Approximately half of the American population will experience a mental disorder in their lifetimes. Since 1950, those who seek professional help are increasingly prescribed psychotropic drugs. Dr Maris deals with this new social phenomenon from a refreshing multi-disciplinary perspective. A guiding theme is the extent to which these drugs can be dangerous both in their side effects and potential to cause suicidal behaviours…
The first two chapters of the book provide a multi-disciplinary overview of the rise and continued prevalence of drug therapies. A series of issues are discussed including overreliance on psychotropic drugs, economic interests, legal procedures regarding rules of research evidence in defending or questioning psychotropic medications and lack of fully rigorous research.
There is evidence of possible over-medicalisation of mental disorders. For example, over two-thirds of patients on anti-depressants do not meet the criteria for major depression. This may be due, in part, to the fact that between 40% and 43% of anti-depressant prescriptions are issued by primary care physicians, not psychiatrists, who may lack an adequate knowledge base in diagnostic and treatment protocols. In 2004 the British government decided against paying for psychiatric medications for mild depression.
Most of the research on the efficacy of drugs for the treatment of mental disorders is funded by major drug companies such as Pfizer and Eli Lilly. Only the evidence that suits a company’s marketing purposes is likely to appear in academic journals. Given that only a few successful research clinical trials are needed to obtain approval for a new drug, there is some concern that negative research results, results that do not demonstrate that a drug is any more effective than a placebo, may be hidden from the public. Given their substantial investment and profits (billions) in these endeavours, and vast resources, the drug companies can afford to hire teams of specialised and vociferous attorneys to protect their interests in litigation. Maris reviews the rules of research evidence in drug litigation. This discussion includes the details on ten Daubert criteria regarding best evidence practices (eg. effort to rule out competing explanations of drug effects). This discussion is enriched by Dr Maris’s extensive experience as an expert witness in legal cases involving the drug companies.
A key problem with the research on the efficacy of drugs involves sampling. The group at high risk of suicide (eg. history of a previous suicide attempt) is generally excluded from randomised control trials (RCTs). Ethical considerations often prevent their inclusion. However, the ultimate test for drug effectiveness in suicide prevention would need to involve this group of high-risk individuals. There is also a lack of any systematic, detailed explanation on exactly how these psychotropic drugs work. Prescribing them is often an exercise in a trial and error quest after the right dosage and combination (drug cocktail) that will best help the patient.
The second part of the book includes four chapters (3, 4, 5 and 6) focused on the pharmacological treatment for four groups of disorders: anti-depressants for depression, mood stabilisers and anti-epileptics for bipolar disorders, anxiolytics or anti-anxiety medications for anxiety disorders and anti-psychotics for schizophrenia. Each of the four chapters has five analytic parts. (1) A brief discussion of the history and overview of the disorder is provided in the introduction. (2) Data are reviewed on prevalence. (3) A third section deals with diagnosis and provides a detailed review of criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM) for defining each disorder. (4) The fourth section deals with the treatment of the disorder. It provides a useful table summarising the generic/brand name, typical dose in milligrammes, manufacturer and year first distributed, and some side effects of each drug. (5) The fifth and central section reviews the principal scientific evidence on the effectiveness and harmful side effects of each drug. There are detailed discussions of the latter including sexual dysfunctions and sleep disorders. Major studies, including meta-analyses, are included in the scientific review. Each fifth section features a table summarising the best research evidence available on each drug.
Special attention is given to official Food and Drug Administration (FDA) warnings regarding the dangerousness of nine anti-depressants (for those under 25 years of age) and for eleven anti-epileptics. These anti-depressants and anti-epileptics both raised the risk of suicidality to approximately twice that of placebos. Special attention is called to the Columbia University re-analysis of 4400 individuals with depression who were subjects in RCT studies, which led to the FDA warning for anti-depressants. Fully 4.0% of those under 25 years of age on anti-depressants experienced suicidality compared to only 2% of those on placebos. Regarding the anti-epileptics, in December 2008, after a review of 199 RCT studies involving 43 892 subjects, the FDA issued warnings on all eleven anti-epileptics drugs. Collectively, the 199 studies showed that 0.43% of those on the drugs developed suicidality compared to 0.22% of those on placebos.
Maris presents a fair-minded review of the scientific evidence. For example, he notes that there are no FDA warnings for anti-anxiety medications. He is an advocate for the use of lithium for bipolar disorders, given that the weight of the scientific evidence shows that they reduce the odds of suicidality. It is also emphasised that the degree of dangerousness of drugs in a category varies. For example, Maris is careful to note that of the nine anti-depressant drugs analysed in the Columbia study, the suicidal risk signal was driven mainly by one, Effexor. The seventh chapter deals with non-prescription drugs including alcohol, cocaine and the barbiturates, which are ones commonly used among suicidal persons. The final ch. 8 discusses many alternatives to drug therapies. Included are varieties of talk therapy such as cognitive-behavioural and dialectical behavioural treatments.
The book provides substantial detail on describing mental disorders and the drugs used in their pharmacological treatment. It also provides detailed and often critical analyses of their effectiveness and dangerousness. Dr Maris is well qualified to highlight the essential points on what he calls ‘pillage’, and he has a passion for the topic given his extensive first-hand experience in drug litigation. However, the work does not rigorously review the analyses of aggregated data on the associations between the rate of psychotropic drug use and suicide rates in society as a whole. This body of research has rather mixed findings and may require an additional book-length critical analysis.
