Media Conflicts of Interest - New York Times (Antidepressant Controversy)

[Guest guest]

Antidepressant Controversy:

Media Conflicts of Interest - New York Times

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and

full

disclosure http://www.ahrp.org

FYI

FDA's advisory warning about antidepressant drugs received wide press

coverage nationally. But few in the national media mentioned

conflicts of

interest as the obstacle to disclosure of evidence showing these

drugs'

adverse effects. Among the few exceptions: The Washington Post

(below) and

The Herald (So. Carolina)

http://www.heraldonline.com/local/story/3443345p-3060286c.html

The New York Times front page article provided an overview of the

controversy and noted the economic stakes-namely, that

antidepressants

generate $12 billion in sales. See: Gardiner , Regulators Want

Antidepressants to List Warning, NYT, March 23, 2004, A-1

http://www.nytimes.com/2004/03/23/health/23DEPR.html?hp

Contrary to FDA's continued efforts to protect drug manufacturers by

reassurances that no evidence has demonstrated a link between

suicide and

antidepressants, children and adolescents did commit suicide after

being

prescribed one of these drugs. In controlled clinical trials,

children

taking an antidepressant were at two-to-three-fold risk of suicidal

acts. An

analysis of that evidence led British drug regulators to ban the

drugs for

children under 18. The FDA has yet to issue clear and unambiguous

warnings

indicating that evidence shows a connection between the effects of

antidepressant drugs and hazardous behavioral changes, including

sudden

violent uncontrolled outbursts that psychiatrists call " toxic

behavior. "

The evidence comes from both clinical trials--mostly concealed until

uncovered during court procedures--and the evidence comes from the

real

world of clinical care. The concealed trial evidence corroborates the

testimonies of families who testified before FDA's advisory

committee on

February 2. FDA's ambiguous warning suggests the possibility of

suicidal

thinking at start of treatment, but is couched with disclaimers

indicating

lack of evidence. This equivocation raises doubts about the validity

of the

warning.

In fact, FDA officials have known for over a decade that

antidepressants

were linked to mania, agitation, extreme physical and psychological

restlessness (called akathisia), and violent and suicidal behavior

(euphemistically called " emotional lability " ) in children and adults

who

tested the drugs, compared to those given a placebo. In truth, the

public

was deliberately misled to believe the drugs were " safe and

effective. "

Indeed, expert psychiatrists from prestigious academic

institutions--including the National Institute of Mental

Health--consistently assured the public through media infomercials

and

uncritical news reports, that antidepressants were " safe and

effective, "

encouraging screening for undiagnosed depression so that treatment

could

begin early in children and adults.

A clear eyed column by Gene Metrick, senior writer and copy desk

chief for

the Rocky Mount Telegram (below) is an indication that Americans in

the

hinterland are watching the spectacle and see through the

smokescreens.

By contrast, a follow-up article in the New York Times appears to be

doing

damage control. This article transmits false assertions of

stakeholders in

the drug industry. Those who have for years deluded the public, with

unsubstantiated claims that antidepressant drugs were " safe and

effective. "

The Times follow-up states:

" Studies in children taking the antidepressants have not found an

increase

in suicide. But studies of some drugs have suggested that they might

increase the risk of suicidal thought and behaviors...There is no

solid data

linking use of the drugs to suicide in adults. "

Readers are led to think that " some drugs " but not antidepressants

increase

the risk of suicide.

See: Overprescribing Prompted Warning on Antidepressants By

Grady and

Gardiner , NYT, March 24, 2004 P. A-13

http://www.nytimes.com/2004/03/24/health/24DEPR.html?

pagewanted=print & positi

on=

Such misleading statements bring into focus a major issue that

compromises

most medical news reports in the major American press/media. An

issue that

is never discussed or acknowledged is the media's own conflict of

interests.

The pharmaceutical industry spent $3.2 billion in direct consumer

advertising in 2003--an increase of 22.5% since 2002. Industry's

lavish

purchase of advertising space bought influence and good will. That

influence

has penetrated the editorial boards and science news departments of

prestigious newspapers, including the New York Times, the major TV

networks,

as well as local news outlets, and supermarket pulp publications.

Industry's overpowering influence is reflected in what, and how,

medical

drug related issues are reported and distorted. The American media

has

become the purveyor of (mostly) upbeat reports about medical

breakthroughs--that almost never actually materialize. The media also

engages in promotions of screening for " disease of the month "

campaigns that

are in fact, marketing campaigns.

News reports, such as the follow-up report about the FDA advisory is

an

accommodation to its advertisers and to the stakeholders in the

psychotropic

drug industry. Not only does the Times reveal advertising bias, but

it fails

to vet their sources of information for conflicts of interest.

The Times quotes Dr. Harold Koplewicz, indicating only that he is the

director of the NYU Child Study Center: " The fear I have about this

warning

is that many teenagers will not get the medicine because it will

build

resistance among their parents, and that is really a tragic outcome. "

Dr. Koplewicz, not only is one of the staunchest promoters of

psychotropic

drugs for children, he was a co-investigator and co-author of a

major Paxil

study (329) in which he and the pillars of American child psychiatry

claimed

to have found that Paxil was " well tolerated and effective " for

adolescents.

The article has now been discredited by the FDA. Furthermore, an

internal

1998 memo by the manufacturer of Paxil indicates that only the

positive data

from study 329 would be published, but the negative findings would

not.

Readers trust the New York Times, believing that the experts

selected by the

Times for their views, are objective unless identified as having a

financial

interest in the product/ company or have taken a position. The Times

failed

to disclose any of the relevant background information that

demonstrates a

decidedly biased point of view. The Times article also failed to

disclose

the very substantial financial ties to the drug industry of either

Dr.

Koplewicz or the NYU Child Study Center.

If the NY Times with its vast resources and expertise is so easily

misled by

industry-sponsored market expansion campaigns which are led by

doctors who

serve the industry as paid consultants, whose claimed scientific

findings

have been shaped by industry's directives, what can we expect from

family

advocacy groups who also receive substantial financial support from

the same

industry?

Failure to disclose financial and professional conflicts of interest

undermines the integrity of Times science / medicine news reports.

One

wonders whether the NY Times should revise its motto, from " All the

News

that's Fit to Print " to All the News that Increases Pharmaceutical

Advertising?

See: Keller MB, ND, Strober M, Klein RG, Kutcher SP, Birmaher

B, Hagino

OR, Koplewicz H, Carlson GA, e GN, Emslie GJ, Feinberg D,

Geller B,

Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller

EB,

Winters NC, Oakes R, McCafferty JP.

Efficacy of paroxetine in the treatment of adolescent major

depression: A

randomized, controlled trial. Journal of the American Academy of

Child &

Adolescent Psychiatry, 2001, 40:762-772.

See: U.S. Food and Drug Administration (FDA) CDER. Memorandum from

P.

Laughren, MD, to Members of PDAC and Peds AC January 5, 2004. Online

at:

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006b1.htm

See: GSK 1998 memo online at:

http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@a...

~~~~~~~~~~~~

http://www.washingtonpost.com/ac2/wp-dyn/A16214-2004Mar22?

language=printer

THE WASHINGTON POST

New Warning Urged On Antidepressants

Alert Would Address Suicidal Tendencies

By Shankar Vedantam

Washington Post Staff Writer

Tuesday, March 23, 2004; Page A03

The Food and Drug Administration urged drugmakers yesterday to put

new

warning labels on popular antidepressant medications, including

Paxil,

Zoloft and Luvox, alerting doctors and consumers to watch for

suicidal

tendencies, hostility and agitation in patients taking the drugs.

The agency's action focuses on 10 antidepressant drugs in all and

follows a

warning by the British government last year advising physicians not

to

prescribe most widely used antidepressants to children. Last month,

families

of American adolescents who killed themselves while taking the

medications

implored the FDA to take comparable steps, and an expert advisory

committee

urged greater vigilance in the use of the medications in children

with

depression.

The agency said it does not know whether the medications -- which

include

several drugs known as selective serotonin reuptake inhibitors, or

SSRIs --

are responsible for reported side effects such as inner restlessness,

agitation and suicidal thoughts in some people. Officials said they

are

drawing greater attention to known cautionary information while a

team of

outside researchers completes a comprehensive analysis of the

possible

risks.

Patients taking the drugs who experience behavioral side effects

should

contact their physicians, said Katz, director of

neuropharmacological drug products at the FDA. If the symptoms are

new or

severe, he added, doctors should consider lowering the dose or

stopping the

drug.

Yesterday's move by the agency calls for warning-label changes for

adults as

well as children, and for patients who are depressed as well as

those who

use the drugs for unrelated problems.

" The advice applies across the board whether the drugs are used for

any

indication -- psychiatric or not, " Katz said.

Critics of the medications called yesterday's move a victory and

demanded

that the FDA go further. Although Prozac is the only one of this

class of

drugs that has been specifically approved to treat depression in

children,

doctors are writing tens of thousands of prescriptions for many of

the

others, based on their clinical judgment that the drugs are safe and

effective.

" Doctors are going to be on the line not to prescribe them as if

they were

pacifiers, " said Vera Hassner Sharav, president of the Alliance for

Human

Research Protection, a patient advocacy group based in New York.

Many critics complain that a majority of studies of the drugs in

children

found that the medications did no better than dummy pills in treating

depression, but that these studies have been hidden from doctors and

the

public. The companies say the studies are proprietary.

Sharav and other critics charge that the FDA and the American

psychiatric

establishment, which has broadly supported the efficacy of the

drugs, have

been unduly influenced by the pharmaceutical industry. Dozens of

lawsuits

against the medications have been filed around the country.

Many psychiatrists say the medications save lives and warn that

discouraging

patients from taking them could lead to greater numbers of suicides.

They

insist that suicidal tendencies or attempts among patients taking

the drugs

are the result of underlying disorders, not the medications.

Rates of suicide among adolescents have generally declined as

antidepressant

use has surged in recent years, said P. Laughren, FDA team

leader for

psychiatric drug products. While no one knows whether the two trends

are

linked, he said at a news conference yesterday, such data framed the

context

in which the FDA acted.

The drugs affected by yesterday's announcement are Prozac, Zoloft,

Paxil,

Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.

C 2004 The Washington Post Company

http://www.rockymounttelegram.com/news/newsfd/auto/feed/news/2004/03/

24/1080

176226.26609.0348.7142.html

Metrick: Is treatment worse than depression?

By Gene Metrick, Rocky Mount Telegram

It seems the pharmaceutical industry may have to add another side

effect to

the long list of warnings that accompanies the stable of

antidepressant

drugs it has been hawking for the past dozen years or so.

The ads touting these drugs as the latest wonder cures for

depression or

anxiety appear repeatedly each day on television. The commercials

always end

with a standard disclaimer advising of the possible side effects of

their

use: nausea, dry mouth, sleeplessness, decreased libido,

constipation,

diarrhea, loss of appetite, etc.

Now the companies might just be warning that the use of an

antidepressant

may also increase the risk of suicide.

The U.S. Food and Drug Administration on Monday asked drug makers to

include

detailed warnings alerting doctors and consumers to watch for

suicidal

tendencies, agitation and hostility in patients using the drugs.

The new warnings cover Prozac, Paxil, Zoloft, Effexor, Celexa,

Lexapro and

Luvox - known as seratonin reuptake inhibitors (SSRIs) - as well as

Wellbutrin, Serzone and Remeron, which are a different class of

drugs.

The FDA's move comes on the heels of an emotionally charged public

hearing

in February in which dozens of distraught family members testified

that they

blamed the drugs for the suicides or suicide attempts of their loved

ones.

Unfortunately, it's uncertain what effect the FDA ruling will have

on drug

makers, who have not said whether they will comply with the agency's

request. Vera Hassner Sharav, president of the New York-based patient

advocacy group, the Alliance for Human Research, told me that she

sees the

ruling as " equivocating and ambiguous. "

" It gives a warning but says, 'We don't have the evidence.' Now, if

you

don't have the evidence that the drugs are to blame, what's the

point of

putting the warnings on them? " she said. " The FDA has had this data

in their

files for years - either they didn't warn the public in order to

shield the

industry, or they're incompetent. "

Dozens of lawsuits have been filed against drug makers by families of

patients who committed or attempted suicide while taking

antidepressants.

For its part, the FDA says it is reviewing 25 clinical trials of the

drugs

on children and will release its findings this summer.

The British government last year banned the use of all such drugs

except

Prozac for the treatment of depression in children. But the problem

is not

confined to adolescent patients.

Independent studies have suggested a link between antidepressants and

suicide since 1990, when Harvard researcher Dr. Teicher

reported that

an internal Eli Lily study of adults showed " a greater incidence of

suicide

attempts in people in the study receiving Prozac than in people

receiving

placebo ... "

The big drug companies have labeled those kinds of studies

as " proprietary "

and have refused to release the findings of such reports. But

they've been

very forthcoming in releasing research results that show no links

between

antidepressants and an increased risk of suicide.

Remember, these antidepressant medications have become a giant cash

cow for

the pharmaceutical industry, with as many as 30 million Americans

estimated

to be taking one or another of them. Heck, you can even visit any

number of

online pharmacies for a free medical consultation with a doctor and

have

your prescription shipped to you right away.

Of course, as one of the service representatives for

prescriptiondrugs.com

told me Wednesday over the telephone, you do have to answer the

doctor's

questions " truthfully. "

Depression is a very serious and debilitating disease. And

antidepressants

can play a vital role in helping people overcome it. But the rush to

overprescribe these drugs for a vast array of ailments is quite

disturbing,

especially when the full range of risks that accompany them seem to

still

remain pretty much uncertain.

It's part of a syndrome that can be thought of as the " Drugging of

America, "

a growing trend reminiscent of the " Brave New World " described by

Aldous

Huxley in his novel of the same name. The residents of Huxley's

future world

were freed from the anxieties, cares and conscience of their present-

day

counterparts through the use of the drug " Soma, " which brought the

phrase,

" Don't worry, be happy " to a whole new level. Better living through

chemistry, indeed.

Gene Metrick is a senior writer and copy desk chief for the Rocky

Mount

Telegram.

[Guest guest]

Antidepressant Controversy:

Media Conflicts of Interest - New York Times

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and

full

disclosure http://www.ahrp.org

FYI

FDA's advisory warning about antidepressant drugs received wide press

coverage nationally. But few in the national media mentioned

conflicts of

interest as the obstacle to disclosure of evidence showing these

drugs'

adverse effects. Among the few exceptions: The Washington Post

(below) and

The Herald (So. Carolina)

http://www.heraldonline.com/local/story/3443345p-3060286c.html

The New York Times front page article provided an overview of the

controversy and noted the economic stakes-namely, that

antidepressants

generate $12 billion in sales. See: Gardiner , Regulators Want

Antidepressants to List Warning, NYT, March 23, 2004, A-1

http://www.nytimes.com/2004/03/23/health/23DEPR.html?hp

Contrary to FDA's continued efforts to protect drug manufacturers by

reassurances that no evidence has demonstrated a link between

suicide and

antidepressants, children and adolescents did commit suicide after

being

prescribed one of these drugs. In controlled clinical trials,

children

taking an antidepressant were at two-to-three-fold risk of suicidal

acts. An

analysis of that evidence led British drug regulators to ban the

drugs for

children under 18. The FDA has yet to issue clear and unambiguous

warnings

indicating that evidence shows a connection between the effects of

antidepressant drugs and hazardous behavioral changes, including

sudden

violent uncontrolled outbursts that psychiatrists call " toxic

behavior. "

The evidence comes from both clinical trials--mostly concealed until

uncovered during court procedures--and the evidence comes from the

real

world of clinical care. The concealed trial evidence corroborates the

testimonies of families who testified before FDA's advisory

committee on

February 2. FDA's ambiguous warning suggests the possibility of

suicidal

thinking at start of treatment, but is couched with disclaimers

indicating

lack of evidence. This equivocation raises doubts about the validity

of the

warning.

In fact, FDA officials have known for over a decade that

antidepressants

were linked to mania, agitation, extreme physical and psychological

restlessness (called akathisia), and violent and suicidal behavior

(euphemistically called " emotional lability " ) in children and adults

who

tested the drugs, compared to those given a placebo. In truth, the

public

was deliberately misled to believe the drugs were " safe and

effective. "

Indeed, expert psychiatrists from prestigious academic

institutions--including the National Institute of Mental

Health--consistently assured the public through media infomercials

and

uncritical news reports, that antidepressants were " safe and

effective, "

encouraging screening for undiagnosed depression so that treatment

could

begin early in children and adults.

A clear eyed column by Gene Metrick, senior writer and copy desk

chief for

the Rocky Mount Telegram (below) is an indication that Americans in

the

hinterland are watching the spectacle and see through the

smokescreens.

By contrast, a follow-up article in the New York Times appears to be

doing

damage control. This article transmits false assertions of

stakeholders in

the drug industry. Those who have for years deluded the public, with

unsubstantiated claims that antidepressant drugs were " safe and

effective. "

The Times follow-up states:

" Studies in children taking the antidepressants have not found an

increase

in suicide. But studies of some drugs have suggested that they might

increase the risk of suicidal thought and behaviors...There is no

solid data

linking use of the drugs to suicide in adults. "

Readers are led to think that " some drugs " but not antidepressants

increase

the risk of suicide.

See: Overprescribing Prompted Warning on Antidepressants By

Grady and

Gardiner , NYT, March 24, 2004 P. A-13

http://www.nytimes.com/2004/03/24/health/24DEPR.html?

pagewanted=print & positi

on=

Such misleading statements bring into focus a major issue that

compromises

most medical news reports in the major American press/media. An

issue that

is never discussed or acknowledged is the media's own conflict of

interests.

The pharmaceutical industry spent $3.2 billion in direct consumer

advertising in 2003--an increase of 22.5% since 2002. Industry's

lavish

purchase of advertising space bought influence and good will. That

influence

has penetrated the editorial boards and science news departments of

prestigious newspapers, including the New York Times, the major TV

networks,

as well as local news outlets, and supermarket pulp publications.

Industry's overpowering influence is reflected in what, and how,

medical

drug related issues are reported and distorted. The American media

has

become the purveyor of (mostly) upbeat reports about medical

breakthroughs--that almost never actually materialize. The media also

engages in promotions of screening for " disease of the month "

campaigns that

are in fact, marketing campaigns.

News reports, such as the follow-up report about the FDA advisory is

an

accommodation to its advertisers and to the stakeholders in the

psychotropic

drug industry. Not only does the Times reveal advertising bias, but

it fails

to vet their sources of information for conflicts of interest.

The Times quotes Dr. Harold Koplewicz, indicating only that he is the

director of the NYU Child Study Center: " The fear I have about this

warning

is that many teenagers will not get the medicine because it will

build

resistance among their parents, and that is really a tragic outcome. "

Dr. Koplewicz, not only is one of the staunchest promoters of

psychotropic

drugs for children, he was a co-investigator and co-author of a

major Paxil

study (329) in which he and the pillars of American child psychiatry

claimed

to have found that Paxil was " well tolerated and effective " for

adolescents.

The article has now been discredited by the FDA. Furthermore, an

internal

1998 memo by the manufacturer of Paxil indicates that only the

positive data

from study 329 would be published, but the negative findings would

not.

Readers trust the New York Times, believing that the experts

selected by the

Times for their views, are objective unless identified as having a

financial

interest in the product/ company or have taken a position. The Times

failed

to disclose any of the relevant background information that

demonstrates a

decidedly biased point of view. The Times article also failed to

disclose

the very substantial financial ties to the drug industry of either

Dr.

Koplewicz or the NYU Child Study Center.

If the NY Times with its vast resources and expertise is so easily

misled by

industry-sponsored market expansion campaigns which are led by

doctors who

serve the industry as paid consultants, whose claimed scientific

findings

have been shaped by industry's directives, what can we expect from

family

advocacy groups who also receive substantial financial support from

the same

industry?

Failure to disclose financial and professional conflicts of interest

undermines the integrity of Times science / medicine news reports.

One

wonders whether the NY Times should revise its motto, from " All the

News

that's Fit to Print " to All the News that Increases Pharmaceutical

Advertising?

See: Keller MB, ND, Strober M, Klein RG, Kutcher SP, Birmaher

B, Hagino

OR, Koplewicz H, Carlson GA, e GN, Emslie GJ, Feinberg D,

Geller B,

Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller

EB,

Winters NC, Oakes R, McCafferty JP.

Efficacy of paroxetine in the treatment of adolescent major

depression: A

randomized, controlled trial. Journal of the American Academy of

Child &

Adolescent Psychiatry, 2001, 40:762-772.

See: U.S. Food and Drug Administration (FDA) CDER. Memorandum from

P.

Laughren, MD, to Members of PDAC and Peds AC January 5, 2004. Online

at:

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006b1.htm

See: GSK 1998 memo online at:

http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@a...

~~~~~~~~~~~~

http://www.washingtonpost.com/ac2/wp-dyn/A16214-2004Mar22?

language=printer

THE WASHINGTON POST

New Warning Urged On Antidepressants

Alert Would Address Suicidal Tendencies

By Shankar Vedantam

Washington Post Staff Writer

Tuesday, March 23, 2004; Page A03

The Food and Drug Administration urged drugmakers yesterday to put

new

warning labels on popular antidepressant medications, including

Paxil,

Zoloft and Luvox, alerting doctors and consumers to watch for

suicidal

tendencies, hostility and agitation in patients taking the drugs.

The agency's action focuses on 10 antidepressant drugs in all and

follows a

warning by the British government last year advising physicians not

to

prescribe most widely used antidepressants to children. Last month,

families

of American adolescents who killed themselves while taking the

medications

implored the FDA to take comparable steps, and an expert advisory

committee

urged greater vigilance in the use of the medications in children

with

depression.

The agency said it does not know whether the medications -- which

include

several drugs known as selective serotonin reuptake inhibitors, or

SSRIs --

are responsible for reported side effects such as inner restlessness,

agitation and suicidal thoughts in some people. Officials said they

are

drawing greater attention to known cautionary information while a

team of

outside researchers completes a comprehensive analysis of the

possible

risks.

Patients taking the drugs who experience behavioral side effects

should

contact their physicians, said Katz, director of

neuropharmacological drug products at the FDA. If the symptoms are

new or

severe, he added, doctors should consider lowering the dose or

stopping the

drug.

Yesterday's move by the agency calls for warning-label changes for

adults as

well as children, and for patients who are depressed as well as

those who

use the drugs for unrelated problems.

" The advice applies across the board whether the drugs are used for

any

indication -- psychiatric or not, " Katz said.

Critics of the medications called yesterday's move a victory and

demanded

that the FDA go further. Although Prozac is the only one of this

class of

drugs that has been specifically approved to treat depression in

children,

doctors are writing tens of thousands of prescriptions for many of

the

others, based on their clinical judgment that the drugs are safe and

effective.

" Doctors are going to be on the line not to prescribe them as if

they were

pacifiers, " said Vera Hassner Sharav, president of the Alliance for

Human

Research Protection, a patient advocacy group based in New York.

Many critics complain that a majority of studies of the drugs in

children

found that the medications did no better than dummy pills in treating

depression, but that these studies have been hidden from doctors and

the

public. The companies say the studies are proprietary.

Sharav and other critics charge that the FDA and the American

psychiatric

establishment, which has broadly supported the efficacy of the

drugs, have

been unduly influenced by the pharmaceutical industry. Dozens of

lawsuits

against the medications have been filed around the country.

Many psychiatrists say the medications save lives and warn that

discouraging

patients from taking them could lead to greater numbers of suicides.

They

insist that suicidal tendencies or attempts among patients taking

the drugs

are the result of underlying disorders, not the medications.

Rates of suicide among adolescents have generally declined as

antidepressant

use has surged in recent years, said P. Laughren, FDA team

leader for

psychiatric drug products. While no one knows whether the two trends

are

linked, he said at a news conference yesterday, such data framed the

context

in which the FDA acted.

The drugs affected by yesterday's announcement are Prozac, Zoloft,

Paxil,

Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.

C 2004 The Washington Post Company

http://www.rockymounttelegram.com/news/newsfd/auto/feed/news/2004/03/

24/1080

176226.26609.0348.7142.html

Metrick: Is treatment worse than depression?

By Gene Metrick, Rocky Mount Telegram

It seems the pharmaceutical industry may have to add another side

effect to

the long list of warnings that accompanies the stable of

antidepressant

drugs it has been hawking for the past dozen years or so.

The ads touting these drugs as the latest wonder cures for

depression or

anxiety appear repeatedly each day on television. The commercials

always end

with a standard disclaimer advising of the possible side effects of

their

use: nausea, dry mouth, sleeplessness, decreased libido,

constipation,

diarrhea, loss of appetite, etc.

Now the companies might just be warning that the use of an

antidepressant

may also increase the risk of suicide.

The U.S. Food and Drug Administration on Monday asked drug makers to

include

detailed warnings alerting doctors and consumers to watch for

suicidal

tendencies, agitation and hostility in patients using the drugs.

The new warnings cover Prozac, Paxil, Zoloft, Effexor, Celexa,

Lexapro and

Luvox - known as seratonin reuptake inhibitors (SSRIs) - as well as

Wellbutrin, Serzone and Remeron, which are a different class of

drugs.

The FDA's move comes on the heels of an emotionally charged public

hearing

in February in which dozens of distraught family members testified

that they

blamed the drugs for the suicides or suicide attempts of their loved

ones.

Unfortunately, it's uncertain what effect the FDA ruling will have

on drug

makers, who have not said whether they will comply with the agency's

request. Vera Hassner Sharav, president of the New York-based patient

advocacy group, the Alliance for Human Research, told me that she

sees the

ruling as " equivocating and ambiguous. "

" It gives a warning but says, 'We don't have the evidence.' Now, if

you

don't have the evidence that the drugs are to blame, what's the

point of

putting the warnings on them? " she said. " The FDA has had this data

in their

files for years - either they didn't warn the public in order to

shield the

industry, or they're incompetent. "

Dozens of lawsuits have been filed against drug makers by families of

patients who committed or attempted suicide while taking

antidepressants.

For its part, the FDA says it is reviewing 25 clinical trials of the

drugs

on children and will release its findings this summer.

The British government last year banned the use of all such drugs

except

Prozac for the treatment of depression in children. But the problem

is not

confined to adolescent patients.

Independent studies have suggested a link between antidepressants and

suicide since 1990, when Harvard researcher Dr. Teicher

reported that

an internal Eli Lily study of adults showed " a greater incidence of

suicide

attempts in people in the study receiving Prozac than in people

receiving

placebo ... "

The big drug companies have labeled those kinds of studies

as " proprietary "

and have refused to release the findings of such reports. But

they've been

very forthcoming in releasing research results that show no links

between

antidepressants and an increased risk of suicide.

Remember, these antidepressant medications have become a giant cash

cow for

the pharmaceutical industry, with as many as 30 million Americans

estimated

to be taking one or another of them. Heck, you can even visit any

number of

online pharmacies for a free medical consultation with a doctor and

have

your prescription shipped to you right away.

Of course, as one of the service representatives for

prescriptiondrugs.com

told me Wednesday over the telephone, you do have to answer the

doctor's

questions " truthfully. "

Depression is a very serious and debilitating disease. And

antidepressants

can play a vital role in helping people overcome it. But the rush to

overprescribe these drugs for a vast array of ailments is quite

disturbing,

especially when the full range of risks that accompany them seem to

still

remain pretty much uncertain.

It's part of a syndrome that can be thought of as the " Drugging of

America, "

a growing trend reminiscent of the " Brave New World " described by

Aldous

Huxley in his novel of the same name. The residents of Huxley's

future world

were freed from the anxieties, cares and conscience of their present-

day

counterparts through the use of the drug " Soma, " which brought the

phrase,

" Don't worry, be happy " to a whole new level. Better living through

chemistry, indeed.

Gene Metrick is a senior writer and copy desk chief for the Rocky

Mount

Telegram.

[Guest guest]

Antidepressant Controversy:

Media Conflicts of Interest - New York Times

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and

full

disclosure http://www.ahrp.org

FYI

FDA's advisory warning about antidepressant drugs received wide press

coverage nationally. But few in the national media mentioned

conflicts of

interest as the obstacle to disclosure of evidence showing these

drugs'

adverse effects. Among the few exceptions: The Washington Post

(below) and

The Herald (So. Carolina)

http://www.heraldonline.com/local/story/3443345p-3060286c.html

The New York Times front page article provided an overview of the

controversy and noted the economic stakes-namely, that

antidepressants

generate $12 billion in sales. See: Gardiner , Regulators Want

Antidepressants to List Warning, NYT, March 23, 2004, A-1

http://www.nytimes.com/2004/03/23/health/23DEPR.html?hp

Contrary to FDA's continued efforts to protect drug manufacturers by

reassurances that no evidence has demonstrated a link between

suicide and

antidepressants, children and adolescents did commit suicide after

being

prescribed one of these drugs. In controlled clinical trials,

children

taking an antidepressant were at two-to-three-fold risk of suicidal

acts. An

analysis of that evidence led British drug regulators to ban the

drugs for

children under 18. The FDA has yet to issue clear and unambiguous

warnings

indicating that evidence shows a connection between the effects of

antidepressant drugs and hazardous behavioral changes, including

sudden

violent uncontrolled outbursts that psychiatrists call " toxic

behavior. "

The evidence comes from both clinical trials--mostly concealed until

uncovered during court procedures--and the evidence comes from the

real

world of clinical care. The concealed trial evidence corroborates the

testimonies of families who testified before FDA's advisory

committee on

February 2. FDA's ambiguous warning suggests the possibility of

suicidal

thinking at start of treatment, but is couched with disclaimers

indicating

lack of evidence. This equivocation raises doubts about the validity

of the

warning.

In fact, FDA officials have known for over a decade that

antidepressants

were linked to mania, agitation, extreme physical and psychological

restlessness (called akathisia), and violent and suicidal behavior

(euphemistically called " emotional lability " ) in children and adults

who

tested the drugs, compared to those given a placebo. In truth, the

public

was deliberately misled to believe the drugs were " safe and

effective. "

Indeed, expert psychiatrists from prestigious academic

institutions--including the National Institute of Mental

Health--consistently assured the public through media infomercials

and

uncritical news reports, that antidepressants were " safe and

effective, "

encouraging screening for undiagnosed depression so that treatment

could

begin early in children and adults.

A clear eyed column by Gene Metrick, senior writer and copy desk

chief for

the Rocky Mount Telegram (below) is an indication that Americans in

the

hinterland are watching the spectacle and see through the

smokescreens.

By contrast, a follow-up article in the New York Times appears to be

doing

damage control. This article transmits false assertions of

stakeholders in

the drug industry. Those who have for years deluded the public, with

unsubstantiated claims that antidepressant drugs were " safe and

effective. "

The Times follow-up states:

" Studies in children taking the antidepressants have not found an

increase

in suicide. But studies of some drugs have suggested that they might

increase the risk of suicidal thought and behaviors...There is no

solid data

linking use of the drugs to suicide in adults. "

Readers are led to think that " some drugs " but not antidepressants

increase

the risk of suicide.

See: Overprescribing Prompted Warning on Antidepressants By

Grady and

Gardiner , NYT, March 24, 2004 P. A-13

http://www.nytimes.com/2004/03/24/health/24DEPR.html?

pagewanted=print & positi

on=

Such misleading statements bring into focus a major issue that

compromises

most medical news reports in the major American press/media. An

issue that

is never discussed or acknowledged is the media's own conflict of

interests.

The pharmaceutical industry spent $3.2 billion in direct consumer

advertising in 2003--an increase of 22.5% since 2002. Industry's

lavish

purchase of advertising space bought influence and good will. That

influence

has penetrated the editorial boards and science news departments of

prestigious newspapers, including the New York Times, the major TV

networks,

as well as local news outlets, and supermarket pulp publications.

Industry's overpowering influence is reflected in what, and how,

medical

drug related issues are reported and distorted. The American media

has

become the purveyor of (mostly) upbeat reports about medical

breakthroughs--that almost never actually materialize. The media also

engages in promotions of screening for " disease of the month "

campaigns that

are in fact, marketing campaigns.

News reports, such as the follow-up report about the FDA advisory is

an

accommodation to its advertisers and to the stakeholders in the

psychotropic

drug industry. Not only does the Times reveal advertising bias, but

it fails

to vet their sources of information for conflicts of interest.

The Times quotes Dr. Harold Koplewicz, indicating only that he is the

director of the NYU Child Study Center: " The fear I have about this

warning

is that many teenagers will not get the medicine because it will

build

resistance among their parents, and that is really a tragic outcome. "

Dr. Koplewicz, not only is one of the staunchest promoters of

psychotropic

drugs for children, he was a co-investigator and co-author of a

major Paxil

study (329) in which he and the pillars of American child psychiatry

claimed

to have found that Paxil was " well tolerated and effective " for

adolescents.

The article has now been discredited by the FDA. Furthermore, an

internal

1998 memo by the manufacturer of Paxil indicates that only the

positive data

from study 329 would be published, but the negative findings would

not.

Readers trust the New York Times, believing that the experts

selected by the

Times for their views, are objective unless identified as having a

financial

interest in the product/ company or have taken a position. The Times

failed

to disclose any of the relevant background information that

demonstrates a

decidedly biased point of view. The Times article also failed to

disclose

the very substantial financial ties to the drug industry of either

Dr.

Koplewicz or the NYU Child Study Center.

If the NY Times with its vast resources and expertise is so easily

misled by

industry-sponsored market expansion campaigns which are led by

doctors who

serve the industry as paid consultants, whose claimed scientific

findings

have been shaped by industry's directives, what can we expect from

family

advocacy groups who also receive substantial financial support from

the same

industry?

Failure to disclose financial and professional conflicts of interest

undermines the integrity of Times science / medicine news reports.

One

wonders whether the NY Times should revise its motto, from " All the

News

that's Fit to Print " to All the News that Increases Pharmaceutical

Advertising?

See: Keller MB, ND, Strober M, Klein RG, Kutcher SP, Birmaher

B, Hagino

OR, Koplewicz H, Carlson GA, e GN, Emslie GJ, Feinberg D,

Geller B,

Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller

EB,

Winters NC, Oakes R, McCafferty JP.

Efficacy of paroxetine in the treatment of adolescent major

depression: A

randomized, controlled trial. Journal of the American Academy of

Child &

Adolescent Psychiatry, 2001, 40:762-772.

See: U.S. Food and Drug Administration (FDA) CDER. Memorandum from

P.

Laughren, MD, to Members of PDAC and Peds AC January 5, 2004. Online

at:

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006b1.htm

See: GSK 1998 memo online at:

http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@a...

~~~~~~~~~~~~

http://www.washingtonpost.com/ac2/wp-dyn/A16214-2004Mar22?

language=printer

THE WASHINGTON POST

New Warning Urged On Antidepressants

Alert Would Address Suicidal Tendencies

By Shankar Vedantam

Washington Post Staff Writer

Tuesday, March 23, 2004; Page A03

The Food and Drug Administration urged drugmakers yesterday to put

new

warning labels on popular antidepressant medications, including

Paxil,

Zoloft and Luvox, alerting doctors and consumers to watch for

suicidal

tendencies, hostility and agitation in patients taking the drugs.

The agency's action focuses on 10 antidepressant drugs in all and

follows a

warning by the British government last year advising physicians not

to

prescribe most widely used antidepressants to children. Last month,

families

of American adolescents who killed themselves while taking the

medications

implored the FDA to take comparable steps, and an expert advisory

committee

urged greater vigilance in the use of the medications in children

with

depression.

The agency said it does not know whether the medications -- which

include

several drugs known as selective serotonin reuptake inhibitors, or

SSRIs --

are responsible for reported side effects such as inner restlessness,

agitation and suicidal thoughts in some people. Officials said they

are

drawing greater attention to known cautionary information while a

team of

outside researchers completes a comprehensive analysis of the

possible

risks.

Patients taking the drugs who experience behavioral side effects

should

contact their physicians, said Katz, director of

neuropharmacological drug products at the FDA. If the symptoms are

new or

severe, he added, doctors should consider lowering the dose or

stopping the

drug.

Yesterday's move by the agency calls for warning-label changes for

adults as

well as children, and for patients who are depressed as well as

those who

use the drugs for unrelated problems.

" The advice applies across the board whether the drugs are used for

any

indication -- psychiatric or not, " Katz said.

Critics of the medications called yesterday's move a victory and

demanded

that the FDA go further. Although Prozac is the only one of this

class of

drugs that has been specifically approved to treat depression in

children,

doctors are writing tens of thousands of prescriptions for many of

the

others, based on their clinical judgment that the drugs are safe and

effective.

" Doctors are going to be on the line not to prescribe them as if

they were

pacifiers, " said Vera Hassner Sharav, president of the Alliance for

Human

Research Protection, a patient advocacy group based in New York.

Many critics complain that a majority of studies of the drugs in

children

found that the medications did no better than dummy pills in treating

depression, but that these studies have been hidden from doctors and

the

public. The companies say the studies are proprietary.

Sharav and other critics charge that the FDA and the American

psychiatric

establishment, which has broadly supported the efficacy of the

drugs, have

been unduly influenced by the pharmaceutical industry. Dozens of

lawsuits

against the medications have been filed around the country.

Many psychiatrists say the medications save lives and warn that

discouraging

patients from taking them could lead to greater numbers of suicides.

They

insist that suicidal tendencies or attempts among patients taking

the drugs

are the result of underlying disorders, not the medications.

Rates of suicide among adolescents have generally declined as

antidepressant

use has surged in recent years, said P. Laughren, FDA team

leader for

psychiatric drug products. While no one knows whether the two trends

are

linked, he said at a news conference yesterday, such data framed the

context

in which the FDA acted.

The drugs affected by yesterday's announcement are Prozac, Zoloft,

Paxil,

Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.

C 2004 The Washington Post Company

http://www.rockymounttelegram.com/news/newsfd/auto/feed/news/2004/03/

24/1080

176226.26609.0348.7142.html

Metrick: Is treatment worse than depression?

By Gene Metrick, Rocky Mount Telegram

It seems the pharmaceutical industry may have to add another side

effect to

the long list of warnings that accompanies the stable of

antidepressant

drugs it has been hawking for the past dozen years or so.

The ads touting these drugs as the latest wonder cures for

depression or

anxiety appear repeatedly each day on television. The commercials

always end

with a standard disclaimer advising of the possible side effects of

their

use: nausea, dry mouth, sleeplessness, decreased libido,

constipation,

diarrhea, loss of appetite, etc.

Now the companies might just be warning that the use of an

antidepressant

may also increase the risk of suicide.

The U.S. Food and Drug Administration on Monday asked drug makers to

include

detailed warnings alerting doctors and consumers to watch for

suicidal

tendencies, agitation and hostility in patients using the drugs.

The new warnings cover Prozac, Paxil, Zoloft, Effexor, Celexa,

Lexapro and

Luvox - known as seratonin reuptake inhibitors (SSRIs) - as well as

Wellbutrin, Serzone and Remeron, which are a different class of

drugs.

The FDA's move comes on the heels of an emotionally charged public

hearing

in February in which dozens of distraught family members testified

that they

blamed the drugs for the suicides or suicide attempts of their loved

ones.

Unfortunately, it's uncertain what effect the FDA ruling will have

on drug

makers, who have not said whether they will comply with the agency's

request. Vera Hassner Sharav, president of the New York-based patient

advocacy group, the Alliance for Human Research, told me that she

sees the

ruling as " equivocating and ambiguous. "

" It gives a warning but says, 'We don't have the evidence.' Now, if

you

don't have the evidence that the drugs are to blame, what's the

point of

putting the warnings on them? " she said. " The FDA has had this data

in their

files for years - either they didn't warn the public in order to

shield the

industry, or they're incompetent. "

Dozens of lawsuits have been filed against drug makers by families of

patients who committed or attempted suicide while taking

antidepressants.

For its part, the FDA says it is reviewing 25 clinical trials of the

drugs

on children and will release its findings this summer.

The British government last year banned the use of all such drugs

except

Prozac for the treatment of depression in children. But the problem

is not

confined to adolescent patients.

Independent studies have suggested a link between antidepressants and

suicide since 1990, when Harvard researcher Dr. Teicher

reported that

an internal Eli Lily study of adults showed " a greater incidence of

suicide

attempts in people in the study receiving Prozac than in people

receiving

placebo ... "

The big drug companies have labeled those kinds of studies

as " proprietary "

and have refused to release the findings of such reports. But

they've been

very forthcoming in releasing research results that show no links

between

antidepressants and an increased risk of suicide.

Remember, these antidepressant medications have become a giant cash

cow for

the pharmaceutical industry, with as many as 30 million Americans

estimated

to be taking one or another of them. Heck, you can even visit any

number of

online pharmacies for a free medical consultation with a doctor and

have

your prescription shipped to you right away.

Of course, as one of the service representatives for

prescriptiondrugs.com

told me Wednesday over the telephone, you do have to answer the

doctor's

questions " truthfully. "

Depression is a very serious and debilitating disease. And

antidepressants

can play a vital role in helping people overcome it. But the rush to

overprescribe these drugs for a vast array of ailments is quite

disturbing,

especially when the full range of risks that accompany them seem to

still

remain pretty much uncertain.

It's part of a syndrome that can be thought of as the " Drugging of

America, "

a growing trend reminiscent of the " Brave New World " described by

Aldous

Huxley in his novel of the same name. The residents of Huxley's

future world

were freed from the anxieties, cares and conscience of their present-

day

counterparts through the use of the drug " Soma, " which brought the

phrase,

" Don't worry, be happy " to a whole new level. Better living through

chemistry, indeed.

Gene Metrick is a senior writer and copy desk chief for the Rocky

Mount

Telegram.

[Guest guest]

Antidepressant Controversy:

Media Conflicts of Interest - New York Times

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and

full

disclosure http://www.ahrp.org

FYI

FDA's advisory warning about antidepressant drugs received wide press

coverage nationally. But few in the national media mentioned

conflicts of

interest as the obstacle to disclosure of evidence showing these

drugs'

adverse effects. Among the few exceptions: The Washington Post

(below) and

The Herald (So. Carolina)

http://www.heraldonline.com/local/story/3443345p-3060286c.html

The New York Times front page article provided an overview of the

controversy and noted the economic stakes-namely, that

antidepressants

generate $12 billion in sales. See: Gardiner , Regulators Want

Antidepressants to List Warning, NYT, March 23, 2004, A-1

http://www.nytimes.com/2004/03/23/health/23DEPR.html?hp

Contrary to FDA's continued efforts to protect drug manufacturers by

reassurances that no evidence has demonstrated a link between

suicide and

antidepressants, children and adolescents did commit suicide after

being

prescribed one of these drugs. In controlled clinical trials,

children

taking an antidepressant were at two-to-three-fold risk of suicidal

acts. An

analysis of that evidence led British drug regulators to ban the

drugs for

children under 18. The FDA has yet to issue clear and unambiguous

warnings

indicating that evidence shows a connection between the effects of

antidepressant drugs and hazardous behavioral changes, including

sudden

violent uncontrolled outbursts that psychiatrists call " toxic

behavior. "

The evidence comes from both clinical trials--mostly concealed until

uncovered during court procedures--and the evidence comes from the

real

world of clinical care. The concealed trial evidence corroborates the

testimonies of families who testified before FDA's advisory

committee on

February 2. FDA's ambiguous warning suggests the possibility of

suicidal

thinking at start of treatment, but is couched with disclaimers

indicating

lack of evidence. This equivocation raises doubts about the validity

of the

warning.

In fact, FDA officials have known for over a decade that

antidepressants

were linked to mania, agitation, extreme physical and psychological

restlessness (called akathisia), and violent and suicidal behavior

(euphemistically called " emotional lability " ) in children and adults

who

tested the drugs, compared to those given a placebo. In truth, the

public

was deliberately misled to believe the drugs were " safe and

effective. "

Indeed, expert psychiatrists from prestigious academic

institutions--including the National Institute of Mental

Health--consistently assured the public through media infomercials

and

uncritical news reports, that antidepressants were " safe and

effective, "

encouraging screening for undiagnosed depression so that treatment

could

begin early in children and adults.

A clear eyed column by Gene Metrick, senior writer and copy desk

chief for

the Rocky Mount Telegram (below) is an indication that Americans in

the

hinterland are watching the spectacle and see through the

smokescreens.

By contrast, a follow-up article in the New York Times appears to be

doing

damage control. This article transmits false assertions of

stakeholders in

the drug industry. Those who have for years deluded the public, with

unsubstantiated claims that antidepressant drugs were " safe and

effective. "

The Times follow-up states:

" Studies in children taking the antidepressants have not found an

increase

in suicide. But studies of some drugs have suggested that they might

increase the risk of suicidal thought and behaviors...There is no

solid data

linking use of the drugs to suicide in adults. "

Readers are led to think that " some drugs " but not antidepressants

increase

the risk of suicide.

See: Overprescribing Prompted Warning on Antidepressants By

Grady and

Gardiner , NYT, March 24, 2004 P. A-13

http://www.nytimes.com/2004/03/24/health/24DEPR.html?

pagewanted=print & positi

on=

Such misleading statements bring into focus a major issue that

compromises

most medical news reports in the major American press/media. An

issue that

is never discussed or acknowledged is the media's own conflict of

interests.

The pharmaceutical industry spent $3.2 billion in direct consumer

advertising in 2003--an increase of 22.5% since 2002. Industry's

lavish

purchase of advertising space bought influence and good will. That

influence

has penetrated the editorial boards and science news departments of

prestigious newspapers, including the New York Times, the major TV

networks,

as well as local news outlets, and supermarket pulp publications.

Industry's overpowering influence is reflected in what, and how,

medical

drug related issues are reported and distorted. The American media

has

become the purveyor of (mostly) upbeat reports about medical

breakthroughs--that almost never actually materialize. The media also

engages in promotions of screening for " disease of the month "

campaigns that

are in fact, marketing campaigns.

News reports, such as the follow-up report about the FDA advisory is

an

accommodation to its advertisers and to the stakeholders in the

psychotropic

drug industry. Not only does the Times reveal advertising bias, but

it fails

to vet their sources of information for conflicts of interest.

The Times quotes Dr. Harold Koplewicz, indicating only that he is the

director of the NYU Child Study Center: " The fear I have about this

warning

is that many teenagers will not get the medicine because it will

build

resistance among their parents, and that is really a tragic outcome. "

Dr. Koplewicz, not only is one of the staunchest promoters of

psychotropic

drugs for children, he was a co-investigator and co-author of a

major Paxil

study (329) in which he and the pillars of American child psychiatry

claimed

to have found that Paxil was " well tolerated and effective " for

adolescents.

The article has now been discredited by the FDA. Furthermore, an

internal

1998 memo by the manufacturer of Paxil indicates that only the

positive data

from study 329 would be published, but the negative findings would

not.

Readers trust the New York Times, believing that the experts

selected by the

Times for their views, are objective unless identified as having a

financial

interest in the product/ company or have taken a position. The Times

failed

to disclose any of the relevant background information that

demonstrates a

decidedly biased point of view. The Times article also failed to

disclose

the very substantial financial ties to the drug industry of either

Dr.

Koplewicz or the NYU Child Study Center.

If the NY Times with its vast resources and expertise is so easily

misled by

industry-sponsored market expansion campaigns which are led by

doctors who

serve the industry as paid consultants, whose claimed scientific

findings

have been shaped by industry's directives, what can we expect from

family

advocacy groups who also receive substantial financial support from

the same

industry?

Failure to disclose financial and professional conflicts of interest

undermines the integrity of Times science / medicine news reports.

One

wonders whether the NY Times should revise its motto, from " All the

News

that's Fit to Print " to All the News that Increases Pharmaceutical

Advertising?

See: Keller MB, ND, Strober M, Klein RG, Kutcher SP, Birmaher

B, Hagino

OR, Koplewicz H, Carlson GA, e GN, Emslie GJ, Feinberg D,

Geller B,

Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller

EB,

Winters NC, Oakes R, McCafferty JP.

Efficacy of paroxetine in the treatment of adolescent major

depression: A

randomized, controlled trial. Journal of the American Academy of

Child &

Adolescent Psychiatry, 2001, 40:762-772.

See: U.S. Food and Drug Administration (FDA) CDER. Memorandum from

P.

Laughren, MD, to Members of PDAC and Peds AC January 5, 2004. Online

at:

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006b1.htm

See: GSK 1998 memo online at:

http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare@a...

~~~~~~~~~~~~

http://www.washingtonpost.com/ac2/wp-dyn/A16214-2004Mar22?

language=printer

THE WASHINGTON POST

New Warning Urged On Antidepressants

Alert Would Address Suicidal Tendencies

By Shankar Vedantam

Washington Post Staff Writer

Tuesday, March 23, 2004; Page A03

The Food and Drug Administration urged drugmakers yesterday to put

new

warning labels on popular antidepressant medications, including

Paxil,

Zoloft and Luvox, alerting doctors and consumers to watch for

suicidal

tendencies, hostility and agitation in patients taking the drugs.

The agency's action focuses on 10 antidepressant drugs in all and

follows a

warning by the British government last year advising physicians not

to

prescribe most widely used antidepressants to children. Last month,

families

of American adolescents who killed themselves while taking the

medications

implored the FDA to take comparable steps, and an expert advisory

committee

urged greater vigilance in the use of the medications in children

with

depression.

The agency said it does not know whether the medications -- which

include

several drugs known as selective serotonin reuptake inhibitors, or

SSRIs --

are responsible for reported side effects such as inner restlessness,

agitation and suicidal thoughts in some people. Officials said they

are

drawing greater attention to known cautionary information while a

team of

outside researchers completes a comprehensive analysis of the

possible

risks.

Patients taking the drugs who experience behavioral side effects

should

contact their physicians, said Katz, director of

neuropharmacological drug products at the FDA. If the symptoms are

new or

severe, he added, doctors should consider lowering the dose or

stopping the

drug.

Yesterday's move by the agency calls for warning-label changes for

adults as

well as children, and for patients who are depressed as well as

those who

use the drugs for unrelated problems.

" The advice applies across the board whether the drugs are used for

any

indication -- psychiatric or not, " Katz said.

Critics of the medications called yesterday's move a victory and

demanded

that the FDA go further. Although Prozac is the only one of this

class of

drugs that has been specifically approved to treat depression in

children,

doctors are writing tens of thousands of prescriptions for many of

the

others, based on their clinical judgment that the drugs are safe and

effective.

" Doctors are going to be on the line not to prescribe them as if

they were

pacifiers, " said Vera Hassner Sharav, president of the Alliance for

Human

Research Protection, a patient advocacy group based in New York.

Many critics complain that a majority of studies of the drugs in

children

found that the medications did no better than dummy pills in treating

depression, but that these studies have been hidden from doctors and

the

public. The companies say the studies are proprietary.

Sharav and other critics charge that the FDA and the American

psychiatric

establishment, which has broadly supported the efficacy of the

drugs, have

been unduly influenced by the pharmaceutical industry. Dozens of

lawsuits

against the medications have been filed around the country.

Many psychiatrists say the medications save lives and warn that

discouraging

patients from taking them could lead to greater numbers of suicides.

They

insist that suicidal tendencies or attempts among patients taking

the drugs

are the result of underlying disorders, not the medications.

Rates of suicide among adolescents have generally declined as

antidepressant

use has surged in recent years, said P. Laughren, FDA team

leader for

psychiatric drug products. While no one knows whether the two trends

are

linked, he said at a news conference yesterday, such data framed the

context

in which the FDA acted.

The drugs affected by yesterday's announcement are Prozac, Zoloft,

Paxil,

Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.

C 2004 The Washington Post Company

http://www.rockymounttelegram.com/news/newsfd/auto/feed/news/2004/03/

24/1080

176226.26609.0348.7142.html

Metrick: Is treatment worse than depression?

By Gene Metrick, Rocky Mount Telegram

It seems the pharmaceutical industry may have to add another side

effect to

the long list of warnings that accompanies the stable of

antidepressant

drugs it has been hawking for the past dozen years or so.

The ads touting these drugs as the latest wonder cures for

depression or

anxiety appear repeatedly each day on television. The commercials

always end

with a standard disclaimer advising of the possible side effects of

their

use: nausea, dry mouth, sleeplessness, decreased libido,

constipation,

diarrhea, loss of appetite, etc.

Now the companies might just be warning that the use of an

antidepressant

may also increase the risk of suicide.

The U.S. Food and Drug Administration on Monday asked drug makers to

include

detailed warnings alerting doctors and consumers to watch for

suicidal

tendencies, agitation and hostility in patients using the drugs.

The new warnings cover Prozac, Paxil, Zoloft, Effexor, Celexa,

Lexapro and

Luvox - known as seratonin reuptake inhibitors (SSRIs) - as well as

Wellbutrin, Serzone and Remeron, which are a different class of

drugs.

The FDA's move comes on the heels of an emotionally charged public

hearing

in February in which dozens of distraught family members testified

that they

blamed the drugs for the suicides or suicide attempts of their loved

ones.

Unfortunately, it's uncertain what effect the FDA ruling will have

on drug

makers, who have not said whether they will comply with the agency's

request. Vera Hassner Sharav, president of the New York-based patient

advocacy group, the Alliance for Human Research, told me that she

sees the

ruling as " equivocating and ambiguous. "

" It gives a warning but says, 'We don't have the evidence.' Now, if

you

don't have the evidence that the drugs are to blame, what's the

point of

putting the warnings on them? " she said. " The FDA has had this data

in their

files for years - either they didn't warn the public in order to

shield the

industry, or they're incompetent. "

Dozens of lawsuits have been filed against drug makers by families of

patients who committed or attempted suicide while taking

antidepressants.

For its part, the FDA says it is reviewing 25 clinical trials of the

drugs

on children and will release its findings this summer.

The British government last year banned the use of all such drugs

except

Prozac for the treatment of depression in children. But the problem

is not

confined to adolescent patients.

Independent studies have suggested a link between antidepressants and

suicide since 1990, when Harvard researcher Dr. Teicher

reported that

an internal Eli Lily study of adults showed " a greater incidence of

suicide

attempts in people in the study receiving Prozac than in people

receiving

placebo ... "

The big drug companies have labeled those kinds of studies

as " proprietary "

and have refused to release the findings of such reports. But

they've been

very forthcoming in releasing research results that show no links

between

antidepressants and an increased risk of suicide.

Remember, these antidepressant medications have become a giant cash

cow for

the pharmaceutical industry, with as many as 30 million Americans

estimated

to be taking one or another of them. Heck, you can even visit any

number of

online pharmacies for a free medical consultation with a doctor and

have

your prescription shipped to you right away.

Of course, as one of the service representatives for

prescriptiondrugs.com

told me Wednesday over the telephone, you do have to answer the

doctor's

questions " truthfully. "

Depression is a very serious and debilitating disease. And

antidepressants

can play a vital role in helping people overcome it. But the rush to

overprescribe these drugs for a vast array of ailments is quite

disturbing,

especially when the full range of risks that accompany them seem to

still

remain pretty much uncertain.

It's part of a syndrome that can be thought of as the " Drugging of

America, "

a growing trend reminiscent of the " Brave New World " described by

Aldous

Huxley in his novel of the same name. The residents of Huxley's

future world

were freed from the anxieties, cares and conscience of their present-

day

counterparts through the use of the drug " Soma, " which brought the

phrase,

" Don't worry, be happy " to a whole new level. Better living through

chemistry, indeed.

Gene Metrick is a senior writer and copy desk chief for the Rocky

Mount

Telegram.