Some drug side effects only identified after hitting market
Posted November 19, 2012 8:27 am.
This article is more than 5 years old.
VANCOUVER (NEWS1130) – You read the directions carefully and then take the pills… and expect them to work; every year, more than 10,000 Canadians die from taking prescription drugs exactly as they were prescribed.
From heartburn pills that cause heart attacks to anti-depressants that lead to suicide, Maclean’s magazine is spotlighting drug side effects and dangers that are often identified only after they come to market.
“It’s a complicated issue. There are dangers associated with prescription drugs that we’re not talking about and our regulatory system is not necessarily equipped to communicate those dangers to us,” says Ann Kingston, a senior writer with Maclean’s.
In 2000, Conservative MP Terrence Young‘s daughter collapsed died of heart failure while taking an acid reflux drug that has since been pulled from the market.
“Nobody thought there was any problem with [the drug] but as Mr. Young investigated after the death, he learned that there were huge dangers associated with it and that Health Canada knew about them and warned doctors. But the mechanism for warning doctors is not always effective in that doctors are swamped; they’re not up to date on what’s going on with drugs,” says Kingston.
“As a result, there were close to 100 deaths in North America from this drug. It’s been taken off the market but that pushed Terrence Young’s crusade. He has a private members bill in front of Parliament.”
Kingston also writes about a young man who went to his doctor and was given a sample package of an anti-depressant; four days after taking the drug he committed suicide, a known possible side effect that was not made clear on the packaging of the drug sample.
“There are many more examples. This is about people understanding the drugs they’re taking and what the consequences are,” she says, adding it can even be difficult for doctors to keep up to date on new drugs when seeing dozens of patients in a day and dealing with drug warnings that are not always clearly stated.
“You cannot always be sure that a new drug has had a wide application in terms of testing. Be cautious about new drugs; understand that the drug you’re taking is a new drug, because clinical trials only give you a small snapshot of how the drug is going to work in the real world,” explains Kingston.
She also feels Canada should adopt the transparency in drug labelling seen in other countries.
“The US FDA has adopted something called ‘plain language labelling,’ which is just common sense. The labels are written in words you can actually understand. For example, if a drug is known to have a suicide risk or other dangers, there is a huge black box, almost like a skull and crossbones, so you know this stuff. We use euphemisms in Canada, the labels are written in legalese and it’s very difficult to understand the medical jargon,” asserts Kingston.
“There’s also a big push for drug companies to reveal their clinical trial data. Right now, because Health Canada works so closely with drug companies, it protects the information it gets from those companies as trade secrets — the public doesn’t get to see it.”
There is also a big push to have greater disclosure on dangers and side effects.
“There have been huge scandals about drug companies suppressing information; they’re not interested in the public knowing that. They’re interested in getting a drug to market. We need to have a regulator that is more stringent in… disclosure and also forcing companies top provide as much data as possible so people can make an informed decision,” says Kingston.
“We live in a culture where we look to drugs to solve all sorts of problems and we expect our doctors to be up to date. Both of those things are unrealistic, I think.”
For more, check this week’s issue of Maclean’s.
