Wednesday 27 June 2018

Medicinal Cannabis: Some Comments













Medicinal Cannabis: Some Comments

Deputy Montfort Tadier was back on the case with a very topical question on medicinal cannabis

Question

Will the Minister outline his understanding of the legal and practical barriers that currently exist within his portfolio for the importation of medicinal cannabis; and will he advise what steps, if any, have been taken to resolve these issues?

Answer

On 28th December 2017, the Chairman of the Misuse of Drugs Advisory Council wrote to the Minister for Health and Social Services recommending that Bedrocan, Bedrobinol, Bediol and Bedica are rescheduled to allow their import into Jersey by the hospital pharmacy and for prescription by hospital consultants. The letter included an update on the practicalities of importing medicinal cannabis products and can be viewed at:

[A link follows]

In the event that the products recommended by the Misuse of Drugs Advisory Council are re-scheduled to allow their importation into Jersey, officers from the Customs and Immigration Service would have no legal basis to prevent their importation on arrival in the Island.

Arrangements to facilitate the arrival of the products into the Island continue to be pursued by the Health Minister and his officers.

The re-scheduling of cannabis based products is not a policy responsibility of the Minister for Home Affairs.

Comments:

The link itself does not work, but looking through the links on FOE for that date one finds this FOE which is the right one.

“I would like the minutes of every meeting but especially the misuse of drugs advisory councils minutes since (name redacted) became its chairman specifically where cannabis and cannabis based products were discussed.”

Response

“The Misuse of Drugs Advisory Council (MDAC) minutes relating to Cannabis and Cannabis based products are provided with the exception of the 12 December 2017 meeting. The minutes of 12 December will not be provided at this time as they have not yet been approved by the meeting and the MDAC considers that the information is exempt under Article 35 of the Freedom of Information (Jersey) Law 2011 (the FOI Law).”

These note the following reports

“Cannabis: The Evidence for Medical Use” by Professor Michael P Barnes MD FRCP

“Access to medicinal cannabis: meeting patient needs” All-Party Parliamentary Group for Drug Policy Reform, Inquiry Report.

And from minutes:

“X stated that the research appears to shows that there is a wide range of conditions for which cannabis may be used, but these must be regulated medicinal products, and that a recommendation of rescheduling should be made in order to enable appropriate use and further research in such medicinal products. She added that the Barnes report refers to other medicinal products which should be researched. She added that while benefits of medicinal cannabis are being considered, it must also be remembered that it can be harmful.”

Looking through the minutes later on, there is a clear distrust of leaving medication prescription of such products in the hands of GPs.

“The prescribing figures received from showed that benzodiazepines, pregabalin and zolpidem were higher in Jersey than the UK. suggested that home detox prescription of chlordiazepoxide might be responsible for higher figures – were GPs doing detox by themselves?”

“X noted that the number of over prescribing GPs had remained at around 20, the same as the last time the Council reviewed the figures. She also noted that each GP has an annual appraisal and the third year figures would soon be available which might show a trend in prescribing.”

The minutes, as stated, run out before 12 December 2017, and we therefore have to rely on the JEP and other news agencies for the next step on 17 January 2018:

“TWO suppliers of cannabis-based products are likely to be reclassified to allow their prescription in Jersey, while Sativex – a cannabis-based painkiller – will be available free of charge from next week when prescribed by a hospital specialist, the Health Minister [Andrew Green] has said.”

The Minister also said that: “A key recommendation of the Misuse of Drugs Advisory Council was that if cannabis-based products were to be used for medicinal purposes they should be quality assured. They must be produced to GMP standards and they must meet those standards consistently.”

ITV news noted on 22 January 2018:

“People in Jersey will be able to receive a free prescription for a cannabis-based painkiller from today. Sativex is used to relieve muscle pain associated with conditions such as Multiple Sclerosis. It was previously only available on private prescription but will now be provided for free if prescribed by a specialist at Jersey's hospital.”

The specialist prescription model suggests that this is a response to what appears to be a distrust of ordinary GPs to be able to prescribe these products – the “over prescription” of some other drugs noted earlier.

But matters are moving very slowly, and the range of ailments for which the medicinal cannabis can be prescribed is very narrow. Deputy Tadier is concerned that it is taking too long for the States to approve them, as the issue has "not been given political priority"

The case of Billy Caldwell is a good illustration as the cannabis oil he had been prescribed abroad was for epilepsy, not as a painkiller.

On June 25, the FDA approved a cannabis-based drug CBD for epilepsy, noting that “Epidiolex is made using cannabidiol but doesn't contain high-inducing THC”. As Maggie Fox reported on NCB News: “The new drug, Epidiolex, is a formulation of cannabidiol — CBD for short. It’s derived from cannabis but doesn’t contain the THC that recreational users value for providing “highs.". It is however restricted at present to particular forms of epilepsy.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said the FDA’s Dr. Billy Dunn.

“In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”

He noted that he FDA would review legitimate applications for approval but said the agency needed solid scientific studies that demonstrate whether a product actually works and is safe.

The scientific research is solid – the Epilepsy Foundation notes that Epidiolex has undergone “gold-standard studies (double-blind, placebo-controlled studies) for difficult epilepsies such as Lennox-Gastaut syndrome (LGS) in children and adults and Dravet syndrome in children.”

Professor Deb Pal, Professor of Paediatric Epilepsy, Institute of Psychiatry, Psychology & Neuroscience at King’s College London, said:

“There is now good evidence from clinical trials conducted in the US and Europe that pharmaceutical preparations of cannabidiol are effective against two types of severe childhood epilepsy known as Dravet syndrome and Lennox-Gastaut syndrome. These types of epilepsy are often resistant to conventional antiepileptic drugs.”

Professor Celia Morgan, Professor of Psychopharmacology, University of Exeter, said that while Billy's cannabis oil was not the same as the FDA approved drug, these results all pointed the same way::

“Trials have largely focused on pharmacological preparations, but the active ingredients in Billy’s cannabis oil are the same as those tested in trials which have been shown to be effective in humans e.g. THC and CBD. As a result of research and clinical experience, cannabidiol has been given a special drug designation by the Food and Drug Administration in the US for the treatment of childhood epilepsy – which I would say is evidence that a scientific consensus exists.”

No comments: