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.