On 10 December 2006 Paul Okami reported malpractices of the pharmaceutical
industry in suppressing studies that showed limited efficacy of their
products. While this goes further in detail than I wrote when I referred
to the practices of some companies that have been deservedly criticised,
the central issue remains whether drug treatments should be dismissed tout
court in the way that Paul does.
Paul cites studies that show limited or no appreciable efficacy for drug
treatment of depression, anxiety, and such syndromes. As I said before, in
this field it is not good enough to simply cite studies that support one's
position, as there are a multitude of such studies, coming to different
conclusions. That is why I emphasized (and re-emphasized!) two recent
articles I regard as of the utmost importance, though unremarked upon by
subsequent posters. These point to the necessity of a thorough revision of
the methodological assumptions underlying current efficacy studies, one
arguing that the current classifications should be radically revised,
another that CBT and drug treatments, and studies of such, are seriously
deficient because of the failure to discriminate in their application. Too
often they treat patients as homogenous groups, when they are in fact
heterogeneous, and drugs appropriate for one group may not be so for
another. Unfortunately most studies of efficacy fail to allow for this.
The fact is that pharmacological applications to psychiatric disorders is,
if not in its infancy, then still in its early childhood, and there is a
long way to go before definitive statements of the kind to which Paul
inclined are appropriate for our present state of knowledge. In short,
currently there are far more questions than definitive answers.
Here are a few quotes from an article by Parker et al (2003) [Parker is
the lead author of one of the articles I previously referenced], made in
relation to the Kirsch et al (2002) article that Paul cites, and
specifically to their writing that "the pharmacological effects of
antidepressants are clinically negligible". He cites problems with the
studies under review by Kirsch et al:
"First, the current classification model.Creating pseudo-entities such as
'major depression' for use as the principal 'diagnostic' measure increases
the chance of non-differential results between interventions.
"Second, recruitment procedures have led to unrepresentative trial
subjects... Inclusion and exclusion criteria ensure a pristine subject
profile remote from clinical practice...
"Third, clinical trails remain subject to bias, despite the efforts of
researchers and the use of placebo-controlled designs. High non-specific
'responsivity' of trial subjects is the fourth factor eroding their value.
It is natural for humans to develop depressive reactions, which - for most
- have the tendency to remit, whether spontaneously or in response to
support or improvement in a stressful situation. Patients with 'clinical
depression' differ by a distinctly lower likelihood of a 'spontaneous
remission', whether reflecting biological, psychological or social
factors. Subjects in clinical trials are likely to be closer to the
general community than to clinical patients in 'responsivity' terms -
either to active treatment or to a placebo - which is a more salient
distorting factor than any 'placebo effect'...
"In summary, current [clinical trial] designs restrict the participation
of 'true' specific responders, being overly weighted towards pristine
subjects with non-biological depressive disorders, with unstable
symptomatology and disorders of marginal severity, and disposed to
'respond' irrespective of the treatment arm. Extrapolation of such studies
to the clinical management of melancholic depression, and possibly other
'biological' expressions of depression, is then illogical."
Parker later reports a study that concludes that "the assumption that RCT
[randomised controlled trials] are representative of the clinical
population is simply untrue".
Parker concludes: "Our position is, therefore, that we simply do not know
how big the effect of antidepressants is in clinical practice because RCTs
are not designed to tell us this. Clinical trials of antidepressants.can
tell us which compounds work (i.e., have efficacy)... What is meaningless
is to ask the trials questions they cannot answer, such as how well do
antidepressants work in usual practice (their effectiveness). The latter
question needs different trial designs from that of standard RCT. This is
no easy task and is one that will require more pragmatic/naturalistic
approaches to be more inclusive, while attempting to minimise allocation
bias. There needs to be careful selection of target groups, comparison
treatments and duration of the assessment period. Only then will we be
able to estimate the real added value of antidepressants in particular
patient groups."
These are the words (as is his article on the efficacy of CBT) of someone
who recognises that we are a long way from being able to make definitive
judgements about the efficacy or otherwise of pharmacological
interventions for psychiatric disorders. I rather prefer his cast of mind
to those of people who have already made up their minds that
pharmacological treatments for psychiatric disorders are little or no
better than placebo.
Moving on: Even allowing for selectivity in the choice of the cited
studies, I find some of Paul's comments puzzling:
The efficacy record of mood stabilizers for bipolar disorder, including
lithium, is dismal. E.g., 50%-70% receive no benefit from lithium, and
the
30-50% who do respond to lithium may only be partial responders (Geddes
et
al, 2004)...
What precisely are you saying here, Paul? Even taking your selected study
at face value, many thousands of individuals are obtaining partial (or
greater) relief from a recurrent nightmare world from which all to many
choose to depart voluntarily.
I note that no one has taken up my invitation to respond to Annette's
implied question to which I alluded in a previous post:
Annette wrote:
I had a sense of an underlying belief that
the disorders are perhaps non-existent as well.
It would be of interest if TIPSters who have already posted
on this thread would comment on this concern of Annette's.
I hope they will not ignore Annette's implied question while
following up the other points.
It remains of interest to obtain responses to Annette's implied query,
even if it is only to report it is without foundation.
Allen Esterson
Former lecturer, Science Department
Southwark College, London
http://www.esterson.org/
References
Parker, G. et al. "Clinical trials of antidepressant medications are
producing meaningless results." British Journal of Psychiatry (2003), 183,
102-104.
Parker, G. "Classifying Depression: Should Paradigms Lost Be Regained?"
American Journal of Psychiatry, 157:8, August 2000.
Parker, G. et al. " 'New' and 'old' antidepressants: all equal in the eyes
of the lore?" British Journal of Psychiatry (2001), 179: 95-96.
-------------------------------------
Sun, 10 Dec 2006 09:37:26 -0500
Author: "Paul Okami" <[EMAIL PROTECTED]>
Subject: Re: SSRIs and depression and anxiety
----- Original Message -----
From: "Allen Esterson" <[EMAIL PROTECTED]>
To: "Teaching in the Psychological Sciences (TIPS)"
<[email protected]>
Sent: Sunday, December 10, 2006 3:38 AM
Subject: [tips] Re: SSRIs and depression and anxiety
>> I note that Paul does not provide any references for his blanket
> statements of inefficacy. And choosing just those that support one's
> position, or studies that do so, is just not good enough in this field,
> as
> is evident from the two articles I recommended in my last (8 December)
> posting (see below), each discussing treatment modalities in a rigorous
> (sceptical, if you will) way, but recognising the pluses as well as the
> minuses (or reservations) in regard to CBT and pharmacological
> treatments.
>
Re: anti-depressants, when the Freedom of Information act was used to
obtain
ALL clinical trials submitted to the FDA from the major pharmaceutical
companies--including the ones they wished to surpress--for the six most
widely prescribed antidepressants, between 80%-90% of the apparent
effects
of antidepressants were duplicated by placebos (Kirsch, Moore, Scorboria
&
Nicholls, 2002). 57% of the clinical trials funded by the pharmaceutical
industry itself found no significant differences at all between drug and
placebo. In commentaries following this article by those who strongly
disagreed with the authors in their general conclusions that
antidepressants
are useless (or the entire enterprise of placebo controlled trials is
useless), the statistical facts--no more than 10-20% advantage of
antidepressants over placebo--were agreed upon by all. Some commentators
complained that methodology was at fault for the poor showing of
antidepressants, others suggested that even a 10-20% advantage over
placebo
is meaningful due to the enormous number of depressed individuals.
Kirsch
and others took a cost-benefit approach and showed that St. John's Wort,
with fewer side effects and lower cost, has just as good an efficacy
record
and much better safety record (e.g. Linde, Berner et al, 2005; Szegedi,
Kohnen et al 2005.
In all, a great many people receive little or no benefit from mental
health
treatement (e.g. Goldberg, Privett, et al., 1998; Rubinow, 2006). STAR*D
data published in 2006 (Rush et al; Trivedi et al) show that only 50% of
patients at best experience relief from treatment, and there are reasons
to
believe these data are biased in the direction of showing benefit. Newer
data showing that after a number of anti-depressants are tried many
eventually find relief are hopelessly confounded with the passage of
time,
as major depression is time limited virtually by definition (even though
it
is actually chronic more often than DSM allows).
The efficacy record of mood stabilizers for bipolar disorder, including
lithium, is dismal. E.g., 50%-70% receive no benefit from lithium, and
the
30-50% who do respond to lithium may only be partial responders (Geddes
et
al, 2004). When mood stabilizers do work at all, they work primarily on
mania, but bipolar disordered people are bothered much more by depression
than mania (e.g.Yatham, 2005).
For schizophrenia, the new generation of antipsychotics is not much
better
than the old, if at all better, with its own severe side effects (e.g.,
Lieberman, Stroup, McEvoy, etc., 2005). Less than 50% of people taking
neuroleptics find relief (e.g., Meyer & Quenzer, 2005).
In my opinion, benzodiazepines work when they work at all by making
people
sleepy, but I can't prove this.
[Snip]
> Paul wrote:
> "Cynicism is the method of the pharmacology and psychotherapy
> industries."
>
> Another blanket statement from Paul! Of course the pharmacological
> industry is out to make profits (as is any other business), and the
> practices of some companies have been deservedly criticised on
> occasion.
> But people often have mixed (or multiple) motives: a desire to make
> profits is not *necessarily* incompatible with a wish to provide
> effective
> treatments, and to include valid results of trials as part of the
> developmental procedures - especially as effective treatments are the
> best
> way to maximise profits. (I hope a debate about motivation doesn't
> become
> a distraction from the central issue, that of efficacy.)
I was objecting to the use of "cynicism" to describe skepticism about
the usefulness of current mental health treatments. If anything, it is
the
psychopharmacology and psychotherapy industries which are based in
cynicism,
because they greatly overstate the effectiveness of their treatments to a
suffering public.
Paul Okami>
>
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