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‘Suicide rating’ could be given to every new drug licensed in UK

February 8 2008 at 10:32 PM
morse 

From
February 9, 2008
 

‘Suicide rating’ could be given to every new drug licensed in UK

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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morse

Drugs with known links to depression

February 8 2008, 10:33 PM 

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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morse

jeezzzzzzzz they are still listening to Dr Posner

February 8 2008, 11:04 PM 

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


 
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morse

Columbia Classification Algorithm of Suicide Assessment

February 8 2008, 11:05 PM 

Am J Psychiatry 164:1035-1043, July 2007
doi: 10.1176/appi.ajp.164.7.1035
© 2007
American Psychiatric Association
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Columbia Classification Algorithm of Suicide Assessment (C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk Analysis of Antidepressants

Kelly Posner, Ph.D., Maria A. Oquendo, M.D., Madelyn Gould, Ph.D., M.P.H., Barbara Stanley, Ph.D., and Mark Davies, M.P.H.

OBJECTIVE: To evaluate the link between antidepressants and suicidal behavior and ideation (suicidality) in youth, adverse events from pediatric clinical trials were classified in order to identify suicidal events. The authors describe the Columbia Classification Algorithm for Suicide Assessment (C-CASA), a standardized suicidal rating system that provided data for the pediatric suicidal risk analysis of antidepressants conducted by the Food and Drug Administration (FDA). METHOD: Adverse events (N=427) from 25 pediatric antidepressant clinical trials were systematically identified by pharmaceutical companies. Randomly assigned adverse events were evaluated by three of nine independent expert suicidologists using the Columbia classification algorithm. Reliability of the C-CASA ratings and agreement with pharmaceutical company classification were estimated. RESULTS: Twenty-six new, possibly suicidal events (behavior and ideation) that were not originally identified by pharmaceutical companies were identified in the C-CASA, and 12 events originally labeled as suicidal by pharmaceutical companies were eliminated, which resulted in a total of 38 discrepant ratings. For the specific label of "suicide attempt," a relatively low level of agreement was observed between the C-CASA and pharmaceutical company ratings, with the C-CASA reporting a 50% reduction in ratings. Thus, although the C-CASA resulted in the identification of more suicidal events overall, fewer events were classified as suicide attempts. Additionally, the C-CASA ratings were highly reliable (intraclass correlation coefficient [ICC]=0.89). CONCLUSIONS: Utilizing a methodical, anchored approach to categorizing suicidality provides an accurate and comprehensive identification of suicidal events. The FDA’s audit of the C-CASA demonstrated excellent transportability of this approach. The Columbia algorithm was used to classify suicidal adverse events in the recent FDA adult antidepressant safety analyses and has also been mandated to be applied to all anticonvulsant trials and other centrally acting agents and nonpsychotropic drugs.


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paula

Following the money...

February 8 2008, 11:23 PM 

The research was funded by the National Institute of Mental Health, the John D. and Catherine T. MacArthur Foundation, the Pfizer Foundation, the U.S. Public Health Service, the Fogarty International Center, the Pan American Health Organization, Eli Lilly, Ortho-McNeil Pharmaceutical, GlaxoSmithKline, and Bristol-Meyers Squibb.

http://www.news.harvard.edu/gazette/2008/02.07/13-suicide.html

7th February 2008

Suicide risk factors consistent globally

9.2 percent of people report having seriously thought about suicide, 2.7 percent attempted suicide

Risk factors for suicidal thoughts, plans, and attempts are consistent across countries, and include having a mental disorder and being female, younger, less educated, and unmarried. So says new research from Harvard University and World Health Organization (WHO) World Mental Health Survey Initiative. The study examined both the prevalence and the risk factors for suicide across 17 countries, and is the largest, most representative examination of suicidal behavior ever conducted.

Published in the February issue of the British Journal of Psychiatry, the study was led by Matthew Nock, associate professor of psychology in the Faculty of Arts and Sciences (FAS) at Harvard, with data collected by the WHO World Mental Health Survey Initiative.

“Our research suggests that suicidal thoughts and behaviors are more common than one might think, and also that key risk factors for these behaviors are quite consistent across many different countries around the world,” says Nock.

Among those interviewed, 9.2 percent reported that they had seriously thought about suicide and 2.7 percent reported having made a suicide attempt at some point in their lives. However, there was variation from country to country with regard to the rates of suicidal thoughts and behaviors. For instance, rates of suicidal thoughts ranged from 3.1 percent of people in China to 15.9 percent of those in New Zealand. A reason for this variation may be that different cultural standards exist with regard to the acceptability of telling others about suicidal thoughts. Therefore, among countries with lower rates of suicidal thoughts, it’s possible that some thoughts of suicide were not reported.

Across the countries included in the study, risk factors for suicidal behavior included female gender, younger age, fewer years of education, unmarried status, and the presence of a mental disorder. Additionally, the risk of suicidal thoughts increased sharply during adolescence and young adulthood in every country studied.

The strongest risk factor associated with suicidal thoughts and behaviors were mood disorders in high-income countries and impulse control disorders in low- and middle-income countries.

“We often think of suicidal thoughts and behaviors as occurring among people who are depressed,” said Nock, “but across all of these countries, we found that it is not just depression that increases the risk of suicidal behaviors. Impulse-control disorders, substance-use disorders, and anxiety disorders all are associated with a significantly higher risk of suicidal thoughts and attempts.”

In fact, the study showed that among people with suicidal thoughts, the risk of actually making an attempt was highest not among those with a mood disorder, but in those with substance abuse and impulse-control disorders, suggesting that these disorders are most strongly associated with acting on suicidal thoughts when they are present.

Among other interesting findings in the study was that among people with suicidal thoughts, 29 percent later made a suicide attempt, and these attempts occurred most often within the first year after the onset of suicidal thoughts. The probability of a suicide attempt among people with both suicidal thoughts and a plan was 56 percent, but only 15.4 percent among those without a plan.

The survey included data from 17 countries: Nigeria, South Africa, Colombia, Mexico, the United States, Japan, New Zealand, China, Belgium, France, Germany, Italy, the Netherlands, Spain, Ukraine, Israel, and Lebanon. A total of 84,850 adults were asked about suicidal behaviors and socio-demographic and psychiatric risk factors.

Previous studies of suicidal behavior have largely relied on smaller, self-selected samples of suicidal individuals, so it has been unclear how well the results would generalize in different countries around the world. This study is the first to examine the thoughts and behaviors of individuals across numerous, diverse countries.

Suicide is a leading cause of death worldwide, but information on its prevalence and risk factors is unavailable in many countries, particularly in those that are less developed. Currently, resources devoted to the treatment of mental disorders and to suicide prevention are lacking in many countries. Further research could help to explain the differences in prevalence of suicide thoughts across nations, Nock said.

The co-authors of the paper, all from the WHO World Mental Health Survey Initiative, were Guilherme Borges, Evelyn J. Bromet, Jordi Alonso, Matthias Angermeyer, Annette Beautrais, Ronny Bruffaerts, Wai Tat Chiu, Giovanni de Girolamo, Semyon Gluzman, Ron de Graaf, Oye Gureje, Josep Maria Haro, Yueqin Huang, Elie Karam, Ronald C. Kessler, Jean Pierre Lepine, Daphna Levinson, Maria Elena Medina-Mora, Yutaka Ono, Jose´ Posada-Villa, and David Williams.

The research was funded by the National Institute of Mental Health, the John D. and Catherine T. MacArthur Foundation, the Pfizer Foundation, the U.S. Public Health Service, the Fogarty International Center, the Pan American Health Organization, Eli Lilly, Ortho-McNeil Pharmaceutical, GlaxoSmithKline, and Bristol-Meyers Squibb."

 

Didn't think they'd mention things like Sweden's National Data, or drug induced suicidality etc.

 


 
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paula

So long as the MHRA don't have to take any action of their own volition...

February 8 2008, 10:56 PM 

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.

 
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paula

UK's watchdog - when up against pharma influence...

February 8 2008, 10:59 PM 


 
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