F.D.A. ALL Antidepressants to Being Suicidal

[Guest guest]

(From Ann Blake Tracy, Ph.D.,)

 

The hearings were wonderful!!!!! I still have jet lag and am busy playing

catch-up, but will get the information out as quickly as I can to you.

 

As the FDA Advisory committee was reaching the conclusion of their

statement

yesterday I had to leave the room several times to step out into the

hallway

to jump and shout for joy! BLACK BOX WARNINGS!!!! We got black box

warnings on

ALL antidepressant medications for children!!! I had begun to wonder if we

would ever see this day.

 

But beyond that they have also agreed to study the violence issue

associated

with antidepressants and the Senate now wants to begin their own

investigation

into these drugs!!!!! So now, we have not only Congress, but the Senate as

well, looking into possible cover-up and criminal actions by all those

responsibility it was to protect the public and most especially these

precious children

who were to be our future.

 

What a bitter/sweet victory this has been in the warnings coming so many

years too late!

 

Dr. Tracy

______________

 

Ann Blake Tracy, Ph.D.,

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio

tape on

safe withdrawal: " Help! I Can't Get Off My Antidepressant! "

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

 

http://www.nytimes.com/2004/09/14/health/14depress.html

 

 

F.D.A. Links Drugs to Being Suicidal

 

By GARDINER HARRIS

 

Published: September 14, 2004

 

ETHESDA, Md., Sept. 13 - Top officials of the Food and Drug Administration

acknowledged for the first time on Monday that antidepressants

appeared to lead

some children and teenagers to become suicidal.

 

Dr. Robert Temple, director of the F.D.A.'s office of medical policy, said

after an emotional public hearing here that analyses of 15 clinical

trials, some

of which were hidden for years from the public by the drug companies that

sponsored them, showed a consistent link with suicidal behavior.

 

" I think that we now all believe that there is an increase in suicidal

thinking and action that is consistent across all the drugs,'' Dr.

Temple said,

summarizing the agency's presentation to a special advisory committee.

" This looks

like it's a true bill.''

 

The acknowledgement, made after the hearing, comes a year after the agency

suppressed the conclusions of its own drug-safety analyst, Dr. Andrew

Mosholder,

who first found a link between the drugs and suicide in teenagers and

children. Agency officials wrote in internal memorandums that Dr.

Mosholder's

analysis was unreliable, and they hired researchers at Columbia

University to

re-analyze the same data. That study recently reached conclusions

nearly identical to

Dr. Mosholder's.

 

The testimony came before an advisory committee of 31 independent experts

that the F.D.A. has charged with making a recommendation about the

labeling and

use of antidepressants in children and teenagers.

 

Family members of suicide victims at the hearing angrily denounced agency

officials for the delay in admitting the risk of antidepressants in

children. The

British health authorities decided in December to ban the use of most

antidepressants in children and teenagers.

 

Mathy Milling Downing of Laytonsville, Md., whose 12-year-old daughter

hanged

herself in January, said: " Candace's death was entirely avoidable had

we been

given the appropriate warnings. " The blood of these children is on your

hands.''

 

Agency officials said that they had no regrets about the months of

study. " I

don't think the data were at that time reliable,'' Dr. Temple said.

" Scaring

people needlessly " or overdoing a warning is worrisome, he added.

 

The most popular pills are Zoloft, made by Pfizer; Paxil, made by

GlaxoSmithKline; and Prozac, made by Eli Lilly & Company. In 2002,

nearly 11 million

children and teenagers were prescribed antidepressants.

 

The risk of suicide among patients given the pills is very small. If 100

children and teenagers are given antidepressants, 2 or 3 will become

suicidal who

otherwise would not have had they been given placebos, agency

officials said.

None of the children in the trials committed suicide, but some thought

about

or attempted suicide, researchers found.

 

In March, the agency required antidepressant manufacturers to include on

labels a warning that therapy with antidepressants could lead some

patients, both

adults and children, to become suicidal. The committee must decide whether

this warning is strong enough or whether the drugs should be banned

for children.

The advisory committee is expected to make a decision on Tuesday. The

F.D.A.

normally follows recommendations of its advisory committees.

 

It is a complex task. Most studies of the drugs have failed to show

that they

have any effect on depression in children and teenagers. But the drugs

have

proven effective in adults, and studies suggest that teenage suicide

rates have

dropped in countries where use of antidepressants is widespread. A large

study of depressed teenagers conducted by the National Institute of

Mental Health

recently found that Prozac was far more effective in treating

depression in

children and teenagers than was talk therapy.

 

Several speakers noted that clinicians would have almost nothing to offer

depressed teenagers and children if antidepressants were banned.

Suicide is the

third leading cause of death among teenagers, trailing only homicide and

accidents. Without treatment, many more teenagers will die, several

experts said. If

the committee suggests an even stronger warning, some patients will resist

therapy and could perhaps die, some speakers said.

 

 

The issue has roiled the agency and is likely to transform the way the

drug

industry markets its products. Committees in both the House and Senate

have

begun investigations following disclosures that Dr. Mosholder's

analysis had been

suppressed.

 

The New York State attorney general Eliot Spitzer, filed suit against

GlaxoSmithKline, charging the drug maker with fraud for failing to

disclose the

results of clinical trials of Paxil that found no benefit while

promoting the drug

to physicians. The company settled the suit this summer by promising to

disclose the results of all of its clinical trials of its marketed

products dating

back to 2000.

 

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The editors of the nation's top medical journals have said they will

not to

accept for publication trials that have not been publicly registered, and

legislation is expected to be offered in both the House and the Senate

requiring

the disclosure of the results of all major drug tests on humans.

 

For some bereaved parents, Monday's hearing was a chance to take drug

makers

and the F.D.A. to task.

 

Mark and Cheryl Miller of Overland Park, Kan.,, told the committee

that their

13-year-old son, Matthew, had committed suicide seven months ago while

taking

Zoloft.

 

" Why haven't parents like Cheryl and myself and countless others been told

the truth?'' Mr. Miller asked.

 

But others said that antidepressants had helped millions. Dr. Suzanne

Vogel-Sibilia of Beaver, Pa., said that she had brought her

15-year-old son, Tony, to

the hearing to represent what she said were the vast majority of

patients who

had been helped by the drugs.

 

" Please help me preserve my future, " Tony told the committee. " Don't take

away my medication. "

 

Claims that antidepressants cause patients to become acutely suicidal have

been made since 1991, just three years after Prozac was introduced.

But drug

makers and regulators long dismissed these claims, saying they were

anecdotal

reports without any basis in rigorous clinical trials.

 

Then last year, GlaxoSmithKline announced that tests of Paxil had

found that

teenagers and children who took the pill were more likely to become

suicidal

than those given placebos. The announcement was quickly followed by a

similar

one from Wyeth, the maker of Effexor, another antidepressant.

Suddenly, the

anecdotal reports were being confirmed by clinical trials.

 

Still, just how the drugs may lead some people to become suicidal

remains the

subject of fierce debate. Many of those at the hearing said that the pills

had brought a change in the personalities of their friends and

relatives. Alice

Erber said that Paxil caused her 21-year-old son, Jake Steinberg, to throw

himself in June from the 24th floor of a Manhattan office building.

 

" If he had not taken Paxil, he would be alive today,'' Ms. Erber said.

 

But Dr. Temple speculated that some people taking the pills become

suicidal

because they are actually getting better. As their depression improves, he

said, they gain the energy to act on suicidal thoughts that their

illness had

suppressed.

 

" I think the work is cut out for us tomorrow,'' Dr. Wayne Goodman,

chairman

of the advisory committee, said at the end of Monday's hearing.

[Guest guest]

, " califpacific "

<califpacific> wrote:

> (From Ann Blake Tracy, Ph.D.,)

BLACK BOX WARNINGS!!!! We got black box

> warnings on

> ALL antidepressant medications for children!!! I had begun to

wonder if we

> would ever see this day.

>

> But beyond that they have also agreed to study the violence issue

> associated

> with antidepressants and the Senate now wants to begin their own

> investigation

> into these drugs!!!!! So now, we have not only Congress, but the

Senate as

> well, looking into possible cover-up and criminal actions by all

those

> responsibility

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

Antidepressants are infamous for something else as well - chest pain.

A few of the notorious ones are Paxil, Effexor, and Zoloft. Amazingly

enough, once stopped the chest pain disappears. Someone needs to

disband the FDA before they kill us all.

 

Regards,

Marge