FDA Alert: Watch for Suicide of Kids on AD's 10/27/03

On Tue, 28 Oct 2003 08:48:38 -0500, Mark D Morin
wrote:

On Tue, 28 Oct 2003 08:54:03 +0000, jake wrote:


despite the attempt to generalise to suicides in general in AD treated
patients the report actually is concerned with CHILDREN who are
attempting suicide more often when taking the AD than those recieving
a placebo.
this is headline news...
here is the actual alert

http://www.fda.gov/cder/drug/advisory/mdd.htm

and where are the nondepressed controls you were talking about who
became suicidal?


I never suggested for one moment they were in the alert..
As you know full well..having discussed it before ..
the data on the the normal volunteers
are hidden as "proprietry information" in the drug company archives.

Disclosure necessitates court orders.


http://www.socialaudit.org.uk/58004-DH.htm

Miss Sarah Wark, Senior Scientific Assessor 28 February 2000
Post-Licensing Division, Medicines Control Agency
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ

Dear Miss Sarah Wark,

[See previous letter]

I will be very happy in due course to send you a copy of the full
study report when this is available. It may however take some weeks or
even some months before I can forward this to you.

In the meantime it is my understanding that a number of the studies
with various different antidepressants that have been conducted with
healthy volunteers as part of a series of pre and post registration
tests have noted similar reactions to the ones that I have reported in
our study. So much is this the case, that there is a general
understanding in the field, certainly among the older practitioners
working with different pharmaceutical companies, that strange
reactions of this type are almost to be expected from healthy
volunteers. 20 or 30 years ago the rationale for accepting such
reactions was that antidepressants would never be given to anybody who
wasn't depressed and that there were clearly differences between the
brains of people who were hospitalised cases of endogenous depression
compared with normal volunteers.

These rationales have vanished as depression has extended to the point
where cases of what were Valium are now cases of Prozac. The most
commonly prescribed use for Prozac it seems to me, and many of the
other SSRIs, is for anxiety and stress reactions. These are the people
whom I see regularly becoming suicidal on these drugs. This is a group
of patients in whom it is not clear that there are likely to be any
great differences between their brain states and those of healthy
volunteers.

My understanding is that there are many people in the field whom the
MCA could consult who would be able to confirm this position. There is
also likely to be a considerable amount of data that companies have
but whether they have submitted this to you or not is less clear to
me.

I think the study on Sertraline induced suicidality in healthy
volunteers is directly relevant to the question of suicide in the
Prozac SPC that you say you will consider in the event that new
information emerges. I feel this is new information directly relevant
to the Prozac SPC. I think it's highly likely that Lilly in addition
to other companies will have data of the kind that I have referred to
above.

As regards Legal Jeopardy I have consulted with a number of lawyers on
this and all appear to agree with me.

The situation as I see it is as follows. Patients entering clinical
trials have a range of adverse effects which are not at present being
coded for either at all or satisfactorily. In the case of side-effects
not coded for satisfactorily these include problems such as suicidal
ideation, which are coded for under depression. Akathisia is not coded
for. Emotional indifference or emotional blunting or disinhibition are
not coded for.

This is an understandable situation. It is understandable and perhaps
acceptable if in the absence of figures to support a proper incidence
for these problems, marketeers for a company claim that the incidence
of these side-effects is zero. Everybody knows, you included I'm sure,
that side-effect data commonly marketed by companies is hopelessly
inadequate and underestimates the true extent of the problems probably
by a six-fold factor. The legal jeopardy arises when patients who
suffer from an adverse effect on the drug to the extent that they
consider a legal action are then faced with a company denying that the
drug causes the problem based upon the way the side-effect data have
been coded in their clinical trials. This could happen to you or me or
Dr Jones. Take the side-effects that have happened on Prozac for
instance, and the way Lilly have handled the data on this issue in
both court cases last year and in print in academic journals within
the last 18 months. It is this that constitutes a state of legal
jeopardy.

I would be very grateful if you could confirm for me that our
understandings coincide on this point. If they do not, and you
consider that this state is not a state of legal jeopardy, I would be
very grateful if you cold explain to me exactly why not. I would not
want to mislead any more people than I might have already misled by
including this understanding of current practices in any more articles
or books that I write.

I would be very grateful therefore to hear back from you on this point
specifically.

Yours sincerely,

David Healy MD FRCPsych
Director, North Wales Department of Psychological Medicine





================================================= ===
Ruby stepped toward him. "Edward," she said softly.
"Learn this from me. Holding anger is a poison. It
eats you from inside. We think that hating is a weapon
that attacks the person who harmed us. But hatred is
a curved blade. And the harm we do, we do to ourselves.
"Forgive, Edward, Forgive. Do you remember the
lightness you felt when you first arrived in heaven?...
No one is born with anger. And when we die, the soul
is freed of it. But now, here, in order to move on,
you must understand WHY you felt what you did, and WHY
you no longer need to feel it.
"Yo need to forgive your father."

Mitch Albom, "the five people you meet in heaven"

http://home.gwi.net/~mdmpsyd/index.htm

In news message: ,
jake typed:
On Tue, 28 Oct 2003 07:46:56 GMT, "Jon Quixote"
wrote:
snip
So far as I can tell, you're both "right", but not for the reason the
other thinks.

Again, if I read this disagreement correctly, you are correct, AFAIK, the
FDA has not previously issued a *general* alert for public consumption
regarding the *possible* link between antiDs and rare increase in
suicidal ideation.

Mark is correct in that the information that is being presented in the
alert regarding that *possible* link is NOT new, and has been included
with most if not all antidepressant literature for quite a long time,
including the warning to the prescriber to monitor the patient's initial
exposure to the drug closely due to the *possible* risk of increased
ideation.

If I misinterpreted either side, my apologies for jumping in on that
particular part of y'all's conversation.


If the FDA had listened to Mark of course..they would have realized
that would have been no need to send out this alert to all doctors
and health care professionals..
In the real world..the data from their studies convinced them there
was....

Interesting. I'm split on the significance of the alert now. On the one
hand, the Reuter's report appears to be a followup on the alert, wherein the
FDA clarified what it had issued in the alert in such a way as to tend to
support Mark's POV - but OTOH, the original alert tends to support your POV.

despite the attempt to generalise to suicides in general in AD treated

Perhaps that phrasing is a bit harsh? I don't know that he's "attempting" to
generalize, rather it appears that he's saying that the information, if the
Reuter's followup is accurate, is basically saying that irregardless of
whether it is being aimed at pediatricians or not, the information contained
therein has been known to health care professionals for quite a while.

I note that your disagreement gets more specific thereafter insofar as
whether medlit included with the drugs are in and of themselves effective
for alerting anyone, whether the ingestor or the prescriber, but that's an
issue I don't feel qualified to comment on except personal feeling: "fine
print" is unfortunately both necessary (due to costs otherwise of
reproducing mandated FYI material in standard print - and this nation
already complains of the cost associated with medication VERY frequently)
and IMO more often an artifact to slip unpleasant information under the
reader's threshold of attention.

"Fine print" is a legally acceptable compromise and one that's difficult to
make a statement pro or con for. Given that fine print would likely not even
be included if not legally mandated, at least the information IS there,
rather than not included at all if they weren't forced to do so.

IIRC, it's already been challenged in the past as inadequate if fine print
information that affects the health or wellbeing of the assignee is kept to
a "for more information, call/goto/write to such and so place" minimum. That
may even be the case for any product or service that materially impacts the
assignee whether physically or financially.

patients the report actually is concerned with CHILDREN who are
attempting suicide more often when taking the AD than those recieving
a placebo.
this is headline news...
here is the actual alert

http://www.fda.gov/cder/drug/advisory/mdd.htm
snip

I guess they should just abandon the meeting huh?
as all the data and findings are on the insert??
sheesh..

I don't believe he was suggesting abandoning the meeting for any reason. It
appeared to me that he was simply saying the information is not new and has
been known to pediatricians and other health care professionals for a while.

HOWEVER, I will say that the original alert's phrasing DOES suggest to me
that the FDA is emphasizing an even GREATER risk than first believed as
applied to children

here is the previous Talk paper that was not "ages ago "
but only four months ago

June 19, 2003

FDA Talk Paper

http://www.fda.gov/bbs/topics/ANSWER.../ANS01230.html

Again, it depends on which phrasing one is reading - Mark's, that claims the
information has been available for quite some time, or yours, where you are
emphasizing that for the FDA to make widespread public announcement
regarding this phenomenon IS new.

I note that elsewhere you claimed that "normal" (presumably meaning
"non-depressed") people committed suicide while taking the drugs in
question during their trials - where did you get that from? I didn't see
any hint of such a statistic.

No..I said became suicidal

So you did. My mistake and my apologies.

nobody did for a long time..the drug company supressed the results of
their safety trials showing this..and only gave then to researchers
when a court forced then too..

http://www.abc.net.au/pm/s312381.htm

Whom to "condemn", then, if somebody isn't aware of the fine print - the
unpleasant (or even "alarming") news, as it were?

In this particular case, I think it depends on how likely the suppression of
evidence is, and if so, why there hasn't been a MUCH bigger stink about it
than apparently only one doctor's concern.

If it turns out the suppression isn't occuring in the way the interview
implies, and that the information is, in fact, available - just not widely
disseminated without query being involved - we kind of come back full
circle: the information IS well known because doctors HAVE done the followup
queries.

That DOESN'T excuse the pharmaceutical companies from playing "head in the
sand" games with their data, of course - but it's a separate point of debate
from this thread, I believe.


--
Jon Quixote
What is axiomatic frequently isn't.

On Tue, 28 Oct 2003 15:36:14 +0000, jake wrote:

On Tue, 28 Oct 2003 08:40:42 -0500, Mark D Morin
wrote:

On Tue, 28 Oct 2003 06:30:33 +0000, jake wrote:


AFAIAA concern with violating copyright is the issue..
rather than your uglyminded interpretations..

This is coming from someone who routinely reposts the entire article
rather than simply provide a link?

are you being deliberately obtuse?
Its not my issue..and I did not post the
article here..

It looks like you are the one being obtuse.
Did you not write: "AFAIAA concern with violating copyright is the
issue.."







It's been on the warning lables and general print outs each patient
gets from the pharmacist for ages.

NO it has not been on inserts for "ages"

It has been here
perhaps you should ..without your alterations..

no alterations jake.

(not medication) exists nowhere in the text..it is your addition..

don't know what you are talking about jake--nothing was inserted nor
deleted in my cutting and pasting.

the words "(not medication)" arrived from where then?

What are you talking about?
I cut and paste jake--there was nothing in what I pasted that wasn't
in what I copied. If there was, tell it to microsoft.




the thread is about concern that children given ADs in clinical trials

That's not what the thread says jake

the thread says nothing..contributors to it do..

the subject line is

FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
on my newsreader anyhow..

and is that equivalent to what you said the thread is about?
================================================== ==
Ruby stepped toward him. "Edward," she said softly.
"Learn this from me. Holding anger is a poison. It
eats you from inside. We think that hating is a weapon
that attacks the person who harmed us. But hatred is
a curved blade. And the harm we do, we do to ourselves.
"Forgive, Edward, Forgive. Do you remember the
lightness you felt when you first arrived in heaven?...
No one is born with anger. And when we die, the soul
is freed of it. But now, here, in order to move on,
you must understand WHY you felt what you did, and WHY
you no longer need to feel it.
"Yo need to forgive your father."

Mitch Albom, "the five people you meet in heaven"

http://home.gwi.net/~mdmpsyd/index.htm

On Tue, 28 Oct 2003 15:49:52 +0000, jake wrote:

On Tue, 28 Oct 2003 06:37:18 -0800, "kc"
wrote:


"jake" wrote in message
. ..
On Tue, 28 Oct 2003 03:24:45 -0800, "kc"
wrote:


"jake" wrote in message
.. .


It is certainly new to the millions of people prescribed these
prescribed these drugs by a GP ..without an initial psychiatric
assessment..let alone any monitoring or supervision of any kind..close
or otherwise..

Not to mention the hundreds of thousands ordering them on the internet
without ever seeing a doctor..


you realize that this is a problem with the doctors

You blame the doctors for believing drug company disinformation and
lies?

no, i blame doctors for not requiring psych consults before perscribing psyc
meds. i blame the doctors for not monitoring patients who need to be
monitored. i don't see any disinfo here. the med inserts say that suicide
is a risk in ANY depressed patient, and indeed it is. if the docs hand out
a pill and ignore a suicidal patient, how on earth can that be the drug co's
fault?

One primary purpose of such advisories is to correct such
disinformation as to the safety and prescribing practices..

execpt there was no disinformation. this advisory doesn't tell anyone
anything new.

really..?

Yes.
Some of us read the literature jake.

"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. "

and that statement still does not support the conclussion that you are
inferring.


the use of SSRIs to treat depression is problematic
and of increasing concern..whatever spin might be used to hide thr
fact

seriously, i have no idea what your little agenda is all about, but SSRIs,
among other depression treatments, save MANY more lives than you claim they
take.

this was the promise..and the sales proposition..

time has proved the confidence misplaced..

How has that been proven jake?

it has yet to be shown that SSRIs "save childrens lives" in any way
shape or form..

i've said it before. don't like them, don't take them. but there's no
reason to wage a campaign against an entire class of meds that have saved so
many lives.

so lets just sweep the victims and ruined lives
under the carpet then...

alone with the ones who decide that they can no longer go on living
because of self riteous assholes like you.
================================================== ==
Ruby stepped toward him. "Edward," she said softly.
"Learn this from me. Holding anger is a poison. It
eats you from inside. We think that hating is a weapon
that attacks the person who harmed us. But hatred is
a curved blade. And the harm we do, we do to ourselves.
"Forgive, Edward, Forgive. Do you remember the
lightness you felt when you first arrived in heaven?...
No one is born with anger. And when we die, the soul
is freed of it. But now, here, in order to move on,
you must understand WHY you felt what you did, and WHY
you no longer need to feel it.
"Yo need to forgive your father."

Mitch Albom, "the five people you meet in heaven"

http://home.gwi.net/~mdmpsyd/index.htm

On Tue, 28 Oct 2003 16:02:27 +0000, jake wrote:

On Tue, 28 Oct 2003 08:48:38 -0500, Mark D Morin
wrote:

On Tue, 28 Oct 2003 08:54:03 +0000, jake wrote:


despite the attempt to generalise to suicides in general in AD treated
patients the report actually is concerned with CHILDREN who are
attempting suicide more often when taking the AD than those recieving
a placebo.
this is headline news...
here is the actual alert

http://www.fda.gov/cder/drug/advisory/mdd.htm

and where are the nondepressed controls you were talking about who
became suicidal?


I never suggested for one moment they were in the alert..
As you know full well..having discussed it before ..
the data on the the normal volunteers
are hidden as "proprietry information" in the drug company archives.

Oh, that's right. That hidden information that's somehow not
available.
Keep at it and you will sound as paranoid as linda.

================================================== ==
Ruby stepped toward him. "Edward," she said softly.
"Learn this from me. Holding anger is a poison. It
eats you from inside. We think that hating is a weapon
that attacks the person who harmed us. But hatred is
a curved blade. And the harm we do, we do to ourselves.
"Forgive, Edward, Forgive. Do you remember the
lightness you felt when you first arrived in heaven?...
No one is born with anger. And when we die, the soul
is freed of it. But now, here, in order to move on,
you must understand WHY you felt what you did, and WHY
you no longer need to feel it.
"Yo need to forgive your father."

Mitch Albom, "the five people you meet in heaven"

http://home.gwi.net/~mdmpsyd/index.htm

On Tue, 28 Oct 2003 13:07:21 -0500, Mark D Morin
wrote:

On Tue, 28 Oct 2003 15:36:14 +0000, jake wrote:

On Tue, 28 Oct 2003 08:40:42 -0500, Mark D Morin
wrote:

On Tue, 28 Oct 2003 06:30:33 +0000, jake wrote:


AFAIAA concern with violating copyright is the issue..
rather than your uglyminded interpretations..

This is coming from someone who routinely reposts the entire article
rather than simply provide a link?

are you being deliberately obtuse?
Its not my issue..and I did not post the
article here..

It looks like you are the one being obtuse.
Did you not write: "AFAIAA concern with violating copyright is the
issue.."

sigh..
the issue for your favourite-NOT
poster ..

I am quite comfortable with fair useage .










It's been on the warning lables and general print outs each patient
gets from the pharmacist for ages.

NO it has not been on inserts for "ages"

It has been here
perhaps you should ..without your alterations..

no alterations jake.

(not medication) exists nowhere in the text..it is your addition..

don't know what you are talking about jake--nothing was inserted nor
deleted in my cutting and pasting.

the words "(not medication)" arrived from where then?

What are you talking about?
I cut and paste jake--there was nothing in what I pasted that wasn't
in what I copied. If there was, tell it to microsoft.




the thread is about concern that children given ADs in clinical trials

That's not what the thread says jake

the thread says nothing..contributors to it do..

the subject line is

FDA Alert: Watch for Suicide of Kids on AD's 10/27/03
on my newsreader anyhow..

and is that equivalent to what you said the thread is about?

the word pedantic springs to mind..

I guess it depends on your interpretation

It seems a fair summation..not particularly
different to the headlines of the major newswires crrying the story..
eg

1)Beware of Suicide witDrugs - FDA

Mon Oct 27, 5:46 PM ET Add Health - Reuters to My Yahoo!

http://story.news.yahoo.com/news?tmp..._depression_dc

WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news -
web sites) alerted doctors on Monday about reports that
antidepressants might raise the risk of suicide in children and
teen-agers with major depression.

While there is no evidence to show most antidepressants could cause
young patients to commit suicide, doctors need to carefully watch
them, the FDA said


or

2) FDA Warns of Possible Drug-Suicide Link


http://www.newsday.com/news/politics...tics-headlines

By Associated Press

October 28, 2003, 9:55 AM EST

WASHINGTON -- Some anti-depressant drugs undergoing trials in children
may be associated with suicides, the Food and Drug Administration said
Monday.

The agency said reports in the press and medical journals describe
suicide attempts and suicides in children receiving antidepressants.
Many such reports also have been submitted to the FDA.


Click2Houston.com

3) FDA: Antidepressants May Be Linked To Kids' Suicide


POSTED: 4:19 p.m. EST October 27, 2003

http://www.click2houston.com/health/2585311/detail.html
WASHINGTON -- The Food and Drug Administration says some
antidepressant drugs undergoing trials in children, including Paxil,
may be associated with suicides.


__

"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

On Tue, 28 Oct 2003 13:11:06 -0500, Mark D Morin
wrote:

On Tue, 28 Oct 2003 15:49:52 +0000, jake wrote:

On Tue, 28 Oct 2003 06:37:18 -0800, "kc"
wrote:


"jake" wrote in message
...
On Tue, 28 Oct 2003 03:24:45 -0800, "kc"
wrote:


"jake" wrote in message
.. .


It is certainly new to the millions of people prescribed these
prescribed these drugs by a GP ..without an initial psychiatric
assessment..let alone any monitoring or supervision of any kind..close
or otherwise..

Not to mention the hundreds of thousands ordering them on the internet
without ever seeing a doctor..


you realize that this is a problem with the doctors

You blame the doctors for believing drug company disinformation and
lies?

no, i blame doctors for not requiring psych consults before perscribing psyc
meds. i blame the doctors for not monitoring patients who need to be
monitored. i don't see any disinfo here. the med inserts say that suicide
is a risk in ANY depressed patient, and indeed it is. if the docs hand out
a pill and ignore a suicidal patient, how on earth can that be the drug co's
fault?

One primary purpose of such advisories is to correct such
disinformation as to the safety and prescribing practices..

execpt there was no disinformation. this advisory doesn't tell anyone
anything new.

really..?

Yes.
Some of us read the literature jake.

I am sure many a busy overworked GP would like the leisure time to be
able to as well..
As it is studies tell us that reliance on information provided by drug
company Reps tends to be the norm..


"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. "

and that statement still does not support the conclussion that you are
inferring.


that more patients on the drug report suicidality than those given a
placebo seems pretty clearcut..and certainly reason for a responsible
safety body to inform prescribers..





the use of SSRIs to treat depression is problematic
and of increasing concern..whatever spin might be used to hide thr
fact

seriously, i have no idea what your little agenda is all about, but SSRIs,
among other depression treatments, save MANY more lives than you claim they
take.

this was the promise..and the sales proposition..

time has proved the confidence misplaced..

How has that been proven jake?

I thought you were saying you read the literature?
a highly selective reading perhaps..


Aside from the enduring risks ongoing treatment poses, the severity of
the anxiety withdrawal engenders can be extreme. In the case of the
healthy volunteer studies undertaken in the 1980s by Beecham one
volunteer in the aftermath of taking Seroxat committed suicide. The
company deny a link between their drug and the suicide but there are
good arguments to put forward in favour of a link.

Not least of those arguments is the data from RCTs. In an accompanying
paper, the evidence was put forward that Lilly, Pfizer and GSK have
recoded under placebo suicidal acts that occurred in the washout phase
of trials – that is following discontinuation of prior treatment.




http://www.socialaudit.org.uk/58092-DH.htm


SSRIs & WITHDRAWAL/DEPENDENCE

BRIEFING PAPER: 20-06-2003

DAVID HEALY

Summary

Dependence on and withdrawal from antidepressants has been recognised
since the early 1960s.

"The withdrawal syndrome complicates the evaluation of patients after
drug discontinuation since both patients and physicians often
interpret the onset of symptoms as an upsurge of "anxiety" related to
incipient relapse, and resume treatment with the gratifying subsidence
of the "anxiety". This may cause both patients and physicians to
overvalue the importance of the medication to the patient’s stability"
(Kramer et al 1961).

Therapeutic drug dependence or normal dose dependence needs to be
distinguished from drug dependence of the sort caused by opiates and
amphetamines.

Therapeutic drug dependence may give rise to withdrawal syndromes
lasting months or more.

Companies have not been required to test their drugs for therapeutic
drug dependence prior to marketing.

In the case of the SSRIs it would seem that therapeutic drug
dependence has been used as a means to claim prophylactic efficacy for
these drugs.

Companies’ marketing for SSRIs implies that these drugs differ from
the benzodiazepines in terms of producing dependence; these claims are
not warranted.

Recognition of dependence on antidepressants will provide safety for
patients and a stimulus to companies to produce safer drugs.

At present under the influence of company marketing many clinicians
and patients are operating with a model that claims depression is a
chronic condition that may need treatment for life – this is a model
with no basis in epidemiological data.





it has yet to be shown that SSRIs "save childrens lives" in any way
shape or form..

i've said it before. don't like them, don't take them. but there's no
reason to wage a campaign against an entire class of meds that have saved so
many lives.

so lets just sweep the victims and ruined lives
under the carpet then...

alone with the ones who decide that they can no longer go on living
because of self riteous assholes like you.

OIC
In your opinion those who believe in informed consent..and free access
to information as to drug safety are responsible for suicides.

Perhaps you think parents should not be told this official concern
as to the advisability of SSRIs for children exists..

On Tue, 28 Oct 2003 13:12:40 -0500, Mark D Morin
wrote:

On Tue, 28 Oct 2003 16:02:27 +0000, jake wrote:

On Tue, 28 Oct 2003 08:48:38 -0500, Mark D Morin
wrote:

On Tue, 28 Oct 2003 08:54:03 +0000, jake wrote:


despite the attempt to generalise to suicides in general in AD treated
patients the report actually is concerned with CHILDREN who are
attempting suicide more often when taking the AD than those recieving
a placebo.
this is headline news...
here is the actual alert

http://www.fda.gov/cder/drug/advisory/mdd.htm

and where are the nondepressed controls you were talking about who
became suicidal?


I never suggested for one moment they were in the alert..
As you know full well..having discussed it before ..
the data on the the normal volunteers
are hidden as "proprietry information" in the drug company archives.

Oh, that's right. That hidden information that's somehow not
available.


nothing "somehow " about it..
All drug companies have archives of safety tests on normal volunteers.
they refuse access to these archives on the grounds of "proprietry
information"

but of course you know this..

slowly but surely..they are being forced to divulge such information..

http://www.guardian.co.uk/print/0,38...103690,00.html

David Healy, director of the North Wales department of psychological
medicine and the UK's foremost expert in antidepressants, found
studies in archives in Harlow, Essex, which show that the company,
then SmithKline Beecham, realised in the 80s that healthy volunteers
were suffering withdrawal symptoms when they stopped taking the drug
after only a couple of weeks.

Yet the company has failed to warn patients or doctors, he says, and
it has argued that people suffering problems when they stop taking the
drug have suffered a recurrence of depression and need to go back on
the medication.


http://www.socialaudit.org.uk/58092-DH.htm

The state of affairs this gives rise to becomes apparent in a review
of Risperidone by A Mosholder cited below - unless a drug company
volunteers information to the FDA that their drug causes withdrawal
and or dependence the FDA will not make an assessment about the drug
as causing withdrawal or dependence. Patients can commit suicide in
the immediate withdrawal period but without an indication from the
company that a withdrawal syndrome is a possibility the FDA will not
consider that this is a possible cause of that suicide.


Keep at it and you will sound as paranoid as linda.

I will discuss issues with you..but your tedious obsession with Linda
you will have to deal with on your own..

jake wrote:

Oh, that's right. That hidden information that's somehow not
available.

nothing "somehow " about it..
All drug companies have archives of safety tests on normal volunteers.
they refuse access to these archives on the grounds of "proprietry
information"

but of course you know this..

I love it when you tell me what I know and what I don't know.
I know no such thing jake.

jake wrote:


Some of us read the literature jake.

I am sure many a busy overworked GP would like the leisure time to be
able to as well..
As it is studies tell us that reliance on information provided by drug
company Reps tends to be the norm..

what studies would those be.
How many physicians have you actually talked to on the issue?

"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. "

and that statement still does not support the conclussion that you are
inferring.

that more patients on the drug report suicidality than those given a
placebo seems pretty clearcut..

That it seems clear cut to you speaks more to what YOU don't know about
depression and it's treatment rather than health care providers.


the use of SSRIs to treat depression is problematic
and of increasing concern..whatever spin might be used to hide thr
fact

seriously, i have no idea what your little agenda is all about, but SSRIs,
among other depression treatments, save MANY more lives than you claim they
take.

this was the promise..and the sales proposition..

time has proved the confidence misplaced..

How has that been proven jake?


I thought you were saying you read the literature?

same question.


Aside from the enduring risks ongoing treatment poses, the severity of
the anxiety withdrawal engenders can be extreme. In the case of the
healthy volunteer studies undertaken in the 1980s by Beecham one
volunteer in the aftermath of taking Seroxat committed suicide. The
company deny a link between their drug and the suicide but there are
good arguments to put forward in favour of a link.

I'm sure I can find one person who drank milk and then comitted suicide.
That data point tells us nothing.


Not least of those arguments is the data from RCTs. In an accompanying
paper, the evidence was put forward that Lilly, Pfizer and GSK have
recoded under placebo suicidal acts that occurred in the washout phase
of trials – that is following discontinuation of prior treatment.

yet another document that is not attainable.


http://www.socialaudit.org.uk/58092-DH.htm

All I see is an extended editorial. Is there supposed to be some data?
it has yet to be shown that SSRIs "save childrens lives" in any way
shape or form..


i've said it before. don't like them, don't take them. but there's no
reason to wage a campaign against an entire class of meds that have saved so
many lives.

so lets just sweep the victims and ruined lives
under the carpet then...

alone with the ones who decide that they can no longer go on living
because of self riteous assholes like you.


OIC
In your opinion those who believe in informed consent..and free access
to information as to drug safety are responsible for suicides.

Your crusade has nothing to do with informed consent. That has been
taken care of in doctors offices for at least the past ten years as far
as a response to medication.

How many people in the recovery phase of nonpharmacological treatment
also experience suicidal ideation? Your placebo controls don't answer
that because a placebo is not treatment.