December 28th, 2010
By: Amy Chaves
The November 2010 issue of Nature reported that several large pharmaceutical companies, including AstraZeneca and GlaxoSmithKline, have chosen to pull out of the psychiatric pharmacology in the treatment of schizophrenia. The reason is obvious, according to Nature author, Abbott: The first generation of schizophrenia drugs (manufactured in the 1950s) and the second generation (manufactured in the 1990s) have not addressed the adverse side effects of antipsychotic drugs on patients.
The World Health Organization (WHO) recognizes schizophrenia as a mental disorder that interferes with a person’s ability to identify what is real. A person affected with this disorder is not able to manage emotions, cognition, as well as communication. Symptoms could appear in early adolescence as “early flickers of paranoia, hypersensitivity, and hallucination” (Dobbs, 2010). According to WHO, schizophrenia is usually characterized by disruptions in the most fundamental human attributes such as perception, language, thought, emotion, and sense of self. In 2001, WHO estimated that schizophrenia affects 7 per thousand of the adult population (the equivalent of 24 million worldwide), mostly between 15 to 35 years old.
The same November 2010 issue of Nature discussed about a US clinical trial involving nearly 1,500 patients in 57 clinical sites, and at a cost of US$43 million. This trial examined an array of second generation antipsychotic drugs to determine if they were better than the first generation antipsychotic drugs. The clinical trial spanned from 2001-2005. When the results of the unblinded trial were released in 2005, the psychiatric community and pharmacological companies were astounded: the findings suggest that the new drugs were barely different from the old ones.
Although both generations of anti-psychotic drugs were reported to control hallucinations and delusions, patients taking the second generation drugs remained confused, withdrawn, and devoid of drive, the same side effects observed in the first generation drugs. The result of this clinical trial, according to psychiatrist Jeffrey Lieberman, is frustrating and humbling for the research community and it had a chilling effect on the pharmaceutical industry (Abbott, 2010).
A systematic review in 2003 by Bagnall, et al., examined the effectiveness, safety, and cost-effectiveness of atypical antipsychotic drugs used to treat schizophrenia. The review consisted of 171 randomized, controlled trials, of which 28 were from drug manufacturers. Although the review showed that atypical drugs (i.e., risperidone, amisulpride, olanzipine, and clozapine) were seen to be more effective in relieving symptoms of schizophrenia than typical ones, it nonetheless found the following common side-effects: agitation, movement disorders, impotence, dry mouth, nausea and vomiting, dizziness, and weight gain.
The same systematic review examined the safety of these drugs and some of the following adverse reactions were found: death, malignant syndrome, seizures, hepatic dysfunction, and cardiac problems.
A systematic review, involving the application of scientific strategies to limit bias, is a synthesis of relevant studies that address specific clinical questions. Reviews of this kind are considered as the best evidence for making clinical decisions.
The findings of the 2001-2005 US clinical trial and the systematic review of Bagnall, et al. point to the ineffectiveness of anti-psychotic drugs in dealing with schizophrenia. Considering that up to 1% of the world’s population is estimated to be affected by this disorder, schizophrenia represents a huge market for any pharmaceutical. However, as research have shown, the pharmaceutical industries have done little in 50 years to address the adverse side-effects that patients have experienced from antipsychotic drugs .