Health Canada ‘gutting’ law to detect dangerous medicines, with possible deadly consequences, advocates warn

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Drug safety advocate concerned over Health Canada ‘retreating’ from Vanessa’s Law
Drug safety advocate and former MP Terence Young concerned over Health Canada ‘retreating’ from Vanessa’s Law – Aug 17, 2017

After Vanessa’s Law successfully navigated Parliament and became the law of the land, then Conservative MP Terence Young felt a sense of relief, able to breathe believing he’d finally won his 14-year battle.

Parliament had passed, without a single dissenting vote, a government bill that had started as his own; a bill to protect patients from potentially dangerous prescription drugs – to protect Canadians from suffering the agony his family suffered when his daughter, 15-year-old Vanessa, died of a heart attack after taking a prescribed drug.

But now, almost three years later, Young’s battle continues as a handful of measures he says are critical to the bill’s efficacy have yet to be enacted.

Vanessa Young died at 15 after taking the drug cisapride while also suffering from bulimia. This drug has since been found by a U.S. government body to be more dangerous for women than men. Courtesy, Terence Young

Specifically, Young says Health Canada is not going to require the reporting of all serious adverse drug reactions, a measure at the heart of the bill Parliament passed.  Scaling back that requirement, he said, means Health Canada won’t be in any position to better understand what prescription drugs are harming – and killing – Canadians.

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These fears stem from a recent discussion paper Health Canada published. The 37-page document details where the department is leaning now in terms of developing the remaining regulations.

“Health Canada has written a guidance document which basically … is the exact opposite of the intent of Vanessa’s Law,” Young said in a recent interview.

A crumbling pillar

As is the case with many bills that pass through Parliament, when Vanessa’s Law was passed in November 2014, some of its provisions were immediately enacted, while others requiring new regulations were not.

Today, Health Canada is in the process of designing those regulations, publishing papers hinting at the direction the department is thinking, and taking advice and input from pharmaceutical companies, safety advocates, the provinces and territories and others.

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The stated goal of this process, according to Health Canada, is to improve the quality and increase the quantity of reports of adverse reactions to prescribed medication, in an effort to ensure the department always has enough data to spot and react to safety problems.

But reading between the lines, says Young, paints a different picture.

One fundamental pillar of the law – that every serious drug reaction occurring at every health-care institution in the country is reported – is being gutted, he says.

“Getting that evidence is absolutely crucial to keeping patients safe,” Young said. “Every serious adverse drug reaction can provide very important data that can lead to saving patients’ lives.”

Burdening the system

It appears, however, as though Health Canada is poised to regulate only acute-care hospitals – rather than including long-term care facilities and clinics, for example – and require them to report only “unexpected” adverse reactions to prescription drugs, rather than all.

In other words, the reports won’t include anything the drug manufacturer includes on the drug label, which often feature a laundry list of symptoms and reactions.

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“With these caveats, they’re only going to get a fraction of the real number of adverse drug reactions,” said Young, who has chaired Drug Safety Canada since 2001.

“If a drug is harming patients, if it’s an unsafe drug, you want to get all serious adverse drug reactions reported as early as possible. And the proposal made under [Health Canada’s] white paper would make sure you don’t.”

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David Lee, chief regulatory officer at Health Canada, told Global News that, in designing and implementing new regulations, the burden on hospital staff and the usefulness of the data also have to be taken into consideration.

“We’re trying to get safety information about drugs, but we also have to remember it’s a hospital. And so you want the health-care professionals spending their time on care,” he said.

“Because this is new, we want to be really careful about overburdening the system. Because really, what we’re talking about is a law that is binding on the health-care system.”

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Tracking known reactions to prescription drugs

What Health Canada is trying to “zero in” on, Lee said, are reactions to prescription drugs that never came up in clinical trials, in a way that is, for example, permanently debilitating. And the reason for including only acute-care hospitals, he said, is because that’s where any patient suffering a serious and debilitating or life-threatening effect will end up.

Lee said the door isn’t closed on eventually expanding the regulations to include more institutions and more adverse reactions. In the meantime, however, the regulator’s focus will be on a narrower set of reactions at acute-care hospitals.

“If this really is, resource wise, a good idea and we feel that we need to capture those other questions through this measure and not some other, then yes [we can look at expanding the scope.]”

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But what of all the other side effects, such as the serious ones listed as possibilities on drug labels?

Currently – and for the foreseeable future, according to Health Canada – the government will rely on pharmaceutical companies to report expected drug reactions.

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This reporting, which relies on patients and doctors to alert a drug manufacturer to a reaction, is how the government tracks the frequency and incident rate of “expected” side effects, Lee said.

For now, that system works, he said, admitting incidents are under-reported.

And what’s more, it’s a tool “that doesn’t sit on top of the doctors and nurses and hospital pharmacists,” added Lee, who was Health Canada’s representative at the table when Justice Canada first drafted Vanessa’s Law.

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It is widely known, however, that adverse drug reactions are wildly under-reported. A 2015 article published in the Canadian Medical Association Journal, specifically addressing Vanessa’s Law, stated that less than five per cent of adverse drug reactions in Canada are reported.

“Extremely serious reactions are under-reported in Canada by as much as 96 per cent,” three medical doctors wrote in their commentary, titled, Can reporting of adverse drug reactions create safer systems while improving health data?

Clearly, says Young, there is a problem with the current system.

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“When Vanessa died at age 15 in 2000, it turned out worldwide, at least 200 people had died a similar way,” he said.

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“If a new drug comes on the market … and it turns out it’s harming patients, you need to know that as soon as possible, Health Canada should want to know that as soon as possible.”

The fact the department isn’t moving faster – and doesn’t appear, according to its discussion papers, prepared to implement regulations to the degree proposed in Vanessa’s Law – suggests one thing to Young.

“I don’t think they understand that their primary duty is to protect patients,” he said. “To me, it looks like their primary duty is to keep all the stakeholders happy. But who’s looking after the patients?”

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