Gross Misconduct — The Final Nail in the Coffin for Antidepressants

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.