A CBC News investigation into the increasing use of atypical anti-psychotics among the elderly

CBC News has learned that despite a Health Canada warning in June 2005 about the dangers of prescribing anti-psychotic drugs to seniors with mild dementia, the prescriptions for those drugs have increased by from seven to 40 per cent in six provinces from October 2005 to September 2007. The trend comes from an analysis of data provided by IMS Health — a company that provides health-care information. A similar trend in the United States has prompted at least one senator to begin asking questions.

Iowa's Senator Chuck Grassley "has asked for a review by the Inspector General for the Department of Health and Human Services into how anti-psychotic drugs are being used in nursing homes, given questions of patient safety and taxpayer liability for the prescriptions, including off-label use of the drugs." In his news release, he also called for other action. On this side of the border, there is little to no activity. Health Canada is silent, despite many requests for a response to the department and minister's office; the provincial colleges of physicians and surgeons don't have much to say; and the provinces still list these anti-psychotics on their formularies despite the fact that there is mounting evidence that they are not only dangerous, but may not be any more effective than the older generation of anti-psychotics.

But it doesn't end there. There is also evidence that Health Canada's advisories don't work — period. The June 2005 advisories to patients and doctors had no effect on sales. And many people we have spoken with were unaware of the advisory; some said they heard about the FDA's warning, but not Health Canada's. Meanwhile, many family members of elderly men and women living in nursing homes or still living in their own homes are left to wonder what to do.

When Norma Galloway moved in with her sons in their North Vancouver home, everyone figured that she would live into her 90s. The odds of longevity were good because Norma's mother had lived until she was 97. At 85, Norma was "slowing down" and troubled by a number of ailments such as osteoarthritis and high blood pressure. And in 2004, she was diagnosed with type-2 diabetes. Still, she got around without a wheelchair, and was able to help out with the cooking and laundry.

Then she was struck with a urinary tract infection that wouldn't go away. The antibiotics didn't work, and the persistence of the infection began to bother Norma, so much so that she became anxious. So her son Rod asked the doctor to prescribe a pill that could calm her down, make her less worried about her health.

The doctor reached into her medicine cabinet and pulled out a sample of a drug she had obtained from a pharmaceutical representative. The drug in question was Risperdal, which Health Canada first approved in 1996 as an "anti-psychotic agent." It belongs to a class of drugs called atypical anti-psychotics, the others being Zyprexa, Seroquel and Clozaril. According to Health Canada Notice of Compliance database, the maker of Clozaril was the first to receive the approval in 1994. These drugs were supposed to be safer than the older brand of anti-psychotics, in large part because they caused fewer side effects while treating the psychosis.

Rod was skeptical because his mother was not psychotic, just suffering from anxiety brought on by the infection. But he had been dealing with family doctors for years and grew to trust them. So Rod gave his mother her first pill that same evening. Then he noticed that Norma became drowsy, which is one of the side effects of the drug.

But there are many more side effects to contend with than drowsiness. Studies have pointed to heart attacks and stroke, problems that also show up in Health Canada's adverse drug reaction database. The CBC had documented many of these problems in 2005 with its award-winning series Prescribed to Death. The same week the series aired, the U.S. Food and Drug Administration used black-box warnings — the most severe warnings the agency issues — to alert health care providers to the dangers. Health Canada followed suit two months later with an advisory on June 15 and Dear Health Care Professional Letter on June 22. The warnings were not as severe and as explicit as those published by the Food and Drug Administration, which warned doctors not to prescribe the drug for patients with mild dementia. Curious about the impact of the Health Canada warnings, the CBC decided to measure their effect. Because adverse reactions are seriously under-reported, even more so for seniors, we decided to look at prescription numbers. For this we went to IMS Health, a health information company that operates in Canada, the United States and around the globe. We asked IMS Health to run prescription numbers for the six provinces it tracks: Alberta, Saskatchewan, Ontario, Quebec, New Brunswick and Nova Scotia. The results show that for a 24-month period, beginning three months after the warning, the number of prescriptions for each of the drugs increased between seven and 40 per cent.

Eric Wooltorton considers these numbers, and CBC's analysis of them, troubling but not surprising. Wooltorton is general practitioner, an assistant professor at the University of Ottawa and an associate editor of the Canadian Medical Association Journal. He sees many elderly people in his practice and does prescribe these drugs if his patients' mental state puts their lives, or the lives of others, in danger. He says in too many instances, doctors misprescribe these drugs as sedatives to keep the elderly suffering from mild forms of dementia in nursing homes or in their own homes from acting out. In other words, doctors are ignoring the warnings from the FDA and Health Canada. In these instances, he wonders who the drugs are really designed to treat — the family member who needs a break, the harried personal support worker, nursing aide, or registered nurse in a long-term care facility, or the doctor who has too many patients?

"What I see in general is that we've created a pill for every ill. I think a lot of things are being used off-label on many conditions because we're trying stuff." Using drugs off-label means they are being prescribed for conditions they were never approved to treat.

The frustration that Wooltorton and others we've spoken to experience is that no one seems to be accountable: Health Canada approves a drug if a company can demonstrate that its product works better than a sugar pill and doesn't kill anyone; the provinces actually pay for the drugs, many times even if there are cheaper and safer versions already on the market; doctors are free to treat their patients by, among other things, prescribing medications off-label; and drug companies promote their drugs, but say it's up to the other players to determine how the products are used; and patients have been trained to rely on medications to treat a "a pill for every ill," as Wooltorton indicates.

The increased prescription numbers are also indicative of something else extremely troubling: Health Canada's advisories don't seem to have much effect. While a regulatory agency or government doesn't have control over what a doctor prescribes, you would expect advisories about a newer class of drugs to carry a lot of weight.

Not so, concludes Paula Rochon, a geriatrician and scientist based at Baycrest at the University of Toronto. Rochon is one of the country's top researchers into drugs and how they affect the elderly. She says Health Canada's warnings are ineffective because they don't provide doctors with enough information. It's not good enough to tell doctors what they shouldn't prescribe without giving them alternatives, she explains.

"As you know there have been warnings associated with these drugs and they're fairly serious warnings. And you would think that would have an effect on prescribing. I don't believe it really has had an effect on prescribing practices. And part of the problem if you ask people about it is that they don't think there's a good alternative, they don't really know what they should be doing. There's certainly not a clear drug option they can move to, and so in the absence of other sort of clear information in their perspective, they've continued on with what they know."

The CBC has learned that Rochon is set to publish her own findings about the ineffectiveness of Health Canada health advisories in a medical journal.

The question becomes who should be responsible for providing doctors with these kinds of answers: Health Canada; the Division of Aging and Seniors, Public Health Agency of Canada, the colleges of physicians and surgeons; provincial ministries of health? Who? The answer is unclear, even after coroner's investigations into two-high profile deaths earlier in this decade strongly recommended that these players get their acts together and improve communications about adverse drug reactions. There was certainly no communication with Rod Galloway. In a letter of complaint to the B.C. Colleges of Physicians and Surgeons, he pointed out that he was told nothing about side effects. In its letter, which ultimately concluded the doctor did nothing wrong, there was this admission: "It is not clear that (the doctor) gave Mr. Galloway any detailed advice about the side effects or toxicity of the drug."

Rod Galloway gave his mother a second pill the morning after the visit with the doctor. Norma became even drowsier. Figuring that all she needed was fresh air, he took her to the store. No luck. He tried giving her a cup of tea and told her to sit on her bed and wait for him. When he returned, she hadn't moved a muscle. Her coat was still on.

While attempting to remove her coat, Norma suffered a grand mal seizure and was rushed to hospital, where she died 10 days later of heart failure, on Tuesday, Sept. 19, 2006.

So convinced was Rod that Risperdal helped kill his mother that he complained to the B.C's college of physicians and surgeons. While the college acknowledged — in the letter quoted above — that the drug probably caused the seizure, it was unwilling to link the drug to the heart failure, despite the fact that it is a recognized side effect of the drug.

Talking about his mother's life and its abrupt ending is not easy for Rod. But he believes strongly that sharing his story with the CBC is the best way to shed light on the use of the atypical anti-psychotics and the inefficacy of Health Canada's advisories. And he can't help blaming himself for asking for a drug to calm his mother's anxiety, and then not conducting enough research on its side effects.

"But as a good friend said to me," Rod reflects philosophically, "you're not the one with the letters ‘DR' in front of your name. As a layperson you don't know all the answers."