A Glimpse Into the Incredible Power of the Pharmaceutical Industry

[Guest guest]

atracyphd2

Thu, 10 Feb 2005 02:32:04 EST

 

 

[drugawareness] A Glimpse Into the Incredible Power of the

Pharmaceutical Industry

 

 

 

Today in the case of Christopher Pittman the world learned of the

great power

of the drug companies over the FDA. Knowing this information was about

to be

used against them in the SC case, Pfizer and their buddies in crime

were able

to strong arm the FDA into backing down once again - not a hard thing

to do

when you consider the spinelessness of the FDA. In the article below

we read:

 

" Limiting the warning language to a risk seen in studies, rather than

saying

the drugs actually could cause suicidal behavior in younger patients, is a

significant retreat for the FDA and came after several months of

lobbying by the

pharmaceutical industry. "

 

Yet the Canadian version of the FDA forced these same companies to list

warnings in their product labeling last summer " harm to self " and

" harm to others. "

 

This is all simple to understand when you look at what the drug

manufacturers

are protecting here in America - their largest market. Last I knew America

used over 90% of the pharmaceutical drugs manufactured. When you are

looking at

protecting that market you can understand why so much effort goes into

keeping

America " in the dark " about the medications they are taking.

 

Do they care that Canada has issued such strong warnings or that the

UK has

issued stronger warnings than America? Why should they? They do not have

anywhere near as much income to protect in those countries as they do

here in this

country.

 

In an interview just this past month the FDA's own Dr. David Graham

had the

courage to state publicly that his superior at the FDA clearly stated

to him

that their " client " was " the industry " . When Dr. Graham said that his

client was

the public, he was reminded that he was incorrect and that the

industry was,

not the public. If this backpedalling by the FDA on this issue of

antidepressant safety in children is not enough for people to realize

that is a true

statement, I do not know what is!

 

 

 

Dr. Tracy

__________________

 

Ann Blake Tracy, Ph.D.,

Executive Director, International Coalition For Drug Awareness

Website: www.drugawareness.org

 

Author of " the Bible " on the SSRI antidepressants: " Prozac:

Panacea or Pandora? - Our Serotonin Nightmare "

& audio tape or CD set on safe withdrawal: " Help! I

Can't Get Off My Antidepressant! "

 

Order Number: 800-280-0730

_______________________________

 

 

http://www.cnn.com/2005/HEALTH/conditions/02/09/fda.antidepressant/

 

FDA backs away from antidepressant warning

 

Change comes to light during murder trial of teen blaming Zoloft

 

By Jim Polk

CNN

Wednesday, February 9, 2005 Posted: 8:50 PM EST (0150 GMT)

 

 

 

 

CHARLESTON, South Carolina (CNN) -- The Food and Drug Administration has

backed off its warning that antidepressants such as Zoloft, Paxil and

Prozac can

cause suicidal actions among children and teens taking those prescription

drugs.

 

In a revised warning posted last week on its Web site, the FDA changed the

wording to say only that the drugs " increased the risk of suicidal

thinking and

behavior in short-term studies of adolescents and children " with

depression

and other psychiatric disorders.

 

News of the FDA's warning change surfaced Wednesday in testimony in

Charleston in the murder trial of 15-year-old Christopher Pittman.

 

The defense contends Zoloft drove him to kill his grandparents when he was

12.

 

The FDA has never suggested a link between Zoloft and other such drugs and

violence against others -- the issue in the Pittman murder trial.

 

Dr. Steve Romano, a psychiatrist and a vice president of Pfizer, which

makes

Zoloft, mentioned the FDA change while testifying about the company's

clinical

trials for the drug. He was called by the defense in the Pittman case to

testify about suicide-related warnings issued in Canada and the United

States.

 

Limiting the warning language to a risk seen in studies, rather than

saying

the drugs actually could cause suicidal behavior in younger patients,

was a

significant retreat for the FDA -- and came after several months of

lobbying by

the pharmaceutical industry.

 

The agency has never approved Zoloft, Paxil or most similar drugs for

use by

younger patients with depression.

 

Even so, many doctors prescribe them for children and teens. Prozac is the

only such antidepressant approved to treat depression in children.

 

The version of the warning that the agency posted on its Web site in

October

included this sentence: " A causal role for antidepressants in inducing

suicidality has been established in pediatric patients. "

 

The latest version omits that sentence.

 

The sentence was not part of the boldface black box warning placed at the

start of the insert that accompanies any prescription, but instead

appeared in

the first paragraph of a separate section on " Suicide Risk, " which

appeared just

below the black box.

 

The replacement sentence now appears as the first sentence inside the

black

box.

 

That first sentence was broader in the original version: " Antidepressants

increase the risk of suicidal thinking and behavior in children. " The

new version

qualifies that by inserting the phrase " in short-term studies. "

 

Romano acknowledged that the wording change was preceded by an extended

" dialogue " between his drug company and others and the FDA.

 

" They had a sentence in there that spoke to a causal link between the

actual

drugs and the events of suicide, and they took that out, " he said.

 

" There was an increased risk of suicidal behavior and suicidal ideation,

which are much more commonly encountered events in patients who are

depressed, as

you can imagine.

 

" There was no causal link to suicide established, and the FDA recognized

that. "

 

Romano testified that the change was " a big difference. "

 

He was asked whether the new phrase meant that these drugs increase

the risk

of suicidal behavior.

 

" I think it means an increased risk was seen, but to what extent it

was due

to the drug or not is not yet confirmed, and that's why the FDA took

out the

'causal' sentence before that, " Romano responded.

 

Romano was referring to an FDA analysis that pooled the results of

clinical

trials by nine manufacturers and found the risk of suicidal behavior

was twice

as high for those on the drugs as for those taking placebos.

 

The FDA said the change was made February 3, after doctors and

academics said

causation could not be proved in any case; that only increased risk

could be.

 

 

The Pittman trial was in its eighth day Wednesday and appears likely

to spill

over into a third week, rather than go to the jury by this weekend, as

once

predicted. (Trial coverage)