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In the ten-year period between 1999 and 2008, DTCA tripled, from $1.3 to $4.8 billion, their efforts at educating patients about their need for psychiatric medication. The modern drug business has been built on “brain” medicines. Valium was the first blockbuster, selling 2 billion tablets in 1978. Then in the 1990s came Prozac, which defined the industry. The pharmaceutical industry spent $4.53 billion on direct-to-consumer advertising in the United States alone in 2014, up 18 percent from the previous year.33
The flagrant disconnect between the advertisements and scientific literature has been written about for more than a decade now, but you probably haven’t read about it. It was clearly stated by Drs. Lacasse and Leo in their 2005 paper: “These advertisements present a seductive concept, and the fact that patients are now presenting with a self-described ‘chemical imbalance’ shows that the [advertising] is having its intended effect: the medical marketplace is being shaped in a way that is advantageous to the pharmaceutical companies.”34 As far back as 1998, at the dawn of consumer advertising of SSRIs, Professor Emeritus of Psychology and Neuroscience Elliot Valenstein of the University of Michigan summarized the scientific data by concluding, “What physicians and the public are reading about mental illness is by no means a neutral reflection of all the information that is available.”35
The United States and New Zealand are the only countries in the world that allow advertisement on television for prescription drugs. In 1997, a change to an FDA regulation opened the floodgates on direct-to-consumer advertising, allowing drug makers to promote their wares on television. This also paved the way for celebrities, athletes, models, and aging baby boomers to dominate those ads.
Given these forces, along with the number of symptoms listed under antidepressant use, it’s really no surprise that more than $11 billion is spent each year on these medications.36 Pharmaceutical companies have more than six hundred lobbyists, and they finance more than 70 percent of FDA trials.37 They court physicians, toss them copious free samples, pay consultants to speak at scientific meetings, advertise in medical journals, fund medical education, and ghostwrite, selectively choosing and redundantly submitting data for publication. Psychiatric studies funded by Big Pharma are four times more likely to be published if they report positive results. Only 18 percent of psychiatrists disclose their conflicts of interest when they publish data.38 Their studies allow for all kinds of indiscretions, such as removing people who are likely to respond to placebo before the study to strengthen the perceived benefit and using sedative medications with the study’s medications, thereby skewing results in favor of the drug (more on this shortly).
A now famous 2008 study in the New England Journal of Medicine led by Dr. Erick Turner at Portland VA Medical Centers sought to expose the extent of data manipulation.39 Through valiant efforts to uncover unpublished data, he and his team determined that from 1987 to 2004, twelve antidepressants were approved based on seventy-four studies; thirty-eight were positive, and thirty-seven of these were published. Thirty-six were negative (showing no benefit), and three of these were published as such, while eleven were published with a positive spin (always read the data, not the author’s conclusion!), and twenty-two were unpublished.
The FDA requires only two studies for drug approval, so you can see how these companies are tossing the coin over and over again until heads comes up and hoping no one is looking when it’s tails. To get a sense of just how misleading the pharmaceutical industry can be, consider the largest study to date funded by the National Institute of Mental Health, conducted at the University of Texas in 2006.40 It cost the public $35 million for researchers to follow more than four thousand patients who were treated with Celexa over twelve months. This was not a double-blind placebo controlled study, so the people knew what they were getting. Half of them reportedly improved at eight weeks. Those who didn’t were switched to Wellbutrin, Effexor, or Zoloft or “augmented” with Buspar or Wellbutrin. Guess what? It didn’t matter who took what, because the same percentage of the group allegedly improved (18 to 30 percent) no matter what drug they were on. Only 3 percent of patients were supposedly in remission at twelve months. Now here’s where the story gets interesting.
In February 2012, a suit was filed against Celexa’s maker, Forest Pharmaceuticals, alleging that the company paid a bribe to the principal investigator 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
