Don't Get Depressed Because Your Antidepressant is a Placebo
Posted: Wed Feb 27, 2008 6:13 pm
Its great to see the word placebo in conjunction with a drug instead of
always with homeopathy
http://www.huffingtonpost.com/alison-ro ... becau_b_88
773.html
Don't Get Depressed Because Your Antidepressant is a Placebo
Posted February 27, 2008 | 04:16 PM (EST)
Stand back and watch the P.R. spin as a new study in a peer-reviewed
journal finds that antidepressants make "virtually no difference at
moderate levels of initial depression to a relatively small difference for
patients with very severe depression."
In an article published in PLoS Medicine, researchers doing a meta-analysis
looked at 47 published and unpublished clinical trials, and found that
depressants attained clinically significant levels of efficacy "only for
patients at the upper end of the very severely depressed category."
In other words, if you have anything short of the upper end of severe
depression, a placebo might do as well as or better than an antidepressant.
Now, to be clear, I would never suggest that anyone out there read this or
any blog, and then suddenly go off their medication. Nor am I a fan of Tom
Cruise so let's take that right off the table.
In fact, I hope I don't disappoint your need for advice if I mention that
I'm not your doctor and I'm not making any clinical recommendations --
though it's widely known that because of the effect on brain chemistry any
alteration in medication dosage should be done gradually and under the care
of a practitioner.
However I will point out that gentle and uplifting supports which some find
helpful in low-grade depression relief, such as exercise, certain herbs,
counseling, guided imagery, relaxation, prayer, (or hey, even that
unscientifically verified behavior of talking with a friend) don't have the
side-effects of medication.
These side-effects have been known to include changes in brain chemistry,
and potential for suicidal ideation, violent urges, loss of libido, and
other goodies -- as well as the risk of harmful interactions with other
drugs, as occurred in the death of Heath Ledger. So choose your placebos
wisely.
The irony here is that conventional medicine routinely dismisses soft touch
approaches as "mere placebos." Therefore, what a surprise to find
prescribed drugs inside the Placebo Club, that feel-good purgatory reserved
only for natural substances developed by the earth.
Now that the Placebo Club is getting crowded, perhaps it's time to consider
whether some of those easily accessible approaches might warrant additional
study. Indeed many have been studied, even though Nature doesn't get the
same grants, let's face it.
Still, there's one underlying question. Clearly, it's the medical aim of
prescription antidepressants to act upon the neurotransmitters and thereby
to correct chemical imbalances in the brain that contribute to depression.
So do these drugs actually balance brain chemistry? Or do they merely
intervene in brain chemistry in a way that could potentially perpetuate or
worsen any imbalance?
Neurologist Fred Baughman, Jr. M.D. cites Dr John D. Griffith, Assistant
Professor of Psychiatry, Vanderbilt University School of Medicine, who as
far back as 1970 testified at a Congressional Hearing that, "Every drug,
however innocuous, has some degree of toxicity. A drug, therefore, is a
type of poison and its poisonous qualities must be carefully weighed
against its therapeutic usefulness."
The risk of toxicity to the brain, the locus for mood and mental function,
is something to ponder, especially since there are health approaches that
balance brain chemistry in a gentler manner.
Over the last seven years, clinicians and researchers have developed
diagnostics and protocols to measure and support key neurotransmitters,
like serotonin and dopamine. (FYI: The former are what antidepressant SSRIs
act upon.) First, they measure neurotransmitter levels and then customize
targeted amino acid supplements, which nourish the brain with the building
blocks of protein. On the biochemical level, these are options to consider.
(For more info, you can go to: www.health-journalist.com)
Beyond the biochemical, if you or someone you know is suffering from
depression, the further question is: "What in our world of suffering is
causing you pain?"
Whatever it is, you need to acknowledge it and then access all the best
"placebos" you can find. Whatever brings real joy, makes you feel a tad
better about yourself, moves you to care, or to reach out and act, go for
that placebo.
*********
http://www.huffingtonpost.com/2008/02/2 ... _n_88523.h
tml?view=print
British researchers have released a report that claims that
antidepressants, for the most part, are ineffective.
The researchers found that compared with placebo, these new-generation
antidepressant medications did not yield clinically significant
improvements in depression in patients who initially had moderate or even
very severe depression. The study found that significant benefits occurred
only in the most severely depressed patients.
So what makes this study different?
There are plenty of studies about antidepressants. What makes this one
so important -- the results were front-page news across the U.K. on Tuesday
-- is that the researchers were able to track down comprehensive
unpublished trial results from the drug makers themselves before the drugs
were authorized for sale in the U.S., and include them in their review of
the literature. The U.S. Food and Drug Administration (FDA) must receive
records of all relevant pharmaceutical-company trials, both published and
unpublished, before it will approve a drug. Under the Freedom of
Information Act, the researchers writing in PLoS Medicine were recently
able to obtain those FDA records of industry-sponsored clinical trials.
They yield data, they believe, that lets them avoid a bias that often
plagues reviews of previous research: the tendency for conclusive positive
results to be published, sometimes more than once, and thus
over-represented, while mediocre results can be ignored or even swept under
the rug.
*********
http://news.bbc.co.uk/2/hi/health/7263494.stm
BBC NEWS
Anti-depressants' 'little effect'
Study author
New generation anti-depressants have little clinical benefit for most
patients, research suggests.
A University of Hull team concluded the drugs actively help only a small
group of the most severely depressed.
Marjorie Wallace, head of the mental health charity Sane, said that if
these results were confirmed they could be "very disturbing".
But the makers of Prozac and Seroxat, two of the commonest
anti-depressants, said they disagreed with the findings.
A spokesman for GlaxoSmithKline, which makes Seroxat, said the study only
looked at a "small subset of the total data available".
Reviewed data
And Eli Lilly, which makes Prozac, said that "extensive scientific and
medical experience has demonstrated it is an effective anti-depressant".
but the most severely depressed patients
Professor Irving Kirsch
University of Hull
Alan Johnson, the Health Secretary, has announced that 3,600 therapists are
to be trained during the next three years in England to increase patient
access to talking therapies, which ministers see as a better alternative to
drugs.
Patients are strongly advised not to stop taking their medication without
first consulting a doctor.
The researchers accept many people believe the drugs do work for them, but
argue that could be a placebo effect - people feel better simply because
they are taking a medication which they think will help them.
In total, the Hull team, who published their findings in the journal PLoS
Medicine, reviewed data on 47 clinical trials.
They reviewed published clinical trial data, and unpublished data secured
under Freedom of Information legislation.
They focused on drugs which work by increasing levels of the mood
controlling chemical serotonin in the brain.
These included fluoxetine (Prozac) and paroxetine (Seroxat), from the class
known as Selective Serotonin Reuptake Inhibitors (SSRIs), alongside another
similar drug called venlafaxine (Efexor) - all commonly prescribed in the UK.
The number of prescriptions for anti-depressants hit a record high of more
than 31 million in England in 2006 - even though official guidance stresses
they should not be a first line treatment for mild depression.
There were 16.2m prescriptions for SSRIs alone.
The researchers found that the drugs did have a positive impact on people
with mild depression - but the effect was no bigger than that achieved by
giving patients a sugar-coated "dummy" pill.
People with severe symptoms appeared to gain more clear-cut benefit - but
this might be more down to the fact that they were less likely to respond
to the placebo pill, rather than to respond positively to the drugs.
HAVE YOUR SAY When used correctly and appropriately anti-depressant therapy
saves lives Stephen Brown, Birmingham
Lead researcher Professor Irving Kirsch said: "The difference in
improvement between patients taking placebos and patients taking
anti-depressants is not very great.
"This means that depressed people can improve without chemical treatments.
"Given these results, there seems little reason to prescribe
anti-depressant medication to any but the most severely depressed patients,
unless alternative treatments have failed to provide a benefit."
Professor Kirsch said the findings called into question the current system
of reporting drug trials.
Reviewing guidance
Dr Tim Kendall, deputy director of the Royal College of Psychiatrists
Research Unit, has published research concluding that drug companies tend
only to publish research which shows their products in a good light.
around the world, who looking at all the evidence, have determined that
they do work better than placebo
Dr Richard Tiner
Association of the British Pharmaceutical Industry
He said the Hull findings undermined confidence in the ability to draw
meaningful conclusions about the merit of drugs based on published data alone.
He called for drug companies to be forced to publish all their data.
The National Institute for Health and Clinical Excellence (NICE) is
currently reviewing its guidance on the use of antidepressants.
Marjorie Wallace of Sane commented: "If these results were upheld in
further studies, they would be very disturbing.
"The newer anti-depressants were the great hope for the future.... These
findings could remove what has been seen as a vital choice for thousands in
treating what can be a life-threatening condition."
Dr Andrew McCulloch, of the Mental Health Foundation, said: "We have become
vastly over-reliant on antidepressants when there is a range of alternatives.
"Talking therapies, exercise referral and other treatments are effective
for depression.
"It is a problem that needs a variety of approaches matched to the
individual patient."
Dr Richard Tiner, of the Association of the British Pharmaceutical
Industry, said there was no doubt that there was a "considerable placebo
effect" from anti-depressants when treating people with mild to moderate
symptoms.
But he said no medicine would get a licence without demonstrating it was
better than a placebo.
Dr Tiner said: "These medicines have been licensed by a number of
regulatory authorities around the world, who looking at all the evidence,
have determined that they do work better than placebo."
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/h ... 263494.stm
Published: 2008/02/26 11:36:21 GMT
© BBC MMVIII
*********
http://www.time.com/time/health/article ... 06,00.html
Tuesday, Feb. 26, 2008
Antidepressants Hardly Help
By LAURA BLUE/LONDON
Popular antidepressants including Prozac and Paxil have little impact on
most patients, according to a comprehensive review of newly released data
from trials that were conducted before the drugs were approved in the U.S.
Researchers from the U.K., U.S. and Canada analyzed results for fluoxetine
(better known by the brand name Prozac), venlafaxine (Effexor), nefazodone
(Serzone) and paroxetine (Paxil or Seroxat) — all members of a class of
drugs known as selective serotonin reuptake inhibitors (SSRIs). The
researchers' paper, published this week in the journal PLoS Medicine,
claims that only patients who are diagnosed "at the upper end of the very
severely depressed category" get any meaningful benefit from the widely
prescribed drugs. For the others, the paper says, antidepressants are
barely more effective than a placebo (although patients suffering from
depression, like those suffering from chronic pain, generally do see a
substantial placebo benefit).
There are plenty of studies about antidepressants. What makes this one so
important — the results were front-page news across the U.K. on Tuesday —
is that the researchers were able to track down comprehensive unpublished
trial results from the drug makers themselves before the drugs were
authorized for sale in the U.S., and include them in their review of the
literature. The U.S. Food and Drug Administration (FDA) must receive
records of all relevant pharmaceutical-company trials, both published and
unpublished, before it will approve a drug. Under the Freedom of
Information Act, the researchers writing in PLoS Medicine were recently
able to obtain those FDA records of industry-sponsored clinical trials.
They yield data, they believe, that lets them avoid a bias that often
plagues reviews of previous research: the tendency for conclusive positive
results to be published, sometimes more than once, and thus
over-represented, while mediocre results can be ignored or even swept under
the rug.
Drug companies claim the review is still flawed, however. One massive
problem: there are many more recent studies than those surveyed in the
article, which looked only at pre-approval trials conducted before 1999.
Nicholas Francis, a U.K. spokesman for Eli Lilly and Company, which
produces Prozac, says that the new study "does not take into account that
today more than 12,000 patients have participated in Prozac clinical trials
and thousands of scientific papers have referenced Prozac, supporting its
use in the treatment of depression." Some 50 million people worldwide have
taken Prozac, and in a company statement Lilly said it "is proud of the
difference Prozac has made to millions of people living with depression."
Similarly, paroxetine producer GlaxoSmithKline warns, "This analysis has
only examined a small subset of the total data available ... and this one
study should not be used to cause unnecessary alarm and concern for
patients." As a spokeswoman for Wyeth, Effexor's maker, points out, these
were, after all, the same data the FDA reviewed before approving the drugs
for public use.
There are really two issues at the heart of the controversy. One is the
difference between "statistical significance" — a measure of whether the
drug's effects are reliable, and that patient improvement is not just due
to chance — and "clinical significance," whether those effects actually are
big enough to make a difference in the life of a patient. The researchers
behind this new paper did find that SSRI drugs have a statistically
significant impact for most groups of patients: that is, there was some
measurable impact on depression compared to the placebo effect. "But a very
tiny effect may not have a meaningful difference in a person's life," says
Irving Kirsch, lead author on the paper and a professor of psychology at
the University of Hull in England. As it happens, only for the most
severely depressed patients did that measurable difference meet a U.K.
standard for clinical relevance — and that was mostly because the very
depressed did not respond as much to placebos. The drug trials showed SSRI
patients improved, on average, by 1.8 points on the Hamilton Depression
Rating Scale, a common tool to rate symptoms such as low mood, insomnia,
and lack of appetite. The U.K. authorities use a drug-placebo difference of
three points to determine clinical significance.
The more troubling question concerns what kind of data is appropriate for
analyzing a drug's efficacy. The companies are correct in claiming there is
far more data available on SSRI drugs now than there was 10 or 20 years
ago. But Kirsch maintains that the results he and colleagues reviewed make
up "the only data set we have that is not biased." He points out that
currently, researchers are not compelled to produce all results to an
independent body once the drugs have been approved; but until they are,
they must hand over all data. For that reason, while the PLoS Medicine
paper data may not be perfect, it may still be among the best we've got.
****************
Sheri Nakken, former R.N., MA, Hahnemannian Homeopath
http://www.wellwithin1.com/homeo.htm
always with homeopathy
http://www.huffingtonpost.com/alison-ro ... becau_b_88
773.html
Don't Get Depressed Because Your Antidepressant is a Placebo
Posted February 27, 2008 | 04:16 PM (EST)
Stand back and watch the P.R. spin as a new study in a peer-reviewed
journal finds that antidepressants make "virtually no difference at
moderate levels of initial depression to a relatively small difference for
patients with very severe depression."
In an article published in PLoS Medicine, researchers doing a meta-analysis
looked at 47 published and unpublished clinical trials, and found that
depressants attained clinically significant levels of efficacy "only for
patients at the upper end of the very severely depressed category."
In other words, if you have anything short of the upper end of severe
depression, a placebo might do as well as or better than an antidepressant.
Now, to be clear, I would never suggest that anyone out there read this or
any blog, and then suddenly go off their medication. Nor am I a fan of Tom
Cruise so let's take that right off the table.
In fact, I hope I don't disappoint your need for advice if I mention that
I'm not your doctor and I'm not making any clinical recommendations --
though it's widely known that because of the effect on brain chemistry any
alteration in medication dosage should be done gradually and under the care
of a practitioner.
However I will point out that gentle and uplifting supports which some find
helpful in low-grade depression relief, such as exercise, certain herbs,
counseling, guided imagery, relaxation, prayer, (or hey, even that
unscientifically verified behavior of talking with a friend) don't have the
side-effects of medication.
These side-effects have been known to include changes in brain chemistry,
and potential for suicidal ideation, violent urges, loss of libido, and
other goodies -- as well as the risk of harmful interactions with other
drugs, as occurred in the death of Heath Ledger. So choose your placebos
wisely.
The irony here is that conventional medicine routinely dismisses soft touch
approaches as "mere placebos." Therefore, what a surprise to find
prescribed drugs inside the Placebo Club, that feel-good purgatory reserved
only for natural substances developed by the earth.
Now that the Placebo Club is getting crowded, perhaps it's time to consider
whether some of those easily accessible approaches might warrant additional
study. Indeed many have been studied, even though Nature doesn't get the
same grants, let's face it.
Still, there's one underlying question. Clearly, it's the medical aim of
prescription antidepressants to act upon the neurotransmitters and thereby
to correct chemical imbalances in the brain that contribute to depression.
So do these drugs actually balance brain chemistry? Or do they merely
intervene in brain chemistry in a way that could potentially perpetuate or
worsen any imbalance?
Neurologist Fred Baughman, Jr. M.D. cites Dr John D. Griffith, Assistant
Professor of Psychiatry, Vanderbilt University School of Medicine, who as
far back as 1970 testified at a Congressional Hearing that, "Every drug,
however innocuous, has some degree of toxicity. A drug, therefore, is a
type of poison and its poisonous qualities must be carefully weighed
against its therapeutic usefulness."
The risk of toxicity to the brain, the locus for mood and mental function,
is something to ponder, especially since there are health approaches that
balance brain chemistry in a gentler manner.
Over the last seven years, clinicians and researchers have developed
diagnostics and protocols to measure and support key neurotransmitters,
like serotonin and dopamine. (FYI: The former are what antidepressant SSRIs
act upon.) First, they measure neurotransmitter levels and then customize
targeted amino acid supplements, which nourish the brain with the building
blocks of protein. On the biochemical level, these are options to consider.
(For more info, you can go to: www.health-journalist.com)
Beyond the biochemical, if you or someone you know is suffering from
depression, the further question is: "What in our world of suffering is
causing you pain?"
Whatever it is, you need to acknowledge it and then access all the best
"placebos" you can find. Whatever brings real joy, makes you feel a tad
better about yourself, moves you to care, or to reach out and act, go for
that placebo.
*********
http://www.huffingtonpost.com/2008/02/2 ... _n_88523.h
tml?view=print
British researchers have released a report that claims that
antidepressants, for the most part, are ineffective.
The researchers found that compared with placebo, these new-generation
antidepressant medications did not yield clinically significant
improvements in depression in patients who initially had moderate or even
very severe depression. The study found that significant benefits occurred
only in the most severely depressed patients.
So what makes this study different?
There are plenty of studies about antidepressants. What makes this one
so important -- the results were front-page news across the U.K. on Tuesday
-- is that the researchers were able to track down comprehensive
unpublished trial results from the drug makers themselves before the drugs
were authorized for sale in the U.S., and include them in their review of
the literature. The U.S. Food and Drug Administration (FDA) must receive
records of all relevant pharmaceutical-company trials, both published and
unpublished, before it will approve a drug. Under the Freedom of
Information Act, the researchers writing in PLoS Medicine were recently
able to obtain those FDA records of industry-sponsored clinical trials.
They yield data, they believe, that lets them avoid a bias that often
plagues reviews of previous research: the tendency for conclusive positive
results to be published, sometimes more than once, and thus
over-represented, while mediocre results can be ignored or even swept under
the rug.
*********
http://news.bbc.co.uk/2/hi/health/7263494.stm
BBC NEWS
Anti-depressants' 'little effect'
Study author
New generation anti-depressants have little clinical benefit for most
patients, research suggests.
A University of Hull team concluded the drugs actively help only a small
group of the most severely depressed.
Marjorie Wallace, head of the mental health charity Sane, said that if
these results were confirmed they could be "very disturbing".
But the makers of Prozac and Seroxat, two of the commonest
anti-depressants, said they disagreed with the findings.
A spokesman for GlaxoSmithKline, which makes Seroxat, said the study only
looked at a "small subset of the total data available".
Reviewed data
And Eli Lilly, which makes Prozac, said that "extensive scientific and
medical experience has demonstrated it is an effective anti-depressant".
but the most severely depressed patients
Professor Irving Kirsch
University of Hull
Alan Johnson, the Health Secretary, has announced that 3,600 therapists are
to be trained during the next three years in England to increase patient
access to talking therapies, which ministers see as a better alternative to
drugs.
Patients are strongly advised not to stop taking their medication without
first consulting a doctor.
The researchers accept many people believe the drugs do work for them, but
argue that could be a placebo effect - people feel better simply because
they are taking a medication which they think will help them.
In total, the Hull team, who published their findings in the journal PLoS
Medicine, reviewed data on 47 clinical trials.
They reviewed published clinical trial data, and unpublished data secured
under Freedom of Information legislation.
They focused on drugs which work by increasing levels of the mood
controlling chemical serotonin in the brain.
These included fluoxetine (Prozac) and paroxetine (Seroxat), from the class
known as Selective Serotonin Reuptake Inhibitors (SSRIs), alongside another
similar drug called venlafaxine (Efexor) - all commonly prescribed in the UK.
The number of prescriptions for anti-depressants hit a record high of more
than 31 million in England in 2006 - even though official guidance stresses
they should not be a first line treatment for mild depression.
There were 16.2m prescriptions for SSRIs alone.
The researchers found that the drugs did have a positive impact on people
with mild depression - but the effect was no bigger than that achieved by
giving patients a sugar-coated "dummy" pill.
People with severe symptoms appeared to gain more clear-cut benefit - but
this might be more down to the fact that they were less likely to respond
to the placebo pill, rather than to respond positively to the drugs.
HAVE YOUR SAY When used correctly and appropriately anti-depressant therapy
saves lives Stephen Brown, Birmingham
Lead researcher Professor Irving Kirsch said: "The difference in
improvement between patients taking placebos and patients taking
anti-depressants is not very great.
"This means that depressed people can improve without chemical treatments.
"Given these results, there seems little reason to prescribe
anti-depressant medication to any but the most severely depressed patients,
unless alternative treatments have failed to provide a benefit."
Professor Kirsch said the findings called into question the current system
of reporting drug trials.
Reviewing guidance
Dr Tim Kendall, deputy director of the Royal College of Psychiatrists
Research Unit, has published research concluding that drug companies tend
only to publish research which shows their products in a good light.
around the world, who looking at all the evidence, have determined that
they do work better than placebo
Dr Richard Tiner
Association of the British Pharmaceutical Industry
He said the Hull findings undermined confidence in the ability to draw
meaningful conclusions about the merit of drugs based on published data alone.
He called for drug companies to be forced to publish all their data.
The National Institute for Health and Clinical Excellence (NICE) is
currently reviewing its guidance on the use of antidepressants.
Marjorie Wallace of Sane commented: "If these results were upheld in
further studies, they would be very disturbing.
"The newer anti-depressants were the great hope for the future.... These
findings could remove what has been seen as a vital choice for thousands in
treating what can be a life-threatening condition."
Dr Andrew McCulloch, of the Mental Health Foundation, said: "We have become
vastly over-reliant on antidepressants when there is a range of alternatives.
"Talking therapies, exercise referral and other treatments are effective
for depression.
"It is a problem that needs a variety of approaches matched to the
individual patient."
Dr Richard Tiner, of the Association of the British Pharmaceutical
Industry, said there was no doubt that there was a "considerable placebo
effect" from anti-depressants when treating people with mild to moderate
symptoms.
But he said no medicine would get a licence without demonstrating it was
better than a placebo.
Dr Tiner said: "These medicines have been licensed by a number of
regulatory authorities around the world, who looking at all the evidence,
have determined that they do work better than placebo."
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/h ... 263494.stm
Published: 2008/02/26 11:36:21 GMT
© BBC MMVIII
*********
http://www.time.com/time/health/article ... 06,00.html
Tuesday, Feb. 26, 2008
Antidepressants Hardly Help
By LAURA BLUE/LONDON
Popular antidepressants including Prozac and Paxil have little impact on
most patients, according to a comprehensive review of newly released data
from trials that were conducted before the drugs were approved in the U.S.
Researchers from the U.K., U.S. and Canada analyzed results for fluoxetine
(better known by the brand name Prozac), venlafaxine (Effexor), nefazodone
(Serzone) and paroxetine (Paxil or Seroxat) — all members of a class of
drugs known as selective serotonin reuptake inhibitors (SSRIs). The
researchers' paper, published this week in the journal PLoS Medicine,
claims that only patients who are diagnosed "at the upper end of the very
severely depressed category" get any meaningful benefit from the widely
prescribed drugs. For the others, the paper says, antidepressants are
barely more effective than a placebo (although patients suffering from
depression, like those suffering from chronic pain, generally do see a
substantial placebo benefit).
There are plenty of studies about antidepressants. What makes this one so
important — the results were front-page news across the U.K. on Tuesday —
is that the researchers were able to track down comprehensive unpublished
trial results from the drug makers themselves before the drugs were
authorized for sale in the U.S., and include them in their review of the
literature. The U.S. Food and Drug Administration (FDA) must receive
records of all relevant pharmaceutical-company trials, both published and
unpublished, before it will approve a drug. Under the Freedom of
Information Act, the researchers writing in PLoS Medicine were recently
able to obtain those FDA records of industry-sponsored clinical trials.
They yield data, they believe, that lets them avoid a bias that often
plagues reviews of previous research: the tendency for conclusive positive
results to be published, sometimes more than once, and thus
over-represented, while mediocre results can be ignored or even swept under
the rug.
Drug companies claim the review is still flawed, however. One massive
problem: there are many more recent studies than those surveyed in the
article, which looked only at pre-approval trials conducted before 1999.
Nicholas Francis, a U.K. spokesman for Eli Lilly and Company, which
produces Prozac, says that the new study "does not take into account that
today more than 12,000 patients have participated in Prozac clinical trials
and thousands of scientific papers have referenced Prozac, supporting its
use in the treatment of depression." Some 50 million people worldwide have
taken Prozac, and in a company statement Lilly said it "is proud of the
difference Prozac has made to millions of people living with depression."
Similarly, paroxetine producer GlaxoSmithKline warns, "This analysis has
only examined a small subset of the total data available ... and this one
study should not be used to cause unnecessary alarm and concern for
patients." As a spokeswoman for Wyeth, Effexor's maker, points out, these
were, after all, the same data the FDA reviewed before approving the drugs
for public use.
There are really two issues at the heart of the controversy. One is the
difference between "statistical significance" — a measure of whether the
drug's effects are reliable, and that patient improvement is not just due
to chance — and "clinical significance," whether those effects actually are
big enough to make a difference in the life of a patient. The researchers
behind this new paper did find that SSRI drugs have a statistically
significant impact for most groups of patients: that is, there was some
measurable impact on depression compared to the placebo effect. "But a very
tiny effect may not have a meaningful difference in a person's life," says
Irving Kirsch, lead author on the paper and a professor of psychology at
the University of Hull in England. As it happens, only for the most
severely depressed patients did that measurable difference meet a U.K.
standard for clinical relevance — and that was mostly because the very
depressed did not respond as much to placebos. The drug trials showed SSRI
patients improved, on average, by 1.8 points on the Hamilton Depression
Rating Scale, a common tool to rate symptoms such as low mood, insomnia,
and lack of appetite. The U.K. authorities use a drug-placebo difference of
three points to determine clinical significance.
The more troubling question concerns what kind of data is appropriate for
analyzing a drug's efficacy. The companies are correct in claiming there is
far more data available on SSRI drugs now than there was 10 or 20 years
ago. But Kirsch maintains that the results he and colleagues reviewed make
up "the only data set we have that is not biased." He points out that
currently, researchers are not compelled to produce all results to an
independent body once the drugs have been approved; but until they are,
they must hand over all data. For that reason, while the PLoS Medicine
paper data may not be perfect, it may still be among the best we've got.
****************
Sheri Nakken, former R.N., MA, Hahnemannian Homeopath
http://www.wellwithin1.com/homeo.htm