iStockPhoto - ROYALTY-FREE A still life of an open bottle of prescription medicine and its content of pills. Credit: iStockPhoto harmacy, Medicine, Prescription Medicine, Bottle, Healthcare And Medicine, Herbal Medicine, SafetyGetty Images/iStockphoto
The federal government has tabled new regulations that should dramatically improve drug safety in Canada.
Bill C-17, Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), is, more than anything, a testament to the unrelenting efforts of one man, Conservative MP Terence Young.
His 15-year-old daughter Vanessa died on March 19, 2000 of a heart attack triggered by the drug cisapride (brand name Prepulsid), which she was taking for acid reflux.
Mr. Young made it his life's mission to seek justice for Vanessa and to ensure her senseless death would not be repeated.
He founded the consumer group Patient Safety Canada to push for better drug safety legislation. He also took legal action against the drug-maker, Johnson & Johnson, with both an individual lawsuit and a class-action suit. (They were settled out-of-court after a six-year legal fight and the terms are confidential.)
Mr. Young wrote a searing book, Death By Prescription: A Father Takes On His Daughter's Killer – The Multi-Billion Dollar Pharmaceutical Industry, and lobbied intensively for legislative change.
When that proved unsuccessful, he decided to work at it from the inside. The former Ontario MPP made a ran for the federal Conservatives and in 2008 became the MP for Oakville.
Last Friday, Mr. Young stood proudly beside Health Minister Rona Ambrose as she unveiled the proposed legislation, aptly called Vanessa's Law.
The new rules – actually amendments to the Food and Drugs Act – are extensive. They would:
- Require mandatory reporting of adverse drug reactions by healthcare institutions;
- Allow Health Canada to recall unsafe products;
- Impose tough new penalties for unsafe products, including jail time and new fines of up to $5-million per day instead of the current $5,000;
- Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
- Compel drug companies to revise labels to clearly reflect health risk information, including updates for health warnings for children; and
- Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.
These changes are welcome and long overdue. After all, adverse drug reactions are a major health challenge and tremendously costly, in dollar terms and human suffering.
An estimated one in four emergency room visits are due to adverse drug reactions. They are also a notable cause of premature death, killing somewhere between 4,500 and 12,000 Canadians a year. (That's a broad range, in large part because the data are poor.)
Yet, the current drug safety system is beyond absurd: Health Canada is a regulator with virtually no regulatory power.
Until the new law is passed, we continue to have a system where Health Canada cannot even order a dangerous drug off the market. All it can do is nudge manufacturers to recall products voluntarily. And, where there are violations of the law, however flagrant, the current penalties are laughable.
The failings of the existing law have been graphically underscored by media reports, particularly in the Toronto Star, which recently focussed on Diane-35, an acne drug prescribed off-label as a birth control pill. The drug, which is known to cause blood clots, is linked to the death of at least 13 Canadian women; it is still on the market and widely prescribed.
While Canada does have a database for adverse drug reactions, called MedEffect, it is not a very useful tool because, by most estimates, fewer than 5 per cent of problems are actually reported.
The new law should dramatically increase the reporting of adverse events because it will be mandatory for health institutions to report (for individual health professionals like family doctors and nurse practitioners reporting will remain voluntary).
The great unknown is: What will Health Canada do with the information? Tracking, if done properly, should alert authorities to drug side effects that crop up in the real world that did not in clinical trials of drugs.
But to ensure patient safety you have to analyze and you have to act promptly on the information. Health Canada is notoriously secretive about its safety reviews and painfully slow to act. It can take years for the department to take action – in the case of the drug Vanessa Young was taking, for example, there had already been 80 deaths in U.S. teenagers and numerous red flags raised yet Prepulsid was not taken off the market (voluntarily) until after a flurry of media reports about her death.
Nothing in the legislation addresses that problem, nor is the department getting additional resources; it will require a big change in culture, and some money and manpower, if drug safety is going to improve in practice, not just in theory.
The other glaring failure in the proposed law is that while it applies to prescription drugs, over-the-counter drugs, cells, tissues and organs, and medical devices, it excludes so-called natural health products.
That is an abomination.
Canadians need to be assured that all drugs, without exception, are as safe as possible, and swift action will be taken when they are not. No exceptions.
A more thorough overhaul and modernizing of the Food and Drugs Act is required, just as the Conservatives planned in 2008 before that proposed legislation died on the order paper.
Mr. Young should be proud of what he has achieved with his advocacy, both outside and inside government. But Bill C-17 should be seen as the beginning, not the end, of honouring Vanessa's legacy.
André Picard is The Globe's health columnist.
André Picard