During the course of this week, an inquest has taken place in Sheffield into the death of Mrs Rene Anderson. Mrs Anderson, a 69 year old diabetic, died in March 2004. One of the factors in her case, which has received media attention, is that she had taken part in a Sativex clinical trial over a three week period during October 2003.
In his verdict at the end of the inquest today, the Coroner stated that “Mrs Anderson died on 3rd March 2004 in the Northern General Hospital as a consequence of prolonged immobility following an illness for which she had been admitted on 28th October 2003. On the balance of probabilities, an idiosyncratic reaction to a trial drug (either alone or in combination with other medications) was at least a significant contributory factor to the initiation of this illness.”
While the case is very sad by its nature, GW does not believe it raises any new or additional safety concerns about Sativex.
The term idiosyncratic reaction was defined by the Coroner as unusual, unexpected and individual. For this reason GW believes it has no wider relevance for patients or for the medicine. Importantly:
Mrs Anderson took a very low dose of the medicine over a very limited period of time.
Confusion is listed on the product information as an effect that can be associated with Sativex, and in the rare cases where it has been observed it has been fully reversed on withdrawal.
Mrs Anderson’s immobility was unresolved despite over four months of hospital care and complicated by a wide range of other drugs.
Dr Stephen Wright, R&D Director of GW, said: “GW Pharmaceuticals extends its condolences to the relatives and friends of Mrs Rene Anderson. This was a unique case. Whatever the sad cause of Mrs Anderson’s death, it does not mean that Sativex is dangerous for patients even if it may have been one of several factors to have caused Mrs Anderson’s initial confusion.
“All relevant information concerning this case was passed to the regulatory authorities at the time according to standard procedures and has been included in all safety information subsequently provided to clinicians and regulators. Since that time, Sativex has successfully undergone rigorous clinical assessment as to safety and quality, and has been licensed as a medicine in Canada. We do not believe that this case has any negative consequences for the regulatory progress of Sativex.
“The extensive safety data on Sativex is very reassuring. GW has been carrying out clinical trials in patients with serious and life-threatening diseases including multiple sclerosis, cancer, and diabetes mellitus since 1999. More than 2,000 patients have taken part in the company’s clinical trials, generating more than 1,000 patient-years of exposure. Within this experience, Sativex has consistently shown itself to be safe and well-tolerated by patients.”
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Notes to Editors:
The inquest into the death of Mrs Rene Anderson commenced on 12 December 2005. Mrs Anderson was 69 years old with a 25 year history of diabetes mellitus, and also suffered from resistant hypertension, clinically significant depression and hyperlipidaemia. She died in March 2004.
One of the factors in her case, which has received media attention, is that Mrs Anderson had taken part in a Sativex clinical trial over a three week period during October 2003. Mrs Anderson’s total exposure to Sativex extended to a total of 42 doses (a total of less than four days worth for a typical patient). During October 2003, Mrs Anderson developed confusion and other intoxication effects and stopped taking Sativex. At the end of October 2003, a full four months before her death, a urine test confirmed that there was no presence of cannabinoids in her body.
A further period of four months of hospital inpatient care passed prior to Mrs Anderson’s death in March 2004 after pneumonia and kidney failure, during which time she received numerous medications under the direction of various doctors.
There were a number of other potential causes of confusion in this patient. Mrs Anderson was also taking a wide range of other medication both before and after her brief involvement in the Sativex trial, including tramadol, haloperidol, nitrazepam, simvastin, citalopram, losartan, frusemide, atenolol and doxazosin. All these medicines have side effects of their own, and a number list confusion on the product label. There are over 50 prescription medicines which list confusion as a side effect.