Thomas Finucane, a geriatric specialist, tells his Alzheimer's
patients and their relatives not to get their hopes up when he
prescribes Pfizer Inc.'s Aricept and similar drugs.

``In ten years we are going to be embarrassed that we were sending
billions of dollars to the drug companies for a pill that patients
can't distinguish from a placebo,'' said Finucane, a professor of
medicine at Johns Hopkins University School of Medicine in Baltimore,
in an interview.

Alzheimer's medicines generated $2.16 billion last year, according to
IMS Health Inc. Approved in 1996, Aricept became the world's
top-selling drug for the disease even amid doubts about its
effectiveness and that of similar pills. Today, in one of the largest
reviews of clinical data on Alzheimer's drugs, researchers found that
all medications in the same class as Aricept, known as cholinesterase
inhibitors, offered the same small improvement in mental functioning.

The study by the U.K.-based Cochrane Collaboration analyzed data from
18 clinical trials involving 9,200 patients. Patients taking
Alzheimer's drugs showed an average 2.5-point improvement on a
70-point scale measuring cognitive function and activities of daily
living compared with those taking a placebo.

The analysis found that 29 percent of patients dropped out of the
trials because of side effects, such as nausea, vomiting and diarrhea.

`Don't Expect Miracles'

``The average benefit is very small. It might escape notice,'' said
lead researcher Jacqueline Birks, a medical statistician for
Cochrane's dementia and cognitive impairment group at University of
Oxford. ``Don't expect miracles.''

Doctors have long debated whether the drugs, which also include
Novartis AG's Exelon and Johnson & Johnson's Razadyne, offer any
benefit at all.

Finucane says his Alzheimer's patients and their relatives can't tell
whether there is improvement after taking the pills. John Morris, a
professor of neurology at Washington University School of Medicine,
says the treatments do help patients. Both say there's dire need for
new medicines.

``All the current drugs only treat the symptoms, they don't get at the
underlying disease process,'' Morris said.

Previous clinical trials have shown that more than half of patients
show no improvement, and for those that do, the degree of benefit is
small, according to the Alzheimer's Association. Findings presented
today at the International Conference on Alzheimer's Disease and
Related Disorders in Madrid will do little to sway opinion on either
side of the debate.

`Not Satisfying'

``It's not ultimately satisfying to anyone, and I think the
manufacturers would agree with that,'' said William Thies, vice
president of medical and scientific relations for the Chicago- based
Alzheimer's Association. ``If you put all these studies together you
do get a consistent effect. It's modest.''

In an e-mailed statement today, Thomas McRae, Pfizer's senior medical
director, said ``there is significant evidence supporting the value
and therapeutic benefit associated with Alzheimer's disease treatments
such as Aricept.''

Cholinesterase inhibitors, approved for patients with mild to moderate
forms of Alzheimer's disease, are designed to curb an enzyme in the
body that breaks down acetylcholine, a brain chemical involved in
memory and other thought processes.

About 4.5 million Americans have Alzheimer's, which often begins with
memory lapses and progresses into severe degeneration of brain cells
that leaves the patients unable to care for themselves.

Five Approved Drugs

There are five FDA-approved Alzheimer's drugs, none of which stop the
inevitable decline of people with the disease. Four of the five are
cholinesterase inhibitors. Forest Laboratories Inc.'s Namenda,
approved in 2003, works by a different mechanism and is approved for
moderate-to-severe Alzheimer's disease.

The marginal efficacy of Alzheimer's drugs also raises the debate
about cost effectiveness. A month's supply of Aricept pills costs
about $150, according to Drugstore.com. Razadyne costs about $160 per
month, and Exelon costs about $170.

Last year, the U.K.'s National Institute for Clinical Excellence,
which evaluates a drug's cost against its benefits for the country's
National Health Service, recommended against prescribing the drugs,
saying they weren't worth the expense.

The cost for the drugs in the U.K. is about 1,000 pounds ($1,825) per
patient per year, Birks said. An outcry among patients, however,
prompted the agency to reconsider the recommendation. It's due to
release revised guidance this month.

`No Clear Evidence'

``The reason there is such a dispute is that there is no clear
evidence that they have an important clinical benefit or that they
make a difference in the lives of patients,'' Sidney Wolfe, director
of the Washington-based Public Citizen's health research group, said
in an interview.

Public Citizen has kept Aricept on its list of ``worst pills'' since
1999. Exelon and Razadyne are also on Public Citizen's list of
medications to be avoided. The group accuses drugmakers of playing on
the ``hope, fear and guilt'' of Alzheimer's patients and their
caregivers through advertising.

``Everyone recognizes that what we need are much better drugs,'' said
Washington University's Morris.

Morris is most excited about two new avenues of research designed to
control the accumulation of beta amyloid and tau proteins that choke
nerve cells in patients' brains. The protein buildup is a hallmark of
the disease and is used to definitively diagnose it, typically during
an autopsy.

New Treatments

Eli Lilly & Co., based in Indianapolis, is developing drugs to both
block the secretion of amyloid and improve the body's ability to clear
it out of the brain. Dublin-based Elan Corp. and Wyeth, based in
Madison, New Jersey, are developing a similar treatment to remove
amyloid deposits, while Switzerland's Novartis is refining a vaccine
that would prompt the body's own immune system to destroy the plaque.

Those drugs are all in early trials, meaning patients may have to wait
years to receive them, researchers said.

''While existing treatments are useful and effective in many people,
the fact is they are dissatisfying because people continue to get
worse,'' Thies said. ``The question of how long we'll wait to see
these disease modifying drugs is always an impossible one to answer.''

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 2:40 AM