SARA CARLIN INQUEST RECOMMENDATIONS
source
http://www.insidehalton.com/news/article/840376--this-jury-listened
RECOMMENDATIONS DIRECTED TOWARDS THE MINISTRY OF HEALTH AND LONG-TERM CARE
1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System.
This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.
2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.
3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.
4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.
5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent `copy cat' suicides from occurring.
6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.
7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.
RECOMMENDATIONS FOR THE ONTARIO COLLEGE OF PHYSICIANS AND SURGEONS AND THE ONTARIO COLLEGE OF FAMILY PHYSICIANS
8. The Ontario College of Physicians and Surgeons and the Ontario College of Family Physicians should develop practice guidelines and training to family physicians on administering and monitoring the use of selected serotonin reuptake inhibitors (SSRIs). Those guidelines should include, but not be limited to the following:
Prior to prescribing SSRIs the physician should:
• Give the patient a physical examination.
• Request laboratory investigations, including drug screen where appropriate.
• Inform the patient of the benefits and risks, inclusive of rare and serious side effects of SSRIs.
• Inform the patient of all reasonable alternative treatments.
• Inform the patient of the treatment plan should SSRIs be prescribed.
• Discuss with the patient alcohol and substance abuse as confounders in the illness.
B: Emphasize to physicians that best practice monitoring patients for drug-related adverse events arising from the introduction of SSRIs includes a regime in which the physician should monitor the patient with weekly visits for the first month, biweekly visits for the second month, and with a following visit in the third month. This effectively would monitor the period of time with the greatest risk for the development of serious drug-related adverse events.
C: Encourage physicians to utilize tools created to monitor both disease symptoms and adverse events of patients undergoing treatment with SSRIs. An example of such a tool is the SSRI Monitoring Form for Children and Adolescents developed in June of 2009 by the British Columbia Children's Hospital in Vancouver, British Columbia.
D: Emphasize to physicians that while having due regard for the relevant health privacy legislation in the jurisdiction of the medical practitioner relevant to capacity and consent; patients undergoing treatment should be encouraged, repeatedly if necessary, to allow communication and engagement of family members, guardians and/or trusted friends by their treating physicians to ensure that the patient and their supports are aware of the nature of their disorder and the potential side effects of prescribed medications and can assist in the monitoring for adverse drug-related events.
RECOMMENDATIONS TO THE ONTARIO HOSPITAL ASSOCIATION
9. The Ontario Hospital Association should inform its hospital members that patients suffering with mental health disorders including depression, anxiety and substance abuse and attempted suicide may present for treatment to their hospitals and emergency department. While respecting the Personal Health Information Protection Act, 2004 every effort should be made to obtain consent from the patient to allow the release of the medical records compiled to the patient's treating family physician.
RECOMMENDATIONS TO HEALTH CANADA
10. In order to maximize the effect of Health Canada Advisories detailed drug-related adverse events, Health Canada should consider that the Health Advisories:
• Be succinct.
• Clearly set out the warning.
• Should clearly set out the body of evidence giving rise to the warning.
• Should be specific.
• Should be profiled in a way to attract the physician's attention.
11. Health Canada, as a regulator of companies seeking drug approval, should make their approval contingent on receiving results of all clinical trials from the drug manufacturers.
RECOMMENDATIONS TO REGULATED HEALTH PROFESSIONALS
12. All colleges legislated under the Regulated Health Professions Act, 1991 should require mandatory reporting to Health Canada by its members of serious drug-related adverse events as defined by Health Canada.
RECOMMENDATIONS TO THE PUBLIC HEALTH BRANCH OF THE MINISTRY OF HEALTH AND LONG-TERM CARE AND THE MINISTRY OF EDUCATION
13. These two ministries should develop an educational program regarding mental health and substance abuse for the adolescents and youth of Ontario's school system. The circumstances of the death of Sara Carlin as presented at the inquest may be of assistance in the development of this program. The program should seek to inform the adolescents and youth in its schools that suffering with mental health disorders including depression and anxiety is common at their age. In addition the program should:
• Seek to de-stigmatize these illnesses.
• Provide information that these conditions are treatable.
• Emphasize the importance of abstinence from alcohol and other substances as utilizing these may contribute to mental health disorders and precipitate suicidal ideation and suicide.
RECOMMENDATIONS TO THE ONTARIO COLLEGE OF PHARMACISTS AND THE ONTARIO PHARMACISTS' ASSOCIATION
14. When a prescription is filled the patient should receive a standardized and plain language information leaflet based on the product monograph. The information provided to the patient should include:
• What the medication is for.
• What the risks of taking the medication are.
• Under what conditions the medication should not be taken.
• Interactions with the medication.
• The proper use of the medication.
• Side effects and what to do about them.
RECOMMENDATIONS TO THE CANADIAN DRUG MANUFACTURERS' ASSOCIATION
15. Drug companies should be required to report to Health Canada all serious adverse events associated with their drugs from all foreign jurisdictions within 30 days of the adverse event.
RECOMMENDATIONS TO THE CANADIAN FEDERAL GOVERNMENT
16. There should be an arms length body independent from Health Canada called the Drug Safety Board, which is solely dedicated to drug safety, which reports to Parliament, which is funded by the Federal Government and which receives no money from drug companies. Amongst its mandated responsibilities should be drug safety research, investigating adverse reactions and issuing warnings to the public and health care professionals and hospitals.
Tuesday, 29 June 2010
Seroxat / Paxil role in Sara Carlin suicide ambiguous
The inquest ruled that depression, cocaine and alcohol had affected Ms. Carlin at the time of her death, but stopped short of adding Paxil to that list, leaving the drug's role in her suicide ambiguous.
http://www.theglobeandmail.com/news/national/toronto/beef-up-rules-on-prescription-drugs-inquest-urges/article1622095/
The provincial and federal governments must ensure patients are better informed about the risks associated with taking prescription drugs, tighten regulations on big pharmaceutical companies and establish an independent agency to regulate such medications, a coroner's inquest has ruled.
The inquest into the suicide of 18-year-old Sara Carlin, whose family believes she became depressed after taking the prescription drug Paxil for anxiety, delivered its verdict in Toronto on Monday, along with a list of sweeping recommendations for changing the way medications are prescribed and regulated in Canada.
"If these things had been in place at the time Sara was prescribed Paxil, she would be alive today," Ms. Carlin's father, Neil Carlin, said outside court. "We consider this a great victory."
Lawyers for Paxil manufacturer GlaxoSmithKline, which maintains the drug didn't cause Ms. Carlin's depression, suggested the existing rules on prescription drugs are adequate. "These regulations are in place," Teresa Walsh said. "Of course, we will be carefully reviewing these recommendations."
The inquest ruled that depression, cocaine and alcohol had affected Ms. Carlin at the time of her death, but stopped short of adding Paxil to that list, leaving the drug's role in her suicide ambiguous.
Ms. Carlin's family said the jury simply avoided assigning blame – which was beyond the inquest's purview – and argued the fact that jurors recommended such an overhaul of prescription drug regulations was proof they were convinced Paxil was responsible.
The most ambitious of the inquest's 16 recommendations is that the federal government create an arm's-length body called the Drug Safety Board to investigate the side effects of prescription drugs and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drug companies.
This recommendation appeared to flow directly from the testimony of Oakville MP and drug safety advocate Terence Young, who told the inquest that Health Canada's use of trials partly funded by pharmaceutical companies to decide which drugs to put on the market creates a bias.
"It's a bit like, he who pays the piper calls the tune," he told the jury.
The inquest also recommended that drug companies be compelled to report all adverse reactions from all jurisdictions to Health Canada within 30 days; that doctors be given clearer warnings on the serious side effects of drugs; that similar information be available to patients at pharmacies; that doctors be compelled to more thoroughly explain these side effects to patients; and that the province create a suicide prevention strategy.
"Most recommendations are acted upon in some fashion, whether they are adopted whole or in part," said Michael Blain, the lawyer charged with advising the coroner.
The inquest heard more than two weeks of testimony. While experts argued there was no evidence that Paxil caused Ms. Carlin's suicide, her family and its lawyer, Gary Will, maintained she became increasingly depressed after being prescribed the drug in February, 2006.
The University of Western Ontario student hanged herself in the basement of her parents' home in the Toronto suburb of Oakville in May, 2007.
http://www.theglobeandmail.com/news/national/toronto/beef-up-rules-on-prescription-drugs-inquest-urges/article1622095/
The provincial and federal governments must ensure patients are better informed about the risks associated with taking prescription drugs, tighten regulations on big pharmaceutical companies and establish an independent agency to regulate such medications, a coroner's inquest has ruled.
The inquest into the suicide of 18-year-old Sara Carlin, whose family believes she became depressed after taking the prescription drug Paxil for anxiety, delivered its verdict in Toronto on Monday, along with a list of sweeping recommendations for changing the way medications are prescribed and regulated in Canada.
"If these things had been in place at the time Sara was prescribed Paxil, she would be alive today," Ms. Carlin's father, Neil Carlin, said outside court. "We consider this a great victory."
Lawyers for Paxil manufacturer GlaxoSmithKline, which maintains the drug didn't cause Ms. Carlin's depression, suggested the existing rules on prescription drugs are adequate. "These regulations are in place," Teresa Walsh said. "Of course, we will be carefully reviewing these recommendations."
The inquest ruled that depression, cocaine and alcohol had affected Ms. Carlin at the time of her death, but stopped short of adding Paxil to that list, leaving the drug's role in her suicide ambiguous.
Ms. Carlin's family said the jury simply avoided assigning blame – which was beyond the inquest's purview – and argued the fact that jurors recommended such an overhaul of prescription drug regulations was proof they were convinced Paxil was responsible.
The most ambitious of the inquest's 16 recommendations is that the federal government create an arm's-length body called the Drug Safety Board to investigate the side effects of prescription drugs and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drug companies.
This recommendation appeared to flow directly from the testimony of Oakville MP and drug safety advocate Terence Young, who told the inquest that Health Canada's use of trials partly funded by pharmaceutical companies to decide which drugs to put on the market creates a bias.
"It's a bit like, he who pays the piper calls the tune," he told the jury.
The inquest also recommended that drug companies be compelled to report all adverse reactions from all jurisdictions to Health Canada within 30 days; that doctors be given clearer warnings on the serious side effects of drugs; that similar information be available to patients at pharmacies; that doctors be compelled to more thoroughly explain these side effects to patients; and that the province create a suicide prevention strategy.
"Most recommendations are acted upon in some fashion, whether they are adopted whole or in part," said Michael Blain, the lawyer charged with advising the coroner.
The inquest heard more than two weeks of testimony. While experts argued there was no evidence that Paxil caused Ms. Carlin's suicide, her family and its lawyer, Gary Will, maintained she became increasingly depressed after being prescribed the drug in February, 2006.
The University of Western Ontario student hanged herself in the basement of her parents' home in the Toronto suburb of Oakville in May, 2007.
Paxil / Seroxat Carlin verdict - suicide "affected by depression, cocaine and ethanol"
The parents of an Oakville teen who committed suicide wept tears of joy Monday as a coroner's jury announced sweeping recommendations aimed at preventing similar deaths.
http://www.torontosun.com/news/torontoandgta/2010/06/28/14546771.html
A coroner's jury determined Sara Carlin died after hanging herself while "affected by depression, cocaine and ethanol (alcohol)."
The 18-year-old scholar and outstanding athlete killed herself on May 6, 2007, at her Oakville home, 14 months after she began taking the antidepressant, Paxil — a member of the family of drugs known as selective serotonin reuptake inhibitors (SSRIs). She had also been using cocaine and drinking heavily.
The coroner's jury heard of the downward spiral of Sara Carlin, who scored 90s in school, played baseball and hockey, held a part-time job, and tutored kids in math.
Later, her parents learned that Sara, who had been taking Paxil, complained of anxiety and depression to her family doctor. Her parents blamed Paxil for their daughter's demise.
Sara's parents were elated by the jury's recommendations which urged measures designed to ensure doctors better communicate the risks of SSRIs to patients and their loved ones.
"If those recommendations were in place a few years ago, Sara would be alive today," said Neil Carlin. "We consider this a great victory."
Among the many recommendations, the jury urged the Ontario College of Physicians and Surgeons to train doctors administering antidepressant drugs to "inform the patient of the benefits and risk — including rare and serious side effects of SSRIs" and of the risks of taking such medications while consuming alcohol or narcotics.
The jury also recommended doctors:
•Give patients full physical exams prior to prescribing SSRIs.
•Request lab investigations, including drugs screens, where appropriate.
•Inform patients of reasonable alternative treatments and the benefits and risks of those remedies.
•There be heightened monitoring of patients for adverse drug-related reactions during the first three months that SSRIs are prescribed.
The jury also called on Ottawa to create an independent agency — the Drug Safety Board — to deal with drug safety, report to the Parliament and receive funding from taxpayers — not pharmceutical companies. Its mandate would include investigating adverse drug reactions and issuing warnings to the public and doctors.
http://www.torontosun.com/news/torontoandgta/2010/06/28/14546771.html
A coroner's jury determined Sara Carlin died after hanging herself while "affected by depression, cocaine and ethanol (alcohol)."
The 18-year-old scholar and outstanding athlete killed herself on May 6, 2007, at her Oakville home, 14 months after she began taking the antidepressant, Paxil — a member of the family of drugs known as selective serotonin reuptake inhibitors (SSRIs). She had also been using cocaine and drinking heavily.
The coroner's jury heard of the downward spiral of Sara Carlin, who scored 90s in school, played baseball and hockey, held a part-time job, and tutored kids in math.
Later, her parents learned that Sara, who had been taking Paxil, complained of anxiety and depression to her family doctor. Her parents blamed Paxil for their daughter's demise.
Sara's parents were elated by the jury's recommendations which urged measures designed to ensure doctors better communicate the risks of SSRIs to patients and their loved ones.
"If those recommendations were in place a few years ago, Sara would be alive today," said Neil Carlin. "We consider this a great victory."
Among the many recommendations, the jury urged the Ontario College of Physicians and Surgeons to train doctors administering antidepressant drugs to "inform the patient of the benefits and risk — including rare and serious side effects of SSRIs" and of the risks of taking such medications while consuming alcohol or narcotics.
The jury also recommended doctors:
•Give patients full physical exams prior to prescribing SSRIs.
•Request lab investigations, including drugs screens, where appropriate.
•Inform patients of reasonable alternative treatments and the benefits and risks of those remedies.
•There be heightened monitoring of patients for adverse drug-related reactions during the first three months that SSRIs are prescribed.
The jury also called on Ottawa to create an independent agency — the Drug Safety Board — to deal with drug safety, report to the Parliament and receive funding from taxpayers — not pharmceutical companies. Its mandate would include investigating adverse drug reactions and issuing warnings to the public and doctors.
Seroxat Sara Carlin - family pleased with inquest jury's recommendations
If these recommendations had been in place at the time Sara was prescribed Paxil she would be alive today. We are truly confident that if these are acted upon there will be young lives saved down the road."- Neil Carlin, Sara's father.
After listening to more than two long weeks of testimony, the Carlin family says they have gotten what they wanted — recommendations that will save lives.
A coroner's inquest into the death of Sara Carlin, 18, concluded Monday with the jury releasing 16 recommendations geared towards preventing similar deaths in the future.
Among the recommendations were calls for greater precautions to be taken when doctors place patients on Selective serotonin reuptake inhibitors (SSRIs) like Paxil, the drug Sara had been taking and which her parents blame for her death.
News of these recommendations were well received by Sara's family.
"We're ecstatic. This jury listened. These recommendations are what we wanted," said Neil Carlin, Sara's father.
"If these recommendations had been in place at the time Sara was prescribed Paxil she would be alive today. We are truly confident that if these are acted upon there will be young lives saved down the road."
Sara, an Oakville resident and graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents' basement on Sunday, May 6, 2007.
For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18.
During the inquest the Carlin's lawyer Gary Will argued the side effects of Paxil drove Sara to kill herself while lawyers for Paxil manufacturer GlaxoSmithKline and three doctors associated with treating Sara, made the argument Sara's suicide was a result of depression and drug and alcohol abuse.
The Carlin family believes the jury attributed Sara's death to Paxil due to the recommendations they made.
However, Teresa Walsh, lawyer for GlaxoSmithKline did not see it that way.
While many of the recommendations are aimed at bringing forward greater awareness of the potential side effects of Paxil and other SSRIs, Walsh said the jury did not list Paxil as causing Sara's death in their verdict.
Under the cause of death, the jury has listed `hanging by ligature while affected by depression, cocaine and ethanol (alcohol).'
"I think the verdict speaks for itself," said Walsh when asked about the role Paxil played in Sara's death.
One recommendation called for guidelines to be put in place so that, prior to prescribing an SSRI like Paxil, physicians would be required to give a patient a physical exam, request laboratory investigations, inform patients of the benefits and risks of treatment including rare and serious side effects, inform the patient of reasonable alternative treatments, inform the patient of an SSRI treatment plan and discuss with the patient the impact drugs or alcohol could have on an illness like depression.
During the inquest, Sara's family doctor testified that he did not inform Sara about the possible risk of Paxil causing suicidal thoughts and behaviour when he prescribed it because, he said, it is difficult to get a patient to take such a medication after that kind of admission.
According to testimony, the appointment where Sara was put on Paxil only lasted 30 minutes.
Other recommendations called for physicians to monitor patients with weekly visits for the first month after initial introduction to an SSRI, then with bi-weekly visits for the second month and with one visit in the third month.
The jury said this would effectively monitor the period where a serious adverse reaction to a drug like Paxil is most likely to happen.
Still another recommendation called for physicians to try, repeatedly, if necessary, to get a patient prescribed an SSRI to allow for their family members, guardians or trusted friends to be brought into the treatment process, so they can monitor for potential side effects.
One of the Carlin family's greatest concerns, which arose during the inquest, was that they were never told that Sara was placed on Paxil and as such they did not know what to look for in the event she had an adverse reaction.
Sara's doctor testified Sara had told him she did not want her medical records shared with her parents. Under doctor patient confidentiality he had no choice but to respect that request.
Other recommendations called for the creation of an independent drug safety board, the creation of an educational program regarding mental health and substance abuse for the adolescents and youth of Ontario's school system, the creation of a provincial and national suicide prevention strategy and the creation of a Drug Information System that would track and monitor all drugs dispensed in Ontario.
This question of how much of a role Paxil did play in Sara's death was hotly debated during the inquest with several of Sara's friends and family members testifying that she went through drastic behavioural changes after she began taking Paxil in February of 2006.
These witnesses testified Sara suddenly changed from an academically and athletically focused young woman into an apathetic person with alcohol and drug abuse problems.
Will argued some of the side effects listed on the Paxil product monograph were increased alcohol consumption, drug dependence, depression and depersonalization to name a few.
Walsh countered that these are not side effects, but things that people taking Paxil have reported and have not been conclusively tied to Paxil as the cause.
Three expert witnesses testified during the trial with each bringing their views on the impact they felt Paxil had in Sara's death.
Dr. David Juurlink, head of the division of pharmacology and toxicology at Toronto's Sunnybrook Hospital and medical toxicologist at the Ontario Regional Poison Information Centre in Toronto's Hospital for Sick Children, testified that Paxil can cause people to commit suicide, but he did not believe this to have happened in Sara Carlin's case.
He said most suicides and side effects from Paxil occur within the first few weeks and months after a person starts taking it. Sara had been taking the drug for more than a year before her death.
Dr. Paul Links, a professor of psychiatry at the University of Toronto and past president of the Canadian Association for Suicide Prevention, testified Paxil was a plausible explanation for Sara's death, but not one he would favour.
Dr. Nathan Scharf , director of crisis services at the Youthdale Treatment Centre in Toronto, testified Paxil could have been a contributing factor in Sara's death, but not as big a factor as alcohol.
Links did agree that a sudden withdrawal from Paxil could result in dysphoria and disinhibition. In his arguments, Will pointed out Sara had been without her pills for one to four days before her death.
Exactly how much information these experts had on Sara Carlin's case was made an issue during the inquest. Will said Scharf had only had access to a page and a half of information.
While the recommendations have been made, the government bodies they are directed at have no legal obligation to implement them.
Coroner's counsel Michael Blain said, however, that more often than not the recommendations do result in action.
"The Coroner's office does track recommendations and a large percentage of recommendations do in fact result in actions being taken," he said.
"Obviously it's not 100 per cent, but there is a significant percentage of recommendations that do end up bringing about change."
While he is hopeful, Will said some of the recommendations made by this jury were also made by a previous jury during the inquest into the death of Oakville MP Terence Young's daughter, Vanessa, nine years ago.
"There were 56 recommendations made during that inquest and very few were actually implemented," said Will. "Hopefully because many of these recommendations have now been made a second time there will be action."
http://www.insidehalton.com/news/article/840376--this-jury-listened
After listening to more than two long weeks of testimony, the Carlin family says they have gotten what they wanted — recommendations that will save lives.
A coroner's inquest into the death of Sara Carlin, 18, concluded Monday with the jury releasing 16 recommendations geared towards preventing similar deaths in the future.
Among the recommendations were calls for greater precautions to be taken when doctors place patients on Selective serotonin reuptake inhibitors (SSRIs) like Paxil, the drug Sara had been taking and which her parents blame for her death.
News of these recommendations were well received by Sara's family.
"We're ecstatic. This jury listened. These recommendations are what we wanted," said Neil Carlin, Sara's father.
"If these recommendations had been in place at the time Sara was prescribed Paxil she would be alive today. We are truly confident that if these are acted upon there will be young lives saved down the road."
Sara, an Oakville resident and graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents' basement on Sunday, May 6, 2007.
For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18.
During the inquest the Carlin's lawyer Gary Will argued the side effects of Paxil drove Sara to kill herself while lawyers for Paxil manufacturer GlaxoSmithKline and three doctors associated with treating Sara, made the argument Sara's suicide was a result of depression and drug and alcohol abuse.
The Carlin family believes the jury attributed Sara's death to Paxil due to the recommendations they made.
However, Teresa Walsh, lawyer for GlaxoSmithKline did not see it that way.
While many of the recommendations are aimed at bringing forward greater awareness of the potential side effects of Paxil and other SSRIs, Walsh said the jury did not list Paxil as causing Sara's death in their verdict.
Under the cause of death, the jury has listed `hanging by ligature while affected by depression, cocaine and ethanol (alcohol).'
"I think the verdict speaks for itself," said Walsh when asked about the role Paxil played in Sara's death.
One recommendation called for guidelines to be put in place so that, prior to prescribing an SSRI like Paxil, physicians would be required to give a patient a physical exam, request laboratory investigations, inform patients of the benefits and risks of treatment including rare and serious side effects, inform the patient of reasonable alternative treatments, inform the patient of an SSRI treatment plan and discuss with the patient the impact drugs or alcohol could have on an illness like depression.
During the inquest, Sara's family doctor testified that he did not inform Sara about the possible risk of Paxil causing suicidal thoughts and behaviour when he prescribed it because, he said, it is difficult to get a patient to take such a medication after that kind of admission.
According to testimony, the appointment where Sara was put on Paxil only lasted 30 minutes.
Other recommendations called for physicians to monitor patients with weekly visits for the first month after initial introduction to an SSRI, then with bi-weekly visits for the second month and with one visit in the third month.
The jury said this would effectively monitor the period where a serious adverse reaction to a drug like Paxil is most likely to happen.
Still another recommendation called for physicians to try, repeatedly, if necessary, to get a patient prescribed an SSRI to allow for their family members, guardians or trusted friends to be brought into the treatment process, so they can monitor for potential side effects.
One of the Carlin family's greatest concerns, which arose during the inquest, was that they were never told that Sara was placed on Paxil and as such they did not know what to look for in the event she had an adverse reaction.
Sara's doctor testified Sara had told him she did not want her medical records shared with her parents. Under doctor patient confidentiality he had no choice but to respect that request.
Other recommendations called for the creation of an independent drug safety board, the creation of an educational program regarding mental health and substance abuse for the adolescents and youth of Ontario's school system, the creation of a provincial and national suicide prevention strategy and the creation of a Drug Information System that would track and monitor all drugs dispensed in Ontario.
This question of how much of a role Paxil did play in Sara's death was hotly debated during the inquest with several of Sara's friends and family members testifying that she went through drastic behavioural changes after she began taking Paxil in February of 2006.
These witnesses testified Sara suddenly changed from an academically and athletically focused young woman into an apathetic person with alcohol and drug abuse problems.
Will argued some of the side effects listed on the Paxil product monograph were increased alcohol consumption, drug dependence, depression and depersonalization to name a few.
Walsh countered that these are not side effects, but things that people taking Paxil have reported and have not been conclusively tied to Paxil as the cause.
Three expert witnesses testified during the trial with each bringing their views on the impact they felt Paxil had in Sara's death.
Dr. David Juurlink, head of the division of pharmacology and toxicology at Toronto's Sunnybrook Hospital and medical toxicologist at the Ontario Regional Poison Information Centre in Toronto's Hospital for Sick Children, testified that Paxil can cause people to commit suicide, but he did not believe this to have happened in Sara Carlin's case.
He said most suicides and side effects from Paxil occur within the first few weeks and months after a person starts taking it. Sara had been taking the drug for more than a year before her death.
Dr. Paul Links, a professor of psychiatry at the University of Toronto and past president of the Canadian Association for Suicide Prevention, testified Paxil was a plausible explanation for Sara's death, but not one he would favour.
Dr. Nathan Scharf , director of crisis services at the Youthdale Treatment Centre in Toronto, testified Paxil could have been a contributing factor in Sara's death, but not as big a factor as alcohol.
Links did agree that a sudden withdrawal from Paxil could result in dysphoria and disinhibition. In his arguments, Will pointed out Sara had been without her pills for one to four days before her death.
Exactly how much information these experts had on Sara Carlin's case was made an issue during the inquest. Will said Scharf had only had access to a page and a half of information.
While the recommendations have been made, the government bodies they are directed at have no legal obligation to implement them.
Coroner's counsel Michael Blain said, however, that more often than not the recommendations do result in action.
"The Coroner's office does track recommendations and a large percentage of recommendations do in fact result in actions being taken," he said.
"Obviously it's not 100 per cent, but there is a significant percentage of recommendations that do end up bringing about change."
While he is hopeful, Will said some of the recommendations made by this jury were also made by a previous jury during the inquest into the death of Oakville MP Terence Young's daughter, Vanessa, nine years ago.
"There were 56 recommendations made during that inquest and very few were actually implemented," said Will. "Hopefully because many of these recommendations have now been made a second time there will be action."
http://www.insidehalton.com/news/article/840376--this-jury-listened
Monday, 28 June 2010
Seroxat Sara Carlin inquest - suicide "affected by depression, cocaine and ethanol,"
An Oakville teen using an anti-depressant drug died after hanging herself while "affected by depression, cocaine and ethanol," a coroner's jury ruled Monday.
Sara Carlin, an 18-year-old scholar and outstanding athlete committed suicide on May 6, 2007, at her Oakville home, 14 months after she had began taking the anti-depressant drug Paxil, which is a type of drug known as selective serotonin re-uptake inhibitors (SSRIs). She had also been using cocaine and drinking heavily.
Carlin's parents, Neil and Rhonda were visibly pleased after the jury released its verdict and also made several recommendations aimed at preventing similar suicides.
Among its many suggestions, the jury recommended the Ontario College of Physicians and Surgeons train doctors administering these drugs to "inform the patient of the benefits and risk — including rare and serious side effects of SSRIs" and of reasonable alternative treatments, and the risks of taking such medications while consuming alcohol or narcotics.
"If those recommendations were in place a few years ago, Sara would be alive today," said Neil Carlin. "We consider this a great victory."
http://www.torontosun.com/news/canada/2010/06/28/14544386.html
Sara Carlin, an 18-year-old scholar and outstanding athlete committed suicide on May 6, 2007, at her Oakville home, 14 months after she had began taking the anti-depressant drug Paxil, which is a type of drug known as selective serotonin re-uptake inhibitors (SSRIs). She had also been using cocaine and drinking heavily.
Among its many suggestions, the jury recommended the Ontario College of Physicians and Surgeons train doctors administering these drugs to "inform the patient of the benefits and risk — including rare and serious side effects of SSRIs" and of reasonable alternative treatments, and the risks of taking such medications while consuming alcohol or narcotics.
"If those recommendations were in place a few years ago, Sara would be alive today," said Neil Carlin. "We consider this a great victory."
http://www.torontosun.com/news/canada/2010/06/28/14544386.html
Sunday, 27 June 2010
Seroxat Sara Carlin - Inquest jury will release findings Monday
The five-member jury in the Sara Carlin inquest will release its findings on Monday morning, according to a representative from the Ontario Coroner's Office.
At that time, the jury is expected to list the cause of Sara Carlin's death and any recommendations it has to prevent similar deaths in the future.
Sara, 18, an Oakville resident and graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents' basement on Sunday, May 6, 2007.
For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada has warned can increase the risk of suicidal events in children and adolescents under 18.
The Coroner's inquest heard testimony from more than 30 witnesses over a two-week period in an effort to determine the circumstances surrounding Sara's death, what role Paxil may have had, and what can be done to prevent similar deaths in the future.
During the inquest, the Carlin family's lawyer Gary Will attempted to make the case that Paxil and its numerous possible side effects were responsible for driving Sara to kill herself.
Lawyers representing Paxil manufacturer GlaxoSmithKline, three doctors associated with treating Sara, and the Coroner's counsel introduced alternate theories suggesting Sara's death was a result of pre-existing depression and drug and alcohol abuse.
The jury was given a total of more than 40 recommendations from the Coroner's counsel and the Carlin family to consider.
http://www.insidehalton.com/news/article/838811--inquest-jury-will-release-findings-monday
At that time, the jury is expected to list the cause of Sara Carlin's death and any recommendations it has to prevent similar deaths in the future.
Sara, 18, an Oakville resident and graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents' basement on Sunday, May 6, 2007.
For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada has warned can increase the risk of suicidal events in children and adolescents under 18.
The Coroner's inquest heard testimony from more than 30 witnesses over a two-week period in an effort to determine the circumstances surrounding Sara's death, what role Paxil may have had, and what can be done to prevent similar deaths in the future.
During the inquest, the Carlin family's lawyer Gary Will attempted to make the case that Paxil and its numerous possible side effects were responsible for driving Sara to kill herself.
Lawyers representing Paxil manufacturer GlaxoSmithKline, three doctors associated with treating Sara, and the Coroner's counsel introduced alternate theories suggesting Sara's death was a result of pre-existing depression and drug and alcohol abuse.
The jury was given a total of more than 40 recommendations from the Coroner's counsel and the Carlin family to consider.
http://www.insidehalton.com/news/article/838811--inquest-jury-will-release-findings-monday
Inquest - definition & available verdicts
Inquest
From Wikipedia, the free encyclopedia
An inquest is a judicial investigation in common law jurisdictions, conducted by a judge, jury, or government official. The most common kind of inquest is an inquiry including a medical examination by a coroner into the cause of a death that was sudden, violent, suspicious, or occurred in prison.[citation needed] A coroner's jury may be convened to assist in this type of proceeding. Inquest can also mean such a jury and the result of such an investigation. In general usage, inquest is also used to mean any investigation or inquiry.
An inquest uses witnesses, but suspects are not permitted to defend themselves. The verdict can be, for example, natural death, accidental death, misadventure, suicide, or murder. If the verdict is murder or culpable accident, criminal prosecution may follow, and suspects are of course able to defend themselves there.
Since juries are not used in most European civil law systems, these do not have any (jury) procedure similar to an inquest, but medical evidence and professional witnesses have been used in court in continental Europe for centuries.[1][2][1]
Larger inquests can be held into disasters, or in some jurisdictions (not England & Wales) into cases of corruption.[1]
From Wikipedia, the free encyclopedia
An inquest is a judicial investigation in common law jurisdictions, conducted by a judge, jury, or government official. The most common kind of inquest is an inquiry including a medical examination by a coroner into the cause of a death that was sudden, violent, suspicious, or occurred in prison.[citation needed] A coroner's jury may be convened to assist in this type of proceeding. Inquest can also mean such a jury and the result of such an investigation. In general usage, inquest is also used to mean any investigation or inquiry.
An inquest uses witnesses, but suspects are not permitted to defend themselves. The verdict can be, for example, natural death, accidental death, misadventure, suicide, or murder. If the verdict is murder or culpable accident, criminal prosecution may follow, and suspects are of course able to defend themselves there.
Since juries are not used in most European civil law systems, these do not have any (jury) procedure similar to an inquest, but medical evidence and professional witnesses have been used in court in continental Europe for centuries.[1][2][1]
Larger inquests can be held into disasters, or in some jurisdictions (not England & Wales) into cases of corruption.[1]
Thursday, 24 June 2010
Seroxat - Panorama not always noted for its accuracy says Lord Winston
http://hansard.millbanksystems.com/lords/2003/may/15/drug-side-effects-reporting-system
Wednesday, 23 June 2010
Seroxat - implicated in Catholic priest suicide linked abuse coverup
Glaxo, Paxil and the Catholic Sex Abuse Cover-Up: Drug Implicated in Priest's Suicide
By Jim Edwards
Apr 7, 2010
http://industry.bnet.com/pharma/10007579/glaxo-paxil-and-the-catholic-church-sex-abuse-cover-up-drug-implicated-in-suicide-of-priest/
(GSK), which was already the focus of controversy over whether it ignored the suicide risk of its antidepressant Paxil, has found itself linked to the Catholic Church’s cover-up of child abuse in the death of a priest who took the drug.
Download the Tucker v. GSK ruling here.
The case seems bound to become a further PR headache for GSK, which in 2008 was accused of obscuring the suicide risk of Paxil in studies for 15 years.
Father Rick Tucker, who took Paxil because he was upset about the way his parish ignored a child abuse scandal, may have committed suicide because of side effects from the drug and not the stress from the cover-up, a federal judge ruled. Judge David H. Hamilton of Indiana’s federal court found that Tucker’s sister Debra could sue GSK over the death of her brother, who shot himself to death in September 2002.
The Tucker case stems from 1966, when Debra Tucker was 10 years old and attended the St. Lawrence Parish church in the Diocese of Lafayette-in-Indiana. At the same time, Rick attended St. Mary’s Seminary in the same parish. Between 1966 and 1968, Debra was raped two to four times a month by St. Lawrence’s children’s choir instructor, a lay employee of the church, she alleges. In 1968, Tucker had an abortion at the abuser’s behest, and then her family — including Rick, who had no idea what was going on — moved and the abuse stopped. Debra remained in the area and over the years the abuser painted her house and attended the funerals of both her parents, she alleges.
In July 2000, after Debra discovered that the abuser had also allegedly assaulted his own children, she attended a meeting with Father Tucker, St. Lawrence’s Monsignor Robert Sell and other church officials. She claims that Sell and the church agreed to ensure that the abuser had no further contact with children in the parish and in return she would not sue the church.
After learning that Sell and the church allegedly did nothing about the man, Debra Tucker sued for breach of contract in a separate case not involving GSK.
Download Debra Tucker’s abuse complain here.
The parish dragged its feet over the lawsuit, and as Father Tucker waited for word over whether his employers would settle his sister’s case, he became increasingly anxious. (The case was later dismissed on appeal.) He was also worried about an upcoming audit by the diocese because, the judge wrote, he had “advanced himself some monies” and the Church would discover these “irregularities.”
However, his anxieties were misplaced: the audit did not uncover any irregularities in Father Tucker’s bookkeeping, the ruling says. The Tucker family’s lawyer said that the amounts involved were in the $50 range — and thus proof that Father Tucker’s anxiety was a product of the drug and not the situation he was in.
After taking Paxil, Tucker went into a sudden depressive tailspin. His diary for Aug. 30, 2002, just two days after he was prescribed the pill, says:
Things have gotten behind and I do not know how to catch up. I want to live, but I want out of the pain. I feel like I am in an ocean and I can’t swim to the top for air. . . . I can see no way out of it. I know that if I follow through with the thoughts that come to my mind, there will be people hurt. … Debra I am sorry.
Father Tucker killed himself on Sept. 18.
Debra Tucker alleges in her complaint against GSK that the company knew as early as 1990 that Paxil potentially had an increased risk of suicide, and that the company failed to warn patients of the risk of akathisia, psychosis or violent self harm. Akathisia is a profound state of anxiety in which patients, unable to rest, believe they are doomed.
Download the complaint in Tucker v. GSK here
GSK had asked the judge to summarily dismiss the case based because the expert witnesses who testified that Father Tucker’s death was triggered by the Paxil and not the other stresses in his life were inadequate. The judge ruled there was a case to answer.
GSK and Msgr. Sell did not immediately respond to emails and a voicemail requesting comment. I’ve decided not to name the alleged abuser — although his name is published in Debra Tucker’s complaint against the church — because I could not reach him for comment.
By Jim Edwards
Apr 7, 2010
http://industry.bnet.com/pharma/10007579/glaxo-paxil-and-the-catholic-church-sex-abuse-cover-up-drug-implicated-in-suicide-of-priest/
(GSK), which was already the focus of controversy over whether it ignored the suicide risk of its antidepressant Paxil, has found itself linked to the Catholic Church’s cover-up of child abuse in the death of a priest who took the drug.
Download the Tucker v. GSK ruling here.
The case seems bound to become a further PR headache for GSK, which in 2008 was accused of obscuring the suicide risk of Paxil in studies for 15 years.
Father Rick Tucker, who took Paxil because he was upset about the way his parish ignored a child abuse scandal, may have committed suicide because of side effects from the drug and not the stress from the cover-up, a federal judge ruled. Judge David H. Hamilton of Indiana’s federal court found that Tucker’s sister Debra could sue GSK over the death of her brother, who shot himself to death in September 2002.
The Tucker case stems from 1966, when Debra Tucker was 10 years old and attended the St. Lawrence Parish church in the Diocese of Lafayette-in-Indiana. At the same time, Rick attended St. Mary’s Seminary in the same parish. Between 1966 and 1968, Debra was raped two to four times a month by St. Lawrence’s children’s choir instructor, a lay employee of the church, she alleges. In 1968, Tucker had an abortion at the abuser’s behest, and then her family — including Rick, who had no idea what was going on — moved and the abuse stopped. Debra remained in the area and over the years the abuser painted her house and attended the funerals of both her parents, she alleges.
In July 2000, after Debra discovered that the abuser had also allegedly assaulted his own children, she attended a meeting with Father Tucker, St. Lawrence’s Monsignor Robert Sell and other church officials. She claims that Sell and the church agreed to ensure that the abuser had no further contact with children in the parish and in return she would not sue the church.
After learning that Sell and the church allegedly did nothing about the man, Debra Tucker sued for breach of contract in a separate case not involving GSK.
Download Debra Tucker’s abuse complain here.
The parish dragged its feet over the lawsuit, and as Father Tucker waited for word over whether his employers would settle his sister’s case, he became increasingly anxious. (The case was later dismissed on appeal.) He was also worried about an upcoming audit by the diocese because, the judge wrote, he had “advanced himself some monies” and the Church would discover these “irregularities.”
However, his anxieties were misplaced: the audit did not uncover any irregularities in Father Tucker’s bookkeeping, the ruling says. The Tucker family’s lawyer said that the amounts involved were in the $50 range — and thus proof that Father Tucker’s anxiety was a product of the drug and not the situation he was in.
After taking Paxil, Tucker went into a sudden depressive tailspin. His diary for Aug. 30, 2002, just two days after he was prescribed the pill, says:
Things have gotten behind and I do not know how to catch up. I want to live, but I want out of the pain. I feel like I am in an ocean and I can’t swim to the top for air. . . . I can see no way out of it. I know that if I follow through with the thoughts that come to my mind, there will be people hurt. … Debra I am sorry.
Debra Tucker alleges in her complaint against GSK that the company knew as early as 1990 that Paxil potentially had an increased risk of suicide, and that the company failed to warn patients of the risk of akathisia, psychosis or violent self harm. Akathisia is a profound state of anxiety in which patients, unable to rest, believe they are doomed.
Download the complaint in Tucker v. GSK here
GSK had asked the judge to summarily dismiss the case based because the expert witnesses who testified that Father Tucker’s death was triggered by the Paxil and not the other stresses in his life were inadequate. The judge ruled there was a case to answer.
GSK and Msgr. Sell did not immediately respond to emails and a voicemail requesting comment. I’ve decided not to name the alleged abuser — although his name is published in Debra Tucker’s complaint against the church — because I could not reach him for comment.
Seroxat - Fix Criminals, Save Big Money by Dr. Keith Ablow
Beyond Depo-Provera and Antabuse, it has been shown that medications like Paxil and Lexapro can decrease impulsivity, presumably by increasing serotonin levels.
http://www.foxnews.com/story/0,2933,595090,00.html
A national Associated Press analysis has found that the 20 states that confine sexual offenders who have completed their jail terms to “civil commitment” in locked psychiatric units, spend $500 million a year to do it. Billions are spent prosecuting, jailing and enforcing rehabilitation stays on those who repeatedly drive drunk or commit crimes while intoxicated. Many more billions are spent due to the recidivism of violent criminals who fail to control their aggressive impulses.
Much of this money is wasted, and far more suffering is allowed to be visited on victims than need be. We have medicines readily available that could drastically decrease the rates of many crimes in America.
I have written before on FoxNews.com that a medicine called Depo-Provera, delivered monthly by injection, can significantly decrease sexual desire in those with abnormal sexual impulses. I believe making the use of Depo-Provera mandatory for all sexual offenders convicted of serious enough offenses would have a profound impact on their likelihood to claim more victims and would be much more cost-effective than the present hit-or-miss system of guessing which offenders should be locked up interminably in psychiatric units. The medication would be required as a condition of lifetime parole. One missed dose would be punishable by a significant prison sentence.
Similarly, I believe that it is reasonable to sentence anyone with an alcohol-related offense of a significant enough variety (e.g. a second driving under the influence conviction or any violent crime committed under the influence of alcohol) to a very lengthy period of probation during which they would be required to take a daily dose of Antabuse (monitored at a community mental health center.) Antabuse makes it impossible to metabolize alcohol normally and causes severe symptoms like racing heart, soaring blood pressure and nausea when someone drinks. Those who drink on Antabuse can even die.
Since a large percentage of violent crimes occurs when assailants are inebriated, I believe it would also be profoundly effective to require anyone who commits a violent crime (except for very minimal infractions) to take Antabuse, as well.
Beyond Depo-Provera and Antabuse, it has been shown that medications like Paxil and Lexapro can decrease impulsivity, presumably by increasing serotonin levels. Certain nutraceuticals, including omega-3 fatty acid-rich fish oil, could also have an impact. Research trials to identify how to use these and other agents to decrease crime should be vigorously pursued.
I believe starting just with Depo-Provera and Antabuse, however, would save billions of dollars and make the case for medicating criminals very, very clear.
Dr. Keith Ablow is a psychiatry correspondent for Fox News Channel and a New York Times bestselling author. His book, “Living the Truth: Transform Your Life Through the Power of Insight and Honesty” has launched a new self-help movement including www.livingthetruth.com. Dr. Ablow can be reached at info@keithablow.com.
A national Associated Press analysis has found that the 20 states that confine sexual offenders who have completed their jail terms to “civil commitment” in locked psychiatric units, spend $500 million a year to do it. Billions are spent prosecuting, jailing and enforcing rehabilitation stays on those who repeatedly drive drunk or commit crimes while intoxicated. Many more billions are spent due to the recidivism of violent criminals who fail to control their aggressive impulses.
Much of this money is wasted, and far more suffering is allowed to be visited on victims than need be. We have medicines readily available that could drastically decrease the rates of many crimes in America.
I have written before on FoxNews.com that a medicine called Depo-Provera, delivered monthly by injection, can significantly decrease sexual desire in those with abnormal sexual impulses. I believe making the use of Depo-Provera mandatory for all sexual offenders convicted of serious enough offenses would have a profound impact on their likelihood to claim more victims and would be much more cost-effective than the present hit-or-miss system of guessing which offenders should be locked up interminably in psychiatric units. The medication would be required as a condition of lifetime parole. One missed dose would be punishable by a significant prison sentence.
Similarly, I believe that it is reasonable to sentence anyone with an alcohol-related offense of a significant enough variety (e.g. a second driving under the influence conviction or any violent crime committed under the influence of alcohol) to a very lengthy period of probation during which they would be required to take a daily dose of Antabuse (monitored at a community mental health center.) Antabuse makes it impossible to metabolize alcohol normally and causes severe symptoms like racing heart, soaring blood pressure and nausea when someone drinks. Those who drink on Antabuse can even die.
Since a large percentage of violent crimes occurs when assailants are inebriated, I believe it would also be profoundly effective to require anyone who commits a violent crime (except for very minimal infractions) to take Antabuse, as well.
Beyond Depo-Provera and Antabuse, it has been shown that medications like Paxil and Lexapro can decrease impulsivity, presumably by increasing serotonin levels. Certain nutraceuticals, including omega-3 fatty acid-rich fish oil, could also have an impact. Research trials to identify how to use these and other agents to decrease crime should be vigorously pursued.
I believe starting just with Depo-Provera and Antabuse, however, would save billions of dollars and make the case for medicating criminals very, very clear.
Dr. Keith Ablow is a psychiatry correspondent for Fox News Channel and a New York Times bestselling author. His book, “Living the Truth: Transform Your Life Through the Power of Insight and Honesty” has launched a new self-help movement including www.livingthetruth.com. Dr. Ablow can be reached at info@keithablow.com.
Seroxat - Coroner says difficult to link Paxil to death - Sara Carlin inquest
Coroner says difficult to link Paxil to death
http://www.insidehalton.com/news/article/837321--coroner-says-difficult-to-link-paxil-to-death
"The fact that an individual commits suicide while taking an anti-depressant does not mean that anti-depressant had a role in the suicide."- Dr. Bert Lauwers,coroner presiding over Sara Carlin inquest. The coroner presiding over the inquest into the death of Sara Carlin, 18, advised the jury Tuesday that the anti-depressant Paxil does not appear to have been a factor in her death.
Sara, an Oakville resident and graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents’ basement on Sunday, May 6, 2007.
At the time of her death, Sara had been taking Paxil, a selective serotonin reuptake inhibitor (SSRI) medication, for more than a year despite Health Canada advisories warning doctors in 2003 and 2004 that Paxil was not recommended for people under 18 due to the increased risk of suicidal events.
A Coroner's inquest into Sara's death has lasted for more than two weeks as more than 30 witnesses were called to determine the circumstances surrounding Sara's death, how much of a role Paxil may have played and if anything can be done to prevent similar deaths in the future.
During these two weeks of testimony, the jury heard from a number Sara's family and friends, who stated she went through radical emotional and behavioural changes after she began taking Paxil in February of 2006.
The jury heard from witnesses that three of the side effects of Paxil, listed on the product monograph, are depression, increased alcohol consumption and drug dependence.
They also heard from Dr. Mary Alexander, a psychotherapist who saw Sara once, that Sara said she had experienced depression and had been drinking heavily for more than a year before she began taking Paxil.
To make sense of all this, the presiding coroner, Dr. Bert Lauwers, advised the jury to consider the testimony of Dr. David Juurlink, head of the division of pharmacology and toxicology at Toronto's Sunnybrook Hospital and medical toxicologist at the Ontario Regional Poison Information Centre in Toronto's Hospital for Sick Children.
Juurlink testified that making a determination that an anti-depressant like Paxil was responsible for a person's suicide is difficult because the reason the person is taking the anti-depressant is normally due to depression, which can lead to suicide.
"The fact that an individual commits suicide while taking an anti-depressant does not mean that anti-depressant had a role in the suicide," said Lauwers.
In his testimony, Juurlink said Paxil can cause people to commit suicide, but added he did not believe this to have happened in Sara Carlin's case.
Lauwers repeated Juurlink's reasoning that most suicides and side effects occur within the first few weeks and months after a person starts taking Paxil. Sara had been taking the drug for more than a year before her death.
Juurlink testified Sara had reported responding favourably to treatment. He said there were competing reasons for her suicide including psychosocial factors and alcohol and cocaine use.
"He addressed the issue of the SSRI (Selective serotonin reuptake inhibitor) Discontinuation Syndrome," said Lauwers. "He stated and I quote, 'There is no evidence in the record that Ms. Carlin displayed the characteristic features of SSRI discontinuation in the days leading up to her death. Moreover, if there was an interruption of therapy followed by a reintroduction of the drug at higher than prescribed doses this does not alter my opinion. Paroxetine was not a causal factor in her suicide."
The Carlins’ lawyer Gary Will has pointed out that Sara was experiencing flu-like symptoms during the one to four-day period she was without her Paxil just before her death in May of 2007.
Lauwers also drew the jury's attention to Dr. Paul Links' testimony.
Links, a professor of psychiatry at the University of Toronto and past president of the Canadian Association for Suicide Prevention also said alcohol and cocaine use were the more likely the cause of Sara's death.
"The acute use of alcohol and cocaine can contribute to the risk of suicide in several ways. Alcohol intoxication and cocaine withdrawal can precipitate an acute disphoric state, increase psychological distress and trigger acute suicidality," said Lauwer, reading Links' comments. "During intoxication the individual may be more disinhibited."
Lauwers went on to point out that Links had concluded there was not much evidence to say Paxil had contributed to Sara's death.
During cross-examination by Will, Links did admit the explanation that Paxil played a role in Sara's death was plausible, but not an explanation he would favour.
Lauwers told the jury he was surprised during the inquest by the prevalence of underage drinking taking place in Oakville as evidenced by several witnesses.
The prevalence of cocaine among youths in Oakville was something else he found concerning.
The degree of suicidal thinking and behaviour among youths, which emerged during Links' testimony, was something else that caught Lauwers' attention. Links pointed out that according to a 2001 survey, 19 per cent of high school students have thought about suicide, 15 per cent have developed a suicide plan while nine per cent have actually made a suicide attempt.
To deal with these issues, Lauwers has suggested the jury recommend that the Halton Regional Health Department develop an education program regarding mental health and substance abuse for adolescents in its school system.
This program should seek to inform adolescents and youths in Halton schools that suffering from mental health disorders including depression and anxiety is common at their age.
This program would seek to de-stigmatize mental illness, provide information that these conditions are treatable. He suggested the program emphasize abstinence from alcohol and other substances that may bring about suicidal thinking and even suicide.
Lauwers said the jury could also recommend the Ministry of Education and the Ministry of Health and Long-Term Care create a similar program on a provincial scale for all Ontario schools.
While the coroner listed a great deal of information indicating Paxil was not responsible for Sara's death, this did not stop him from suggesting the jury make recommendations for greater drug safety in Canada.
These suggestions included the creation of a province-wide Drug Information System that would track and monitor all drugs dispensed in Ontario.
It was pointed out such a system could aid researchers greatly in their research into drug-related adverse events.
Another suggestion called for the creation of a province-wide Suicide Prevention Strategy that would seek to enhance mental health and well-being of Ontarians, de-stigmatize mental health disorders, improve intervention and support for Ontarians affected by depression and substance abuse, improve intervention in the treatment of those who are at risk of suicide, increase research activities in Ontario with regard to suicide, suicidal behaviour and suicide prevention, inform and educate the media about strategies when reporting deaths due to suicide to prevent 'copy cat' suicides from occurring.
Other suggestions called for the Canadian Medical Protective Association to encourage physicians to involve the families of children, adolescents and young adults when they are being treated with medications for mental disorders like anxiety and depression whenever possible.
This will allow the patient and the family to be aware of the nature of the patients' disorder and the potential side effects of the medication they are taking.
Some of the other recommendations put forward by the coroner dealt with doctors being required to report serious adverse drug events to Health Canada; weekly appointments during a patient's first month of taking an SSRI; stricter emphasis that prior to a youth being put on an SSRI they go through a thorough diagnostic consideration and evaluation, a physical examination, laboratory investigations where appropriate, a discussion with the patient's family (if possible) with respect to target symptoms and monitoring, and an inquiry and consideration of alcohol and substance abuse being confounders of the illness.
The jury is now in deliberations and will consider these along with 26 other recommendations made by the Carlin family with respect to preventing deaths similar to Sara's in the future.
http://www.insidehalton.com/news/article/837321--coroner-says-difficult-to-link-paxil-to-death
"The fact that an individual commits suicide while taking an anti-depressant does not mean that anti-depressant had a role in the suicide."- Dr. Bert Lauwers,coroner presiding over Sara Carlin inquest. The coroner presiding over the inquest into the death of Sara Carlin, 18, advised the jury Tuesday that the anti-depressant Paxil does not appear to have been a factor in her death.
Sara, an Oakville resident and graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents’ basement on Sunday, May 6, 2007.
At the time of her death, Sara had been taking Paxil, a selective serotonin reuptake inhibitor (SSRI) medication, for more than a year despite Health Canada advisories warning doctors in 2003 and 2004 that Paxil was not recommended for people under 18 due to the increased risk of suicidal events.
A Coroner's inquest into Sara's death has lasted for more than two weeks as more than 30 witnesses were called to determine the circumstances surrounding Sara's death, how much of a role Paxil may have played and if anything can be done to prevent similar deaths in the future.
During these two weeks of testimony, the jury heard from a number Sara's family and friends, who stated she went through radical emotional and behavioural changes after she began taking Paxil in February of 2006.
The jury heard from witnesses that three of the side effects of Paxil, listed on the product monograph, are depression, increased alcohol consumption and drug dependence.
They also heard from Dr. Mary Alexander, a psychotherapist who saw Sara once, that Sara said she had experienced depression and had been drinking heavily for more than a year before she began taking Paxil.
To make sense of all this, the presiding coroner, Dr. Bert Lauwers, advised the jury to consider the testimony of Dr. David Juurlink, head of the division of pharmacology and toxicology at Toronto's Sunnybrook Hospital and medical toxicologist at the Ontario Regional Poison Information Centre in Toronto's Hospital for Sick Children.
Juurlink testified that making a determination that an anti-depressant like Paxil was responsible for a person's suicide is difficult because the reason the person is taking the anti-depressant is normally due to depression, which can lead to suicide.
"The fact that an individual commits suicide while taking an anti-depressant does not mean that anti-depressant had a role in the suicide," said Lauwers.
In his testimony, Juurlink said Paxil can cause people to commit suicide, but added he did not believe this to have happened in Sara Carlin's case.
Lauwers repeated Juurlink's reasoning that most suicides and side effects occur within the first few weeks and months after a person starts taking Paxil. Sara had been taking the drug for more than a year before her death.
Juurlink testified Sara had reported responding favourably to treatment. He said there were competing reasons for her suicide including psychosocial factors and alcohol and cocaine use.
"He addressed the issue of the SSRI (Selective serotonin reuptake inhibitor) Discontinuation Syndrome," said Lauwers. "He stated and I quote, 'There is no evidence in the record that Ms. Carlin displayed the characteristic features of SSRI discontinuation in the days leading up to her death. Moreover, if there was an interruption of therapy followed by a reintroduction of the drug at higher than prescribed doses this does not alter my opinion. Paroxetine was not a causal factor in her suicide."
The Carlins’ lawyer Gary Will has pointed out that Sara was experiencing flu-like symptoms during the one to four-day period she was without her Paxil just before her death in May of 2007.
Lauwers also drew the jury's attention to Dr. Paul Links' testimony.
Links, a professor of psychiatry at the University of Toronto and past president of the Canadian Association for Suicide Prevention also said alcohol and cocaine use were the more likely the cause of Sara's death.
"The acute use of alcohol and cocaine can contribute to the risk of suicide in several ways. Alcohol intoxication and cocaine withdrawal can precipitate an acute disphoric state, increase psychological distress and trigger acute suicidality," said Lauwer, reading Links' comments. "During intoxication the individual may be more disinhibited."
Lauwers went on to point out that Links had concluded there was not much evidence to say Paxil had contributed to Sara's death.
During cross-examination by Will, Links did admit the explanation that Paxil played a role in Sara's death was plausible, but not an explanation he would favour.
Lauwers told the jury he was surprised during the inquest by the prevalence of underage drinking taking place in Oakville as evidenced by several witnesses.
The prevalence of cocaine among youths in Oakville was something else he found concerning.
The degree of suicidal thinking and behaviour among youths, which emerged during Links' testimony, was something else that caught Lauwers' attention. Links pointed out that according to a 2001 survey, 19 per cent of high school students have thought about suicide, 15 per cent have developed a suicide plan while nine per cent have actually made a suicide attempt.
To deal with these issues, Lauwers has suggested the jury recommend that the Halton Regional Health Department develop an education program regarding mental health and substance abuse for adolescents in its school system.
This program should seek to inform adolescents and youths in Halton schools that suffering from mental health disorders including depression and anxiety is common at their age.
This program would seek to de-stigmatize mental illness, provide information that these conditions are treatable. He suggested the program emphasize abstinence from alcohol and other substances that may bring about suicidal thinking and even suicide.
Lauwers said the jury could also recommend the Ministry of Education and the Ministry of Health and Long-Term Care create a similar program on a provincial scale for all Ontario schools.
While the coroner listed a great deal of information indicating Paxil was not responsible for Sara's death, this did not stop him from suggesting the jury make recommendations for greater drug safety in Canada.
These suggestions included the creation of a province-wide Drug Information System that would track and monitor all drugs dispensed in Ontario.
It was pointed out such a system could aid researchers greatly in their research into drug-related adverse events.
Another suggestion called for the creation of a province-wide Suicide Prevention Strategy that would seek to enhance mental health and well-being of Ontarians, de-stigmatize mental health disorders, improve intervention and support for Ontarians affected by depression and substance abuse, improve intervention in the treatment of those who are at risk of suicide, increase research activities in Ontario with regard to suicide, suicidal behaviour and suicide prevention, inform and educate the media about strategies when reporting deaths due to suicide to prevent 'copy cat' suicides from occurring.
Other suggestions called for the Canadian Medical Protective Association to encourage physicians to involve the families of children, adolescents and young adults when they are being treated with medications for mental disorders like anxiety and depression whenever possible.
This will allow the patient and the family to be aware of the nature of the patients' disorder and the potential side effects of the medication they are taking.
Some of the other recommendations put forward by the coroner dealt with doctors being required to report serious adverse drug events to Health Canada; weekly appointments during a patient's first month of taking an SSRI; stricter emphasis that prior to a youth being put on an SSRI they go through a thorough diagnostic consideration and evaluation, a physical examination, laboratory investigations where appropriate, a discussion with the patient's family (if possible) with respect to target symptoms and monitoring, and an inquiry and consideration of alcohol and substance abuse being confounders of the illness.
The jury is now in deliberations and will consider these along with 26 other recommendations made by the Carlin family with respect to preventing deaths similar to Sara's in the future.
Seroxat birth defects - stitch up - GSK & plaintifs settle !
Moss also said the Paxil litigation has been resolving successfully in the last few months because of the cooperation between the plaintiffs and the defense bars and because GSK has not taken a stance that they're "not offering a penny."
"I think there is a great deal of cooperation between the plaintiffs and defendants," Moss said. "They actually work well together. There is not a lot of animosity."
Moss has been meeting monthly with the Paxil plaintiffs lawyers and the Paxil defense team, Sheller said
http://www.law.com/jsp/article.jsp?id=1202462916664&Paxil_Litigation_Over_Birth_Defects_Shifts_to_Settlement
Paxil Litigation Over Birth Defects Shifts to Settlement
Amaris Elliott-Engel
The Legal Intelligencer
June 23, 2010
Drugmaker GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects.
Only one case in Philadelphia's mass tort Paxil program has gone to trial.
GSK has settled every other case scheduled for trial in the eight months since a Philadelphia jury awarded a $2.5 million plaintiffs verdict in the first Philadelphia Paxil test case to go to trial.
GSK started to appeal that plaintiffs verdict from October. The jury awarded only compensatory damages and no punitive damages. But GSK then decided to settle Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline along with another 190 cases, according to an order signed by Philadelphia Common Pleas Judge Sandra Mazer Moss last week.
The cases have settled for confidential amounts, said Jamie Sheller of the Sheller firm and local plaintiffs liaison counsel for the Paxil pregnancy mass tort program. GSK confirmed the settlements but said in a spokeswoman's statement that the terms of the settlements are confidential.
Sheller estimates that up to another 100 cases, including cases that have not yet been filed, have settled. The litigation is two-thirds over, Moss and Sheller said.
The Kilker case was viewed by the plaintiffs mass torts bar as a leading indicator of the strength of more than 600 similar cases.
"When you're dealing with children with birth defects that's a concern for any company," Sheller said. "GSK gave it their all at that trial. ... Despite that, the plaintiffs were successful in the case and that set a tone for their analysis. Even though they mounted an excellent and strong defense they weren't able to overcome the plaintiffs' position."
The next cases in the litigation are scheduled for trial in the fall.
GSK spokeswoman Sarah Alspach said in an e-mail statement that GSK has agreed to settle some cases involving the use of Paxil during pregnancy "despite its litigation defenses, in order to avoid the costs, burdens and uncertainties of ongoing litigation."
Moss, the coordinating judge of Philadelphia's mass tort program, the Complex Litigation Center, said the philosophy of GSK "is to try and settle what they can and to settle in groups."
Moss also said the Paxil litigation has been resolving successfully in the last few months because of the cooperation between the plaintiffs and the defense bars and because GSK has not taken a stance that they're "not offering a penny."
"I think there is a great deal of cooperation between the plaintiffs and defendants," Moss said. "They actually work well together. There is not a lot of animosity."
Moss has been meeting monthly with the Paxil plaintiffs lawyers and the Paxil defense team, Sheller said.
Michael T. Scott, a defense attorney with Reed Smith's life sciences health industry group, said that settling a case is not an admission that the company did anything wrong and does not mean that all cases are going to settle. Scott said his firm represents GSK in some matters, but not in cases involving Paxil.
Tom Kline, a plaintiffs attorney with Kline & Specter, said that it appears that the Kilker trial was a "cathartic event" that influenced the course of the litigation.
Pharmaceutical companies have "economic and reputational incentives" to turn away from litigation, Kline said.
Pharmaceutical companies think in terms of billions of dollars, Kline said, and settling cases en masse doesn't break their bottom line and must be weighed against the impact on their reputation with the public -- including the federal Food and Drug Administration and health care professionals -- with every case that goes to trial, Kline said.
Moss said a mediator paid for by the defendants and the plaintiffs also was very helpful in settling the cases.
More of the cases that are settling involve cardiac defects, but there are other minor plaintiffs alleging defects because of their mothers' use of Paxil, Sheller said.
Because the cases involve minors, Orphans' Court approval is necessary, Moss said.
Moss said because the cases involve many out-of-state plaintiffs, she is working with Judge Joseph D. O'Keefe, administrative judge of Orphans' Court, on how to handle settlements for out-of-state minor plaintiffs.
Moss said it is contemplated that out-of-state minor plaintiffs can have approval for their settlements given by the state court jurisdictions in which the plaintiffs live. However, cases will come back to Philadelphia Orphans' Court if there is any reason that approval by judges in other states doesn't happen, Moss said.
O'Keefe said last week the Orphans' Court has not yet started to receive any Paxil cases.
Despite settling many of the Paxil cases, GSK continues to argue it acted appropriately regarding the drug.
"GSK believes it acted properly and responsibly in conducting its clinical trial program for Paxil, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine's label as new information became available," Alspach said.
In post-trial motions seeking judgment notwithstanding the verdict or a new trial in Kilker, GSK said that 65 percent of all birth defects have no known cause and less than 1 percent of all birth defects are attributable to a mother's exposure to medication during pregnancy.
Plaintiff Lyam Kilker has three congenital defects in his heart: a defect between the upper two chambers of his heart, a defect between the lower two chambers of his heart and a defect that has left a hole in the wall of his heart that separates the two pumping chambers of the heart as well as preventing the heart's aorta from forming a complete "tube," according to court papers.
The last of Kilker's heart defects, called an interrupted aortic arch, is a defect that GSK argued has not been found in research to be associated with the use of Paxil by pregnant mothers and the cause of this type of heart defect is generally considered to be unknown.
"There is no established -- or even speculative -- link between Paxil and interrupted aortic arch," GSK said in its post-trial motions.
Sheller said last fall that GSK thought it could win on Kilker's more rare defect, which is why they took Kilker to trial and settled other cases.
Prior to Kilker, three other bellwether cases settled for confidential amounts.
Joseph O'Neil of Philadelphia's Lavin O'Neil Ricci Cedrone & DiSipio is the local defense liaison counsel for the Paxil pregnancy program.
The main plaintiffs firms include Clark Burnett Love & Lee in Houston, the Tracey Law Firm in Houston and Robinson Calcagnie & Robinson in Newport Beach, Calif., Sheller said.
"I think there is a great deal of cooperation between the plaintiffs and defendants," Moss said. "They actually work well together. There is not a lot of animosity."
Moss has been meeting monthly with the Paxil plaintiffs lawyers and the Paxil defense team, Sheller said
http://www.law.com/jsp/article.jsp?id=1202462916664&Paxil_Litigation_Over_Birth_Defects_Shifts_to_Settlement
Paxil Litigation Over Birth Defects Shifts to Settlement
Amaris Elliott-Engel
The Legal Intelligencer
June 23, 2010
Drugmaker GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects.
Only one case in Philadelphia's mass tort Paxil program has gone to trial.
GSK has settled every other case scheduled for trial in the eight months since a Philadelphia jury awarded a $2.5 million plaintiffs verdict in the first Philadelphia Paxil test case to go to trial.
GSK started to appeal that plaintiffs verdict from October. The jury awarded only compensatory damages and no punitive damages. But GSK then decided to settle Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline along with another 190 cases, according to an order signed by Philadelphia Common Pleas Judge Sandra Mazer Moss last week.
The cases have settled for confidential amounts, said Jamie Sheller of the Sheller firm and local plaintiffs liaison counsel for the Paxil pregnancy mass tort program. GSK confirmed the settlements but said in a spokeswoman's statement that the terms of the settlements are confidential.
Sheller estimates that up to another 100 cases, including cases that have not yet been filed, have settled. The litigation is two-thirds over, Moss and Sheller said.
The Kilker case was viewed by the plaintiffs mass torts bar as a leading indicator of the strength of more than 600 similar cases.
"When you're dealing with children with birth defects that's a concern for any company," Sheller said. "GSK gave it their all at that trial. ... Despite that, the plaintiffs were successful in the case and that set a tone for their analysis. Even though they mounted an excellent and strong defense they weren't able to overcome the plaintiffs' position."
The next cases in the litigation are scheduled for trial in the fall.
GSK spokeswoman Sarah Alspach said in an e-mail statement that GSK has agreed to settle some cases involving the use of Paxil during pregnancy "despite its litigation defenses, in order to avoid the costs, burdens and uncertainties of ongoing litigation."
Moss, the coordinating judge of Philadelphia's mass tort program, the Complex Litigation Center, said the philosophy of GSK "is to try and settle what they can and to settle in groups."
Moss also said the Paxil litigation has been resolving successfully in the last few months because of the cooperation between the plaintiffs and the defense bars and because GSK has not taken a stance that they're "not offering a penny."
"I think there is a great deal of cooperation between the plaintiffs and defendants," Moss said. "They actually work well together. There is not a lot of animosity."
Moss has been meeting monthly with the Paxil plaintiffs lawyers and the Paxil defense team, Sheller said.
Michael T. Scott, a defense attorney with Reed Smith's life sciences health industry group, said that settling a case is not an admission that the company did anything wrong and does not mean that all cases are going to settle. Scott said his firm represents GSK in some matters, but not in cases involving Paxil.
Tom Kline, a plaintiffs attorney with Kline & Specter, said that it appears that the Kilker trial was a "cathartic event" that influenced the course of the litigation.
Pharmaceutical companies have "economic and reputational incentives" to turn away from litigation, Kline said.
Pharmaceutical companies think in terms of billions of dollars, Kline said, and settling cases en masse doesn't break their bottom line and must be weighed against the impact on their reputation with the public -- including the federal Food and Drug Administration and health care professionals -- with every case that goes to trial, Kline said.
Moss said a mediator paid for by the defendants and the plaintiffs also was very helpful in settling the cases.
More of the cases that are settling involve cardiac defects, but there are other minor plaintiffs alleging defects because of their mothers' use of Paxil, Sheller said.
Because the cases involve minors, Orphans' Court approval is necessary, Moss said.
Moss said because the cases involve many out-of-state plaintiffs, she is working with Judge Joseph D. O'Keefe, administrative judge of Orphans' Court, on how to handle settlements for out-of-state minor plaintiffs.
Moss said it is contemplated that out-of-state minor plaintiffs can have approval for their settlements given by the state court jurisdictions in which the plaintiffs live. However, cases will come back to Philadelphia Orphans' Court if there is any reason that approval by judges in other states doesn't happen, Moss said.
O'Keefe said last week the Orphans' Court has not yet started to receive any Paxil cases.
Despite settling many of the Paxil cases, GSK continues to argue it acted appropriately regarding the drug.
"GSK believes it acted properly and responsibly in conducting its clinical trial program for Paxil, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine's label as new information became available," Alspach said.
In post-trial motions seeking judgment notwithstanding the verdict or a new trial in Kilker, GSK said that 65 percent of all birth defects have no known cause and less than 1 percent of all birth defects are attributable to a mother's exposure to medication during pregnancy.
Plaintiff Lyam Kilker has three congenital defects in his heart: a defect between the upper two chambers of his heart, a defect between the lower two chambers of his heart and a defect that has left a hole in the wall of his heart that separates the two pumping chambers of the heart as well as preventing the heart's aorta from forming a complete "tube," according to court papers.
The last of Kilker's heart defects, called an interrupted aortic arch, is a defect that GSK argued has not been found in research to be associated with the use of Paxil by pregnant mothers and the cause of this type of heart defect is generally considered to be unknown.
"There is no established -- or even speculative -- link between Paxil and interrupted aortic arch," GSK said in its post-trial motions.
Sheller said last fall that GSK thought it could win on Kilker's more rare defect, which is why they took Kilker to trial and settled other cases.
Prior to Kilker, three other bellwether cases settled for confidential amounts.
Joseph O'Neil of Philadelphia's Lavin O'Neil Ricci Cedrone & DiSipio is the local defense liaison counsel for the Paxil pregnancy program.
The main plaintiffs firms include Clark Burnett Love & Lee in Houston, the Tracey Law Firm in Houston and Robinson Calcagnie & Robinson in Newport Beach, Calif., Sheller said.
Tuesday, 22 June 2010
Seroxat - Carlin's cocaine & booze use grim, says Judge at inquest
Jury ponders antidepressant's role in teen suicide
http://www.torontosun.com/news/torontoandgta/2010/06/22/14477976.html
The grimmest evidence a coroner learned during a two-week inquest into an Oakville teen’s suicide was her heavy cocaine and booze consumption, he told a jury in his summary Tuesday.
At the end of his review of testimony into Sara Carlin’s death, Dr. Bert Lauwers said the key issue is whether the prescribed antidepressant drug Paxil led to the 18-year-old athlete and student hanging herself on May 6, 2007 in the basement of her family’s home.
Lauwers spent 77 minutes reviewing 22 recommendations submitted by coroner’s counsel Michael Blain and other lawyers, including Gary Will, who represents Carlin’s parents.
The submissions could become part of the jury’s decisions into what caused the teen’s death and recommendations about what precautions doctors and government agencies can take to prevent suicides.
Lauwers placed special emphasis on testimony pointing to an alarming increase in suicides by Ontario teenagers.
A doctor specializing in the subject testified that 19% of high school students in the province had considered killing themselves during the past year, 15% actually began planning methods to end their lives and 9% tried suicide.
Recommendations being considered include warning students about the potentially lethal combination of using booze and illegal drugs while taking antidepressants. Experts testified about the higher risk of suicide among younger people taking such medication.
The jury also has been asked to consider urging governments to require manufacturers to make public negative findings resulting from tests on a larger number of drugs.
Jurors didn’t hear enough about “what was going on in Sarah’s life,” which may have contributed to her suicide, Will told the coroner.
Will told jurors Monday there is “powerful evidence” that the antidepressant drug played a stronger role in her decision to kill herself than the consumption of alcohol and cocaine.
Court heard that Carlin, an aspiring dermatologist, had dropped out of her second year of health sciences at the University of Western Ontario after complaining to her family doctor about anxiety and depression. She was prescribed Paxil 14 months before her death.
Lauwers told the jury her doctor was aware of the drug’s risks.
Her family insisted Carlin had exhibited no signs of depression.
Will argued Paxil had been proven ineffective and dangerous for patients under 19, adding the teen and her parents were not told of its risks or questionable status.
While complimenting the family for offering several recommendations, Lauwers cautioned the jury that experts on both sides presented conflicting opinions during the inquest about the heightened risk of youths taking antidepressants compared with the contribution to suicides of existing depression conditions.
Lawyers representing Paxil’s manufacturer, Glaxosmith Kline Inc., were at the inquest.
The coroner told the jury that trying to determine a direct link between Paxil and Carlin’s suicide posed a “serious challenge” for them. He said he learned of her cocaine and alcohol use only during testimony.
The five-member jury, whose decisions do not have to be unanimous, will remain behind closed doors during
deliberations.
ian.robertson@sunmedia.ca
http://www.torontosun.com/news/torontoandgta/2010/06/22/14477976.html
The grimmest evidence a coroner learned during a two-week inquest into an Oakville teen’s suicide was her heavy cocaine and booze consumption, he told a jury in his summary Tuesday.
At the end of his review of testimony into Sara Carlin’s death, Dr. Bert Lauwers said the key issue is whether the prescribed antidepressant drug Paxil led to the 18-year-old athlete and student hanging herself on May 6, 2007 in the basement of her family’s home.
Lauwers spent 77 minutes reviewing 22 recommendations submitted by coroner’s counsel Michael Blain and other lawyers, including Gary Will, who represents Carlin’s parents.
The submissions could become part of the jury’s decisions into what caused the teen’s death and recommendations about what precautions doctors and government agencies can take to prevent suicides.
Lauwers placed special emphasis on testimony pointing to an alarming increase in suicides by Ontario teenagers.
A doctor specializing in the subject testified that 19% of high school students in the province had considered killing themselves during the past year, 15% actually began planning methods to end their lives and 9% tried suicide.
Recommendations being considered include warning students about the potentially lethal combination of using booze and illegal drugs while taking antidepressants. Experts testified about the higher risk of suicide among younger people taking such medication.
The jury also has been asked to consider urging governments to require manufacturers to make public negative findings resulting from tests on a larger number of drugs.
Jurors didn’t hear enough about “what was going on in Sarah’s life,” which may have contributed to her suicide, Will told the coroner.
Will told jurors Monday there is “powerful evidence” that the antidepressant drug played a stronger role in her decision to kill herself than the consumption of alcohol and cocaine.
Court heard that Carlin, an aspiring dermatologist, had dropped out of her second year of health sciences at the University of Western Ontario after complaining to her family doctor about anxiety and depression. She was prescribed Paxil 14 months before her death.
Lauwers told the jury her doctor was aware of the drug’s risks.
Her family insisted Carlin had exhibited no signs of depression.
Will argued Paxil had been proven ineffective and dangerous for patients under 19, adding the teen and her parents were not told of its risks or questionable status.
While complimenting the family for offering several recommendations, Lauwers cautioned the jury that experts on both sides presented conflicting opinions during the inquest about the heightened risk of youths taking antidepressants compared with the contribution to suicides of existing depression conditions.
Lawyers representing Paxil’s manufacturer, Glaxosmith Kline Inc., were at the inquest.
The coroner told the jury that trying to determine a direct link between Paxil and Carlin’s suicide posed a “serious challenge” for them. He said he learned of her cocaine and alcohol use only during testimony.
The five-member jury, whose decisions do not have to be unanimous, will remain behind closed doors during
deliberations.
ian.robertson@sunmedia.ca
Health Canada - safety warnings on ALL SSRI's from 2004 - it's in the packet !
Advisory
2004-31
June 3, 2004
For immediate release
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2004/2004_31-eng.php
OTTAWA - Health Canada is advising Canadians that Selective Serotonin Re-uptake Inhibitors (SSRIs) and other newer anti-depressants, now carry stronger warnings. These new warnings indicate that patients of all ages taking these drugs may experience behavioural and/or emotional changes that may put them at increased risk of self-harm or harm to others.
The new warning for each of these drugs, which are listed below, appears in the information package received by patients and in the prescribing information available to health professionals.
Patients, their families and caregivers should note that a small number of patients taking drugs of this type may feel worse instead of better, particularly within the first few weeks of treatment or when doses are adjusted. For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self-harm or harm to others.
Should this happen to you, consult your doctor immediately. Do not discontinue your medication on your own. It is very important that patients do NOT stop taking their medication without first consulting with their doctor due to the labelled risk of discontinuation symptoms with all of these drugs, except bupropion. Treatment with these types of medications is safest and most effective when the patient communicates well with the treating physician about how he or she is feeling.
It is important to note that Health Canada has not authorized these drugs for use in patients under 18 years of age. The prescribing of drugs is a physician's responsibility. Although these drugs are not authorized for use in children, doctors rely on their knowledge of patients and the drugs to determine whether to prescribe them at their discretion in a practice called off-label use. Off-label use of these drugs in children is acknowledged to be an important tool for doctors.
Doctors are advised to carefully monitor patients of all ages for emotional or behavioural changes that may indicate potential for harm, including suicidal thoughts and the onset or worsening of agitation-type adverse events.
This advisory stems from advice given by an independent expert panel and is the result of Health Canada's extensive review of the latest worldwide safety data available for these drugs. It follows the advisory Health Canada issued on February 3 advising Canadians of the need for patients under the age of 18 who are being treated with newer anti-depressants to consult a physician. Following the meeting with the expert panel, Health Canada conducted an analysis of all adverse reactions experienced by patients taking SSRIs. Although Health Canada did not find a direct link between taking SSRIs and incidents of death, the Department felt it important to let health professionals and consumers know of the possible risks associated with the drugs.
This advisory applies to the following anti-depressants:
•Bupropion (Wellbutrin® and Zyban®)
Note that both of these drugs share the same active ingredient. Zyban, a smoking cessation drug, now carries an appropriately modified version of the above warning.
•Citalopram (Celexa®)
•Fluoxetine (Prozac®)
•Fluvoxamine (Luvox®)
•Mirtazapine (Remeron®)
•Paroxetine (Paxil®)
•Sertraline (Zoloft®)
•Venlaflaxine (Effexor®)
Note: Health Canada issued another advisory on this topic on August 9, 2004. To access this advisory, visit: www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2004/2004_44-eng.php
2004-31
June 3, 2004
For immediate release
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2004/2004_31-eng.php
OTTAWA - Health Canada is advising Canadians that Selective Serotonin Re-uptake Inhibitors (SSRIs) and other newer anti-depressants, now carry stronger warnings. These new warnings indicate that patients of all ages taking these drugs may experience behavioural and/or emotional changes that may put them at increased risk of self-harm or harm to others.
The new warning for each of these drugs, which are listed below, appears in the information package received by patients and in the prescribing information available to health professionals.
Patients, their families and caregivers should note that a small number of patients taking drugs of this type may feel worse instead of better, particularly within the first few weeks of treatment or when doses are adjusted. For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self-harm or harm to others.
Should this happen to you, consult your doctor immediately. Do not discontinue your medication on your own. It is very important that patients do NOT stop taking their medication without first consulting with their doctor due to the labelled risk of discontinuation symptoms with all of these drugs, except bupropion. Treatment with these types of medications is safest and most effective when the patient communicates well with the treating physician about how he or she is feeling.
It is important to note that Health Canada has not authorized these drugs for use in patients under 18 years of age. The prescribing of drugs is a physician's responsibility. Although these drugs are not authorized for use in children, doctors rely on their knowledge of patients and the drugs to determine whether to prescribe them at their discretion in a practice called off-label use. Off-label use of these drugs in children is acknowledged to be an important tool for doctors.
Doctors are advised to carefully monitor patients of all ages for emotional or behavioural changes that may indicate potential for harm, including suicidal thoughts and the onset or worsening of agitation-type adverse events.
This advisory stems from advice given by an independent expert panel and is the result of Health Canada's extensive review of the latest worldwide safety data available for these drugs. It follows the advisory Health Canada issued on February 3 advising Canadians of the need for patients under the age of 18 who are being treated with newer anti-depressants to consult a physician. Following the meeting with the expert panel, Health Canada conducted an analysis of all adverse reactions experienced by patients taking SSRIs. Although Health Canada did not find a direct link between taking SSRIs and incidents of death, the Department felt it important to let health professionals and consumers know of the possible risks associated with the drugs.
This advisory applies to the following anti-depressants:
•Bupropion (Wellbutrin® and Zyban®)
Note that both of these drugs share the same active ingredient. Zyban, a smoking cessation drug, now carries an appropriately modified version of the above warning.
•Citalopram (Celexa®)
•Fluoxetine (Prozac®)
•Fluvoxamine (Luvox®)
•Mirtazapine (Remeron®)
•Paroxetine (Paxil®)
•Sertraline (Zoloft®)
•Venlaflaxine (Effexor®)
Note: Health Canada issued another advisory on this topic on August 9, 2004. To access this advisory, visit: www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2004/2004_44-eng.php
Paxil CR™ product monograph Canada - BEHAVIOURAL AND EMOTIONAL CHANGES / Suicidality
POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL
CHANGES, INCLUDING SELF-HARM.
http://www.gsk.ca/english/docs-pdf/Paxil_CR_2010.pdf
Pediatrics: Placebo-Controlled Clinical Trial Data
• Recent analyses of placebo-controlled clinical trial safety databases from
SSRIs and other newer anti-depressants suggests that use of these drugs in
patients under the age of 18 may be associated with behavioural and
emotional changes, including an increased risk of suicidal ideation and
behaviour over that of placebo.
• The small denominators in the clinical trial database, as well as the
variability in placebo rates, preclude reliable conclusions on the relative
safety profiles among these drugs.
Adult and Pediatrics: Additional data
• There are clinical trial and post-marketing reports with SSRIs and other
newer anti-depressants, in both pediatrics and adults, of severe agitationtype
adverse events coupled with self-harm or harm to others. The
agitation-type events include: akathisia, agitation, disinhibition, emotional
lability, hostility, aggression, depersonalization. In some cases, the events
occurred within several weeks of starting treatment.
Rigorous clinical monitoring for suicidal ideation or other indicators of potential for
suicidal behaviour is advised in patients of all ages. This includes monitoring for
agitation-type emotional and behavioural changes.
CHANGES, INCLUDING SELF-HARM.
http://www.gsk.ca/english/docs-pdf/Paxil_CR_2010.pdf
Pediatrics: Placebo-Controlled Clinical Trial Data
• Recent analyses of placebo-controlled clinical trial safety databases from
SSRIs and other newer anti-depressants suggests that use of these drugs in
patients under the age of 18 may be associated with behavioural and
emotional changes, including an increased risk of suicidal ideation and
behaviour over that of placebo.
• The small denominators in the clinical trial database, as well as the
variability in placebo rates, preclude reliable conclusions on the relative
safety profiles among these drugs.
Adult and Pediatrics: Additional data
• There are clinical trial and post-marketing reports with SSRIs and other
newer anti-depressants, in both pediatrics and adults, of severe agitationtype
adverse events coupled with self-harm or harm to others. The
agitation-type events include: akathisia, agitation, disinhibition, emotional
lability, hostility, aggression, depersonalization. In some cases, the events
occurred within several weeks of starting treatment.
Rigorous clinical monitoring for suicidal ideation or other indicators of potential for
suicidal behaviour is advised in patients of all ages. This includes monitoring for
agitation-type emotional and behavioural changes.
PAXIL CR® - PRESCRIBING INFORMATION black box suicide warning - USA
PRESCRIBING INFORMATION
http://us.gsk.com/products/assets/us_paxilcr.pdf
PAXIL CR®
(paroxetine hydrochloride)
Controlled-Release Tablets
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL CR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL CR is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
http://us.gsk.com/products/assets/us_paxilcr.pdf
PAXIL CR®
(paroxetine hydrochloride)
Controlled-Release Tablets
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL CR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL CR is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
Seroxat - Sara Carlin inquest jury considering recommendations
Inquest jury considering recommendations
"They (Sara's parents) had an innate sense that it just wasn't right that this young girl was on Paxil, an anti-depressant, but they deferred to the people they thought they could trust. If the doctors had told Sara that Paxil might cause her to feel suicidal, when it was actually happening to her, to this very confused young girl, she could have put two and two together, and realized the thoughts of suicide she was experiencing were not a result of her own inadequacies, but were a result of the negative consequences of Paxil. If she was told or her parents were told, is there any doubt there would have been a different outcome." - Carlin family lawyer Gary Will. Lawyer Gary Will, on behalf of the Carlin family, submitted 26 recommendations to the jury examining the suicide of the daughter, Sara.
The recommendations are:
1. We recommend that all doctors be required to provide informed consent to all patients being prescribed antidepressant drugs, including Paxil and all other SSRI and SNRIs, using the model currently considered good clinical practice in British Columbia for anyone under 18 years of age. (Ex. 20)
This includes an SSRI/SNRI monitoring form and information sheet being provided to patients (and their families) and a requirement for the doctor to discuss the true risk/benefit analysis with the patients, and document that discussion.
This discussion should also include a discussion of all reasonable alternative treatments and any material risks and benefits of such alternative treatments.
This discussion should include all material risks and the risk of suicide and record exactly how the patient will be monitored for suicide.
2. Patients should have a published Bill of Rights which incorporates as a principle: “The Right to Informed Consent”. This means good, complete and balanced information based on scientific evidence of a drug’s efficacy and safety.
3. That in all cases where a drug has not been approved for use in children where there are potential life threatening adverse consequences that the doctor must discuss the drug with the parents or legal guardians of the patient unless there is a written direction from the patient that which prohibits this communication.
4. That the College of Physicians and Surgeons of Ontario provide practice guidelines and training to family physicians on administering and monitoring the use of antidepressants (SSRIs) in adolescents.
5. The information provided to patients should be standardized and handed out with the drugs and be in plain language.
6. The information provided to patients should include:
(i) the benefits of the drug, not just “it might help”. That includes the real effects of the drug, how many people it helped and under what conditions, and how much better it was than a placebo;
(ii) the risks of taking the drug: not just the common side effects, but the things that might happen and the rare serious side effects. A layperson should be able to understand the true level of risk in their personal situation and make an informed choice;
(iii) the alternative treatments to the drug: including what would happen if you do nothing, any lower cost treatment that might work as well, or a lifestyle change that might help the condition.
7. Drug labels and patient safety information leaflets should make patients prescribed a drug aware of any safety issues related to that drug in other countries, including but not limited to any related deaths or serious injuries due to drug reactions.
8. Consumer Package Inserts should state up-front in plain language, any warnings patients may need to decide whether or not this drug is safe for them, or if they wish to go back to their doctor for more advice.
9. Monographs should not list only officially reported adverse reactions, which are a tiny fraction of real reactions, but the fact that reported adverse reactions represent only a tiny fraction of actual events.
10. Any and all clinical studies that are sponsored by drug companies or their affiliates should be registered when begun and the results reported to a Canadian drug safety agency by law.
11. The Dear Healthcare Professional letters issued by drug manufacturers and/or Health Canada when issuing a drug warning should include other suggested alternative treatments.
12. Patients should know when a drug has never been tested on a large group of people or never tested on children.
13. Drug companies should provide software and updates to doctors which list all contraindications for their products in plain language on the Internet available by download to PCs and hand-held computers on demand.
14. Drug companies should be required to report all serious adverse events associated with their drugs from all foreign jurisdictions within 30 days of the adverse event.
15. Any company that blocks the dissemination of significant safety / efficacy information on drugs sold in Canada, or withholds such information, should face significant penalties commensurate with their financial position.
16. That drug manufacturers be required to report the results of all clinical trials to Health Canada.
17. That drug manufacturers be prohibited from requiring researchers to sign non-disclosure contracts.
18. Patients should also be able to get this approved information from an independent drug safety agency by calling a free 1-800 # as well as information regarding their right to be properly informed.
19. There should be an arms length body independent from Health Canada called the Drug Safety Board which is solely dedicated to drug safety and which reports to Parliament and is funded by the Federal Government, which receives no money from drug companies. Amongst its mandated responsibilities should be investigating adverse reactions and issuing warnings to the public and health care professionals and hospitals.
20. Health Canada, or the new Drug Safety Board, should study the extent to which serious adverse events remain unreported. This data should then be used when sending out information to physicians or the public concerning reported adverse events by cautioning the reader that actual adverse reported events likely only represent 10% of the actual adverse events.
21. Health Care Professionals should be required by law to report any suspected adverse drug reaction to Health Canada, or the new Drug Safety Board, within 48 hours. This would act as an early warning system with new drugs, and help identify rare but serious reactions and dangerous contraindications.
22. There should be a presumption that all health care records concerning a patient are to be forwarded to the patient’s family physician unless there is a written direction from the patient that particular records are not to be forwarded to the family physician.
23. Ontario should adopt a Provincial Suicide Prevention strategy.
24. Canada should adopt a National Suicide Prevention strategy.
25. The Province should develop a strategy to create a single prescription drug database to facilitate research into drug safety issues.
26. The Provincial Ministry of Education should incorporate into its high school curriculum courses directed towards dealing with alcohol and drug abuse issues.
The arguments have been made, the witnesses heard and now the time has come for the jury to ask themselves, 'Did Paxil play a role in Sara Carlin's death,' and if so what should be done?
Lawyers for the Carlin family, Paxil manufacturer GlaxoSmithKline and the three doctors associated with treating Sara made closing statements to the jury on Monday, concluding a coroner's inquest into the death of the young Oakville woman, which has lasted for more than two weeks and seen more than 30 witnesses testify.
Sara, 18, a graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents’ basement on Sunday, May 6, 2007.
She had been taking the anti-depressant Paxil, a selective serotonin reuptake inhibitor (SSRI) medication, for more than a year leading up to her death despite Health Canada advisories being sent to health care professionals in 2003 and 2004 warning the drug could increase the risk of suicidal events in children and adolescents under 18.
During his statements to the jury Carlin lawyer Gary Will hammered home the theory that Paxil was the reason for Sara's suicide and that her death was entirely preventable.
He talked about how there were two Saras.
The one who existed before Paxil, who was academically and athletically focused and dreamed of becoming a doctor, and the one after Paxil, who was withdrawn, who no longer seemed to care about anything and for whom drug and alcohol abuse was a problem.
Will talked about Sara, then 17, being prescribed Paxil in the February of 2006, for anxiety, following a half hour appointment with Dr. Tom Stanton, her family doctor.
He talked about how Stanton did not warn her that the drug had been associated with increased suicidal thoughts and behaviours because he was afraid doing so would make her not want to take the drug.
He also talked about how Sara's parents Neil and Rhonda were not told about Sara being put on Paxil.
Stanton testified this was done at Sara's request.
"There isn't any detailed treatment plan. He doesn't rule out physical causes. He doesn't do any laboratory analysis. He doesn't talk to her about substance abuse. He doesn't recommend counseling and he doesn't discuss any other treatment options," said Will.
"He gives her a pill."
Will then pointed to the incidents, which he said, showed the drug was having an adverse effect on Sara.
This included the Carlin family trip to Palm Springs in March when Sara refused to get out of bed for much of the time and at one point got drunk in front of her parents.
All of which was very uncharacteristic for her.
For every increase in Sara's Paxil dosage Will pointed to another adverse incident.
After the dose was increased to 20 mgs per day in March, witnesses testify to increased drug and alcohol use by Sara, as well as being withdrawn at a family get together.
During a cottage party that summer Sara makes statements about suicide to her friends.
Two weeks after the dose was increased to 30 mgs in September of 2006, Sara wrote a note to herself, which some have characterized as being close to a suicide note.
A short time after the dose was increased to 40 mgs in October of 2006, Sara was taken to a London emergency room for mixing alcohol, sleeping pills and cocaine.
Although Sara denied it at the time, some would characterize this as a suicide attempt.
Upon Sara's return to Oakville, her family doctors referred her to ADAPT (Alcohol, Drug and Gambling Assessment, Prevention and Treatment Services).
Sara stopped attending after one session with neither her family, or doctor or anyone else being informed.
Will said this story reached its grim conclusion when she lost her prescription and went between one to four days without Paxil shortly before her suicide.
Will has previously talked about how the withdrawal symptoms of Paxil can include suicidal thinking and behaviour.
He said feelings of suicidality can occur when a person resumes taking Paxil. He speculated that when Sara got her prescription back, she may have taken as much as 120 mgs of Paxil in 36 hours to make up the doses she missed.
Shortly after this, Sara hanged herself in her parents' basement after an evening out with her friends.
Will said the side effects of Paxil, which includes increased drinking, possible drug dependence, depression, depersonalization, akathisia, (feeling of intense inner torment) are all listed on the product monograph.
What happened to Sara was a known side effect of Paxil, said Will. This was known to GlaxoSmithKline, Health Canada and Sara's doctors, said Will, but not to the people who needed to know the most — Sara and her parents.
Those who had the most contact with Sara didn't know what side effects to look for because they weren't told, said Will.
"They (Sara's parents) had an innate sense that it just wasn't right that this young girl was on Paxil, an anti-depressant, but they deferred to the people they thought they could trust," said Will.
"If the doctors had told Sara that Paxil might cause her to feel suicidal, when it was actually happening to her, to this very confused young girl, she could have put two and two together, and realized the thoughts of suicide she was experiencing were not a result of her own inadequacies, but were a result of the negative consequences of Paxil. If she was told or her parents were told, is there any doubt there would have been a different outcome."
Ensuring patients are informed of the risks of the drugs they are taking was one of the 26 recommendations put forward by the Carlin family.
Other recommendations included one stating when minors are prescribed medication that has not been approved for use by children and may have potential life threatening adverse consequences, the doctor must discuss the drug with the parents or legal guardians of the patient, unless there is a written direction from the patient that prohibits this communication.
The Coroner's Counsel Michael Blain also brought forward 23 recommendations including one calling for the creation of a province-wide drug information system, which would conduct research into drug and patient safety.
Will's theory that Paxil played a role in Sara's death was not the only theory brought forward. Teresa Walsh, lawyer for GlaxoSmithKline, and Steve Schenke, for Sara’s three doctors, both blamed Sara's suicide on a combination of depression and drug and alcohol abuse shortly before her death.
Both pointed out their theory had the support of the expert witnesses, including Dr. David Juurlink who testified he believed Paxil could cause a person to commit suicide, but did not believe this happened in Sara's case.
Expert witness Dr. Nathan Scharf testified Paxil may have been a contributing factor to Sara's suicide to some degree, but said alcohol was most likely a greater contributing factor.
Expert witness Dr. Paul Links said it was plausible Sara's death was connected to Paxil, but added it was not very probable.
All of these experts said Paxil was probably not responsible for Sara's death because she had been taking the drug for more than a year. Any adverse side effects and associated suicidality usually occur when the drug is first introduced, they said.
Walsh said Sara's drinking and depression were not things that suddenly happened when Sara started taking Paxil, as Will said they were.
The Psychotherapist Mary Alexander, who met with Sara once, said Sara said she had been drinking excessively and was depressed well before the Paxil. According to Alexander, Sara said Paxil was actually helping her.
Walsh said one of Sara's friends also noted in a police statement that Sara had been depressed throughout high school over the loss of her older brother Brendan from a drug overdose on New Year's Eve 1999.
Alexander testified Sara said these feelings of sadness over Brendan's death had been bottled up since it happened, but were overwhelming her now resulting in anxiety and panic attacks.
Schenke also pointed out that when Sara came to Stanton she said she was suffering three panic attacks a day. While Stanton did make an appointment for her to see a psychotherapist to get at the underlying issues behind her anxiety, Schenke said he needed to give her Paxil in the meantime due to a long waiting list.
Stanton referred Sara to Alexander in March and Alexander was not able to see her until July.
Schenke also said that if Stanton is wrong for putting Sara on Paxil, using his clinical judgment to prescribe a medication for someone for which it is not recommended, than there are thousands of other doctors who are wrong, too.
Regardless of whether the jury believes Paxil played a role in Sara’s death, Blain said they can still make recommendations calling for greater safety measures for Paxil prescriptions.
There has been no time frame given as to how long the jury will deliberate for.
http://www.insidehalton.com/news/article/836973--inquest-jury-considering-recommendations
"They (Sara's parents) had an innate sense that it just wasn't right that this young girl was on Paxil, an anti-depressant, but they deferred to the people they thought they could trust. If the doctors had told Sara that Paxil might cause her to feel suicidal, when it was actually happening to her, to this very confused young girl, she could have put two and two together, and realized the thoughts of suicide she was experiencing were not a result of her own inadequacies, but were a result of the negative consequences of Paxil. If she was told or her parents were told, is there any doubt there would have been a different outcome." - Carlin family lawyer Gary Will. Lawyer Gary Will, on behalf of the Carlin family, submitted 26 recommendations to the jury examining the suicide of the daughter, Sara.
The recommendations are:
1. We recommend that all doctors be required to provide informed consent to all patients being prescribed antidepressant drugs, including Paxil and all other SSRI and SNRIs, using the model currently considered good clinical practice in British Columbia for anyone under 18 years of age. (Ex. 20)
This includes an SSRI/SNRI monitoring form and information sheet being provided to patients (and their families) and a requirement for the doctor to discuss the true risk/benefit analysis with the patients, and document that discussion.
This discussion should also include a discussion of all reasonable alternative treatments and any material risks and benefits of such alternative treatments.
This discussion should include all material risks and the risk of suicide and record exactly how the patient will be monitored for suicide.
2. Patients should have a published Bill of Rights which incorporates as a principle: “The Right to Informed Consent”. This means good, complete and balanced information based on scientific evidence of a drug’s efficacy and safety.
3. That in all cases where a drug has not been approved for use in children where there are potential life threatening adverse consequences that the doctor must discuss the drug with the parents or legal guardians of the patient unless there is a written direction from the patient that which prohibits this communication.
4. That the College of Physicians and Surgeons of Ontario provide practice guidelines and training to family physicians on administering and monitoring the use of antidepressants (SSRIs) in adolescents.
5. The information provided to patients should be standardized and handed out with the drugs and be in plain language.
6. The information provided to patients should include:
(i) the benefits of the drug, not just “it might help”. That includes the real effects of the drug, how many people it helped and under what conditions, and how much better it was than a placebo;
(ii) the risks of taking the drug: not just the common side effects, but the things that might happen and the rare serious side effects. A layperson should be able to understand the true level of risk in their personal situation and make an informed choice;
(iii) the alternative treatments to the drug: including what would happen if you do nothing, any lower cost treatment that might work as well, or a lifestyle change that might help the condition.
7. Drug labels and patient safety information leaflets should make patients prescribed a drug aware of any safety issues related to that drug in other countries, including but not limited to any related deaths or serious injuries due to drug reactions.
8. Consumer Package Inserts should state up-front in plain language, any warnings patients may need to decide whether or not this drug is safe for them, or if they wish to go back to their doctor for more advice.
9. Monographs should not list only officially reported adverse reactions, which are a tiny fraction of real reactions, but the fact that reported adverse reactions represent only a tiny fraction of actual events.
10. Any and all clinical studies that are sponsored by drug companies or their affiliates should be registered when begun and the results reported to a Canadian drug safety agency by law.
11. The Dear Healthcare Professional letters issued by drug manufacturers and/or Health Canada when issuing a drug warning should include other suggested alternative treatments.
12. Patients should know when a drug has never been tested on a large group of people or never tested on children.
13. Drug companies should provide software and updates to doctors which list all contraindications for their products in plain language on the Internet available by download to PCs and hand-held computers on demand.
14. Drug companies should be required to report all serious adverse events associated with their drugs from all foreign jurisdictions within 30 days of the adverse event.
15. Any company that blocks the dissemination of significant safety / efficacy information on drugs sold in Canada, or withholds such information, should face significant penalties commensurate with their financial position.
16. That drug manufacturers be required to report the results of all clinical trials to Health Canada.
17. That drug manufacturers be prohibited from requiring researchers to sign non-disclosure contracts.
18. Patients should also be able to get this approved information from an independent drug safety agency by calling a free 1-800 # as well as information regarding their right to be properly informed.
19. There should be an arms length body independent from Health Canada called the Drug Safety Board which is solely dedicated to drug safety and which reports to Parliament and is funded by the Federal Government, which receives no money from drug companies. Amongst its mandated responsibilities should be investigating adverse reactions and issuing warnings to the public and health care professionals and hospitals.
20. Health Canada, or the new Drug Safety Board, should study the extent to which serious adverse events remain unreported. This data should then be used when sending out information to physicians or the public concerning reported adverse events by cautioning the reader that actual adverse reported events likely only represent 10% of the actual adverse events.
21. Health Care Professionals should be required by law to report any suspected adverse drug reaction to Health Canada, or the new Drug Safety Board, within 48 hours. This would act as an early warning system with new drugs, and help identify rare but serious reactions and dangerous contraindications.
22. There should be a presumption that all health care records concerning a patient are to be forwarded to the patient’s family physician unless there is a written direction from the patient that particular records are not to be forwarded to the family physician.
23. Ontario should adopt a Provincial Suicide Prevention strategy.
24. Canada should adopt a National Suicide Prevention strategy.
25. The Province should develop a strategy to create a single prescription drug database to facilitate research into drug safety issues.
26. The Provincial Ministry of Education should incorporate into its high school curriculum courses directed towards dealing with alcohol and drug abuse issues.
The arguments have been made, the witnesses heard and now the time has come for the jury to ask themselves, 'Did Paxil play a role in Sara Carlin's death,' and if so what should be done?
Lawyers for the Carlin family, Paxil manufacturer GlaxoSmithKline and the three doctors associated with treating Sara made closing statements to the jury on Monday, concluding a coroner's inquest into the death of the young Oakville woman, which has lasted for more than two weeks and seen more than 30 witnesses testify.
Sara, 18, a graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents’ basement on Sunday, May 6, 2007.
She had been taking the anti-depressant Paxil, a selective serotonin reuptake inhibitor (SSRI) medication, for more than a year leading up to her death despite Health Canada advisories being sent to health care professionals in 2003 and 2004 warning the drug could increase the risk of suicidal events in children and adolescents under 18.
During his statements to the jury Carlin lawyer Gary Will hammered home the theory that Paxil was the reason for Sara's suicide and that her death was entirely preventable.
He talked about how there were two Saras.
The one who existed before Paxil, who was academically and athletically focused and dreamed of becoming a doctor, and the one after Paxil, who was withdrawn, who no longer seemed to care about anything and for whom drug and alcohol abuse was a problem.
Will talked about Sara, then 17, being prescribed Paxil in the February of 2006, for anxiety, following a half hour appointment with Dr. Tom Stanton, her family doctor.
He talked about how Stanton did not warn her that the drug had been associated with increased suicidal thoughts and behaviours because he was afraid doing so would make her not want to take the drug.
He also talked about how Sara's parents Neil and Rhonda were not told about Sara being put on Paxil.
Stanton testified this was done at Sara's request.
"There isn't any detailed treatment plan. He doesn't rule out physical causes. He doesn't do any laboratory analysis. He doesn't talk to her about substance abuse. He doesn't recommend counseling and he doesn't discuss any other treatment options," said Will.
"He gives her a pill."
Will then pointed to the incidents, which he said, showed the drug was having an adverse effect on Sara.
This included the Carlin family trip to Palm Springs in March when Sara refused to get out of bed for much of the time and at one point got drunk in front of her parents.
All of which was very uncharacteristic for her.
For every increase in Sara's Paxil dosage Will pointed to another adverse incident.
After the dose was increased to 20 mgs per day in March, witnesses testify to increased drug and alcohol use by Sara, as well as being withdrawn at a family get together.
During a cottage party that summer Sara makes statements about suicide to her friends.
Two weeks after the dose was increased to 30 mgs in September of 2006, Sara wrote a note to herself, which some have characterized as being close to a suicide note.
A short time after the dose was increased to 40 mgs in October of 2006, Sara was taken to a London emergency room for mixing alcohol, sleeping pills and cocaine.
Although Sara denied it at the time, some would characterize this as a suicide attempt.
Upon Sara's return to Oakville, her family doctors referred her to ADAPT (Alcohol, Drug and Gambling Assessment, Prevention and Treatment Services).
Sara stopped attending after one session with neither her family, or doctor or anyone else being informed.
Will said this story reached its grim conclusion when she lost her prescription and went between one to four days without Paxil shortly before her suicide.
Will has previously talked about how the withdrawal symptoms of Paxil can include suicidal thinking and behaviour.
He said feelings of suicidality can occur when a person resumes taking Paxil. He speculated that when Sara got her prescription back, she may have taken as much as 120 mgs of Paxil in 36 hours to make up the doses she missed.
Shortly after this, Sara hanged herself in her parents' basement after an evening out with her friends.
Will said the side effects of Paxil, which includes increased drinking, possible drug dependence, depression, depersonalization, akathisia, (feeling of intense inner torment) are all listed on the product monograph.
What happened to Sara was a known side effect of Paxil, said Will. This was known to GlaxoSmithKline, Health Canada and Sara's doctors, said Will, but not to the people who needed to know the most — Sara and her parents.
Those who had the most contact with Sara didn't know what side effects to look for because they weren't told, said Will.
"They (Sara's parents) had an innate sense that it just wasn't right that this young girl was on Paxil, an anti-depressant, but they deferred to the people they thought they could trust," said Will.
"If the doctors had told Sara that Paxil might cause her to feel suicidal, when it was actually happening to her, to this very confused young girl, she could have put two and two together, and realized the thoughts of suicide she was experiencing were not a result of her own inadequacies, but were a result of the negative consequences of Paxil. If she was told or her parents were told, is there any doubt there would have been a different outcome."
Ensuring patients are informed of the risks of the drugs they are taking was one of the 26 recommendations put forward by the Carlin family.
Other recommendations included one stating when minors are prescribed medication that has not been approved for use by children and may have potential life threatening adverse consequences, the doctor must discuss the drug with the parents or legal guardians of the patient, unless there is a written direction from the patient that prohibits this communication.
The Coroner's Counsel Michael Blain also brought forward 23 recommendations including one calling for the creation of a province-wide drug information system, which would conduct research into drug and patient safety.
Will's theory that Paxil played a role in Sara's death was not the only theory brought forward. Teresa Walsh, lawyer for GlaxoSmithKline, and Steve Schenke, for Sara’s three doctors, both blamed Sara's suicide on a combination of depression and drug and alcohol abuse shortly before her death.
Both pointed out their theory had the support of the expert witnesses, including Dr. David Juurlink who testified he believed Paxil could cause a person to commit suicide, but did not believe this happened in Sara's case.
Expert witness Dr. Nathan Scharf testified Paxil may have been a contributing factor to Sara's suicide to some degree, but said alcohol was most likely a greater contributing factor.
Expert witness Dr. Paul Links said it was plausible Sara's death was connected to Paxil, but added it was not very probable.
All of these experts said Paxil was probably not responsible for Sara's death because she had been taking the drug for more than a year. Any adverse side effects and associated suicidality usually occur when the drug is first introduced, they said.
Walsh said Sara's drinking and depression were not things that suddenly happened when Sara started taking Paxil, as Will said they were.
The Psychotherapist Mary Alexander, who met with Sara once, said Sara said she had been drinking excessively and was depressed well before the Paxil. According to Alexander, Sara said Paxil was actually helping her.
Walsh said one of Sara's friends also noted in a police statement that Sara had been depressed throughout high school over the loss of her older brother Brendan from a drug overdose on New Year's Eve 1999.
Alexander testified Sara said these feelings of sadness over Brendan's death had been bottled up since it happened, but were overwhelming her now resulting in anxiety and panic attacks.
Schenke also pointed out that when Sara came to Stanton she said she was suffering three panic attacks a day. While Stanton did make an appointment for her to see a psychotherapist to get at the underlying issues behind her anxiety, Schenke said he needed to give her Paxil in the meantime due to a long waiting list.
Stanton referred Sara to Alexander in March and Alexander was not able to see her until July.
Schenke also said that if Stanton is wrong for putting Sara on Paxil, using his clinical judgment to prescribe a medication for someone for which it is not recommended, than there are thousands of other doctors who are wrong, too.
Regardless of whether the jury believes Paxil played a role in Sara’s death, Blain said they can still make recommendations calling for greater safety measures for Paxil prescriptions.
There has been no time frame given as to how long the jury will deliberate for.
http://www.insidehalton.com/news/article/836973--inquest-jury-considering-recommendations
Seroxat - Sara Carlin sad & anxious two years before she took Paxil
The teen told one doctor she had been sad and anxious since mid-2004 and sometimes experienced three panic attacks a day by February, 2006, said Teresa Walsh. Over the months after Ms. Carlin began taking Paxil, Ms. Walsh said, her doctors testified that she reported sleeping better and was more engaged with school.
http://www.theglobeandmail.com/news/national/toronto/inquest-probes-link-between-medication-and-teens-suicide/article1612522/
.To Sara Carlin’s family, a prescription drug meant to cure her anxiety triggered a deep depression that led her to hang herself. To the company that makes the drug, the Oakville teen was already troubled and her medication was working.
These were the competing narratives at the close of a coroner’s inquest into Ms. Carlin’s death.
Ms. Carlin, who had just finished her first year at the University of Western Ontario, hanged herself with an electrical cable in the basement of the family home in May, 2007.
A lawyer for Ms. Carlin’s family attempted to draw a strong link between her death and Paxil, a selective serotonin reuptake inhibitor (SSRI) medication that the young woman had been taking for over a year when she died.
“Paxil put Sara Carlin on a downward spiral, starting almost as soon as she was on it,” Gary Will told the inquest jury. Before she was prescribed the drug in February, 2006, he said Ms. Carlin was a happy, athletic woman with ambitions of becoming a doctor.
Over the months after she began taking Paxil, he said, she told friends she was suicidal, wrote a note in which she said she was tired of life and later landed in hospital after a session of drinking and cocaine use.
Mr. Will also presented a Health Canada report that showed 26 people between ages 12 and 19 had committed suicide while taking an SSRI between 1993 and 2009 and cited federal government warnings that such drugs could cause suicidal thoughts for teens.
A lawyer for Paxil manufacturer GlaxoSmithKline, however, argued that Ms. Carlin had been depressed before she was given the drug.
The teen told one doctor she had been sad and anxious since mid-2004 and sometimes experienced three panic attacks a day by February, 2006, said Teresa Walsh. Over the months after Ms. Carlin began taking Paxil, Ms. Walsh said, her doctors testified that she reported sleeping better and was more engaged with school.
“On each occasion, she talked about the fact that she was feeling some better, in some cases, much better,” Ms. Walsh said.
She suggested several other possible reasons for Ms. Carlin’s depression, including pressure at school and the death of her brother, who suffered a drug overdose on New Years’ Eve 2000, which continued to haunt her.
Outside court, her father disputed this characterization. “All through high school, this kid was at the top of her class,” said Neil Carlin. “We never saw her as depressed.”
While the inquest cannot assign blame in her death, it can make recommendations to prevent similar deaths in the future.
Mr. Will asked the jury make several such recommendations, including that doctors be forced to inform patients about the possible side-effects of prescription drugs; that pharmaceutical companies be compelled to publish the results of every study into the efficacy of a drug and that the government set up a new agency to regulate prescription drugs.
Michael Blain, counsel to the coroner, presented jurors with recommendations calling for better monitoring of patients taking prescription drugs and that Health Canada work harder to inform doctors of the risks associated with such drugs.
The inquest is the culmination of a three-year fight by Ms. Carlin’s parents to shine a spotlight on their contention that her death was caused by Paxil.
“I am feeling much more hopeful about the future than I was before the inquest,” said Rhonda Carlin after the proceedings. “I feel more hopeful for other families and that helps just a little bit.”
http://www.theglobeandmail.com/news/national/toronto/inquest-probes-link-between-medication-and-teens-suicide/article1612522/
.To Sara Carlin’s family, a prescription drug meant to cure her anxiety triggered a deep depression that led her to hang herself. To the company that makes the drug, the Oakville teen was already troubled and her medication was working.
These were the competing narratives at the close of a coroner’s inquest into Ms. Carlin’s death.
Ms. Carlin, who had just finished her first year at the University of Western Ontario, hanged herself with an electrical cable in the basement of the family home in May, 2007.
A lawyer for Ms. Carlin’s family attempted to draw a strong link between her death and Paxil, a selective serotonin reuptake inhibitor (SSRI) medication that the young woman had been taking for over a year when she died.
“Paxil put Sara Carlin on a downward spiral, starting almost as soon as she was on it,” Gary Will told the inquest jury. Before she was prescribed the drug in February, 2006, he said Ms. Carlin was a happy, athletic woman with ambitions of becoming a doctor.
Over the months after she began taking Paxil, he said, she told friends she was suicidal, wrote a note in which she said she was tired of life and later landed in hospital after a session of drinking and cocaine use.
Mr. Will also presented a Health Canada report that showed 26 people between ages 12 and 19 had committed suicide while taking an SSRI between 1993 and 2009 and cited federal government warnings that such drugs could cause suicidal thoughts for teens.
A lawyer for Paxil manufacturer GlaxoSmithKline, however, argued that Ms. Carlin had been depressed before she was given the drug.
The teen told one doctor she had been sad and anxious since mid-2004 and sometimes experienced three panic attacks a day by February, 2006, said Teresa Walsh. Over the months after Ms. Carlin began taking Paxil, Ms. Walsh said, her doctors testified that she reported sleeping better and was more engaged with school.
“On each occasion, she talked about the fact that she was feeling some better, in some cases, much better,” Ms. Walsh said.
She suggested several other possible reasons for Ms. Carlin’s depression, including pressure at school and the death of her brother, who suffered a drug overdose on New Years’ Eve 2000, which continued to haunt her.
Outside court, her father disputed this characterization. “All through high school, this kid was at the top of her class,” said Neil Carlin. “We never saw her as depressed.”
While the inquest cannot assign blame in her death, it can make recommendations to prevent similar deaths in the future.
Mr. Will asked the jury make several such recommendations, including that doctors be forced to inform patients about the possible side-effects of prescription drugs; that pharmaceutical companies be compelled to publish the results of every study into the efficacy of a drug and that the government set up a new agency to regulate prescription drugs.
Michael Blain, counsel to the coroner, presented jurors with recommendations calling for better monitoring of patients taking prescription drugs and that Health Canada work harder to inform doctors of the risks associated with such drugs.
The inquest is the culmination of a three-year fight by Ms. Carlin’s parents to shine a spotlight on their contention that her death was caused by Paxil.
“I am feeling much more hopeful about the future than I was before the inquest,” said Rhonda Carlin after the proceedings. “I feel more hopeful for other families and that helps just a little bit.”
Sunday, 20 June 2010
Seroxat - Coroner disallowed Drug Safety Canada from becoming party to the Carlin Inquest
Terence Young appears as expert witness Sarah Carlin inquest
Friday, June 18, 2010 - Oakville Ontario News
Terence Young MP Oakville and Chair of Drug Safety Canada will be appearing as an expert witness at the Inquest into the Death of Sara Carlin on Friday June 18, 2010 at 9:30 am.
Eighteen year old Sara Carlin of Oakville hanged herself in May 1997 after abruptly discontinuing the prescription drug Paxil.
Young, author of Death by Prescription will testify about how the safety of Paxil was the subject of five Health Canada warning letters sent out to every doctor in Canada regarding suicide and discontinuation symptoms, amongst other risks.
"The death of Sara Carlin is eerily similar to the Death of Vanessa Young in 2000," said Young. "Both cases include a blockbuster drug given for an unapproved use; no patient warning of possible deadly adverse effects from several doctors; and the drug had been the subject of numerous safety warnings for the cause of death.
Sadly nothing significant has changed since Vanessa Young died in 2000. With this inquest we have another chance for change."
The Coroner disallowed Drug Safety Canada from becoming party to the Carlin Inquest, and has severely limited the scope of Young's testimony in advance.
"A favourite trick of the drug companies in these cases is to blame the patient for their own death in court. I hope and pray this Coroner allows the jury to hear the true risks of Paxil related suicide, which include suicide warnings right on the label, and hundreds of settled law suits for Paxil related suicide in the U.S."
Young has introduced a Private Member's Bill onto the Order Paper of Parliament that would create a new independent drug agency for Canada that would regulate safety warnings and other safety matters for Canadians using prescription drugs.
http://www.oakville.com/news/headlines/2010-06-18-terence-young-appears-as-expert-witness-sarah-carlin-inquest
Friday, June 18, 2010 - Oakville Ontario News
Terence Young MP Oakville and Chair of Drug Safety Canada will be appearing as an expert witness at the Inquest into the Death of Sara Carlin on Friday June 18, 2010 at 9:30 am.
Eighteen year old Sara Carlin of Oakville hanged herself in May 1997 after abruptly discontinuing the prescription drug Paxil.
Young, author of Death by Prescription will testify about how the safety of Paxil was the subject of five Health Canada warning letters sent out to every doctor in Canada regarding suicide and discontinuation symptoms, amongst other risks.
"The death of Sara Carlin is eerily similar to the Death of Vanessa Young in 2000," said Young. "Both cases include a blockbuster drug given for an unapproved use; no patient warning of possible deadly adverse effects from several doctors; and the drug had been the subject of numerous safety warnings for the cause of death.
Sadly nothing significant has changed since Vanessa Young died in 2000. With this inquest we have another chance for change."
"A favourite trick of the drug companies in these cases is to blame the patient for their own death in court. I hope and pray this Coroner allows the jury to hear the true risks of Paxil related suicide, which include suicide warnings right on the label, and hundreds of settled law suits for Paxil related suicide in the U.S."
Young has introduced a Private Member's Bill onto the Order Paper of Parliament that would create a new independent drug agency for Canada that would regulate safety warnings and other safety matters for Canadians using prescription drugs.
http://www.oakville.com/news/headlines/2010-06-18-terence-young-appears-as-expert-witness-sarah-carlin-inquest
Seroxat - Terence Young MP testifies at Sara Carlin inquest
Oakville MP Terence Young showed no mercy as he testified before the inquest into the death of Sara Carlin Friday blasting Health Canada, GlaxoSmithKline and others for not doing enough to protect Canadians from the dangers of prescription drugs.
http://www.insidehalton.com/news/article/836117--young-testifies-at-carlin-inquest
Young, who founded the advocacy group Drug Safety Canada in 2002, was called by the Carlin family's lawyer Gary Will to speak about the adequacy and availability of health information on Paxil to the general public.
The Carlins' daughter Sara had been taking the anti-depressant for more than a year when she hanged herself in her parents' basement on Sunday, May 6, 2007.
An inquest has been called by the Ontario Coroner's Office to examine the circumstances surrounding Sara's death and what, if any, role Paxil may have played.
Health Canada has issued a number of advisories stating the drug may increase the risk of suicidal events in children and adolescents under 18.
Young began his testimony by stating he got into drug safety advocacy following the death of his 15-year-old daughter Vanessa, who died of a heart arrhythmia, which he believes was caused by the prescription drug she was taking at the time.
Young said he sees many similarities between what happened to his daughter and what happened to Sara stating that, like Vanessa, the drug Sara was prescribed was 'off label,' meaning it was not recommended for her use.
In Sara's case, this was because she was 17 when she was prescribed Paxil, which was not recommended for people under 18.
Young said that like Vanessa and his family, Sara and her family were given no warnings about some of the greatest side effects associated with the drug she was being given.
Dr. Tom Stanton, the family doctor who prescribed Paxil to Sara, testified he told Sara to come back and see him if she started to feel worse, but did not tell her Paxil may cause suicidal thoughts or behaviour.
Stanton said it is difficult to get patients to begin medications if such information is provided.
Young also said that like the Carlin family, his family only found out about the warnings associated with the drug their daughter was taking after her death when they began to search for information about it online.
When Sara died and Young found out she had been taking Paxil he said he suspected the drug may be involved after discussions with her father.
Young spoke of some of the adverse reactions listed on GlaxoSmithKline's product monograph, such as akathisia.
"Akathisia has been described as a horrible torture where you feel like you want to crawl out of your own skin. It's just a living nightmare. It also says Paxil can cause alcohol abuse and depersonalization. This (depersonalization) is perhaps the worst one where you feel like you're watching yourself, but you can't stop what you're doing," said Young.
"We know Paxil causes nightmares."
At this point Paxil manufacturer GlaxoSmithKline's lawyer Teresa Walsh called on the Coroner to restrict Young to the topics he was called to the inquest to testify about.
Young said that while the possible side effects of Paxil are listed on the product monograph, doctors and patients are not finding them because the warnings are not until page six of the Canadian version.
This is in stark contrast to the Paxil monograph in America, which, Young said, has a warning about the potential for increased suicidality in a separate box on the first page.
"The first thing the doctor sees, the first thing anybody sees, is that anti-depressants increase the risk, compared to a placebo, of suicidality (suicidal thinking and behaviour) in children and adolescents. That's right up there in bold," said Young.
"I think Canadians should get the same safety warnings as Americans."
Young also called for this warning to be written in plain language that is easy to understand.
He pointed out similar recommendations were made following a Coroner's inquest into the death of his daughter Vanessa, but have yet to be carried out.
Young said that when Canadians receive a prescription they should also get some kind of pamphlet outlining what the risks, including worst possible side effects.
Again Young pointed out this is something that is already in place in the United States.
When a new safety issue is found with a medication, Young said, it should be delivered to doctors in a brightly coloured envelope with big letters drawing their attention to the important safety information inside.
He said Health Canada should also purchase ads in newspapers to get the message out when a safety issue is found.
Stanton has testified that he was aware of the Health Canada advisories associated with Paxil when he prescribed it to Sara.
Young also said an independent drug safety agency needs to be set up that would be responsible for things like educating doctors about the safety issues surrounding certain drugs.
This agency he said would receive no funding from drug companies and would be responsible directly to Parliament.
Young currently has a private members' motion before Parliament calling for the creation of such an agency, but says it will be some time before the motion is discussed.
Another recommendation Young brought forward was that drug companies be required to publish the results of all their clinical trials and not just the successful ones.
"It's a huge problem in the pharmaceutical industry called publication bias. In fact, Paxil had clinical trials in New York State, there were seven trials done, one of them showed that Paxil worked better than the placebo, six showed it didn't and those six didn't get published," said Young.
"The attorney general came to an agreement with GlaxoSmithKline that from now on they would publish all their trials for all their drugs on the Internet. That should be done for all trials for every drug and it should certainly be done in Canada."
Young also said patients should be made aware if the drug they are taking has a history of adverse reactions in other countries and said health care professionals should be required to report all suspected adverse drug reactions to Health Canada within 48 hours of the reaction taking place.
During cross-examination Walsh pointed out Young did not know Sara Carlin and as such did not have a great deal of information about the role alcohol or drugs may have played in her suicide.
Young fired back that Walsh was mentioning alcohol over and over again to make sure that was all the jury remembered.
"It's like a bad tune you can't get out of your head," said Young.
"This is leading nowhere."
Walsh also said Young was not a doctor and as such had no medical support for believing Paxil was responsible for Sara's death.
She also said Paxil warnings are present on page three of the product monograph, however, Young noted this warning is not clear.
Walsh also said the Paxil monograph lists the results of the clinical trials conducted stating they did not show the drug to be effective within the pediatric population and as such the drug is not recommended for people under 18.
Walsh next pointed out that all of the adverse reactions Young had listed were only things that had been reported as happening in association with Paxil use, but for which Paxil had not been proven as the cause.
Young did not accept this.
"Who would have a product and put on that product that it might make you want to kill yourself unless they absolutely had to?" asked Young.
Young saved his parting shots for Coroner's counsel Michael Blain whose opening statement, Young said, offered jurors only one side of the story, that being that Sara's suicide had more to do with drugs and alcohol and her brother's death on New Year's Eve 1999, than Paxil.
"It's not my theory sir," said Blain.
"I read the reports, I told the jury what the reports said."
http://www.insidehalton.com/news/article/836117--young-testifies-at-carlin-inquest
http://www.insidehalton.com/news/article/836117--young-testifies-at-carlin-inquest
Young, who founded the advocacy group Drug Safety Canada in 2002, was called by the Carlin family's lawyer Gary Will to speak about the adequacy and availability of health information on Paxil to the general public.
The Carlins' daughter Sara had been taking the anti-depressant for more than a year when she hanged herself in her parents' basement on Sunday, May 6, 2007.
An inquest has been called by the Ontario Coroner's Office to examine the circumstances surrounding Sara's death and what, if any, role Paxil may have played.
Health Canada has issued a number of advisories stating the drug may increase the risk of suicidal events in children and adolescents under 18.
Young began his testimony by stating he got into drug safety advocacy following the death of his 15-year-old daughter Vanessa, who died of a heart arrhythmia, which he believes was caused by the prescription drug she was taking at the time.
Young said he sees many similarities between what happened to his daughter and what happened to Sara stating that, like Vanessa, the drug Sara was prescribed was 'off label,' meaning it was not recommended for her use.
In Sara's case, this was because she was 17 when she was prescribed Paxil, which was not recommended for people under 18.
Young said that like Vanessa and his family, Sara and her family were given no warnings about some of the greatest side effects associated with the drug she was being given.
Dr. Tom Stanton, the family doctor who prescribed Paxil to Sara, testified he told Sara to come back and see him if she started to feel worse, but did not tell her Paxil may cause suicidal thoughts or behaviour.
Stanton said it is difficult to get patients to begin medications if such information is provided.
Young also said that like the Carlin family, his family only found out about the warnings associated with the drug their daughter was taking after her death when they began to search for information about it online.
When Sara died and Young found out she had been taking Paxil he said he suspected the drug may be involved after discussions with her father.
Young spoke of some of the adverse reactions listed on GlaxoSmithKline's product monograph, such as akathisia.
"Akathisia has been described as a horrible torture where you feel like you want to crawl out of your own skin. It's just a living nightmare. It also says Paxil can cause alcohol abuse and depersonalization. This (depersonalization) is perhaps the worst one where you feel like you're watching yourself, but you can't stop what you're doing," said Young.
"We know Paxil causes nightmares."
At this point Paxil manufacturer GlaxoSmithKline's lawyer Teresa Walsh called on the Coroner to restrict Young to the topics he was called to the inquest to testify about.
Young said that while the possible side effects of Paxil are listed on the product monograph, doctors and patients are not finding them because the warnings are not until page six of the Canadian version.
This is in stark contrast to the Paxil monograph in America, which, Young said, has a warning about the potential for increased suicidality in a separate box on the first page.
"The first thing the doctor sees, the first thing anybody sees, is that anti-depressants increase the risk, compared to a placebo, of suicidality (suicidal thinking and behaviour) in children and adolescents. That's right up there in bold," said Young.
"I think Canadians should get the same safety warnings as Americans."
Young also called for this warning to be written in plain language that is easy to understand.
He pointed out similar recommendations were made following a Coroner's inquest into the death of his daughter Vanessa, but have yet to be carried out.
Young said that when Canadians receive a prescription they should also get some kind of pamphlet outlining what the risks, including worst possible side effects.
Again Young pointed out this is something that is already in place in the United States.
When a new safety issue is found with a medication, Young said, it should be delivered to doctors in a brightly coloured envelope with big letters drawing their attention to the important safety information inside.
He said Health Canada should also purchase ads in newspapers to get the message out when a safety issue is found.
Stanton has testified that he was aware of the Health Canada advisories associated with Paxil when he prescribed it to Sara.
Young also said an independent drug safety agency needs to be set up that would be responsible for things like educating doctors about the safety issues surrounding certain drugs.
This agency he said would receive no funding from drug companies and would be responsible directly to Parliament.
Young currently has a private members' motion before Parliament calling for the creation of such an agency, but says it will be some time before the motion is discussed.
Another recommendation Young brought forward was that drug companies be required to publish the results of all their clinical trials and not just the successful ones.
"It's a huge problem in the pharmaceutical industry called publication bias. In fact, Paxil had clinical trials in New York State, there were seven trials done, one of them showed that Paxil worked better than the placebo, six showed it didn't and those six didn't get published," said Young.
"The attorney general came to an agreement with GlaxoSmithKline that from now on they would publish all their trials for all their drugs on the Internet. That should be done for all trials for every drug and it should certainly be done in Canada."
Young also said patients should be made aware if the drug they are taking has a history of adverse reactions in other countries and said health care professionals should be required to report all suspected adverse drug reactions to Health Canada within 48 hours of the reaction taking place.
During cross-examination Walsh pointed out Young did not know Sara Carlin and as such did not have a great deal of information about the role alcohol or drugs may have played in her suicide.
Young fired back that Walsh was mentioning alcohol over and over again to make sure that was all the jury remembered.
"It's like a bad tune you can't get out of your head," said Young.
"This is leading nowhere."
Walsh also said Young was not a doctor and as such had no medical support for believing Paxil was responsible for Sara's death.
She also said Paxil warnings are present on page three of the product monograph, however, Young noted this warning is not clear.
Walsh also said the Paxil monograph lists the results of the clinical trials conducted stating they did not show the drug to be effective within the pediatric population and as such the drug is not recommended for people under 18.
Walsh next pointed out that all of the adverse reactions Young had listed were only things that had been reported as happening in association with Paxil use, but for which Paxil had not been proven as the cause.
Young did not accept this.
"Who would have a product and put on that product that it might make you want to kill yourself unless they absolutely had to?" asked Young.
Young saved his parting shots for Coroner's counsel Michael Blain whose opening statement, Young said, offered jurors only one side of the story, that being that Sara's suicide had more to do with drugs and alcohol and her brother's death on New Year's Eve 1999, than Paxil.
"It's not my theory sir," said Blain.
"I read the reports, I told the jury what the reports said."
http://www.insidehalton.com/news/article/836117--young-testifies-at-carlin-inquest
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