Sara Carlin, Paxil And Drug Safety In Canada
15 CommentsBy Ed Silverman // June 30th, 2010 // 7:26 am
There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.
“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”
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. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…
Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.
A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”
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.
Hat tip to Bob Fiddaman
Read more in Inside Halton and The Toronto Globe & Mail
Stephany
Bob Fiddaman has been writing relentlessly about this story also:
http://fiddaman.blogspot.com/2010/06/exclusive-sara-carlin-inquest-jury.html
Former Pharma Marketing Director
These guidelines could very easily be transported over to other therapeutical drugs as well.
It shouldn’t just be for SSRI’s!
Great work, we need to see more of this!
Laurie
That’s for getting this up Ed. While Canada was way behind in their warnings on ssri’s, they have now taken definitive action to prevent further tragedies.
Now, if we could get the US to take the same action…..
Bob Fiddaman
Hey Ed,
You should really read the articles I’ve written over the past three weeks regarding this inquest.
There is more to this than the papers are reporting.
Fid
J Lyons
verdict
The jury concluded that the cause of death was “hanging by ligature while affected by depression, cocaine and ethanol.”
Read more: http://www.cbc.ca/canada/ottawa/story/2010/06/29/carlin-inquest-drug-safety.html#ixzz0sHKoz533
M. Black
And we’re finding about this NOW?
MB
Matthew Holford
GSK spokesperson said:
““is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.””
I love studying the language constructions that people use, as they try to say something, without actually saying anything, at all… “Is supportive of appropriate recommendations”? Appropriate as assessed by whom? And if they’re not deemed appropriate, what then? “Will give the recommendations… our full attention and consideration…”? Before doing what, exactly? “Our deepest sympathies”? Oh, fucking dear!.. That’s effectively the World’s Tallest Midget Competition (apologies to any midgets reading), because GSK doesn’t appear to have any sympathies, deep, or otherwise.
GSK had to respond, but it has succeeded in saying absolutely nothing. Does this indicate the extent of its determination to ensure that deaths such as Sara Carlin’s never happen again? How would I know? But it doesn’t look good.
Matt
Neil D
Life causes suicide, not drugs. I find it odd that we think we can use drugs to change a persons will to live.
Oh sure, they had a chemical imbalance that is corrected by SSRI.
So what is worse? Being depressed and committing suicide or taking and anti-depressant that doesn’t work and committing suicide?
Cause and effect or just the same result no matter what you do?
truthman30
Neil.. You say that ‘life causes suicide and not drugs’.. I beg to differ. Yes, indeed if an individual not on ssri drugs commits suicide then of course the drugs played no part. But.. In the case of SSRI’s , which are known to increase the risk of suicide, then of course the drugs can be implicated as a possible cause.. I’m talking from experience here. I was on paxil and it did make me suicidal, it also changed my personality and numbed me. It is a combination of the side effects which leads to suicide. The drugs alter your mind, they skew your senses and reason and they warp your thoughts. People who are depressed are at a risk of suicide, this is true. But people on ssri drugs are at an increased risk because the effects of the drugs take away your self control, your ability to think reasonably and your self empowerment. This is why they are dangerous and this is why they can be lethal..
Bob Fiddaman
“So what is worse? Being depressed and committing suicide or taking and anti-depressant that doesn’t work and committing suicide?”
Straw Man argument Neil D
Some facts for you
1. Sara was prescribed Paxil for anxiety.
2. At no point did her doctor tell her that Paxil was potentially dangerous for people that fell within her age group.
3. Some of the rare side-effects on the Paxil monograph include both substance abuse and alcohol abuse.
4. On each occasion Sara’s Paxil dosage was increased, there was an incident.
5. There is no such thing as a chemical imbalance - unless you can show me the science?
6. Nobody is saying Paxil didn’t work?
7. Drop a sponge into water and it gets wet. Take it out, it dries. - Feed a brain serotonin, it acts differently. Stop feeding it serotonin, and it wonders why you have stopped - hence the withdrawal reaction.
When you have read up on akathisia, come back and have a reasoned argument.
End of the day - Sara Carlin was prescribed a drug off-label - she was not told of its potential dangers, neither were her parents.
The recommendations made by the jury, will hopefully help future Sara Carlin’s - In her death, she should be commended for bringing about possible change into the way these drugs are prescribed and regulated - that should not be questioned.
Fid
Ariel
Having been on Paxil, and free of it for about 10 years now (never felt better!!!), I can tell you that it blows away reluctance, caution, temperance and self control. Your thoughts take on a new life, and you get MORE feelings of “if I just acted out this thought, I would feel so much better”, regardless of their helpful or destructive nature.
You can literally try to feel the traditional reaching for familiar personal boundaries and where your insecurities live but not being able to feel them anymore, and then you’re pushed off the cliff with its motivation sensation where you feel rewarded for thoughts brought to life. It’s one mind-altering drug let me tell you! When I was on it, I had emotional outbursts unlike any other period in my life, wanted everybody to know the truth about each other at all times (to the point of ruining other peoples’ friendships), and had a mouth on me that would…not…shut…up. EVERY SINGLE IMPULSE comes out of you unhindered with a force that your mind can’t catch nor fathom when on this drug.
When suicidal ideations visited me, for the first time in my life on Paxil, I miraculously forced myself to lie in bed and not move. Oh god it was hard. I felt so motivated, so energized to do it, so free of fear and boundaries to prevent it. The sensation felt like it would be an orgasmic release to do it, that I’d be rewarded and at peace if I did it. My mind was conjuring up bloody image after bloody image of what I would do to myself to finally escape the incessant drumming march feeling that drug constantly caused. It was like having mental tinnitus.
Now that I’m 10 years free and all that is just a memory, it seems like it was a different person, possessed by a chemical demon. I have never thought like that again, am totally in love with life and have a deep rooted happiness that I can’t begin to describe. Life is rich and rewarding without Paxil but life seemed like an easily discarded pop can while on it, and full of phantom urges to recycle.
Julie
I know WAY more people who’s lives have been affected positively by the use of properly prescribed/monitored antidepressent use. I agree that antidepressants are not right for all depressed people - clearly this is the case - I argue for stricter monitoring of antidepressant use by QUALIFIED providers.
Stephany
Explain why, in 1999 a friend’s 11yr old son was placed on PAXIL for ’social anxiety’, and consquently stood on a cliff at summer camp threatening to jump? Never acting or thinking suicidally before the PAXIL. Off-label prescription for ’social anxiety’ for an 11 yr old in 1999.
—
The fact remains that people in the industry do not want to hear real stories from real people by the 1000’s who have had direct result negative outcomes on psychiatric medications.
Anyone who speaks out become called ‘antipsychiatry or ’scientologist’ and dismissed.
The dangerous problem with PCP doctors having ability to prescibe these drugs is the fact that these people are NOT monitored, and frankly psychiatrists rarely monitor either.
I applaud Bob Fiddaman for reporing on Sara Carlin’s story, long before it received the attention it is gaining now.
I also frankly, being within the mental health system for a decade, have never ONCE had one patient tell me they feel better on SSRI’s. Not one. Seriously.
My own daughter while dosed up on Zoloft, off-label at age 11 attempted to jump from my vehicle on the freeway. As a 13 yr old she noted how the drug induced those thoughts, and found out again, how SSRI’s induced the thoughts and behaviors when a psychiatrist gave her Prozac at age 17.
NOW she has a “NO SSRI” in her chart listed with allergies. THAT is how severely those drugs affect her.
And they affect MANY people the same way! it’s time to acknowledge that.
P
I was someone who was prescribed paxil for social anxiety at age 17. It CAUSED me to be depressed, and feel suicidal. After stopping it, the withdrawal symptoms went on for several years (these drugs can caused prolonged withdrawal syndrome) and during that time I was unable to work and felt suicidal often.
Julie said: “I know WAY more people who’s lives have been affected positively by the use of properly prescribed/monitored antidepressent use.”
-This doesn’t justify their use. Studies indicate that the amount of people who respond positively are in a minority. Also it may be the case that longterm use can damage the brain and body. What may help someone in the short-term may make the person worse in the longterm.
Have a look on the website paxil progress to see the thousands of people affected negatively by SSRI use. There are two sides to every story.
Justice in MI
At least two!
I was reviewing the SSRI saga recently and was reminded how much it was fuled by insurance companies–pills a lot cheapter than therapy, at least in the short-term and in those days.
Psychiatry went through a revolution–as though overnight, it was all about medication, almost exclusively.
And then, of course, the critical move–getting GPs to prescribe in enormous numbers, not only SSRIS but SGAs as well. “Recreating the paradigm” of bipolar, as the Zyprexa internal documents show so well.
Throw in ailing schools and uncertain parents, and you have the “perfect storm.”