CCHR says millions of taxpayer dollars are wasted on psychotropic drug research later found to be flawed and harmful to consumers

By CCHR International
The Mental Health Industry Watchdog
March 22, 2024

Researchers have reanalyzed data from a $35 million U.S. National Institute of Mental Health (NIMH)-funded study, challenging its conclusions and raising further concerns about flaws in antidepressant research. Published in BMJ, the study debunks the 2006 Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, which claimed a 67% depression remission rate for antidepressants. Instead, it suggests a success rate of only 35%—only half of what was previously thought—questioning past psychiatric research and treatment decisions.[1] Indeed, other studies also indicate that antidepressants may be largely ineffective and potentially harmful.[2]

The mental health industry watchdog, Citizens Commission on Human Rights International, says this is another example of inflated results about antidepressant efficacy, which can mislead consumers into taking antidepressants and could be a driving force behind why 45 million Americans currently take the drugs.  

The BMJ authors concluded that “STAR*D’s cumulative remission rate was approximately half of that reported” originally and response rates were significantly inflated.

In an article in the Psychiatric Times titled “The STAR*D Dethroned?” the author, John J. Miller, M.D. stated, “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.”[3]

Michael P. Hengartner from the Department of Applied Psychology, Zurich University of Applied Sciences in Switzerland, analyzed discontinuation trials focusing on the efficacy of antidepressants in maintenance therapy, finding them questionable. He also found that “a growing body of evidence from hundreds of randomized controlled trials suggests that antidepressants cause suicidality, but this risk is underestimated because data from industry-funded trials are systematically flawed. The strong reliance on industry-funded research results in an uncritical approval of antidepressants.” The harm, he added, “is systematically underestimated.”[4]

Such potential harm was flagged in 2022 when a major study by researchers at the University College of London disproved the decades-old theory that a brain-based chemical abnormality causes depression requiring antidepressants to correct it.[5] Since the early 1990s, the industry has propagated this fabricated theory, and as lead author Professor Joanna Moncrieff, M.D. said, “The popularity of the ‘chemical imbalance’ theory has coincided with a huge increase in the use of antidepressants.”[6]

In 2018, Prof. Moncrieff was asked to review the first reports of the primary outcome measure of STAR*D, 14 years after the study was finished. “The paper I was asked to review, which is now published in Psychology of Consciousness: Theory, Research and Practice, is written by a group led by Irving Kirsch and based on the original data obtained through the NIMH.”

“Whatever the reason,” she said, based on the follow-up, “people taking antidepressants do not do very well. In fact, given that for the vast majority of people depression is a naturally remitting condition, it is difficult to believe that people treated with antidepressants do any better than people who are offered no treatment at all.”[7]

Ed Pigott, Ph.D., added this: “Before STAR*D, I wasn’t prone to believing in conspiracy theories but as we peeled back its layers I found myself spinning theories about how this study became so profoundly misrepresented given all of the actors involved (20+ top-tier researchers/NIMH), anyone of whom could have objected and ‘blown the whistle;’ but none did.” He went a great deal further saying STAR*D’s results were “falsely portrayed in ways that harm those who suffer with depression.”[8]

Piggot cited Thomas Insel, head of NIMH, who observed that “The unfortunate reality is that current medications help too few people to get better and very few people to get well.”

“What a sad commentary on the 50+ years of psychotropic drug research efforts,” Piggot wrote.

Thirteen of the 16 authors of the original STAR*D study reported financial affiliations with numerous pharmaceutical companies, including Bristol-Myers Squibb, Forest Laboratories, GlaxoSmithKline, Organon, and Pfizer, and King Pharmaceuticals and Wyeth provided medications at no cost for this trial.[9]

Indeed, the lead researcher, John Rush, was under U.S. Senate investigation in 2008 for his undisclosed conflicts of interest. That inquiry, headed by Senator Charles Grassley, looked at seven psychiatrists who had failed to declare nearly $9.9 million between them to universities and agencies with whom they worked and who required such disclosure.[10] Rush, former Vice-Chairman of the Dept. of Clinical Sciences at the University of Texas Southwestern Medical Center, reported only $3,000 of the nearly $18,000 that Eli Lilly, the manufacturer of antidepressants, paid him in 2001. Between 2000 and 2007, he failed to report another $12,000 from various drug companies.[11]

Because of the serious potential harm psychotropic drugs can cause, CCHR says flawed studies should be retracted and independently investigated for consumer fraud.

RIFE WITH CONFLICTS OF INTEREST

The original STAR*D study in 2006 disclosed these researchers’ strong ties to pharmaceutical-psychiatric treatment device companies.

Dr. Augustus John Rush, M.D.: Has served as an advisor, consultant, or speaker for or received research support from Advanced Neuromodulation Systems, Inc.; Bristol-Myers Squibb; Cyberonics, Inc.; Eli Lilly & Company; Forest Pharmaceuticals, Inc.; Gerson Lehman Group; GlaxoSmithKline; Jazz Pharmaceuticals; Merck & Co., Inc.; Neuronetics; Ono Pharmaceutical; Organon USA Inc.; Pfizer Inc.; the Robert Wood Johnson Foundation; the Stanley Medical Research Institute; Wyeth-Ayerst Laboratories Inc. He has equity holdings in Pfizer Inc. and receives royalty/patent income from Guilford Publications and Healthcare Technology Systems, Inc.

Dr. Madhukar H. Trivedi, M.D.: Has served as an advisor, consultant, or speaker for or received research support from Abbott Laboratories, Inc.; Akzo (Organon Pharmaceuticals Inc.); Bayer; Bristol-Myers Squibb Company; Cephalon, Inc.; Corcept Therapeutics, Inc.; Cyberonics, Inc.; Eli Lilly & Company; Forest Pharmaceuticals; GlaxoSmithKline; Janssen Pharmaceutica; Johnson & Johnson PRD; Meade Johnson; Novartis; Parke-Davis Pharmaceuticals, Inc.; Pfizer Inc; Pharmacia & Upjohn; Predix Pharmaceuticals; Sepracor; Solvay Pharmaceuticals, Inc.; and Wyeth-Ayerst Laboratories.

Dr. Stephen Wisniewski, Ph.D.: Has served as an advisor/consultant for Cyberonics, Inc.

Dr. Andrew A. Nierenberg, M.D.: Has served as an advisor, consultant, or speaker for or received research support from Bristol-Myers Squibb Company; Cederroth; Cyberonics, Inc.; Eli Lilly & Company; Forest Pharmaceuticals Inc.; Genaissance; GlaxoSmithKline; Innapharma; Janssen Pharmaceutica; Lichtwer Pharma; Neuronetics; Organon, Inc.; Pfizer Inc; Sepracor; Shire; Stanley Foundation; and Wyeth-Ayerst Laboratories.

Dr. Jonathon Stewart, M.D.: Has served as an advisor, consultant, or speaker for or received research support from Eli Lilly & Company; GlaxoSmithKline; Organon USA Inc.; Shire; and Somerset.

Dr. Diane Warden, Ph.D., M.B.A.: Has equity holdings in Bristol-Myers Squibb Company and Pfizer, Inc.

Dr. Michael E. Thase, M.D.: Has served as an advisor, consultant, or speaker for AstraZeneca; Bristol-Myers Squibb Company; Cephalon, Inc.; Cyberonics, Inc.; Eli Lilly & Company; Forest Laboratories, Inc.; GlaxoSmithKline; Janssen Pharmaceutica; Eli Lilly & Company; Novartis; Organon, Inc.; Pfizer Pharmaceutical; Sanofi Aventis; Sepracor, Inc.; Shire US Inc.; and Wyeth Pharmaceuticals.

Dr. Philip W. Lavori, Ph.D.: Has served as an advisor, consultant, or speaker for or received research support from Bristol-Myers Squibb Company; Celera Diagnostics Inc.; Cyberonics, Inc.; Forest Pharmaceuticals, Inc.; Glaxo SmithKline; and Neuronetics, Inc.

Dr. Patrick W. McGrath, M.D.: Has served as an advisor, consultant, or speaker for or received research support from Eli Lilly & Company; GlaxoSmithKline; Lipha Pharmaceuticals; Organon, Inc.; and Somerset Pharmaceuticals.

Dr. Jerrold F Rosenbaum, M.D.: Has served as an advisor, consultant, or speaker for or received research support from AstraZeneca; Boehringer-Ingelheim; Bristol-Myers Squibb Company; Cephalon; Compellis; Cyberonics; EPIX; Forest; GlaxoSmithKline; Janssen; Lilly; MedAvante; Neuronetics; Novartis; Orexigen; Organon; Pfizer, Inc; Roche Diagnostics; Sanofi; Schwartz; Somaxon; Somerset; Sepracor; Shire; Supernus; and Wyeth. He has equity holdings in Compellis, Medavante, and Somaxon.

Dr. Harold Sackeim, Ph.D.: Has served as an advisor, consultant, or speaker for or received research support from Cyberonics, Inc.; Eli Lilly & Company; Magstim Ltd.; MECTA Corporation; Neurocrine Biosciences Inc.; Neuronetics Inc.; NeuroPace Inc.; and Pfizer Inc.

Dr. David. J Kupfer, M.D.: Has served as an advisor, consultant, or speaker for or received research support from Amersham; Corcept Corporated; Eli Lilly & Company; F. Hoffmann-La Roche Ltd.; Forest Pharmaceuticals; Lundbeck, Novartis; Pfizer, Inc; Servier Amerique; and Solvay/Wyeth. He has equity holdings in Body Media and Med Avante and receives royalty income from Oxford University Press.

Dr. Maurizio Fava, M.D.: Has served as an advisor, consultant, or speaker for or received research support from Abbott Laboratories; Alkermes; Aspect Medical Systems; Astra-Zeneca; Bayer AG; Biovail Pharmaceuticals, Inc.; BrainCells, Inc.; Bristol-Myers Squibb Company; Cephalon; Compellis; Cypress Pharmaceuticals; Dov Pharmaceuticals; Eli Lilly & Company; EPIX Pharmaceuticals; Fabre-Kramer Pharmaceuticals, Inc.; Forest Pharmaceuticals Inc.; GlaxoSmithKline; Grunenthal GmBH; J & J Pharmaceuticals; Janssen Pharmaceutica; Jazz Pharmaceuticals; Knoll Pharmaceutical Company; Lichtwer Pharma GmbH; Lorex Pharmaceuticals; Lundbeck; MedAvante, Inc.; Novartis; Organon Inc.; PamLab, LLC; Pfizer, Inc; PharmaStar; Pharmavite; Roche; Sanofi/Synthelabo; Sepracor; Solvay Pharmaceuticals, Inc.; Somerset Pharmaceuticals; and Wyeth-Ayerst Laboratories. He has equity holdings in Compellis and MedAvante.

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[1] John J. Miller, MD, “STAR*D Dethroned?” Psychiatric Times, 12 Dec. 2023, https://www.psychiatrictimes.com/view/star-d-dethroned

[2] Michael P. Hengartner, “Methodological Flaws, Conflicts of Interest, and Scientific Fallacies: Implications for the Evaluation of Antidepressants’ Efficacy and Harm,” Frontiers in Psychiatry, Dec. 2017; 8: 275, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5725408/

[3] Op. cit., John J. Miller, MD, Psychiatric Times, 12 Dec. 2023

[4] Op. cit., Michael P. Hengartner, Frontiers in Psychiatry, Dec. 2017

[5] https://www.cchrint.org/2022/08/19/with-the-chemical-imbalance-myth-exposed-thats-not-all-psychiatry-got-wrong/ citing Joanna Moncrieff, Ruth E. Cooper, et al., “The serotonin theory of depression: a systematic umbrella review of the evidence,” Molecular Psychiatry, 20 July 2022, https://www.nature.com/articles/s41380-022-01661-0

[6] https://www.cchrint.org/2022/07/22/cchr-lauds-study-disproving-chemical-imbalance-causes-depression/ citing “A $15 billion hustle? Expert says pill-prescribing psychiatrists KNEW that depression isn’t caused by low serotonin levels – as landmark study shows that pricy drugs do little to help mental health,” Daily Mail, 21 July 2022, https://www.dailymail.co.uk/news/article-11035903/Expert-says-psychiatrists-KNOW-theory-low-serotonin-levels-cause-depression-incomplete.html; Op. cit., Joanna Moncrieff, Ruth E. Cooper, et al., Molecular Psychiatry, 20 July 2022

[7] Joanna Moncrieff, MD, “Results of World’s Largest Antidepressant Study Look Dismal,” MAD, 12 Oct. 2018, https://www.madinamerica.com/2018/10/results-world-largest-antidepressant-study-look-dismal/

[8] Ed Pigott, Ph.D., “An Introduction: The Story of Bias in the STAR*D Trial and More,” MAD, 23 Mar. 2011, https://www.madinamerica.com/2011/03/%EF%BB%BFan-introduction-the-story-of-bias-in-the-stard-trial-more/

[9] John Rush, et al., “Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report,” American Journal of Psychiatry, 2006

[10] https://www.cchrint.org/issues/psycho-pharmaceutical-front-groups/dbsa-advisory-board/

[11] https://www.cchrint.org/2010/05/21/dsm-panel-members-still-getting-pharma-funds/; https://globalhealth.duke.edu/news/dr-augustus-john-rush-joins-duke-nus-graduate-medical-school-vice-dean-clinical-sciences