[“. . . if the major media picks up on this story, they will
have the chance to report on what arguably is the worst—and most
harmful—scandal in American medical history” ]
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SCIENTIFIC MISCONDUCT AND FRAUD: THE FINAL NAIL IN PSYCHIATRY’S
ANTIDEPRESSANT COFFIN  
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Bruce E. Levine
January 17, 2024
Counterpunch
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_ “. . . if the major media picks up on this story, they will have
the chance to report on what arguably is the worst—and most
harmful—scandal in American medical history” _

, Photo by Nastya Dulhiier

 

Historically, there have always been some patients who report
that _any_ treatment for depression—including bloodletting—has
worked for them, but science demands that for a treatment to be deemed
truly effective, it must work better than a placebo or the passage of
time without any treatment. This is especially important for
antidepressant drugs—including Prozac, Zoloft, and other selective
serotonin reuptake inhibitors (SSRIs), as well as Effexor, Cymbalta,
and other serotonin and norepinephrine reuptake inhibitors
(SNRIs)—because all of these drugs have uncontroversial troubling
side effects.

Researchers have long known that any single antidepressant drug is
little more effective than a placebo in the majority of trials, shown
to be less effective than a placebo
[[link removed]] in some studies, and
generally found to be “clinically negligible
[[link removed]]” with respect
to depression remission, while often resulting in severe adverse
effects; for example, resulting in a higher percentage of sexual
dysfunction
[[link removed]] than
depression remission. However, for nearly twenty years, psychiatry and
Big Pharma have told us that while one antidepressant may not work for
the majority of patients, in the “real world,” doctors provide
patients who have been failed by their initial antidepressant with
another antidepressant, and if that fails, still another; and that
this real-world treatment is successful for nearly 70% of patients.
This narrative has been repeatedly reported by the mainstream media,
including the _New York Times _
[[link removed]]in
2022
[[link removed]].

The problem with this “nearly 70%” story is that the research that
has been used to justify it, a 2006 report on the results of
the Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
[[link removed]],
has long been disputed by researchers
[[link removed]].
Moreover, a recent reanalysis
[[link removed]] of previously
undisclosed data reveals that STAR*D, owing to scientific misconduct
that dramatically inflated remission rates, may go down in US medical
history as one of its most harmful scandals. Among the few journalists
in the world who have recognized the implications of STAR*D for the
treatment of millions of people is Robert Whitaker, and in his
September 2023 report, “The STAR*D Scandal: Scientific Misconduct on
a Grand Scale
[[link removed]],”
he stated: “The protocol violations and publication of a fabricated
‘principal outcome’—the 67% cumulative remission rate—are
evidence of scientific misconduct that rises to the level of fraud.”

EARLIER ANTIDEPRESSANT COFFIN NAILS

Prozac, the first SSRI antidepressant, received FDA approval in 1987
and entered the market in 1988; with Zoloft entering the market in
1991, followed by Paxil in 1992. By the late 1990s, Americans were
seeing drug commercials on television, which would eventually include
antidepressant commercials such as the early 2000s “sad blob”
Zoloft commercial [[link removed]] that
promoted the belief that SSRIs could correct the chemical imbalance
that was causing depression. However, by the 1990s, researchers had
already discarded the serotonin imbalance theory of depression, with
the invalidity of this theory finally reported by the mainstream
media in 2022 [[link removed]].

Psychiatry and Big Pharma have never disputed the adverse effects of
its antidepressants, but have claimed that the great benefits of these
drugs outweigh their adverse effects. Is this claim valid?

Receiving little attention by the mainstream media in 2002,
the _Journal of the American Medical
Association _(_JAMA_) published
[[link removed]] a study aimed at
discrediting the herb St. John’s wort as an antidepressant. However,
in this randomized controlled trial (RCT), in addition to one group
receiving a placebo and a second group receiving St. John’s wort,
there was a third group that received the standard dose of the SSRI
Zoloft. The results? The placebo worked _better_ than both St.
John’s wort and Zoloft. Specifically, a positive “full response”
occurred in 32 percent of the placebo-treated patients, 25 percent of
the Zoloft-treated patients, and 24 percent of the St. John’s
wort-treated patients.

A major reason why most of the general public never heard about this
study was that it was published with the title, “Effect of Hypericum
Perforatum (St John’s wort) in Major Depressive Disorder: A
Randomized Controlled Trial.” Why was there no mention of Zoloft in
the study title? Zoloft is manufactured by Pfizer, and the financial
disclosure of this study’s lead author, psychiatrist Jonathan R. T.
Davidson, states: “Dr. Davidson holds stock in Pfizer [manufacturer
of Zoloft] . . . and has received speaker fees from Pfizer.”

While this 2002 study showing that the placebo worked better than both
Zoloft and St John’s wort was buried, later in 2002, a large study
did receive significant attention. A leading researcher of the placebo
effect, Irving Kirsch, examined forty-seven drug company studies on
various antidepressants. These studies included published and
unpublished trials, but all had been submitted to the Food and Drug
Administration (FDA), so Kirsch used the Freedom of Information Act to
gain access to all data. He reported
[[link removed]] that
“all antidepressants, including the well-known SSRIs . . . had no
clinically significant benefit over a placebo.”

The adverse effects of antidepressant drugs have long been known and
acknowledged by psychiatry and Big Pharma. Even that “sad blob”
Zoloft commercial mentions the side effects of “dry mouth, insomnia,
sexual side effects, diarrhea, nausea, and sleepiness” (omitted are
several other adverse effects that affect a high percentage of
patients, including debilitating withdrawal reactions
[[link removed]] that
can be severe and persistent
[[link removed]]).
Let’s take a closer look at one of those adverse effects that is
mentioned in the commercial: “sexual side effects.”

“Sexual dysfunction is a common side effect of antidepressants,”
reported the journal _Drug, Healthcare and Patient Safety_ in a 2010
examination of several studies in the review:
“Antidepressant-Associated Sexual Dysfunction: Impact, Effects, and
Treatment [[link removed]].”
Sexual dysfunction problems range from decreased sexual desire, to the
inability to achieve an erection, to several other sexual
difficulties. This review reported that the percentage of sexual
dysfunction for SSRI antidepressants over several studies runs from
25%–73%; and in one study of 344 patients who had a history of
normal sexual function before SSRI treatments, there was an overall
incidence of 58% sexual dysfunction, with the percentage of sexual
dysfunction for Paxil users at 65%, for Luvox users at 59%, for Zoloft
users at 56%, and for Prozac users at 54%. Furthermore, the
long-buried iatrogenic illness (physician-caused) of post-SSRI sexual
dysfunction (PSSD) [[link removed]], in
which sexual dysfunction exists even after discontinuation of the
SSRI, was first reported to regulators in 1991, but it took until 2006
for it to be formally characterized as a syndrome.

Psychiatry today acknowledges antidepressant adverse effects and even
acknowledges that antidepressants are often ineffective, however, it
clings to the idea that if depressed patients are treated with enough
different antidepressants, nearly 70% of them will achieve remission.
They justify this by quoting the 2006 STAR*D study results, and the
mainstream media has not challenged this.

THE FINAL COFFIN NAIL: STAR*D SCIENTIFIC MISCONDUCT AND FRAUD

The goal of the STAR*D study, reported in 2006
[[link removed]],
was to assess antidepressant effectiveness in the “real
world”—where depressed patients who don’t remit with one
antidepressant are prescribed another.

In the STAR*D study, there were 4041 subjects and four treatment
stages, each lasting three months. In the first stage, all depressed
patients received the SSRI Celexa, and these Celexa-treated patients
who failed to have remission of depression symptoms were then, in a
second three-month stage, assigned to several other treatment modes,
including the substitution of Celexa with other antidepressants.
Depressed patients who continued to be non-remitters after these first
two stages were encouraged to enter a third stage that included other
types of antidepressants; and for those who continued to be
non-remitters, there was a fourth stage of other antidepressants.
STAR*D investigators reported, “The overall cumulative remission
rate was 67%,” which the _New York Times _
[[link removed]]in
2022
[[link removed]] reported
this way: “nearly 70 percent of people had become symptom-free by
the fourth antidepressant.”

However, this “nearly 70%” is based on scientific misconduct.
Psychologist Ed Pigott and his co-researchers published a
deconstruction of the STAR*D trial in 2010
[[link removed]],
and then with access to more of the study’s data, published a
reanalysis of STAR*D in the journal _BMJ_ in 2023
[[link removed]], concluding: “In
contrast to the STAR*D-reported 67% cumulative remission rate after up
to four antidepressant treatment trials, the rate was 35.0% when using
the protocol-stipulated HRSD [Hamilton Rating Scale for Depression]
and inclusion in data analysis criteria.”

Whitaker points out, “The essential element in scientific misconduct
is this: it does not result from honest mistakes, but rather is born
from an intent to deceive.” For him, the most glaring scientific
misconduct that rises to the level of fraudis STAR*D authors’
inclusion of ineligible 931 patients who were initially excluded by
STAR*D investigators as not meeting the criteria for depression.
Specifically, after the first treatment step, a report by the STAR*D
investigators
[[link removed]]noted
that among the 4041 subjects, only 3110 met the depression criteria,
and so 931 patients should be excluded from the calculation of a
remission rate. However, Whitaker reports, “the STAR*D investigators
snuck this group back into their count of ‘evaluable’ patients.”

Thus, STAR*D investigators moved a group of subjects that they
themselves had previously excluded as being non-evaluable into the
evaluable patients category, knowing full well that this would
dramatically inflate the remission rate. “That tells of a conscious
act of scientific fraud,” reports Whitaker.

This was not STAR*D investigators’ only scientific misconduct. They
also switched the primary outcome measures during the study to inflate
remission rates. Additionally, STAR*D investigators had originally
designated subjects who dropped out of the study to be counted as
treatment failures [[link removed]],
however, they reversed this protocol so that these dropouts were
excluded from the tally, again inflating remission rates. Even with
the research misconduct of violating their original protocol, STAR*D
remission rates were so unimpressive that STAR*D investigators
orchestrated another maneuver to further inflate remission rates: they
created a “theoretical” remission rate based on the notion that if
the drop-outs had stayed in the trial through all four stages of
treatment, they would have remitted at the same rate as those who did
stay in the trial to that end. STAR*D investigators’ assumptions
about drop-outs, Pigott points out, “are not true” as they are
counter to previous research.

In summary, STAR*D investigators’ protocol violations and a baseless
theoretical calculation raised the cumulative remission rate to
67%—in contrast to the 35% remission rate that Pigott calculated had
STAR*D researchers stuck to the original study design.

So, what could have been the motivation for the STAR*D investigators
to inflate these remission rates? The two lead STAR*D investigators
were psychiatrists A. John Rush and Madhukar H. Trivedi, and in the
2006 STAR*D report, at its end in small print, 
[[link removed]]are
the details of their financial relationships with multiple
pharmaceutical companies, including the manufacturers of several of
the antidepressants used in STAR*D, such as Forest Pharmaceuticals
(Celexa), Wyeth-Ayerst Laboratories (Effexor), GlaxoSmithKline
(Wellbutrin), and Pfizer (Zoloft). Also detailed are the financial
relationships of several other STAR*D investigators with drug
companies.

Ironically, given what we know about the remission rate of
non-medicated depressed patients, even the fabricated 67% depression
remission rate should never have been celebrated by psychiatry and the
mainstream media. While STAR*D received a great deal of publicity in
2006, another study reported that same year received almost no
attention. This study, “The Naturalistic Course of Major Depression
in the Absence of Somatic Therapy
[[link removed]],”
examined depressed patients who had recovered from an initial episode
of depression, then relapsed but did not take any medication following
their relapse. The recovery rate of these non-medicated depressed
patients was tracked, and after one year, 85% of them recovered. The
study authors concluded: “If as many as 85% of depressed individuals
who go without somatic treatments spontaneously recover within 1 year,
it would be extremely difficult for any intervention to demonstrate a
superior result to this.”

EPILOGUE

Thanks in large part to research psychologist Ed Pigott and journalist
Robert Whitaker, one establishment psychiatry publication has finally
dealt with the reality that trusting STAR*D findings may have been a
“huge setback” for psychiatry.

The _Psychiatric Times_ has a history of being the most willing,
among establishment psychiatry publication, to report painful news to
its psychiatrist readers—albeit, long after such truths have been
exposed by non-establishment researchers and independent journalists.
For example, while researchers had discarded the serotonin chemical
imbalance theory of depression by the 1990s, the first unequivocal
declaration by an establishment psychiatry publication of the
jettisoning of this theory was in the _Psychiatric Times_
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2011, when psychiatrist Ronald Pies stated: “In truth, the
‘chemical imbalance’ notion was always a kind of urban
legend—never a theory seriously propounded by well-informed
psychiatrists.”

Once again it is the _Psychiatric Times_, in its December 2023 issue,
that has finally broken the bad news about standard antidepressant
treatment to its psychiatrist readers. This issue’s cover announces:
“STAR*D Dethroned? Since 2006 It Stands Out As An Icon Guiding
Treatment Decisions Of Major Depressive Disorders. But What If It’s
Broken?” In this issue, an article written by John Miller
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editor-in-chief of the _Psychiatric Times_, acknowledges that Pigott
and his co-researchers reanalysis is “well-researched,” and he
concludes:

“In my clinical opinion, it is urgent for the field of psychiatry to
reconcile the significant differences in remission rates for patients
with MDD [major depressive disorder] as published in the original
STAR*D article in 2006 with the [Pigott] reanalysis just published in
the _BMJ _article this year. . . For us in psychiatry, if
the _BMJ _authors are correct, this is a huge setback, as all of the
publications and policy decisions based on the STAR*D findings that
became clinical dogma since 2006 will need to be reviewed, revisited,
and possibly retracted.”

While Miller stops short of concluding that Pigott’s reanalysis is
proof of STAR*D investigators fraudulently inflated remission results,
he recognizes that psychiatry needs to deal with the reality that if
STAR*D’s authors had in fact inflated remission results, this has
resulted in psychiatry doing great harm to the general public.

Historically, establishment psychiatry and Big Pharma have routinely
made declarations about mental illness causes and treatments that are,
soon after being declared, disproven by research; this followed by
psychiatry taking 10 to 20 years to acknowledge such false claims;
which is then followed by the mainstream media taking another 10 to 20
years to report that psychiatry has moved on to other theories and
treatments. Always psychiatry repeats some version of its slogan:
“We are a young science that is making great progress.”

We have seen this phenomenon with respect to the chemical imbalance
theory of low levels of serotonin causing depression, which was
definitively disproven by researchers by the 1990s, a discarding that
establishment psychiatry would not unequivocally acknowledge until
2011, and which was finally reported in the mainstream media in 2022.

It is likely that we are witnessing this same phenomenon with respect
to standard antidepressant treatment. Politically astute psychiatrists
know that the mainstream media will eventually report standard
antidepressant realities, and so the most politically astute among
them are now promoting other treatments, including ketamine
[[link removed]], a dissociative anesthetic
and party drug known on the street as “Special K.” Ketamine
clinics are popping up
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the United States, including those offered by Field Trip, a national
chain of clinics. However, the research on ketamine as an
antidepressant is worse than disappointing.

A Stanford University study published in early 2023
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intravenous ketamine to an active placebo and concluded: “A single
dose of intravenous ketamine compared to placebo has no short-term
effect on the severity of depression symptoms in adults with major
depressive disorder.” Janssen Pharmaceuticals has created a ketamine
nasal spray called esketamine (branded as Spravato), which received a
highly controversial FDA approval
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2019. A study presented at the American Psychiatric Association annual
conference in 2023 reported no difference
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intravenous ketamine and esketamine; and the _British Journal
of Psychiatry _
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in 2020
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following about esketamine: “Licensing trials did not establish
efficacy: two trials were negative, one showed a statistically
significant but clinically uncertain effect, and a flawed
discontinuation trial was included, against Food and Drug
Administration precedent.” Furthermore, a 2022 review published in
the journal _Pharmacotherapy_
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adverse effects of ketamine: feeling weird, strange, or bizarre in 78%
of patients; spacey in 74%; woozy/loopy in 72%; and dissociations in
62% of patients.

The question for Ed Pigott, Robert Whitaker, myself, and others who
have spent a good part of our professional lives debunking
psychiatry’s latest absurdities is this: Are we simply like
Sisyphus, rolling an immense boulder up a hill only for it to roll
back down every time we near the top? This is a somewhat depressing
question, however, I do have my own personal antidepressant, which is
Albert Camus’s essay _The Myth of Sisyphus_. Camus argues that the
realization of the absurd does not justify suicide, and instead
compels rebellion that can be vitalizing. Camus concludes, “The
struggle itself towards the heights is enough to fill a man’s heart.
One must imagine Sisyphus happy.”

_Bruce E. Levine [[link removed]], a practicing clinical
psychologist, writes and speaks about how society, culture, politics,
and psychology intersect. His most recent book is A Profession
Without Reason: The Crisis of Contemporary
Psychiatry—Untangled and Solved by Spinoza, Freethinking, and
Radical Enlightenment
[[link removed]] (2022).
His Web site is brucelevine.net [[link removed]]_

* depression
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* pharmaceuticals
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* research
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* misinformation
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