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Nominal Benefits Seen in Drugs for Alzheimer's
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April 7, 2004
Nominal Benefits Seen in Drugs for Alzheimer's
By DENISE GRADY
The drugs now available to treat the memory and thinking
problems of Alzheimer's disease have not lived up
to the public's high expectations for them and offer
such modest benefits on average that many doctors
are unsure about whether to prescribe them.
Although the drugs have their advocates, grateful
for any sign of improvement, others express disappointment
in light of earlier hopes that the drugs approved
in the last decade would stop the disease or markedly
slow it.
At a meeting in late March at Johns Hopkins University,
doctors and other health professionals heard Alzheimer's
researchers debate the usefulness of the drugs and
the prospects of better treatments becoming available
any time soon. Some researchers say it may be decades
before real progress is made in reducing the toll
of the disease.
When a frustrated doctor in the audience accused a
panel of experts of evading the question of whether
the drugs should be prescribed, the auditorium burst
into applause. One expert replied that there was just
one chance in 10 that the drugs would have an effect
and that patients should try them for six to eight
weeks and then quit if there was no improvement.
A second expert gave the drugs somewhat better odds
of helping. A third said to try the drugs for six
months. A fourth said, "The kind of evidence
you want may not be available." The moderator
summed up, saying: "For us to tell you what to
do, I think would be wrong. All you can do is look
at your soul and do the best you can."
About 4.5 million Americans suffer from Alzheimer's
disease, and many patients and their families see
the five drugs now available to treat it as their
only defense against its relentless destruction of
the mind. Patients usually take one drug. Each costs
about $120 a month. They are meant to aid thinking
and memory, though they do not change the underlying
course of the illness. A million Americans take them,
at an overall cost of $1.2 billion a year.
"We don't want to raise expectations that the
effects of these drugs are large," said Dr. Peter
Whitehouse, a professor of neurology and bioethics
at Case Western Reserve University. And yet the medicines
are all that doctors have to offer. Though researchers
are trying to develop new treatments, no breakthrough
is near, said Dr. Constantine G. Lyketsos, director
of the Alzheimer's center at Johns Hopkins.
Clearly, the drugs can alter brain chemistry, and
some studies show statistically significant improvements
on tests that measure thinking and memory. But while
a few extra points on a mental exam, or other changes
obvious to a specialist, may be enough to get a drug
approved by the Food and Drug Administration, they
may not be enough to help a person with Alzheimer's
dementia function in the real world.
"You can name 11 fruits in a minute instead of
10," said Dr. Thomas Finucane, a professor at
Johns Hopkins and a geriatrician. "Is that worth
120 bucks a month?"
Dr. Finucane, the conference speaker who advocated
a six-to-eight-week trial of the drugs, said that
most of his patients tried Aricept, the leading drug,
but that only 10 percent of them found it worth continuing.
"There is very limited efficacy in making the
patient's life or the caregiver's life better,"
he said, noting that a professional group, the Academy
of Neurology, had stopped short of recommending the
drugs but had instead urged doctors to "consider"
using them.
Four drugs — Aricept, Exelon, Reminyl and Tacrine
— are approved to treat the symptoms of mild
to moderate Alzheimer's. All raise levels of acetylcholine,
a chemical that transmits nerve signals in the brain.
A fifth drug, Namenda, which works on a different
neurotransmitter, was approved last year for moderate
to severe cases.
"In my opinion, in 10 years we'll be embarrassed
by how much of this stuff we prescribed," Dr.
Finucane said, adding that he thought hundreds of
millions of dollars were being wasted on the drugs.
But he also said he understood why patients and families
wanted them. "Alzheimer's disease is a slow-motion
disaster," he said. "It's very hard to sit
by and watch. There is an overwhelming desire to do
something, even if it's to give a useless pill every
day."
Dr. Steven T. DeKosky, chairman of neurology and director
of an Alzheimer's research center at the University
of Pittsburgh, said he took a very different approach,
prescribing drugs for all his Alzheimer's patients
unless they cannot tolerate them. He said that it
took at least six months to tell whether the drugs
were helping.
Dr. DeKosky said the "data are overwhelming"
that the drugs help patients stay functional a bit
longer. In addition, he said, family members often
tell him that patients improve with the medicines,
or at least seem to decline less steeply. From 7 to
10 percent, he said, have a noticeable, if temporary,
improvement, which researchers call a "Lazarus
effect."
"They are symptomatic, mildly effective medications,"
Dr. DeKosky said. "They are not the silver bullets
to stop the disease or slow it down. They don't restore
anybody's memory to what it was in the past."
The drugs can buy patients some time, blunting the
deterioration for up to a year, Dr. DeKosky said.
"At this point, small victories are what we have
to settle for," he said.
Researchers acknowledge that opinions diverge widely
on the treatments. Dr. Jason Karlawish, a geriatrician
at the University of Pennsylvania's Institute on Aging,
said, "There is substantial controversy over
the claim that current F.D.A.-approved treatments
improve function or slow a patient's decline."
He blamed several factors for the controversy, including
"the lack of widely understood and accepted measures
to show improvement or slowing of decline, small effects
on the few measures some experts agree are appropriate,
and controversial and even outrageous approaches to
analyzing the data to make the claim the drug slows
a patient's decline."
Dr. Karlawish, Dr. Finucane and other researchers
said they were particularly irked by a study published
last July in The Journal of the American Geriatrics
Society, claiming that Aricept could delay a patient's
need for nursing-home care by nearly two years —
something that would clearly matter to patients and
families.
Pfizer, which makes Aricept, paid for the study and
its scientists were among the article's authors. The
critics said the study was flawed, and its data did
not support the claim. Letters criticizing the study,
and the authors' rebuttal, are to be published in
the May and June issues of the
geriatrics journal.
The editor of the journal, Dr. Thomas Yoshikawa, declined
by e-mail to discuss the details of the study but
said that it had passed muster with journal editors
and several outside experts. But he also noted that
expert opinion was divided as to whether the drugs
improve quality of life for patients or those caring
for them.
An author of the study, Dr. David S. Geldmacher, a
neurology professor at the University of Virginia,
said, "I believe the data we report are accurate
and the conclusions are appropriate."
In interviews, Alzheimer's patients and their relatives
said they were pleased to have the drugs, and most
thought they helped. Cathleen McBride, 64, a retired
guidance counselor and English teacher in Bridgewater,
Mass., whose case of
Alzheimer's was diagnosed two and half years ago,
said she had been taking Aricept for almost two years.
"I'm holding my own," she said. She can
no longer cook or drive, but she continues to read,
do crossword puzzles and give public talks about Alzheimer's
disease.
Asked if the drug made a difference, she said: "I
can't say. It's hard to observe oneself in a situation
like this." Her husband, Owen, said, "There's
no way to check it unless you stop and see if you
fall through the floor." Isabel Shipmon, a real
estate agent in Middletown, N.Y., said that her mother,
Luisa Cancel, took Aricept off and on for a few months
at a time, for a total of about a year.
"It kept everything balanced for a minute,"
Ms. Shipmon said. "She seemed like she was a
little bit more alert, held her thoughts a little
longer, like it didn't progress. You have her for
a second, and that's it."
Gradually the drug seemed to stop working, Ms. Shipmon
said. Her mother is now in a nursing home. Marie Heuer,
a retired secretary in St. Louis, has been taking
Aricept since learning she had Alzheimer's disease
about four years ago at age 55.
The drug had an immediate effect, she said: "It
was like a cloud being lifted. I'm very grateful we've
gotten it." Martha Daly, who lives with Ms. Heuer,
said: "The progression slowed immediately. It
was obvious to her
friends and certainly to her family."
Copyright 2004 The New York Times
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