Gross Misconduct — The Final Nail in the Coffin for Antidepressants

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study published in 2006 was the largest and longest-running antidepressant effectiveness trial ever conducted and, importantly, it u

by Dr. Joseph Mercola

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study published in 2006 was the largest and longest-running antidepressant effectiveness trial ever conducted and, importantly, it used real-world patients

The authors claimed an overall cumulative remission rate of 67%, and this study has since been used to prop up the idea that antidepressants work in the real world

However, the widely-made claim that antidepressants work for nearly 7 out of 10 patients in real-world clinical settings is based on scientific misconduct and fraud

In his reanalysis of the STAR*D study, psychologist Ed Pigott and colleagues showed that, had the study protocol been followed, the cumulative remission rate would only have been 35%. Moreover, the STAR*D report omitted the stay-well rate. Only 3% of the 4,041 patients who entered the trial and went into remission were still in remission at the end of their one-year follow-up

Most clinical drug trials have found the effectiveness of antidepressants are on par with placebo, and many studies have debunked the serotonin theory that underpins the use of antidepressants. Meanwhile, large-scale meta-analyses show that physical exercise is the most effective remedy — about 1.5 times more effective than antidepressants — for depression

According to medical journalist Robert Whitaker, author of “Mad in America” and publisher of madinamerica.com, the widely-made claim that antidepressants work for nearly 7 out of 10 real-world patients is based on research misconduct and scientific fraud.

“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,” he wrote in a January 3, 2024, article.1

The STAR*D Study

The study in question, the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study,2 was published in 2006. This was the largest and longest-running antidepressant effectiveness trial ever conducted and, importantly, it used real-world patients, who often cannot participate in industry trials due to exclusionary criteria.

In the end, the authors claimed an overall cumulative remission rate of 67% — far better than placebo — and this study has since been used to prop up the idea that antidepressants work in the real world, even though most clinical drug trials have found their effectiveness are on par with placebo,3 and despite the many studies debunking the serotonin theory that underpins the use of antidepressants in the first place.

As reported in a 2023 systematic umbrella review of the evidence for the serotonin theory of depression:4

“The main areas of serotonin research provide no consistent evidence of there being an association between serotonin and depression, and no support for the hypothesis that depression is caused by lowered serotonin activity or concentrations.”

Research Misconduct Revealed

However, a reanalysis5 of the STAR*D data in 2010 by psychologist Ed Pigott and colleagues revealed serious problems. As explained by Whitaker in early September 2023,6 Pigott filed a Freedom of Information Act request to obtain the complete STAR*D protocol and previously undisclosed data, and with that they were able to identify the ways in which the STAR*D investigators had inflated the remission rate.

An extensive explanation of how they did this, which clearly demonstrates an intent to deceive, is given by Whitaker in a September 9, 2023, article.7 If you want to understand exactly how the remission rate was inflated, I suggest you read it, as there’s simply too much data and too many fine points to cover here.

While complex, Whitaker does a fine job explaining how the fraud was carried out, step by step, by violating the study protocol. As just one example, patients who didn’t qualify as depressed enough to even be included in the study in the first place were counted as remitted, as were patients who dropped out, mostly due to intolerance to the drugs. They also switched outcome measures and introduced theoretical elements in clear violation of the study protocol.

In summary, Pigott’s team was able to show that, had the study protocol been followed, the cumulative remission rate would only have been 35%, not 67%. Moreover, the STAR*D report omitted the stay-well rate, probably because only 3% of the 4,041 patients who entered the trial and went into remission were still in remission at the end of their one-year follow-up.

Yet, in 2009, National Institute of Mental Health (NIMH) director Thomas Insel wrote8 that “at the end of 12 months, with up to four treatment steps, roughly 70% of participants were in remission.”

As noted by Whitaker, Insel was telling the public and working psychiatrists that 70% of the patients in the study got well and stayed well, “a statement that exemplifies the grand scale of the STAR*D fraud.”

Similarly, the NIMH’s 2006 press release9 falsely announced that “almost 70% of those who did not withdraw from the study became symptom-free” — a clear falsehood, as the only way they got to the 67% was by including dropouts and ineligible patients.

Scientific Misconduct Rising to the Level of Fraud

Whitaker continues:¹⁰

“Seventy percent versus a reality of 3% — those are the bottom-line numbers for the public to remember when it judges whether, in the reporting of outcomes in the STAR*D study, there is evidence of an ‘intent to deceive’ ...

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.

Yet, as Pigott and colleagues have published their papers deconstructing the study, the NIMH investigators have never uttered a peep in protest.

They have remained silent, and this was the case when Pigott and colleagues, in August of this year, published their latest paper¹¹ in BMJ Open. In it, they analyzed patient-level data from the trial and detailed, once again, the protocol violations used to inflate the results ...

[T]he one time a STAR*D investigator was prompted to respond, he confirmed that the 3% stay-well rate that Pigott and colleagues had published was accurate ... That was 13 years ago.

The protocol violations, which are understood to be a form of scientific misconduct, had been revealed. The inflation of remission rates and the hiding of the astoundingly low stay-well rate had been revealed.

In 2011, Mad in America published two blogs^12,13 by Ed Pigott detailing the scientific misconduct and put documents¹⁴ online that provided proof of that misconduct. In 2015, Lisa Cosgrove and I ... published a detailed account of the scientific misconduct in our book ‘Psychiatry Under the Influence.’ The fraud was out there for all to see ...

Yet, there has been no public acknowledgement by the American Psychiatric Association (APA) of this scientific misconduct. There has been no call by the APA — or academic psychiatrists in the United States — to retract the studies that reported the inflated remission rates. There has been no censure of the STAR*D investigators for their scientific misconduct ...

Thus, given the documented record of scientific misconduct, in the largest and most important trial of antidepressants ever conducted, there is only one conclusion to draw: In American psychiatry, scientific misconduct is an accepted practice.”

Action Item — Demand the Withdrawal of the STAR*D Report

Since the APA is refusing to take action and has allowed the deception to stand for 17 years, Whitaker is now calling on the public to make the fraud known and demand that the 2006 STAR*D report¹⁵ be withdrawn.

“As STAR*D was designed to guide clinical care, it is of great public health importance that this be done,” he says.¹⁶

Mad in America has posted a petition on change.org urging the American Journal of Psychiatry to retract the November 2006 summary article of the STAR*D results. Please consider adding your signature.

Corruption Puts Real People in Lethal Jeopardy

Considering the severity of the misconduct, it comes as no surprise to find that eight of the 12 STAR*D investigators had ties to the manufacturer of citalopram, the first-line antidepressant used in this study. In all, the 12 investigators had 151 different ties to drug companies.

As noted by Whitaker, this scientific misconduct “has done extraordinary harm” to the public, because the study was expressly designed to assess outcomes in real-world patients and guide future clinical care. As it stands, the study has lured patients into one of the least effective and most hazardous treatment options there is.

Few psychiatrists dispute the fact that antidepressants have adverse effects — including suicidal and homicidal ideation — but the routine counterargument is that the benefits of the drugs outweigh these risks. If the 12-month effectiveness of these drugs is 3%, would that risk-benefit justification still stand? I think not.

“The American Psychiatric Association, which is best understood as a trade association that promotes the financial and professional interests of its members, has long touted antidepressants as an effective and safe treatment ... The STAR*D results, if they had been accurately reported, would have derailed that societal belief,” Whitaker writes.¹⁷

“If the public had been told that in this NIMH study, which had been conducted in real-world patients, only 35% remitted, even after four treatment steps, and that only 3% remitted and were still well at the end of one year, then prescribing of these drugs — and societal demand for these drugs — surely would have plummeted.”

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