jake

Watch for Suicide with Depression Drugs, FDA Says
Mon October 27, 2003 02:31 PM ET

http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=3698174&src=eDialog/GetContent&section=news

WASHINGTON (Reuters) - The U.S. Food and Drug Administration issued a
public health advisory on Monday to alert doctors to reports that
children and ****-agers with major depression thought about or
attempted suicide in several clinical trials of antidepressants.
Only one drug, fluoxetine, sold by Eli Lilly and Co. under the name
Prozac, is approved for treating pediatric depression. But doctors are
free to prescribe any approved drug and several are being tested.

"The data do not clearly establish an association between the use of
these drugs and increased suicidal thoughts or actions by pediatric
patients," the FDA said in a statement.

"Nevertheless, it is not possible at this point to rule out an
increased risk of these adverse events for any of these drugs,
including Paxil (paroxetine)." Paxil is made by GlaxoSmithKline Plc .

"The labeling of antidepressant drugs already carries precautionary
language that the possibility of a suicide attempt is inherent in
major depressive disorder and may persist until significant remission
occurs. Close supervision of high-risk patients should accompany
initial drug therapy," the FDA advised.

It said no one should stop taking the drugs abruptly, and certainly
not without consulting a doctor.

The FDA said it had reviewed reports about eight antidepressant drugs
-- Paxil, Prozac, citalopram, fluvoxamine, mirtazapine, nefazodone,
sertraline, and venlafaxine.

"FDA is aware of press and medical journal reports of suicide attempts
and completed suicides in pediatric patients receiving
antidepressants, and many such reports have also been submitted to FDA
as spontaneous reports," the agency said.

But it said it is hard to tell whether the drugs actually caused the
suicide, because depression is the leading cause of suicide.

The FDA has scheduled a meeting on Feb. 2, 2004, of the
Psychopharmacologic Drugs Advisory committee and the Pediatric
Subcommittee of the Anti-Infective Drugs Advisory Committee.

Experts say an estimated 750,000 U.S. adolescents suffer from
depression and 500,000 attempt suicide every year. About 1,700
succeed.

__

"When society turns a blind eye to the dangers of drugs and rushes to embrace a
pharmaceutical cure for nearly every condition, there is almost no end to the
harm that may result".

Thomas.J.Moore

irishqueen17

well I'll tell you something. I was more depressed on my meds than not
being on my me. Topamz and Lexapro made it worse. I did 2 suicide
attempts while being on the meds and cried all the time. I stopped
taking my meds, Neither doctor nor parents know about it. I feel 100%
better off of them than being on them. So I dont need the FDA to tell me
that I was a high risk case on the meds, I had the proof on my arms.

jake

how ghastly.. I stopped


Time is the great healer..
congratulations on coming out of such a hideous ordeal..and long may
your fire burn..

__

"In its recent infatuation with symptomatic, push-button remedies,
psychiatry has lost its way not only intellectually but spiritually
and morally. Even when it is not actually doing damage to the people
it is supposed to help,…it is encouraging among doctors and patients
alike the fraudulent and dangerous fantasy that life's every passing
'symptom' can be clinically diagnosed and, once diagnosed, alleviated
if not eliminated by pharmacological intervention."

Paul R. McHugh
Professor of Psychiatry,
Johns Hopkins University School of Medicine

kc

i'm not sure how this is news. everyone knows that being depressed puts one
at greater risk for suicide. the main theories i've read about people
comitting suicide on ADs are as follows. one is that people are
undermedicated and still depressed when they do the deed. the other is that
people have begun to feel the increased energy levels that come with relief
from depression, but the actually lifting of the depression hasn't yet
occurred. so you have the same black thoughts with more energy. obviously
this makes suicide more likely. this is why most suicides on ADs occur
within the first month of treatment.

there's a reason that docs don't send you home with meds and no one to watch
out for you if you say you've thought of suicide. and i don't think blaming
the meds makes any sense at all.

-kelly

jake

that is not the issue here
the issue is whether being treated with certain anti-depressants..in
itself..puts one at greater risk of suicide attempts and ideation.
In children this has been found to be the case..hence the advisory..

but then you know that..


FDA PUBLIC HEALTH ADVISORY

October 27, 2003

Subject: REPORTS OF SUICIDALITY IN PEDIATRIC PATIENTS BEING TREATED
WITH ANTIDEPRESSANT MEDICATIONS FOR MAJOR DEPRESSIVE DISORDER (MDD)

Dear Health Care Professional:

The Food and Drug Administration (FDA) would like to call your
attention to reports of the occurrence of suicidality (both suicidal
ideation and suicide attempts) in clinical trials for various
antidepressant drugs in pediatric patients with major depressive
disorder (MDD).

While occurrences of suicidality are not unexpected in patients with
MDD, preliminary data suggest an excess of such reports for patients
assigned to several of these antidepressant drugs compared to those
assigned to placebo.


FDA has completed a preliminary review of such reports for 8
antidepressant drugs (citalopram, fluoxetine, fluvoxamine*,
mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine)
studied under the pediatric exclusivity provision, and has determined
that additional data and ****ysis, and also a public discussion of
available data, are needed. FDA plans to hold an advisory committee
meeting before the Psychopharmacologic Drugs Advisory Committee and
the Pediatric Subcommittee of the Anti-Infective Drugs Advisory
Committee on February 2, 2004.


ah but they do routinely..

what part of

"While occurrences of suicidality are not unexpected in patients with
MDD, preliminary data suggest an excess of such reports for patients
assigned to several of these antidepressant drugs compared to those
assigned to placebo."

do you not understand?


--
"Behind the ostensible government sits enthroned an
invisible government owing no allegiance and
acknowledging no responsibility to the people. To
destroy this invisible government, to befoul the
unholy alliance between corrupt business and corrupt
politics is the first task of the statesmanship of
today."

- Theodore Roosevelt, 19 April 1906

sammy

Very well stated. It's simply obvious.
This new warning is just a legal maneuver to prevent stupid lawsuits
against Doctors and drug companies.

martin c

Problem is that information that might indicate an increased
chance of suicide with the SSRI drugs gets suppressed by the
drug companies. Even with the help of the FDA. There might
be something to the story about how people with depression
might be more suicidal , because it makes sense that at
least some of those who have depression might not think they
have as much to live for as one who does not.. That seems
logical.

The story about how as one gets better one might have more
energy etc , could possibly also make some sense. Or maybe
not. But unfortunately the story can also make it easier
to cover up suicides that might be caused by the drugs
(SSRIs) themselves. For people who might not even have been
suicidal in the first place. Or might not have even had
depression in the first place.

There have been a number of cover ups of the potential of
increased suicide using SSRIs over more than a decade now.
Possibly the same could also have happened when it comes to
violence from people , who have never been violent before.
But the specifics of suicide cover ups have been better
publicized at least by a few authors.

Dr Joseph Glenmullen has gone into this in extensive detail.
in his Prozac Backlash book. Lots of information about how
doctors in the early 1990s, discovered cases of suicide ,
which they believed to be caused by the then new SSRI -
Prozac

And he provided lots of information about the supposed panel
set up by the FDA at that time. Which met for only one
day, and was loaded with people who were tied in with the
SSRI manufactures. Including those who were even part of
the drug company original Prozac studies. These people were
incorrectly given waivers by the FDA, in spite of the
obvious conflict of interests. And the incident is so well
known, that for more than a decade there has not been a
satisfactory closure on the topic.

There was also Dr Healy's study which provided information
as to greater suicidal tendencies with people he gave the
SSRIs to The cover up story about the extra energy etc
could not even possibly apply in that case because the
people that took the drugs were healthy physicians. So the
cover up story became more like a so what, because healthy
people supposedly do not take the drugs.

But they do, because the doctors are giving people free
samples of SSRIs for not much more than relatively mild
symptoms as compared with depression . Such as mild
symptoms of anxiety, or shyness etc. People who do not fit
into the category of depression and who do not have even
the potential of suicidal tendencies. .

And the Dr Healy information got suppressed in North America
in part by taking away the job offer he had been given
with a University in Canada.


One of the things that came up in the recent news from the
UK included information that not only were there more
suicides, but the SSRIs don' t appear to even benefit the
children. Which is just one more thing which might tend to
make what could just be a drug company cover up story appear
to be just that. A cover up story.

And there are a number of times that someone became violent
when taking the SSRIs and actually murdered people including
their own family etc.. Yet all those who knew the murderer
could testify that there was no tendency to violence
before taking the drugs. On a few occasions the court
ruled in favor of the person. Don't have the references for
those situations . But a few of them came up over the last
few years. including a case in Australia best I can
remember.

Other factors include how some drug proponents tried to
claim taking the drugs so as to prevent suicides. But when
the drug companies were asked for proof that drugs reduced
suicide, they did not respond. Plus the entire situation
with the kids, and the shootings in the schools. Where a
number of them were on the SSRI drugs.

As far as I am concerned, I do not know whether the drugs
cause more suicides or not.

But at minimum I have been concerned when people use that
argument to try to make it easier to force people to take
the SSRI drugs. And also have been concerned with how
things like this manage to get suppressed , even under the
supposed watchful eye of the FDA.

And would also be concerned that the FDA might buy into the
story just like so man others do. Such as where it says in
the article "

quote:

" FDA is aware of press and medical journal reports of
suicide attempts and completed suicides in pediatric
patients receiving antidepressants, and many such reports
have also been submitted to FDA as spontaneous reports," the
agency said. But it said it is hard to tell whether the
drugs actually caused the suicide, because depression is the
leading cause of suicide "

So the FDA is using the exact same story that has been used
in this thread to pooh pooh whatever information might be
available.


They appear to be critical of things that might go against
American drug companies . Such as where they held up Celexa
for a number of years , when Prozac was first introduced. Or
how they held up SAMe for decades. Or seem to want to go
after the people's herbs and vitamins, or how they
criticize Canadian drugs. For no apparent reason other
then they cost less than the American companies want to
charge. And how they suppressed the suicide information
back in the early 1990s etc.

So when the use what has been the standard cover up story
for a decade there is reason to have some skepticism. It
is possible that could be right.

But not good enough an excuse to ignore what researches
outside the U.S. have, or have not, found.. Of course
it has to come from foreign researchers, since it does not
seem like anything that could be a major problem for a
high profit SSRI drug company is likely to emerge from U.S
doctors. With a few exceptions such as Dr Glenmullen of
course.

corey

Here is another idea about why SSRI's might cause people to commit
suicide. It's not the drug itself that does it.
The person has been feeling depressed and has had suicidal ideation.
Then they find out about SSRI's and start taking them. They begin to
feel better, but nothing else in their life has changed. They still
have the same old problems and the same old mental approach to
everything. So they think, geez, this is really hopeless.

However, if they don't go ahead and kill themselves, they will soon
begin to think differently. They will become happier and they will
have better relationships with everyone. Then their life will be
changed for the better.

As for your concern that too many people are being given
anti-depressants by their doctors:
Consider that caffeine is an anti-depressant. It makes you more awake
and gets you moving. This is what anti-depressants do too. Most people
are self-medicating with caffeine, and there are undesirable side
effects, such as difficulty falling asleep and difficulty staying
asleep, and nervousness. This is managed by drinking alcohol at night
or by taking sleep remedies.

What I'm saying is that it's too easy to blame the problems on
anti-depressants, and it doesn't make sense when the majority of
people are using caffeine for the same purpose. It's not like if you
take away anti-depressants, the world will be a better place.

tin-tin

-People are gineau pigs for pharm companies pretty often. Meds are only
tested for six weeks before approval by the FDA (ftnote in Breggin &
Cohen's book), and doctors have no information about long-term treatment
risks. I asked my doc and he confirmed that he does not know what new
meds could do after let's say 10 years of use. We are the tests, if
nobody dies or becomes debilitated from the med, they continue selling
it. If not, they buy out the plaintiff. Remember Thalidomide and some
other anticholesterol med that killed people - could happen again.

Many psychiatric drugs are believed to have bad effects and sometimes
make people more suicidal. Oh, here is the best part, all the studies
given to the FDA and Canadian Government are all funded by the
pharmaceutical companies themselves. You get the drift... I don't
trust the FDA nor the government when it comes to drugs. Tin-Tin

jake

The American Medical Association seems to agree with you..

http://www.ama-assn.org/ama/pub/category/10619.html


Safeguarding the Quality of Clinical Research
by Joel Lexchin, MD

Three colleagues and I have just published a systematic literature
review demonstrating that pharmaceutical research funded by drug
companies is more than 4 times as likely to favor the drug made by the
sponsor than research funded by other sources [1]. This finding
extended to pharmaceuticals that treat a wide range of diseases such
as osteoarthritis of the knee, multiple myeloma, various psychiatric
problems, Alzheimer’s disease, and venous thromboembolism. The
totality of the evidence reported in our meta-****ysis of a subset of
homogeneous studies suggests that there is some kind of systematic
bias to the outcome of published research funded by the pharmaceutical
industry.

Our results are quite disturbing given that in Canada and the United
States the pharmaceutical industry is the largest direct funder of
medical research. In the US in 2002, the industry outspent the
National Institutes of Health by $26.4 billion to $24 billion [2]. All
of the world’s leading medical journals publish industry-sponsored
research; doctors and scientists need to be able to have confidence in
the conclusions of this research. We are calling for a major push
toward making the process of research and publication more
transparent.

The data we examined did not allow us to reach any definitive answers
about the source of outcome bias, but we think there are 2 possible
sources––publication bias and the use of inappropriate comparator
agents. The reluctance of journals to publish negative findings is a
well-known form of publication bias, but there are other forms this
bias can take. In the case of some negative findings, pharmaceutical
companies may own the data, and, naturally enough, are not interested
in submitting these unfavorable findings to a journal. Researchers may
self-censor, reasoning that if they publish results showing the
inferiority of a company’s products it may be more difficult to obtain
research funding from a company. In some instances, companies help
researchers write up their results because the investigators do not
have the time or lack the necessary skills to do it themselves. Will a
company be willing to assist in writing up a research trial that does
not favor its product?

Appropriate comparative trials between drugs are frequently lacking
and are often replaced by trials against placebos. In instances where
there is a strong placebo effect or where the course of a disease is
highly variable, placebo-controlled trials are justified. In other
instances, however, trials may use a placebo for comparison as a way
of producing positive results for the drug being tested. In trials
where 2 active drugs are being compared, the doses may not be
equivalent. For example, the dose of the comparator may be too
high––leading to more side effects––or too low––leading to lesser
efficacy. It should be noted that, in the literature we examined, we
could not determine who was responsible for the choice of the
comparator agent––the sponsoring company, the investigators, or a
regulatory authority.

Some steps have already been taken to improve the reporting of
randomized clinical trials. An international group of investigators,
statisticians, epidemiologists, and biomedical editors met to revise
the CONSORT statement in 2001 [3]. Journals that follow these
recommendations, give their readers a transparent rationale for why
the study was undertaken and how it was conducted and ****yzed. That
same year, the editors of 13 major medical journals, including JAMA,
CMAJ, and Lancet, issued a declaration regarding publication
requirements for their respective journals. These standards require
authors submitting a manuscript to disclose all financial and personal
relationships between themselves and others that might bias their
work. They must describe the role of the study sponsor(s) in study
design and the collection, ****ysis, and interpretation of data.
Authors must also disclose the trial funders’ involvement in the
writing of the report and the decision to submit for publication; and,
in certain cases, editors may ask authors to sign a statement such as
"I had full access to all of the data in this study, and I take
complete responsibility for the integrity of the data and the accuracy
of the data ****ysis."

In my opinion, and that of my collaborators, more needs to be done to
improve the integrity of clinical research reports. We echo the
repeatedly made suggestion that all clinical trials be registered
prospectively in order to prevent publication bias. Such a registry
would allow interested parties to see if there were trials that did
not make it to publication and ****yze any links between funding
status and publication. We also recommend that authors and editors
consider including a statement about the beliefs of the investigators
prior to conducting research about the uncertainty of the treatments
they plan to study. Uncertainty about the superiority or inferiority
of the different agents being compared would assure readers that
comparators were not chosen to ensure the final outcome of the study.

We recommend other measures such as, to the extent possible,
disengaging pharmaceutical companies from the design of clinical
trials; this is the responsibility of the investigators. Drug
companies should restrict themselves to funding the trials. Assessment
scales for the methodologic quality of research should be expanded to
include a measurement of the appropriateness of the comparator(s). All
journals that publish clinical trials should embrace the statement
from the 13 editors on publication requirements. Finally, readers need
to be alert to the funding sources of clinical trials, whatever they
may be, and take into consideration whether the sponsoring group may
have influenced the trial results.

Reference
1. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry
sponsorship and research outcome and quality: systematic review. BMJ
2003;326:1167-70.
2. Pharmaceutical Research and Manufacturers of America. PhRMA:
Industry Profile 2003 (Chapter 2). Available at:
http://www.phrma.org/publications/publications/profile02/2003%20CHAPTER%202.pdf.
Accessed June 30, 2003.
3. The CONSORT statement is an important research tool comprising a
checklist and flow diagram to help improve the quality of reports of
randomized controlled trials. The statement offers a standardized way
for researchers to report trials and is intended to make experimental
process more transparent so that readers can more appropriately
evaluate the study’s validity. See CONSORT. Available at:
http://www.consort-statement.org/. Accessed June 27, 2003.

Joel Lexchin, MD, teaches health policy at York University and also
works as an emergency physician at the University Health Network, both
in Toronto, Canada. He has written extensively on the relationship
between physicians and the pharmaceutical industry and has served as a
consultant on pharmaceutical issues to the province of Ontario, the
Canadian and New Zealand governments, the Australian National
Prescribing Service and the World Health Organization.