Aid package for Alzheimer’s

More than a year after its release, Aricept —
           the first Alzheimer’s medication approved in
           Canada — is still making waves, as
      evidenced by a recent study from Dr. Rachelle Smith Doody, clinical core
      director of the Department of Neurology and co-director of the Alzheimer’s
      Disease Research Center at Baylor College of Medicine in Houston, Texas.

      In their study, Doody and her colleagues used a number of outcome
      measures to assess patients taking Aricept. One test — known as the AD
      assessment scale/cognitive, or ADAS-Cog — assesses a person’s memory;
      their ability to use and understand language; their orientation, meaning their
      ability to keep track of the day and date, time and place; their attention span
      and concentration, and ability to perforskilled motor actions. "It’s a very
      unforgiving test," Doody says, "because it scores your errors, from zero to 70
      [each wrong answer raises the score]. We know from other studies that a
      mild AD patient tends to get worse by about six units a year, a moderate
      patient by about 12 units per year."

      The problem with such tests, Doody says, is that while they may show a
      small difference in a score, "you don’t know what that means to the patient."

      Thus, a second test involved a clinician’s interview-based impression of
      change. "That’s a complicated way of saying it was a structured interview
      between the doctor or clinician giving the drug and the patient taking it, along
      with their caregiver," says Doody. Clinicians were given lists of questions in
      specific areas. First, general events: occurrences that have an impact on
      patients’ abilities. Second, cognitive events: their capability to remember, to
      stay oriented, their use of language.

      Doody explains: "Was the patient agitated, for example, or experiencing
      hallucinations or delusions?

      We talked about their daily activities, both simple things like eating and
      dressing, and more complex activities like using a telephone or programming
      a VCR.

      "We asked the clinician after each visit to score whether the patient had
      changed — compared to the baseline — or not, and we asked them to score it
      on a seven-point scale, so that five, six or seven meant the patient had
      worsened to some degree. Less than four meant the patient had improved
      and indicated the degree."

      As it happened, the two tests, or measures, provided very similar results.

      Patients on Aricept for the first 24 weeks of the study improved and stayed
      better, whereas those in the placebo group — patients not on the drug — got
      steadily worse. After week 24, the drug was purposely stopped, and the
      symptomatic effects dried up, Doody says. "So we know the drug does not
      cure AD, but for the duration of the time people took it, it made a statistically
      significant difference — no matter what dose they were on — compared to the

      Patients also tolerated the medication very well. Over 80 per cent of those
      who started the study finished it, which is very high for an AD study, Doody
      observes. When side effects did come up — nausea, headache or diarrhea —
      they were "the sort of things you’d expect from this type of agent, but in low
      overall percentages," Doody says.

      What the study couldn’t reveal is what happens if patients stay on the drug
      longer than six months, a question that’s ethically difficult to answer. To
      discover how long the drug remains effective, they’d have to maintain the
      study conditions — one group of patients on placebo, another group on the
      drug — for an extended period. "That’s something we’re not willing to do,"
      Doody says. "How long would that treatment effect last if they stayed on the
      drug? Various study designs are being explored to try to answer that
      question." On the political front, meanwhile, Aricept hasn’t been so
      successful, as a panel of doctors and a caregiver noted earlier this fall.

      Every day, Dr. Joceyln Charles, a family physician at the Sunnybrook and
      Women’s College Health Sciences Centre in Toronto, sees patients with
      Alzheimer’s disease "who suffer from increasing memory loss, decreasing
      ability to do the activities they enjoy and ultimately becoming dependent for
      care themselves. I also see many family members struggle as their relatives
      become more and more confused, eventually failing to recognize even their
      spouse and children."

      Aricept can help most of these people, Charles notes. The problem is, many
      of them can’t afford it as the medication isn’t available through the Drug
      Benefit Formularies of any province in Canada. "It’s very difficult and
      frustrating for me to explain to my patients and their families that Aricept is
      only available to those who can afford it or to those who have private drug
      coverage," Charles says. "It’s not available to patients over the age of 65 who
      are dependent on the government to provide them with access to their
      medications. So, it’s therefore not available to seniors living on fixed incomes.
      This inequality of access to the only drug treatment available for Alzheimer’s
      is unfair and unacceptable."

      Dick Watt is in his 70s and lives in Matheson, in northeastern Ontario. Watt
      cared for his wife, Kathleen, through the last decade of her life as she slowly
      succumbed to Alzheimer’s. She died in 1981, one of several family members
      who developed the disease. Now the Watts’ eldest daughter is in a nursing
      home in the terminal stages of the disease, while their youngest daughter,
      Susan — age 36 and with two small children of her own — has been
      undergoing treatment for early Alzheimer’s.

      Since Susan was prescribed Aricept 18 months ago, Watt says, "her attitude
      and her whole psychological being changed from one of very strong
      depression and negativity to one of being very, very positive." And although
      the symptoms are hard to measure, Watt says, "the disease has not
      progressed. Without Aricept, I don’t know what we’d do. Living with
      Alzheimer’s for many, many years, this is the first time we’ve had something
      to fight back with. Previously there was nothing. You sit and watch the
      disease progress. In this instance, I see a breakthrough, and I just think it
      should be available without the extra worry of where it’s coming from or how
      much it costs."

      Dr. Sandra Black, head of the Division of Neurology at the Sunnybrook and
      Women’s College Health Sciences Centre, notes that numerous clinical trials
      have demonstrated Aricept’s effectiveness in stabilizing or improving many of
      the symptoms associated with AD. "However, the results of the formal
      clinical trials don’t capture what we as physicians are observing in the 18
      months we’ve had this drug in our clinics — that the families report a

      "Mr. Watt was expressing this — whereby the person seems to return to
      some of their previous activities, to enjoy leisure activities again, to be more
      motivated, more Ôwith it,’ more part of the family."

      Dr. William Dalziel, chief of geriatric medicine at Ottawa Civic Hospital, has
      been a geriatric medicine specialist for about 20 years, and he’s seen
      thousands of patients and families with AD. "Unfortunately," he says, "I’ll
      probably see thousands more [because] Canada is a very rapidly aging
      country… and the biggest risk factor for developing Alzheimer’s is age. Drug
      therapy is an important component of managing chronic diseases and their
      symptoms, and, despite the upfront cost, drug therapy can also decrease the
      downstream cost by saving acute care days or, in the issue of Alzheimer’s,
      by delaying institutionalization."

      As Dick Watt points out, "it’s not only reducing the number of days you need
      a home care worker, but it postpones the time for extended nursing or
      another establishment. Susan, at just 36, was at the point where I thought
      she’d have to go into at least a moderate care home. That was two years
      ago. Right now, she’s living by herself with a home care worker coming in
      twice a week. Her whole lifestyle has changed. She keeps her apartment,
      everything is neat. It certainly gives her a life — a quality of life — that she
      didn’t have before. And, if I may be selfish, it’s also improving the quality of
      my life as a caregiver."

      In September, the Canadian Medical Association Journal looked at care
      costs in relation to the severity of AD, from around $10,000 a year per patient
      in the early stages of the disease to about $36,000 a year at a more severe
      stage. "One could argue that if you therefore are holding somebody at an
      earlier stage of the disease for one to two years, you would certainly be
      delaying some of those costs to the family and to society," Black says. "We
      don’t know over the long run how the length of the person’s life is going to be
      increased, and whether those costs mount up later on. But the assumption is
      that you’re going to be dying from other natural causes and that we’ll be
      improving the quality of their life for the time they have left."

      "As a physician," Dalziel says, "I’m very aware of the benefits of new drugs to
      my patients, treating their symptoms, slowing disease progression and
      improving function and quality of life. As a geriatrician, I know of no more
      tragic a disease, in terms of its impact on families and friends as well as the
      patients themselves.

      "Aricept still doesn’t have formulary approval. Seniors who can’t afford it don’t
      get it. There are going to be other drugs available for AD in the next six
      months, and they may also not get formulary approval. Alzheimer’s patients
      and families don’t have the time to wait months or years. What keeps
      patients and families with Alzheimer’s going is a sense of hope. Let’s hope
      that the right drugs are available, and soon, before time and hope run out.