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UK: Patient died during cannabis drug trial

Russell Jenkins

The Times

Tuesday 13 Dec 2005

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A WOMAN taking part in trials of an experimental cannabis-based drug
appeared drunk and became so confused that she was admitted to hospital
where she later died, an inquest was told yesterday.

Rene Anderson, 69, of Frecheville, Sheffield, was prescribed the drug
Sativex by researchers to ease pain caused by diabetes. She developed
pneumonia, respiratory problems and died of kidney failure, the hearing
in Sheffield was told.

Some patients claim that cannabis-based medicines relieve their symptoms
and ease pain but Sativex has yet to win a licence in Britain, pending
further data from GW Pharmaceuticals, its manufacturer. It has been
licensed in Canada and can be used in Britain under special licence from
the Home Office, and at a doctor's discretion.

Yesterday the Royal College of Physicians said that more clinical trials
were needed into cannabis-based medicines, which appeared to be
beneficial in some cases.

Christopher Dorries, the coroner, said at the start of yesterday's
hearing that its purpose was to decide whether there was a "clear or
direct link" between the patient's death and the drug.

Mrs Anderson had suffered from diabetic neuropathy, a complication of
diabetes that causes extreme pain and numbness in the limbs. She was
considered to be a suitable candidate for the trial to find out whether
the condition would respond to a cannabis-based drug. Soloman Tesfaye,
the consultant in charge of the trial, told the inquest that he had
wanted to test claims made by users of cannabis.

Mrs Anderson was on the trial drug for 23 days. Dr Tesfaye said that on
the third day he learnt that things were "not quite right". Her family
complained that she appeared to be in a state of confusion, as if she
were drunk. The drugs company advised reducing the dose, and the
symptoms appeared to dissipate. But 18 days into the trial, Jackie
Sadler, the patient's daughter, told reseachers that her mother was
behaving strangely. Mrs Anderson was admitted to hospital several days
later after a series of hypoglycaemic attacks. She died on March 3 last
year.

John Shortland, the pathologist who conducted the post-mortem
examination, said he understood that Mrs Anderson's mental condition and
mobility had changed after taking the trial drug.

He was asked whether there was a relationship between Mrs Anderson's
mental problems and the physical "shut-down" that occured while she was
in hospital. Dr Shortland said: "There was a progressive decline and
worsening of her general condition. She developed acute renal failure
that required dialysis. I can only say that the two came together".

The inquest is expected to hear evidence from experts in cannabis
psychosis, a condition that is seen in some users of the drug. Sativex
contains two chemicals found in cannabis: tetrahydrocannabinol and
cannabidol.

 

 

 

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