Fibromyalgia remains excluded from medical cannabis legislation

The chronic pain disease, also known as the ‘invisible illness’, will likely be excluded from the Government’s plan for medical cannabis access. The HPRA’s report claims there is inadequate evidence but campaigners refute their findings.

“Can you hear me, Minister? Are you going to let me live, because right now I’m not living, this is merely an existence. Please recognise that we need access to medical cannabis and we need it now. We are patients, recognise our pain and don’t make us criminals.” (Anonymous patient experience from fibroireland.com)

The medical cannabis bill passed without any significant opposition in early December, contrary to the decades of dismissal the issue had seen previously. Yet now as the bill moves through the committee stage, the opposition voice is not that of fringe conservatives opposed to anything with the word ‘cannabis’ on it, but the very proponents who spurred it on.

A relatively unknown yet severely debilitating disorder called fibromyalgia has been recommended for exclusion from the Government’s compassionate access programme. Patients, researchers, politicians, and activists have reacted critically to what they see as a misguided attempt to limit the scope of this legislation.

The Health Products Regulatory Authority (HPRA), who issued the report directing Simon Harris’s decision, said that there is insufficient evidence supporting the efficacy of medicinal cannabis. It claims that there is not enough clinical data available to broaden access to fibromyalgia sufferers.

People-Before-Profit TD Gino Kenny, who introduced the Cannabis for Medicinal Use Regulation Bill in December, referred to the HPRA report as a “seriously flawed document”. He claims it underestimates the benefits of medicinal cannabis and has restricted access for reasons not consistent with that of other drugs.

FM-pic
Fibromyalgia is referred to as the ‘invisible illness’ because it shows no visible symptoms despite widespread pain.

What is Fibromyalgia?

Fibromyalgia patients endure an over-sensitised nervous system that heightens the response to stimuli and produces pain signals even without external stimulation. Noises, lights, and smells are amplified, while concentration and memory are problematic.

Most fibromyalgia patients suffer from a lack of sleep. Worse still, even when a full night’s sleep is achieved, it is non-restorative.

The body needs sleep to recover from pain, but since the disorder disrupts it, there is a cyclical effect of worsening pain.

Approximately one in five people in Ireland live with chronic pain. The condition costs €5.34 billion annually, translating as a -2.86% drop in GDP.


The Department of Social Protection says that:

  • Fibromyalgia is one of the most common causes of chronic pain
  • 21% of people with chronic pain report pain so severe they sometimes wish to die
  • The average duration of chronic pain is 4.9 years, although almost 20% of individuals with chronic pain have experienced it for over 20 years
  • 19% were diagnosed with depression as a result of chronic pain
  • 50-66% of individuals with chronic pain reported reduced ability to exercise, sleep, perform household chores, attend social activities, drive a car, walk or have sexual relations

Failure of conventional services

A diagnosis is only the beginning, however, as the current structures in place fail to help people with fibromyalgia.

“Public patients can be faced with a waiting period for up to several years to see a consultant rheumatologist,” says Ursula Hakman of FibroIreland.

Anti-epileptic drugs designed to dampen the nervous system like Lyrica and Neurontin are usually prescribed, but the side-effects often prove to be intolerable.

Hakman described herself as being completely unable to function due to brain fog while on the medication. “I stopped this medication a long time ago on the advice of my consultant,” she added.

Painkillers such as opiates and over-the-counter medications are also prescribed, but these often fail and result in nausea and dizziness. This is on top of the risks of toxicity and addiction that accompany such drugs.

One patient experience from FibroIreland.com reads: “The medication I have been prescribed over the years has made my quality of life worse. It has landed me in A&E with severe side effects on numerous occasions. I have thought about suicide at times because no doctor knows how to treat me so what’s the point in living this life?”

A 2006 study titled the ‘Pain in Europe Study’ reported that as many as 40% of chronic pain patients say their pain medication is “inadequate”.

The HPRA disagreed: “There are a large number of authorised medicines that are of proven effectiveness, and other non-pharmacological treatments available to treat the many factors involved in chronic pain.”

Hakman says her own experience of failed drugs ended with a pain consultant telling her there was “nothing we can do for you.”

Flawed science?

Clinical trials with flawed methodologies and biased results were called out by the report, citing these reasons among many in the need for caution and rationality.

Taylor Lyons, a research assistant working under the ex-chief drug adviser to the UK government Professor David Nutt, agreed with the HPRA thatthere is a lack of high quality clinical trials in humans.”

However, she added that “there is a vast body of evidence showing that certain cannabinoids have anti-inflammatory and neuroprotective functions which may help in patients suffering from fibromyalgia.”

Another point of contention is over the potential for drug abuse once a large number of patients have access to medical cannabis. The report specifically cites “concerns about misuse and diversion into the wider community.”

Lyons dismissed this reasoning as “extremely unfair as it undermines those actually suffering from [fibromyalgia] and prevents them from getting the relief that they require. My guess is that this is probably a more likely reason than a ‘lack of research’.”

The short-term effects of using cannabis are widely known, but the long-term effects are where the concerns of some scientists are. Potential effects such as chronic psychosis pose pertinent questions to legislators about the risks-versus-benefits.

Data on dependency, cognitive impairment, and an increased risk of suicidal ideation were all cited as major concerns by the report, which claimed that “no studies have evaluated the long term safety of treatment with cannabis products.”

Fine Gael Deputy Kate O’ Connell, a pharmacist by profession, dismissed claims in support of medical cannabis as both “madness” and “verging on the immoral”.

2016-06-10_new_21813669_I1
Fine Gael TD Kate O’ Connell: completely opposed to the liberalisation of medical cannabis laws.

“I see this Bill as undermining the current regulatory framework we have with the [HPRA] and the Pharmaceutical Society of Ireland, who are internationally recognised as the competent authorities,” she told the Oireachtas Committee on Health.

Echoing O’ Connell’s sceptical sentiments, Patricia Casey, a professor of psychiatry at UCD, lauded the Government’s cautious approach to the issue: “For now the evidence is very limited and the studies do not yet meet the criteria normally required by authorities charged with licensing new medications, i.e. randomised, controlled, double-blind trials in large numbers of individuals. The judicious approach of our Government is the correct one.”

At a separate session, TD Richard Boyd Barrett told the Committee that GPs could safely assess a patient’s needs and suitability for treatment based on their background and medical history. The majority of access programs in Europe dispense cannabis through pharmacies with a prescription.

Gino Kenny’s criticism of the HPRA extended to the report’s position on other access programmes and their distribution models: “The HPRA does not explain why it doesn’t advise on these legislative options. Why is good practice in countries like Germany, Australia, Canada, the US, and Italy not suitable for Ireland?”

Germany grants access

In mid-January the German parliament’s lower house approved medical cannabis for a wide range of illnesses common to other access programmes. Conditions like glaucoma, AIDS related appetite issues, chronic pain, and Tourette’s will receive treatment as per the doctor’s orders.

When asked to comment on the general acceptance of chronic pain in international contexts, the HPRA’s public office said “the HPRA cannot comment on the position taken in relation to medical conditions by these countries.”

Despite this, the body’s report claims to have examined the “relevant scientific reviews and publications available worldwide, as well as the international approaches to cannabis for medical use.”

The Irish Pain Society’s official response suggests that the HPRA contradicted itself by recommending against the inclusion of chronic pain despite acknowledging that chronic pain is the most researched indication for cannabinoids.

“The majority of clinical studies, meta-analyses and systematic reviews cited in the HPRA report conclude that cannabis or individual cannabinoids afford moderate to substantial benefit to patients with chronic pain.”

The ‘dope molecule’

So how does medical cannabis actually work? Cannabis Sativa comes in many varieties and has been used for all manner of reasons over thousands of years. Hemp is used in everything from building materials to furniture, while marijuana is the strain most associated with dope.

The cannabis plant has over 60 cannabinoid molecules, three of which bind to cannabinoid receptors in the brain. These include phytocannabinoids, synthetic cannabinoids, and endocannabinoids. A phytocannabinoid called tetrahydrocannabinol (THC – the ‘dope molecule’) is the primary psychoactive component of cannabis and is the centre of studies trying to understand the plant’s analgesic effects.

Another point of interest is cannabidiol (CBD), a non-psychoactive molecule that has been linked to anti-inflammatory and analgesic effects. A July 2016 paper published in the Canadian magazine, Practical Pain Management, set out to review some of the current literature available on medical cannabis. It noted that “when the CBD percent amount is four times or more higher than the THC percent amount, there are minimal to no psychoactive effects.”

There is no mention by the HPRA about the four-to-one ratio for neutralising psychoactive effects, however.

Over to the Committee

As of now, activists, organisations, and parties such as the PBP are lobbying for Kenny’s vision of unrestricted medicinal cannabis legislation.

“We need the Bill or the HPRA restrictions will apply for at least five years. More than 90% of those that would benefit from [cannabis] need the Bill to make access real,” says Gino Kenny.

The bill continues to be debated by the Oireachtas Committee on Health but as of yet there is no indication that restrictions will be amended to include chronic pain sufferers such as the fibromyalgia community.

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