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Part 4: “I’VE LOST SO MUCH” How Abilify became the best-selling drug in America

“Chemically lobotomized"



Beginning in 2009, television viewers were treated to a series of commercial messages featuring animated images of winsome young mothers whose lives had been turned around by taking Abilify. In one memorable spot, an actress declaims in voice over: “My antidepressant worked hard to help with my depression. But sometimes I struggled to get going – even to get through the day.”
At this point, does our fictional heroine consider the possibility that her problems are not of the sort amenable to pharmaceutical solutions? She does not. Let her tell her story in her own words:
“So I was honest with my doctor. I told him I’d been feeling stuck for a long time. He said that for some people an antidepressant alone only helps so much, and suggested we add Abilify – aripiprazole. He said that by taking both, some people had symptom improvement as early as one to two weeks. I wish I’d talked to my doctor sooner.”
This is followed by a second actress reading the following notice:
“Abilify is not for everyone. Call your doctor if your depression worsens or you have unusual changes in behavior or thoughts of suicide. Antidepressants can increase these in children, teens, and young adults. Elderly dementia patients taking Abilify have an increased risk of death or stroke. Call your doctor if you have high fever, stiff muscles, and confusion, to address a possible life-threatening condition, or if you have uncontrollable muscle movements, as these can become permanent. High blood sugar has been reported with Abilify and medicines like it and in extreme cases can lead to coma or death. Other risks include increased cholesterol, weight gain, decreases in white blood cells which can be serious, dizziness upon standing, seizure, trouble swallowing, and impaired judgment or motor skills.”

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“I’VE LOST SO MUCH” How Abilify became the best-selling drug in America Part 1: “Psychiatry has destroyed my life" Part 2: A medicinal lobotomy Part 3: “Works like a thermostat” Part 4: “Chemically lobotomized" Throughout this recitation of the toxic effects of Abilify, our pixelated heroine remains serene, smiling blissfully as she sits in the stands, watching her young son playing soccer, her handsome husband by her side. The announcer concludes with these words of wisdom: “Ask your doctor about a free trial of Abilify and go to addabilify-dot-com.” The genesis of these ads was two brief trials paid for by Otsuka Pharmaceuticals and Bristol-Myers Squibb, which examined the effect of Abilify on so-called “treatment-resistant” depression. The whole concept of “treatment-resistant” depression is one that deserves scrutiny. When clinicians characterize depression as “treatment-resistant,” they don’t mean that psychotherapy or lifestyle changes have been tried and found wanting. Rather, the “treatment” they are referring to is drugs. A few years ago, psychologist Irving Kirsch and his colleagues used a Freedom of Information Act request to obtain data for all clinical trials that had been submitted to the FDA for approval for four antidepressants: Prozac, Effexor, Paxil, and Serzone. When Doctor Kirsch and his colleagues analyzed the data for these four antidepressants, they found that overall they were no better than a placebo for treating depression. (N.B.: All but one of the trials were for patients suffering from “very severe depression,” and omission of that one study did not significantly change the results.) When we say a patient’s depression is “resistant” to treatment with drugs that themselves may be no better than a placebo, have we really said anything at all? Nevertheless, let’s take a look at what the researchers found. Both studies had an identical experimental design, so we can look at them together. Patients suffering from depression were put on an eight-week course of antidepressant medication. In both studies, only a minority of patients were judged to have responded to the medication. (By the way, when they say a patient “responded” to antidepressant therapy, it does not mean the patient has achieved remission from his depression; it just means that his score on a questionnaire has improved by some arbitrarily chosen value.) The majority of patients either failed to respond and/or dropped out of the trials entirely. Of the ones who failed to respond and stayed in the trials, half were given Abilify for six weeks, and half were given a placebo, in both cases addition to their antidepressant medication. The primary endpoint for the study was the score on the Montgomery-Asberg Depression Rating Scale. Patients are rated on 10 symptoms, and for each symptom a score ranging from 0 to 6 is assigned. The higher the score, the more severe the depression. In both trials, patients receiving Abilify improved their scores relative to the patients getting the placebo, but the difference between the two groups was small – three points or less on a rating scale that goes from 0 to 60. And there is no way of knowing how much of even this paltry improvement is due to what is known as an “enhanced placebo effect.” As Doctor Kirsch explains, so-called double-blind trials really aren’t blind at all – patients and doctors alike know perfectly well who is getting the placebo and who is getting the real thing, based on the severity of side effects. Nonetheless, the difference between treatments was judged to be statistically significant, and, based on these meager results, the FDA approved Abilify as adjunctive therapy for ‘treatment-resistant” depression. Abilify went on to become the best-selling drug in America, with a whopping $7.5 billion in sales from October 2013 through September 2014. Otsuka Pharmaceuticals’ patent on Abilify is set to expire on April 20 of this year, clearing the way for generic versions of the drug to enter the market. However, last December, the FDA approved Abilify for a new indication, treating Tourette’s Syndrome in children. The new indication means that Otsuka Pharmaceuticals will be given another seven years of exclusive marketing rights under the Orphan Drug Act, worth billions of dollars to the company. But this extension of marketing rights could be jeopardized by an FDA decision last month to amend the approval to include patients of all ages, not just children. In an unheard-of move, Otsuka Pharmaceuticals in suing the FDA to prevent it from widening the market for one of its drugs. The company is being represented by Ralph Tyler, former Chief Counsel for the FDA. Meanwhile, on March 27 of this year, a federal judge dropped claims against Otsuka and Bristol-Myers Squibb for illegal marketing of Abilify, although he let stand claims against BMS for unlawfully terminating two employees in retaliation for blowing the whistle on the alleged illegal marketing. As for Jarrett, he did not fare well on Abilify. He moved out of his father’s house and he was able to secure work cleaning toilets, but while taking Abilify he gained nearly a hundred pounds. He also experienced elevated blood sugar, apathy, irritability (“I just feel like punching my fist through a wall”), uncontrollable restlessness, anxiety, worsening depression (“I have thoughts of wanting to die”), and cognitive impairment. “I have a hard time concentrating. I used to be a really good writer. I haven’t written anything since the four years I’ve been on psych meds. It’s just completely shut off my brain. And I think Abilify has contributed immensely to that.” “I’ve just lost my creativity,” he laments. “Chemically lobotomized” is how he describes himself. For Jarrett, it has been a long hard road back to normalcy, one he still is traversing. Under the guidance of a new doctor, he is discontinuing the medications one by one. Currently he is taking only two – Abilify and Depakote – and he hopes to be completely free of psych meds in a couple of years. He still cleans toilets for a living, but he is looking for a better job. “I’ve lost so much because of those drugs,” he concludes. “It’s been a bad experience for sure. I wouldn’t wish it on anyone. “These drugs will destroy your life.”

List of Sources

  1. Kirsch, I. 2009. The Emperor’s New Drugs: Exploding the Antidepressant Myth. Basic Books.
  2. Berman, R.M. et al. 2007. The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: A multicenter, randomized, double-blind, placebo-controlled study. Journal of Clinical Psychiatry 68:843-853.
  3. Marcus, R.N. et al. 2008. The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: A second multicenter, randomized, double-blind, placebo-controlled study. Journal of Clinical Psychopharmacology 28:156-165.
  4. Brown, T. 2015. 100 most prescribed, best-selling branded drugs through September.
  5. Silverman, E. 2015. FDA is sued by Otsuka for ‘unlawfully’ widening the market for Abilify.
  6. Staton, T. 2015. Judge tosses Abilify kickback claims, but puts BMS on notice for firing whistleblowers.
  7. United States District Court Southern District of Ohio Western Division 2015. Joseph Ibanez et al. vs. Bristol-Myers Squibb Co. et al.


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Patrick D Hahn -- Bio and Archives

Patrick D Hahn is the author of Prescription for Sorrow: Antidepressants, Suicide, and Violence (Samizdat Health Writer’s Cooperative) and Madness and Genetic Determinism: Is Mental Illness in Our Genes? (Palgrave MacMillan). Dr. Hahn is an Affiliate Professor of Biology at Loyola University Maryland.



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