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Anger as Cannabis Drug Fails MS Trial.

By admin | December 7, 2004

The Guardian
By Heather Tomlinson
Dec 4, 2004.

A multiple sclerosis treatment made from cannabis has been rejected by UK regulators, outraging patient groups who say it has benefits for sufferers.

The news that Sativex cannot go on sale sent the shares of GW Pharmaceuticals, the company developing the drug, down 25% to close at 106.5p. The news precedes a meeting between Home Office and Department of Health ministers next week.

The meeting was prompted by MPs’ concerns that MS sufferers are having to buy cannabis off the street to relieve their symptoms. The meeting had planned to look at ways of getting the treatment out more quickly.

“The [regulator] has failed to listen to those with MS who reported positive and sustained benefit from Sativex, in a properly designed and statistically significant trial,” said Christine Jones, the chief executive of the MS Trust. “I hope the [regulator] will reconsider their position and give some thought to the impact of this decision on the lives of those with painful, chronic disease.”

The MS Society said the news was “extremely disappointing”.

Sativex is a nasal spray made from extracts of cannabis plants, which the Home Office allows GW to farm for medical purposes. It contains THC – the compound in cannabis that causes the “high”.

The committee on safety of medicines told the firm that it will have to conduct another clinical trial before the spray can be licensed for sale because it is not sure of its benefits. The firm already has a trial under way which it intends to model to the regulator’s requirements but it will not be completed by the end of next year at the earliest.

The firm also intends to appeal the decision to the Medicines Commission, a separate body. This will take six months. It will also try to get approval from the Home Office to sell it unlicensed.

The CSM had said it is happy with the safety of the drug and the quality of the manufacturing. It is an unusual drug to make because it is farmed from plants.

GW has data that demonstrates the drug reduces a number of MS symptoms. But it decided to choose one particular clinical trial to put in front of the regulators, which tested the drug’s reduction of muscle spasms. This is hard to measure objectively, but GW said it focused on this because it was advised to by UK regulators. The CSM told GW that that the data might not be “clinically relevant”.

“The only issue left is not does it work, it is: is the size of the effect one that the patient believes is meaningful?” said Justin Gover, the managing director of GW Pharmaceuticals.

He added that the problems will not cost it any more cash. The company has enough money left to cover costs for 18 months, but Mr Gover said that approval for sale in Canada might bring in revenues before the cash runs out.

The news did not impress the City. “The bottom line was that the regulators were not convinced that he had shown it had made a difference that mattered to patients,” said Erling Refsum, an analyst at investment bank Nomura. “It was GW’s fault for doing a trial without using an end point regulators were happy with.”

Scientists expressed surprise at the outcome. “I am very disappointed that the CSM has not followed my recommendation that the data fully supports the approval of Sativex,” said Professor Mike Barnes, the president of the World Federation of Neuro-rehabilitation, who has “long and substantial” experience of treating MS patients and is independent of the company.

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