Scientific Misconduct and Fraud: The Final Nail in Psychiatry’s Antidepressant Coffin Series, P3
- Shidonna Raven
- 11 hours ago
- 2 min read
By Bruce E. Levine
January 17, 2024
Source: US Department of HHS/OIG
Photo / Image Source: Unsplash,
The Final Coffin Nail: STAR*D Scientific Misconduct and Fraud
The goal of the STAR*D study, reported in 2006, 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 in 2022 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, and then with access to more of the study’s data, published a reanalysis of STAR*D in the journal BMJ in 2023, 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 investigatorsnoted 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.”
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