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