REGULATORS ACCUSED OF BIAS AGAINST CANNABIS BASED MEDICINES

A select committee of Britain's House of Lords this week accused the
Medicines Control Agency of not dealing with cannabis based medicines in
the same impartial manner as it dealt with other medicines. In its
report it said that the agency's insistence that new toxicology data
were needed on one of the 60 cannabinoids present in raw cannabis would
delay the approval of new cannabis based medicines, which patients with
severe conditions, such as multiple sclerosis, needed. The select
committee on science and technology also deplored the "postcode
prosecuting" of people who used cannabis for their own therapeutic
purposes. It called for an end to the prosecution of genuine therapeutic
users who possessed or grew cannabis for their own use. It claimed that
the medical authorities were making it more difficult than necessary for
drug companies to produce cannabis based medicines.

So far only two trials into cannabis based products had been approved by
the Medical Research Council, one in Derriford Hospital, Plymouth, and
one in Hammersmith Hospital, London. Only one of those had started
recruiting patients. The committee was particularly critical of the
Medicines Control Agency for "not approaching the question of licensing
cannabis based medicines in a properly balanced way, especially given
the long-established history of cannabis use and the needs of patients
for whom there is no medicinal alternative. "To end the delay in the
development of an effective cannabis-based medicine, we recommend that
the MCA [Medicines Control Agency] should reconsider their position on
the licensing of medicines containing cannabidiol [one of the 60
cannabinoids in raw cannabis]." The agency had said that it was
satisfied enough with the toxicological profile of
delta-9-tetrahydrocannabinol (THC) for it to be used in trials but that
it was unhappy with the toxicology data on cannabidiol, in particular
the evidence that it inhibited spermatogenesis in animals.

The committee pointed out that the studies which the agency took to
indicate an inhibition of spermatogenesis involved doses at least 100
times higher than the doses contemplated. "The attitude of the MCA in
not allowing patients to make their own decisions could be regarded as
over-protective," the report said. It could delay the production of a
useful medicine by the pharmaceutical company, GW Pharmaceuticals, by
two or three years. The report added, however, that since February, when
the committee had taken evidence from the agency, the agency had
conducted a review of its decisions on cannabis and was considering
modifications to its position. The committee, which is chaired by Lord
Winston, said that it stood by its original recommendation that cannabis
should be rescheduled from a schedule 1 to a schedule 2 drug under the
Misuse of Drugs Regulations Act 1985, in order to facilitate research
(BMJ 1998; 317:1337). The select committee's report is available at
http://www.parliament.uk .