Note from Ilena Rosenthal:
http://ilenarose.blogspot.com
Health Lover

If history were to repeat itself, if any one of the elderly had taken
a  homeopathic and died ... the Quacks at Quackwatch would be holding
press conferences and working behind scenes to get the licenses of any
doctor who might have recommended them.

www.BreastImplantAwareness.org/QuackWatchWatch.htm

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St. Petersburg Times

Dementia relief, with a huge side effect

The off-label use of some drugs is helping elderly patients, but may
be
killing thousands.

By KRIS HUNDLEY    hund...@sptimes.com
November 18, 2007
 _____  

Two years ago, federal regulators sounded a dire warning: Elderly
people
with dementia who take drugs like Seroquel, Risperdal and Zyprexa
could
suffer the ultimate side effect.

They could die.

Yet today, about one in four nursing home residents still take these
antipsychotic drugs. Sales to the elderly continue to rise, generating
a
total of $13-billion in revenues for their manufacturers this year.

The disconnect between government warnings about the increased risk of
death and physician prescribing practices led a prominent Food and
Drug
Administration safety expert to make a stunning estimate.

Dr. David Graham, who had blown the whistle on the dangers of Vioxx,
was
back before a congressional panel in February. He testified that
Zyprexa
and other antipsychotics kill about 15,000 nursing home residents each
year.

His pronouncement did not spark any followup investigations; it did
not
prompt government-sponsored research for safer alternatives. Instead,
there was resounding silence.

* * *

Why was there no outrage?

Barbara Hengstebeck, executive director of the Tallahassee-based
Coalition to Protect America's Elders, thinks she knows.

"A lot of people feel like the elderly in nursing homes are
expendable,"
she said. "They're old anyway, they have dementia anyway, they're of
no
value to society. So what's the big deal? That's a sad commentary."

But people who deal with dementia patients say it's a devil's dilemma.
Yes, the drug might kill them. Then again, it might make their
remaining
days easier - not only for the patients but for those around them.

In nursing homes, where resources are strained and staff overworked,
medication that can prevent residents from hurting themselves or
others
is often the only option, regardless of the risks.

"There are time restraints, financial restraints and limited
resources,"
said Dr. Fadi Saba, a St. Petersburg internist who sees patients at
several local nursing homes. "So we go to pharmaceutical
intervention."

Psychosis and behavioral problems associated with dementia are the No.
1
reason people end up in nursing homes. If their behavior can be
controlled with these drugs, sometimes they can stay home longer.

Robert Wager, an 89-year-old St. Pete Beach resident, was diagnosed
three years ago with Alzheimer's disease, one of the leading causes of
dementia. He would erupt into eye-popping rages over nothing.

"It would come out of the blue and all hell would break loose," his
wife, Leora, said of the incidents, one triggered by dirty measuring
spoons. "It was to the point where I was absolutely terrified."

Two years ago, Wager's doctor, David LeVine, recommended 2.5 mg of
Zyprexa at bedtime. It has made all the difference.

"Now he's a pussycat," Leora said. "It's not like he's in a stupor.
He's
still active, walking the dog and pulling weeds. If he weren't on
Zyprexa, he'd probably have to go somewhere."

LeVine, a family practice doctor and medical director at Menorah Manor
in St. Petersburg, said he focuses on improving a terminal patient's
quality of life.

"If it means speeding death slightly, there's some risk/benefit
there,"
he said. "If it means being able to keep them in their homes longer,
it's the quality of the time that they're here. That's why we keep
prescribing these drugs."

* * *

Seroquel, Zyprexa and Risperdal are the bestselling brands in a class
of
drugs called atypical antipsychotics. Approved by the FDA during the
1990s, they were hailed as a major improvement over earlier
antipsychotics, known as typicals.

Those drugs, including Haldol and Thorazine, could turn patients into
zombies and cause severe shakes and involuntary facial tics. With
atypicals, those side effects were far less likely.

The FDA approved atypicals only for bipolar disorder and
schizophrenia,
diseases that affect just 1 percent of all adults. But doctors can
prescribe drugs for unapproved, "off-label" uses. They quickly
discovered that atypicals seemed to be effective in dealing with
behavioral problems associated with dementia in the elderly.

"They calm a person down," Saba said. "And when you find something
that
works, you stick with it."

Eager to boost sales, drugmakers began targeting family practice
doctors
and nursing homes. Pharmaceutical reps should have been hamstrung: By
law, drug companies are allowed to promote their products for
FDA-approved uses only. And few elderly suffer from schizophrenia and
bipolar disorder.

But legal restrictions only meant drug reps were smoother in their
sales
spiels.

Doctors like Amanda Smith at the Suncoast Alzheimer's and Gerontology
Center in Tampa say that the reps know just how to avoid crossing the
line. "A lot of this is ridiculous charade," said Smith, who said
sales
reps never specifically claimed their products worked for dementia.

"They know full well that we don't see anyone with schizophrenia or
bipolar disorder. But they figure if people are going to get something
an atypical, they might as well get their product."

The extent of the charade at Eli Lilly & Co. can be seen in
confidential
marketing documents that became public late last year in response to
thousands of lawsuits that claimed Zyprexa led to weight gain and
diabetes in younger patients.

Buried in those documents are details abouthow the company created a
280-person "long-term care" sales force and internal memos that
referred
to nursing homes and assisted living facilities as an "opportunistic
market."

Lilly also coached sales reps to approach family doctors, who would
normally refer patients with schizophrenia to psychiatrists. During a
"Viva Zyprexa" sales meeting in March 2001, company executives urged
reps to build sales by using an imaginary patient dubbed "Martha."

Described as a widow who lives alone and is increasingly agitated,
confused and unable to sleep, Martha was portrayed as an ideal
candidate
for Zyprexa.

"What's the first thing you notice about Martha?" Mike Bandick,
Zyprexa's brand manager, asked the sales reps. "She's old!"

Martha's age "reinforces Zyprexa as a nursing home drug," Bandick
said,
but her symptoms also are commonly seen by family doctors.

"Agitation, tension, anger, hostility all show up in primary care in a
variety of packages," he said.

Using the generic name for Zyprexa, Bandick told sales reps,
"Olanzapine
is the molecule that keeps on giving."

Marni Lemons, a Lilly spokeswoman, defended the company's sales to
primary care physicians, saying they often deal with serious mental
illness.

"We believe that it is absolutely appropriate to discuss Zyprexa and
its
indicated uses with primary care physicians in the interest of meeting
a
critical medical need," she said.

* * *

As it turned out, it was partly Lilly's desire to legitimize Zyprexa's
use for dementia that led to the FDA's black-box warning. Lilly halted
a
study of the drug in the elderly population after it showed increased
risk of death and strokes.

The FDA then analyzed data from 17 studies of four atypicals and found
that the rate of death for elderly dementia patients treated with an
atypical was 1.6 to 1.7 times that of a placebo. Most common causes of
death were heart failure or pneumonia.

The FDA and researchers are not sure how atypicals increase the risk
of
death in the elderly, though they've long been aware of dangers with
antipsychotics.

Since 1987, when medications like Haldol were widely used to control
behavior, federal rules have required nursing homes to keep close tabs
on the use of what are called "chemical restraints."

No physician in Florida prescribed more Zyprexa to elderly Medicaid
patients last year than Dr. Laurence Petty, according to state data. A
geriatrician for 17 years, his practice involves visiting more than 30
nursing homes in the Tampa Bay area.

Petty said the FDA's black-box warning on atypicals had no impact on
his
prescribing practices. Nor has the demand for these drugs lessened, he
said, despite him spelling out the potentially fatal risk to patients
and their relatives.

"I have family members asking me to put their moms and dads on
something," he said. "It's hard to visit them in the nursing homes
when
they're screaming."

Ginny Hoar, consulting pharmacist at St. Petersburg's Bon
Secours-Maria
Manor, said she often suggests patients be weaned off atypicals,
especially if staffers detect side effects like excessive drowsiness
or
falling.

Hoar recently found that 60 of 260 patients at Maria Manor were on
atypicals. She recommended discontinuing the treatment for just two of
them.

"The FDA can put out a black-box warning, but that doesn't mean the
disruptive behavior just goes away," she said. "You have to consider
the
risks if we don't use the medicine. But it would be nice if there were
other options."

* * *

There are other options, but they take time, money and effort.

At the Cobble Hill Health Center in Brooklyn, Dr. Louis Mudannayake
decided to try to change the thinking at his 400-bed nursing home.

Ignoring naysayers and the doomsday predictions of senior nurses, 18
months ago he put together a team of pharmacists, social workers and
recreational therapists to review every atypical prescription.

If a new roommate caused agitation, room assignments were changed. If
a
new aide was hit while dressing a patient, the aide was given special
training on that patient's preferences and routine.

Though the nursing home's resources were initially stretched,
Mudannayake said the quality of patients' lives improved. "Ultimately,
I'm convinced financial expenditures will be diminished, because it's
easier to manage a patient who is calm," he said.

Atypical use at Cobble Hill has been cut from about 25 percent of
patients to about 10 percent, he said. Almost 40 percent of patients
were taken off the drugs completely; 75 percent of those still on the
drugs have had their dosage reduced.

"We instituted a cultural change. That's what's required to bring the
numbers down," said Mudannayake, who said psychiatric hospitalizations
did not increase as medication dropped.

"You'll always have doctors say there's nothing else to use but
atypicals, and I agree there are a small minority of patients where
you
need to use these drugs. But not in the numbers we are using them."

* * *

Despite an undeniable and growing need for safer medications to
control
dementia, drug companies have little incentive to develop such drugs
when their existing products are still bringing in billions.

Though Lilly warned doctors in 2004 that Zyprexa can cause death in
the
elderly, last year the over-64 age group still accounted for more than
26 percent of the drug's total prescriptions. Zyprexa had $4.4-billion
in sales last year.

"There's very high risk for trying to study new drugs in older
patients
because it's always more complicated," said Dr. Bruce Pollock, with
the
Rotman Research Institute at Baycrest in Toronto.

"But what good does it do if drug trials are only conducted in
healthy,
middle-aged people with only one condition? It's a disservice to the
biggest consumers of pharmacy that we don't have adequate data."

About the drugs

What the FDA said: Based on results from 17 trials, the agency
concluded
in April 2005 that the death rate for patients on atypical
antipsychotics was about 1.6 to 1.7 times higher for elderly patients
with dementia than for those taking a placebo.

What's a black-box warning? So named because of the black border that
surrounds it on the drug label, it's the FDA-required disclosure that
a
drug can have serious or life-threatening side effects.

What drugs got black-box warnings? Abilify, Zyprexa, Seroquel,
Risperdal, Clozaril, Geodon and Symbyax (a combination atypical and
antidepressant)

Top-selling atypicals: total 2006 sales, percent of Rx to elderly

Seroquel: $3.4-billion, 19 percent to patients over 64

Risperdal: $4.2-billion, 19.7 percent to patients over 64

Zyprexa: $4.4-billion, 26.6 percent to patients over 64

Source: Company reports, Verispan

'What are some of the other red flags we should be watching for?'

Testifying at a congressional hearing, Dr. David Graham, a prominent
FDA
drug safety expert, was asked if he had issues with any medications
already on the market.

"I would pay careful attention to antipsychotic medications. ... The
problem with these drugs are that we know that they are being used
extensively off-label in nursing homes to sedate elderly patients with
dementia and other types of disorders. ...

"But the fact is, is that it increases mortality perhaps by 100
percent.
It doubles mortality. So I did a back-of-the-envelope calculation on
this and you have probably got 15,000 elderly people in nursing homes
dying each year from the off-label use of antipsychotic medications.
...

"With every pill that gets dispensed in a nursing home, the drug
company
is laughing all the way to the bank."