Patient died during cannabis drug trial

Discussion in 'Cannabis & Health' started by Micklemouse, Dec 14, 2005.

  1. Micklemouse

    Micklemouse Platinum Member & Advisor

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    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.
     
  2. IHrtHalucingens

    IHrtHalucingens Palladium Member

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    Are they sure it was the drug that killed her? (sry if the article answered this question but im really stoned and cant concentrate long enough to comprehend the whole thing) but ne way couldnt it have been a pre-existing problem?
     
  3. Alfa

    Alfa Productive Insomniac Staff Member Administrator

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    CALL FOR CANNABIS TRIALS TO BE HALTED AFTER MOTHER DIES
    The family of a diabetic woman who died after developing mental problems while undergoing a cannabis-based treatment have called for trials of the drug to be halted.
    A coroner decided yesterday that Rene Anderson's reaction to the drug Sativex was a "significant contributory factor" in the onset of the illness which killed her.
    Mrs Anderson, 69, a retired supermarket worker, was taking part in a trial to determine whether cannabis-based treatments could help relieve the effects of diabetic neuropathy which caused nerve pain in her hands and feet.
    She was said to have developed "disturbed behaviour" within hours of taking Sativex in September 2003 as part of the Diabetes UK-funded project at the Royal Hallamshire Hospital, Sheffield.
    Mrs Anderson began telling her family that there were X-ray cameras on the roof of the house, that the police had planted drugs at her home and officers were circling in a helicopter.
    Her family contacted the hospital, describing her as "confused and intoxicated" and within three days the level of the drug was reduced.
    After she had been taking the drug for 28 days, her family reported her as "not the same person" and she was admitted to the Royal Hallamshire where her physical condition dramatically worsened.
    Mrs Andreson then became immobile and suffered from a range of problems. She died of acute kidney failure on March 3 2004 after being transferred to the city's Northern General Hospital for renal treatment.
    Chris Dorries, the Sheffield coroner, recorded a narrative verdict after a week-long inquest in the city.
    He said: "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."
    Jacqui Sadler, Mrs Anderson's daughter, said after the inquest that she believed her mother had been used as a guinea pig and called for the trials to be scrapped.
    She said her mother, who had two children and four grandchildren, had decided to go on the trial of the drug - which is licensed in Canada - as a last resort.
     
  4. Creeping Death

    Creeping Death Iridium Member

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    She might have had a reaction to one of the other chemicals in Setivex. It's not uncommon for people to die while testing experimental drugs.
     
  5. Woodman

    Woodman A very strange person. Platinum Member & Advisor

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    Oh my God.

    The poor woman was "stoned" to death!
     
  6. Colby

    Colby Newbie

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    thats pretty crazy ive never heard of a canabis overdose, wierd..
     
  7. Colby

    Colby Newbie

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    and it could have just been her time to go too, u never know, i just really dont think she overdosed on weed
     
  8. Muirner

    Muirner Gold Member

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    This is true, but also the other drug she was taking, if the side effects are read, which mickle. was nice enough to post for us, then we'd all know that she was taking pills that would suppress the appitite. As we all know Diabetics, have a tough time maitining/regulation the blood sugar. Most have to eat to keep the sugar at an acceptable level. If it drops to low then that's the end, either coma, faiting, passing out, ect and so on. SOO maybe that sativaex didnt do it to her, but they are looking for something to blame it on, not on the hunger suppression pill no way

    Muirner
     
  9. hazeinmybong2

    hazeinmybong2 Newbie

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    I've never heard of Sativex. THC and canabanoids. I've only had marinol in the states and it was weak. They were 5mg little orange gellies I chewed them and it had a small amount of liquid in it. I ate four and caught a small buzz. Anyone else every try marinol?
     
  10. Sklander

    Sklander Silver Member

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    Weed didn't kill her. She was 69. Apparently Mother Nature killed her. It happens.
     
  11. Micklemouse

    Micklemouse Platinum Member & Advisor

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    Just to clarify, the side effects listed were for Nabilone, a synthetic cannabinoid. basically the U.K. version of Marinol. When I first posted the story I couldn't find a side effect profile of any descrption for Sativex itself, so chose to go with the nearest option. Neither could i find much else on the story other than the article posted. However...


    Press release (http://production.investis.com/gwp/pressreleases/currentpress/2005-12-16/)

    Statement In Response To The Verdict Of The Inquest Into The Death Of Mrs Rene Anderson

    "16/12/2005

    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.”
    - Ends -
    Enquiries:

    GW Pharmaceuticals plcMark Rogerson, Press and PR+ 44 7885 638810Weber Shandwick Square MileKevin Smith/Rachel Taylor + + 44 20 7067 0700

    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."


    (Press release ends)




    Given knowledge of past psychiatric and medication history, probably not the most suitable candidate for a trial of this nature.
     
  12. rideburton56

    rideburton56 Silver Member

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    OH MY GOD A 70 YEAROLD DIABETIC DIED

    IT MUST HAVE BEEN THE POT

    ive never seen such shameless propaganda
     
  13. rsmo

    rsmo Newbie

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    Marijuana based medicine?!?

    If they put a whole bunch of other chemical and also add marijuana content
    and if something goes wrong... then it must be weeds fault...

    I wonder if maybe her age had something to do with her death


    naw... its the weed
     
  14. snapper

    snapper Gold Member

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    Gotta wonder what the family's agenda is. Some people need to find someone or something to blame for whatever misforture befalls them. They may have some kind of anti-drug agenda. either way, it does not sound like the trial did it. More likely, the family feels the need to blame it on something, because god forbid that she could have actually died from hyperlipidemia (which can cause dementia), diabetes (which can cause dementia), hypertension (which can cause dementia) and old age (which can cause dementia). Oh, and don't forget the drugs like all the benzos, antipsychotics, tramadol, etc.
    These people are seriously deluded to have blamed it on the cannabis derivative.
     
  15. D.U.M.B

    D.U.M.B Gold Member

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    the woman was on so many different drugs she was bound to die at some stage with drug related problems. It doesn't matter if she was 70 or 17 taking that amount of drugs with her other conditions would kill many of my fellow SWIMMERS.They blame the weed but not the hundreds of other chemicals in her bodies. Ya think maybe it has something to do with the fact those other chemicals come from prescription drugs that companies make millions off each year.

    When you could just grow some dope instead for a fraction of the price

    For shame I say to those mega rich drug producing companies. You killed this woman not weed.
     
  16. Nagognog2

    Nagognog2 Iridium Member

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    Patient arrived in hospital with 17 gunshot wounds, 33 deep stab wounds to upper thorax, both legs blown off, and a marijuana cigarette. Patient died from marijuana poisoning.