A new study has found that rare and previously undetectable genetic variations may significantly increase the risk that a person will develop schizophrenia.
Experts said the study, while not identifying the cause of the disorder, provided a striking demonstration of how new gene-scanning technology can open a new frontier in the quest to understand the biology of mental disorders.
Until now, researchers had focused on finding common and known genetic variations that, when acting in some combination, might increase the risk for schizophrenia. They have had little success. The new analysis, being published Friday in the journal Science, detected extremely rare and unknown mutations that turned up three to four times as often in people with schizophrenia as in those without it.
The findings point scientists to previously unappreciated developmental problems that may help them develop more effective treatments, experts said.
READ MORE @ NY TIMES
Friday, March 28, 2008
Thursday, March 27, 2008
Clozapine Better Than "High-Dose" Olanzapine for the Treatment of Adolescents With Schizophrenia
The results of a 12-week, double-blind, randomised study published in the March issue of Biological Psychiatry suggest that clozapine is more effective than "high-dose" olanzapine for the treatment of children and adolescents with schizophrenia who do not respond to standard, first-line antipsychotic treatment.
There is a wealth of scientific literature available on the treatment of adults with schizophrenia. However, there is a paucity of data to guide the treatment of children and adolescents with schizophrenia.
"Although the US Food and Drug Administration has recently approved the use of aripiprazole and risperidone for adolescents with schizophrenia, few controlled data are available to help guide clinicians regarding the management of children and adolescents with schizophrenia who fail to respond to these standard 'first-line' antipsychotic treatments," according to Dr. Sanjiv Kumra, University of Minnesota, Minneapolis, Minnesota, one of the authors of the study.
READ MORE @ DOCTOR'S GUIDE
There is a wealth of scientific literature available on the treatment of adults with schizophrenia. However, there is a paucity of data to guide the treatment of children and adolescents with schizophrenia.
"Although the US Food and Drug Administration has recently approved the use of aripiprazole and risperidone for adolescents with schizophrenia, few controlled data are available to help guide clinicians regarding the management of children and adolescents with schizophrenia who fail to respond to these standard 'first-line' antipsychotic treatments," according to Dr. Sanjiv Kumra, University of Minnesota, Minneapolis, Minnesota, one of the authors of the study.
READ MORE @ DOCTOR'S GUIDE
Wednesday, March 26, 2008
Drug bill would give doctors unbiased details on medication
Imagine our doctors getting an unbiased education on the medications they prescribe instead of having to rely on drug company sales reps to tell them what's on the market and how well it works.
That's already happening in other countries -- Australia, England, the Netherlands and some provinces of Canada. It's happening -- or about to -- in some parts of the United States, too, including Maine, Pennsylvania, South Carolina, Vermont and Washington, D.C.
Ohio and the rest of the nation could see the same thing if a couple of U.S. senators get their way.
Democrats Herb Kohl of Wisconsin and Dick Durbin of Illinois are writing a bill that would provide accurate and objective drug information to any doctor in America who wants it.
Government-funded pharmacists and nurses who've studied the drugs -- all of them, even generics and over-the-counter ones -- and who understand their pros and cons would prepare the information and present it to doctors interested in having it. And the information would be available to consumers, those of us who end up having to take this stuff.
READ MORE @ THE PLAIN DEALER
That's already happening in other countries -- Australia, England, the Netherlands and some provinces of Canada. It's happening -- or about to -- in some parts of the United States, too, including Maine, Pennsylvania, South Carolina, Vermont and Washington, D.C.
Ohio and the rest of the nation could see the same thing if a couple of U.S. senators get their way.
Democrats Herb Kohl of Wisconsin and Dick Durbin of Illinois are writing a bill that would provide accurate and objective drug information to any doctor in America who wants it.
Government-funded pharmacists and nurses who've studied the drugs -- all of them, even generics and over-the-counter ones -- and who understand their pros and cons would prepare the information and present it to doctors interested in having it. And the information would be available to consumers, those of us who end up having to take this stuff.
READ MORE @ THE PLAIN DEALER
Labels:
legislation,
Ohio,
physician education,
prescription drugs
Tuesday, March 25, 2008
The Increasing Use Of Antidepressants: Some Reasons For Concern
Two articles in the March issue of the European Journal Psychotherapy and Psychosomatics raise serious concern about the increasing use of antidepressant medications. In the first article, David Healy and collaborators (University of Cardiff) formulate a critique of many studies which try to support the use of antidepressants on the basis of variations in suicide rates.
The Authors compare suicide rates in the Nordic countries with autopsy and ill-defined death rates, and antidepressant sales, during the period 1961 through to 2003, finding a close correlation between suicide rates and both autopsy and ill-defined death rates.The Authors conclude that the role of autopsies and other factors in the registration of a death as a suicide appear to need further clarification.
In another article Mojtabai and collaborators analyze the increase in antidepressant medication in the US in the past decade in two US general population surveys.
READ MORE @ MEDICAL NEWS TODAY
The Authors compare suicide rates in the Nordic countries with autopsy and ill-defined death rates, and antidepressant sales, during the period 1961 through to 2003, finding a close correlation between suicide rates and both autopsy and ill-defined death rates.The Authors conclude that the role of autopsies and other factors in the registration of a death as a suicide appear to need further clarification.
In another article Mojtabai and collaborators analyze the increase in antidepressant medication in the US in the past decade in two US general population surveys.
READ MORE @ MEDICAL NEWS TODAY
Labels:
antidepressant treatment,
psychosomatics,
suicides
Monday, March 24, 2008
Know Suicide's Warning Signs - More people likely to take their lives in the spring, doctors say
While many people view spring as a time of renewal and hope, the greatest number of suicides in the United States occur each year in April and May, notes the American College of Emergency Physicians.
It's not clear why suicide rates spike in the spring, said ACEP President Dr. Linda L. Lawrence. But "we do know that suicide is the 11th leading cause of death for all ages in the United States, with one suicide occurring every 16 minutes or about 11 suicides per 100,000 people," she said in a prepared statement.
"Moreover, suicide is the second leading cause of death among 25- to 34-year-olds and the third leading cause of death among 15- to 24-year-olds. Men take their own lives nearly four times more often than women, with men ages 75 and older having the highest rate of suicide, although over a lifetime, women attempt suicide two to three times as often as men," Lawrence said.
READ MORE @ US NEWS & WORLD REPORT
It's not clear why suicide rates spike in the spring, said ACEP President Dr. Linda L. Lawrence. But "we do know that suicide is the 11th leading cause of death for all ages in the United States, with one suicide occurring every 16 minutes or about 11 suicides per 100,000 people," she said in a prepared statement.
"Moreover, suicide is the second leading cause of death among 25- to 34-year-olds and the third leading cause of death among 15- to 24-year-olds. Men take their own lives nearly four times more often than women, with men ages 75 and older having the highest rate of suicide, although over a lifetime, women attempt suicide two to three times as often as men," Lawrence said.
READ MORE @ US NEWS & WORLD REPORT
Sunday, March 23, 2008
Seriously Depressed Teens Respond to Combined Therapy
"If at first..." Many high-risk teenagers with depression show improvement on treatment combining medication with cognitive-behavioral therapy.
Over half of adolescents who don't respond to a first antidepressant improve when switched to a combination of a different antidepressant and cognitive-behavioral therapy (CBT). This is a key finding of an NIMH-funded clinical trial, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA).
Previous trials have shown that SSRI antidepressants or CBT or the combination can produce an adequate clinical response in up to 60 percent of treated adolescents, the authors noted, but, "There are no empirical studies to guide clinicians regarding the management of adolescents with depression not responsive to an initial treatment with an SSRI."
Previously, the Treatment of Adolescent Depression Study (TADS) demonstrated a similar benefit for combined therapy, but it tested a treatment-naïve group of depressed adolescents. TORDIA differed in two ways from TADS. It was aimed at youth who had not responded to a first round of treatment, and it included more chronically depressed adolescents (averaging two years) and more with suicidal ideation (59 percent)—groups often excluded from clinical trials, said lead author David Brent, M.D., in an interview with Psychiatric News.
READ MORE @ PSYCHIATRIC NEWS
Over half of adolescents who don't respond to a first antidepressant improve when switched to a combination of a different antidepressant and cognitive-behavioral therapy (CBT). This is a key finding of an NIMH-funded clinical trial, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA).
Previous trials have shown that SSRI antidepressants or CBT or the combination can produce an adequate clinical response in up to 60 percent of treated adolescents, the authors noted, but, "There are no empirical studies to guide clinicians regarding the management of adolescents with depression not responsive to an initial treatment with an SSRI."
Previously, the Treatment of Adolescent Depression Study (TADS) demonstrated a similar benefit for combined therapy, but it tested a treatment-naïve group of depressed adolescents. TORDIA differed in two ways from TADS. It was aimed at youth who had not responded to a first round of treatment, and it included more chronically depressed adolescents (averaging two years) and more with suicidal ideation (59 percent)—groups often excluded from clinical trials, said lead author David Brent, M.D., in an interview with Psychiatric News.
READ MORE @ PSYCHIATRIC NEWS
Saturday, March 22, 2008
Practicing Patients
Todd Small was stuck in quicksand again. It happened, as always, on the floor of the Seattle machine shop where he worked. His shift complete, Small was making the 150-yard walk from his workstation to his car, when he realized that his left leg was sinking deep in the stuff. Though this had happened before — it happened nearly every day now — he stopped and glanced down at his feet. His Nikes looked normal, still firmly planted on the shop’s concrete floor. But he was stuck, just the same. His brain was sending an electrical pulse saying “walk,” but as the signal streaked from his cerebellum and down his spinal cord, it snagged on scar tissue where the myelin layer insulating his nerve fibers had broken down. The message wasn’t getting to his hip flexors or his hamstrings or his left foot. That connection had been severed by his multiple sclerosis. And once again, Small was left with the feeling that, as he described it, “I’m up to my waist in quicksand.”
For the 400,000 Americans with multiple sclerosis, Todd Small’s description will most likely ring true. Muscle stiffness is a hallmark of the disease, and “foot drop” — the term for Small’s quicksand feeling — is a frequent complaint. The condition is usually treated, as it was in Small’s case, with baclofen, a muscle relaxant that works directly on the spinal cord. Every day for 14 years, he took a single 10-milligram pill. “My neurologist always told me if you take too much it will weaken your muscles. So I never wanted to go over 10 milligrams.” It didn’t seem to have much effect, but he carried on as best he could.
Small would have continued just as he was had he not logged on last June to a Web site called PatientsLikeMe. He expected the sort of online community he’d tried and abandoned several times before — one abundant in sympathy and stories but thin on practical information. But he found something altogether different: data.
READ MORE @ NY TIMES
For the 400,000 Americans with multiple sclerosis, Todd Small’s description will most likely ring true. Muscle stiffness is a hallmark of the disease, and “foot drop” — the term for Small’s quicksand feeling — is a frequent complaint. The condition is usually treated, as it was in Small’s case, with baclofen, a muscle relaxant that works directly on the spinal cord. Every day for 14 years, he took a single 10-milligram pill. “My neurologist always told me if you take too much it will weaken your muscles. So I never wanted to go over 10 milligrams.” It didn’t seem to have much effect, but he carried on as best he could.
Small would have continued just as he was had he not logged on last June to a Web site called PatientsLikeMe. He expected the sort of online community he’d tried and abandoned several times before — one abundant in sympathy and stories but thin on practical information. But he found something altogether different: data.
READ MORE @ NY TIMES
Friday, March 21, 2008
Frank Berger, 94, Miltown Creator, Dies
Dr. Frank M. Berger, who helped start the modern era of drug development with his invention of Miltown, the first mass-market psychiatric drug and a forerunner of medical and cultural phenomena like Valium and Prozac, died on Tuesday in Manhattan. He was 94.
The cause was cardiac arrest after a fall, said his wife, Alma Christine Spadi Berger.
Dr. Berger was working at a Yorkshire, England, laboratory, trying to find a preservative for penicillin, when he noticed that a chemical agent he was working with had a calming effect on laboratory animals including mice, rats and guinea pigs.
He described this “tranquilizing” action in a now classic 1946 article in The British Journal of Pharmacology.
He was intrigued, he said later, by the way that anxiety seemed to come and go in people without apparent reason: “These people are not insane; they simply are overexcitable and irritable, and create crisis situations over things that are unimportant. What is the physiological basis of this overexcitability?”
READ MORE @ NY TIMES
The cause was cardiac arrest after a fall, said his wife, Alma Christine Spadi Berger.
Dr. Berger was working at a Yorkshire, England, laboratory, trying to find a preservative for penicillin, when he noticed that a chemical agent he was working with had a calming effect on laboratory animals including mice, rats and guinea pigs.
He described this “tranquilizing” action in a now classic 1946 article in The British Journal of Pharmacology.
He was intrigued, he said later, by the way that anxiety seemed to come and go in people without apparent reason: “These people are not insane; they simply are overexcitable and irritable, and create crisis situations over things that are unimportant. What is the physiological basis of this overexcitability?”
READ MORE @ NY TIMES
Thursday, March 20, 2008
A pioneer in psychiatry
Dr. Frank J. Ayd Jr., a Baltimore psychiatrist who pioneered the field of psychopharmacology when he began treating schizophrenics with Thorazine in the early 1950s, died in his sleep Monday at Lorien Mays Chapel Health Care Center. He was 87.
At a time when the psychiatric establishment rejected the notion that mental illness was rooted in biology, Dr. Ayd championed the use of medications to adjust brain chemistry and, in so doing, relieve a patient's suffering.
"He was a biological psychiatrist, one of the important kinds of people who in spite of - and against - the establishment had the guts to stand up and really do things," said Dr. Thomas Ban, an emeritus professor of psychiatry at Vanderbilt University in Nashville, Tenn.
"Many people claim pioneering, but he really was. He entered the field when the whole thing started."
Dr. Philip G. Janicak, a Chicago psychiatrist and editor of International Drug Therapy Newsletter, said, "Dr. Ayd was one of the founding fathers of modern psychiatry. He changed the direction of psychiatry."
Dr. Janicak added: "He saw the potential value of medications to treat serious psychiatric disorders."
READ MORE @ BALTIMORE SUN
At a time when the psychiatric establishment rejected the notion that mental illness was rooted in biology, Dr. Ayd championed the use of medications to adjust brain chemistry and, in so doing, relieve a patient's suffering.
"He was a biological psychiatrist, one of the important kinds of people who in spite of - and against - the establishment had the guts to stand up and really do things," said Dr. Thomas Ban, an emeritus professor of psychiatry at Vanderbilt University in Nashville, Tenn.
"Many people claim pioneering, but he really was. He entered the field when the whole thing started."
Dr. Philip G. Janicak, a Chicago psychiatrist and editor of International Drug Therapy Newsletter, said, "Dr. Ayd was one of the founding fathers of modern psychiatry. He changed the direction of psychiatry."
Dr. Janicak added: "He saw the potential value of medications to treat serious psychiatric disorders."
READ MORE @ BALTIMORE SUN
Wednesday, March 19, 2008
Antidepressant linked to worsening white matter in elderly
The results of a study employing serial cranial MRI suggest that elderly adults who use tricyclic antidepressants may be at increased risk for progression of white matter lesions, which have been linked with late-life depression by previous studies.
Still, the progression of these lesions may be the indication for use, or certain side effects, such as hypotension, may be directly responsible.
Late-life depression has been tied to white matter lesions on MRI. The contribution of the various antidepressant agents to this finding has been unclear. Prior research has suggested that selective serotonin reuptake inhibitors (SSRI) inhibit platelet aggregation, which might be expected to slow progression of these lesions.
Dr. David C. Steffens, from Duke University Medical Center in Durham, North Carolina and associates addressed this topic by comparing the initial and five-year follow-up MRI scans in 1829 adults, 65 years or older, who were not using antidepressants at baseline.
The use of an antidepressant from any class during the study period hastened the progression of white matter disease, according to the report in the March issue of Stroke.
READ MORE @ MEDICEXCHANGE
Still, the progression of these lesions may be the indication for use, or certain side effects, such as hypotension, may be directly responsible.
Late-life depression has been tied to white matter lesions on MRI. The contribution of the various antidepressant agents to this finding has been unclear. Prior research has suggested that selective serotonin reuptake inhibitors (SSRI) inhibit platelet aggregation, which might be expected to slow progression of these lesions.
Dr. David C. Steffens, from Duke University Medical Center in Durham, North Carolina and associates addressed this topic by comparing the initial and five-year follow-up MRI scans in 1829 adults, 65 years or older, who were not using antidepressants at baseline.
The use of an antidepressant from any class during the study period hastened the progression of white matter disease, according to the report in the March issue of Stroke.
READ MORE @ MEDICEXCHANGE
Tuesday, March 18, 2008
Solving The US Drug Price Crisis, Experts Propose Solution
The mounting U.S. drug price crisis can be contained and eventually reversed by separating drug discovery from drug marketing and by establishing a non-profit company to oversee funding for new medicines, according to two MIT experts on the pharmaceutical industry.
Stan Finkelstein, M.D., senior research scientist in MIT's Engineering Systems Division, and Peter Temin, Elisha Gray II Professor of Economics, present their research and detail their proposal in their new book, "Reasonable Rx: Solving the Drug Price Crisis."
Finkelstein and Temin address immediate national problems--the rising cost of available medicines, the high cost of innovation and the 'blockbuster' method of selecting drugs for development--and predict worsening new ones, unless bold steps are taken.
"Drug prices in the United States are higher than anywhere else in the world. Right now, the revenues from those drugs finance research and development of new drugs. We propose to reduce prices, not at the expense of innovation, but by changing the way innovation is financed," said Temin, also the author of "Taking Your Medicine: Drug Regulation in the US."
READ MORE @ SCIENCE DAILY
Stan Finkelstein, M.D., senior research scientist in MIT's Engineering Systems Division, and Peter Temin, Elisha Gray II Professor of Economics, present their research and detail their proposal in their new book, "Reasonable Rx: Solving the Drug Price Crisis."
Finkelstein and Temin address immediate national problems--the rising cost of available medicines, the high cost of innovation and the 'blockbuster' method of selecting drugs for development--and predict worsening new ones, unless bold steps are taken.
"Drug prices in the United States are higher than anywhere else in the world. Right now, the revenues from those drugs finance research and development of new drugs. We propose to reduce prices, not at the expense of innovation, but by changing the way innovation is financed," said Temin, also the author of "Taking Your Medicine: Drug Regulation in the US."
READ MORE @ SCIENCE DAILY
Monday, March 17, 2008
Military Mental Health Policies Examined
Chris Scheuerman believes the military he served for 20 years failed his Army son Jason, who shot himself to death in his Iraq barracks almost three years ago.
Carefully choosing his words before a hushed congressional audience Friday, the father spoke of how the 20-year-old private's superiors largely ignored the soldier's signs of distress and his family's expressions of alarm in the days leading up to his suicide.
"I do not believe there is a safety net right now for those who fall through," Scheuerman, a veteran with service in Army medicine, told a House Armed Services subcommittee.
Scheuerman was one of several people who testified about their experiences with the military's mental health system. Military personnel, facing prolonged warfare and lengthy deployments, are under particular stress these days.
Army Chief Warrant Officer Richard Gutteridge, an Iraq war veteran treated for post-traumatic stress disorder, spoke of the military's prejudices toward service members with mental health problems. "PTSD sufferers are lepers without lesions," he said.
At the same time, Gutteridge and others cited improvements in the military's responses to the high levels of mental health problems and brain injuries among those serving in Iraq and Afghanistan.
Dr. S. Ward Casscells, assistant defense secretary for health affairs, and the surgeons general of the Army, Navy and Air Force also efforts to help address psychological issues. Steps include recruiting more mental health professionals, providing prompt care and extending outreach programs to military personnel and their families.
READ MORE @ ASSOCIATED PRESS
Carefully choosing his words before a hushed congressional audience Friday, the father spoke of how the 20-year-old private's superiors largely ignored the soldier's signs of distress and his family's expressions of alarm in the days leading up to his suicide.
"I do not believe there is a safety net right now for those who fall through," Scheuerman, a veteran with service in Army medicine, told a House Armed Services subcommittee.
Scheuerman was one of several people who testified about their experiences with the military's mental health system. Military personnel, facing prolonged warfare and lengthy deployments, are under particular stress these days.
Army Chief Warrant Officer Richard Gutteridge, an Iraq war veteran treated for post-traumatic stress disorder, spoke of the military's prejudices toward service members with mental health problems. "PTSD sufferers are lepers without lesions," he said.
At the same time, Gutteridge and others cited improvements in the military's responses to the high levels of mental health problems and brain injuries among those serving in Iraq and Afghanistan.
Dr. S. Ward Casscells, assistant defense secretary for health affairs, and the surgeons general of the Army, Navy and Air Force also efforts to help address psychological issues. Steps include recruiting more mental health professionals, providing prompt care and extending outreach programs to military personnel and their families.
READ MORE @ ASSOCIATED PRESS
Sunday, March 16, 2008
Statement from Eli Lilly and Company: Response to Today's New York Times Article, 'Lilly E-Mail Discussed Off-Label Drug Use'
See Friday, March 14, 2008 post.
Eli Lilly and Company today called the assertions in a New York Times online article 'flat out wrong.' The Times report in question focused on the State of Alaska v. Eli Lilly and Company trial that is underway and attempted to interpret a 2003 email from John C. Lechleiter, Ph.D., currently Lilly's president and chief operating officer. About this email and the Times report, the company makes the following statement:
READ MORE @ EARTHTIMES
Eli Lilly and Company today called the assertions in a New York Times online article 'flat out wrong.' The Times report in question focused on the State of Alaska v. Eli Lilly and Company trial that is underway and attempted to interpret a 2003 email from John C. Lechleiter, Ph.D., currently Lilly's president and chief operating officer. About this email and the Times report, the company makes the following statement:
READ MORE @ EARTHTIMES
Saturday, March 15, 2008
Pharmaceuticals found in US drinking water - Trace quantities could endanger wildlife, humans
An array of pharmaceuticals - including antibiotics, anticonvulsants, mood stabilizers, and sex hormones - have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation found.
The concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. And utilities insist that their water is safe.
But the presence of so many prescription drugs - and over-the-counter medicines like acetaminophen and ibuprofen - in so much of our drinking water is heightening worries among scientists of long-term consequences to human health.
In the course of a five-month inquiry, the AP discovered that drugs have been detected in the drinking water supplies of 24 major metropolitan areas - from southern California to northern New Jersey, from Detroit to Louisville, Ky.
Water providers rarely disclose results of pharmaceutical screenings, unless pressed, the Associated Press found.
READ MORE @ BOSTON GLOBE
The concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. And utilities insist that their water is safe.
But the presence of so many prescription drugs - and over-the-counter medicines like acetaminophen and ibuprofen - in so much of our drinking water is heightening worries among scientists of long-term consequences to human health.
In the course of a five-month inquiry, the AP discovered that drugs have been detected in the drinking water supplies of 24 major metropolitan areas - from southern California to northern New Jersey, from Detroit to Louisville, Ky.
Water providers rarely disclose results of pharmaceutical screenings, unless pressed, the Associated Press found.
READ MORE @ BOSTON GLOBE
Friday, March 14, 2008
Lilly E-Mail Discussed Off-Label Drug Use
John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote e-mail in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators.
Dr. Lechleiter’s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.
The e-mail message was discussed earlier this week in an Anchorage courtroom in a lawsuit against Lilly by the state of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa. The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.
Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it “off label” for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug. In his e-mail message, Dr. Lechleiter discusses the use of Zyprexa by children and teenagers.
READ MORE @ NY TIMES
Dr. Lechleiter’s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.
The e-mail message was discussed earlier this week in an Anchorage courtroom in a lawsuit against Lilly by the state of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa. The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.
Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it “off label” for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug. In his e-mail message, Dr. Lechleiter discusses the use of Zyprexa by children and teenagers.
READ MORE @ NY TIMES
Thursday, March 13, 2008
Researchers May Have Found Test For Depression
Researchers from the University of Illinois at Chicago College of Medicine have discovered that a change in the location of a protein in the brain could serve as a biomarker for depression, allowing a simple, rapid, laboratory test to identify patients with depression and to determine whether a particular antidepressant therapy will provide a successful response.
"This test could serve to predict the efficacy of antidepressant therapy quickly, within four to five days, sparing patients the agony of waiting a month or more to find out if they are on the correct therapeutic regimen," said Mark Rasenick, UIC distinguished university professor of physiology and biophysics and psychiatry.
Despite decades of research, the biological basis of depression is unknown, and the molecular and cellular targets of antidepressant treatment remain elusive, although it is likely that these drugs have one or more primary targets.
Rasenick said the discovery could help millions who suffer from undiagnosed depression or receive unsuccessful treatment.
READ MORE @ SCIENCE DAILY
"This test could serve to predict the efficacy of antidepressant therapy quickly, within four to five days, sparing patients the agony of waiting a month or more to find out if they are on the correct therapeutic regimen," said Mark Rasenick, UIC distinguished university professor of physiology and biophysics and psychiatry.
Despite decades of research, the biological basis of depression is unknown, and the molecular and cellular targets of antidepressant treatment remain elusive, although it is likely that these drugs have one or more primary targets.
Rasenick said the discovery could help millions who suffer from undiagnosed depression or receive unsuccessful treatment.
READ MORE @ SCIENCE DAILY
Wednesday, March 12, 2008
Drugs giant attacked over dangers of anti-depressant drug
Health regulators have criticised drugs firm Glaxosmithkline (GSK) for withholding information over the risk of suicide relating to one of its anti-depressant drugs.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said today it remained concerned that GSK failed to raise the alarm earlier over the side-effects of Seroxat.
Government prosecutors have ruled that there is no realistic prospect of getting a conviction over the issue.
But new legislation ensuring drugs companies pass on results of clinical trials promptly is to be introduced, public health minister Dawn Primarolo told Parliament.
Seroxat is the most frequently-prescribed anti-depressant in the UK, but there have been complaints that it triggers suicidal feelings in some patients.
READ MORE @ THE INDEPENDENT
The Medicines and Healthcare Products Regulatory Agency (MHRA) said today it remained concerned that GSK failed to raise the alarm earlier over the side-effects of Seroxat.
Government prosecutors have ruled that there is no realistic prospect of getting a conviction over the issue.
But new legislation ensuring drugs companies pass on results of clinical trials promptly is to be introduced, public health minister Dawn Primarolo told Parliament.
Seroxat is the most frequently-prescribed anti-depressant in the UK, but there have been complaints that it triggers suicidal feelings in some patients.
READ MORE @ THE INDEPENDENT
Tuesday, March 11, 2008
Depression After a Heart Attack Dangerous for Years
The increased risk of death associated with depression after a heart attack persists for at least five years, a study finds.
"We've known for a number of years that depression increases the risk of mortality as well as morbidity [illness] after a heart attack for at least three to six months," said study author Robert M. Carney, a professor of psychiatry at Washington University School of Medicine in St. Louis. "We assumed that we would find a decline in risk, but that was not what we found. The risk remained worse after five years."
Carney and his colleagues followed more than 750 people after their heart attacks, according to their report in the current online issue of theJournal of Affective Disorders. Using diagnostic interviews rather than the self-reporting common in most such studies, the researchers determined that 163 had major depression, and 195 had minor depression. Over the five-year study, the death rate was 87 percent higher for those with major depression and 76 percent higher for those with any form of depression.
READ MORE @ WASHINGTON POST
"We've known for a number of years that depression increases the risk of mortality as well as morbidity [illness] after a heart attack for at least three to six months," said study author Robert M. Carney, a professor of psychiatry at Washington University School of Medicine in St. Louis. "We assumed that we would find a decline in risk, but that was not what we found. The risk remained worse after five years."
Carney and his colleagues followed more than 750 people after their heart attacks, according to their report in the current online issue of theJournal of Affective Disorders. Using diagnostic interviews rather than the self-reporting common in most such studies, the researchers determined that 163 had major depression, and 195 had minor depression. Over the five-year study, the death rate was 87 percent higher for those with major depression and 76 percent higher for those with any form of depression.
READ MORE @ WASHINGTON POST
Monday, March 10, 2008
Troop Depression on Rise in Afghanistan
U.S. troop morale improved in Iraq last year, but soldiers fighting in Afghanistan suffered more depression as violence there worsened, according to an Army mental health report.
And in a recurring theme for a force strained by its seventh year at war, the annual battlefield study released Thursday found once again that soldiers on their third and fourth tours of duty had sharply greater rates of mental health problems than those on their first or second deployments.
The repositioning of troops closer to the Iraqi population last year, part of counterinsurgency tactics, made it harder for soldiers to get mental health treatment, the study found.
The report recommended longer home time between deployments, more focused suicide-prevention training and sending civilian psychologists and other mental health professionals to the warfront to add to the uniformed corps there. Officials said they've had some civilian volunteers.
The report was drawn from the work of a team of mental health experts who traveled to the wars last fall and surveyed more than 2,200 soldiers in Iraq and nearly 900 in Afghanistan. In the fifth such effort, the team also gathered information from more than 400 medical professionals, chaplains, psychiatrists, psychologists and other mental health workers serving with the troops — coming away with statistics on a range of issues such as marital problems, mental illness and troop ethics.
"They do show the effects of a long war," Col. Elspeth Ritchie, psychiatry consultant to Army Surgeon General Lt. Gen. Eric Schoomaker, said of the data.
READ MORE @ ASSOCIATED PRESS
And in a recurring theme for a force strained by its seventh year at war, the annual battlefield study released Thursday found once again that soldiers on their third and fourth tours of duty had sharply greater rates of mental health problems than those on their first or second deployments.
The repositioning of troops closer to the Iraqi population last year, part of counterinsurgency tactics, made it harder for soldiers to get mental health treatment, the study found.
The report recommended longer home time between deployments, more focused suicide-prevention training and sending civilian psychologists and other mental health professionals to the warfront to add to the uniformed corps there. Officials said they've had some civilian volunteers.
The report was drawn from the work of a team of mental health experts who traveled to the wars last fall and surveyed more than 2,200 soldiers in Iraq and nearly 900 in Afghanistan. In the fifth such effort, the team also gathered information from more than 400 medical professionals, chaplains, psychiatrists, psychologists and other mental health workers serving with the troops — coming away with statistics on a range of issues such as marital problems, mental illness and troop ethics.
"They do show the effects of a long war," Col. Elspeth Ritchie, psychiatry consultant to Army Surgeon General Lt. Gen. Eric Schoomaker, said of the data.
READ MORE @ ASSOCIATED PRESS
Sunday, March 9, 2008
FDA Warning of Suicidal Risk Associated with Antidepressants in Juveniles and Young Adults Reviewed at Recent ISCTM Meeting
The International Society for CNS Clinical Trials and Methodology (ISCTM) held its 2008 annual meeting in Washington, DC, February 25-27. This organization involves collaborative efforts among academic and research clinicians, representatives of the pharmaceutical industry, and governmental drug-regulatory bodies to improve methods for testing efficacy and safety of drugs used to treat psychiatric and neurological disorders. A half-day symposium explored FDA-required "black-box" drug safety warnings of evidence of increased risk of suicidal thoughts and actions during treatment with antidepressants in juvenile and young-adult patients as a case study. The symposium was chaired by FDA-advisor Andrew Leon, Ph.D. (Cornell Medical Center), and Ross J. Baldessarini, M.D. (Harvard Medical School). Other speakers were Neil Chayet, J.D. (Harvard Medical School), Thomas Laughren, M.D. (US FDA), James McNulty (Past-President, National Alliance on Mental Illness [NAMI]), and Sharon-Lise Normand, Ph.D. (Harvard School of Public Health).
Dr. Baldessarini noted: "Studies aimed at reducing risk of suicide remain far less well developed than many other treatments for psychiatric patients, despite the importance of the problem. Evidence of whether antidepressants increase or reduce risk of suicidal behaviors remains surprisingly inconsistent and inconclusive."
Symposium speakers reviewed evidence supporting the expanded safety warning for all drug products that are FDA-approved for the treatment of major depression, that involve 180-million prescriptions a year in the US. The FDA also is conducting a systematic review of suicidal risks associated with anti-epilepsy drugs and considering use of more systematic assessments of suicidal thinking and behaviors to replace current incidental patient and clinician reporting of adverse events during trials.
READ MORE @ EARTH TIMES
Dr. Baldessarini noted: "Studies aimed at reducing risk of suicide remain far less well developed than many other treatments for psychiatric patients, despite the importance of the problem. Evidence of whether antidepressants increase or reduce risk of suicidal behaviors remains surprisingly inconsistent and inconclusive."
Symposium speakers reviewed evidence supporting the expanded safety warning for all drug products that are FDA-approved for the treatment of major depression, that involve 180-million prescriptions a year in the US. The FDA also is conducting a systematic review of suicidal risks associated with anti-epilepsy drugs and considering use of more systematic assessments of suicidal thinking and behaviors to replace current incidental patient and clinician reporting of adverse events during trials.
READ MORE @ EARTH TIMES
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