Monday, November 21, 2005

Misleading psychiatric ads . . . from

Have a good Thanksgiving!
Jeff Schaler
BELOW are more new media articles
about how psychiatric drug ads
may be misleading the public about
a "chemical imbalance," from:

* _Wall Street Journal_ 11/18/05

* _United Press International_ 11/10/05

* _WebMD_ 11/7/05

* _Time Magazine Pacific_ 11/21/05

AT BOTTOM are links to the latest
news about this controversy.


_The Wall Street Journal_

November 18, 2005; Page B1



Some Drugs Work To Treat Depression,
But It Isn't Clear How

Hardly any patients know how Lipitor
lowers cholesterol, how Lotensin
reduces blood pressure, or even how
ibuprofen erases headaches. But when
it comes to Prozac, Zoloft and Paxil,
ads and glowing accounts in the press
have turned patients with depression
into veritable pharmacologists, able
to rattle off how these "selective
serotonin reuptake inhibitors" keep
more of the brain chemical serotonin
hanging around in synapses,
correcting the neurochemical
imbalance that causes depression.

There is only one problem. "Not a
single peer-reviewed article ...
support[s] claims of serotonin
deficiency in any mental disorder,"
scientists write in the December
issue of the journal PLoS Medicine.

Indeed, a steady drip of studies have
challenged the "serotonin did it"
hypothesis. A 2003 mouse experiment
suggested that SSRIs work by inducing
the birth and growth of new brain
neurons, not by monkeying with
serotonin. In March, a review of
decades of research concluded that
something other than "changes in
chemical balance might underlie
depression." And as Jeffrey Lacasse
and Jonathan Leo write in PLoS
Medicine, although ads for SSRIs say
they correct a chemical imbalance,
"there is no such thing as a
scientifically correct 'balance' of

How did so many smart people get it
so wrong? Medicinal chemist Derek
Lowe, who works in drug development
for a pharmaceutical firm, offered an
explanation in his "In the Pipeline"
blog. "I worked on central nervous
system drugs for eight years, and I
can confidently state that we know
just slightly more than jack" about
how antidepressants work.

It is not for lack of trying. In
1965, psychiatrist Joseph Schildkraut
of Harvard University suggested that a
deficiency of a brain chemical causes
depression. With the success of drugs
that block the reuptake of these
chemicals, that idea started to look
pretty good.

Yet the evidence was always
circumstantial. You can't measure
serotonin in the brains of living
human beings. The next best thing,
measuring the compounds that
serotonin breaks down to in
cerebrospinal fluid, suggested that
clinically depressed patients had
less of it than healthy people did.
But it was never clear whether
depression caused those low levels,
or vice versa. A 2002 review of these
early experiments took them to task
for such flaws.

There had always been data that don't
fit the serotonin-imbalance theory.
Depleting people's serotonin levels
sometimes changed their mood for the
worse and sometimes didn't. Sending
serotonin levels through the roof
didn't help depression, a study found
as early as 1975.

There is little doubt that the SSRIs
do what their name says, keeping more
serotonin in the brain's synapses. But
the fact "that SSRIs act on the
serotonin system does not mean that
clinical depression results from a
shortage of serotonin," says Dr. Leo,
professor of anatomy at Lake Erie
College of Osteopathic Medicine,
Bradenton, Fla. No more so, anyway,
than the fact that steroid creams
help rashes means that rashes are
caused by a steroid shortage.

A clue to how SSRIs do work comes
from how long they take to have any
effect. They rarely make a dent in
depression before three weeks, and
sometimes take eight weeks to kick
in. But they affect serotonin levels
right away. If depression doesn't
lift despite that serotonin hit, the
drugs must be doing something else;
it's the something else that eases

The best evidence so far is that the
something else is neurogenesis -- the
birth of new neurons. When scientists
led by Rene Hen of Columbia
University and Ronald Duman of Yale
blocked neurogenesis in mice, SSRIs
had no effect. When neurogenesis was
unimpeded, SSRIs made the mice less
anxious and depressed -- for rodents.
As best scientists can tell, SSRIs
first activate the serotonin system,
which is somehow necessary for
neurogenesis. That is what takes

Claiming that depression results from
a brain-chemical imbalance, as ads do,
is problematic on several fronts.
Patients who believe this are more
likely to demand a prescription. If
you have a disease caused by too
little insulin, you take insulin; if
you have one caused by too little
serotonin, you take serotonin

Most people treated for depression
get pills rather than psychotherapy,
and this week a study from Stanford
University reported that drugs have
been supplanting psychotherapy for
depressed adolescents. Clinical
guidelines call for using both, and
for psychotherapy to be the
first-line treatment for most kids.
Psychotherapy "can be as effective as
medications" for major depression,
concluded a study in April of 240
patients, in the Archives of General
Psychiatry. Numerous other studies
find the same.

The hegemony of the serotonin
hypothesis may be keeping patients
from a therapy that will help them
more in the long term. The relapse
rate for patients on pills is higher
than for those getting
cognitive-behavior psychotherapy.

Some 19 million people in the U.S.
suffer from depression in any given
year. For many, SSRIs help little, if
at all. To do better, we have to get
the science right.

Write to Sharon Begley at

or use this smaller url:


_United Press International_

Health Business

Study: Public misled by depression ads

WASHINGTON, Nov. 10 (UPI) -- The most
commonly prescribed anti-depressants
may be effective, but drug ads are
misleading about how the drugs work,
a new study suggests.

The study, published in the December
issue of the Public Library of Science
Medicine, focuses on manufacturers
that market the cutting-edge class of
anti-depressants known as selective
serotonin reuptake inhibitors.

The study results add to the
criticism of drug companies for
allegedly filling the airwaves with
slick but deceptive advertising on
various medications.

SSRIs can help relieve depression,
but the medical evidence that they do
so by correcting low levels of
serotonin in the brain is weak, and
therefore should be eliminated from
direct-to-consumer ads in magazines
and on television, the study's
authors said.

The authors were Jonathan Leo, a
professor of neuroanatomy at Lake
Erie College of Osteopathic Medicine
in Bradenton, Fla., and Jeffrey R.
Lacasse, a Ph.D. candidate at Florida
State University's College of Social

The duo attacked the widespread use
of the "serotonin theory of
depression" in their accompanying
text, saying clinical evidence does
not adequately support the statement
that serotonin imbalances in the
brain are responsible for clinical

"Depression and anxiety are
complicated issues that cannot be
explained in a 30-second commercial,"
the authors wrote. "When the serotonin
theory is portrayed with clever visual
portrayals that do not accurately
represent the neuroscience research,
consumers are led to believe that
medication is necessary for the
treatment for depression."

Leo added that, contrary to the
message in the ads, the prescribing
information on the drug labels do not
say that SSRIs correct serotonin

Leo and Lacasse called on the Food
and Drug Administration to exercise
more authority about what goes into
direct-to-consumer advertising to
make sure it is fair and balanced and
urged people to become more active in
their own care.

"In terms of real-life effects of
this advertising, we are concerned
that this oversimplified theory has
become the intellectual justification
for 10-minute office visits which
result in the prescription of
antidepressants for a variety of
ill-defined conditions," Lacasse
concluded. "In general, people need
to be more skeptical regarding claims
of chemical imbalance as explanation
for psychological distress."

or use this smaller url:


WebMD Medical News

Essay Questions Role of

Authors Challenge Link Between
Chemical Imbalance and Depression

By Salynn Boyles

Reviewed By Louise Chang, MD

Nov. 7, 2005 -- Do the most widely
prescribed antidepressants work by
correcting a chemical imbalance in
the brain? That's being challenged in
a newly published essay.

The essay's authors say the assertion
that depression results from an
imbalance in the brain chemical
serotonin and related chemicals is
not supported by the scientific

They write that there is "a growing
body of medical literature casting
doubt" on the so-called "serotonin
hypothesis." But a widely known
antidepressant researcher who spoke
to WebMD disagrees.

Brown University psychiatry professor
Peter D. Kramer, MD, is the author of
Listening to Prozac and Against

"The connection between what these
drugs do and what seems to be useful
in the treatment of mood disorders is
just as strong or stronger today as it
was 13 years ago when I wrote
Listening to Prozac," he says.

Kramer acknowledges that there is
still much to be learned about the
impact of brain chemistry on
depression and other mental
illnesses. He says it is unlikely
that serotonin imbalance alone
explains depression, but he adds that
Prozac and other antidepressants that
target serotonin clearly help many

Are Ads Misleading?

Selective serotonin reuptake
inhibitors (SSRIs), include the drugs
Prozac, Paxil, Zoloft, Lexapro, and
Celexa. The drugs increase the
availability of serotonin, which acts
as a chemical messenger in the brain
among other areas.

Millions of Americans take SSRIs for
depression and other mood disorders,
and in the U.S. alone sales of the
drugs top $10 billion a year.

In a newly published essay, anatomy
professor Jonathan Leo, PhD, along
with colleague Jeffrey Lacasse, say
that SSRI ads aimed at the public are
often misleading.

Leo teaches neuroanatomy at Lake Erie
College of Osteopathic Medicine in
Bradenton, Fla.

"The advertising is not portraying
the science in a true light," Leo
tells WebMD.

He says the ads typically claim that
SSRIs restore the serotonin balance
of the brain but adds that there is
"no such thing as a scientifically
established correct balance of

Leo cites a 2002 review which found
that SSRIs were only slightly more
effective than placebo for treating
depression. He adds that efforts to
use brain imaging to document
chemical imbalances linked to mental
illness have proven disappointing.

He also points to studies suggesting
that nondrug treatments, including
psychotherapy and exercise, may be as
effective as drugs for treating
certain mental illnesses.

"As long as people are told about all
these things I have no problem with
using these drugs," he says. "Without
a doubt, they help some people. Our
point is that the explanation for why
they work is simplistic and
potentially misleading."

Movie Star Spat

Leo and Lacasse published their essay
in the December issue of the Public
Library of Science journal PLoS
Medicine. The Public Library of
Science is a privately funded,
nonprofit group that publishes
scientific and medical research and
makes it freely available on its web

Leo says he hopes the paper will make
the public aware that there is
legitimate scientific debate about
whether depression is caused by
chemical imbalance.

"Professionals have researched and
debated this issue for years. It is
not just a public spat between two
movie stars," he says.

He is referring to actor Tom Cruise's
highly publicized criticism of actress
Brooke Shields, who wrote earlier this
year that SSRIs helped her recover
from postpartum depression after the
birth of her first child.

In a June appearance on NBC's Today
Show, Cruise called antidepressants
"very dangerous" and claimed there
was no proof that chemical imbalances
in the brain drive depression.

Shields responded in a New York Times
op-ed piece, calling Cruise's
assertions a "ridiculous rant."

Kramer tells WebMD that while the
serotonin hypothesis may not tell the
whole story, it has led to the
development of an important treatment
for depression and other mental

"It turns out that the medicines that
affect serotonin do other things, such
as protect the nerve cells and enhance
[the generation of new nerve cells],"
he says.

SOURCES: Lacasse, J. PLoS Medicine,
December 2005; vol. 2: pp. 101-106.
Jonathan Leo, PhD, associate
professor of anatomy, Lake Erie
College of Osteopathic Medicine,
Bradenton, FL. Peter D. Kramer, MD,
clinical professor of psychiatry and
human behavior, Brown University,
Providence, R.I. Kirsch et al,
British Medical Journal. NDC Health


_Time Magazine Pacific_ 21 November 2005

The cover story has two articles, too
long to post here:

"Bad Medicine? — Millions of people take
drugs to ward off depression. But skeptics
say the pills may do more harm than good."

"Taking on the Drug Defenders": A spotlight
on journalist Robert Whitaker, author of
_Mad in America_.,13674,503051121,00.html

or this smaller url:



BELOW are web pages with information
about the "chemical imbalance" controversy.


17 Nov. 2005: MindFreedom alert -- How you may
comment to the FDA about psychiatric drug ads:

or use this shorter url:


See the 11/14/05 MindFreedom alert about the
excellent essay published by PLoS debunking
advertising claims about a chemical imbalance:

or use this smaller url:


Here is an 11/8/05 MEDSCAPE news article
about the topic and the PLoS essay:

or use the smaller url:


Here is the text of the 12/05 PLoS essay
that debunks the "chemical imbalance" ads:

or use this smaller url:

[For individuals who have trouble viewing
the above, MindFreedom has a plain text
version that can be e-mailed to you free.]


Here is a print PDF (205 K) version of the PLoS essay:

or use this smaller url:


For background by FDA on their request for comments:

[Please note there is no "period" at end of this
URL; a previous alert added this, our apologies.]

If you have questions about the FDA process
contact Rose Cunningham at the FDA at


See MindFreedom's debate with Pfizer, Inc.,
manufacturer of Zoloft, about their
chemical imbalance claims:


Also see the historic debate with the
American Psychiatric Association resulting
from MindFreedom's 2003 hunger strike:



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