: Philadelphia Inquirer article on meds : Tarnished View of Wonder Drugs, 2/17/08

[Guest guest]

***********************

Posted on Sun, Feb. 17, 2008

Tarnished View of Wonder Drugs

By Karl Stark

http://www.philly.com/philly/business/20080217_Tarnished_View_of_Wonder_Drugs.ht\

ml

Inquirer Staff Writer

When they were first introduced in the early 1990s, new antipsychotic

medications for severe mental illness were seen as wonder drugs that were safer

and more effective than their predecessors.

Sales soared as doctors tried them on new conditions, including dementia,

aggression and other behavioral problems. Children and the elderly were among

the biggest users.

But now, several studies questioning some of the drugs' benefits have led many

doctors to talk of using them for shorter periods and with tighter monitoring,

because of side effects that include sedation, obesity and diabetes.

" You can't just pop someone on it and see them in a year, " said Karlawish,

a geriatric psychiatrist at the University of Pennsylvania.

These drugs, known as atypical antipsychotics, offer a contentious case study of

a common pattern in pharmaceuticals. New drugs are typically approved for narrow

uses and get tried off-label on conditions that are difficult to treat.

Companies' sales efforts stoke up overall use until the research catches up

years later, dulling the early enthusiasm. While some patients are helped,

lawsuits are also a common legacy.

The atypicals were originally approved for severe mental illness - schizophrenia

and bipolar disorder - which had limited markets.

But under a determined marketing effort portraying them as safer and more

effective than their predecessors, the atypicals came to be tried beyond their

approved uses for nursing-home residents, prisoners, and children younger than 6

years old.

Total U.S. sales for the class reached $13 billion in 2007, doubling sales of

2002, according to IMS Health Inc., a pharmaceutical-information firm. Atypicals

carry such names as Risperdal, made by Janssen Pharmaceutica, part of &

; Zyprexa from Eli Lilly & Co.; Seroquel by AstraZeneca P.L.C.; Geodon by

Pfizer Inc.; and Abilify by Bristol-Myers Squibb Co.

All over the country, state officials are discovering that atypicals have become

the largest drug class in Medicaid, the health program for the poor. And many

state officials question whether that reflects overzealous marketing or real

need. Several states, including Pennsylvania, are suing some drugmakers for

allegedly promoting the drugs beyond approved uses and commissioning

" ghost-written " articles to stoke use of the drugs.

The drugmakers reject the suits' claims and are obtaining new approvals from the

Food and Drug Administration to treat more conditions. In the last two years,

Janssen's Risperdal got approval to treat schizophrenia in adolescents and the

irritability of autism in ages 5 to 16.

Atypicals remain a cornerstone of care for serious mental illness.

Ellen Sholevar, director of child and adolescent psychiatry at the Temple

University School of Medicine, said atypicals could help children even though

they had not been well-studied. Antipsychotics are used when young children

appear to be out of control and represent a danger to themselves or others, or

have " very severe disorders where there is no other viable treatment option, "

she said.

Naas Siddiqui, 25, of West Philadelphia, said that antipsychotics eased her

manic symptoms and helped her graduate from Yale University in 2007.

While Zyprexa made her lethargic and gain weight, she said, Abilify calmed her.

She gets her blood tested every six months and sees a physician more frequently.

" I don't want to stay on it permanently. But I think it's helped me

significantly, " she said.

A different view of the drugs came from Nicola Huff of Pleasantville, N.J.,

whose son, , took Risperdal for seven years to resolve his behavioral

problems.

But at age 14, he developed a well-known drug side effect: female-size breasts

that had to be surgically removed.

" He would ask me 'Am I a girl?' And I would tell him 'no,' " Nicola Huff said.

Tammy Wandling, whose son Austin has autism, said a psychiatrist put him on

Risperdal at age 4. In less than nine months, Austin developed a baseball-size

growth in his right breast.

" I couldn't believe how big it was, " said his mother, who lives near ton,

W.Va.

Research suggests Risperdal, like the older antipsychotics, can cause an

increase in the hormone prolactin, which directs breasts to enlarge and make

milk. Risperdal's label warns about the possibility.

The experience helped drive both women to hire Steve Sheller and J.

Pepper, both Philadelphia lawyers.

" They're being given an easy out with a pill. But the easy out may create a much

more serious problem, " Sheller said.

A spokeswoman for Risperdal's maker, Janssen, rejected the claims and said the

side effect was rare.

Experts say the condition can be avoided by close monitoring or by switching to

another antipsychotic.

The drugmakers still face vast legal threats.

Zyprexa-maker Lilly has set aside $1.2 billion to settle 31,000 claims, mostly

about whether the firm failed to warn patients of diabetes in package inserts

before 2003.

Lilly still faces 1,200 cases as well as a federal probe over its marketing of

Zyprexa.

Much litigation has focused on how doctors have prescribed antipsychotics beyond

their approved use. Doctors may prescribe off-label, and have done so for

dementia, attention deficit, aggression, autism and post-traumatic stress

disorder.

But firms are not allowed to promote off-label uses.

Bristol-Myers Squibb, maker of Abilify, agreed last year to pay $515 million in

part to settle allegations that it improperly promoted the antipsychotic for

off-label uses.

The firms also face thousands of additional claims. AstraZeneca, for example,

said it had 8,000 suits pending for Seroquel.

It was not always that way. The first antipsychotics, including Thorazine,

helped free many people from state hospitals. But that generation came with

severe side effects, including the involuntary and debilitating movements called

tardive dyskinesia.

The second generation, dubbed atypicals, began appearing in the 1990s.

They are thought to cause fewer involuntary movements and other severe effects.

But they are more likely to cause weight gain and diabetes, said Tom ,

director of clinical affairs for the American Society of Consultant Pharmacists

Foundation.

" There's more awareness of the risks of these drugs, " added. " There's a

tendency to more caution. "

Amy Brodkey, a Philadelphia psychiatrist, agreed, saying she and her colleagues

use antipsychotics, with more monitoring. " Everybody is thinking about it a lot

more, " she said.

Some of the dramatic sales growth has come in nursing homes, where the drugs are

used to combat the delusions and aggressiveness that often accompany dementia.

Such behavior is one of the thorniest problems in geriatrics and often becomes

the tipping point that sends patients into nursing homes.

More than 26 percent of the nation's nursing-home residents were on

antipsychotics in early 2007. That compares with 19.4 percent in 1999, federal

surveys show.

U.S. Sen. Grassley (R., Iowa) has asked the government to review how

antipsychotic drugs are being used off-label in nursing homes, and whether

residents are being sedated unnecessarily.

Those drugs do little to help dementia patients, said Lon S. Schneider, a

California psychiatrist and lead investigator of the CATIE-AD study of

outpatients with Alzheimer's. He and his colleagues found that patients on

antipsychotics for 12 weeks had a slightly greater risk of dying sooner than

those on placebo.

While actual deaths were rare, physicians should monitor the drugs more closely

and stop them when they do not seem to help, he said.

Antipsychotic use also has exploded in young people. Doctor visits with

antipsychotic prescriptions became six times more common from 1993 to 2002 in

people 20 and younger, according to a study led by Columbia University

psychiatrist Mark Olfson.

" I've seen the growth of these agents for several years, " added Mark Helm, a

pediatrician in Arkansas, where the state attorney general is also suing a maker

of an antipsychotic drug.

In Pennsylvania, Medicaid in 2006 paid for atypicals for at least 824 children

under the age of 6, said Terri Cathers, director of pharmacy for Medicaid. Both

Pennsylvania and New Jersey have hired a firm, Comprehensive NeuroScience Inc.,

to identify unusual prescriptions and send doctors letters about the use.

" We want to make sure all other avenues are exhausted before they resort to

putting children on these drugs, " Cathers said.

To pose questions about this subject to psychiatrist Ellen Sholevar, visit

http://go.philly.com/ellensholevar

Contact staff writer Karl Stark at 215-854-5363 or kstark@....

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[Guest guest]

Maybe I missed something- did someone ask for list members opinions

and research on meds, specifically antipsychotics?

Just wondering.

Diane S

-- In IPADDUnite , sunshinebeaches3@... wrote:

>

>

>

>

>

>

> ***********************

> Posted on Sun, Feb. 17, 2008

> Tarnished View of Wonder Drugs

> By Karl Stark

>

http://www.philly.com/philly/business/20080217_Tarnished_View_of_Wonde

r_Drugs.html

>

> Inquirer Staff Writer

> When they were first introduced in the early 1990s, new

antipsychotic

> medications for severe mental illness were seen as wonder drugs

that were safer

> and more effective than their predecessors.

>

> Sales soared as doctors tried them on new conditions, including

dementia,

> aggression and other behavioral problems. Children and the elderly

were among

> the biggest users.

>

> But now, several studies questioning some of the drugs' benefits

have led many

> doctors to talk of using them for shorter periods and with tighter

monitoring,

> because of side effects that include sedation, obesity and diabetes.

>

> " You can't just pop someone on it and see them in a year, " said

Karlawish,

> a geriatric psychiatrist at the University of Pennsylvania.

>

> These drugs, known as atypical antipsychotics, offer a contentious

case study of

> a common pattern in pharmaceuticals. New drugs are typically

approved for narrow

> uses and get tried off-label on conditions that are difficult to

treat.

> Companies' sales efforts stoke up overall use until the research

catches up

> years later, dulling the early enthusiasm. While some patients are

helped,

> lawsuits are also a common legacy.

>

> The atypicals were originally approved for severe mental illness -

schizophrenia

> and bipolar disorder - which had limited markets.

>

> But under a determined marketing effort portraying them as safer

and more

> effective than their predecessors, the atypicals came to be tried

beyond their

> approved uses for nursing-home residents, prisoners, and children

younger than 6

> years old.

>

> Total U.S. sales for the class reached $13 billion in 2007,

doubling sales of

> 2002, according to IMS Health Inc., a pharmaceutical-information

firm. Atypicals

> carry such names as Risperdal, made by Janssen Pharmaceutica, part

of &

> ; Zyprexa from Eli Lilly & Co.; Seroquel by AstraZeneca

P.L.C.; Geodon by

> Pfizer Inc.; and Abilify by Bristol-Myers Squibb Co.

>

> All over the country, state officials are discovering that

atypicals have become

> the largest drug class in Medicaid, the health program for the

poor. And many

> state officials question whether that reflects overzealous

marketing or real

> need. Several states, including Pennsylvania, are suing some

drugmakers for

> allegedly promoting the drugs beyond approved uses and

commissioning

> " ghost-written " articles to stoke use of the drugs.

>

> The drugmakers reject the suits' claims and are obtaining new

approvals from the

> Food and Drug Administration to treat more conditions. In the last

two years,

> Janssen's Risperdal got approval to treat schizophrenia in

adolescents and the

> irritability of autism in ages 5 to 16.

>

> Atypicals remain a cornerstone of care for serious mental illness.

>

> Ellen Sholevar, director of child and adolescent psychiatry at the

Temple

> University School of Medicine, said atypicals could help children

even though

> they had not been well-studied. Antipsychotics are used when young

children

> appear to be out of control and represent a danger to themselves or

others, or

> have " very severe disorders where there is no other viable

treatment option, "

> she said.

>

> Naas Siddiqui, 25, of West Philadelphia, said that antipsychotics

eased her

> manic symptoms and helped her graduate from Yale University in 2007.

>

> While Zyprexa made her lethargic and gain weight, she said, Abilify

calmed her.

> She gets her blood tested every six months and sees a physician

more frequently.

>

> " I don't want to stay on it permanently. But I think it's helped me

> significantly, " she said.

>

> A different view of the drugs came from Nicola Huff of

Pleasantville, N.J.,

> whose son, , took Risperdal for seven years to resolve

his behavioral

> problems.

>

> But at age 14, he developed a well-known drug side effect: female-

size breasts

> that had to be surgically removed.

>

> " He would ask me 'Am I a girl?' And I would tell him 'no,' " Nicola

Huff said.

>

> Tammy Wandling, whose son Austin has autism, said a psychiatrist

put him on

> Risperdal at age 4. In less than nine months, Austin developed a

baseball-size

> growth in his right breast.

>

> " I couldn't believe how big it was, " said his mother, who lives

near ton,

> W.Va.

>

> Research suggests Risperdal, like the older antipsychotics, can

cause an

> increase in the hormone prolactin, which directs breasts to enlarge

and make

> milk. Risperdal's label warns about the possibility.

>

> The experience helped drive both women to hire Steve Sheller and

J.

> Pepper, both Philadelphia lawyers.

>

> " They're being given an easy out with a pill. But the easy out may

create a much

> more serious problem, " Sheller said.

>

> A spokeswoman for Risperdal's maker, Janssen, rejected the claims

and said the

> side effect was rare.

>

> Experts say the condition can be avoided by close monitoring or by

switching to

> another antipsychotic.

>

> The drugmakers still face vast legal threats.

>

> Zyprexa-maker Lilly has set aside $1.2 billion to settle 31,000

claims, mostly

> about whether the firm failed to warn patients of diabetes in

package inserts

> before 2003.

>

> Lilly still faces 1,200 cases as well as a federal probe over its

marketing of

> Zyprexa.

>

> Much litigation has focused on how doctors have prescribed

antipsychotics beyond

> their approved use. Doctors may prescribe off-label, and have done

so for

> dementia, attention deficit, aggression, autism and post-traumatic

stress

> disorder.

>

> But firms are not allowed to promote off-label uses.

>

> Bristol-Myers Squibb, maker of Abilify, agreed last year to pay

$515 million in

> part to settle allegations that it improperly promoted the

antipsychotic for

> off-label uses.

>

> The firms also face thousands of additional claims. AstraZeneca,

for example,

> said it had 8,000 suits pending for Seroquel.

>

> It was not always that way. The first antipsychotics, including

Thorazine,

> helped free many people from state hospitals. But that generation

came with

> severe side effects, including the involuntary and debilitating

movements called

> tardive dyskinesia.

>

> The second generation, dubbed atypicals, began appearing in the

1990s.

>

> They are thought to cause fewer involuntary movements and other

severe effects.

> But they are more likely to cause weight gain and diabetes, said

Tom ,

> director of clinical affairs for the American Society of Consultant

Pharmacists

> Foundation.

>

> " There's more awareness of the risks of these drugs, "

added. " There's a

> tendency to more caution. "

>

> Amy Brodkey, a Philadelphia psychiatrist, agreed, saying she and

her colleagues

> use antipsychotics, with more monitoring. " Everybody is thinking

about it a lot

> more, " she said.

>

> Some of the dramatic sales growth has come in nursing homes, where

the drugs are

> used to combat the delusions and aggressiveness that often

accompany dementia.

>

> Such behavior is one of the thorniest problems in geriatrics and

often becomes

> the tipping point that sends patients into nursing homes.

>

> More than 26 percent of the nation's nursing-home residents were on

> antipsychotics in early 2007. That compares with 19.4 percent in

1999, federal

> surveys show.

>

> U.S. Sen. Grassley (R., Iowa) has asked the government to

review how

> antipsychotic drugs are being used off-label in nursing homes, and

whether

> residents are being sedated unnecessarily.

>

> Those drugs do little to help dementia patients, said Lon S.

Schneider, a

> California psychiatrist and lead investigator of the CATIE-AD study

of

> outpatients with Alzheimer's. He and his colleagues found that

patients on

> antipsychotics for 12 weeks had a slightly greater risk of dying

sooner than

> those on placebo.

>

> While actual deaths were rare, physicians should monitor the drugs

more closely

> and stop them when they do not seem to help, he said.

>

> Antipsychotic use also has exploded in young people. Doctor visits

with

> antipsychotic prescriptions became six times more common from 1993

to 2002 in

> people 20 and younger, according to a study led by Columbia

University

> psychiatrist Mark Olfson.

>

> " I've seen the growth of these agents for several years, " added

Mark Helm, a

> pediatrician in Arkansas, where the state attorney general is also

suing a maker

> of an antipsychotic drug.

>

> In Pennsylvania, Medicaid in 2006 paid for atypicals for at least

824 children

> under the age of 6, said Terri Cathers, director of pharmacy for

Medicaid. Both

> Pennsylvania and New Jersey have hired a firm, Comprehensive

NeuroScience Inc.,

> to identify unusual prescriptions and send doctors letters about

the use.

>

> " We want to make sure all other avenues are exhausted before they

resort to

> putting children on these drugs, " Cathers said.

>

>

>

>

>

> To pose questions about this subject to psychiatrist Ellen

Sholevar, visit

> http://go.philly.com/ellensholevar

>

>

>

> Contact staff writer Karl Stark at 215-854-5363 or kstark@...

>

> Recent Activity

> 9New Members

> Visit Your Group

> Health

> Healthy Aging

> Improve your

> quality of life.

> Meditation and

> Lovingkindness

> A Group

> to share and learn.

> Ads on

> Learn more now.

> Reach customers

> searching for you..

>

>

>

[Guest guest]

I read the article and it has me a little concerned because

started Risperdal 6 months ago. has a lot of self-injury

behaviors (mainly hitting himself & head banging). We are hoping the

medication will help him get through this and eventually he can stop

taking it. I had a hard time putting him on the medication due to the

side effects (mainly the TDK). I had talked to three different

doctors regarding the medication and one finally told me that it was a

quality of life issue. I agreed and this is why I finally decided to

put him on it. However, we still don't like the medication due to the

side effects. I didn't know that Risperdal affected hormones.

I'm curious if a lot of our children are or have been on anti-

psychotics. Has anybody's child ever developed a side effect from it?

Thanks,

Proud Mom to DOB 7/4/03

Undiagnosed Syndrome: Microcephaly, GERD, bilateral clubfeet,

bilateral undescended testes (corrected), right kidney small due to

cysts on upper 20% that turned into scar tissue (low functioning

kidney), left kidney is enlarged due to Grade 3 reflux, low muscle

tone, non-verbal, global developmental delays, etc, etc. Visit 's

website at http://www.caringbridge.org/visit/jacobludwig

" ...There's no lesser than. There's just different from. It isn't just

great minds that matter. It's great spirits too. " Dr. Bruce Blumberg

(from The Boy In The Moon).

>

>

>

>

>

>

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