Historically, there have always been some patients who report that any treatment for depression—including bloodletting—has worked for them, but science demands that for a treatment to be deemed truly effective, it must work better than a placebo or the passage of time without any treatment. This is especially important for antidepressant drugs—including Prozac, Zoloft, and other selective serotonin reuptake inhibitors (SSRIs), as well as Effexor, Cymbalta, and other serotonin and norepinephrine reuptake inhibitors (SNRIs)—because all of these drugs have uncontroversial troubling side effects.
Researchers have long known that any single antidepressant drug is little more effective than a placebo in the majority of trials, shown to be less effective than a placebo in some studies, and generally found to be “clinically negligible” with respect to depression remission, while often resulting in severe adverse effects; for example, resulting in a higher percentage of sexual dysfunction than depression remission. However, for nearly twenty years, psychiatry and Big Pharma have told us that while one antidepressant may not work for the majority of patients, in the “real world,” doctors provide patients who have been failed by their initial antidepressant with another antidepressant, and if that fails, still another; and that this real-world treatment is successful for nearly 70% of patients. This narrative has been repeatedly reported by the mainstream media, including the New York Times in 2022.
The problem with this “nearly 70%” story is that the research that has been used to justify it, a 2006 report on the results of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D), has long been disputed by researchers. Moreover, a recent reanalysis of previously undisclosed data reveals that STAR*D, owing to scientific misconduct that dramatically inflated remission rates, may go down in US medical history as one of its most harmful scandals. Among the few journalists in the world who have recognized the implications of STAR*D for the treatment of millions of people is Robert Whitaker, and in his September 2023 report, “The STAR*D Scandal: Scientific Misconduct on a Grand Scale,” he stated: “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.”
Earlier Antidepressant Coffin Nails
Prozac, the first SSRI antidepressant, received FDA approval in 1987 and entered the market in 1988; with Zoloft entering the market in 1991, followed by Paxil in 1992. By the late 1990s, Americans were seeing drug commercials on television, which would eventually include antidepressant commercials such as the early 2000s “sad blob” Zoloft commercial that promoted the belief that SSRIs could correct the chemical imbalance that was causing depression. However, by the 1990s, researchers had already discarded the serotonin imbalance theory of depression, with the invalidity of this theory finally reported by the mainstream media in 2022.
Psychiatry and Big Pharma have never disputed the adverse effects of its antidepressants, but have claimed that the great benefits of these drugs outweigh their adverse effects. Is this claim valid?
Receiving little attention by the mainstream media in 2002, the Journal of the American Medical Association (JAMA) published a study aimed at discrediting the herb St. John’s wort as an antidepressant. However, in this randomized controlled trial (RCT), in addition to one group receiving a placebo and a second group receiving St. John’s wort, there was a third group that received the standard dose of the SSRI Zoloft. The results? The placebo worked better than both St. John’s wort and Zoloft. Specifically, a positive “full response” occurred in 32 percent of the placebo-treated patients, 25 percent of the Zoloft-treated patients, and 24 percent of the St. John’s wort-treated patients.
A major reason why most of the general public never heard about this study was that it was published with the title, “Effect of Hypericum Perforatum (St John’s wort) in Major Depressive Disorder: A Randomized Controlled Trial.” Why was there no mention of Zoloft in the study title? Zoloft is manufactured by Pfizer, and the financial disclosure of this study’s lead author, psychiatrist Jonathan R. T. Davidson, states: “Dr. Davidson holds stock in Pfizer [manufacturer of Zoloft] . . . and has received speaker fees from Pfizer.”
While this 2002 study showing that the placebo worked better than both Zoloft and St John’s wort was buried, later in 2002, a large study did receive significant attention. A leading researcher of the placebo effect, Irving Kirsch, examined forty-seven drug company studies on various antidepressants. These studies included published and unpublished trials, but all had been submitted to the Food and Drug Administration (FDA), so Kirsch used the Freedom of Information Act to gain access to all data. He reported that “all antidepressants, including the well-known SSRIs . . . had no clinically significant benefit over a placebo.”
The adverse effects of antidepressant drugs have long been known and acknowledged by psychiatry and Big Pharma. Even that “sad blob” Zoloft commercial mentions the side effects of “dry mouth, insomnia, sexual side effects, diarrhea, nausea, and sleepiness” (omitted are several other adverse effects that affect a high percentage of patients, including debilitating withdrawal reactions that can be severe and persistent). Let’s take a closer look at one of those adverse effects that is mentioned in the commercial: “sexual side effects.”
“Sexual dysfunction is a common side effect of antidepressants,” reported the journal Drug, Healthcare and Patient Safety in a 2010 examination of several studies in the review: “Antidepressant-Associated Sexual Dysfunction: Impact, Effects, and Treatment.” Sexual dysfunction problems range from decreased sexual desire, to the inability to achieve an erection, to several other sexual difficulties. This review reported that the percentage of sexual dysfunction for SSRI antidepressants over several studies runs from 25%–73%; and in one study of 344 patients who had a history of normal sexual function before SSRI treatments, there was an overall incidence of 58% sexual dysfunction, with the percentage of sexual dysfunction for Paxil users at 65%, for Luvox users at 59%, for Zoloft users at 56%, and for Prozac users at 54%. Furthermore, the long-buried iatrogenic illness (physician-caused) of post-SSRI sexual dysfunction (PSSD), in which sexual dysfunction exists even after discontinuation of the SSRI, was first reported to regulators in 1991, but it took until 2006 for it to be formally characterized as a syndrome.
Psychiatry today acknowledges antidepressant adverse effects and even acknowledges that antidepressants are often ineffective, however, it clings to the idea that if depressed patients are treated with enough different antidepressants, nearly 70% of them will achieve remission. They justify this by quoting the 2006 STAR*D study results, and the mainstream media has not challenged this.
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.”
Bruce E. Levine, a practicing clinical psychologist, writes and speaks about how society, culture, politics, and psychology intersect.
Source: CounterPunch
