Patient died during cannabis drug trial

[Micklemouse]

Britain

The Times December 13, 2005

Patient died during cannabis drug trial
By Russell Jenkins
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.



End of article. Basically, this was an accident waiting to happen. Can't find any info on contraindications or side effects for Sativex, but Nabilone is not recommended for the elderly(the patient was 69), lists psychotic features among it's features, as well as decreased appetite, which is something you do not want when you have diabetes - the patient was admitted to hospital after a series of hypoglycaemic attacks, i..e severe lowering of blood sugar, generally caused by not eating or not taking blood sugar stabilisers, which is something that psychotic diabetics are prone to do. Sorry to all the psychotic diabetics out there if that seems inflammatory, but the statement comes from experience.

If anything the clinicians responsible for prescribing this are the ones who should be on trial, not Sativex.