PAXIL Sara Carlin - Health Canada’s inaction on inquest recommendations - FIDDAMAN ignored

The family of a teen who committed suicide and an outspoken Conservative MP are  accusing Health Canada of failing to adopt key recommendations from a coroner’s inquest, which examined her suicide in an effort to prevent similar deaths in the future.


http://www.theglobeandmail.com/news/national/dead-teens-family-assails-health-canadas-inaction-on-inquest-recommendations/article2096677/

A coroner’s inquest into the death of Sara Carlin, an 18-year-old from Oakville, Ont., who hanged herself in her parents’ home in 2007 after taking the antidepressant Paxil, ruled last summer that Health Canada should take steps to improve the safety of medications, including the creation of an independent drug-safety board and improving its mechanisms for warning doctors about potential adverse reactions. The inquest also urged Health Canada to require drug companies to submit all clinical trials, including those with mixed or negative results, before considering approval of a new medication.



Ms. Carlin’s family contends she became depressed after taking Paxil for anxiety and that it may have played a role in her suicide. GlaxoSmithKline, which manufactures the drug, told the inquest Ms. Carlin was depressed when she began taking the drug, that the treatment helped her, and that other factors, such as pressure at school and family issues, may have been to blame.




Health Canada, which posted its response to the recommendations online this week, said it is either considering or has already implemented them.



But Terence Young, a Conservative member of Parliament for Oakville who advocates for increased vigilance around medications, said Health Canada has ignored the recommendations and is “misleading” the public into thinking it makes drug safety a priority.



“They are being totally disingenuous,” Mr. Young said.



One of the most significant recommendations from the inquest was for the creation of a board that would operate independently from Health Canada, with no funding from the pharmaceutical industry, to investigate drug safety and issue public warnings.



Health Canada responded by saying it already implemented that recommendation, citing the 2002 creation of the Marketed Health Products Directorate within the department that focuses on surveillance of drugs. It also noted the government set up the Drug Safety and Effectiveness Network, which operates as part of the Canadian Institutes of Health Research.



Neil Carlin, Ms. Carlin’s father, said that doesn’t come close to what the inquest recommended. The MHPD is part of Health Canada and the DSEN is part of an organization that appointed a top Pfizer executive to its governing council, putting their independence into question, Mr. Carlin said.



“We fail to see how that can be considered independent,” he said. “I don’t think we truly believed there was going to be anything earth-shattering in their response. … I’m not surprised.”



The department did not respond to a request for comment Wednesday.



In the document, Health Canada said the recommendation to require drug companies to report all clinical trials, including ones with negative results, before approving new drugs is “under consideration.” The department also said that its website provides information on drug safety and that it has fulfilled the remaining recommendations.



Mr. Young characterized the document as an “absolute disgrace” that will do little to help ensure Canadians receive accurate, timely information about drug safety and keep potentially dangerous ones off the market.



“They had the audacity to say they’ve already solved this problem,” Mr. Young said. “That is blatantly untrue. It’s blatantly misleading.”