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Every new drug licensed in Britain will be given a “suicide rating” under proposals for a big shake-up in the rules governing pharmaceutical development. European regulators are also to require pharmaceutical companies to include a comprehensive suicide assessment into trials of new medicines.
The reform, based on a system adopted recently in the United States, has been fuelled by a growing body of evidence that drugs that affect the brain can heavily influence behaviour through seemingly innocuous changes in body chemistry. Medicines to treat acne, swelling, heartburn, pain, obesity, high blood pressure and cholesterol, bacterial infections, smoking and insomnia have all been associated recently with psychiatric problems. There have been warnings about the potential side-effects of Acomplia, an antiobesity drug, Roaccutane, an acne treatment, and Champix, an antismoking medication, which together have been prescribed to more than 60,000 patients in Britain.
Acomplia, also known as rimonabant, is designed to suppress the appetite but has been reported to more than double the rate of suicidal symptoms. Champix (varenicline), a drug that negates the pleasurable effects of smoking, has also received 1,513 reports of adverse reactions, including 62 reports of suicidal feelings.
David Roberts is one of 26 people said to have killed themselves while taking Roaccutane. The “cheerful” 20-year-old was found hanged near his Liverpool home three months after he began taking the drug.
The European Medicines Agency (EMEA), which regulates all drugs, has sent letters to an undisclosed number of drug companies requiring them to analyse their data again, using the system approved by the US Food and Drug Administration (FDA).
Discussions have also taken place between Kelly Posner, the designer of a suicide risk-assessment system, the EMEA and the pharmaceutical giants. They are due to meet in April to discuss how to introduce a suicide risk questionnaire, which has already been translated into 80 languages, into future drug trials.
“All the players, the FDA, EMEA, representatives from the drug companies, will be at the meeting to discuss how to move forward,” Dr Posner, a research scientist based at Columbia University, New York, told The Times. “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.”
Dr Posner and her team spent months creating a comprehensive questionnaire known as the Columbia Suicide Severity Rating, in which patients’ actions can be classified as either suicidal or nonsuicidal.
The questionnaire takes less than five minutes to administer and looks for four different types of suicidal behaviours. Each behaviour is rated for its severity and the drug is given an overall “suicide rating” out of 23.
The system could also vindicate the reputation of the class of antidepressant drugs known as selective serotonin reuptake inhibitors (SSRIs), which are no longer prescribed to people under 18 because of fears that they encourage suicidal thoughts in this age group.
“All the previous studies that these risks were based on were not set up to assess suicide risk,” Dr Posner said. “What we can learn from them is very limited. After the warnings [about SSRIs] were issued there was a 22 per cent decline in prescriptions in the US and in parts of Europe. There is a concerning correlation between reduced prescriptions and increased suicide.”
The Medicines and Healthcare Products Regulatory Authority, the British watchdog, said yesterday that it would follow the EMEA if the Columbia test became more widely used. “The EMEA would probably implement the change through a directive, which we would be bound to follow,” a spokeswoman said.
Drugs with known links to depression
Acomplia, an antiobesity drug
Dianette, a treatment for severe acne
Strattera, a medicine used to treat attention deficit hyperactivity disorder
Interferon alfa, used to treat certain cancers and hepatitis B
Roaccutane, an acne treatment
Zarontin, drug used to control epileptic seizures Source: British National Formulary
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Serious omissions from leaflets accompanying psychopharmaceutical drugs put lives at risk. For genetic reasons, many people cannot respond to the drugs they are prescribed. In psychiatry this problem is exacerbated by the fact that the dose is increased if there is no response. Although described as selective serotonin reuptake inhibitors, this class of drug is anything but selective. The listed side effects relating to many different regions and systems of the body are ample proof of this. Relevant genetic tests already exist. They are also cheap enough to be used in a screening procedure for certain conditions. They should be undertaken prior to the start of treatment. This general warning should be included in the leaflet accompanying the drug. Psychiatry is unfortunately also based on assumptions as well as science. It is self-referential. Dissenting voices are drowned out. Thanks to the internet, however, the practitioners no longer have a knowledge monopoly.
CPark, Dortmund, Germany
To Cinamon of London...Touch of the blues eh?
These drugs are powerfull biochemical manipulators who in susceptible people are a death drug.
Steve Price, Llanelli, Dyfed
I totally agree with the first comment. People don't commit suicide on a whim or because some drug is giving them a touch of the blues. Suicide is an incredibly hard decision to make and one that most people who opt for this course of action will have felt driven to by overwhelming circumstances.
D whitts, sheffield,
People kill themselves because they want to, not because a drug made them do it . Without the general wish being there, it won't just suddenly pop up out f nowhere. And it's more likely that those who get those drugs are depressed anyway and so more likely to commit suicide.
Remember, death by drowning in Brighton rises as ice cream sales go up...
Cinnamon, London,
The reification of scientific medicine has resulted in the elimination the dictum 'first do no harm'. The administration of medicine results in what is referred to as 'side effects' which is a term used to obscure the fact that drugs produce effects beyond the scope that they are intended to address.
Scientific medicine has reified the study of human health through the chemical-biological paradigm which analytically discards the living consciousness from the realm of understanding health and does not understand the relationship between the physical and phenomenological domains of the human being.
The effects of supposedly non-psychotropic drugs may be difficult to detect but the adverse reaction on the mind is brought about through the psysiological alterations of cellular processes and the feedback mechanism of this alteration which results in shifts of bio- energy circuits which the person experiences in the form of changes in energy, mood and thought process.
Greg Hessenauer, Tunbridge Wells, Kent
Those 4 drugs listed are not the only drugs that can cause mental changes that are debilitating. I took Celexa for a few months, realized it was making me behave in impulsive ways I knew were not necessarily beneficial, so I stopped. I was fine for about 2 weeks, then I went down fast. For months, I was feeling worse & worse. At that time, I did not have a psychiatrist or family doctor, I had no one to talk to & furthermore, I didn't feel like going anywhere. I basically became a shut-in, going out rarely, seeing almost no one, sometimes spending 22 hrs/day in bed. It took me about a year after I stopped taking it to even start feeling "normal".
I do not think anyone should be prescribed anti-depressants unless they have frequent doctor visits with close supervision all the while they are taking them & afterward. They can - and do - cause a person to act & feel completely different. I can see how some people would commit suicide, because I thought about it often.
Jennie, SC, USA
It is the responsibility of every doctor who prescribes these drugs to make sure that their patients aren't getting depressed and for them to have regular check ups. Anything less is not good practice. Anyone with acne has low self esteem anyway or they wouldn't come and ask for Roaccutane. Acne scars people and it is disfiguring.
The profession has known about Roaccutane and its side effects for over a decade or more.
Why is no one looking after people properly? or is it the case that this is another little spin cycle to make sure that the populace at large dont realise that the NHS is quite frankly down the tubes.
Henry North London, London, UK
-not to mention Prozac, which ( in my case ) caused clinical depression, tinnitus and anxiety.
SSRI`s are crude, dangerious and unpredictable. It is beyond comprehension that they are still so widely prescribed outside hospitals.
Stuart.
Stuart, London, UK
One needs to bear in mind that Ro-Accutane is only prescribed by Consultant dermatologists to patients who suffer from very severe acne, which has generally not responded well to more conservative therapies. Indeed, many GPs resort to referring patients via a psychiatrist because of the paucity of dermatology appointments within the NHS.
Many patients with very severe pustular acne are at their wits' end. The degree of disfigurement isolates that they suffer from them from school or college friends, and in too many cases renders them liable to ridicule and abuse. It stands to reason, therefore, that many patients who are given Ro-Accutane are already suffering from a marked degree of psychological morbidity.
After all, patients are told of the potential side-effects (girls are told that they must NOT get pregnant, or if they do must have a termination of pregnancy), yet still they agree to treatment.
Chris Palmer, Southampton, England
Am I the only one who thinks that f it has to have a suicide rating shouldn't be prescribed in the first place?
Farrukh, Woking, UK