How to Devise Your Own Clinical Trial

As activists, particularly those of us concerned with
the provision of medicinal cannabis to people who are
seriously ill, it's often too easy to overlook the
fact that the politicians and bureaucrats we need to
win over are human beings, too. When someone suffers
on a daily basis from a condition which only cannabis
appears to alleviate, it's hard not to take it
personally when they're told that they can't smoke
pot. Makes you wonder what so-called health officials
in their jobs for, since they don't seem to care about
your health. But public officials must operate within
a framework of bureaucratic responsibility.

Ministry of Health officials would be incompetent if they weren't informed of international developments in the movement toward medicinal cannabis and they would be negligent if they weren't interested in making some progress on this issue in New Zealand. In reply to inquiries, the Ministry has repeatedly stated that cannabis can only be authorised for use as a part of a properly constituted research study and that no such studies have been proposed in this country. However, recent communications have clearly indicated that the Ministry is more than willing to receive properly prepared applications to use cannabis therapeutically, so long as certain provisions are satisfied.

Like they've been saying since 1995, any approved use of cannabis can only be in the context of a clinical trial. An ethics committee would require the trial protocol to identify the symptoms to be controlled (the primary end-points) and any other gains in health status that may occur (secondary end-points) and detail objective measurement techniques to assess effectiveness over a limited period of time. If that seems like a tall order, remember that it's not unreasonable to expect to collect some data from experimental use of cannabis. Bearing this basic requirement in mind, a letter to Greg Soar of Green Cross*, from the Associate Minister Of Health, Tariana Turia, makes the following points in regard to any prospective applications to use cannabis :

1. Any therapeutic use of cannabis must be under the authorisation of a medical practitioner.

The doctor who is to dispense the pot and collect the clinical data pertaining to its usage must submit the application to prescribe. So, the whole process starts with a sympathetic doctor who is prepared to go the distance with you.

2. To be approved for a therapeutic purpose, the cannabis must be manufactured to a quality standard and have uniformity of dose. Standardisation would be 'extremely difficult, but is possible'.

As we know, it wouldn't be too difficult to obtain a plant with a known cannabinoid profile. Any clones from this mother plant would have an identical, or 'standarised' cannabinoid profile.

3. If standard cannabis in a controlled dose were available, it could be considered for use in a clinical trial.

The Associate Minister mentions standardised cigarettes (joints), but a vaporiser would be a better method of administration, obviating the smoking issue and providing a more precisely controlled dose.

4. In order for the Minister of Health to grant permission to use cannabis therapeutically, the use must be part of a bona fide clinical trial, which must also be approved by the Police.

A bona fide trial is one that's been devised by doctors and approved by a review panel. The only legitimate concern of the Police is security. As the space needed to produce a continuous supply of standarised cannabis via a hydroponic system is no bigger than a large closet, it would be feasible to grow medicinal cannabis securely in any Police station.

5. Ministry of Health staff would be willing to discuss the possible design of a clinical trial application for evaluation by the Health Research Council pursuant to section 31 of the Medicines Act 1981.

This is a fairly unequivocal message that they want to help. So, once you've found a sympathetic doctor to make the application and/or a specialist willing to devise a trial protocol, tell them to get in touch with the Ministry for advice, which will be forthcoming.

6. The GP or Specialist who is interested in pursuing such a trial should contact this person for further details on what would be required: Dr Stewart Jessamine, Medsafe, Ministry of Health, PO Box 5013. Wellington. Phone (04) 496 2274

* The full text of the Associate Minister's letter can be found on the Green Cross web site www.greencross.org.nz

By Russell Cronin

30/10/01

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Published on: 2003-03-05 (4714 reads)