In 15 year old Cody Miller’s case, a switch to Singulair to relieve the symptoms of an allergy to ragweed, had such a profound effect on Cody’s mood and behaviour that he ended up taking his own life within two weeks of starting on the drug. Yet, according to his parents, Cody’s mental health had been sound until the drug started meddling with it. How had a drug designed to treat asthma and the symptoms of allergy passed clinical trials when it was capable of such a destructive effect on the mind?

Prior to Cody’s death in the summer of 2007, the FDA had focused its investigations on suicide risks among young patients on psychiatric drugs; notably Selective Serotonin Re-uptake Inhibitors (SSRIs), such as ‘Paxil’, ‘Prozac’, ‘Wellbutrin’ and ‘Zoloft’ (www.lawyerseek.com). These drugs are designed to treat psychiatric so it stands to reason they will influence mood and mental state. The boxes containing antidepressants such as these carry required warnings that the drugs can increase suicidal thinking and behaviour in some children, adolescents and young adults (www.foxnews.com).

By early 2008, after Cody’s death ignited media attention, FDA officials began to look into suicide risks associated with drugs not specifically designed to directly affect the brain. Asthma medication, notably Singulair, drugs to control seizures, including 11 ‘antiepiletics’ or ‘anticonvulsives’ (www.medicinenet.com), drugs used to help patients stop smoking, such as ‘Chantix’, drugs to alleviate acne, such as ‘Accutane’, and drugs to treat the symptoms of influenza, Tamiflu and Relenza have all come under scrutiny. It seems that a steady drip, drip of drugs having no cause to affect mood are doing so to devastating effect. Is there something wrong with the system of clinical trials?

Of course, everyone knows, or should know, that when chemicals are pumped into one’s system there is always the prospect of side effects. One should be comfortable in the knowledge that one’s doctor prescribes a drug because any negative side effects will be sufficiently outweighed by its potential benefits. To prescribe effectively a doctor requires complete disclosure if he is to accurately weigh pros and cons. What a pharmaceutical company discloses is largely dependent on the clinical trials it puts a drug through. In the case of Singulair, the pharmaceutical company, Merck, changed the wording of the drug’s instruction leaflet four times, but not before Cody had paid the ultimate price. What went wrong between Singulair’s clinical trials and case reports showing it be a problem?

A tendency to jump on pharmaceutical companies with accusations of non-disclosure in the name of profits must be tempered by the fact that the vast majority of prescribed drugs do what they say they do in their instruction leaflets. It would be foolish to demonise an industry which has done enormous good for the world but it would also be foolish to imagine that ethics always prevails in a market-led industry.

The problem is that so little is really known about how the brain operates and how drugs can affect the brain’s operation. Not all drugs affect the brain because the brain’s cellular barrier keeps out certain substances circulating in the blood (www.pharmaceuticalonline.com). Problems arise when drugs not designed to circumvent this barrier end up doing so against the predictions or desires of anyone concerned. Until more is known about which chemicals are likely to pass through the brain’s barrier, there is always going to be a risk that the results of clinical trials could be incomplete, particularly when individual variations muddy the waters. Dr. Thomas Laughren, director of the FDA’s division of psychiatry products, has said “The difficulty is that we have such a primitive understanding of human behaviour on a biological level … it is hard to predict which compounds are going to have psychiatric effects.” (http://articles.latimes.com).

Pharmaceutical companies tend to promote the view that psychiatric problems are associated with chemical imbalance because this allows them to sell their products; our chemicals will fill your gaps. But chemical imbalance is only one factor affecting mood and psychiatry. Attitude to stress, and the frequency and intensity of stressful episodes in an individual’s life, genetic predisposition, a propensity for melancholic musings, an undirected creative streak, learned ways to respond to society in general and to situations where expectations fail to match achievements, lack of healthy pursuits, poor diet, quality and quantity of sleep, and dreams therein, socio-environmental factors, hormonal cycles and much, much more all influence an individual’s state of mind and how that state of mind will be affected by the sudden introduction of chemicals from a box or bottle. Individuals differ; there will always be disparities when drugs designed for general use are administered without taking individual characteristics sufficiently into account.
Medical research has been conducted into imaging techniques to map brain circuits and chemical systems involved in mood disorders such as bipolar disorder and depression. According to Dr. Ellen Leibenluft, of the National Institute of Mental Health, “We find that the brain systems involved and the exact nature of the difficulties differs among patients, even when those patients have similar symptoms. Eventually, data like these will allow us to develop more individualised and targeted treatments for depression.” (www.healthscout.com).

The FDA helped pay for research at Columbia University into ways to collect and analyse data on individuals enrolling on drug trials, focusing on their thought patterns and propensity for suicidal thoughts. This seems a jolly good idea, so it is puzzling that pharmaceutical companies are not required to use the system the research has come up with. Surely, any data which would assist in understanding how types of individual respond to drugs would be a positive move. It is to be hoped that one day individual screening will play an important role in whether a doctor prescribes a particular person a particular drug. Until then, generalities always have the potential to result in the sort of individual tragedies which lead to case reports defying clinical trials.