STAR*D: The Harms of Orchestrated Psychiatric Fraud

This post was first published on Mad In America on September 18th 2024

Depression is the most frequent psychiatric diagnosis. A few years ago, one in five US adults reported having ever received a diagnosis of depression.

At a cost of 35 million dollars, NIMH’s STAR*D study, which was published in 2006, is the most extensive and expensive study ever conducted to determine the effectiveness of drug treatment for depression. The study was well-designed and particularly of value because it is of real-world patients, not carefully selected participants, and includes an assessment of long-term as well as short-term drug effectiveness.

The results of this landmark research have been reported fraudulently by its authors and by psychiatric leaders. They claim the study found the drugs to be effective treatments for depression, leading to remission in 67% of patients, but this is false; that finding was inflated by various types of research misconduct, even including imaginary remission rates from people who dropped out of the study. In addition, since STAR*D’s publication, the prescription of these drugs is generating and exacerbating depression more than alleviating it.

In 2010, I was one of the authors of a published critique of the STAR*D study’s reported findings. We showed how STAR*D’s authors had manipulated the data to manufacture fraudulent results. Three other published critiques of the STAR*D study document this malfeasant reporting of the findings—all to no avail because psychiatry is in total control of the narrative. What follows is another effort to expose this unrecognized travesty to the public and to doctors and to set the record straight.

The STAR*D study was the third of three major studies conducted by the National Institute of Mental Health (NIMH) to determine the effectiveness of drug treatment of depression.

The first NIMH treatment outcome study, which was published in 1989, found the drug treatment (imipramine) to be no more effective than placebo when measures were taken after three months of treatment. The second NIMH depression treatment study, which was published in 1992, reported on the long-term outcome of these drug treated patients. After 18 months of drug treatment, when these patients were compared with patients treated with placebo, the patients who were treated with drugs showed higher relapse rates, a lower number of weeks being symptom free, and a higher percentage seeking treatment. Thus, measured long-term—the more meaningful measure of drug effectiveness—patients treated with sugar pills fared better than those prescribed antidepressant drugs.

The STAR*D study provides data on the effectiveness of drug treatment (SSRIs), short-term and long-term. Analyzed correctly, its results replicate NIMH’s prior findings. Although the STAR*D study does not include a placebo control group, when measured short-term (after three months of treatment), the results for drug treatment are the same as those found for placebo in other depression outcome studies that do include a placebo control group (30-35% remission rates). In addition, when measured long-term, the results for the SSRIs replicate the previous negative results that were found by NIMH. After 12 months of treatment), patients treated with drugs fare worse than those given a placebo (7% remission).

Moreover, a comprehensive review of all the evidence in the UK’s National Institute for Health and Care Excellence depression guideline found antidepressant drugs to be no more helpful than placebo in the short term, and much worse than placebo in the long term.

These studies are the most substantial outcome studies ever done to assess the effectiveness of drug treatment of depression. To repeat, they all found that when measured short-term, antidepressants have a very modest benefit, being only as effective as placebos. They also found that after 12 to 18 months of continued drug treatment the benefit declined, becoming much worse than placebo. Thus, the results for antidepressant drugs, short-term and long-term, are not an endorsement for their prescription.

Regarding the outcome of measures of the effectiveness of psychological treatment for depression, the first of the NIMH studies cited above also found behavior therapy to be no better than placebo as a treatment for depression. However, since then, numerous studies have found behavior therapy to be an effective treatment for depression, significantly exceeding placebo. As a prime example, McPherson and Hengartner’s review, published 20 years later, reported psychological treatment of depression to be significantly more effective than placebo. McPherson and Hengartner also found the effectiveness of psychological treatment for depression increases with time, in stark contrast to antidepressant drugs whose outcome declines with time to be much worse than placebo.

As I have indicated, STAR*D’s researchers did not report these findings as their results, claiming falsely that drug treatment is effective with nearly 70% of patients. Despite the malfeasance of their statistical analyses having been documented in four publications in scientific journals, the truth has been suppressed by psychiatric leaders and academic psychiatrists, who have embraced the specious reporting of STAR*D’s results.

For 18 years, academic psychiatry has taught psychiatric residents STAR*D’s falsehoods. The same falsehoods are taught in continuing education programs to previously credentialed psychiatrists. Consequently, psychiatrists routinely prescribe antidepressant drugs to their patients. But the largest prescribers are primary care doctors, acting on the falsely reported results. STAR*D’s fictitiously reported success rate has led to antidepressant drugs being established as the treatment of choice for depression and has persuaded psychiatrists and other doctors to prescribe costly drugs that only demonstrate a short-term placebo effect and are associated with outcomes much worse than placebo.

Irving Kirsch, at Harvard Medical School, is medical science’s most prominent placebo researcher. The placebo effect is based on faith in our doctor. It is a well-known psychological factor that contributes to the effectiveness of medical and psychological treatments. His research expands our understanding of the anecdotal basis for patients’ (and doctors’) belief in antidepressant drugs.

Kirsch retrieved the data from published drug/depression outcome studies, including the clinical trials that led to the FDA’s approval of antidepressant drugs, and measured the sizes of the drug effects and the placebo effects in these studies. These calculations enabled him to determine how much of the response to antidepressant drugs in the treatment of depression is a drug effect and how much is a placebo effect.

He found that the response to antidepressant drugs is not a drug effect, it is a placebo effect—a placebo effect that also is determined by the patient’s interpretation of the side effects of the drugs. The side effects of the SSRIs vary individually but they include tremor, insomnia, blurred vision, headache, nausea, joint and muscular pain, weight gain, and sexual dysfunction.

He discovered that antidepressants were functioning as active placebos; the placebo effect was enhanced by many of the side effects of antidepressants. The surprising effect found by Kirsch was that the patients who identified the side effects were the very patients who improved on the drug. He summarized the findings: “The association between side effects and improvement is so strong as to be nearly perfect.” In other words, the positive effect attributed to the chemicals in the drugs is not the result of a helpful chemical treatment but attributable to patients believing they received a helpful drug since they were experiencing the side effects of the drug.

Kirsch’s findings signal a warning. Not only are antidepressant drugs found to be ineffective as treatments for depression, they are powerful drugs that have adverse effects.

Some of the other harmful effects of antidepressants include causing suicidal and homicidal urges, depression, anxiety, mania, Parkinsonism, increased balance problems with aging, and serotonin syndrome. The drugs also lead to increased likelihood of relapse and of never recovering from depression.

Data, not anecdotal opinions of scientists and doctors, must rule in health science.

Yet it should be clear that the malfeasance perpetrated by STAR*D’s researchers represents the intentions of NIMH, which is led by psychiatrists. The STAR*D study was the culmination of a seven-year NIMH contract investigating antidepressant drug treatment of depression, that led directly to the design and funding of the STAR*D study; three of STAR*D’s authors were staff members of the NIMH, two of them being branch chiefs; and the study’s statistician was one of them. NIMH’s psychiatric fingerprints are all over the manipulation of the STAR*D data.

The press is showing no interest in getting this story right, content to repeat STAR*D’s malfeasant reporting, and is therefore playing a large role in promoting the public’s belief in psychiatry’s fictitious narrative, unintentionally contributing to the damage being done. The New York Times, this country’s most prominent newspaper, known for its investigative reporting, inexplicably allows psychiatric word salad to trump science, and passively accepts and disseminates STAR*D’s falsified results. Anecdote is favored over science. I recently communicated with Ellen Barry, a Times mental health reporter, about the Times’ failure to report STAR*D’s malfeasance; she told me she has no plans to write about this subject. Science journalist Robert Whitaker made a similar effort with the Times. He, too, was spurned.

The New York Times has adopted a double standard in reporting errant research analyses related to mental health versus physical health. Within days of learning of the misreporting of cancer research at Dana Farber, that story was on page one of the Times. Pigott’s 2023 publication in the British Medical Journal of data obtained through the Freedom of Information Act, which appeared not many months before that story, documents STAR*D’s flagrantly erroneous data analyses. The revelations are of comparable importance since these falsified results are relevant to tens of millions of people, yet the STAR*D story has not been covered by the Times, despite being brought to their attention several times. I raised this double standard, too, with Ellen Barry, and got no response.

In March 2024, Psychiatric Times did acknowledge STAR*D’s fabricated reporting, becoming the first psychiatric publication to do so. Moreover, the editor underlined the significance of these findings by pointing out that STAR*D’s actual results undermine decades of psychiatric practice. Nevertheless, there has been no psychiatric follow up to this very important acknowledgment.

Instead, in April of this year, an National Institutes of Health (NIH) press release was published which purports to inform the public about the treatment options available for depression. Entitled, “Research Matters: Treating Depression,” it doubles down on the fraudulent reporting of the treatments. Cognitive behavior therapy is described as effective, but only for mild depression—if you really need help, you are advised to choose drug treatment.

So, NIH has joined NIMH in an unwarranted extolling of the value of antidepressant drugs and has compounded the fraud by adding unwarranted limitations on the value of therapy. By disseminating a false appraisal of what science has told us, NIH, along with NIMH, is failing to inform the public about the value of therapy versus drugs in the treatment of depression.

The NIH article also repeats another of STAR*D’s drug-related falsehoods. One of the aims of the STAR*D study was to demonstrate the value of psychiatry’s scientifically unsupported biological heterogeneity theory of depression, that there are different forms of depression, and patients can be treated successfully by finding the right drug for their kind of depression, “matching patients with their optimal treatments.” It repeats STAR*D’s false claim that the study’s results bear this out. But the data show that it did not matter what drug was prescribed; every drug produced the same limited effect as every other drug. There is no support for the theory that treating failed patients with drugs having different biochemical actions enhances the outcome.

The NIH goes on to extoll the value of ECT as a medical treatment for depression. This claim, too, not only is scientifically unsupported, it is highly misleading and a disservice to the public. A recent detailed review of the scientific basis for ECT comes to a very different conclusion, pointing out: The last outcome study of ECT was almost 40 years ago; the ECT outcome studies that were published back then are of such poor quality that they provide no basis for claiming ECT is an effective treatment for depression; however, those studies do reveal there is a high risk of ECT causing permanent memory loss (brain damage) and even a small mortality risk; the reviewers call for ECT to be suspended immediately until satisfactory outcome studies show it has value and is safe.

The concerns regarding ECT apply to antidepressant drugs, as well. The now thoroughly discredited serotonin chemical imbalance theory of depression was the basis for the medicalization of psychiatry in 1980, leading to drug prescriptions becoming established as the treatment of choice for mental disorder. The long-term negative results for drug treatment that were found by NIMH and NICE suggest an iatrogenic outcome for antidepressant drug prescriptions. The evidence is consistent with the conclusion that prescription of antidepressant drugs is generating and exacerbating mental disorder more than alleviating it. These concerns are not without precedent. Not that long ago, during my lifetime, psychiatry inflicted great harm advocating eugenics and lobotomy, for which a psychiatrist was awarded a Nobel prize.

The most important question is why psychiatric leaders, NIMH, and NIH are making these terrible false claims. The answer is that they have nothing else. NIMH has spent many tens of billions of research dollars over many decades attempting to substantiate a physiological basis for depression and other mental disorders, only to come up empty handed. After a hundred years of looking, psychiatry has failed to find empirical evidence for a medical/biological basis for depression, the anxiety disorders, and the great majority of the DSM’s diagnoses. So, STAR*D’s actual results are too bitter a pill for psychiatric leaders to swallow and they have chosen malfeasance, becoming a rogue medical specialty.

Scientific evidence points to the conclusion that although our physical and psychological realms are continuously interacting with one another, the explanation for physical illness is fundamentally physiological and the explanation for mental disorder is fundamentally psychological. This is why psychiatry’s efforts have failed to verify physiological explanations and medical treatments for mental disorder that parallel the verified physiological explanations and medical treatments for physical illnesses.

STAR*D’s results are in alignment with a host of studies which indicate we are pursuing the wrong explanatory paradigm for mental disorder. This same century that has witnessed an exponential explosion of evidence for a medical/biological basis for countless physical illnesses, guiding medical treatments that work, also has produced abundant evidence pointing to a social/psychological explanation and well-validated psychological treatments for depression, phobias, social anxiety, OCD, and PTSD.

With very few exceptions, the mental disorders are explained by our brain’s great capability for learning and cognition, which not only accounts for the acquisition of functional behaviors but also the establishment of dysfunctional behaviors – research that has enabled behavioral psychologists to develop treatments that are the most effective treatments we have for mental disorder.

Our behavior, including abnormal behavior, is shaped by our environment and the consequences of our actions. In contrast to the failed results of tests of brain theories, an abundance of research has confirmed psychological cause and effect explanations for mental disorder. Parsimony is a time-tested rule for the scientific explanation of causation. The psychological paradigm for mental disorder posits that in the commonly occurring mental disorders the brain is acting normally, according to behavioral principles that explain normal as well as abnormal behavior. This is the simpler explanation, that fits with the data, but psychiatrists are adamantly opposed to psychological explanations for mental disorder.

Psychological treatments work because they provide people with the tools they need to problem-solve. Whereas drug treatment promotes passivity (expecting a drug to do the work), the goal of behavior therapy is to engage the patient in problem-solving behaviors. These behaviors are a part of the patient’s repertoire after therapy ends, sustaining and enhancing the positive outcome.

Behavioral research is a significant contributor to a great body of research findings which led the World Health Organization and the United Nations to call for a paradigm shift regarding mental disorder from a medical/biological paradigm to a social/psychological paradigm.

This travesty needs to be ended. Instead of NIMH spending its precious research dollars in pursuit of a chimera, it should be investing these funds in studying psychological factors in mental disorder, improving the efficiency and effectiveness of behavioral treatments and other social/psychological remedies, and pursuing a validated behaviorally-based DSM.