Norma Galloway in 2004, two years before she died.

On Sept. 19, 2006, Norma Galloway died in a Vancouver hospital, 10 days after suffaering a seizure at home. She was on a number of drugs, the latest one being Risperdal. She had taken two tablets of the atypical antipsychotic medication, which belongs to a family of drugs that has prompted concerns about efficacy and safety.

Risperdal is only supposed to be used in seniors for short-term treatment of aggression and psychosis. Norma was not psychotic. She was simply agitated due to a stubborn urinary tract infection.

A year before Norma's death, Health Canada issued an advisory warning that, in 13 studies, elderly, demented patients prescribed second-generation antipsychotic medications had an average 60 per cent greater death rate than similar patients taking placebos. Health Canada listed four drugs that could pose adverse risks for seniors:

• Risperidone (Risperdal)
• Quetiapine (Seroquel)
• Olanzapine (Zyprexa)
• Clozapine (Clozaril)

This warning came two months after a CBC News investigation called Prescribed to Death, which examined the over-use of drugs in the elderly. In its advisory, Health Canada requested that the drugs' manufacturers include a warning describing the risk in the safety information sheet for each drug, and that health care providers refrain from relying too much on the drugs to treat dementia.

But a CBC News investigation has discovered that despite the warning, doctors are prescribing more of the drugs to their patients suffering from dementia as a way to calm their behaviour. David McKie of CBC's Investigative Unit spoke with Norma's son, Rod Galloway, about the events leading up to the death of his mother.

Here is an excerpt of that interview:

Rod Galloway

Well, she got a urinary tract infection at the end of August, beginning of September 2006, and we knew the signs. We knew the course of action: Phone the doctor and tell him and they'll take a sample to the lab and test it, and if it's positive, then they prescribe a course of antibiotics, which they did. But we didn't think it was really working that well. After about seven or eight days, she was still having problems. So I went back to her family doctor, and his suggestion was that with a lot of seniors, they put them on a low-dose antibiotic for 30 days and that works well to keep them clear of urinary tract infections. But in the next couple days we noticed that she was getting a little bit more agitated and a bit more confused, which is a sign that a urinary tract infection is not cleared up. So I went back to our other family doctor that was sharing the practice and she prescribed another antibiotic.

And so I thought, OK, that's great, they're going to try something different that could be effective for her, and I mentioned to her that is there anything that you can give her to just take the edge off, to stop any agitation or the confusion just until the antibiotic kicked in and she felt a little better. And she went to her pharmaceutical cupboard and gave me a pharmaceutical rep sample of Risperdal, which she said that I was to give to her one twice a day for two days, and I think there was four in the package.

David McKie

At that point, what were you told about Risperdal?

Rod Galloway

The only thing I was told by the family doctor was that it was an antipsychotic and my mother should take one twice a day for two days. That's all I was told. I was never told to be aware of any adverse reactions or anything or, you know, that I should look out for anything.

David McKie

The doctor goes to her cupboard, brings back a 5 milligram sample of Risperdal, by Johnson.

Rod Galloway

Yeah, which they say is the lowest strength.… I was told that Risperdal works effectively with low doses in seniors with that type of problem and that it was safe and effective. But for us, I don't think it was either safe or effective.

David McKie

And what was it about the low dose that was safe and effective, do you recall?

Rod Galloway

Well, I don't think it was effective, for one because the effect that it had on my mother.... The description I used was that it was like someone who was drugged out. Someone was like they're not really there. So and she did have a seizure at home right in front of me, so I don't think it was really safe or effective.

David McKie

So you thought she was a little confused but not psychotic?

Rod Galloway

Yeah, and agitated because of the urinary tract infection. We don't believe that that type of medication was appropriate for the situation, but that's our opinion anyway, so…

David McKie

Did you have any trepidation when she prescribed it? Did she prescribe it as an antipsychotic? Or did she just say, "Here, this will calm your mom's nerves"?

Rod Galloway

No, she just said, "This is Risperdal. It's an antipsychotic. Take one twice a day," and that was it. So yeah, that was all she said to me.

David McKie

And you recall thinking at the time, "Antipsychotic? My mom isn't psychotic."

Rod Galloway

Well I just, for a second I thought well, this is funny, but you put a lot of trust in your family doctor and you think, well, geez, they should know what they're doing and they should know if a medication is safe and effective. So you know, I guess a lot of people put a lot of trust in their family physician and they hope that they know what they're doing. Even though you might think it's a funny choice of medication, you just put a lot of trust in your family doctor…

David McKie

So you give her one Risperdal tablet that afternoon.

Rod Galloway

Yeah, and like I said I really didn't like the effect that it had on her. It was like someone that was really like groggy or sedated and not really that with it. And on the next morning we were debating should we, should we give her another one, and we reluctantly gave her a second Risperdal, so that's two altogether, and the effects seemed to be more pronounced with the second Risperdal. So I thought, well, maybe it'll wear off after awhile, I'll take her to the local grocery store, maybe a breath of fresh air will sort of clear her head, but it had no effect so…

David McKie

You bring her home around four o'clock

Rod Galloway

Yeah, and I said to her, "Oh, go sit down on your bed and I'll put the kettle on, I'll make you a cup of tea," and I came back into her bedroom and she was still sitting on the bed with her jacket on, she hadn't taken her jacket off, and I helped her stand up, you know, I was going to help her get her jacket off, and that's when she had a seizure and collapsed to the floor. So at that point, you're calling the emergency services and getting the fire and ambulance people to come and respond.

David McKie

So when you say a seizure, can you describe to me exactly what you saw?

Rod Galloway

Well she sort of contorted her face and she made this funny sort of sound, and she collapsed right to the floor and her, both her legs sort of shot out straight and went stiff and then sort of relaxed, and then she had sort of like short heavy breathing. So at that point I got the phone and called the emergency, and they're telling me to make sure her airway's clear and turn her on her side so she could breathe, and then by that time the fire paramedics had arrived and then the ambulance shortly after.

David McKie

So the doctor you had, did you go to the hospital with her?

Rod Galloway

Yeah, I rode in the ambulance to the hospital and then about I guess sort of an hour after the first seizure she had a second seizure in emergency. And they thought that she may have had a stroke, and I was told, "Well, she's probably had a stroke and she's not going to survive the night." But we had given all her medications to the ambulance personnel, and my brother told one of the nurses that she'd been introduced to a new drug called Risperdal. And her comment to my brother was, "Oh, when you said Risperdal my red flags went up." So obviously they have experienced and things have happened with people getting this drug that, you know, there's people having seizures and strokes and heart attacks because of this drug. I guess there's an awareness there in the emergency anyway.

David McKie

So at this point you begin to suspect the Risperdal?

Rod Galloway

Oh yeah, because we went to the website and we were sort of amazed at some of the stuff that we found, that there's a warning by the FDA in the States about Risperdal and other drugs in that category and that there's class-action lawsuits against the manufacturers of Risperdal and other drugs in that category all over the U.S. We found information that said that if someone is over 65 years of age they really shouldn't be getting the Risperdal. If they have high blood pressure and are under treatment for high blood pressure, if they have Type 2 diabetes, and she also had osteoarthritis, too, and had been getting Celebrex I believe at that point, which also increases your risk of heart attacks and stroke, so if you add something else into the mix, then there's more potential for an adverse reaction I guess.

David McKie

You mentioned the Food and Drug Administration advisory. That was a black-box warning, actually, that came out April 2005. Were you also aware that Health Canada had come out with an advisory in June of 2005?

Rod Galloway

I wasn't aware of the warning by Health Canada but by the FDA in the States for sure.

David McKie

When was the first time you found out about the warning from Health Canada?

Rod Galloway

Well, I think my brother checked on the internet again and found it, and I also called the Health Canada adverse drug reaction line and reported what had happened and what medications she was on. So I think they're aware there is a problem with this category of drugs

David McKie

But the point that I'm making is that at no time were you aware of that June 2005 Health Canada advisory on these drugs?

Rod Galloway

No I wasn't, no.

David McKie

And what did you, do you think you should have been made aware of that somehow?

Rod Galloway

Well, yeah, I think we should have been made aware, but obviously we weren't. I mean, for us, we think that if a doctor's going to prescribe something or dispense something like a pharmaceutical sample, that they really have to weigh the risks versus the benefits of a drug they want to give to their patient. I think, sometimes I think it'd be good for them to pause for a second and say, Is there something safer and just as effective that I could give my patient? So I guess that's our feeling on that.

David McKie

If you had been aware of the Health Canada warning, would it have made any difference? Would you have asked questions, would you have been more skeptical, would it have made any difference at all?

Rod Galloway

Well, if I had been aware of the advisory, I probably would have clicked in, I would have said, Are you sure this is safe or is this appropriate for my mother? You know, if I had been aware, yes, I would have questioned what the doctor wanted to give her. But-

David McKie

But you weren't aware.

Rod Galloway

No, we weren't aware. Only the U.S. advisory, not the Health Canada advisory.

David McKie

And are you thinking that more should have been done to publicize the advisory so that people like yourself with an elderly mother would have known more about it?

Rod Galloway

Oh definitely, I think so, and if they're receiving reports of adverse drug reactions from this drug and others in this category, they should be putting out an advisory to doctors as well saying, "Look, we're having a problem with this drug, use with extreme caution," or the patient should meet certain criteria before it should be prescribed.

David McKie

So let me get back to your mom. She's not doing well, she's had a couple of seizures, this is according to the diary Tuesday, September 19, but you are told that it has nothing to do with the drug.

Rod Galloway

Yeah, they're saying it's nothing to do with the drug, but, you know, we found that she wasn't really getting her strength back after the seizures. I think it really took a lot out of her and I don't know exactly what a grand mal seizure does to your system, but by seeing it firsthand you think, "Well, this can't be good. It must be really hard on someone," and so yeah, she wasn't really, she was really slow to get her strength back, so we were told that she might have to go into transitional care until she got her strength back after leaving hospital because it was a really slow recovery. So yeah, we thought it must have done something to her, but what it actually does, I don't know firsthand.

David McKie

So she's rushed to the hospital Tuesday, September 19, 2006.

Rod Galloway

She was rushed to the hospital on the 9th and she passed away on the 19th of September. So she was in there for about 10 days altogether, I think.

…

David McKie

Are you convinced that the drug killed her?

Rod Galloway

Well, what I'm convinced of is that it's the straw that broke the camel's back. You know, if you have pre-existing conditions — you're under medication for high blood pressure, you're under medication for Type- or late-onset diabetes, you're taking medication for osteoarthritis — and all those things sort of have an effect on your system, and to us it's like it sort of overloads your system, and it's too much. It was definitely, I think it was a downhill slide from there after she had the two grand mal seizures, so I think it really weakens you so it may have not been the ultimate cause of her death, but I think it was a major contributor to her death.

David McKie

And she only had two tablets…

Rod Galloway

Yeah, she only had two tablets, so it wasn't the four she was supposed to get so, and they weren't two in one day; there was one one day and one later on the next morning. So it wasn't like back to back or anything.

David McKie

Do you feel any guilt at all that you were the one who asked the doctor to prescribe something, that you were the one who gave her the pills?

Rod Galloway

Yeah, you do feel guilt and it weighs heavy on your conscience. But as a good friend said to me, you're not the one with "Dr." in front of your name, so as a layperson you don't know all the answers, you don't know the potential harm that can be done by some of these drugs, so yeah, you do feel a sense of guilt and remorse and you sort of say, Why did I do this, or why did I ask for something? You sort of kick yourself, but as my friend said, you're not the one with "Dr." in front of your name, and they're the ones that are supposed to know that there's a potential for adverse reaction from either one drug or a combination of drugs.

David McKie

You complained to the College of Physicians and Surgeons and in their response, they acknowledge that the drug may have had some contributory factor but it didn't really. You're reaction to their response?

Rod Galloway

Well, I think what it is is that I guess you're never going to get the whole truth or the whole answer because I think, unfortunately, we've become such a litigious society that doctors are really afraid that they're going to be sued for wrongful death, and I think their regulatory bodies and their insurance agent and legal council will only let them say certain things and they won't let you say everything or let them say everything, so I just think, yeah, there's probably more to it, but I don't know if you're ever going to find out the whole answer.

[an error occurred while processing this directive]