Healthy Skepticism Library item: 12835

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

'Suicide rating' on the cards for new drugs
PM Live 2008 Feb 14
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6482

Full text:

New drugs licensed in the UK could be accompanied with a full ‘suicide rating’, informing how much of an effect the substance may have on the patient’s suicidal feelings, according to proposals being considered by the European Medicines Agency (EMEA).

European regulators will also be required to ensure that pharma companies include a comprehensive suicide assessment in trials of new drugs.

The EMEA has recently sent letters to all drug companies, requesting them to re-analyse their data in accordance with a system already developed and approved by the US Food and Drug Administration (FDA).

According to reports, the Medicines and Healthcare products Regulatory Authority (MHRA) has said that they would follow the EMEA’s actions if the US tests became more widely used.

Dr Kelly Posner, a research scientist based at Columbia University, has organised and held discussions between the EMEA major pharma companies.

She has also created a comprehensive questionnaire named the ‘Columbia suicide severity rating’, within which drugs will be given a score out of 23 for hazardousness. The questionnaire has already been translated into 80 different languages, for use across Europe.

“All the players, the FDA, EMEA, representatives from the drug companies, will be at the meeting to discuss how to move forward,” Posner told The Times newspaper.

“I’ve been getting requests from clinics and authorities in Europe asking how to implement the study. It’s really moved the field in that way. Hopefully this will be the first step to broadening the study across Europe,” Posner concluded.

An increasing body of evidence suggest serious suicidal thoughts may be associated with certain treatments for acne, swelling, heartburn, pain, obesity, high blood pressure, cholesterol, bacterial infections, smoking cessation and insomnia.

The reform suggestions follow recent health warnings over sanofi-aventis’ obesity drug Acomplia, Roche’s acne drug Roaccutane and Pfizer’s smoking cessation drug Champix.