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