When Good Drugs Go Bad

A Vancouver-based group says people are dying because Canada does not do enough to monitor prescription drugs once they are on the market.PharmaWatch says Health Canada does too little to encourage consumers and doctors to report the side effects of drugs, or adverse drug reactions (ADRs), which have been cited by the World Health Organization as a leading cause of death in the United States. Pharmawatch claims that manufacturers often fail to report them even though they are required to do so by law. The group estimates that only one to three percent of ADRs are reported to Health Canada. In response, PharmaWatch has launched a web site, the first of its kind in North America, that allows consumers to report their experiences online.The group hopes increased monitoring of drugs will cut down on health risks and even deaths that occur because doctors are not aware of the dangers. For example, in 2000, 15-year-old Vanessa Young of Oakville, Ontario, suddenly fell over and died while talking to her father in his study. She had suffered a cardiac arrest, "undoubtedly caused by the drug cisapride, "according to the Canadian Medical Association. Young's family doctor had prescribed cisapride for a minor eating disorder.A 'welcome thorn'PharmaWatch calls itself "a welcome thorn in the side of both Health Canada and the pharmaceutical industry." Spokesperson Colleen Fuller claims that Canadians' safety is being compromised because of the influence of a powerful and heavily funded pharmaceutical lobby."Health Canada is slow to the point of negligence when it comes to intervening in the market in a way that will result in protecting public health but may harm the investment climate for the pharmaceutical industry," she says. "They are far too close to the industry. They need to distance themselves."Fuller, a diabetic, became involved in consumer advocacy when she had a reaction to a form of genetically engineered insulin. While taking the insulin she vomited and blacked out unexpectedly, and fell into five comas within three months. After using it for five years she weighed 88 pounds."It was horrible," she says. "It was awful. And for five years I was using that drug because I didn't know that I was able to use any other drug." Fuller claims the company that makes the product, Eli Lilly, wants it to become a replacement for animal insulin.She and other diabetics formed an organization called the Society for Diabetic Rights, but when they brought their concerns to Health Canada they were surprised at the lack of response. "I think that all of us just assumed that all we had to do was tell Health Canada what was happening and then they would do something about it," says Fuller. "And of course three years later we are still pushing them and trying to get them to do something."She says one of the reasons that PharmaWatch was formed was to represent people like her "rebellious group of diabetics" whose concerns about dangerous drugs on the market are being ignored.Doctors are 'poor reporters'Health Canada's Jirina Vlk agrees that it is important to keep an eye on drugs even after they are approved. She points out that "Health Canada accepts adverse reaction reports directly from consumers and encourages this route of reporting if consumers are not able to report through their health care professionals."Fuller argues that Health Canada's emphasis on reporting ADRs to your doctor is a mistake. "Physicians are notoriously poor reporters," she says.In 2002, the World Health Organization (WHO) released Safety of Medicines: A guide to detecting and reporting adverse drug reactions, which stated that ADRs "are the 4th to 6th largest cause for mortality in the USA."WHO says "[t]he objectives of the guide are to raise awareness of the magnitude of the drug safety problem and to convince health professionals that reporting of adverse reactions is their moral and professional obligation."Fuller says Canadian doctors complain that the half-hour it takes to fill out a report is often time wasted. "There are no incentives to physicians to report. In fact, I would say that there are disincentives because they spend the time reporting and then there's no result.Nothing happens," she says.Don't count on drug companiesVlk says that in addition to accepting ADR reports from individuals and doctors, "manufacturers are obliged by law to submit severe ADRs" to Health Canada.Jaques Lefebvre, of Rx and D, the biggest association of drug manufacturers in a Canada and their main advocacy voice in Ottawa: "Our companies have departments with a responsibility for capturing and transmitting adverse event and adverse drug reaction information they receive to Health Canada."But Fuller maintains that groups like Rx and D constitute a powerful lobby that argues for "as minimally regulated an environment as possible." She says post-market surveillance often results in drugs being pulled off the market, which can cost pharmaceutical companies huge sums of money.She says Health Canada doesn't do enough to oversee the companies: "It's not quite self regulation, but it's far too close to self regulation." What we need, Fuller insists, is a vigorous system of monitoring.She thinks Health Canada needs to put more money into educating consumers about drug safety and the importance of reporting ADRs directly.'Snobbery' against consumersFuller says the health profession has historically had a bias against direct from the consumer reporting. "There's a snobbery towards people and their ability determine what's going on when they are taking medication."Vlk says that Health Canada uses scientific studies and other sources of information to assess the unintended side effects of drugs. In addition, "Health Canada encourages the concept of improving ADR reporting and consumers to report ADRs to Health Canada."But Fuller says Health Canada's ADR reporting centres are underfunded and that Health Canada doesn't promote public awareness of the opportunity for consumer reporting. "Most consumers don't really know what an ADR is," she says. "They don't understand what role that plays in a system of drug safety."She maintains that "some people at Health Canada believe that consumer reports are a poor quality report" because consumers often do not know the correct medical terminology, or may not be able to differentiate between the effects of drugs if they are taking multiple medications.Lefebvre warns that "Reliable reporting of ADRs presents a number of challenges such as variability and precision of the terminology used to describe symptoms, disease conditions and treatments." He says the reliability of a report depends to a great degree on the training and experience of the person reporting the ADR.Consumer reports 'important'However, the idea that consumers have something valuable to add is gaining ground. A February 2004 report by WHO said "perhaps it is time to focus on creating a 'culture' of reporting. Consumer reporting could provide valuable information on ADRs.. Consumer reports may not be thorough, but they are nevertheless important."WHO also notes that where the incidence of ADRs is low, every report is important. "At least 30,000 people need to be treated with a drug to be sure that you do not miss at least one patient with an ADR which has an incidence of 1 in 10,000 exposed individuals."Fuller thinks consumer reports are necessary in order to catch ADRs that happen very infrequently. "You can't rely on single doctors' offices or individual patients who may or may not come forward," she says. "You have to cast the net very, very widely."And she says that consumers cannot rely on government or industry to do the job. "The fact that we're setting up a separate system from Health Canada is an implicit criticism of Health Canada and also the pharmaceutical industry."Jared Ferrie has written for the Globe and Mail and the Georgia Straight and is a former staff member at The Tyee.