Patients with frequently relapsing bipolar disorder had a significant delay in the time to an initial relapse when risperidone long-acting injection (RLAI) was combined with standard treatment, according to a new study. The study compared patients who received RLAI and standard treatment to those who received standard treatment combined with placebo.
The study was presented yesterday at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disordersin Montreux, Switzerland.1 This one-year, phase 3, trial is the first placebo-controlled study to explore the use of a long-acting injection medication in the maintenance treatment of frequently relapsing bipolar disorder (FRBD). FRBD, defined as four or more manic or depressive episodes in the previous year that require a doctor's care, may affect 20% of the 27 million people with bipolar disorder worldwide.2, 3
The study compared the time to the next mood episode, also known as a relapse, in FRBD patients receiving RLAI plus standard treatment vs. patients receiving placebo plus standard treatment. For most patients, standard treatment consisted of mood stabilizers, antidepressants, anxiolytics or combinations thereof. The trial showed that time to relapse was significantly longer in patients receiving RLAI compared with placebo (p=0.004) and the relative risk of relapse was 2.4 times higher with placebo. The relapse rates were 47.8% with placebo and 22.2% with RLAI.
READ MORE @ MEDICAL NEWS TODAY
Thursday, February 14, 2008
Wednesday, February 13, 2008
Making Sense of the Great Suicide Debate
AN expression of true love or raw hatred, of purest faith or mortal sin, of courageous loyalty or selfish cowardice: The act of suicide has meant many things to many people through history, from the fifth-century Christian martyrs to the Samurais’ hara-kiri to more recent literary divas, Hemingway, Plath, Sexton.
But now the shadow of suicide has slipped into the corridors of modern medicine as a potential drug side effect, where it is creating a scientific debate as divisive and confounding as any religious clash.
And the shadow is likely to deepen.
After a years-long debate about whether antidepressant drugs like Prozac and Paxil increase the risk of suicide in some people, the Food and Drug Administration in recent days reported that other drugs, including medications used to treat epilepsy, also appear to increase the remote risk of suicide. The agency has been evaluating suicide risk in a variety of medicines, and more such reports — and more headlines — are expected.
READ MORE @ NY TIMES
But now the shadow of suicide has slipped into the corridors of modern medicine as a potential drug side effect, where it is creating a scientific debate as divisive and confounding as any religious clash.
And the shadow is likely to deepen.
After a years-long debate about whether antidepressant drugs like Prozac and Paxil increase the risk of suicide in some people, the Food and Drug Administration in recent days reported that other drugs, including medications used to treat epilepsy, also appear to increase the remote risk of suicide. The agency has been evaluating suicide risk in a variety of medicines, and more such reports — and more headlines — are expected.
READ MORE @ NY TIMES
Tuesday, February 12, 2008
Antidepressants Can Increase Depression, Impulsivity and Suicide Risk by Decreasing Dopamine
Antidepressant medications which increase serotonin neurotransmitter levels can depress dopamine levels. Decreasing dopamine level can increase depression, impulsivity and suicide risk in depressed patients, who were previously dopamine deficient. "When physicians prescribe serotonin enhancement medications to dopamine deficient patients, patients sometimes become more depressed, impulsive and suicidal," said Dr. Rick Sponaugle, Medical Director of Florida Detox.
Many depressed patients do not improve with Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants, such as Prozac, Paxil or Zoloft. Prozac and Paxil only increase serotonin and norepinephrine activity. When serotonin is increased above normal levels with medication, the brain downregulates dopamine production. Dopamine downregulation explains why some patients become suicidal on "antidepressants."
Physicians must differentiate which "happy chemicals" require adjustment. There are five main "happy chemical" neurotransmitters, serotonin, dopamine, glutamate, norepinephrine and acetylcholine. Deficiency in any of these, can produce clinical depression.
Recent PET brain scan studies clearly reveal dopamine activates the human "pleasure center" (nucleus accumbens). The dopamine D2 receptor within the pleasure center appears to be our happy receptor. PET studies can accurately measure the difference in D2 activity among different patients.
READ MORE @ PR NEWSWIRE
Many depressed patients do not improve with Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants, such as Prozac, Paxil or Zoloft. Prozac and Paxil only increase serotonin and norepinephrine activity. When serotonin is increased above normal levels with medication, the brain downregulates dopamine production. Dopamine downregulation explains why some patients become suicidal on "antidepressants."
Physicians must differentiate which "happy chemicals" require adjustment. There are five main "happy chemical" neurotransmitters, serotonin, dopamine, glutamate, norepinephrine and acetylcholine. Deficiency in any of these, can produce clinical depression.
Recent PET brain scan studies clearly reveal dopamine activates the human "pleasure center" (nucleus accumbens). The dopamine D2 receptor within the pleasure center appears to be our happy receptor. PET studies can accurately measure the difference in D2 activity among different patients.
READ MORE @ PR NEWSWIRE
Monday, February 11, 2008
Growing Up to Prozac: Drug makes new neurons mature faster
Peter Pan won't be pleased to hear the latest theory about how Prozac works. A new study shows that the antidepressant stimulates growth of neurons in the hippocampus and speeds the young brain cells toward maturity. The maturation process could be the mechanism by which the drug relieves depression.
Fluoxetine, the drug commonly known as Prozac, has been used to treat depression since the 1980s. Prozac and other SSRIs (selective serotonin reuptake inhibitors) block the ability of the neurons to take up serotonin, thereby raising levels of the active neurotransmitter in the brain. When people with depression begin taking such drugs, serotonin levels in the brain increase rapidly, but it often takes 2 to 4 weeks before they begin to feel better.
The new study, published Feb. 6 in the Journal of Neuroscience, suggests that the lag is due to the time it takes for serotonin to stimulate new neurons to grow, mature, and integrate into brain circuits.
René Hen, a neuroscientist at Columbia University, and his colleagues tested the long-term effects of Prozac treatment on a specially bred strain of nervous mice.
READ MORE @ SCIENCE NEWS
Fluoxetine, the drug commonly known as Prozac, has been used to treat depression since the 1980s. Prozac and other SSRIs (selective serotonin reuptake inhibitors) block the ability of the neurons to take up serotonin, thereby raising levels of the active neurotransmitter in the brain. When people with depression begin taking such drugs, serotonin levels in the brain increase rapidly, but it often takes 2 to 4 weeks before they begin to feel better.
The new study, published Feb. 6 in the Journal of Neuroscience, suggests that the lag is due to the time it takes for serotonin to stimulate new neurons to grow, mature, and integrate into brain circuits.
René Hen, a neuroscientist at Columbia University, and his colleagues tested the long-term effects of Prozac treatment on a specially bred strain of nervous mice.
READ MORE @ SCIENCE NEWS
Sunday, February 10, 2008
Antidepressants are all the rage but have a dark side
Despite recent bad publicity over withheld studies showing marginal results, the resume of America's arsenal of antidepressants is enviable: consort to celebrities, subject of best-selling books and tabloid headlines. They may be the most celebrated pills since Valium.
Prozac, Zoloft, Paxil, Celexa and Lexapro, among others, have become both household words and medicine-cabinet staples. Known collectively as selective serotonin reuptake inhibitors, or SSRIs, these antidepressants are prescribed for anxiety, social phobia, obsessive-compulsive disorder and numerous conditions besides depression.
SSRIs are now the most commonly prescribed of all medications in this country. The rate at which physicians prescribed SSRIs more than doubled between 1995 and 2004, according to the Centers for Disease Control and Prevention. SSRIs are considered the first line of defense in treating depression, an illness that afflicts more than 20 million Americans.
READ MORE @ CHICAGO TRIBUNE
Prozac, Zoloft, Paxil, Celexa and Lexapro, among others, have become both household words and medicine-cabinet staples. Known collectively as selective serotonin reuptake inhibitors, or SSRIs, these antidepressants are prescribed for anxiety, social phobia, obsessive-compulsive disorder and numerous conditions besides depression.
SSRIs are now the most commonly prescribed of all medications in this country. The rate at which physicians prescribed SSRIs more than doubled between 1995 and 2004, according to the Centers for Disease Control and Prevention. SSRIs are considered the first line of defense in treating depression, an illness that afflicts more than 20 million Americans.
READ MORE @ CHICAGO TRIBUNE
Saturday, February 9, 2008
Tainted Pills Hit U.S. Mainland
The first warning sign came when a sharp-eyed worker sorting pills noticed that the odd blue flecks dotting the finished drug capsules matched the paint on the factory doors.
After the flecks were spotted again on the capsules, a blood-pressure medication called Diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas.
But the factory owner, Canadian drug maker Biovail Corp., never tried to find out whether past shipments of the drug were contaminated — or prevent future contamination, according to U.S. regulators.
Thirteen of the 20 best-selling drugs in the United States come from plants on this island. But an investigation by The Associated Press has found dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the U.S.
An AP review of 100 pages of Food and Drug Administration reports shows even modern drug plants here under the watch of U.S. regulators have failed to keep laboratories sterile and have exported tainted pills.
READ MORE @ ASSOCIATED PRESS
After the flecks were spotted again on the capsules, a blood-pressure medication called Diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas.
But the factory owner, Canadian drug maker Biovail Corp., never tried to find out whether past shipments of the drug were contaminated — or prevent future contamination, according to U.S. regulators.
Thirteen of the 20 best-selling drugs in the United States come from plants on this island. But an investigation by The Associated Press has found dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the U.S.
An AP review of 100 pages of Food and Drug Administration reports shows even modern drug plants here under the watch of U.S. regulators have failed to keep laboratories sterile and have exported tainted pills.
READ MORE @ ASSOCIATED PRESS
Friday, February 8, 2008
Antidepressants That Are More Efficient And Faster
In the PhD defended by the pharmacologist and biochemist Jorge Emilio Ortega Calvo at the University of the Basque Country, a new anti-depressant treatment strategy is proposed that is capable of improving on the current one with its drawbacks.
Depression is a chronic and recurrent illness that can affect at least 20% of the population at some period in their lifetime, according to a number of studies carried out. Moreover, according to the WHO, by 2020 emotional state disorders could be the foremost or second cause for sick leave from work in the developed countries. Current ant-depressive therapies, nevertheless, are far from optimum.
This was the theme of the PhD thesis* presented by the pharmacologist and biochemist from the Basque province of Gipuzkoa, Jorge Emilio Ortega Calvo, undertaken at the Faculty of Medicine and Odontology of the University of the Basque Country (UPV/EHU). Basically it was a study in which an analysis was undertaken of the action mechanisms of current antidepressant pharmacological drugs and new antidepressant treatment strategies put forward and that could be useful in the near future in order to address the failings in the current ones.
READ MORE @ SCIENCE DAILY
Depression is a chronic and recurrent illness that can affect at least 20% of the population at some period in their lifetime, according to a number of studies carried out. Moreover, according to the WHO, by 2020 emotional state disorders could be the foremost or second cause for sick leave from work in the developed countries. Current ant-depressive therapies, nevertheless, are far from optimum.
This was the theme of the PhD thesis* presented by the pharmacologist and biochemist from the Basque province of Gipuzkoa, Jorge Emilio Ortega Calvo, undertaken at the Faculty of Medicine and Odontology of the University of the Basque Country (UPV/EHU). Basically it was a study in which an analysis was undertaken of the action mechanisms of current antidepressant pharmacological drugs and new antidepressant treatment strategies put forward and that could be useful in the near future in order to address the failings in the current ones.
READ MORE @ SCIENCE DAILY
Thursday, February 7, 2008
Lilly's Monthly Zyprexa Causes Sleepiness, FDA Says (Update3)
Eli Lilly & Co's once-a-month version of its top-selling antipsychotic medicine Zyprexa, while effective, has risks that include excessive sleepiness, U.S. regulators said.
People with schizophrenia taking a monthly injection instead of daily tablets already on the market may experience ``profound sedation,'' staff of the Food and Drug Administration said in documents posted today on the agency's Web site. The sleepiness is a ``serious safety concern'' because of its severity and ``relatively high'' incidence, the FDA said.
An FDA advisory panel meets Feb. 6 to consider whether Lilly should be allowed to sell the monthly Zyprexa. Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9 percent to $4.76 billion last year, accounting for about a quarter of Indianapolis-based Lilly's revenue. The drugmaker is investing in new and reformulated products because the original Zyprexa may face generic competition as early as 2011.
``There's a huge demand,'' said Jeffrey Lieberman, the chairman of psychiatry at Columbia University in New York in a telephone interview. ``Even though this is a long-acting form of an existing drug, it's a significant event for the simple reason that the biggest trouble with treating people with antipsychotics is adherence to treatment.''
READ MORE @ BLOOMBERG
People with schizophrenia taking a monthly injection instead of daily tablets already on the market may experience ``profound sedation,'' staff of the Food and Drug Administration said in documents posted today on the agency's Web site. The sleepiness is a ``serious safety concern'' because of its severity and ``relatively high'' incidence, the FDA said.
An FDA advisory panel meets Feb. 6 to consider whether Lilly should be allowed to sell the monthly Zyprexa. Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9 percent to $4.76 billion last year, accounting for about a quarter of Indianapolis-based Lilly's revenue. The drugmaker is investing in new and reformulated products because the original Zyprexa may face generic competition as early as 2011.
``There's a huge demand,'' said Jeffrey Lieberman, the chairman of psychiatry at Columbia University in New York in a telephone interview. ``Even though this is a long-acting form of an existing drug, it's a significant event for the simple reason that the biggest trouble with treating people with antipsychotics is adherence to treatment.''
READ MORE @ BLOOMBERG
Tuesday, February 5, 2008
Antidepressants Don’t Ease Back Pain
Nearly one in four primary care doctors prescribes antidepressants as a treatment for low back pain. But a new report shows there’s no evidence the drugs offer any relief.
The finding comes from a review by the Cochrane Collaboration, a not-for-profit group that evaluates medical research. The use of depression pills to treat back pain has been controversial. Some studies have suggested a benefit while others have shown the drugs don’t help. Complicating matters is the fact that depression is common among sufferers of chronic back pain, so it’s not always clear if doctors are prescribing the drugs for pain relief or as a preventative measure against depression.
The Cochrane review, led by Donna Urquhart, a research fellow at Monash University in Melbourne, Australia, analyzed 10 published studies that compared antidepressants to placebos in patients with low back pain. Some of the patients had ruptured discs, slipped vertebrae, pinched nerves or other problems; some were depressed, while others were free of depression.
READ MORE @ NY TIMES
The finding comes from a review by the Cochrane Collaboration, a not-for-profit group that evaluates medical research. The use of depression pills to treat back pain has been controversial. Some studies have suggested a benefit while others have shown the drugs don’t help. Complicating matters is the fact that depression is common among sufferers of chronic back pain, so it’s not always clear if doctors are prescribing the drugs for pain relief or as a preventative measure against depression.
The Cochrane review, led by Donna Urquhart, a research fellow at Monash University in Melbourne, Australia, analyzed 10 published studies that compared antidepressants to placebos in patients with low back pain. Some of the patients had ruptured discs, slipped vertebrae, pinched nerves or other problems; some were depressed, while others were free of depression.
READ MORE @ NY TIMES
Sunday, February 3, 2008
Sleep disorders: Don't take it lying down
Millions suffer from sleep disorders – and many never seek help. But the cures are out there, says Roger Dobson
Getting to sleep tonight will be a big problem for millions of Britons. Insomnia affects one in four of us at some time, but it's far from the only disorder that spoils our sleep – researchers have now identified 75 such conditions, from snoring, sleep apnoea, restless legs, bruxism and nocturnal cramps, to sleep-talking, rhythmic movement disorder and confusional arousal. Some 31 per cent of people, including children and teenagers, have one or more of these disorders at some time. They can severely affect everyday life.
"Most of those with sleeping problems considered them to have an impact on their daily functioning, with family life most affected," say Paris University researchers who quizzed 10,000 men and women in the UK and other countries.
The research shows that many people don't seek help with their problems. "Almost half had never taken any steps to resolving them, and the majority had not spoken to a physician about their problems," researchers found. Yet treatments exist for many of the conditions that work well for large numbers of patients. Although half of those who see a doctor are prescribed drugs, other treatments and lifestyle changes can work, too.
READ MORE @ THE INDEPENDENT
Getting to sleep tonight will be a big problem for millions of Britons. Insomnia affects one in four of us at some time, but it's far from the only disorder that spoils our sleep – researchers have now identified 75 such conditions, from snoring, sleep apnoea, restless legs, bruxism and nocturnal cramps, to sleep-talking, rhythmic movement disorder and confusional arousal. Some 31 per cent of people, including children and teenagers, have one or more of these disorders at some time. They can severely affect everyday life.
"Most of those with sleeping problems considered them to have an impact on their daily functioning, with family life most affected," say Paris University researchers who quizzed 10,000 men and women in the UK and other countries.
The research shows that many people don't seek help with their problems. "Almost half had never taken any steps to resolving them, and the majority had not spoken to a physician about their problems," researchers found. Yet treatments exist for many of the conditions that work well for large numbers of patients. Although half of those who see a doctor are prescribed drugs, other treatments and lifestyle changes can work, too.
READ MORE @ THE INDEPENDENT
Thursday, January 31, 2008
Battle Concussions Tied to Stress Disorder
The study, in The New England Journal of Medicine, is the military’s first large-scale effort to gauge the effect of mild head injuries — concussions, many of them from roadside blasts — that some experts worry may be causing a host of undiagnosed neurological deficiencies.
The new report found that soldiers who had concussions were more likely than those with other injuries to report a variety of physical and mental symptoms in their first months back home, including headaches, poor sleep and balance problems. But they were also at higher risk for the stress disorder, or PTSD, and that accounted for most of the difference in complaints, the researchers concluded. Symptoms of the disorder include irritability, sleep problems and flashbacks.
Experts cautioned that the study had not been designed to detect subtle changes in mental performance, like slips in concentration or short-term memory, that might have developed in the wake of a concussion and might be unrelated to stress reactions. Many returning veterans are still struggling with those problems, which can linger for months.
The findings are in line with previous research linking concussions to post-traumatic stress disorder that develops after frightening events outside a military context, like car accidents; concussions from athletic collisions rarely lead to the disorder.
READ MORE @ NY TIMES
The new report found that soldiers who had concussions were more likely than those with other injuries to report a variety of physical and mental symptoms in their first months back home, including headaches, poor sleep and balance problems. But they were also at higher risk for the stress disorder, or PTSD, and that accounted for most of the difference in complaints, the researchers concluded. Symptoms of the disorder include irritability, sleep problems and flashbacks.
Experts cautioned that the study had not been designed to detect subtle changes in mental performance, like slips in concentration or short-term memory, that might have developed in the wake of a concussion and might be unrelated to stress reactions. Many returning veterans are still struggling with those problems, which can linger for months.
The findings are in line with previous research linking concussions to post-traumatic stress disorder that develops after frightening events outside a military context, like car accidents; concussions from athletic collisions rarely lead to the disorder.
READ MORE @ NY TIMES
Wednesday, January 30, 2008
Drugs may increase falls in nursing home residents
Cutting down on medication, especially tranquilizers and antidepressants, and using wheelchairs and bed rails selectively, could help reduce the number of falls among nursing home residents, Swedish researchers report.
"Although freedom-restricting actions cannot eliminate falls totally, our results support the hypothesis that they might be protective when used selectively with fewer...benzodiazepines," Edit Fonad of the Karolinska Institutet in Stockholm and colleagues write.
Fonad and her team investigated risk factors for falls among residents of 21 nursing home units over a 4-year period, during which time 2,343 falls occurred.
Patients in wheelchairs were more likely to also be using bed rails, safety belts, sleeping pills and antidepressants. Those who were using bed rails were also more likely to be using safety belts and medication. Patients using safety belts were more likely to be on several different drugs.
READ MORE @ REUTERS
"Although freedom-restricting actions cannot eliminate falls totally, our results support the hypothesis that they might be protective when used selectively with fewer...benzodiazepines," Edit Fonad of the Karolinska Institutet in Stockholm and colleagues write.
Fonad and her team investigated risk factors for falls among residents of 21 nursing home units over a 4-year period, during which time 2,343 falls occurred.
Patients in wheelchairs were more likely to also be using bed rails, safety belts, sleeping pills and antidepressants. Those who were using bed rails were also more likely to be using safety belts and medication. Patients using safety belts were more likely to be on several different drugs.
READ MORE @ REUTERS
Tuesday, January 29, 2008
New focus on foster kids' meds
Psychiatric drugs - DHS prescribes more oversight and follow-up for youngsters under its care
Children in state foster care who are on psychiatric drugs would receive more oversight under a new plan to make sure they're on the right medications and getting the mental health help they need.
The draft proposal by the Oregon Department of Human Services could affect more than 2,000 foster children who receive psychiatric medications.
State officials last spring adopted new rules regarding psychiatric medications and foster children.
But The Oregonian reported in November that state law and rules governing the use of psychiatric medications in foster care are often ignored and that hundreds of children are taking multiple prescriptions with little or no state scrutiny.
READ MORE @ THE OREGONIAN
Children in state foster care who are on psychiatric drugs would receive more oversight under a new plan to make sure they're on the right medications and getting the mental health help they need.
The draft proposal by the Oregon Department of Human Services could affect more than 2,000 foster children who receive psychiatric medications.
State officials last spring adopted new rules regarding psychiatric medications and foster children.
But The Oregonian reported in November that state law and rules governing the use of psychiatric medications in foster care are often ignored and that hundreds of children are taking multiple prescriptions with little or no state scrutiny.
READ MORE @ THE OREGONIAN
Monday, January 28, 2008
Depression - the facts and the fables
If there's one thing I love, it's academics who take on the work of investigative journalism, because they are dogged. This has been a bad week for the SSRI antidepressants. First there's the stuff you already know: bad data got buried. In a cracking new analysis of the "publication bias" in the literature, a group of academics this week published a paper in the New England Journal of Medicine which listed all the trials on SSRIs that had ever been formally registered with the Food and Drug Administration, and then went to look for the same trials in the academic literature.
Thirty-seven studies were assessed by the FDA as positive and, with one exception, every single one of those positive trials got properly written up and published. Meanwhile, 22 studies that had negative or iffy results were simply not published at all, and 11 were written up and published in a way that described them as having a positive outcome.
You're a sophisticated reader, so you understand this doesn't mean that they're necessarily rubbish drugs, but you also understand that this is dodgy behaviour, all the same.
That's the easy one.
READ MORE @ THE GUARDIAN
Thirty-seven studies were assessed by the FDA as positive and, with one exception, every single one of those positive trials got properly written up and published. Meanwhile, 22 studies that had negative or iffy results were simply not published at all, and 11 were written up and published in a way that described them as having a positive outcome.
You're a sophisticated reader, so you understand this doesn't mean that they're necessarily rubbish drugs, but you also understand that this is dodgy behaviour, all the same.
That's the easy one.
READ MORE @ THE GUARDIAN
Saturday, January 26, 2008
FDA fast-tracks first cocaine, meth addiction fighter
Deerfield-based Ovation Pharmaceuticals said Tuesday its drug vigabatrin, being developed to treat cocaine and methamphetamine dependence, has landed “fast track” designation from U.S. regulators potentially speeding up the process for market approval.
The drug would be the first approved by the U.S. Food and Drug Administration for treatment of the addictions.
The anticonvulsant drug, to be marketed under the brand name Sabril, is believed to block the craving and euphoria associated with cocaine and meth use. It is thought to work by increasing brain levels of so-called gamma-aminobutyric acid, a transmitter that inhibits certain activity in the brain.
Data from animal testing and two small-scale early-stage studies in people with chronic cocaine and meth addiction have found that when given Sabril, cocaine and meth users no longer have a craving for the drugs, and if the drugs are taken, the users have no euphoria related to taking them, executives have said.
Ovation is collaborating with the National Institute on Drug Abuse on Phase II studies to evaluate the safety of the drug. Phase III trials are expected to be launched by the end of next year.
READ MORE @ CHICAGO SUN-TIMES
The drug would be the first approved by the U.S. Food and Drug Administration for treatment of the addictions.
The anticonvulsant drug, to be marketed under the brand name Sabril, is believed to block the craving and euphoria associated with cocaine and meth use. It is thought to work by increasing brain levels of so-called gamma-aminobutyric acid, a transmitter that inhibits certain activity in the brain.
Data from animal testing and two small-scale early-stage studies in people with chronic cocaine and meth addiction have found that when given Sabril, cocaine and meth users no longer have a craving for the drugs, and if the drugs are taken, the users have no euphoria related to taking them, executives have said.
Ovation is collaborating with the National Institute on Drug Abuse on Phase II studies to evaluate the safety of the drug. Phase III trials are expected to be launched by the end of next year.
READ MORE @ CHICAGO SUN-TIMES
Friday, January 25, 2008
Genetic changes key in antidepressant drugs: study
Changes in a gene that protects the brain from foreign substances may affect whether commonly used antidepressants work -- and a simple test could help doctors prescribe the right drug, researchers said on Wednesday.
The findings could also help doctors adjust doses to make the drugs more effective while cutting down on harmful side effects, said Florian Holsboer, director of the Max Planck Institute for Psychiatry in Munich, who led the study.
"This is the first step into personalized antidepressant treatment according to genetic makeup," Holsboer said. "The gene test can help the clinician when he makes a choice for the antidepressant he gives to the patient."
Depression is a leading cause of suicide and affects about 121 million people worldwide, according to the World Health Organization.
READ MORE @ REUTERS
The findings could also help doctors adjust doses to make the drugs more effective while cutting down on harmful side effects, said Florian Holsboer, director of the Max Planck Institute for Psychiatry in Munich, who led the study.
"This is the first step into personalized antidepressant treatment according to genetic makeup," Holsboer said. "The gene test can help the clinician when he makes a choice for the antidepressant he gives to the patient."
Depression is a leading cause of suicide and affects about 121 million people worldwide, according to the World Health Organization.
READ MORE @ REUTERS
Thursday, January 24, 2008
F.D.A. Requiring Suicide Studies in Drug Trials
After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials.
The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.
READ MORE @ NY TIMES
The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.
READ MORE @ NY TIMES
Wednesday, January 23, 2008
Jury Trials In 2008 Expected To Expose SSRI Maker's Dirty Secrets
Jury Trials In 2008 Expected To Expose SSRI Maker's Dirty Secrets
The blockbuster sales figures for the new generation of selective serotonin reuptake inhibitor antidepressants (SSRI's), which have resulted from their promotion for so many unapproved uses, represents the most profitable off-label marketing coup in the history of modern medicine. Sales total about $21 billion a year, according to IMS Health.
However, in the end these drugs will probably also hold the title for the most lawsuits filed against drug companies for overstating their benefits while concealing their serious side effects from as far back as 20 years ago.
The SSRI's include Prozac by Eli Lilly; Paxil marketed by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro from Forest Laboratories. Cymbalta by Eli Lilly and Effexor by Wyeth are often called SSRI's, but they are actually serotonin norepinephrine reuptake inhibitors (SNRI's). Wellbutrin sold by Glaxo is an inhibitor of the neuronal uptake of norepinephrine and dopamine. Several of these antidepressants now have generic counterparts.
READ MORE @ OPEDNEWS
The blockbuster sales figures for the new generation of selective serotonin reuptake inhibitor antidepressants (SSRI's), which have resulted from their promotion for so many unapproved uses, represents the most profitable off-label marketing coup in the history of modern medicine. Sales total about $21 billion a year, according to IMS Health.
However, in the end these drugs will probably also hold the title for the most lawsuits filed against drug companies for overstating their benefits while concealing their serious side effects from as far back as 20 years ago.
The SSRI's include Prozac by Eli Lilly; Paxil marketed by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro from Forest Laboratories. Cymbalta by Eli Lilly and Effexor by Wyeth are often called SSRI's, but they are actually serotonin norepinephrine reuptake inhibitors (SNRI's). Wellbutrin sold by Glaxo is an inhibitor of the neuronal uptake of norepinephrine and dopamine. Several of these antidepressants now have generic counterparts.
READ MORE @ OPEDNEWS
Tuesday, January 22, 2008
Antidepressants behind 52 percent of all suicides among women
Incredible data have just been revealed that antidepressant drugs were behind 52 percent of all suicides among women (18-84) in Sweden (2006)
This is not data from a limited study; it instead concerns information on a national level for ALL suicides (18-84 years) for 2006. The information is unique; registries now exist in Sweden making it possible for the National Board of Health and Welfare to see how many of the suicides were preceded by psychiatric drug treatment.
Among a total number of 377 women who committed suicide, 197 (52%) had filled a prescription for antidepressants within 180 days before their death. And 29 women (8%) had filled a prescription for neuroleptics ("antipsychotics") ONLY within 180 days before the suicide.
This means that 229 women - 60% - of those who committed suicide (18-84) in Sweden (2006) had filled a prescription for antidepressant drugs OR neuroleptics within 180 days before their suicide.
Neuroleptics were involved in total in 97 (26%) of the suicides among women, (68 women, 18%, got BOTH antidepressants and neuroleptics). NOT included in these figures is the percentage of women who got other forms of psychiatric drugs, like benzodiazepines.
The data are revealed just after the news broke that pharmaceutical companies have systematically hidden negative and exaggerated positive results in their clinical trials of antidepressants (see article Antidepressant Studies Unpublished in NYT), thus misleading patients and doctors for many years.
READ MORE @ TRANS WORLD NEWS
This is not data from a limited study; it instead concerns information on a national level for ALL suicides (18-84 years) for 2006. The information is unique; registries now exist in Sweden making it possible for the National Board of Health and Welfare to see how many of the suicides were preceded by psychiatric drug treatment.
Among a total number of 377 women who committed suicide, 197 (52%) had filled a prescription for antidepressants within 180 days before their death. And 29 women (8%) had filled a prescription for neuroleptics ("antipsychotics") ONLY within 180 days before the suicide.
This means that 229 women - 60% - of those who committed suicide (18-84) in Sweden (2006) had filled a prescription for antidepressant drugs OR neuroleptics within 180 days before their suicide.
Neuroleptics were involved in total in 97 (26%) of the suicides among women, (68 women, 18%, got BOTH antidepressants and neuroleptics). NOT included in these figures is the percentage of women who got other forms of psychiatric drugs, like benzodiazepines.
The data are revealed just after the news broke that pharmaceutical companies have systematically hidden negative and exaggerated positive results in their clinical trials of antidepressants (see article Antidepressant Studies Unpublished in NYT), thus misleading patients and doctors for many years.
READ MORE @ TRANS WORLD NEWS
Monday, January 21, 2008
Height link to suicide attempts
Men are less likely to attempt suicide if they are tall, research has shown.
A study in the Journal of Epidemiology and Community Health examined the suicide and death figures for 320,000 Swedish men born between 1973 and 1980.
It found that short babies - those less than 47cm in length at birth - were more likely to attempt suicide as adults, regardless of their eventual height.
Short birth length more than doubled the risk of violent suicide, defined as the use of guns or knives, jumping from a height or in front of vehicles, or drowning.
But short men who were born a normal length were also affected.
The study found they were 56% more likely to take their own lives than tall men.
The authors of the study suggested the brain chemical serotonin, which is crucial to brain development, could be the reason for their findings.
Low serotonin levels can trigger impulsive, aggressive and suicidal behaviour, and can be caused by premature birth and other factors affecting growth in the womb.
READ MORE @ THE PRESS ASSOCIATION
A study in the Journal of Epidemiology and Community Health examined the suicide and death figures for 320,000 Swedish men born between 1973 and 1980.
It found that short babies - those less than 47cm in length at birth - were more likely to attempt suicide as adults, regardless of their eventual height.
Short birth length more than doubled the risk of violent suicide, defined as the use of guns or knives, jumping from a height or in front of vehicles, or drowning.
But short men who were born a normal length were also affected.
The study found they were 56% more likely to take their own lives than tall men.
The authors of the study suggested the brain chemical serotonin, which is crucial to brain development, could be the reason for their findings.
Low serotonin levels can trigger impulsive, aggressive and suicidal behaviour, and can be caused by premature birth and other factors affecting growth in the womb.
READ MORE @ THE PRESS ASSOCIATION
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