Lisa Carbo knew something was wrong. The former registered nurse from Metairie, La., began experiencing difficulty in remembering how to perform various functions at her job. Multitasking became harder. Eventually she was written up for poor performance, prompting her to seek medical help.
Carbo was diagnosed with early onset Alzheimer's disease in November 2007, at the age of 53.
Before her Alzheimer's diagnosis, Carbo had plans for her golden years. "I hoped to semi-retire, spend the rest of [my] life with someone, continue to be productive, travel," she said. "I love animals, I had planned to do a lot more volunteering with animal shelters."
Her diagnosis changed everything: She lost her job and her boyfriend left her. "All those hopes and dreams are smashed. They're all gone. It's like everything that you planned on for your life is gone."
Fortunately for Carbo, she was able to find help to deal with the depression brought about by her diagnosis. She began taking antidepressants and started seeing a therapist.
READ MORE @ ABC NEWS
Friday, May 15, 2009
Thursday, May 14, 2009
Antidepressants: Brand Name or Generic?
For many antidepressants, the issue of brand-name versus generic has no practical significance. Elavil was first marketed almost a half century ago, and its patent has long expired. It lives on, however, but as generic amitriptyline. Today, only a few antidepressants are still fully protected by patents, namely, Cymbalta (2010), Lexapro (2012), and Pristiq (2022) for major depressive disorder (MDD); and Seroquel (2011) and Symbyax (2017) for bipolar depression.
The issue of brand-name versus generic, however, is far more complex than merely listing patent expiration dates. Patents can be extended, challenged, and infringed on; financial considerations are enormous; and patient care issues are often of central importance. To place antidepressants in proper perspective, it is first necessary to provide some general background about patents and drug regulation.
READ MORE @ PSYCHIATRIC TIMES
The issue of brand-name versus generic, however, is far more complex than merely listing patent expiration dates. Patents can be extended, challenged, and infringed on; financial considerations are enormous; and patient care issues are often of central importance. To place antidepressants in proper perspective, it is first necessary to provide some general background about patents and drug regulation.
READ MORE @ PSYCHIATRIC TIMES
Wednesday, May 13, 2009
Role of Acupuncture in the Treatment of Depression Benefits and Limitations of Adjunctive Treatment and Monotherapy
Acupuncture is being integrated into Western medicine, particularly for treatment of pain, nausea, asthma, and neurological conditions.1 Although the exact mechanism of action for acupuncture is unknown, it is associated with an increase in the level of neurobiologically active substances, such as endorphins and enkephalins.2 There are also data indicating that acupuncture induces the release of norepinephrine, serotonin, and dopamine.3-5
ADVERSE EFFECTS
Acupuncture is well tolerated compared with tricyclic antidepressant medications.6-9 Adverse effects are mild and transient and include tiredness, drowsiness, exacerbation of primary symptoms, and itching in the area of acupuncture.10 Complications such as pneumothorax, infection, cardiac conditions, and spinal cord injury are extremely rare.10
AVAILABLE DATA
The number of studies of Western acupuncture in the treatment of depression and conditions associated with depression is limited.10 Even fewer reports provide objective data to support efficacy (eg, neurotransmitter) level change, imaging studies, and electroencephalographic alterations. Only 7 randomized comparative studies have been published, even though the first attempts to compare acupuncture with conventional treatments for depression began in the 1970s.
READ MORE @ PSYCHIATRIC TIMES
ADVERSE EFFECTS
Acupuncture is well tolerated compared with tricyclic antidepressant medications.6-9 Adverse effects are mild and transient and include tiredness, drowsiness, exacerbation of primary symptoms, and itching in the area of acupuncture.10 Complications such as pneumothorax, infection, cardiac conditions, and spinal cord injury are extremely rare.10
AVAILABLE DATA
The number of studies of Western acupuncture in the treatment of depression and conditions associated with depression is limited.10 Even fewer reports provide objective data to support efficacy (eg, neurotransmitter) level change, imaging studies, and electroencephalographic alterations. Only 7 randomized comparative studies have been published, even though the first attempts to compare acupuncture with conventional treatments for depression began in the 1970s.
READ MORE @ PSYCHIATRIC TIMES
Tuesday, May 12, 2009
Participants in antidepressant drug trials are atypical patients, UT Southwestern researchers report
One reason antidepressant medication treatments do not work as well in real life as they do in clinical studies could be the limited type of study participants selected, researchers at UT Southwestern Medical Center have found.
"We are basing our judgment of clinical care in the United States on samples of patients that are totally different from the patient population actually treated in primary care and mental health facilities," said Dr. Madhukar Trivedi, professor of psychiatry at UT Southwestern and senior author of a study published in the May issue of the American Journal of Psychiatry. "Antidepressants should not be seen as a panacea. The general belief is that they work well, but they are less effective in real-world practice, and more work is needed."
As part of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study scientists found that only 22 percent of the 2,855 participants treated with a commonly prescribed antidepressant would have met the criteria for inclusion in a typical antidepressant efficacy trial. Those who did meet criteria had shorter bouts of depression, quicker response to medication, less severe side effects and fewer adverse events compared with those people with depression who would have been excluded from such a trial, used to gain Food and Drug Administration approval of the drugs used.
The STAR*D trial was the first large-scale study to define the effectiveness of several treatment steps in primary care and mental health settings for people with depression, Dr. Trivedi said.
The six-year, $35 million STAR*D study is the largest investigation on the treatment of major depressive disorder and is considered a benchmark in the field of depression research. It initially included more than 4,000 people from outpatient treatment sites across the country. About 65 percent of STAR*D participants, however, had a medical co-morbidity such as diabetes that typically would have excluded them from participating in other clinical trials to test the efficacy of antidepressants, said Dr. Trivedi, co-principal investigator of STAR*D.
READ MORE @ EUREKAERT
"We are basing our judgment of clinical care in the United States on samples of patients that are totally different from the patient population actually treated in primary care and mental health facilities," said Dr. Madhukar Trivedi, professor of psychiatry at UT Southwestern and senior author of a study published in the May issue of the American Journal of Psychiatry. "Antidepressants should not be seen as a panacea. The general belief is that they work well, but they are less effective in real-world practice, and more work is needed."
As part of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study scientists found that only 22 percent of the 2,855 participants treated with a commonly prescribed antidepressant would have met the criteria for inclusion in a typical antidepressant efficacy trial. Those who did meet criteria had shorter bouts of depression, quicker response to medication, less severe side effects and fewer adverse events compared with those people with depression who would have been excluded from such a trial, used to gain Food and Drug Administration approval of the drugs used.
The STAR*D trial was the first large-scale study to define the effectiveness of several treatment steps in primary care and mental health settings for people with depression, Dr. Trivedi said.
The six-year, $35 million STAR*D study is the largest investigation on the treatment of major depressive disorder and is considered a benchmark in the field of depression research. It initially included more than 4,000 people from outpatient treatment sites across the country. About 65 percent of STAR*D participants, however, had a medical co-morbidity such as diabetes that typically would have excluded them from participating in other clinical trials to test the efficacy of antidepressants, said Dr. Trivedi, co-principal investigator of STAR*D.
READ MORE @ EUREKAERT
Monday, May 11, 2009
Antidepressants: The right people aren't always getting them
The medications are widely used to treat complaints such as loneliness or low energy. Meanwhile, studies say many with depression go untreated.
It was just over 20 years ago that the antidepressant Prozac was first approved by the U.S. Food and Drug Administration. The medication was touted as nothing short of a miracle: Not only was it was highly effective in treating depression, it also caused very few side effects.
The drug's popularity grew rapidly, and pharmaceutical companies got busy developing a variety of other, chemically similar antidepressants, collectively referred to as selective serotonin reuptake inhibitors (or SSRIs). There are at least half a dozen SSRIs on the market, including Lexapro, Paxil, Zoloft, Celexa and Luvox.
Since the introduction of these drugs, the number of Americans being treated for depression has increased dramatically; the Centers for Disease Control and Prevention says antidepressants are the most commonly prescribed medication in the country. But it's not always the right people taking them. Some who probably have very little to gain from their use are on SSRIs; others who stand to benefit are not.
READ MORE @ LOS ANGELES TIMES
It was just over 20 years ago that the antidepressant Prozac was first approved by the U.S. Food and Drug Administration. The medication was touted as nothing short of a miracle: Not only was it was highly effective in treating depression, it also caused very few side effects.
The drug's popularity grew rapidly, and pharmaceutical companies got busy developing a variety of other, chemically similar antidepressants, collectively referred to as selective serotonin reuptake inhibitors (or SSRIs). There are at least half a dozen SSRIs on the market, including Lexapro, Paxil, Zoloft, Celexa and Luvox.
Since the introduction of these drugs, the number of Americans being treated for depression has increased dramatically; the Centers for Disease Control and Prevention says antidepressants are the most commonly prescribed medication in the country. But it's not always the right people taking them. Some who probably have very little to gain from their use are on SSRIs; others who stand to benefit are not.
READ MORE @ LOS ANGELES TIMES
Sunday, May 10, 2009
Women Stopping Antidepressant Medication For Premenstrual Syndrome Experience Relapse
A report in the May issue of the Archives of General Psychiatry (one of the JAMA/Archives journals) indicates that many women take the antidepressant called sertraline to relieve severe premenstrual symptoms, and it seems that half of them go through relapse after six to eight months after stopping the medication. There is a higher probability of relapse for women with more severe symptoms and those who consumed the drug during a shorter period.
Background facts sustained in the report demonstrate that premenstrual syndrome (PMS) is one of the most frequent health problems among women of reproductive age. Sertraline hydrochloride and other antidepressant medications are approved to treat PMS when it is most severe, also known as premenstrual dysphoric disorder (PMDD).
The authors explain: "There is little information about the optimal duration of treatment, although anecdotal reports and small pilot investigations suggest that premenstrual symptoms return rapidly in the absence of effective medication."
READ MORE @ MEDICAL NEWS TODAY
Background facts sustained in the report demonstrate that premenstrual syndrome (PMS) is one of the most frequent health problems among women of reproductive age. Sertraline hydrochloride and other antidepressant medications are approved to treat PMS when it is most severe, also known as premenstrual dysphoric disorder (PMDD).
The authors explain: "There is little information about the optimal duration of treatment, although anecdotal reports and small pilot investigations suggest that premenstrual symptoms return rapidly in the absence of effective medication."
READ MORE @ MEDICAL NEWS TODAY
Saturday, May 9, 2009
Is The FDA Easing Up? How one company turned a rejection into a thumbs up, and what it could mean for the drug industry as a whole.
After the Food and Drug Administration told Vanda Pharmaceuticals that the company's schizophrenia drug was "not approvable" last July, Wall Street marked the tiny biotech for dead.
The FDA asked for a new clinical trial; Vanda insisted it could change the agency's mind with its existing data. Its shares sank from $4 to 45 cents. A hedge fund, Tang Capital Partners, started a proxy fight to try and get Vanda to liquidate and distribute the proceeds to shareholders.
Then Wednesday night, the FDA announced it was approving the drug, Fanapt, based on data from 3,000 patients. Vanda shares exploded 700% to $8. That's the kind of jackpot that could start getting investors interested in gambling on tiny biotechs again.
But the Vanda story may signal something far more important for investors than just a reminder that biotech stocks can pop: an easier FDA. Both Wyeth ( WYE - news - people ), which is being bought by Pfizer ( PFE - news - people ), and Schering-Plough ( SGP - news - people ), which is being bought by Merck ( MRK - news - people ), were rebuffed last year by the FDA after submitting data for schizophrenia drugs.
READ MORE @ FORBES
The FDA asked for a new clinical trial; Vanda insisted it could change the agency's mind with its existing data. Its shares sank from $4 to 45 cents. A hedge fund, Tang Capital Partners, started a proxy fight to try and get Vanda to liquidate and distribute the proceeds to shareholders.
Then Wednesday night, the FDA announced it was approving the drug, Fanapt, based on data from 3,000 patients. Vanda shares exploded 700% to $8. That's the kind of jackpot that could start getting investors interested in gambling on tiny biotechs again.
But the Vanda story may signal something far more important for investors than just a reminder that biotech stocks can pop: an easier FDA. Both Wyeth ( WYE - news - people ), which is being bought by Pfizer ( PFE - news - people ), and Schering-Plough ( SGP - news - people ), which is being bought by Merck ( MRK - news - people ), were rebuffed last year by the FDA after submitting data for schizophrenia drugs.
READ MORE @ FORBES
Friday, May 8, 2009
More Americans taking drugs for mental illness
Many more Americans have been using prescription drugs to treat mental illness since 1996, in part because of expanded insurance coverage and greater familiarity with the drugs among primary care doctors, U.S. researchers said on Tuesday.
They said 73 percent more adults and 50 percent more children are using drugs to treat mental illness than in 1996.
Among adults over 65, use of so-called psychotropic drugs -- which include antidepressants, antipsychotics and Alzheimer's medicines -- doubled between 1996 and 2006.
"What we generally find is there has been an increase in access to care for all populations," said Sherry Glied of Columbia University in New York, whose study appears in the journal Health Affairs.
READ MORE @ REUTERS
They said 73 percent more adults and 50 percent more children are using drugs to treat mental illness than in 1996.
Among adults over 65, use of so-called psychotropic drugs -- which include antidepressants, antipsychotics and Alzheimer's medicines -- doubled between 1996 and 2006.
"What we generally find is there has been an increase in access to care for all populations," said Sherry Glied of Columbia University in New York, whose study appears in the journal Health Affairs.
READ MORE @ REUTERS
Thursday, May 7, 2009
For Old Drugs, New Tricks - Advice Veers Away From Flushing Unused Pills
At the Leesburg Pharmacy, located in a Loudoun County strip mall, a big, round fish tank sits atop the prescription counter. There are no fish inside, not even any water: The tank is a repository for unused medications. People can drop off the Vicodin that didn't get used once the pain of a root canal subsided. Or the heart pills remaining after a grandmother's death. Or an asthma inhaler that had passed its expiration date. Or an antidepressant that turned out to have unpleasant side effects.
Once a week, the tank is emptied; the drugs are packed in cartons by pharmacy personnel and ultimately incinerated by a commercial waste firm.
"Our customers are thrilled because they had no idea what else to do with this stuff," said Cheri Garvin, chief executive of the employee-owned pharmacy.
These are customers who are trying to do the responsible thing. Over the years, Americans have been alerted to the dangers of a lot of problematic waste materials -- paint thinner, batteries, air conditioners. But leftover pills can seem so small, so easily disposable, that many people routinely flush them down toilets, wash them down sinks or throw them in trash that goes to a landfill.
And then they often end up in places where they shouldn't be, like the public water supply.
The average American takes more than 12 prescription drugs annually, with more than 3.8 billion prescriptions purchased each year, according to the Kaiser Family Foundation. The most commonly cited estimates from Environmental Protection Agency researchers say that about 19 million tons of active pharmaceutical ingredients are dumped into the nation's waste stream every year.
READ MORE @ WASHINGTON POST
Once a week, the tank is emptied; the drugs are packed in cartons by pharmacy personnel and ultimately incinerated by a commercial waste firm.
"Our customers are thrilled because they had no idea what else to do with this stuff," said Cheri Garvin, chief executive of the employee-owned pharmacy.
These are customers who are trying to do the responsible thing. Over the years, Americans have been alerted to the dangers of a lot of problematic waste materials -- paint thinner, batteries, air conditioners. But leftover pills can seem so small, so easily disposable, that many people routinely flush them down toilets, wash them down sinks or throw them in trash that goes to a landfill.
And then they often end up in places where they shouldn't be, like the public water supply.
The average American takes more than 12 prescription drugs annually, with more than 3.8 billion prescriptions purchased each year, according to the Kaiser Family Foundation. The most commonly cited estimates from Environmental Protection Agency researchers say that about 19 million tons of active pharmaceutical ingredients are dumped into the nation's waste stream every year.
READ MORE @ WASHINGTON POST
Wednesday, May 6, 2009
Why Antidepressants Don't Live Up to the Hype
In the '90s, Americans grew fond of the idea that you can fix depression simply by taking a pill — most famously fluoxetine (better known as Prozac), though fluoxetine is just one of at least seven selective serotonin reuptake inhibitors (SSRIs) that have been prescribed to treat hundreds of millions of people around the world.
But in the past few years, researchers have challenged the effectiveness of Prozac and other SSRIs in several studies. For instance, a review published in the Journal of Affective Disorders in February attributed 68% of the benefit from antidepressants to the placebo effect. Likewise, a paper published in PLoS Medicine a year earlier suggested that widely used SSRIs, including Prozac, Effexor and Paxil, offer no clinically significant benefit over placebos for patients with moderate or severe depression. Meanwhile, pharmaceutical companies maintain that their research shows that SSRIs are powerful weapons against depression. (Here's a helpful blog post that summarizes the debate.)
Now a major new study suggests that both critics and proponents might be right about SSRIs: the drugs can work, but they appear to work best for only a subset of depressed patients — those with a limited range of psychological problems. People whose depression is compounded with, say, substance abuse or a personality disorder may not get much help from SSRIs — which is unfortunate for the 45% to 60% of patients in the U.S. who have been diagnosed with a common mental disorder like depression and also meet the criteria for at least one other disorder, like substance abuse. (Multiple diagnoses are known in medical parlance as comorbidities.)
READ MORE @ TIME
But in the past few years, researchers have challenged the effectiveness of Prozac and other SSRIs in several studies. For instance, a review published in the Journal of Affective Disorders in February attributed 68% of the benefit from antidepressants to the placebo effect. Likewise, a paper published in PLoS Medicine a year earlier suggested that widely used SSRIs, including Prozac, Effexor and Paxil, offer no clinically significant benefit over placebos for patients with moderate or severe depression. Meanwhile, pharmaceutical companies maintain that their research shows that SSRIs are powerful weapons against depression. (Here's a helpful blog post that summarizes the debate.)
Now a major new study suggests that both critics and proponents might be right about SSRIs: the drugs can work, but they appear to work best for only a subset of depressed patients — those with a limited range of psychological problems. People whose depression is compounded with, say, substance abuse or a personality disorder may not get much help from SSRIs — which is unfortunate for the 45% to 60% of patients in the U.S. who have been diagnosed with a common mental disorder like depression and also meet the criteria for at least one other disorder, like substance abuse. (Multiple diagnoses are known in medical parlance as comorbidities.)
READ MORE @ TIME
Tuesday, May 5, 2009
New Route To Treat Depression - Finding could help people failed by current antidepressants
A NEW TARGET for treating depression, discovered by researchers in Iowa, may offer an alternative to current antidepressants, which target other mechanisms to treat the condition.
"The mechanism issue is important because if a patient doesn't respond to one drug, the chances of them responding to another drug that works through the same mechanism are low," says John A. Wemmie, who led the research team. Wemmie is an associate professor of psychiatry and neurosurgery at the University of Iowa and a staff physician and researcher at the Iowa City Veterans Affairs Medical Center.
Wemmie's team focused on a biochemical pathway involving acid-sensing ion channel (ASIC) proteins expressed by neurons. ASICs are activated by protons that are believed to act as neurotransmitters (C&EN, Jan. 14, 2008, page 10). Wemmie and his colleagues concentrated on the ASIC1a class of these ion channels, which are abundant in regions of the brain associated with mood.
The research group had previously shown in mice that ASIC1a activity is associated with anxiety, which often accompanies depression. In the new work, the researchers showed that mice lacking the gene for ASIC1a were less susceptible than normal mice to depression caused by stress. In a second experiment, the researchers treated normal mice with A-317567, an experimental ASIC inhibitor that Abbott Laboratories has been studying for pain treatment. Wemmie's team reports that blocking ASIC1a in this way produced antidepressant effects in the animals (J. Neurosci. 2009, 29, 5381).
READ MORE @ CHEMICAL & ENGINEERING NEWS
"The mechanism issue is important because if a patient doesn't respond to one drug, the chances of them responding to another drug that works through the same mechanism are low," says John A. Wemmie, who led the research team. Wemmie is an associate professor of psychiatry and neurosurgery at the University of Iowa and a staff physician and researcher at the Iowa City Veterans Affairs Medical Center.
Wemmie's team focused on a biochemical pathway involving acid-sensing ion channel (ASIC) proteins expressed by neurons. ASICs are activated by protons that are believed to act as neurotransmitters (C&EN, Jan. 14, 2008, page 10). Wemmie and his colleagues concentrated on the ASIC1a class of these ion channels, which are abundant in regions of the brain associated with mood.
The research group had previously shown in mice that ASIC1a activity is associated with anxiety, which often accompanies depression. In the new work, the researchers showed that mice lacking the gene for ASIC1a were less susceptible than normal mice to depression caused by stress. In a second experiment, the researchers treated normal mice with A-317567, an experimental ASIC inhibitor that Abbott Laboratories has been studying for pain treatment. Wemmie's team reports that blocking ASIC1a in this way produced antidepressant effects in the animals (J. Neurosci. 2009, 29, 5381).
READ MORE @ CHEMICAL & ENGINEERING NEWS
Monday, May 4, 2009
AAN: Atypical Antipsychotic Reduces Autism Irritability
Aripiprazole (Abilify) may be effective off-label for treating the irritability associated with autism, researchers here said.
The atypical antipsychotic fared significantly better than placebo on a parent-rated scale of irritability (P<0.05), Donald Lewis, M.D., of Sentara Norfolk General Hospital in Virginia, and colleagues reported at the American Academy of Neurology meeting.
It also had significant advantages over placebo with regard to clinician assessments of Aripiprazole and hyperactivity.
Only one atypical antipsychotic -- risperidone (Risperdal) -- is currently FDA approved for irritability associated with autism. However, treatment guidelines recommended that other atypical antipsychotics be considered for behavioral problems in autism.
Researchers involved in the current study could not comment on whether aripiprazole was in the process of FDA approval for this indication.
But Benjamin L. Handen, Ph.D., of the University of Pittsburgh, who was not involved in this study but is involved in similar trials, said FDA approval for the indication would give doctors an alternative for children who respond poorly to risperidone.
READ MORE @ MEDPAGE TODAY
The atypical antipsychotic fared significantly better than placebo on a parent-rated scale of irritability (P<0.05), Donald Lewis, M.D., of Sentara Norfolk General Hospital in Virginia, and colleagues reported at the American Academy of Neurology meeting.
It also had significant advantages over placebo with regard to clinician assessments of Aripiprazole and hyperactivity.
Only one atypical antipsychotic -- risperidone (Risperdal) -- is currently FDA approved for irritability associated with autism. However, treatment guidelines recommended that other atypical antipsychotics be considered for behavioral problems in autism.
Researchers involved in the current study could not comment on whether aripiprazole was in the process of FDA approval for this indication.
But Benjamin L. Handen, Ph.D., of the University of Pittsburgh, who was not involved in this study but is involved in similar trials, said FDA approval for the indication would give doctors an alternative for children who respond poorly to risperidone.
READ MORE @ MEDPAGE TODAY
Sunday, May 3, 2009
Drugs 'can help mild depression'
Antidepressants can help mild to moderate depression and should not just be used in bad cases, researchers say.
Current guidelines urge doctors to avoid antidepressants as an initial treatment in mild depression.
But an NHS-funded study of 200 patients from across England found the drugs, called SSRIs, were more effective than GP advice and support alone.
The team hope national advisers will look at their findings, reported on the Health Technology Assessment website.
Study leader Professor Tony Kendrick, a GP and researcher at the University of Southampton, said although the National Institute of Health and Clinical Excellence wants doctors to restrict SSRIs to the most severe cases, GPs frequently prescribe them for milder cases.
"Just because someone has mild depression does not mean it is a mild illness, because it can cause them to be off work for months," he said.
"And often you don't have psychological treatments to offer because they're not available so you end up prescribing quite frequently."
READ MORE @ BBC
Current guidelines urge doctors to avoid antidepressants as an initial treatment in mild depression.
But an NHS-funded study of 200 patients from across England found the drugs, called SSRIs, were more effective than GP advice and support alone.
The team hope national advisers will look at their findings, reported on the Health Technology Assessment website.
Study leader Professor Tony Kendrick, a GP and researcher at the University of Southampton, said although the National Institute of Health and Clinical Excellence wants doctors to restrict SSRIs to the most severe cases, GPs frequently prescribe them for milder cases.
"Just because someone has mild depression does not mean it is a mild illness, because it can cause them to be off work for months," he said.
"And often you don't have psychological treatments to offer because they're not available so you end up prescribing quite frequently."
READ MORE @ BBC
Saturday, May 2, 2009
Researchers find common genetic variations in autistic people
Findings show that many autistic people have a deviation in a portion of their DNA that affects the way brain cells connect with one another. The discovery may lead to treatments.
Researchers have found that many people with autism share common genetic variations, a discovery that may improve diagnosis and offers the promise of developing treatments for the frustratingly mysterious disorder.
Their findings, published in the journal Nature, compared the genomes of thousands of autistic people with those of thousands of people without the disorder -- a massive task that new technology has only recently made possible. The genome is the complex system of DNA coding that builds and runs the human body.
The review showed that most autistic people examined have a genetic variation in a portion of their DNA that affects the way brain cells connect with one another. Scientists also reported a link between autism and small "mistakes" in another DNA segment involved with cell communication. Both reports add weight to the idea that autism is related to problems with the way brain cells connect.
READ MORE @ LOS ANGELES TIMES
Researchers have found that many people with autism share common genetic variations, a discovery that may improve diagnosis and offers the promise of developing treatments for the frustratingly mysterious disorder.
Their findings, published in the journal Nature, compared the genomes of thousands of autistic people with those of thousands of people without the disorder -- a massive task that new technology has only recently made possible. The genome is the complex system of DNA coding that builds and runs the human body.
The review showed that most autistic people examined have a genetic variation in a portion of their DNA that affects the way brain cells connect with one another. Scientists also reported a link between autism and small "mistakes" in another DNA segment involved with cell communication. Both reports add weight to the idea that autism is related to problems with the way brain cells connect.
READ MORE @ LOS ANGELES TIMES
Friday, May 1, 2009
Off-Label Prescribing
Medications cannot be marketed in the United States without an FDA determination that they are safe and effective for their intended use. To obtain such certification, pharmaceutical companies submit their products to rigorous scrutiny (eg, in vitro studies, animal studies, human clinical trials) and present the subsequent data to the FDA, which determines whether the medication in question is safe and effective for a specific purpose. FDA approval comes with specific labeling requirements for the product, including the approved indications for use, the appropriate dosing, and the specific populations for its use. Once a medication has been approved for a specific use, physicians and other prescribers are permitted to prescribe the medication for conditions not covered by the approved use.
Several recent studies have demonstrated that off-label prescribing is very common among physicians, particularly among psychiatrists. Legal scholars have estimated that approximately 40% to 60% of prescriptions are for off-label use.1 In one important study, researchers examined office-based prescribing patterns for 160 commonly prescribed medications and determined that approximately 21% were for off-label use. In this study, off-label use was most common for cardiac medications (46%), anticonvulsant medications (46%), and asthma medications (42%). The investigators also found that most off-label use (73%) had limited or no scientific support.
The greatest disparity in the percentage of scientifically supported versus unsupported off-label use occurred with psychiatric medications. In 96%, the off-label use was determined to have little or no sound scientific evidence for the condition for which the drug was prescribed.2
READ MORE @ PSYCHIATRIC TIMES
Several recent studies have demonstrated that off-label prescribing is very common among physicians, particularly among psychiatrists. Legal scholars have estimated that approximately 40% to 60% of prescriptions are for off-label use.1 In one important study, researchers examined office-based prescribing patterns for 160 commonly prescribed medications and determined that approximately 21% were for off-label use. In this study, off-label use was most common for cardiac medications (46%), anticonvulsant medications (46%), and asthma medications (42%). The investigators also found that most off-label use (73%) had limited or no scientific support.
The greatest disparity in the percentage of scientifically supported versus unsupported off-label use occurred with psychiatric medications. In 96%, the off-label use was determined to have little or no sound scientific evidence for the condition for which the drug was prescribed.2
READ MORE @ PSYCHIATRIC TIMES
Thursday, April 30, 2009
What Is Neuropathy? What Causes Neuropathy?
Neuropathy is a collection of disorders that occurs when nerves of the peripheral nervous system (the part of the nervous system outside of the brain and spinal cord) are damaged. The condition is generally referred to as peripheral neuropathy, and it is most commonly due to damage to nerve axons. Neuropathy usually causes pain and numbness in the hands and feet. It can result from traumatic injuries, infections, metabolic disorders, and exposure to toxins. One of the most common causes of neuropathy is diabetes.
Neuropathy can affect nerves that control muscle movement (motor nerves) and those that detect sensations such as coldness or pain (sensory nerves). In some cases - autonomic neuropathy - it can affect internal organs, such as the heart, blood vessels, bladder, or intestines.
READ MORE @ MEDICAL NEWS TODAY
Neuropathy can affect nerves that control muscle movement (motor nerves) and those that detect sensations such as coldness or pain (sensory nerves). In some cases - autonomic neuropathy - it can affect internal organs, such as the heart, blood vessels, bladder, or intestines.
READ MORE @ MEDICAL NEWS TODAY
Wednesday, April 29, 2009
Are we cherry picking participants for studies of antidepressants?
People with depression often excluded from clinical studies and tend not to fare as well as study participants
Findings from clinical studies used to gain Food and Drug Administration approval of common antidepressants are not applicable to most patients with depression, according to a report led by the University of Pittsburgh Graduate School of Public Health. Published in the May issue of the American Journal of Psychiatry, the study suggests only a small percentage of people with depression qualify for these studies, and those who do not qualify are often treated with the same medications but may suffer poorer clinical outcomes.
A part of the National Institute of Mental Health-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project – the largest study of the treatment of depression conducted in the United States – researchers compared symptoms and outcomes in depressed patients who met phase III study inclusion criteria to those who did not. Phase III studies for antidepressants determine the effectiveness of the drug in comparison to a placebo. The inclusion criteria for these studies are not standardized nor subject to federal guidelines, resulting in some variation from study to study in the profile of eligible patients. Typically excluded are patients with milder forms of depression, who might be more likely to respond to a placebo drug, and those who may have chronic depression or psychiatric and medical co-morbidities – additional illnesses or conditions.
After assessing 2,855 patients treated with citalopram, a commonly prescribed selective serotonin reuptake inhibitor for mood disorders, study authors concluded that fewer than one in four, or 22.2 percent, of the patients met the usual criteria for inclusion in phase III antidepressant trials.
"Only a small percentage of depressed patients in our study would have qualified for inclusion in phase III efficacy trials of depression drugs," said study lead author, Stephen Wisniewski, Ph.D., professor of epidemiology and co-director of the Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health. "This raises major concerns about whether results from traditional phase III studies can be generalized to most people with depression, who also often suffer from anxiety, substance abuse and other medical and psychiatric problems."
READ MORE @ EUREKALERT
Findings from clinical studies used to gain Food and Drug Administration approval of common antidepressants are not applicable to most patients with depression, according to a report led by the University of Pittsburgh Graduate School of Public Health. Published in the May issue of the American Journal of Psychiatry, the study suggests only a small percentage of people with depression qualify for these studies, and those who do not qualify are often treated with the same medications but may suffer poorer clinical outcomes.
A part of the National Institute of Mental Health-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project – the largest study of the treatment of depression conducted in the United States – researchers compared symptoms and outcomes in depressed patients who met phase III study inclusion criteria to those who did not. Phase III studies for antidepressants determine the effectiveness of the drug in comparison to a placebo. The inclusion criteria for these studies are not standardized nor subject to federal guidelines, resulting in some variation from study to study in the profile of eligible patients. Typically excluded are patients with milder forms of depression, who might be more likely to respond to a placebo drug, and those who may have chronic depression or psychiatric and medical co-morbidities – additional illnesses or conditions.
After assessing 2,855 patients treated with citalopram, a commonly prescribed selective serotonin reuptake inhibitor for mood disorders, study authors concluded that fewer than one in four, or 22.2 percent, of the patients met the usual criteria for inclusion in phase III antidepressant trials.
"Only a small percentage of depressed patients in our study would have qualified for inclusion in phase III efficacy trials of depression drugs," said study lead author, Stephen Wisniewski, Ph.D., professor of epidemiology and co-director of the Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health. "This raises major concerns about whether results from traditional phase III studies can be generalized to most people with depression, who also often suffer from anxiety, substance abuse and other medical and psychiatric problems."
READ MORE @ EUREKALERT
Tuesday, April 28, 2009
No Data Supporting Antipsychotic Drug for Low-IQ Kids With ADHD
A new Cochrane review finds no evidence to support the use of risperidone to treat attention- deficit/hyperactivity disorder (ADHD) in people with intellectual disabilities, even though the review authors say this is a common prescribing pattern.
Risperidone, or Risperdal, is a second-generation antipsychotic drug. Long-term use of these drugs is associated with serious side effects, including weight gain and increased risk for type 2 diabetes.
“People who have intellectual disability are more likely to receive treatment with second- generation antipsychotics for ADHD,” said lead review author Dr. Alex Thomson. “Doctors should be aware that there is no research to demonstrate the effectiveness of risperidone for ADHD in people with intellectual disability, and should carefully monitor each case and consider alternative treatments before trying risperidone.”
Laurel Leslie, M.D., an associate professor at Tufts University School of Medicine whose research centers on pediatric mental health, concurred: “This study demonstrates that we have a gap between what we’re doing clinically and what we have any research evidence for. It’s an important study, as it highlights the need for careful consideration of how we treat children’s mental health issues.” Leslie has no affiliation with the Cochrane review.
Thomson’s research group did not find one study that met their criteria for inclusion among more than 2,000 studies that they initially identified. The group analyzed 15 studies in depth, but ultimately rejected them all.
READ MORE @ NEWSWISE
Risperidone, or Risperdal, is a second-generation antipsychotic drug. Long-term use of these drugs is associated with serious side effects, including weight gain and increased risk for type 2 diabetes.
“People who have intellectual disability are more likely to receive treatment with second- generation antipsychotics for ADHD,” said lead review author Dr. Alex Thomson. “Doctors should be aware that there is no research to demonstrate the effectiveness of risperidone for ADHD in people with intellectual disability, and should carefully monitor each case and consider alternative treatments before trying risperidone.”
Laurel Leslie, M.D., an associate professor at Tufts University School of Medicine whose research centers on pediatric mental health, concurred: “This study demonstrates that we have a gap between what we’re doing clinically and what we have any research evidence for. It’s an important study, as it highlights the need for careful consideration of how we treat children’s mental health issues.” Leslie has no affiliation with the Cochrane review.
Thomson’s research group did not find one study that met their criteria for inclusion among more than 2,000 studies that they initially identified. The group analyzed 15 studies in depth, but ultimately rejected them all.
READ MORE @ NEWSWISE
Monday, April 27, 2009
Medication Errors Could Be Cut: Experts - Two reports show promise of computers, pharmacists for proper prescribing
Medication errors and adverse drug reactions cost lives and dollars each year in the United States, but two new reports suggest ways hospitals and pharmacists can work to reduce these mistakes.
Medication errors are one of the most common medical errors, affecting at least 1.5 million people every year and costing the health-care system between $77 billion and $177 billion annually, researchers point out in the April 27 issue of the Archives of Internal Medicine.
In the first report, researchers led by Dr. Jeffrey L. Schnipper, of Brigham and Women's Hospital and Harvard Medical School, used a computer system to keep track of the medications patients were taking when they were admitted to the hospital and the medications they were taking when they were discharged.
"It turns out that we commit about 1.5 errors per patient either for the admissions orders in the hospital or, much more commonly, in the discharge orders, which is kind of appalling," Schnipper said. "These are errors with potential for patient harm. There are about three times as many errors without potential for patient harm."
READ MORE @ FORBES
Medication errors are one of the most common medical errors, affecting at least 1.5 million people every year and costing the health-care system between $77 billion and $177 billion annually, researchers point out in the April 27 issue of the Archives of Internal Medicine.
In the first report, researchers led by Dr. Jeffrey L. Schnipper, of Brigham and Women's Hospital and Harvard Medical School, used a computer system to keep track of the medications patients were taking when they were admitted to the hospital and the medications they were taking when they were discharged.
"It turns out that we commit about 1.5 errors per patient either for the admissions orders in the hospital or, much more commonly, in the discharge orders, which is kind of appalling," Schnipper said. "These are errors with potential for patient harm. There are about three times as many errors without potential for patient harm."
READ MORE @ FORBES
Saturday, April 25, 2009
Study: Medicaid patients get wrong drugs
Drugs designed to treat severe mental illnesses are being prescribed to Medicaid patients at inappropriately low doses, at considerable expense and for conditions where their benefits haven't been proven, a team of mostly Oregon researchers reports.
Scientists from the Oregon State University College of Pharmacy, Oregon Health and Science University and Columbia University's psychiatry department reviewed records for 830 Oregon Medicaid patients who had been given antipsychotic medications approved for conditions such as schizophrenia and bipolar disorder. The researchers found the majority of those patients did not have the underlying mental conditions for which the drugs were approved for prescription. Instead, they were given to patients to treat health concerns such as depression, anxiety, post-traumatic stress disorder or insomnia.
READ MORE @ STATESMAN JOURNAL
Scientists from the Oregon State University College of Pharmacy, Oregon Health and Science University and Columbia University's psychiatry department reviewed records for 830 Oregon Medicaid patients who had been given antipsychotic medications approved for conditions such as schizophrenia and bipolar disorder. The researchers found the majority of those patients did not have the underlying mental conditions for which the drugs were approved for prescription. Instead, they were given to patients to treat health concerns such as depression, anxiety, post-traumatic stress disorder or insomnia.
READ MORE @ STATESMAN JOURNAL
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