By Robert Mackay
Under new proposals made by European pharmaceutical regulators, all new drugs will have to be given be given a 'suicide rating'. Pharmaceutical companies will also be required to include a suicide assessment in trials of all new medicines.
The proposals, stemming from a system recently adopted in the United States, have come about due to a growing body of evidence that certain drugs which affect the brain can also affect behaviour. Drugs used to treat acne, swelling, heartburn, obesity, pain, high blood pressure, bacterial infections, insomnia and smoking have all recently been associated with psychiatric problems in patients. Drugs including the anti-obesity drug, Acomplia, the smoking cessation drug Champix and the acne treatment Roaccutane have been prescribed to more than 60,000 patients in the UK alone.
The European Medicines Agency has sent letters to an undisclosed number of pharmaceutical companies requiring them to analyse their data again to include these risks. A suicide risk-assessment system, designed by Dr. Kelly Posner, will also be introduced into future drug trials in the form of a questionnaire which has already been translated into 80 languages. The questionnaire is known as the Columbia Suicide Severity rating and is able to determine whether patients' actions are suicidal or non-suicidal. It looks for four different types of suicidal behaviour and gives the drug a 'rating' out of 23.
The irony of this new situation is twofold. First, patients are demanding powerful drugs that have the ability to change patterns in the brain whilst not having any side effects and secondly, some of the most widely consumed and apparently less contentious drugs around would fail to meet regulatory guidelines if they were brought onto the market today. Aspirin, for example, is taken in more than 60 billion doses every year, more as prevention against heart attack than as a pain relief remedy. Yet if it had been discovered today this drug would not pass licensing regulations. It can cause damage to the lining of the stomach and can also cause ulcers and bleeding. In children it can also trigger Reye's syndrome, a potentially fatal condition. Overall, however, aspirin has done far more good than harm.
A rare side-effect may come to the fore simply due to the fact that a large number of people are using the medication. When new safety rules are introduced the knock-on effect is that costs rise and it becomes less and less profitable to produce drugs which have a limited market. This in turn could mean that it becomes undesirable for drug companies to develop drugs for rare conditions, which of course has massive implications for those people who are suffering.
It seems, then, that a balance has to be struck between the benefits which drugs have to offer and the side-effects which they can incur. In the increasingly risk-obsessed culture of drug development it could mean that vital drugs are not seen as viable for development. In the long run the consequence of this can only be a negative one.
This article was submitted by Robert MacKay who has an association with The Online Clinic. The Online Clinic is one of the largest online diagnosing and prescribing services in the UK. It is possible to have Acomplia prescribed by this clinic following a secure consultation with a GMC registered doctor. All medications are despatched from a pharmacy in the UK for next day delivery. For regulatory reasons, The Online Clinic cannot send medications to countries outside the UK. For the latest information on European Drug approvals please follow this hyperlink.
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