement in every member nation of the U.N. and millions of people in prison the world around there is no less drug abuse now than there was before prohibition was implemented. There is so much cocaine use in some nations it is measurable in the drinking water supply. After eight decades of open warfare a plant that only grows in a small part of South America it is still present in the water supply of the United Kingdom on the other side of the planet; it makes you think long and hard about just how realistic the goal of drug eradication actually is.

There is a certain point past which a society cannot consume any more drugs, and modern western civilization is at about that threshold. We’re arguably at that stage now, where drug abuse is so common in our society, quite often with the stamp of approval from medical professionals, that the repeal of prohibition laws wouldn’t really have a measurable impact. Are you going to go out tomorrow and take up smoking crack if criminal penalties for possession and distribution were removed? It doesn’t seem likely.

Even assuming we don’t reduce drug dependence by ending prohibition, we still accomplish the goal of harm reduction. Hard drug users are no longer forced to seek their supply from organized crime. Quality and dosage could be controlled, preventing overdoses and other health concerns associated with contaminants in drugs. Revenue could be taken from criminal enterprises and redirected to legitimate and regulated industry which is easier to hold to account. There are two potential options here, both of them result in people using drugs, but only one route gives us measures of control on that situation.

The trouble is that prohibition does not function as prohibition; rather it has become a de facto deregulation of dangerous drugs. The marketplace has not been eliminated, demand has not been measurably curbed, and so we have a multibillion dollar marketplace world-wide which we have absolutely no control over. The idea of unregulated milk on store shelves is unthinkable, that stuff can go bad and make people sick. The idea of unregulated drugs on our streets is a daily reality, and we just accept that without question, continually given empty assurances by our leaders that they are doing something to solve the problem.

They’ve had eight decades now to “do something” about this problem, and thus far all we have is an ocean of blood and a bigger prison population than any point in human history. They’ve done a terrible job! Why do we keep letting them do this crap?

There are risks, and we are right to be cautious about those risks. With every other market we have developed we mitigate those risks by regulating. The old saying “if you outlaw guns then only outlaws will have guns” holds true as much for drugs as it does for firearms. It’s actually easier to make drugs than it is a gun, that’s why there are more rogue meth cooks than rogue gunsmiths. In many cases the same group of people who decry the notion of banning guns are quick to say we must ban certain drugs – how do those thoughts fit in the same head?

This concept is hopelessly broken and not fit for any purpose, and so we have to start to formulate sensible schemes of production and regulation. Drugs are here to stay, they’ve been here since before the point when we had words to label them, and animals will probably get high long after we are dust. We can’t kill the big beast called “drugs”, so what are we going to do with it?

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RE: Would some cannabinoids ameliorate symptoms of autism?

Some (but not all) cannabinoids may partially (but not fully) and reversibly (but not permanently) reduce some (but not all) symptoms of autism for some (but not all) people with some (but probably not all) autism spectrum conditions.

In response to Bou Khalil RWould some cannabinoids ameliorate symptoms of autism,
Eur Child Adolesc Psychiatry. 2012 Apr;21(4):237-8. doi: 10.1007/s00787-012-0255-z. Epub 2012 Feb 17.

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Use of dronabinol (delta-9-THC) in autism


A prospective single-case-study with an early infantile autistic child.

René Kurz, Kurt Blaas. 21 Nov 2010

Abstract

Objective: To evaluate the effectiveness of dronabinol (delta-9-THC) as supplementary therapy in a child with autistic disorder.

Methods: A child who met the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for a diagnosis of autistic disorder and who took no other medication during the observation time was included in an open and uncontrolled study. Symptom assessment was performed using the Aberrant Behavior Checklist (ABC) before and after six months of medical treatment.

Result: Compared to baseline, significant improvements were observed for hyperactivity, lethargy, irritability, stereotypy and inappropriate speech at follow-up (p=0.043).

Conclusion: This study showed that the use of dronabinol may be able to reduce the symptoms of autism.

Keywords: early infantile autism, autistic disorder, dronabinol, cannabinoid

Download here: www.cannabis-med.org/data/pdf/en_2010_04_1.pdf

Or read an article about it here.

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