Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs.
The study, to be published Wednesday in The Journal of the American Medical Association, found that 257 young children and adolescents in New York City and on Long Island added 8 to 15 percent to their weight after taking the pills for less than 12 weeks.
The patients, ages 4 to 19, added an average of one to one-and-a-half pounds a week.
“The degree of weight gain is alarming,” said Dr. Wayne K. Goodman, head of a Food and Drug Administration advisory panel on the drugs last summer and chairman of psychiatry at Mount Sinai School of Medicine in Manhattan. “The magnitude is stunning,” he said.
Although the drugs’ influence on weight and metabolism had been previously detected, Dr. Goodman, who was not involved in the study, said the speed and magnitude of the effects found in the study were greater than previously reported — findings he said were made possible by looking exclusively at new patients.
READ MORE @ NY TIMES
Thursday, October 29, 2009
Wednesday, October 28, 2009
Prescribing drugs 'off-label': an ethical prescription
More than one in five of the prescriptions U.S. doctors write for 160 common drugs is for a use other than that approved by the Food and Drug Administration. The practice is perfectly legal, though patients are largely in the dark about what "indications" or uses the FDA has approved for different prescription medications. (You can, however, always check the FDA-approved product labels for a prescription drug here.).
These "off-label uses" have not been scrutinized by the FDA for safety and effectiveness. It's not legal for drug companies actively to promote a drug for "off-label" purposes. But the practice means big money for drug makers, and some do it anyway (just last month, Pfizer agreed to plead guilty to promoting off-label uses for some of its medications and was fined $2.3 billion by the Justice Department, according to the Justice Department website).
So, while it's legal, the practice is controversial.
That leaves doctors, who often feel immense pressure to offer something--anything--to relieve a patient's suffering, in uncharted ethical waters. In some cases, the "off-label" use of a drug might be just the treatment the patient needed. But it might just as likely be a waste of time and money--or worse, pose unpredictable dangers to the patient. When "everybody's doing it" (and, yes, even physicians say stuff like that sometimes), what's a physician to do?
READ MORE @ LOS ANGELES TIMES
These "off-label uses" have not been scrutinized by the FDA for safety and effectiveness. It's not legal for drug companies actively to promote a drug for "off-label" purposes. But the practice means big money for drug makers, and some do it anyway (just last month, Pfizer agreed to plead guilty to promoting off-label uses for some of its medications and was fined $2.3 billion by the Justice Department, according to the Justice Department website).
So, while it's legal, the practice is controversial.
That leaves doctors, who often feel immense pressure to offer something--anything--to relieve a patient's suffering, in uncharted ethical waters. In some cases, the "off-label" use of a drug might be just the treatment the patient needed. But it might just as likely be a waste of time and money--or worse, pose unpredictable dangers to the patient. When "everybody's doing it" (and, yes, even physicians say stuff like that sometimes), what's a physician to do?
READ MORE @ LOS ANGELES TIMES
Tuesday, October 27, 2009
Antidepressants 'work instantly'
Antidepressants get to work immediately to lift mood, contrary to current belief, UK researchers say.
Although patients may not notice the effects until months into the therapy, the team say they work subconsciously.
The action is rapid, beginning within hours of taking the drugs, and changes negative thoughts, according to the Oxford University researchers.
These subtle, positive cues may add up over time to lift the depression, the American Journal of Psychiatry reports.
It may also explain why talking therapies designed to break negative thought cycles can also help.
Psychiatrist Dr Catherine Harmer and her team at Oxford University closely studied the reactions of 33 depressed patients and 31 healthy controls given either an antidepressant or a dummy drug.
The depressed patients who took the active drug showed positive improvements in three specific measures within three hours of taking them.
These patients were more likely to think about themselves in a positive light, rather than dwelling on their bad points, the researchers said.
They were also more likely to see the positive in others. For example, if they saw a grumpy person they no longer internalised this to think that they must have done something wrong to upset the person.
READ MORE @ BBC NEWS
Although patients may not notice the effects until months into the therapy, the team say they work subconsciously.
The action is rapid, beginning within hours of taking the drugs, and changes negative thoughts, according to the Oxford University researchers.
These subtle, positive cues may add up over time to lift the depression, the American Journal of Psychiatry reports.
It may also explain why talking therapies designed to break negative thought cycles can also help.
Psychiatrist Dr Catherine Harmer and her team at Oxford University closely studied the reactions of 33 depressed patients and 31 healthy controls given either an antidepressant or a dummy drug.
The depressed patients who took the active drug showed positive improvements in three specific measures within three hours of taking them.
These patients were more likely to think about themselves in a positive light, rather than dwelling on their bad points, the researchers said.
They were also more likely to see the positive in others. For example, if they saw a grumpy person they no longer internalised this to think that they must have done something wrong to upset the person.
READ MORE @ BBC NEWS
Monday, October 26, 2009
Purging the stigma of mental illness
Joseph Rochford, associate professor of psychiatry at McGill and a director at the Douglas Hospital, hopes the hospital's Mini-Psych School will help debunk myths surrounding people suffering from mental disorders.
"Molecular biologists and geneticists are like the engineers who develop a new Formula One racing car. We're the ones who test drive it and then go back and say 'this is how it behaves.' "
That's Joseph Rochford, associate professor of psychiatry at McGill University and director of the Douglas Hospital Research Centre, on what a behaviour pharmacologist does.
The head of the neurophenotyping centre at the Douglas Institute studies how drugs used for treating mental disorders affect behaviour.
Starting this week, Rochford - also the director of academic affairs - will launch the Douglas's Mini-Psych School by giving the first session on the myths of mental illness. The purpose of the six-week course is to educate and sensitize the public to mental health issues.
READ MOEW @ MONTREAL GAZETTE
"Molecular biologists and geneticists are like the engineers who develop a new Formula One racing car. We're the ones who test drive it and then go back and say 'this is how it behaves.' "
That's Joseph Rochford, associate professor of psychiatry at McGill University and director of the Douglas Hospital Research Centre, on what a behaviour pharmacologist does.
The head of the neurophenotyping centre at the Douglas Institute studies how drugs used for treating mental disorders affect behaviour.
Starting this week, Rochford - also the director of academic affairs - will launch the Douglas's Mini-Psych School by giving the first session on the myths of mental illness. The purpose of the six-week course is to educate and sensitize the public to mental health issues.
READ MOEW @ MONTREAL GAZETTE
Sunday, October 25, 2009
New Pfizer unit to take on autism
Diane Stephenson of Groton has three tangible reasons for wanting to know as much as possible about autism.
Stephenson, associate research fellow at Pfizer Inc.'s Groton laboratories who helped start an autism research unit there earlier this year, has two nephews and a niece with the neurological disorder, which is often accompanied by language difficulties, behavioral problems, sleep interruptions, poor eye contact and low social skills.
Her sister's son Thomas, 23, has never spoken a word. And two of her brother's children, Clarise, 5, and Craig, 2, also have been diagnosed with autism.
Autism is believed to be caused by a combination of environmental and genetic factors, but there is little doubt the disorder tends to run in families. Stephenson said couples who have one autistic child are 30 times more likely than others to have a second with the same disorder.
"Everyone wants a cure," said Stephenson, who has worked at the Groton labs for six years. "I felt there was something I could do."
So Stephenson, along with Pfizer colleague Howie Mayer, who has two children with autism, worked behind the scenes for a year with the idea of forming a separate research unit focusing on autism. They later added another colleague, Larry Fitzgerald, as the group put the finishing touches on its proposal, contacting key experts outside Pfizer who had a grasp on the latest breakthroughs in autism research.
READ MORE @ HARTFORD COURANT
Stephenson, associate research fellow at Pfizer Inc.'s Groton laboratories who helped start an autism research unit there earlier this year, has two nephews and a niece with the neurological disorder, which is often accompanied by language difficulties, behavioral problems, sleep interruptions, poor eye contact and low social skills.
Her sister's son Thomas, 23, has never spoken a word. And two of her brother's children, Clarise, 5, and Craig, 2, also have been diagnosed with autism.
Autism is believed to be caused by a combination of environmental and genetic factors, but there is little doubt the disorder tends to run in families. Stephenson said couples who have one autistic child are 30 times more likely than others to have a second with the same disorder.
"Everyone wants a cure," said Stephenson, who has worked at the Groton labs for six years. "I felt there was something I could do."
So Stephenson, along with Pfizer colleague Howie Mayer, who has two children with autism, worked behind the scenes for a year with the idea of forming a separate research unit focusing on autism. They later added another colleague, Larry Fitzgerald, as the group put the finishing touches on its proposal, contacting key experts outside Pfizer who had a grasp on the latest breakthroughs in autism research.
READ MORE @ HARTFORD COURANT
Saturday, October 24, 2009
Increase In Long-term Antidepressant Drug Use, UK Study Reveals
A dramatic rise in antidepressant prescriptions issued by GPs has been caused by a year on year increase in the number of people taking antidepressant drugs on a long-term basis, according to researchers from the University of Southampton.
In a paper, published in the printed edition of British Medical Journal (BMJ), scientists found that despite a drop in the number of new patients diagnosed with depression over 11 years, the number of prescriptions doubled.
"We estimate that more than 2 million people are now taking antidepressants long-term over several years, in particular women aged between 18 and 30," comments Tony Kendrick, a professor in Primary Medical Care of the University's School of Medicine, who led the study.
The number of prescriptions issued per patient rose from 2.8 in 1993 to 5.6 in 2004.
Prescription Pricing Authority data shows that more than 30 million prescriptions for SSRIs (selective serotonin reuptake inhibitors) such as Prozac and Seroxat, are now issued per year, twice as many as the early 1990s. Researchers at the University of Southampton found 90 per cent of people diagnosed with depression are now taking SSRIs either continuously or as repeated courses over several years.
RED MORE @ SCIENCE DAILY
In a paper, published in the printed edition of British Medical Journal (BMJ), scientists found that despite a drop in the number of new patients diagnosed with depression over 11 years, the number of prescriptions doubled.
"We estimate that more than 2 million people are now taking antidepressants long-term over several years, in particular women aged between 18 and 30," comments Tony Kendrick, a professor in Primary Medical Care of the University's School of Medicine, who led the study.
The number of prescriptions issued per patient rose from 2.8 in 1993 to 5.6 in 2004.
Prescription Pricing Authority data shows that more than 30 million prescriptions for SSRIs (selective serotonin reuptake inhibitors) such as Prozac and Seroxat, are now issued per year, twice as many as the early 1990s. Researchers at the University of Southampton found 90 per cent of people diagnosed with depression are now taking SSRIs either continuously or as repeated courses over several years.
RED MORE @ SCIENCE DAILY
Friday, October 23, 2009
Why antidepressants don't work for so many Northwestern research finds drugs aim at wrong target
More than half the people who take antidepressants for depression never get relief.
Why? Because the cause of depression has been oversimplified and drugs designed to treat it aim at the wrong target, according to new research from the Northwestern University Feinberg School of Medicine. The medications are like arrows shot at the outer rings of a bull's eye instead of the center.
A study from the laboratory of long-time depression researcher Eva Redei, presented at the Neuroscience 2009 conference in Chicago this week, appears to topple two strongly held beliefs about depression. One is that stressful life events are a major cause of depression. The other is that an imbalance in neurotransmitters in the brain triggers depressive symptoms.
Both findings are significant because these beliefs were the basis for developing drugs currently used to treat depression.
Redei, the David Lawrence Stein Professor of Psychiatry at Northwestern's Feinberg School, found powerful molecular evidence that quashes the long-held dogma that stress is generally a major cause of depression. Her new research reveals that there is almost no overlap between stress-related genes and depression-related genes.
READ MORE @ EUREKALERT
Why? Because the cause of depression has been oversimplified and drugs designed to treat it aim at the wrong target, according to new research from the Northwestern University Feinberg School of Medicine. The medications are like arrows shot at the outer rings of a bull's eye instead of the center.
A study from the laboratory of long-time depression researcher Eva Redei, presented at the Neuroscience 2009 conference in Chicago this week, appears to topple two strongly held beliefs about depression. One is that stressful life events are a major cause of depression. The other is that an imbalance in neurotransmitters in the brain triggers depressive symptoms.
Both findings are significant because these beliefs were the basis for developing drugs currently used to treat depression.
Redei, the David Lawrence Stein Professor of Psychiatry at Northwestern's Feinberg School, found powerful molecular evidence that quashes the long-held dogma that stress is generally a major cause of depression. Her new research reveals that there is almost no overlap between stress-related genes and depression-related genes.
READ MORE @ EUREKALERT
Thursday, October 22, 2009
Texas Lawsuit Blames Antipsychotic Seroquel for Woman’s Diabetes
Taking Seroquel to treat a mental disorder caused a Texas woman to develop diabetes and she wouldn’t have taken the drug if she knew of the risks, according to a lawsuit filed in Texas federal court.
Misty Peters claims she took the atypical antipsychotic drug, which is approved for treating schizophrenia and bipolar disorder but also is widely used by physicians to treat other unapproved “off-label” conditions, according to a report in the Southeast Texas Record.
Peters’ product liability lawsuit, filed last week in the Beaumont Division of the Eastern District of Texas, accuses Seroquel’s maker, Astra Zeneca Pharmaceuticals, and others of promoting the drug’s benefits and downplaying its risks while knowing it could cause users to develop diabetes and other medical problems.
Seroquel Linked to Diabetes, Other Blood-Sugar Disorders
Seroquel was approved by the Food and Drug Administration in 1997 as a member of a newer class of drugs called atypical antipsychotics. The drugs, which control levels of dopamine in the brain, are billed as being just as effective as older antipsychotic drugs like Haldol with fewer side effects, but more recent research has found a link between taking Seroquel and developing diabetes and other blood-sugar disorders.
READ MORE @ ATORNEY AT LAW
Misty Peters claims she took the atypical antipsychotic drug, which is approved for treating schizophrenia and bipolar disorder but also is widely used by physicians to treat other unapproved “off-label” conditions, according to a report in the Southeast Texas Record.
Peters’ product liability lawsuit, filed last week in the Beaumont Division of the Eastern District of Texas, accuses Seroquel’s maker, Astra Zeneca Pharmaceuticals, and others of promoting the drug’s benefits and downplaying its risks while knowing it could cause users to develop diabetes and other medical problems.
Seroquel Linked to Diabetes, Other Blood-Sugar Disorders
Seroquel was approved by the Food and Drug Administration in 1997 as a member of a newer class of drugs called atypical antipsychotics. The drugs, which control levels of dopamine in the brain, are billed as being just as effective as older antipsychotic drugs like Haldol with fewer side effects, but more recent research has found a link between taking Seroquel and developing diabetes and other blood-sugar disorders.
READ MORE @ ATORNEY AT LAW
Wednesday, October 21, 2009
In praise of 'electroshock'
What does it feel like to be profoundly depressed?
“Sometimes you feel like your head is going to explode,” Richard Braudo explains. “There were times I was so depressed, I was comatose. You can reach the point where you don't want to live – the pain is too much.”
Mr. Braudo knows. His diagnosis: treatment-resistant bipolar affective disorder.
The Toronto lawyer and management consultant has survived 30 bouts of severe depression, each lasting many months, not to mention a couple of suicide attempts.
But, at the age of 55, he has finally achieved “stable wellness.”
Mr. Braudo credits electroconvulsive therapy for his recovery. He has undergone 10 courses of ECT since 1991, the last about 18 months ago – the longest period, by far, in his adult life that he has gone without a bout of depression.
He has chosen to tell his story to help counter the negative public image of ECT as barbaric and painful and to underscore that prescription drugs are not the be-all and end-all for people with psychiatric illnesses.
READ MORE @ GLOBE AND MAIL
“Sometimes you feel like your head is going to explode,” Richard Braudo explains. “There were times I was so depressed, I was comatose. You can reach the point where you don't want to live – the pain is too much.”
Mr. Braudo knows. His diagnosis: treatment-resistant bipolar affective disorder.
The Toronto lawyer and management consultant has survived 30 bouts of severe depression, each lasting many months, not to mention a couple of suicide attempts.
But, at the age of 55, he has finally achieved “stable wellness.”
Mr. Braudo credits electroconvulsive therapy for his recovery. He has undergone 10 courses of ECT since 1991, the last about 18 months ago – the longest period, by far, in his adult life that he has gone without a bout of depression.
He has chosen to tell his story to help counter the negative public image of ECT as barbaric and painful and to underscore that prescription drugs are not the be-all and end-all for people with psychiatric illnesses.
READ MORE @ GLOBE AND MAIL
Tuesday, October 20, 2009
MENTAL DISORDERS DON'T HINDER HEADACHE TREATMENT
Contrary to long-standing thinking, medications may offer comparable headache relief to those with and without mental disorders.
For an especially miserable time, mix recurring headaches with depression, anxiety or both. But people in such a fix have cause for optimism, courtesy of a team led by psychologist Bernadette Heckman of Ohio University in Athens.
Drug treatments for headaches work just as well for patients with these psychiatric disorders as for those with no such problems, Heckman and her colleagues report in the November Pain.
Researchers and clinicians generally assume that the presence of one or more psychiatric ailments worsens headache symptoms and thus the prospects for successful treatment. Heckman and her colleagues conducted one of the few prospective studies to test that conviction.
“Contrary to conventional clinical wisdom, many patients with psychiatric disorders responded favorably to headache treatment,” Heckman says.
The team found that, during six months of treatment at any of four outpatient headache clinics, rates of improvement in headache frequency and intensity were about the same for patients with depression, anxiety, a combination of the two or no psychiatric disorders.
In a comment published with the new study, psychologist Todd Smitherman of the University of Mississippi in Oxford and psychiatrist Donald Penzien of the University of Mississippi Medical Center in Jackson say that the new findings “give us pause to reconsider our earlier predictions” that people with mental disorders respond poorly to headache treatment.
READ MORE @ SCIENCE NEWS
For an especially miserable time, mix recurring headaches with depression, anxiety or both. But people in such a fix have cause for optimism, courtesy of a team led by psychologist Bernadette Heckman of Ohio University in Athens.
Drug treatments for headaches work just as well for patients with these psychiatric disorders as for those with no such problems, Heckman and her colleagues report in the November Pain.
Researchers and clinicians generally assume that the presence of one or more psychiatric ailments worsens headache symptoms and thus the prospects for successful treatment. Heckman and her colleagues conducted one of the few prospective studies to test that conviction.
“Contrary to conventional clinical wisdom, many patients with psychiatric disorders responded favorably to headache treatment,” Heckman says.
The team found that, during six months of treatment at any of four outpatient headache clinics, rates of improvement in headache frequency and intensity were about the same for patients with depression, anxiety, a combination of the two or no psychiatric disorders.
In a comment published with the new study, psychologist Todd Smitherman of the University of Mississippi in Oxford and psychiatrist Donald Penzien of the University of Mississippi Medical Center in Jackson say that the new findings “give us pause to reconsider our earlier predictions” that people with mental disorders respond poorly to headache treatment.
READ MORE @ SCIENCE NEWS
Monday, October 19, 2009
Men on Tricyclic Antidepressant More Likely to Think of Suicide
All antidepressants may not be created equal when it comes to worsening of suicidal ideation during treatment, researchers found.
Men taking nortriptyline (Aventyl, Pamelor) were 2.4 times more likely to have an increase in suicidal thoughts than were those taking escitalopram (Lexapro), Nader Perroud, MD, of King's College London, and colleagues reported online in BMC Medicine.
Nortriptyline, a tricyclic antidepressant, was also associated with a 9.8-fold higher risk of new onset of suicidal ideation compared with the selective serotonin reuptake inhibitor (SSRI) in the prospective open-label trial.
The reason behind the difference may be that nortriptyline acts predominantly on the noradrenergic system, which, when overactive, is associated with anxiety and agitation.
Because "suicidal ideation is more common in agitated and irritable types of depression," the researchers said, "it is possible that nortriptyline may induce or worsen suicidal thoughts in some male subjects possibly through an induction of this more agitated type of depression."
Another possibility is that nortriptyline is less effective against mood symptoms, they noted.
All antidepressants now carry black box warnings of suicidality risk, particularly in children and young adults, and especially early in treatment, but whether this risk differs between agents or by gender has been debated.
READ MORE @ MEDPAGE TODAY
Men taking nortriptyline (Aventyl, Pamelor) were 2.4 times more likely to have an increase in suicidal thoughts than were those taking escitalopram (Lexapro), Nader Perroud, MD, of King's College London, and colleagues reported online in BMC Medicine.
Nortriptyline, a tricyclic antidepressant, was also associated with a 9.8-fold higher risk of new onset of suicidal ideation compared with the selective serotonin reuptake inhibitor (SSRI) in the prospective open-label trial.
The reason behind the difference may be that nortriptyline acts predominantly on the noradrenergic system, which, when overactive, is associated with anxiety and agitation.
Because "suicidal ideation is more common in agitated and irritable types of depression," the researchers said, "it is possible that nortriptyline may induce or worsen suicidal thoughts in some male subjects possibly through an induction of this more agitated type of depression."
Another possibility is that nortriptyline is less effective against mood symptoms, they noted.
All antidepressants now carry black box warnings of suicidality risk, particularly in children and young adults, and especially early in treatment, but whether this risk differs between agents or by gender has been debated.
READ MORE @ MEDPAGE TODAY
Sunday, October 18, 2009
'ECG for the mind' could diagnose depression in an hour
An innovative diagnostic technique invented by a Monash University researcher could dramatically fast-track the detection of mental and neurological illnesses.
Monash biomedical engineer Brian Lithgow has developed electrovestibulography which is something akin to an 'ECG for the mind'. Patterns of electrical activity in the brain's vestibular (or balance) system are measured against distinct response patterns found in depression, schizophrenia and other Central Nervous System (CNS) disorders.
The vestibular system is closely connected to the primitive regions of the brain that relate to emotions and behaviour, so Lithgow saw the diagnostic potential of measuring and comparing different patterns of electrovestibular activity.
Working with psychiatry researchers at Monash University's Alfred Psychiatry Research Centre (MAPrc) in Melbourne, Australia, he tested volunteers and found distinct response patterns, or "biomarkers", that distinguished different CNS diseases from each other and from regular electrovestibular activity.
READ MORE @ EUREKALERT"
Monash biomedical engineer Brian Lithgow has developed electrovestibulography which is something akin to an 'ECG for the mind'. Patterns of electrical activity in the brain's vestibular (or balance) system are measured against distinct response patterns found in depression, schizophrenia and other Central Nervous System (CNS) disorders.
The vestibular system is closely connected to the primitive regions of the brain that relate to emotions and behaviour, so Lithgow saw the diagnostic potential of measuring and comparing different patterns of electrovestibular activity.
Working with psychiatry researchers at Monash University's Alfred Psychiatry Research Centre (MAPrc) in Melbourne, Australia, he tested volunteers and found distinct response patterns, or "biomarkers", that distinguished different CNS diseases from each other and from regular electrovestibular activity.
READ MORE @ EUREKALERT"
Saturday, October 17, 2009
Should Michigan repeal immunity law for drug industry? Even after a felony plea, residents can't sue
Recently we learned that the Department of Justice will fine Pfizer $2.3 billion in civil and criminal penalties for its illegal marketing of the drugs Bextra, Zyvox, Geodon and Lyrica. This is not only the largest penalty ever levied against a drug company. It is the largest penalty ever levied against any company in American history.
That is saying something.
Pfizer and its subsidiary entities -- the former Upjohn and Pharmacia -- not only promoted these drugs for uses that were not approved by the FDA. They also marketed the drugs for uses that were explicitly rejected by the FDA, primarily because of safety concerns. To the degree that patients were killed or injured as a result, Pfizer's off-label marketing scheme amounts to negligent homicide.
That is probably why Pfizer was compelled to plead guilty to felony charges, which is also unprecedented in such contexts. In most instances, companies plea-bargain to misdemeanor admissions, fines are levied, and that is the end of it.
READ MORE @ DETROT FREE PRESS
That is saying something.
Pfizer and its subsidiary entities -- the former Upjohn and Pharmacia -- not only promoted these drugs for uses that were not approved by the FDA. They also marketed the drugs for uses that were explicitly rejected by the FDA, primarily because of safety concerns. To the degree that patients were killed or injured as a result, Pfizer's off-label marketing scheme amounts to negligent homicide.
That is probably why Pfizer was compelled to plead guilty to felony charges, which is also unprecedented in such contexts. In most instances, companies plea-bargain to misdemeanor admissions, fines are levied, and that is the end of it.
READ MORE @ DETROT FREE PRESS
Friday, October 16, 2009
Response to Nortriptyline and Paroxetine Linked to Level of Neuropsychological Impairment in Patients With Parkinson's Disease: Presented at ANA
The use of nortriptyline and paroxetine in the treatment of depression does not affect cognitive functioning in patients with Parkinson's disease (PD); however, the higher the baseline performance on measures of executive functioning, speed of processing, and verbal memory, the better the response to antidepressant treatment, according to results presented here at the American Neurological Association (ANA) 134th Annual Meeting.
"This is one of the few studies to examine the impact of antidepressant treatment on cognition in PD patients with depression," said Roseanne D. Dobkin, PhD, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, New Jersey.
More than 1 million people are affected by PD in the United States alone. It is the second most common neurodegenerative disease in the country, said Dr. Dobkin on October 10.
"Depression is one of the most common nonmotor symptoms of PD, affecting as many as half of these patients," she added.
READ MORE @ DOCTOR'S GUIDE"
"This is one of the few studies to examine the impact of antidepressant treatment on cognition in PD patients with depression," said Roseanne D. Dobkin, PhD, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, New Jersey.
More than 1 million people are affected by PD in the United States alone. It is the second most common neurodegenerative disease in the country, said Dr. Dobkin on October 10.
"Depression is one of the most common nonmotor symptoms of PD, affecting as many as half of these patients," she added.
READ MORE @ DOCTOR'S GUIDE"
Thursday, October 15, 2009
Older antidepressant spurs more suicidal thinking in men than newer medication
The largest clinical trial to date comparing an older, tricyclic antidepressant with a newer antidepressant of the selective serotonin reuptake inhibitor (SSRI) class has found that the emergence of suicidal thinking was almost 10 times more common in men taking the older drug than in those taking the newer medication.
The study also found that for men and women taking either medication, suicidal thinking was spread over the first six weeks of treatment, but peaked at roughly the fifth week before declining significantly after week six. Taking place at academic medical institutions across Europe, the trial, called Genome-Based Therapeutic Drugs for Depression--or GENDEP--gauged the responses to antidepressants of 811 persons ranging from 18 to 72 with depression.
READ MORE @ LOS ANGELES IMES
The study also found that for men and women taking either medication, suicidal thinking was spread over the first six weeks of treatment, but peaked at roughly the fifth week before declining significantly after week six. Taking place at academic medical institutions across Europe, the trial, called Genome-Based Therapeutic Drugs for Depression--or GENDEP--gauged the responses to antidepressants of 811 persons ranging from 18 to 72 with depression.
READ MORE @ LOS ANGELES IMES
Wednesday, October 14, 2009
Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia
-- Fanapt (iloperidone), an antipsychotic therapy, is indicated in US for the acute treatment of schizophrenia in adults, set for US launch in early 2010
-- Addition of Fanapt will strengthen Novartis psychiatry portfolio and build on history in schizophrenia
-- Schizophrenia is a chronic, severe and disabling psychiatric disorder estimated to affect more than two million adults in the US and nearly 250,000 Canadians
-- Rights to Fanapt acquired from Vanda Pharmaceuticals Inc. for upfront payment of USD 200 million; Vanda eligible for milestones and sales royalties
Novartis Pharma AG has entered into an agreement for exclusive US and Canadian rights to Fanapt(TM) (iloperidone), a new oral medication that is approved by the US Food and Drug Administration (FDA) for the acute treatment of adults with schizophrenia. Novartis plans to launch Fanapt in the US in early 2010.
As part of the agreement with Vanda Pharmaceuticals Inc., Novartis will have exclusive commercialization rights to the oral formulation of this medicine in the US and Canada as well as exclusive rights to develop and commercialize a long-acting injectable (or "depot") formulation of this medicine for these markets.
Schizophrenia is a severe psychiatric disorder that is estimated to affect more than 2 million adults in the US and nearly 250,000 Canadians. Fanapt belongs to a class of medication for schizophrenia known as atypical antipsychotics.
READ MORE @ PR NEWSWIRE
-- Addition of Fanapt will strengthen Novartis psychiatry portfolio and build on history in schizophrenia
-- Schizophrenia is a chronic, severe and disabling psychiatric disorder estimated to affect more than two million adults in the US and nearly 250,000 Canadians
-- Rights to Fanapt acquired from Vanda Pharmaceuticals Inc. for upfront payment of USD 200 million; Vanda eligible for milestones and sales royalties
Novartis Pharma AG has entered into an agreement for exclusive US and Canadian rights to Fanapt(TM) (iloperidone), a new oral medication that is approved by the US Food and Drug Administration (FDA) for the acute treatment of adults with schizophrenia. Novartis plans to launch Fanapt in the US in early 2010.
As part of the agreement with Vanda Pharmaceuticals Inc., Novartis will have exclusive commercialization rights to the oral formulation of this medicine in the US and Canada as well as exclusive rights to develop and commercialize a long-acting injectable (or "depot") formulation of this medicine for these markets.
Schizophrenia is a severe psychiatric disorder that is estimated to affect more than 2 million adults in the US and nearly 250,000 Canadians. Fanapt belongs to a class of medication for schizophrenia known as atypical antipsychotics.
READ MORE @ PR NEWSWIRE
Tuesday, October 13, 2009
Dementia's effects vary with cause
Dementia is an illness characterized by significant impairment of one or more areas of higher cognitive functioning, such as memory or ability to calculate. Dr. Mel Daly, a geriatrician at Greater Baltimore Medical Center Greater Geriatrics Group, discusses symptoms and treatment for dementia.
•About one in five people over age 80 have some form of dementia. Close relatives of people with early onset (before age 60) Alzheimer's disease have a greater chance of getting the disease. Those with genes from a group called ApoE are at increased risk for developing Alzheimer's disease. All persons with Down syndrome will eventually get Alzheimer's if they live long enough, and about half of patients with Parkinson's disease will develop a dementia similar to Alzheimer's. Head trauma or repeated blows to the head are also risk factors.
•Chronic alcoholism often results in dementia. Persons with high blood pressure, diabetes mellitus, cigarette smokers, high cholesterol levels, and atrial fibrillation are at risk for strokes that impair higher cognitive functioning.
Dementia can occur in patients with AIDS. Rarely, dementia is caused by other infections such as tertiary syphilis and viruses (Jacob-Creutzfeld disease).
READ MORE @ BALTIMORE SUN
•About one in five people over age 80 have some form of dementia. Close relatives of people with early onset (before age 60) Alzheimer's disease have a greater chance of getting the disease. Those with genes from a group called ApoE are at increased risk for developing Alzheimer's disease. All persons with Down syndrome will eventually get Alzheimer's if they live long enough, and about half of patients with Parkinson's disease will develop a dementia similar to Alzheimer's. Head trauma or repeated blows to the head are also risk factors.
•Chronic alcoholism often results in dementia. Persons with high blood pressure, diabetes mellitus, cigarette smokers, high cholesterol levels, and atrial fibrillation are at risk for strokes that impair higher cognitive functioning.
Dementia can occur in patients with AIDS. Rarely, dementia is caused by other infections such as tertiary syphilis and viruses (Jacob-Creutzfeld disease).
READ MORE @ BALTIMORE SUN
Monday, October 12, 2009
Clemson bioengineer uses nanoparticles to target drugs
Clemson bioengineer Frank Alexis is designing new ways to target drugs and reduce the chances for side effects.
Pharmaceutical commercials can cause the unsettling feeling that if the disease doesn't kill, the cure will, what with a drug's long list of side effects and warnings. Many therapeutic drugs administered by pill, cream, syringe, IV or liquid can be a hit or miss delivery system. Researchers report that only 1 of 100,000 molecules of an intravenous drug make it to the intended spot in the body.
"The big issues for making medicines more effective are getting drugs to where they are needed and keeping them from breaking down as they circulate through the body," said Alexis. "A way to improve targeting a drug and preventing it from being passed out of the body is putting it in envelopes — putting the drug inside something to protect it until it's at the right spot."
The envelopes Alexis uses are nanoparticles. Think of an M&M, with the nanoparticle being the hard outer candy shell and the chocolate being the medicine. The goal would be the same as for an M&M — to melt in the right place.
Nanotechnology operates on the molecular level. It involves engineering materials on such a small scale that the results can be seen only with electron and atomic force microscopes. Nano-engineers take advantage of natural forces — positive and negative electrical charges, attraction and repulsion, surface texture — to have materials self assemble.
READ MORE @ CLEMSON UNIVERSITY NEWSROOM
Pharmaceutical commercials can cause the unsettling feeling that if the disease doesn't kill, the cure will, what with a drug's long list of side effects and warnings. Many therapeutic drugs administered by pill, cream, syringe, IV or liquid can be a hit or miss delivery system. Researchers report that only 1 of 100,000 molecules of an intravenous drug make it to the intended spot in the body.
"The big issues for making medicines more effective are getting drugs to where they are needed and keeping them from breaking down as they circulate through the body," said Alexis. "A way to improve targeting a drug and preventing it from being passed out of the body is putting it in envelopes — putting the drug inside something to protect it until it's at the right spot."
The envelopes Alexis uses are nanoparticles. Think of an M&M, with the nanoparticle being the hard outer candy shell and the chocolate being the medicine. The goal would be the same as for an M&M — to melt in the right place.
Nanotechnology operates on the molecular level. It involves engineering materials on such a small scale that the results can be seen only with electron and atomic force microscopes. Nano-engineers take advantage of natural forces — positive and negative electrical charges, attraction and repulsion, surface texture — to have materials self assemble.
READ MORE @ CLEMSON UNIVERSITY NEWSROOM
Sunday, October 11, 2009
FDA Eases Rules on Access to Investigational Psychotropic Drugs
The FDA’s new rule on “expanded access programs” would allow pharmaceutical companies to give seriously ill patients broader access to investigational drugs outside of clinical trials. A limited number of expanded access programs were created in the past under sketchy FDA rules; the 2 new allied rules—one on the conditions drug companies must meet to create a program, the other on how they can charge for the drugs—ostensibly give pharma a wider berth. Moreover, psychotropic drugs can be provided under the clarified policy.
When the FDA was considering changes to its policy (in part prompted by a lawsuit), it contended with the issue of whether the use of psycho-tropic drugs fits in the definition of “serious medical condition”—with which a patient must be afflicted before a drug company can make an investigational agent available outside a clinical trial. The health insurance industry made an effort to convince the FDA to exclude mental health conditions from serious medical conditions.
In her comments to the FDA after the agency proposed a rule in March 2007, Karen Ignagni, president and CEO of America’s Health Insurance Plans (AHIP), pressed the agency to include a definition in the final rule that said, “A serious disease or condition is one which is persistent, substantially disabling, progressive, and likely to result in death within 6 to 12 months.” She noted that schizophrenia and chronic depression are among the conditions that “cause disabling health effects and suffering for a period of time without death occurring prematurely or in a matter of months.” AHIP was concerned about exposure of its insurance company members to wide claims from policy holders for reimbursement for expensive, investigational drugs obtained through expanded access programs, which might multiply because of the FDA rule liberalization.
READ MORE @ PSYCHIATRIC TIMES
When the FDA was considering changes to its policy (in part prompted by a lawsuit), it contended with the issue of whether the use of psycho-tropic drugs fits in the definition of “serious medical condition”—with which a patient must be afflicted before a drug company can make an investigational agent available outside a clinical trial. The health insurance industry made an effort to convince the FDA to exclude mental health conditions from serious medical conditions.
In her comments to the FDA after the agency proposed a rule in March 2007, Karen Ignagni, president and CEO of America’s Health Insurance Plans (AHIP), pressed the agency to include a definition in the final rule that said, “A serious disease or condition is one which is persistent, substantially disabling, progressive, and likely to result in death within 6 to 12 months.” She noted that schizophrenia and chronic depression are among the conditions that “cause disabling health effects and suffering for a period of time without death occurring prematurely or in a matter of months.” AHIP was concerned about exposure of its insurance company members to wide claims from policy holders for reimbursement for expensive, investigational drugs obtained through expanded access programs, which might multiply because of the FDA rule liberalization.
READ MORE @ PSYCHIATRIC TIMES
Saturday, October 10, 2009
Antidepressant Use in Children With Cancer What We Now Know (and Need to Know) About the Use of Antidepressants
In 2007, cancer was diagnosed in 10,400 children and adolescents under the age of 15 years.1 While cancer remains the second leading cause of death in children, increasing numbers of children with cancer are surviving into adulthood.2 Over the past 30 years, 5-year survival rates for children with cancer have significantly improved, from 59% in 1975 to 1977 to 80% in 1996 to 2004.3 Pediatric cancer, increasingly considered a chronic rather than an acute condition, is an intense emotional and physical experience for patients and their families.4
Comprehensive psychiatric assessment of these children is complicated by symptoms of medical comorbidities that overlap mental health conditions. Few resources exist to guide clinicians in the psychiatric treatment of children with cancer. This article describes the sparse research from small clinical studies on the extent of psychiatric treatment in children with cancer and evidence from outcome studies of medication use in these children. Minimal knowledge on the role of antidepressants in such children motivated us to examine the question in a broad population-based approach.
Psychopathology
One area of interest in caring for children with cancer is the prevalence of psychiatric diagnoses. Assessment of psychiatric disorders in these children from either research or community settings is difficult because of the complex medical and emotional presentation of illness.5,6 DSM-IV criteria for mood disorders, for example, include both somatic and cognitive symptom criteria, and clinicians must decide which symptoms are caused by the illness and treatment and which are related to a separate psychiatric diagnosis.7
In addition, doctors and nurses may overestimate psychosocial distress and symptoms in children and adolescents with cancer.6 Assessment tools for psychiatric disorders are not often validated in children with medical illnesses, which may lead in part to the varying research prevalence of psychiatric disorders in this population.8
Reports of psychiatric illness in children with cancer range from a high of 17% to rates that do not differ significantly from those for the general population.9 Specific cancers and their treatments may also contribute to the variable rates of depression. Without more precise estimates that generalize to large youth populations, it is unclear whether children with cancer are at higher risk for a psychiatric disorder than children who are not medically ill.
READ MORE @ PSYCHIATRIC TIMES
Comprehensive psychiatric assessment of these children is complicated by symptoms of medical comorbidities that overlap mental health conditions. Few resources exist to guide clinicians in the psychiatric treatment of children with cancer. This article describes the sparse research from small clinical studies on the extent of psychiatric treatment in children with cancer and evidence from outcome studies of medication use in these children. Minimal knowledge on the role of antidepressants in such children motivated us to examine the question in a broad population-based approach.
Psychopathology
One area of interest in caring for children with cancer is the prevalence of psychiatric diagnoses. Assessment of psychiatric disorders in these children from either research or community settings is difficult because of the complex medical and emotional presentation of illness.5,6 DSM-IV criteria for mood disorders, for example, include both somatic and cognitive symptom criteria, and clinicians must decide which symptoms are caused by the illness and treatment and which are related to a separate psychiatric diagnosis.7
In addition, doctors and nurses may overestimate psychosocial distress and symptoms in children and adolescents with cancer.6 Assessment tools for psychiatric disorders are not often validated in children with medical illnesses, which may lead in part to the varying research prevalence of psychiatric disorders in this population.8
Reports of psychiatric illness in children with cancer range from a high of 17% to rates that do not differ significantly from those for the general population.9 Specific cancers and their treatments may also contribute to the variable rates of depression. Without more precise estimates that generalize to large youth populations, it is unclear whether children with cancer are at higher risk for a psychiatric disorder than children who are not medically ill.
READ MORE @ PSYCHIATRIC TIMES
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