Heartburn pills that cause heart attacks, antidepressants that lead to suicide
by Anne Kingston on Tuesday, November 20, 2012 5:10am
On Oct. 17, 2012, Terence Young’s tireless 12-year crusade took him before a Senate committee looking into the safety and regulation of prescription drugs in Canada. The Conservative MP for Oakville, Ont., gave the panel an earful. “Doctors and patients have no way to know when a drug is safe and when it is not,” he argued, noting that his own government’s drug monitoring system is “primarily in the hands of the big pharma companies themselves, even as a growing number of injuries and deaths are reported related to their use.”
Young was there not as a politician but as a father seeking to redress colossal systemic failure—a mission dating back to March 19, 2000, the day he watched his 15-year-old daughter Vanessa collapse on the floor at home. She was rushed to hospital, where she died a day later. The cause: cardiac arrest.
None of it made sense. Vanessa was a healthy girl. She didn’t drink or smoke or take drugs— with one exception: over the past year, she had periodically taken cisapride, an acid-reflux drug marketed as Prepulsid. Her doctor, who’d diagnosed her with a minor form of bulimia, prescribed it after she complained of reflux and feeling bloated after meals. Neither their doctor or pharmacist mentioned risks; her parents considered it “super Rolaids.”
But when Young dug deeper, he found cisapride was far more toxic than the heartburn it treated: it was linked to 80 deaths in Canada and the U.S. and had generated a total of 341 “adverse reaction” reports in the two countries. More shocking to the former Ontario MPP, Health Canada knew of these risks: since approving Prepulsid in 1990, the agency, which approves and monitors prescription drugs through its Therapeutic Products Directorate, had sent four letters to doctors, the last in 1998, warning about serious adverse effects, including heart risks in children, women and infants.
Had the family lived in the U.S., Young learned, Vanessa might not have been prescribed cisapride. In 1998, the U.S. Food and Drug Administration (FDA) had given it its ominous “black box” warning, an alarm bell that makes doctors far less likely to prescribe a drug. In January 2000, two months before Vanessa died, the FDA issued an advisory alerting doctors of heart attack risks and rewrote label warnings; in April, it announced cisapride would be pulled from the market in July 2000. Health Canada followed suit that May, taking Prepulsid off the market in August.
In 2001, Young marshalled his political connections and demanded an inquest into Vanessa’s death; the 16-day hearing resulted in 59 recommendations, including mandatory reporting of adverse drug reactions by health care professionals and clearer label warnings. A Canadian Medical Association Journal (CMAJ) editorial on the inquest’s findings noted Vanessa’s death was “undoubtedly caused by cisapride” and criticized Health Canada’s response as another example of its “advisory and regulatory actions lagging behind the FDA’s.”
Young also launched a $100-million class-action suit, naming Janssen-Ortho Inc., Prepulsid’s marketer, Johnson & Johnson, its parent company, and Health Canada. And he filed an individual suit against all three parties. The six-year battle, settled out of court, is chronicled in his book Death by Prescription: A Father Takes on his Daughter’s Killer—The Multi-Billion Dollar Pharmaceutical Industry, published in 2009.
His journey into the netherworld of Canadian drug surveillance revealed a system structured to serve the interests of the industry it regulates before the public it’s entrusted to protect. Under the “user-fee” model adopted in 1995, drug companies pay to submit a drug for approval and provide the supporting research. The result is an industry-regulator alliance primed to bring drugs to market. Health Canada has an online database listing adverse reactions to drugs. But navigating it is next to impossible, and reporting adverse effects is voluntary for doctors and pharmacists. Even if a drug is found unsafe, the agency lacks the authority to unilaterally revise the label or remove it from market—or order a company to do so.
Young’s quest to improve drug safety spurred his entry to federal politics. In 2009, a year after he was elected, he tabled a private member’s bill calling for an independent drug-monitoring agency with the power to order unsafe drugs off the market and issue plainly worded risk warnings. It won’t be debated until late next year, at the earliest.
Sitting in his constituency office in October, Young expresses incredulity that prescription drugs aren’t regulated as stringently as other public safety threats: “The minister of transportation doesn’t ‘negotiate’ with truckers to keep unsafe vehicles off roads,” he says. By law, doctors must report unfit drivers, and are paid to do so. Fast-tracking drugs to market is like “air-traffic controllers being told to land planes more quickly,” he says. Eleven years after his daughter’s inquest, none of its major recommendations have been implemented, he says: “Nothing has changed since Vanessa died. It has only gotten worse.”
Vanessa Young’s tragic death thrust her into a big, undiscussed demographic: the 10,000-plus Canadians estimated to die each year from a prescription drug taken exactly as prescribed. And that figure is likely a gross understatement: it is extrapolated from a 14-year-old study, led by University of Toronto researchers and published in the April 1998 Journal of the American Medical Association, that found deaths linked to prescription drugs accounted for some 106,000 fatalities annually in the U.S., making it the fourth-leading cause of death, behind cancer, heart disease and stroke. A 2011 Health Council of Canada study additionally estimated that 150,000 people annually experience serious reactions from prescription drugs.
Those numbers are destined to rise given a market growing by $1 billion a year, according to the Canadian Institute of Health Information (CIHI), which estimates that Canadians spend nearly as much on prescription drugs ($26.9 billion) as on doctors. These medications can improve and save lives. But they’re increasingly prescribed from cradle to grave for an expanding list of syndromes, dysfunctions and disorders—infant reflux, ADHD, adult ADD, social anxiety disorder, female sexual arousal disorder—as well as new health “risks” to manage, such as high cholesterol.
When concerns are raised about prescription drugs, they invariably focus on misuse or abuse: sports doping, OxyContin addiction, teenagers taking parents’ pain meds to get high. That more Canadians are harmed or killed by drugs taken as prescribed than by tainted meat, tainted water and handguns combined is not a blip on the public radar.
But this is changing: a growing number of voices are putting the spotlight on the risks of “proper” drug use. At the Senate committee hearing, Janet Currie, a social worker with the Victoria-based Psychiatric Medication Awareness Group, called prescription-drug side effects “one of the most serious public health problems we have.” Physician David Juurlink, a drug-safety expert and scientist with Toronto-based Institute for Clinical Evaluative Sciences, agrees: “It’s an enormous problem,” he says.