[drugawareness] STUDY: ATYPICAL ANTIPSYCHOTICS (SEROTONERGIC ANTIPSYCHOTICS) DO

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atracyphd2

Thu, 12 Oct 2006 13:47:28 EDT

[drugawareness] STUDY: ATYPICAL ANTIPSYCHOTICS (SEROTONERGIC

ANTIPSYCHOTICS) DO NOT WORK!!

 

FIND BELOW THREE ARTICLES OUT TODAY ON THE NEWER ATYPICAL ANTIPSYCHOTIC

DRUGS [ZYPREXA, GEODON, ABILIFY, RIPIRDAL, SEROQUEL, ETC.] FROM THE

NATION'S

THREE LEADING NEWSPAPERS - THE LA TIMES, THE NY TIMES AND THE

WASHINGTON POST.

THE THREE USED IN THIS PARTICULAR STUDY WERE ZYPREXA, RISPIRDAL AND

SEROQUEL.

 

FOR ALL OF YOU WHO HAVE READ MY BOOK THIS IS FAR FROM BREAKING NEWS! FROM

DECADES OLD RESEARCH WE KNOW THAT THE NEW ANTIPSYCHOTICS, WHICH ARE

BASICALLY A

MIX OF THE NEW SSRIs AND THE OLD ANTIPSYCHOTICS AND THEREFORE INCREASE

LEVELS OF SEROTONIN, COULD NOT POSSIBLY BE OF BENEFIT FOR ALZHEIMER'S OR

SCHIZOPHRENIA - BOTH CONDITIONS OF HIGH SEROTONIN LEVELS. SO WHY WOULD

INCREASING

SEROTONIN EVEN FURTHER BE EXPECTED TO HELP?!!

 

IF THE RESEARCHERS HAD FIRST READ THEIR OLD RESEARCH BEFORE EMBARKING UPON

SUCH A STUDY THEY COULD HAVE SAVED $17 - $18 MILLION. AND YET WE HAVE HAD

OTHER STUDIES OUT FOR SOME TIME, FIRST MENTIONED IN THE 1994 EDITION

OF MY BOOK

ON SSRIs, THAT THE HERB GINGKO, KNOWN FOR HELP WITH MEMORY, IS VERY

EFFECTIVE

FOR ALZHEIMER'S. THE ONLY " PROBLEM " WITH GINGKO IS THAT IT WILL NOT

BRING IN

THE BIG $$$$$$$$$ THAT A NEW GROUP OF PATENTABLE PHARMACEUTICAL DRUGS

COULD.

 

WHAT REALLY AMAZES ME ABOUT THIS LA TIMES ARTICLE IS THE STATEMENT THAT

DOCTORS INTEND TO CONTINUE TO USE THESE DRUGS EVEN THOUGH THEY ARE OF

NO BENEFIT

AND ACTUALLY HARMFUL. WHY? BECAUSE THEY CLAIM " THERE ARE NO

ALTERNATIVES " !!!!!!!!! !!!! THAT DOES SEEM TO BE THE MEDICAL MOTTO

ANYMORE " IF YOU CAN'T GIVE

THEM SOMETHING THAT WORKS, GIVE THEM SOMETHING THAT SOUNDS GOOD AND IS

KNOWN

NOT TO WORK AND WILL MAKE THE SYMPTOMS WORSE!! " I LOOK FOR THE DAY WHEN

PHYSICIANS WILL ACTUALLY BEGIN TO READ RESEARCH AND LEARN SOMETHING

ABOUT THE

DRUGS THEY HAND OUT LIKE CANDY TO PATIENTS!

 

SKIP BELOW TO SEE MY COMMENTS [iN ALL CAPS] AND HIGHLIGHTS OF EACH OF THE

OTHER TWO ARTICLES FROM THE NY TIMES AND THE WASHINGTON POST AS EACH

HAD MUCH

INSIGHT INTO THESE DRUGS AND THE CONTINUED " GOOF UPS " FROM OUR ALL

POWERFUL

DRUG PUSHING PHARMACEUTICAL COMPANIES.

 

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition for Drug Awareness

www.drugawareness.org (http://www.drugawareness.org/) and author of

Prozac:

Panacea or Pandora? - Our Serotonin Nightmare

and audio Help! I Can't Get Off My Antidepressant!

(Order Number: 800-280-0730)

 

____________ _________ _________ _________ _____

 

LOS ANGELES TIMES:

 

Antipsychotic Drugs of Limited Benefit in Alzheimer's, Study Finds

 

Drugs widely prescribed to control agitation, aggression,

hallucinations or

delusions in Alzheimer's patients provided few, if any, benefits and

carried

severe side effects, according to a large study released Wednesday.

 

The findings challenged conventional wisdom about the medications and

painted a grim picture of the state of Alzheimer's treatment.

 

 

" We need a new generation of drugs for these very serious behaviors, " said

Dr. Thomas R. Insel, director of the National Institute of Mental Health,

which paid for the study. " These existing drugs are not the answer for

most. "

[THAT IS RIGHT, THEY ARE FAR FROM ANY ANSWER FOR ANYTHING. BUT FOR MR.

INSEL TO

SUGGEST THAT THE WORLD NEEDS ANY MORE DRUGS IS SHEER INSANITY!]

 

The drugs carry a " black box " warning †" the Food and Drug

Administration' s

strongest †" about an increased risk of death in Alzheimer's patients.

 

The study set out to assess the effectiveness of antipsychotics Zyprexa by

Eli Lilly & Co., Seroquel by AstraZeneca and Risperdal by Johnson &

Johnson.

 

Dr. Claudia Kawas of UC Irvine, who was not involved in the study,

predicted

doctors would continue to use the drugs because there were no

alternatives.

____________ _________ _________ __

 

SINCE PARKINSON'S SYMPTOMS WERE THE FIRST THING RESEARCHERS NOTICED FROM

PROZAC WHY WOULD WE BE SURPRISED TO FIND IT WITH THESE DRUGS AS WELL?

 

AND NOTE THAT THIS IS THE THIRD, YES THIRD, I DID SAY THIRD STUDY - AT

WHAT

TOTAL COST? - TO SHOW THE SAME RESULTS: THESE DRUGS JUST PLAIN DO NOT

WORK AND

ARE NOT HELPFUL, BUT CAUSE MORE PROBLEMS. HOW MANY TIMES DO WE HAVE TO

LEARN

THAT LESSON BEFORE IT SINKS INTO THEIR HEADS?

____________ _________ _________ __

NEW YORK TIMES:

 

Alzheimer’s Drugs Offer No Help, Study Finds

 

The drugs most commonly used to soothe agitation and aggression in people

with Alzheimer’s disease are no more effective than placebos for

most patients,

and put them at risk of serious side effects, including confusion,

sleepiness

and Parkinson’s disease-like symptoms, researchers are reporting today.

 

The report is the third large study in the last year to conclude that

atypical antipsychotics are not as effective or as safe as initially

portrayed.

Last year, government researchers found that three of four drugs

tested were no

more effective than an older, far less expensive drug in treating

schizophrenia †" the disorder for which the medications were

originally approved.

And last week, English researchers published a study that found that

schizophrenia patients did as well on older medications †" or better

†" than on

newer, atypical drugs.

____________ _________ _________ _

 

NOTE THAT THEY ADMIT HERE THAT EVEN WATER IS POSSIBLY MORE EFFECTIVE THAN

THESE DRUGS AS THEY STATE THAT ONE OF THE POSSIBLE CAUSES OF THE

AGITATION IN

THESE PATIENTS IS DEHYDRATION - ANOTHER COMMON SIDE EFFECT OF ALL OF THESE

TYPES OF MEDICATIONS. THEY GO ON TO LIST OTHER CONCERNS OF

OVERSTIMULATION, WHICH

LEADS TO SEIZURE ACTIVITY, WHICH IN TURN IS KNOWN TO PRODUCE ANGER

OUTBURSTS, AND SLEEP DEPRIVATION THAT CAN CAUSE PSYCHOTIC BREAKS IN

THE FORM OF

DREAMING DURING PERIODS OF WAKEFULNESS,

 

AND NOTE THAT THE DRUGS NOW HAVE BLACK BOX WARNINGS FOR STROKE AND DEATH

ASSOCIATED WITH THEIR USE.

 

ALSO POINTED OUT IS THAT THE SHORT-TERM STUDIES FOR SAFETY AND

EFFECTIVENESS

DONE BY THE DRUG COMPANIES TO GET A NEW DRUG ON THE MARKET TELL US NOTHING

ABOUT LONGER TERM SERIOUS ADVERSE EFFECTS. AND THAT SO MANY DRUGS ARE

BEING

PRESCRIBED OFF LABEL (FOR CONDITIONS THEY HAVE NEVER BEEN APPROVED)

WITH NO

DATA AS TO THEIR SAFETY OR EFFECTIVENESS.

____________ _________ _________ _

WASHINGTON POST:

 

Little Benefit Seen in Antipsychotics Used in Alzheimer's

 

" The question is, why is there agitation? "

 

Such symptoms could be the result of overstimulation, sleep deprivation,

untreated pain, moving to a new environment or dehydration, the

experts said.

 

 

Taken together, the government-sponsore d clinical trials have highlighted

two troublesome issues in the regulation and use of psychiatric

medications in

the United States.

 

The schizophrenia study showed that the short-term trials that

pharmaceutical companies sponsor to gain Food and Drug Administration

approval have

limited value in telling doctors how patients will fare overall, or

whether newer

drugs are worth their higher cost.

 

The Alzheimer's study has revealed a different problem -- the extent to

which physicians are prescribing and using medications in the absence of

empirical data to guide them. None of the antipsychotic drugs is

currently approved

for Alzheimer's disease, and several short-term industry-sponsored

clinical

trials have failed to show a benefit. The FDA has required prominent

" black

box " warnings on the drugs' labels about side effects in elderly people

following cases where the drugs were associated with strokes and death.

 

____________ _________ _________ ________

 

http://www.latimes.com/news/nationworld/nation/la-sci-alzheimers12oct12,1,311

 

 

Antipsychotic Drugs of Limited Benefit in Alzheimer's, Study Finds

By Denise Gellene, Times Staff Writer

October 12, 2006

 

Drugs widely prescribed to control agitation, aggression,

hallucinations or

delusions in Alzheimer's patients provided few, if any, benefits and

carried

severe side effects, according to a large study released Wednesday.

 

The findings challenged conventional wisdom about the medications and

painted a grim picture of the state of Alzheimer's treatment.

 

 

" We need a new generation of drugs for these very serious behaviors, " said

Dr. Thomas R. Insel, director of the National Institute of Mental Health,

which paid for the study. " These existing drugs are not the answer for

most. "

 

Alzheimer's disease is a brain disorder that progressively impairs memory,

thinking and behavior. An estimated 4.5 million Americans have the

disease,

most of them older than 65.

 

In the later stages of the illness, many experience severe personality

changes and psychotic symptoms, posing major challenges to caregivers.

 

No drugs have been approved to treat these symptoms, but studies have

suggested antipsychotic drugs developed for treating schizophrenia may

help.

 

The drugs carry a " black box " warning †" the Food and Drug

Administration' s

strongest †" about an increased risk of death in Alzheimer's patients.

 

The study set out to assess the effectiveness of antipsychotics Zyprexa by

Eli Lilly & Co., Seroquel by AstraZeneca and Risperdal by Johnson &

Johnson.

 

A total of 421 patients with moderate to severe psychotic symptoms,

agitation or aggression were randomly assigned to receive either a

placebo or one of

the antipsychotics for up to 36 weeks. All patients lived at home or at an

assisted-living facility.

 

The trial measured effectiveness by how long patients took a drug before

quitting because they couldn't tolerate side effects or saw no

improvement. On

average, patients stopped taking their pills after about eight weeks,

about

the same duration as those taking a placebo.

 

Depending on the drug, 37% to 50% of patients discontinued their pills

because they weren't working, and up to 24% stopped taking them

because of side

effects such as drowsiness, weight gain and confusion. All told, 82% of

patients quit their drugs.

 

The findings, published in the New England Journal of Medicine, were

unexpected, said lead author Lon Schneider of USC.

 

Despite the results, Schneider said the drugs had a role in treating

some of

the worst Alzheimer's symptoms. The study hinted that some patients might

benefit from the pills, he said.

 

" The message from this study cannot be that the drugs are not useful, " he

said. But doctors should change or discontinue medications if patients

have

side effects or don't improve in a matter of weeks, he said.

 

Dr. Claudia Kawas of UC Irvine, who was not involved in the study,

predicted

doctors would continue to use the drugs because there were no

alternatives.

 

" The behavioral problems of Alzheimer's disease are huge, " Kawas said. " To

my mind, this study says these are powerful drugs and if given in high

enough

doses to do any good there are going to be side effects. "

 

An earlier trial, also federally funded, found the medications provided

little benefit for schizophrenia patients and were no better than an

older, less

expensive drug, clozapine. That drug is not used to treat Alzheimer's.

 

In the latest study, patients who discontinued their medication went

on to a

second phase of the $16.9-million study in which they received one of the

drugs they hadn't tried or the antidepressant Celexa. The results of

that trial

are being analyzed.

 

____________ _________ _________ ______

 

denise.gellene (denise.gellene)

____________ _________ _________ ______

 

http://www.nytimes.com/2006/10/12/health/12dementia.html?hp & ex=1160712000 & en=9a9\

3772b6e8b2e6c & ei=5059 & partner=AOL

 

 

Alzheimer’s Drugs Offer No Help, Study Finds

 

By _BENEDICT CAREY_

http://topics.nytimes.com/top/reference/timestopics/people/c/benedict_carey/inde\

x.html?inline=nyt-per

 

Published: October 12, 2006

 

The drugs most commonly used to soothe agitation and aggression in people

with Alzheimer’s disease are no more effective than placebos for

most patients,

and put them at risk of serious side effects, including confusion,

sleepiness

and Parkinson’s disease-like symptoms, researchers are reporting today.

The report, based on a large government comparison of the drugs’

effectiveness, challenges current practice so sharply that it could

quickly alter

prescribing habits, some experts said. About 4.5 million Americans

suffer from the

progressive dementia of Alzheimer’s disease, and most patients with the

advanced disease exhibit agitation or delusions at some point.

The drugs tested in the study †" Zyprexa from Eli Lilly; Seroquel from

AstraZeneca; and Risperdal from Janssen Pharmaceutical †" belong to a

class of

medications known as atypical antipsychotics. The drugs are used to treat

_schizophrenia_

(http://topics. nytimes.com/ top/news/ health/diseasesc

onditionsandheal thtopics/ schizophrenia/ index.html? inline=nyt-

classifier) and other psychoses,

and are commonly prescribed for elderly patients in long-term care

facilities.

About a third of the estimated 2.5 million Medicare beneficiaries in

nursing

homes in the United States have taken the medications, researchers

found. And

the use of atypical antipsychotics in the elderly accounts for an

estimated

$2 billion in the annual sales of the drugs, much of the cost paid by

Medicare and Medicaid.

Spokesmen for Lilly, AstraZeneca and Johnson & Johnson, which owns

Janssen,

noted that the drugs were not approved by the _Food and Drug

Administration_

(http://topics. nytimes.com/ top/reference/ timestopics/

organizations/ f/food_and_ dr

ug_administration/ index.html? inline=nyt- org) for use in Alzheimer’s

patients, and that the companies did not market them for that purpose.

The results of the study, published today in The _New England Journal of

Medicine_

(http://topics.nytimes.com/top/reference/timestopics/organizations/

n/new_england_journal_of_medicine/index.html?inline=nyt-org) , simply reflected

the

need for more research into the treatment of behavioral problems in

Alzheimer

’s patients, the spokesmen said.

Prescribing information for the drugs warns that patients with

Alzheimer’

s-related psychosis “are at increased risk of death compared to

placebo.â€

But the medications are commonly prescribed for Alzheimer’s patients

“off

label†by doctors because families are desperate, because these

drugs sometimes

seem to help, and because company-sponsored doctors promoted them.

“The question is whether these drugs have a place in the treatment of

Alzheimer’s patients at all,†said Dr. Jason Karlawish, an

associate professor of

medicine at the _University of Pennsylvania

who wrote an editorial accompanying the study. “I think the

answer is yes, but only for a subgroup of patients who can tolerate

them, and in

facilities that have the expertise to manage the side effects.â€

In the study, researchers followed 421 Alzheimer’s patients with

disabling

agitation, delusions or hallucinations who were randomly assigned to

receive

either dummy pills or one of the three antipsychotic drugs. Doctors

adjusted

the doses as needed, tracked how long they stayed on the drugs, and

noted their

improvement, if any.

Experts say that the amount of time a patient spends on a medication is an

important measure of its usefulness, because patients often stop

taking a drug

if it is not doing any good or if the side effects are intolerable.

After 12 weeks, “there were no significant differences between the

groups

with regard to improvement†on a scale that measured symptom relief,

said Dr.

Lon S. Schneider, professor of psychiatry, neurology and gerontology

at the

_University of Southern California_

(http://topics. nytimes.com/ top/reference/ timestopics/ organ

izations/u/universi ty_of_southern_ california/ index.html?

inline=nyt- org) School of Medicine, and the lead author of the study.

The researchers also found no significant difference in the amount of time

the patients stayed on the drugs or the placebos; about 80 percent stopped

taking the drugs and the placebos alike before the end of the study.

But those

on the drugs were far more likely to quit because of side effects.

The side effects included sedation in 15 percent to 24 percent of the

patients, and confusion in 6 percent to 18 percent; both symptoms can

increase the

risk of falls. And 12 percent of the patients on either Zyprexa or

Risperdal

experienced Parkinson’s-like symptoms, including tremors.

“What the study does indicate is that this is a very sensitive

population and

that any treatment needs to be done with a lot of forethought and constant

reevaluation†said Dr. Bruce J. Kinon, a Lilly psychiatrist.

Dr. Thomas R. Insel, director of the National Institute of Mental Health,

which financed the research, said, “What this study shows is that

these drugs

are clearly not the answer; they may be helpful for a minority of

patients but

we need to come up with better medications.â€

Dr. Gary Kennedy, director of geriatric psychiatry at _Montefiore Medical

Center_

(http://topics. nytimes.com/ top/reference/ timestopics/

organizations/ m/montefiore_ medical_center/ index.html? inline=nyt-

org) in the Bronx, said that the

results gave psychiatrists the first clear picture of what many had

observed

in their practices: that improvement on the drugs is usually modest at

best,

and that behavior and environment are often more important in managing

combative behaviors.

“Oftentimes the family is unwittingly provoking the agitation,â€

Dr. Kennedy

said.

A demented, confused person, he noted, can become suddenly aggressive over

seemingly trivial things, like a change in daily routine or feeling

crowded or

rushed. “Working on these kinds of behavioral factors should always

be the

first line of treatment,†Dr. Kennedy said.

The report is the third large study in the last year to conclude that

atypical antipsychotics are not as effective or as safe as initially

portrayed.

Last year, government researchers found that three of four drugs

tested were no

more effective than an older, far less expensive drug in treating

schizophrenia †" the disorder for which the medications were

originally approved.

And last week, English researchers published a study that found that

schizophrenia patients did as well on older medications †" or better

†" than on

newer, atypical drugs.

 

____________ _________ _________ ______

 

http://www.washingtonpost.com/wp-dyn/content/article/2006/10/11/AR2006101101595_\

pf.html

 

 

Little Benefit Seen in Antipsychotics Used in Alzheimer's

 

By Shankar Vedantam

Washington Post Staff Writer

Thursday, October 12, 2006; A09

 

Antipsychotic drugs that are widely used to calm agitated patients with

Alzheimer's disease help very few of them, and those modest benefits

are canceled

out by the frequent side effects, a comprehensive government-funded study

has found.

 

The surprising finding is expected to trigger a broad reevaluation of the

widespread use of the drugs in patients with Alzheimer's and other

forms of

dementia. As many as a quarter of the Alzheimer's patients in nursing

homes are

prescribed the powerful drugs, even though they have never been formally

approved for this purpose.

 

" I wish I could say the odds are better, " said Thomas R. Insel,

director of

the National Institute of Mental Health, which funded the $17 million

study.

" This paper says most people are not going to be any different on

these drugs

than they would on placebo. "

 

The researchers did not conclude that the drugs should never be used,

and a

minority of patients do benefit. But the study suggests that doctors

would be

well advised to prescribe the drugs sparingly and as a last resort,

experts

said.

 

The study is the latest to produce sobering data on the newer, expensive

antipsychotics such as Zyprexa, Risperdal and Seroquel, which are

among the most

widely prescribed drugs in the United States at an annual cost of

about $10

billion. Another government-funded study recently showed that the

drugs were

no better than an older and much cheaper drug called perphenazine in the

treatment of schizophrenia.

 

Taken together, the government-sponsore d clinical trials have highlighted

two troublesome issues in the regulation and use of psychiatric

medications in

the United States.

 

The schizophrenia study showed that the short-term trials that

pharmaceutical companies sponsor to gain Food and Drug Administration

approval have

limited value in telling doctors how patients will fare overall, or

whether newer

drugs are worth their higher cost.

 

The Alzheimer's study has revealed a different problem -- the extent to

which physicians are prescribing and using medications in the absence of

empirical data to guide them. None of the antipsychotic drugs is

currently approved

for Alzheimer's disease, and several short-term industry-sponsored

clinical

trials have failed to show a benefit. The FDA has required prominent

" black

box " warnings on the drugs' labels about side effects in elderly people

following cases where the drugs were associated with strokes and death.

 

" Clearly the drugs cannot be cost-effective, because there is nothing to

choose between drugs and placebo, " said Lon Schneider, the lead author

of the

new study published today in the New England Journal of Medicine.

" Most patients

are not benefiting. "

 

Insel, Schneider and Jason H.T. Karlawish, an Alzheimer's expert at the

University of Pennsylvania who wrote a commentary about the new study,

said it

also underscores the desperate need to develop better treatments for

Alzheimer's

patients who are agitated or psychotic.

 

About 5 million Americans suffer from dementias, including

Alzheimer's, and

large numbers of them experience periods of agitation and psychotic

symptoms

that are extremely debilitating for them, their caregivers and medical

facilities.

 

" You can't respond to agitation by saying 'Here is some olanzapine,' "

said

Karlawish, referring to the drug sold under the brand name Zyprexa. " The

question is, why is there agitation? "

 

Such symptoms could be the result of overstimulation, sleep deprivation,

untreated pain, moving to a new environment or dehydration, the

experts said.

 

Like young children, patients with dementia can also be set off by a

conversation that normal adults brush off or find routine. Karlawish

suggested that

this could be because dementias affect the frontal lobe of the brain,

which

plays an important role in judgment and self-control.

 

" Any good parent knows there are effective and ineffective ways to respond

to their 4-year-old, " Karlawish said. Similarly, he said, " there are

effective

and non-effective ways to respond to someone with frontal-lobe damage. "

 

Clinicians and caregivers would do well to deal with such potential

triggers

of agitation before considering antipsychotic medication, Schneider

agreed.

The drugs might be useful in patients who continue to have agitation and

breaks with reality despite such efforts, but Schneider cautioned that

the drugs

ought to be prescribed for limited periods and stopped if side effects

emerge.

Those effects include uncontrolled muscle movements, excessive sedation,

worsened mental functioning and confusion.

 

The manufacturers of the three drugs used in the study all said they

do not

recommend their products for Alzheimer's patients. Eli Lilly and Co. makes

Zyprexa, AstraZeneca makes Seroquel, and Janssen Pharmaceutica makes

Risperdal.

 

The new study found that Risperdal and Zyprexa seemed to help Alzheimer's

patients more than Seroquel, but those two medications also had more

serious

side effects.