sobering thoughts

[Guest guest]

The most important question to ask here: Why on earth would it take

at least a

decade and a half to two decades to review the clinical trials and

issue this

most significant warning - a warning you have heard over and over

again from the

Drug Awareness Website. How many more years will it take to issue

warnings on

all the other serious reactions that we know and they know to be

significant?

 

Dr. Ann Blake Tracy, Executive Director, International Coalition For

Drug

Awareness www.drugawareness.org & author of Prozac: Panacea or

Pandora? - Our

Serotonin Nightmare (800-280-0730)

______________

Paragraph four [last sentence}: " But the Glaxo study ? the first by

a drug

company to find a link between antidepressants and suicidal behavior

in adults,

experts say ? is likely to persuade some skeptics that the risk is

real and not

confined to minors. "

 

http://www.nytimes.com/2006/05/12/health/12depress.html?

_r=1 & th= & oref=slogin & emc=th & pagewanted=print

 

May 12, 2006 Antidepressant May Raise Suicide Risk

 

By BENEDICT CAREY and GARDINER HARRIS

 

After analyzing data from clinical trials, GlaxoSmithKline has sent

letters to

doctors warning that its antidepressant drug Paxil appears to

increase the risk

of suicide attempts in some young adults.

 

The company said it had changed the labeling on the drug to reflect

the finding

of the study, which analyzed clinical trial data involving some

15,000 people.

The study found that reported suicide attempts were rare but

significantly more

common in adults who took the drug for depression than in those who

received

placebo pills.

 

The Glaxo researchers reported only one suicide in the trials, a

number so small

it says nothing about the drug's risk, experts said.

 

In October 2004, the Food and Drug Administration ordered drug

companies to

place a strong warning on antidepressant labels after studies

suggested that

some drugs increased suicidal thinking or behavior in children and

adolescents.

But the Glaxo study ? the first by a drug company to find a link

between

antidepressants and suicidal behavior in adults, experts say ? is

likely to

persuade some skeptics that the risk is real and not confined to

minors.

 

The studies of children and adolescents found mainly evidence of

suicidal

thinking and agitation. There were no completed suicides reported.

 

In a statement issued this week, the F.D.A. said that though it was

still

evaluating the data, " we are recommending that consumers and

prescribers follow

current advice to carefully observe adults being treated with

antidepressants

for worsening of depression and for increased suicidal thinking and

behavior. "

The statement said, " It is essential that patients taking Paxil do

not suddenly

stop taking their medication. "

 

Last year, the agency asked psychiatric drug makers to review all

their data on

side effects in adults after a prolonged international debate over

whether

antidepressant drugs increase the risk of suicide in some children.

Other

companies have not yet reported their findings.

 

" This is the first analysis to show a relationship between suicide

attempts and

one of the antidepressants " since the F.D.A. required the warning

label for

children and adolescents, said Kelly Posner, an assistant professor

in the

department of child psychiatry at Columbia, who has helped the

agency interpret

bad reactions to antidepressants.

 

Dr. Posner said the Glaxo findings should be treated with caution,

because the

antidepressant trials done to date were not designed to evaluate

suicide risk.

 

" It's not clear that the drug caused the behavior, " she said.

 

Glaxo sent out the warnings voluntarily, and its data still show

that the drug's

benefits outweigh the risks for people with depression, said Mary

Anne Rhyne, a

company spokeswoman.

 

" We are now advising doctors to monitor all patients to make sure

their symptoms

don't worsen " in the full course of treatment, Ms. Rhyne said.

 

Previous research has suggested that the risk of suicidal thinking

or behavior

was highest in the first few weeks of treatment, or when people went

off the

medication. One large review of antidepressant trials, published

last year in

BMJ, a British medical journal, found that people taking Paxil and

similar drugs

like Prozac reported suicide attempts more often.

 

But experts have debated the interpretation and value of these

findings. In the

Glaxo analysis, the researchers analyzed trials that included 8,958

people who

took Paxil and 5,953 who received placebo pills. The study

participants ranged

in age from 18 to 64 years old and were taking the medication for

depression or

other disorders, like panic attacks and obsessive compulsive

disorder.

 

The analysis found that 11 of 3,455 people who were taking Paxil for

depression

reported an attempted suicide, compared with 1 in 1,978 taking

placebo in the

trials. Most were among adults ages 18 to 30, the company said.

 

Over all, the analysis found no increased risk of suicidal behavior

in adults

over 30.

 

" The new findings are not going to change my practice a lot, but I

say, yes,

they provide a reason to do even more careful monitoring of people

on the

medication, " said Dr. George Simpson, a professor in psychiatry and

behavioral

sciences at the Keck School of Medicine at the University of Southern

California.

 

Dr. Simpson said the warning underscored the need for more careful

tracking of

side effects once drugs went on the market.

 

" The current system of postmarketing surveillance is lousy, " he said.

[Guest guest]

pjb wrote:

 

a warning you have heard over and over

again from the Drug Awareness Website.

How many more years will it take to issue

warnings on all the other serious reactions

that we know and they know to be significant?

 

 

The significance of a news item is not

always in what is said, but in who says it,

in which medium.

Alternative-savvy folk like us know about

http://drugawareness.org, but many people

have to hear truth from a certain establishment,

or they can't get it.

 

It's like the discoverer of asteroid B612, the

home of St Exupery's " The little prince " .

It was discovered by a Turkish scientist and

announced at a conference. Alas, the scientist

was wearing a robe and a fez, so no one could

hear what he had to say. At the next conference

he was wearing a three piece suit and this time

everyone agreed with him.

 

Ien in the Kootenays

http://profiles./free_green_living