Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
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Thursday, January 01, 2009

Ontario: Dr. Andrew McCallum. I salute you.

Let's hope Dr. Andrew McCallum, Ontario’s newly appointed Chief Coroner, can give the Carlin's some form of closure on their daughter, Sara's death.

This article from The Oakville Beaver.

As per usual, GlaxoSmithKline spokesperson, dismisses any wrong doing [despite their previous knowledge that Seroxat/Paxil could cause suicide in adolescents]

Coroner grants family’s request for inquest into daughter’s suicide

By David Lea, Oakville Beaver Staff

Dec 31, 2008

Rhonda and Neil Carlin are not calling it a victory, but maybe now they can finally find some answers into the suicide of their daughter, Sara, in May 2007.

For months, the Carlins have pushed the Ontario Coroner’s Office to conduct an inquest into the death of their 18-year-old daughter.

Last week that request was finally granted.

“This is what we feel needs to happen in order for Sara’s story to be told so we can really understand what happened to her,” said Rhonda. “I think we are starting down a good path here, but it’s going to be a long one. I really believe good will come from this. That’s what we want.”

The build up to this moment stretches back to Sunday, May 6, 2007 when Sara hanged herself in the basement of her family home.

The parents blame her death on the apparent side effects of a powerful anti-depressant drug,

Sara, a graduate of St. Ignatius of Loyola Catholic Secondary School and an Ontario Scholar, was described by her parents as a beautiful and intelligent woman of limitless potential.

She was an accomplished athlete who excelled at her part-time job and was looking forward to finishing university so she could pursue a career as a dermatologist.

All this changed, according to her parents, when Sara began taking the antidepressant Paxil (paroxetine), which was prescribed to alleviate some of the anxiety she was feeling about leaving home for the first time to attend university.

The Carlins said Sara’s behaviour changed radically after she began taking the antidepressant. It appeared to them that their daughter lost interest in almost everything.

She soon quit her high school hockey team, was fired from her job and began experimenting with drugs and alcohol.

According to her parents, Sara also had trouble sleeping and suffered from nightmares whenever she did sleep.

This downward spiral ended with Sara’s suicide.

Suspicion about the drug’s possible role in his daughter’s death turned to anger when Neil discovered two Health Canada online advisories stating that Paxil should not be given to children or adolescents under the age of 18 due to a possible increased risk of suicidal events.

Sara was 17 when she was first prescribed Paxil.

The Carlins want to know how their daughter could have been prescribed a drug with potentially lethal side effects. They also want to stop a similar tragedy from happening to anyone else.

A public inquest, they feel, is the best vehicle for that purpose.

“We believe there will be many good recommendations that will come out to prevent this sort of thing from happening again,” said Neil.

“It will also help answer some important questions for us, answers that would otherwise be impossible for us to get. This will help us to get some closure.”

The Carlins drive for an inquest hit a roadblock in June of 2008 when the Regional Supervising Coroner, Dr. David Evans, contacted the Carlins and denied their request for a public inquest.

In a letter to the Carlins, the coroner noted an inquest must serve the public interest and stated that such an inquest into Sara’s death would not do that. He also said a jury would not make useful recommendations that could prevent similar deaths in the future.

Earlier this month, however, the Carlins met with Ontario’s newly-appointed Chief Coroner, Dr. Andrew McCallum, as part of an appeal process to the regional coroner’s decision.

After hearing their case, McCallum ruled an inquest would take place.

“We were very surprised, it wasn’t what we expected to hear,” said Neil. “We thought they had pretty much dug their heels in on this.”

“Talking to Dr. McCallum really brought me renewed hope that Sara will have a voice,” said Rhonda. “I truly think he believes that some good will come from an inquest. It just goes to show what one person can do.”

Rhonda is hoping a number of recommendations will come out of the inquest, which has yet to be scheduled, including some pertaining to the way Paxil is currently prescribed.

The campaign for an inquest into Sara’s death has crossed party lines with Oakville’s Conservative MP Terence Young and Oakville’s Liberal MPP Kevin Flynn both pushing the issue forward through their respective channels.

Young was pleased the inquest would take place and hopes the jury’s recommendations will be adopted by Health Canada.

He said this was not the case following the inquest into the death of his daughter Vanessa, who died in 2000 after taking a prescription drug.

“The jury made 59 recommendations on how to make the drug surveillance system safer and nothing significant has changed in the area of drug safety in Canada since that time,” said Young.

“The jury recommended some major changes and some minor changes and Health Canada made some of the minor changes that were easy to make. It was like having a meal in front of you that you don’t want to eat so you just move the food around on the plate.”

Young wants to see patients get easy-to-understand information leaflets placed in their hands when they receive prescription drugs. He wants the information to include a list of the risks and side effects of the drug, as well as the contraindications and even alternatives to taking the drug.

“The ones (information pamphlets) people get in the drug stores now are worse than useless,” said Young. “In fact they create a sense of false security for patients.”

Young knows an inquest will not be easy on the Carlins. They may find their daughter is put on trial.

He said this occurred during the inquest into his daughter’s death.

“What happened, in our case, was the various parties to the inquest, who were given standing, attempted to bring out information that would blame Vanessa for her own death,” he said. “That might happen with the inquest into Sara Carlin’s death as well. They might try to do that. I don’t think they will be successful, but that’s up to the jury.”

The Carlins note that whatever comes next they are prepared to face it.

“We’d rather not have to go through this. I’d much prefer my daughter was here with us and we weren’t dealing with any of this, but that’s not an option,” said Neil.

“We’ve been through hell since this happened so for us this new development is just another path on the walkway. What else can we do? Wait for another family to go through this and then try to change things? To me that doesn’t seem responsible. ”

* * *

Statement from drug manufacturer

In response to queries from The Oakville Beaver, Peter Schram, of Corporate Communications, GlaxoSmithKline, the manufacturer of Paxil, issued this statement: "Any suicide is tragic and the greatest risk for suicide is untreated depression. Paroxetine has been used by tens of millions of patients and has been proven to be a safe and effective treatment since its launch more than 15 year ago. The label contains instructions regarding the use of paroxetine and important safety information about the product."

If patients have questions regarding the use of paroxetine, or the management of their depression, they should contact their health care professional.”

Also, it is very important that patients do not stop taking paroxetine without first consulting with their doctor."


Something GlaxoSmithKline spokesperson, Peter Schram failed to add was this:

It was very important that patients were made aware that paroxetine did not work in children and posed a suicide risk.

Fid




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