Results from olanzapine )long-acting injection (LAI) clinical trials showed that the efficacy and safety profile of olanzapine LAI was generally consistent with that of Zyprexa(R) (olanzapine) with the exception of injection-related events. Results from a 24-week maintenance study (HGKA) and interim findings from an ongoing open-label study (HGKB) were presented at the first annual Schizophrenia International Research Society (SIRS) Conference in Venice, Italy.
Olanzapine LAI is an investigational formulation that combines olanzapine with a pamoate salt, resulting in an extended delivery of up to four weeks. Since olanzapine was introduced in 1996, it has been prescribed to approximately 24 million people worldwide.
"These studies offer insight into the potential of olanzapine LAI as a maintenance treatment for patients with schizophrenia who may have difficulty taking medication on a daily basis," said David McDonnell, M.D., clinical research physician at Lilly. "Schizophrenia is a challenging and complex disease to manage, which is why finding new ways to support patient compliance with medication is so important."
READ MORE @ PR NEWSWIRE
Wednesday, June 25, 2008
Tuesday, June 24, 2008
The working wounded
Mental illness is costing the Canadian economy a staggering $51-billion a year, and each day 500,000 people miss work because of psychiatric problems. What are employers doing about it? Not much.
The day Sylvie Giasson lost her job at the National Gallery of Canada – a victim of restructuring – it was as if a black hole opened up to swallow her.
The Gatineau, Que., translator began stuttering and crying. The tears wouldn't stop. She couldn't sleep. Suicidal thoughts overwhelmed her.
It took all the energy Ms. Giasson could muster to get herself to hospital, where she was diagnosed with severe depression and anxiety disorder. She spent seven months in the Royal Ottawa Hospital, being treated with medication, counselling and electroconvulsive therapy. And she endured it all virtually alone.
“Nobody wants to visit a loved one in a mental hospital,” Ms. Giasson said. There were no flowers or get-well-soon cards. No one called.
Society's silence about mental health is deafening. When you are diagnosed, you disappear. Yet the vast majority of Canadians suffering from mental illness – such severe conditions as depression, bipolar disorder and schizophrenia – are not in hospital but in the community and at work.
Mental illness accounts for a stunning 40 per cent of disability claims and sick leaves in Canada. While employees jest about “mental-health days,” they are no joke. Every day, 500,000 Canadians are absent from work due to psychiatric problems; the most recent estimate pegged the annual economic burden of mental illness at a staggering $51-billion. The World Health Organization estimates that by 2020, depression will be the leading cause of disability on the planet.
READ MORE @ THE GLOBE AND MAIL
The day Sylvie Giasson lost her job at the National Gallery of Canada – a victim of restructuring – it was as if a black hole opened up to swallow her.
The Gatineau, Que., translator began stuttering and crying. The tears wouldn't stop. She couldn't sleep. Suicidal thoughts overwhelmed her.
It took all the energy Ms. Giasson could muster to get herself to hospital, where she was diagnosed with severe depression and anxiety disorder. She spent seven months in the Royal Ottawa Hospital, being treated with medication, counselling and electroconvulsive therapy. And she endured it all virtually alone.
“Nobody wants to visit a loved one in a mental hospital,” Ms. Giasson said. There were no flowers or get-well-soon cards. No one called.
Society's silence about mental health is deafening. When you are diagnosed, you disappear. Yet the vast majority of Canadians suffering from mental illness – such severe conditions as depression, bipolar disorder and schizophrenia – are not in hospital but in the community and at work.
Mental illness accounts for a stunning 40 per cent of disability claims and sick leaves in Canada. While employees jest about “mental-health days,” they are no joke. Every day, 500,000 Canadians are absent from work due to psychiatric problems; the most recent estimate pegged the annual economic burden of mental illness at a staggering $51-billion. The World Health Organization estimates that by 2020, depression will be the leading cause of disability on the planet.
READ MORE @ THE GLOBE AND MAIL
Sunday, June 22, 2008
EU drugmakers demand repackaging ban to stop fakes
Drugmakers called on Thursday for a ban on the repackaging of medicines within the European Union in order to stamp out the growing threat of counterfeits.
"It is absolutely imperative, if we are going to try and protect consumers from counterfeits, that we do not allow a system that can take our medicines out of its packaging," industry association head and Bayer Healthcare (BAYG.DE: Quote, Profile, Research) CEO Arthur Higgins told reporters.
Pharmaceutical manufacturers blame the legal practice of parallel trade -- in which drugs bought in low-priced markets are repackaged and resold in high-price countries -- for fuelling counterfeit traffic. Parallel traders deny the charge.
Preventing repackaging would deal a blow to the parallel trade and could also help drugmakers' profits, since companies' revenues are currently eroded by arbitrage dealings in their products across borders.
READ MORE @ REUTERS
"It is absolutely imperative, if we are going to try and protect consumers from counterfeits, that we do not allow a system that can take our medicines out of its packaging," industry association head and Bayer Healthcare (BAYG.DE: Quote, Profile, Research) CEO Arthur Higgins told reporters.
Pharmaceutical manufacturers blame the legal practice of parallel trade -- in which drugs bought in low-priced markets are repackaged and resold in high-price countries -- for fuelling counterfeit traffic. Parallel traders deny the charge.
Preventing repackaging would deal a blow to the parallel trade and could also help drugmakers' profits, since companies' revenues are currently eroded by arbitrage dealings in their products across borders.
READ MORE @ REUTERS
Saturday, June 21, 2008
Treatment-Resistant Depression Affects Millions of Americans Each Year
Millions of Americans with depression are able to successfully manage their condition with a combination of available therapies. However, according to an article in the Journal of Clinical Psychiatry, up to 35 percent of patients treated for depression may have a little-known condition called Treatment-Resistant Depression, or TRD.
“There are evolving definitions of TRD among the research community, but at this point, a TRD diagnosis is usually given to a patient with major depressive disorder who has failed two adequate trials of an antidepressant medication,” said Dr. W. Clay Jackson, a primary care physician and assistant professor of clinical psychiatry at the University of Tennessee.
READ MORE @ NORTH AMERICAN PRESS SYNDICATE
“There are evolving definitions of TRD among the research community, but at this point, a TRD diagnosis is usually given to a patient with major depressive disorder who has failed two adequate trials of an antidepressant medication,” said Dr. W. Clay Jackson, a primary care physician and assistant professor of clinical psychiatry at the University of Tennessee.
READ MORE @ NORTH AMERICAN PRESS SYNDICATE
Friday, June 20, 2008
Falls, depression and antidepressants in later life
Older people are at high risk for falls and subsequent injuries. Those who have depression have an increased risk of falls and the medications they take for depression increase their risk even more, New Zealand and Australian researchers reported in the open-access journal PLoS ONE.
"People with depression and those taking antidepressants, especially SSRIs, are 50% more likely to fall than other older people," said Ngaire Kerse, lead author of the study and associate professor in the Department of General Practice and Primary Healthcare at the School of Population Health in the University of Auckland, New Zealand. "Falls are very common and risk factors for falls are easy to identify. We need to emphasise fall prevention during treatment of depression in older people."
In a study of 21,900 older Australians, over age 60, who responded to a survey sent out by their GP, 24 percent reported at least one fall during the last 12 months, 11% had injured themselves with falling and 8% had needed to see a doctor because of a fall.
About one quarter of the group reported symptoms of depression and 12% were taking some form of antidepressant. While using antidepressants was a significant risk for falls, the highest risk (66% increase in falls) was seen when older people used SSRIs, the most frequently prescribed antidepressant (6% of people took this medication).
"This risk associated with SSRIs has been reported before but not in such a large group of older people living in the community," Kerse said. "More than 60% of women aged over 80 with depression and taking an SSRI fell in the last year. This means that falls prevention strategies must really be thought of when prescribing antidepressants for older people."
READ MORE @ EUREKALERT
"People with depression and those taking antidepressants, especially SSRIs, are 50% more likely to fall than other older people," said Ngaire Kerse, lead author of the study and associate professor in the Department of General Practice and Primary Healthcare at the School of Population Health in the University of Auckland, New Zealand. "Falls are very common and risk factors for falls are easy to identify. We need to emphasise fall prevention during treatment of depression in older people."
In a study of 21,900 older Australians, over age 60, who responded to a survey sent out by their GP, 24 percent reported at least one fall during the last 12 months, 11% had injured themselves with falling and 8% had needed to see a doctor because of a fall.
About one quarter of the group reported symptoms of depression and 12% were taking some form of antidepressant. While using antidepressants was a significant risk for falls, the highest risk (66% increase in falls) was seen when older people used SSRIs, the most frequently prescribed antidepressant (6% of people took this medication).
"This risk associated with SSRIs has been reported before but not in such a large group of older people living in the community," Kerse said. "More than 60% of women aged over 80 with depression and taking an SSRI fell in the last year. This means that falls prevention strategies must really be thought of when prescribing antidepressants for older people."
READ MORE @ EUREKALERT
Thursday, June 19, 2008
Mentally ill face extra-long ER waits
Psychiatric patients who need hospitalization wait for hours in emergency departments for admission because hospitals are dropping mental health units and beds are scarce, a new survey says.
Nearly 80% of hospitals said mentally ill patients sometimes wait four hours or more to be admitted, says the American College of Emergency Physicians, which surveyed 328 emergency medical directors. About 10% said patients wait more than a day on average.
Average admission times for non-psychiatric patients were shorter: Only 30% of directors said those patients waited four hours or more. Yet 84% of the medical directors said ER wait times for all patients would drop if their hospitals had better psychiatric services.
Only half of the hospitals surveyed had psychiatric units. The rest transferred patients, sometimes far from homes and families. Hospitals are closing their units because of inadequate payments from government and insurers, unpaid costs for the uninsured and too few psychiatrists willing to work in hospitals, says James Bentley of the American Hospital Association.
READ MORE @ USA TODAY
Nearly 80% of hospitals said mentally ill patients sometimes wait four hours or more to be admitted, says the American College of Emergency Physicians, which surveyed 328 emergency medical directors. About 10% said patients wait more than a day on average.
Average admission times for non-psychiatric patients were shorter: Only 30% of directors said those patients waited four hours or more. Yet 84% of the medical directors said ER wait times for all patients would drop if their hospitals had better psychiatric services.
Only half of the hospitals surveyed had psychiatric units. The rest transferred patients, sometimes far from homes and families. Hospitals are closing their units because of inadequate payments from government and insurers, unpaid costs for the uninsured and too few psychiatrists willing to work in hospitals, says James Bentley of the American Hospital Association.
READ MORE @ USA TODAY
Wednesday, June 18, 2008
FDA Orders Warning Label on Older Antipsychotics
The U.S. Food and Drug Administration is cautioning physicians that certain types of antipsychotic drugs can boost the death risk of seniors with dementia.
Doctors sometimes use antipsychotics to help treat behavioral problems in demented patients.
But from now on these older, so-called "conventional" antipsychotics -- which include drugs such as thorazine and prolixin -- will carry a new black box warning alerting physicians of the danger, FDA officials announced Monday.
"We issued letters to all the manufacturers of antipsychotic drugs, both conventional and atypical, requiring them to update their labeling with new language for a box warning about an increased risk of death in elderly patients with dementia," Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products at the Center for Drug Evaluation and Research, said during an afternoon teleconference.
This is a new warning for conventional antipsychotics, but it is not new for another class of the medications, called atypical antipsychotics. Back in 2005, the FDA ordered warning labeling for those medications, which include newer drugs such as Zyprexa and Risperdal. That labeling warned of a higher risk for heart attack and pneumonia for elderly patients with dementia who received atypical antipsychotics.
READ MORE @ WASHINGTON POST
Doctors sometimes use antipsychotics to help treat behavioral problems in demented patients.
But from now on these older, so-called "conventional" antipsychotics -- which include drugs such as thorazine and prolixin -- will carry a new black box warning alerting physicians of the danger, FDA officials announced Monday.
"We issued letters to all the manufacturers of antipsychotic drugs, both conventional and atypical, requiring them to update their labeling with new language for a box warning about an increased risk of death in elderly patients with dementia," Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products at the Center for Drug Evaluation and Research, said during an afternoon teleconference.
This is a new warning for conventional antipsychotics, but it is not new for another class of the medications, called atypical antipsychotics. Back in 2005, the FDA ordered warning labeling for those medications, which include newer drugs such as Zyprexa and Risperdal. That labeling warned of a higher risk for heart attack and pneumonia for elderly patients with dementia who received atypical antipsychotics.
READ MORE @ WASHINGTON POST
Tuesday, June 17, 2008
ADD: not just child's play
Imagine you have to do something difficult like translating a document into ancient Greek. Not only that, but you have to do it in a room where the walls and ceiling are covered in television screens, each showing a different programme and on at full volume. At the same time, people are poking you with sharp sticks. When you ask to leave the room, all they say in reply is: "Just try harder."
This is how Garret Smyth, a British novelist with a degree in neuroscience, describes what it is like to live with Attention Deficit Disorder (ADD) - something he himself suffers from. Unable to concentrate, prone to annoying and impulsive behaviour, and incapable of following the instructions for filling in a tax return, it is, he says, scarcely surprising that many adult sufferers fail in their working or private lives, and succumb to depression. "Everyone knows someone who is late for everything, surrounded by huge piles of paper, who is thinking about 10 things instead of focusing on one. You can take a moral line - this person is hopeless - or you can decide the person needs help."
Between one and four per cent of children are believed to have AD(H)D. Hyperactivity (H) decreases as the brain matures. But the inability to concentrate can persist into adulthood. The idea that adults can have ADD is only just gaining acceptance and, at present, medication to deal with it is only licensed for children. That means treatment often comes to a sudden end at 18, and adults seeking help often report finding their GPs are dismissive. Adult ADD is currently being studied in centres in London, Cambridge, Canterbury and Swansea but elsewhere adults are forced to queue in clinics geared to children, sitting on tiny chairs among finger paintings. "That's humiliating," says Smyth.
READ MORE @ TELEGRAPH
This is how Garret Smyth, a British novelist with a degree in neuroscience, describes what it is like to live with Attention Deficit Disorder (ADD) - something he himself suffers from. Unable to concentrate, prone to annoying and impulsive behaviour, and incapable of following the instructions for filling in a tax return, it is, he says, scarcely surprising that many adult sufferers fail in their working or private lives, and succumb to depression. "Everyone knows someone who is late for everything, surrounded by huge piles of paper, who is thinking about 10 things instead of focusing on one. You can take a moral line - this person is hopeless - or you can decide the person needs help."
Between one and four per cent of children are believed to have AD(H)D. Hyperactivity (H) decreases as the brain matures. But the inability to concentrate can persist into adulthood. The idea that adults can have ADD is only just gaining acceptance and, at present, medication to deal with it is only licensed for children. That means treatment often comes to a sudden end at 18, and adults seeking help often report finding their GPs are dismissive. Adult ADD is currently being studied in centres in London, Cambridge, Canterbury and Swansea but elsewhere adults are forced to queue in clinics geared to children, sitting on tiny chairs among finger paintings. "That's humiliating," says Smyth.
READ MORE @ TELEGRAPH
Monday, June 16, 2008
Hunger hormone increases during stress, may have antidepressant effect
New research at UT Southwestern Medical Center may explain why some people who are stressed or depressed overeat.
While levels of the so-called "hunger hormone" ghrelin are known to increase when a person doesn't eat, findings by UT Southwestern scientists suggest that the hormone might also help defend against symptoms of stress-induced depression and anxiety.
"Our findings in mice suggest that chronic stress causes ghrelin levels to go up and that behaviors associated with depression and anxiety decrease when ghrelin levels rise. An unfortunate side effect, however, is increased food intake and body weight," said Dr. Jeffrey Zigman, assistant professor of internal medicine and psychiatry at UT Southwestern and senior author of a study appearing online today and in a future print edition of Nature Neuroscience.
Dr. Michael Lutter, instructor of psychiatry at UT Southwestern and lead author of the study, said, "Our findings support the idea that these hunger hormones don't do just one thing; rather, they coordinate an entire behavioral response to stress and probably affect mood, stress and energy levels."
READ MORE @ EUREKALERT
While levels of the so-called "hunger hormone" ghrelin are known to increase when a person doesn't eat, findings by UT Southwestern scientists suggest that the hormone might also help defend against symptoms of stress-induced depression and anxiety.
"Our findings in mice suggest that chronic stress causes ghrelin levels to go up and that behaviors associated with depression and anxiety decrease when ghrelin levels rise. An unfortunate side effect, however, is increased food intake and body weight," said Dr. Jeffrey Zigman, assistant professor of internal medicine and psychiatry at UT Southwestern and senior author of a study appearing online today and in a future print edition of Nature Neuroscience.
Dr. Michael Lutter, instructor of psychiatry at UT Southwestern and lead author of the study, said, "Our findings support the idea that these hunger hormones don't do just one thing; rather, they coordinate an entire behavioral response to stress and probably affect mood, stress and energy levels."
READ MORE @ EUREKALERT
Sunday, June 15, 2008
Mutation Related To ADHD Drug Metabolism Discovered
Researchers within the Darby Children’s Research Institute at the Medical University of South Carolina (MUSC) have discovered a gene mutation directly involved in the metabolism of the most common and perhaps most known medication used to treat ADHD, methylphenidate (MPH), or Ritalin. The discovery may open the door to pre-testing of patients for the appropriate ADHD medication, instead of having to undergo trial and error.
It’s not unusual for scientists to focus their work in one direction, only to discover something unexpected. Researchers within the Darby Children’s Research Institute at the Medical University of South Carolina (MUSC) have discovered a gene mutation directly involved in the metabolism of the most common and perhaps most known medication used to treat ADHD, methylphenidate (MPH), or Ritalin®. This research is described in full detail in the June 2008 issue of the American Journal of Human Genetics.
READ MORE @ SCIENCE DAILY
It’s not unusual for scientists to focus their work in one direction, only to discover something unexpected. Researchers within the Darby Children’s Research Institute at the Medical University of South Carolina (MUSC) have discovered a gene mutation directly involved in the metabolism of the most common and perhaps most known medication used to treat ADHD, methylphenidate (MPH), or Ritalin®. This research is described in full detail in the June 2008 issue of the American Journal of Human Genetics.
READ MORE @ SCIENCE DAILY
Saturday, June 14, 2008
GlaxoSmithKline faces US scrutiny over Paxil suicide link
GlaxoSmithKline (GSK), the UK's largest drug maker, is facing new scrutiny in America in the wake of a British government inquiry that found the company withheld data on the suicide risk of an antidepressant.
A US senator today asked the food and drug administration (FDA), the agency that regulates American pharmaceuticals, to follow its UK counterpart in probing whether GSK concealed clinical trial evidence.
"If the company engaged in this behaviour in the UK, then I want to make sure that the same didn't happen here in the US," Grassley said.
"The FDA should investigate this question thoroughly and be forthcoming about its findings."
The drug in question - Paxil, marketed in the UK as Seroxat - has been the subject of suicide warnings since 2003, when the British government told doctors not to prescribe it to young adults. A warning to that effect was added to its US labels in 2006.
In responding to the UK conclusion that GSK failed to inform authorities of Paxil's suicide risk, Grassley quoted the Guardian's report on imminent British legislation requiring drug companies to promptly publicise clinical trial data.
READ MORE @ THE GUARDIAN
A US senator today asked the food and drug administration (FDA), the agency that regulates American pharmaceuticals, to follow its UK counterpart in probing whether GSK concealed clinical trial evidence.
"If the company engaged in this behaviour in the UK, then I want to make sure that the same didn't happen here in the US," Grassley said.
"The FDA should investigate this question thoroughly and be forthcoming about its findings."
The drug in question - Paxil, marketed in the UK as Seroxat - has been the subject of suicide warnings since 2003, when the British government told doctors not to prescribe it to young adults. A warning to that effect was added to its US labels in 2006.
In responding to the UK conclusion that GSK failed to inform authorities of Paxil's suicide risk, Grassley quoted the Guardian's report on imminent British legislation requiring drug companies to promptly publicise clinical trial data.
READ MORE @ THE GUARDIAN
Friday, June 13, 2008
Antidepressants Alone: Not For Bipolar Depression
Psychiatrists have cautioned against the use of antidepressants alone in people with bipolar disorders, saying they could worsen a patient's condition by causing a destabilisation in mood.
Dr Ajeet Singh and Professor Michael Berk, consultant psychiatrists from the University of Melbourne, state in the current edition of Australian Prescriber that the goal of treatment in bipolar disorder is to stabilise mood, and antidepressants may defeat this purpose if they are not taken with other drugs.
"Patients may need an antidepressant, but this must be taken with a mood-stabilising drug. Antidepressants place patients at risk of switching to elevated phases of the disorder and rapid cycling patterns," they say in the article.
Patients should not simply be left on antidepressants long term without review, say the authors, as there is no good evidence of efficacy in the maintenance phase. If symptoms of elevated mood emerge, the patient should have their dose of the antidepressant reduced or stopped.
READ MORE @ MEDICAL NEWS TODAY
Dr Ajeet Singh and Professor Michael Berk, consultant psychiatrists from the University of Melbourne, state in the current edition of Australian Prescriber that the goal of treatment in bipolar disorder is to stabilise mood, and antidepressants may defeat this purpose if they are not taken with other drugs.
"Patients may need an antidepressant, but this must be taken with a mood-stabilising drug. Antidepressants place patients at risk of switching to elevated phases of the disorder and rapid cycling patterns," they say in the article.
Patients should not simply be left on antidepressants long term without review, say the authors, as there is no good evidence of efficacy in the maintenance phase. If symptoms of elevated mood emerge, the patient should have their dose of the antidepressant reduced or stopped.
READ MORE @ MEDICAL NEWS TODAY
Thursday, June 12, 2008
ADA: Metabolic Monitoring Guidelines for Antipsychotics Largely Unheeded
Recommendations for lipid and glucose monitoring for patients on atypical antipsychotic drugs have made scarcely a dent on clinical practice, researchers found.
Metabolic screening and monitoring rates rose by 5% or less since 2004, when the FDA warned of increased diabetes and cardiovascular risk with antipsychotic medications, according to two separate analyses of large insurance claim databases reported here at the American Diabetes Association meeting.
Only about 20% of patients on second-generation antipsychotics received recommended glucose monitoring and just 10% had lipids monitored, reported Dan W. Haupt, M.D., of Washington University in St. Louis, and colleagues in one of the studies.
Changes in screening rates were no better than, and in some cases worse, for patients starting antipsychotics than for other commercially-insured patients, found Elaine Morrato, Dr.P.H., M.P.H., of the University of Colorado in Denver, and colleagues in the other study.
READ MORE @ MEDPAGE TODAY
Metabolic screening and monitoring rates rose by 5% or less since 2004, when the FDA warned of increased diabetes and cardiovascular risk with antipsychotic medications, according to two separate analyses of large insurance claim databases reported here at the American Diabetes Association meeting.
Only about 20% of patients on second-generation antipsychotics received recommended glucose monitoring and just 10% had lipids monitored, reported Dan W. Haupt, M.D., of Washington University in St. Louis, and colleagues in one of the studies.
Changes in screening rates were no better than, and in some cases worse, for patients starting antipsychotics than for other commercially-insured patients, found Elaine Morrato, Dr.P.H., M.P.H., of the University of Colorado in Denver, and colleagues in the other study.
READ MORE @ MEDPAGE TODAY
Wednesday, June 11, 2008
US troops in Iraq and Afghanistan turning to anti-depressants in record numbers
Overwhelmed by the horrors and rigours of war, American troops are turning to prescription anti-depressants in record numbers.
America is facing accusations that it is maintaining the troop strength of its overstretched forces through a quiet policy of plying soldiers serving in Iraq and Afghanistan with prescription drugs.
The numbers of American servicemen on medications such as Prozac and Zoloft in combat zones now exceeds 20,000.
Critics claim a regulatory sleight of hand by service chiefs triggered the explosion in drug use. In November, 2006 the military issued a fresh order banning the use of older drugs, including lithium, anticonvulsants and antipsychotics, but omitted new generation of psychotropic medicine.
READ MORE @ TELEGRAPH
America is facing accusations that it is maintaining the troop strength of its overstretched forces through a quiet policy of plying soldiers serving in Iraq and Afghanistan with prescription drugs.
The numbers of American servicemen on medications such as Prozac and Zoloft in combat zones now exceeds 20,000.
Critics claim a regulatory sleight of hand by service chiefs triggered the explosion in drug use. In November, 2006 the military issued a fresh order banning the use of older drugs, including lithium, anticonvulsants and antipsychotics, but omitted new generation of psychotropic medicine.
READ MORE @ TELEGRAPH
Tuesday, June 10, 2008
With Precautions, Psychiatrists Need Not Shun off-Label Prescribing
Fear of lawsuits should not stop psychiatrists from prescribing medications for off-label indications as long as they make patient-centered decisions based on evidence and talk to patients about risks and benefits.
By focusing on patient care and providing appropriate informed consent, consultation-liaison psychiatrists can protect themselves from liability lawsuits regarding the use of antipsychotics and other medications for indications not approved by the Food and Drug Administratio (FDA). So said experts who led a workshop for consultation-liaison (C-L) psychiatrists at APA's 2008 annual meeting in Washington, D.C., in May.
Off-label use includes prescribing medications not only for unapproved indications, but also for unapproved dosages and patient populations, some of which may be subject to specific warnings by the FDA, said Ramaswamy Viswanathan, M.D. He is the director of the C-L Psychiatry Department at the State University of New York Downstate Medical Center in Brooklyn, N.Y. Intravenous infusion of haloperidol and the use of antipsychotics to treat dementia-related agitation are only two notable examples.
READ MORE @ PSYCHIATRIC NEWS
By focusing on patient care and providing appropriate informed consent, consultation-liaison psychiatrists can protect themselves from liability lawsuits regarding the use of antipsychotics and other medications for indications not approved by the Food and Drug Administratio (FDA). So said experts who led a workshop for consultation-liaison (C-L) psychiatrists at APA's 2008 annual meeting in Washington, D.C., in May.
Off-label use includes prescribing medications not only for unapproved indications, but also for unapproved dosages and patient populations, some of which may be subject to specific warnings by the FDA, said Ramaswamy Viswanathan, M.D. He is the director of the C-L Psychiatry Department at the State University of New York Downstate Medical Center in Brooklyn, N.Y. Intravenous infusion of haloperidol and the use of antipsychotics to treat dementia-related agitation are only two notable examples.
READ MORE @ PSYCHIATRIC NEWS
Monday, June 9, 2008
Researchers Fail to Reveal Full Drug Pay
A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.
By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.
Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.
READ MORE @ NY TIMES
By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.
Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.
READ MORE @ NY TIMES
Sunday, June 8, 2008
Experts Analyze Real Meaning of CATIE Study Findings
Despite the finding that SGAs are on average only marginally more efficacious than an FGA, perphenazine, most experts emphasize that what is true for "the average" patient may be not be best for the individual patient.
Science without the industry spin. That's the idea behind a series of nine papers appearing as a special section in the May issue of the APA journal Psychiatric Services looking at the results of the landmark Clinical Antipsychotic Trials of Intervention effectiveness (CATIE).
Prior to the appearance of the first CATIE study results in the New England Journal of Medicine (September 22, 2005), the superiority of second-generation antipsychotics (SGA) over first-generation antipsychotics (FGA) was widely considered a given. Though the trial pitted a proxy FGA, perphenizine, against five SGAs, the primary question for many was which SGA was most efficacious.
So when results showed that, with the exception of clozapine, SGAs had only marginal superiority over perphenazine, the response from quarters with vested interests was not tepid; the pharmaceutical industry was loudest in attacking CATIE on methodological grounds.
READ MORE @ PSYCHIATRIC NEWS
Science without the industry spin. That's the idea behind a series of nine papers appearing as a special section in the May issue of the APA journal Psychiatric Services looking at the results of the landmark Clinical Antipsychotic Trials of Intervention effectiveness (CATIE).
Prior to the appearance of the first CATIE study results in the New England Journal of Medicine (September 22, 2005), the superiority of second-generation antipsychotics (SGA) over first-generation antipsychotics (FGA) was widely considered a given. Though the trial pitted a proxy FGA, perphenizine, against five SGAs, the primary question for many was which SGA was most efficacious.
So when results showed that, with the exception of clozapine, SGAs had only marginal superiority over perphenazine, the response from quarters with vested interests was not tepid; the pharmaceutical industry was loudest in attacking CATIE on methodological grounds.
READ MORE @ PSYCHIATRIC NEWS
Saturday, June 7, 2008
New research explores role of serotonin
Findings provide insight into clinical disorders characterised by low serotonin level, such as depression, obsessive compulsive disorder and severe anxiety
New research by scientists at the University of Cambridge suggests that the neurotransmitter serotonin, which acts as a chemical messenger between nerve cells, plays a critical role in regulating emotions such as aggression during social decision-making.
Serotonin has long been associated with social behaviour, but its precise involvement in impulsive aggression has been controversial. Though many have hypothesised the link between serotonin and impulsivity, this is one of the first studies to show a causal link between the two.
Their findings highlight why some of us may become combative or aggressive when we haven't eaten. The essential amino acid necessary for the body to create serotonin can only be obtained through diet. Therefore, our serotonin levels naturally decline when we don't eat, an effect the researchers took advantage of in their experimental technique.
The research also provides insight into clinical disorders characterised by low serotonin levels, such as depression and obsessive compulsive disorder (OCD), and may help explain some of the social difficulties associated with these disorders.
This research, funded by the Wellcome Trust and the Medical Research Council, suggests that patients with depression and anxiety disorders may benefit from therapies that teach them strategies for regulating emotions during decision making, particularly in social scenarios.
READ MORE @ EUREKALERT
New research by scientists at the University of Cambridge suggests that the neurotransmitter serotonin, which acts as a chemical messenger between nerve cells, plays a critical role in regulating emotions such as aggression during social decision-making.
Serotonin has long been associated with social behaviour, but its precise involvement in impulsive aggression has been controversial. Though many have hypothesised the link between serotonin and impulsivity, this is one of the first studies to show a causal link between the two.
Their findings highlight why some of us may become combative or aggressive when we haven't eaten. The essential amino acid necessary for the body to create serotonin can only be obtained through diet. Therefore, our serotonin levels naturally decline when we don't eat, an effect the researchers took advantage of in their experimental technique.
The research also provides insight into clinical disorders characterised by low serotonin levels, such as depression and obsessive compulsive disorder (OCD), and may help explain some of the social difficulties associated with these disorders.
This research, funded by the Wellcome Trust and the Medical Research Council, suggests that patients with depression and anxiety disorders may benefit from therapies that teach them strategies for regulating emotions during decision making, particularly in social scenarios.
READ MORE @ EUREKALERT
Friday, June 6, 2008
Antipsychotics May Improve Psychiatric Symptoms In Alzheimer's Disease
Psychiatric and behavioral symptoms associated with Alzheimer's disease-such as anger, agitation, aggression, and paranoid thoughts and ideas-may improve with the use of second-generation antipsychotic medications, a new federally funded study has found. Improvements were seen both in global measures and in measures of specific symptoms. In addition, the analysis indicates that particular symptoms may respond better to different second-generation antipsychotic medications.
The new analysis of data from the Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD), funded by the National Institute of Mental Health, will be published online ahead of print by The American Journal of Psychiatry (AJP), the official journal of the American Psychiatric Association. The report will appear online1 under AJP in Advance on June 2, and will appear in print in the July issue of AJP.
READ MORE @ MEDICAL NEWS TODAY
The new analysis of data from the Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD), funded by the National Institute of Mental Health, will be published online ahead of print by The American Journal of Psychiatry (AJP), the official journal of the American Psychiatric Association. The report will appear online1 under AJP in Advance on June 2, and will appear in print in the July issue of AJP.
READ MORE @ MEDICAL NEWS TODAY
Thursday, June 5, 2008
Eating And Weight Gain Not Necessarily Linked, Study Shows
You may not be what you eat after all. A new study shows that increased eating does not necessarily lead to increased fat. The finding in the much-studied roundworm opens the possibility of identifying new targets for drugs to control weight, the researchers say.
The discovery reveals that the neurotransmitter serotonin, already known to control appetite and fat build-up, actually does so through two separate signaling channels. One set of signals regulates feeding, and a separate set of signals regulates fat metabolism. The worm, known scientifically as Caenorhabdtis elegans, shares half of its genes with humans and is often a predictor of human traits.
The signaling pathways are composed of a series of molecular events triggered by neurons in the brain that ultimately "instruct" the body to burn or store fat.
READ MORE @ SCIENCE DAILY
The discovery reveals that the neurotransmitter serotonin, already known to control appetite and fat build-up, actually does so through two separate signaling channels. One set of signals regulates feeding, and a separate set of signals regulates fat metabolism. The worm, known scientifically as Caenorhabdtis elegans, shares half of its genes with humans and is often a predictor of human traits.
The signaling pathways are composed of a series of molecular events triggered by neurons in the brain that ultimately "instruct" the body to burn or store fat.
READ MORE @ SCIENCE DAILY
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