David BruserThe Toronto Star
Date Published: Friday, September 28, 2012
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Health Canada has detailed records of probes into ADHD drug safety, including fatalities, that it is keeping secret from the public.
Every six months to a year, drug companies submit summaries of side effects suspected to have been caused by their drugs worldwide, information Health Canada says it evaluates.
These summaries, called periodic safety update reports, are not available to the public.
“They may contain personal or confidential business information,” Health Canada said in an email to the Star.
That means parents of kids taking ADHD drugs are being kept in the dark about what the makers of these drugs are revealing to Health Canada about their safety.
Health Canada said the drug company reports can be requested under access to information legislation, adding details could be blacked out “on a case-by-case basis” if released.
“Health Canada is claiming privileged information? How does that trump the health of my son?” said Christopher Folz, a special-education teacher from Sault Ste. Marie whose 9-year-old son tried to hurt himself while on ADHD drugs Strattera and Biphentin.
Folz said his son suffered headaches last year that made him double over in pain and gag. “He’s had these really troubling depressive outbursts in class where he has tried to stab himself with a pencil in his hand.
“I know my own son. He’s not like that,” Folz said. “(The drugs are) damaging him, in my opinion. I’m worried about him.”
The Star learned of the drug company safety reports when asking Health Canada how it regulates the drug industry. The Star’s questions were part of its investigation, published this week, that found nearly 600 cases of Canadian kids suffering serious, sometimes fatal side effects suspected to have been caused by ADHD medications in the past 10 years.
Health Canada said it monitors drug safety by reading the side-effect reports and scientific literature and by gathering updates from other regulatory agencies, as well as reviewing the periodic safety reports.
An international body that provides standards for the pharmaceutical industry developed the concept of the safety update reports, and countries such as the U.S. and Canada use the standardized reports to help evaluate drug safety.
The reports, which are on a specific drug, are designed to show the safety issues and emerging trends detected by a drug company’s surveillance network. The reports contain both statistical analysis and some actual case examples, particularly deaths.
The reports contain “proprietary information,” according to the U.S. Food and Drug Administration, and it appears regulators around the world keep these documents from the public.
“Is there any way I can get a hold of these?” asked concerned parent Brent Patrick, whose 9-year-old son threatened to kill himself while on Concerta. “It’s invaluable,” said the father from Creemore, Ont. “People should know what might happen with the use of these drugs. We’re totally uninformed.”
Patricia Fontyn, who recently took her daughter off an ADHD medication, was troubled when told the safety reports are not available to the public.
“I have every expectation that I should have available to me all relevant information about the benefits and risks of medication that you’re asking me to put my 7-year-old child on,” she said. “I can’t understand how they could get away with not disclosing that.”
Janssen Inc., maker of Concerta, said it cannot comment on specific cases of suspected side effects. The Star was unable to get comment from Eli Lilly Canada, maker of Strattera, and Purdue Pharma, maker of Biphentin.
The Star has made an access to information request for these documents.
(Please note that CMHO staff does not reply to comments that are posted on news stories.)