Could cannabis derived Sativex have killed a trial patient? Or was it the Ethanol carrier?
This is a tragic story. On the 3rd of March 2004, 69 year old Rene Anderson passed away as a result of a combination of complications, six months after ceasing a three week trial of the drug Sativex.
Sativex is a cannabis derived drug that contains the cannabinoid components delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). It is administered through a spray pump under the tongue or on the inside of the cheek.
Mrs Anderson developed symptoms of confusion and intoxication effects three days into the trial and eventually, after 23 days, stopped taking Sativex. Four months after ceasing the trial, a urine test showed no signs of the drug in her body. Sadly, her condition worsened to the point where she suffered numerous serious complications and eventually passed away in hospital.
The coroner, Christopher Dorries, who examined Mrs Anderson made a number of findings:
(Mrs Anderson died from) 'acute renal failure, acute tubular necrosis, ARDS following resolving pneumonia due to immoblility arising from "toxic brain syndrome", and diabetes mellitus'.
He went on to state that (the) 'initial drug reaction, whether in combination or singly, must have been a significant contributory factor in at least the initiation of the illness'.
The 'Manufacturing Chemist' website carries a report on the inquest which says in part:
'Mrs Anderson's immobility was unresolved despite over four months of hospital care and complicated by a wide range of other drugs,' stated GW* following the verdict. The company reported the other medications to have included tramadol, haloperidol, nitrazepam, simvastin, citalopram, losartan, frusemide, atenolol and doxazosin, a number of which specifically name 'confusion' as a side-effect, and Dorries did raise the possibility of 'serotonin syndrome', in which the interaction of drugs leads to an excess of serotonin in the brain, before saying that he 'found little reason to believe that this syndrome alone has brought about Mrs Anderson's death'.
*GW refers to GW Pharmaceuticals, the company manufacturing Sativex.
Mrs Anderson had a history of diabetes mellitus for 25 years and suffered from resistant hypertension, clinically significant depression and hyperlipidaemia (excess lipids in the blood).
A number of articles about this case appeared in newspapers and journals in 2005. However, there seems that another significant factor was never mentioned in any of the reports.
Sativex contains Ethanol.
The leaflet that comes with Sativex carries this warning:
Warning:
This product contains approximately 50% v/v ethanol. Each spray contains approximately O.04g of alcohol. The usual daily dose will be greater than one spray. It may be harmful for those suffering from alcoholism. However, this should be taken into account if you have a condition which may be affected by alcohol, such as liver disease, or epilepsy.
Another problem with this is that alcohol is bad for diabetics. Long term consumption of alcohol will lead to low blood sugar levels (Hypoglycemia).
The MedicineNet site states:
If a person does not or cannot respond by eating something to raise blood glucose, the levels of glucose continue to drop. Somewhere in the 45 mg/dl range, most patients progress to neuro-glyco-penic ranges (the brain is not getting enough glucose). At this point, symptoms progress to confusion, drowsiness, changes in behavior, coma and seizure.
Now, given that some studies have shown that THC can increase the effects of ethanol, could it be possible that this combination resulted in exacerbating Mrs Anderson's Diabetes condition to a point where she developed further complications, ultimately leading to her death? Is it possible that a non-ethanol based form of Sativex may have prevented her death? I don't know, but it would be interesting to hear from some experts who may be able to study this theory further.
Thanks to Max at the 'Sports Blog' for piquing my interest in this story.
I'll leave the final comment to 'Schmoo', whose blog entry prompted me to follow this story up:
Ironically there is no record of anyone ever dying from cannabis - until a drug company tried to 'make it safe'.
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