Do you know more than doctors? Cannabis Wellbeing & Epilepsy!

Background

In August 2018, I was a guest on “Good Morning Britain” (GMB). I thought they wanted to ask me why my children were so healthy after an article appeared about us in the Mail online. A good diet, exercise and lots of laughter meant they had never needed any kind of medicine. What they wanted to do was tell me off, because I had not followed the propaganda and fear peddled by governments and the 21st century medical establishment. They even had TV doctor Hilary Jones there to reinforce the message, that we had neglected our children, by not giving them pharmaceuticals that they had no need for. In frustration one of the GBM presenters Kate Garraway, asked me “why do you think you know more than doctors”?

I could have said I no longer use the Doctor title because I hated being confused with medical doctors and I practice chiropractic, which I studied for five years. The tutor that influenced my thinking the most was a medical doctor, our anatomy lecturer, Angela Peel White. If they had asked me who had influenced my thinking on children’s health, I would have said a Medical Doctor; the late pediatrician Robert Mendolsohn, whose book “How to Bring up a Healthy Child – in spite of your doctor”; is a must read for parents concerned about the medicalisation of their children’s health and wellbeing. If the presenters had mentioned that I had any education and asked who influenced me to do my Masters in Health Promotion, I would have said the late Professor Theodore MacDonald, a qualified Medical Doctor, the most intelligent man I have ever met. Six medical doctors came out of my class at school and we are still friends. My partner Janette, has a PhD in chemistry and is a solicitor.

That was not the discussion I wanted, as there are alternatives to medical opinion, so I answered the question by telling my cancer story, thinking they would be impressed; I was diagnosed in 2011, had orthodox treatment at Royal Marsden, given all clear in 2012. In 2013 cancer came back and had metastasised, average life expectancy with chemotherapy was 22 months. Started chemo, then decided to go against doctors advice and try cannabis oil. I have been clear of cancer now for 5 years. I might as well have been talking to the wall, so focused were they on me being wrong. “You take medicine for yourself and won’t give it to your children”? Proffesor Michael Barnes describes similar anecdotes in his excellent book “The Beginner’s Guide to Medical Cannabis” an excellent book, outlining where the UK is as of January 2019 regarding cannabis. A great advert for the therapeutic uses of this plant and acknowledging the problem. Cannabis is not freely available in the UK even after it was legalised for medical use.

In recent years, the Main Stream Media and our politicians have been brainwashed by people from the pharmaceutical industry, presenting PR masquerading as “science”. The health of generations of children has been medicalised to the point this is the first generation in history that have a lower life expectancy than their parents. Type 2 diabetes has gone through the roof because economic growth is more important to politicians than public health. Iatrogenic disorders (a doctor-, drug-, vaccine-, surgery- or other medical treatment-caused disorder) are the third leading cause of death in the US. You can extrapolate the problem is similar in the UK.

Hannah Deacon & Alfie Dingley

In 2016, Hannah Deacon contacted me and asked if the cannabis plant I was taking for my cancer might help her son, Alfie who had epilepsy. I had no idea if it could help, but was certain the oil I was taking was way too strong for a child. In 2017, Hannah raised £7987 to help the family move to Holland where she could have cannabis prescribed legally for Alfie. In March 2018, Hannah presented a petition with 400,000 signatures to Prime Minister, Theresa May, at 10 Downing Street. Hannah gave them time to act when they didn’t Hannah went on the offensive again in June the licence was issued for Alfi.In November cannabis was formerly legalised for medical use in the UK. Our shared interest in this extraordinary plant has meant our paths have crossed on numerous occasions on our respective cannabis journeys and we keep in touch.

If Kate Garraway had asked me if I knew more than doctors about epilepsy, I would have said no. If she asked if I knew more about cannabis than medical doctors, who have only issued 2 cannabis prescriptions since it was legalised in 2018. I would have to guess that I probably know more about cannabis, its effects and the different strains than most medical doctors (and there are loads of people out there who know more about cannabis than me and have been criminalised for it) Then there are doctors out there who are observing the effects on Alfie Dingley and Billy Caldwell and a few others who are learning. Because I know nothing about epilepsy does not mean I can’t question their guidelines or how they are interpreting “Evidence” to suit their own agenda.

Having recently taken the time to read up about epilepsy and the anecdotes of therapeutic benefits of consuming oil from the cannabis plant, I would say the UK is probably back where the US was in 2013. There are very few doctors in this country who know much about cannabis. GP friends that have enquired about prescribing for other conditions have been warned off. GPs I know, that are knowledgable are the ones that smoke it recreationally, but they keep quiet as their regulator the General Medical Council (GMC) would be after them for bringing the profession into disrepute. Ask yourself why do sports people get banned for smoking cannabis even though cannabis is not a performance-enhancing drug, yet painkillers, which enhance performance and are likely to lead to exacerbating injuries and addiction are permitted? Is the UK ready to acknowledge that cannabis is the emperor of all plants?

Charlotte Finges Cannabis & Epilepsy 2012

If one of my children had epilepsy, I would first take them to a medical doctor and if they provided satisfactory answers to my questions, and a good prognosis, I would follow the advice. However if the advice turned out to be incorrect and there was little resolution of the symptoms, I would start thinking outside the box. This can be problematic with children as Social Services could step in if they don’t approve of the treatment choice . There are many crappy parents out there whose children need to be protected so I would be very reluctant to criticise an underfunded Social Services. Nevertheless, reading comments on social media after my 15 minutes of fame on GMB, you realise there are people who believe I should be locked up and our children put in care, because I question medical orthodoxy. Those are the risks parents sometimes have to take when they want whats best for their children. When I had cancer, I was able to comfort myself that it was me and not one of the children that was ill. Having cancer is easy compared to one of your children being seriously ill, I can’t imagine anything worse and than being where the parents of Charlotte Finges were in 2012

If one of my children had epilepsy, I would first take them to a medical doctor and if they provided satisfactory answers to my questions, and a good prognosis, I would follow the advice. However if the advice turned out to be incorrect and there was little resolution of the symptoms, I would start thinking outside the box. This can be problematic with children as Social Services could step in if they don’t approve of the treatment choice . There are many crappy parents out there whose children need to be protected so I would be very reluctant to criticise an underfunded Social Services. Nevertheless, reading comments on social media after my 15 minutes of fame on GMB, you realise there are people who believe I should be locked up and our children put in care, because I question medical orthodoxy. Those are the risks parents sometimes have to take when they want whats best for their children. When I had cancer, I was able to comfort myself that it was me and not one of the children that was ill. Having cancer is easy compared to one of your children being seriously ill, I can’t imagine anything worse and than being where the parents of Charlotte Finges were in 2012

They were told their five year old daughter Charlotte’s days were numbered. Charlotte, a twin, had a rare form of epilepsy. She was experiencing Grand Mal seizures every 25 minutes and the seizures could last 20 minutes. Her life was basically being in a state of permanent seizures. Charlotte was taking 7 different types of powerful drugs which were not controlling the seizures, then Charlotte’s doctors warned the parents the end was near. The parents had heard anecdotes that cannabis might help Charlotte and it was the final throw of the dice. The story was presented in a CNN a documentary by Dr. Sanjay Gupta, called “Weed”. This short version focuses on how a particular strain of cannabis low in THC and high in CBD changed Charlottes life.

Then, with the help of Josh Stanley a grower from Colorado, (the first state in the US to legalise cannabis in 2014), aspecific strain of cannabis plant was developed for children with epilepsy. The strain was so low in THC it was initially called the “Hippies Disapointment” but was found to drastically reduce seizures for many pediatric patients in Colorado and other US states

So why have only 2 people in the UK received a cannabis prescription for epilepsy when as many as 100,000 people have chronic epilepsy in the UK which is not responding well to Anti Epileptic Drugs (AEDs) . The Secretary of State for Heath Matt Hancock would say it’s because of “lack of evidence”. but the recommented NHS treatments are hardly supported by a plethora of evidence and AEDs have many side effects.

Then, even if you get access to a cannabis prescription in UK, it costs about £1,000 a month. In Canada, where cannabis is legal for recreational use, a 5ml bottle of Tilray cannabis oil cost approximately £50. The only people who benefit from keeping cannabis ilegal are drug dealers and the pharmaceutical industry.

In addition in the UK, a parent seeking alternatives for a child with poorly managed epilepsy, has to navigate through a maze of smoke and mirrors. However I believe parents can pick the salient points from the NICE guidelines to rebut, particularly how the “British Paediatric Neurology Association (BPNA) are explaining their reluctance to prescribe (unless there has been a mass of publicity around the case). Failing that, I am certain a good lawyer would make the BPNA look very foolish were they to attempt to maintain their position in a class action.

NICE Epilepsy Guidelines in UK

In the UK The National Institute for Health and Clinical Excellence is the arbitrator for clinical interventions in the NHS. They are assessed on the basis of a risk-benefit ratio and cost effectiveness. In 2012 they commissioned a Report on; “The Epilepsies; diagnosis and management of the epilepsies in adults and children in primary and secondary care” and will gather as much evidence as can be provided by interested parties to include cannabis in the guideline by November 2019. I am not holding my breath on what they will come up with, as NICE has rejected contributions from the most qualified expert on cannabis and epilepsy on the GMC register, Professor Mike Barnes? So for now read the book by Professor Barnes or here is a review of research of Cannabis Therapeutics and the Future of Neurology; that was published in October 2018.

NICE defines epilepsy as a neurological condition characterised by recurrent epileptic seizures unprovoked by any immediately identifiable cause. An epileptic seizure is the clinical manifestation of an abnormal and excessive discharge of a set of neurons in the brain. The principal treatment for epilepsy are Anti Epileptic Drugs (AEDs), 70% of patients respond well to treatment. 30% dont and epilepsy becomes chronic, so presumably, this is the group looking for an alternative to orthodox medical treatment in the form of cannabis. It is estimated that as many as 400,000 have epilepsy in UK and up to 500 of them die each year as a result of seisures.

In 2004 it was reported that costs of treating epilepsy are increasing, given the new trends in prescribing patterns towards newer and more expensive AEDs. A 2004 study estimated that prescribing costs in the community had risen three‐fold in 10 years, from £26million to £86 million, no doubt much effort goes into lobbying (CPD) of doctors to continue prescribing these drugs.
.
The NICE guideline recommends three key points in the management of epilepsy;

• Healthcare professionals should adopt a consulting style that enables the child, young person or adult with epilepsy, and their family and/or carers as appropriate, to participate as partners in all
decisions about their healthcare.

• All children, young people and adults with epilepsy should have a comprehensive care plan that is agreed between the person, their family and/or carers as appropriate, and primary and secondary care providers.

• The AED (anti‐epileptic drug) treatment strategy should be individualised according to the seizure type, epilepsy syndrome, co‐medication and co‐morbidity, the child, young person or adult’s lifestyle, and the preferences of the person, their family and/or carers as appropriate.

Anti Epileptic Drugs (AED’s)

Reading the |”Guidance” from the section about providing AEDs, there is no justification for Consultants not to try medical cannabis on the 30% of patients who are not benefiting from AEDs. All the usual AEDs will have been tried and found not to be helpful. The guidance would suggest any AED would be worth trying, Cannabis has been legal since November 2018, it’s not as if their AEDs were supported by a mass of evidence in this group or are without side effects. For example, the guidance warns clinicians to carefully consider the risk-benefit ratio when using Vigabatrin because of the risk of an irreversible effect on visual fields. Or when using steroids as first‐line treatment to infants with spasms carefully consider the risk−benefit ratio, and the evidence of any side effects.

The evidence of side effects from cannabis use is limited to cannabis very high in THC and to mental health issues and I would say compares favourably to side effects from AEDs. The rationale for the concerns of the BPNA for Bedrocan and Tilray cannabis oil, is equivelent to restricting access to Calpol because some teenagers have become addicted to Co-codamol because both contain paracetamol.

When you study AED recommendations, in the guidlines certain points stand out.

52.It is recommended that combination therapy (adjunctive or ‘add‐on’ therapy) should only be considered when attempts at monotherapy with AEDs have not resulted in seizure freedom. If trials of combination therapy do not bring about worthwhile benefits, treatment should revert to
the regimen (monotherapy or combination therapy) that has proved most acceptable to the child, young person or adult, in terms of providing the best balance between effectiveness in reducing seizure frequency and tolerability of side effects. (parents have been to Holland, given cannabis to their child under the supervision of a neurologist, and cannabis has reduced seizures. So according to the NICE guidance and best available evidence, doctors are obliged to try something in line with parent’s wishes)


53.If an AED has failed because of adverse effects or continued seizures, a second drug should be started (which may be an alternative first‐line or second‐line drug) and built up to an adequate or maximum tolerated dose and then the first drug should be tapered off slowly. (If they are willing to try a Ketog diet on the children they should be willing to try cannabis as the next option)

56.The decision to initiate AED therapy should be taken between the child, young person or adult, their family and/or carers (as appropriate) and the specialist after a full discussion of the risks and benefits of treatment. This discussion should take into account details of the person’s epilepsy syndrome, prognosis and lifestyle.

58.It should be recognised that some children, young people and adults (through their families and/or carers, in some instances) may choose not to take AED therapy following a full discussion of the risks and benefits. (again “patient centered care” and the patients want to try cannabis on very sick children where AEDs have not worked)

282 Children, young people and adults with epilepsy and their families should be empowered to manage their condition as well as possible. (That is not happening if they are not being offered cannabis when all else has failed)

On page 131; Expert opinion suggested that before combination
therapy is considered, adults and children should be given a trial of all appropriate monotherapy regimens, and that caution is needed during changeover periods between drugs. (again they could be trialing cannabis oil from Bedrocan or Tilray)

This statement crops up often in relation to the various AEDs being “tried” on patients. The considered evidence is poor and different patients react differently to the different drugs. There may be a need to try different options to get the balance right between seizure freedom and adverse effects. If the first AED is ineffective, a second AED should be added alongside the initial AED and if seizures are controlled, the first AED may be withdrawn.

Prescribing cannabis as an alternative to AED’s

So reading through the recommendations you might ask why clinicians are not prescribing cannabis within the NHS. In my opinion, its because prescribing cannabis is not “politically correct” due to the prejudices of those that have been put in charge that go back year.

For ten years, Spinal Manipulation by chiropractors or osteopaths were the NICE recommendations for acute low back pain. It did not matter to the powers that be in the NHS, they wanted the status quo and spinal manipulation was rarely made available in A&E. After ten years lobbying by sceptics of alternative approaches, the guidelines were changed and now recommending “exercise” for acute low back pain, as if anyone with acute low back pain is able to engage in an hours exercise?

In March 2018, the Prime Minister, Theresa May told Hannah Deacon that the Home Office was dealing with her request for a licence for cannabis oil for Alfie. The Home office then passed this “poisoned chalice” to the Department of Health, who sent a letter to all clinicians on October 31 telling them that the government has announced plans to reschedule certain cannabis-based products for medicinal use on November 1. The letter states that; “there is conclusive evidence of therapeutic benefit for certain medical conditions, and reasonable evidence in several other medical conditions”

So far so good, but then the recommendations become subject to political necessity rather than patient need.

“Due to the limited evidence base and their unlicensed nature, the government has chosen to restrict the decision to prescribe cannabis-based products for medicinal use to only those clinicians listed on the Specialist Register of the General Medical Council”.

NHS England expects that cannabis-based products for medicinal use should only be prescribed for indications where there is clear published evidence of benefit or UK Guidelines and in patients where there is a clinical need which cannot be met by a licensed medicine and where established treatment options have been exhausted.

Recommendations by “British Paediatric Neurology Association” (BPNA)

In October 2018 the BPNA hurridly produced their interim guidelines, based on 4 main English speaking sources and concluded; there was either insufficient evidence or limited evidence that cannabis‐based products were of therapeutic benefit in epilepsy and specifically that good quality evidence was confined to the use of cannabidiol (CBD) a legally available product in health food stores. (remember we are talking about prescribing for the 30% of patients who have been experimented with on with a whole cocktail of AEDs which have not helped and caused horrible side effects, according to parents )

2.4 UK government proposed prescribing framework:
2.4.1 Prescribing will be restricted to doctors on the Specialist Register, prescribing only within their relevant specialist registration.
2.4.2 There will be three access routes:
 Prescribing these products will
treated as “Specials”; in other words, in the same way as an unlicensed medication.
 As an investigational product in the context of a clinical trial
 As a medicinal product with a marketing authorisation

This “prescribing framework”, is so restrictive its not surprising so few prescriptions have been made, in fact it would be reasonable to ask why “Bedrocan” was prescribed for Alfi Digley if this is the prescribing framework. Presumably, because they are unable to refuse a parent as well informed as Hannah Deacon.

2.4.3 The assumption is that such prescribing is “a last resort” and “used only when no other drug with MHRA marketing authorisation meets the clinical need”.

2.4.4 Responsibility remains with the prescribing clinician.

An open‐label non‐randomised study from Canada examined the use of the product TIL‐TC150 – a cannabis plant extract produced by Tilray®, (containing 100mg/ml CBD and 2mg/ml THC) in twenty children with Dravet syndrome and has demonstrated some short‐term safety and dosing data and some evidence of effectiveness. However, the study was small, unblinded and had no control group and therefore does not constitute high quality evidence of either effectiveness or safety.

In David Sacket’s model of “Evidence Based Medicine” this small trial passes the test of “best available evidence” and is enough to guide a clinician’s decision who is out of options. I go into the concept of “evidence” in more detail in the “About” section of this site.


3.5 There is concern about the effect of exposure to THC on the developing brain of both the younger child and adolescent. There is evidence that chronic high exposure to THC during recreational cannabis use can affect brain development, structure and mental health. These effects are seen more clearly in adolescents than in adults. This is ridiculous because the cannabis oil used on Charlotte Finges was so low in THC no one would buy it and it was first named “The Hippies Disappointment”. As I said above, its the equivalent to not prescribing Calpol because adults have problems with paracetamol. Bedrocan oil has been made in Holand for many years and prescribed by their neurologists. It would appear the BPNA did not include any of their case studies in their review of evidence. Case Studies are not the best of evidence, but thats where you start in clinical science, when looking for new interventions after the old have failed. If the BPNA have genuine concerns about prescribing CO for children, they would start with a phase 2 trial before proceeding to a RCT, which will cost hundreds of thousands of pounds. The researchers would be accused of incompetence, to proceed to a RCT with no evidence from a phase two trial, after having many children who want to volunteer for a phase 2 trial available.

I would say clinicians thinking of prescribing are warned of by BPNA;

4 Background considerations for prescribers
4.1 While the changes put forward by the Home Secretary are moving CBPMs from Schedule 1 to Schedule 2 to allow their legal use, the responsibility for the prescribing and potential adverse effects of a CBPM prescription will remain with the prescribing clinician. The evidence base for the efficacy and safety of most of the CBPMs is extremely limited. You should be aware of the GMC guidance on the prescription of unlicensed medications. You should also investigate whether your medical protection insurance and hospital indemnity will cover you for the prescription of unlicensed CBPMs.

While the BPNA is happy with Sativex I believe the BPNA would have questions about CBPM’s produced by Bedrocan and Tiray who are independent . They would prefer production in the hands of the pharmaceutical industry, who would do their own trials and charge the price that suited them. This is the industry that destroyed a 600 years supply, 8,000 packs of Orkambi, a breakthrough medicine for cystic fibrosis because the NHS can’t pay the high price it wants to charge for the drug.

4.2 The MHRA has a standard of what constitutes a “pharmaceutical grade” product. Good Manufacturing Practice (GMP) ‐ the minimum standard that a medicine manufacturer must meet in their production processes; and Good Distribution Practice (GDP) ‐ medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions.

4.6 The GMC has published guidance on prescribing unlicensed medications. It states: “When prescribing an unlicensed medicine you must:
 be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy
 take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow‐up treatment

With all these protections in these guidlines, its extraordinary so many people die from prescribed medicines?

5.2 Prescription of a non‐licensed cannabis‐based product for medicinal use should be used as a treatment of last resort for children who meet the following three criteria:
5.2.1 Have
an epilepsy that has proven intractable to treatment with conventional licensed anti‐epileptic drugs given at therapeutic doses.
5.2.2 Have not responded to the ketogenic diet or for whom the diet
is
inappropriate.
5.2.3 Are not candidates for epilepsy surgery.

Clinicians should not feel under pressure to prescribe CBPMs until they have undergone appropriate clinical trials. We recommend that these products undergo randomised clinical trials for efficacy and safety before they are routinely prescribed in the UK.

5.9 We do not recommend the prescription of artisanal cannabis oils. These products will not meet GMP and GDP standards. They will contain both CBD and THC in varying quantities and proportions. Different batches of the same product may have different concentrations of constituents and the labelling of constituents may be inaccurate.

Dilemma for parents who can’t get cannabis on prescription

I would not disagree with this advice where children are involved, but to almost bracket homemade oil, with the oil you get from Bedrocan or Tilray and that pharmaceutical grade “Epidiolex” is all that is acceptable is unfounded and merley reflects prejudice to products produced outside the pharmaceutical industry.


5.11 We recommend that patients who are already taking other cannabis‐based products of GMP and GDP standard that contain higher proportions of THC (>0.2%) with apparent benefit are transitioned to CBD (Epidiolex®) until robust evidence emerges of these products safety and efficacy.

5.12 If a doctor feels under pressure to prescribe a medication that they believe is not in the patient’s interests, the doctor should follow the GMC guidance “Consent: patients and doctors making decisions together”29. Paragraph 5d states: “If the patient asks for a treatment that the doctor considers would not be of overall benefit to them, the doctor should discuss the issues with the patient and explore the reasons for their request. If, after discussion, the doctor still considers that the treatment would not be of overall benefit to the patient, they do not have to provide the treatment. But they should explain their reasons to the patient, and explain any other options that are available, including the option to seek a second opinion.”

Having read the BPNA guidelines, I would conclude they are uninformed in relation to the three pillars of “Evidence Based Medicine” proposed by David Sackett, to explore the potential for using low THC cannabis in the management of epilepsy. They do not follow on from the logic of the NICE guidelines in situations where AEDs have not been successful. I am sure advocates of the Ketotonic diet had similar problems getting this intervention included, even as a “last resort” in the guidelines when I believe conservative interventions should always be first choice as its the least invasive.

Just to reading the advice to GPs from the “The Royal College of General Practitioner“, about cannabis, explains the problem for parents seeking a prescription. The RCGP are the people who are responsible for the “Continuing Professional Development” of GPs. Their advice is like reading something ill-informed from the Daily Mail, they state: “It is a credit to the pro-cannabis debate that the legalisation issue has proved such an effective ‘smoke screen’ to health risks associated with the drug. It is hardly surprising that cannabis has health risks. It contains over 400 chemicals including 60 or so carcinogens and is a markedly stronger drug than 20–30 years ago. A ‘reefer’ in the 1980s contained about 10mg of 9-tetrahydrocannabinol (THC), the main active chemical, where as a ‘joint’ today may contain around 300mg THC” This cannabis is completly different from the stuff been given to children and for most theraputic uses.

I would have thought the people who developed the BPNA guidlines are unlikly to be clinicians, working every day with suffering children, academics I suspect, who have been brain washed by the pharmaceutical industry. The people who wrote the BPNA guidlines, remind me of the people in authority who looked the other way when people like Jimmy Savile and catholic priests were abusing children. How can anyone have so little empathy for suffering children who have been failed by the system. What is the point of getting a second opinion from a consultant whose hands are tied by GMC guidelines for prescribing? So in such situations, what is a parent to do? I had a decision to make when told my cancer was incurable and I know what I would do if medical doctors were not helping my child.

From the BPNA guidelines, I would conclude consultants are unlikely to prescribe cannabis for a child who is not responding to AEDs, because its so far removed from what they have been taught at university or post graduate CPD and the view of the RCGP reflet those prejudices. They are applying the worst case scenario of side effects, of an adolescent habitually smoking high strength cannabis, to justify their advice to clinicians. When the worst case scenario of badly managed chronic epilepsy is also mental health problems and the possibility of death. Fortunatly NICE do have “guidline” 196 for this eventuality for consultants unwilling to try the “best available evidence” from Tilray or Bedrocan.

196 Where families and/or carers have been affected by “Sudden Unexpected Death” (SUDEP) healthcare professionals should contact families and/or carers to offer their condolences, invite them to discuss the death,and offer referral to bereavement counselling and a SUDEP support group.

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