A Mind of Your Own: The Truth About Depression and How Women Can Heal Their Bodies to Reclaim Their Lives. Dr Brogan Kelly
of this particular study to fix the results in favor of Celexa.41 The suit was settled out of court, and it came on the heels of the company having to pay a criminal fine of $150 million and forfeit assets of $14 million for suppressing and misrepresenting data on the negative effects of using their drug to treat adolescents. Celexa was only approved to treat adults, but in pursuit of selling more drugs and increasing profits, the company targeted doctors who treated children and teens.42
It’s a foregone conclusion: these practices sabotage the accuracy of data and convey information that corrupts a doctor’s delivery of care and endangers patients. The tragic cost of this data manipulation is the loss of true informed consent. Physicians cannot adequately share with their patients the risks and benefits if the benefits are fabricated and the risks are not uncovered or are unacknowledged. What’s more, these drugs are no more effective than a placebo. As far back as 1984, the National Institute of Mental Health was quoted as saying: “Elevations or decrements in the functioning of serotonergic systems per se are not likely to be associated with depression.” The good old placebo effect likely explains any perceived short-term effects from the antidepressants.
SHORT-TERM EFFICACY: THE POWER OF THE PLACEBO EFFECT
Despite Big Pharma’s efforts, the truth about these brain bombs is emerging. In 1998, the year direct-to-consumer advertising took off, Harvard psychologist and researcher Dr. Irving Kirsch, an established and respected expert on the placebo effect, published a landmark meta-analysis of nearly three thousand patients who were treated with antidepressants, psychotherapy, placebo, or no treatment.43 The results of the study became front-page news and received widespread attention—and criticism. Kirsch found that placebo duplicated 75 percent of the drug’s effect, that non-antidepressant medications had the same effect as antidepressants, and that the remaining 25 percent of the apparent drug effect was attributable to what’s called the “active placebo effect.”
Kirsch uses this term to refer to the effect of the mere belief in antidepressants—a belief that is triggered by the experience of side effects such as nausea, headache, and dry mouth. What happens in a trial is that subjects are put in either the placebo group or the medication group without knowing which group they were assigned to. Because the placebo is without side effects (an inactive placebo), when they develop side effects, all of those commercial-inspired beliefs about their brain’s chemical correction are kicked into high gear, and at least a quarter of these people begin feeling better because of it.
So how much can we thank the placebo effect when we experience fewer symptoms while taking an antidepressant? The backlash to Kirsch’s study inspired him to continue exploring the power of the placebo. By 2008 he’d published another compelling meta-analysis study that further stirred up an incendiary response from critics.44 This time he leveraged the Freedom of Information Act to access unpublished studies and found that when these unpublished studies were included, antidepressants outperformed placebo in only twenty of forty-six trials. That’s less than half! What’s more, the overall difference between drugs and placebos was 1.7 points on the 52-point Hamilton Rating Scale for Depression, used to rate depression in clinical research. Put simply, this small increment is clinically insignificant, and likely accounted for by minor side effects (such as activation and sedation).
The response to this publication led Kirsch to come out with another paper that clearly laid out the facts, counterchallenged his critics, and further demonstrated the power of the placebo.45 In his concluding thoughts, he writes: “Without accurate knowledge, patients and physicians cannot make informed treatment decisions, researchers will be asking the wrong questions, and policymakers will be implementing misinformed policies. If the antidepressant effect is largely a placebo effect, it is important that we know this. It means that improvement can be obtained without reliance on addictive drugs with potentially serious side effects.”
When Kirsch’s book The Emperor’s New Drugs: Exploding the Antidepressant Myth came out in 2010 with proof that antidepressants do not have a clinically meaningful advantage over placebo, his analysis was acknowledged by researchers as a valid albeit provocative contribution to medical literature. But it didn’t change clinical psychiatry or the number of antidepressants prescribed, and it continued to incur the criticism and even rage of prescribing psychiatrists desperate to pick apart his findings to defend their now baseless practices. It’s hard to blame them—they put a lot of time, money, and effort into learning mistruths around antidepressants! The irony in Kirsch’s findings is that the results came from studies that were underwritten and designed by the drug companies themselves. These studies were conducted in a way that would give the drugs an advantage, yet they still didn’t outperform the placebo.46
In order for a drug to be approved, it must be shown to be superior to placebo. As you can imagine, drug companies despise placebo effects. They will do everything in their power to minimize the impact of placebo in their studies. That the FDA allows them to use these techniques is wrong, another example of Big Pharma’s shameless misconduct.
Because the FDA database contains all of the data from initial trials, both published and unpublished, analyzing its data is exceptionally useful. Keep in mind that drug companies normally don’t publish negative results. They prefer to file away those studies in a drawer where they will never be found; hence the “file drawer” phenomenon.
A fascinating 2014 study published in the Journal of Clinical Psychiatry, one of my field’s most respected journals, explored—and exposed—the real power of belief in psychiatric treatment. A group of researchers at Columbia University analyzed data from two large, multicenter discontinuation trials encompassing 673 people diagnosed with major depressive disorder and who were taking fluoxetine (generic Prozac) for twelve weeks.47 After those three months, they were told that they’d be randomized to either a placebo or continued fluoxetine. So while they all knew they were taking the antidepressant in the first three months, they didn’t know if what they were given afterward was an active antidepressant or a sugar pill. The results spoke for themselves: both groups—the ones still taking the fluoxetine and those on the placebo—experienced a worsening of depressive symptoms. This outcome suggests two significant interpretations: (1) the initial effect during the first three months was attributable to placebo, as all patients knew they were receiving treatment; and (2) the worsening of symptoms upon the mere possibility of getting just a placebo is indicative of the undoing of the placebo effect, what’s sometimes called the nocebo effect.
Identifying a tremendous placebo effect has been further echoed by other meta-analyses. The power of belief and the expectation of healing cannot be dismissed when medical treatments appear to work. In my opinion, the use of medications associated with serious short- and long-term side effects and which primarily ride the placebo effect represents an ethically questionable practice.
I work with the placebo effect every day in my office because I aim to inspire a different set of beliefs. Even people who claim to be suicidal can experience the placebo effect under my care. The decision to consider taking your own life is not a trait that would have been selected for over the millennia of human evolution. It’s more logical to assume it has roots in physiological imbalances, which is where I like to spend my time searching for solutions with my patients. I look for problems like nutrient deficiencies, endocrine disruption, and autoimmunity. The first and most important thing I like to convey to patients is that they are in charge. They have agency. This sensibility can go a long way, because they’re coming to me thinking I have what they don’t have—a quick fix. A quick fix is a lovely idea, and if one existed, it could be great. Unfortunately, the weight of the data suggests that it doesn’t and that we may be doing more harm than good by collectively pretending it does. The challenge is that it’s human nature to feel better after doing something we think will make us feel better. But sometimes inaction is the best medicine.
LONG-TERM SIDE EFFECTS: MORE MEDS, MORE DEPRESSION, MORE DISABILITY . . . AND DEATH?
But you might ask, “What if these drugs are in fact working some of the time for some people?” They still wouldn’t be worth the consequences for the placebo effect, particularly given their side effects, which are notoriously hidden from the lay public. I find it outrageous that drug companies