A U.S. study suggested cognitive gains in schizophrenic patients treated with newer antipsychotic medications are due to practice effects, not the drugs.
Second-generation antipsychotic medicines were designed to improve the speed, clarity, and rationality of thought among people with schizophrenia and other psychotic illnesses.
But psychiatric researchers at the Zucker Hillside Hospital and the Feinstein Institute for Medical Research studied the cognitive performance of 104 people newly diagnosed with schizophrenia who were taking second-generation medicines.
READ MORE @ NEWS DAILY
Friday, October 19, 2007
Wednesday, October 17, 2007
Valdoxan(R), the First Melatonergic Antidepressant, Confirms its Efficacy in Preventing Relapse Whatever the Severity of the Depression
Valdoxan(R) (agomelatine), the first melatonergic antidepressant, is an effective, long-term treatment for Major Depressive Disorder (MDD) according to new data presented today at the European College of Neurospsychopharmacology(ECNP) annual congress. The new international study showed Valdoxan's efficacy in preventing relapse in out-patients with MDD over six-months, irrespective of the severity of depression(1).
"The short term efficacy of this novel antidepressant has already been demonstrated in several clinical studies", points out study investigator Professor Guy Goodwin from the Department of Psychiatry,University of Oxford, UK. "This new study demonstrated the long-term efficacy of Valdoxan in the prevention of depressive relapses, after an initial response to the drug, over a treatment period of six months. The results show that Valdoxan is a promising therapeutic agent for the short-and-long-term management of MDD, which offers remission to our depressed patients with very few adverse effects".
READ MORE @ JURA FORUM
"The short term efficacy of this novel antidepressant has already been demonstrated in several clinical studies", points out study investigator Professor Guy Goodwin from the Department of Psychiatry,University of Oxford, UK. "This new study demonstrated the long-term efficacy of Valdoxan in the prevention of depressive relapses, after an initial response to the drug, over a treatment period of six months. The results show that Valdoxan is a promising therapeutic agent for the short-and-long-term management of MDD, which offers remission to our depressed patients with very few adverse effects".
READ MORE @ JURA FORUM
Tuesday, October 16, 2007
Mental Disorders Are Disorders Of The Brain
Depression, anxiety disorders such as panic disorder and obsessive-compulsive disorders, alcohol and drug dependence, dementia and Parkinson's disease are just a few examples of "disorders of the brain."
The size, the burden and cost of brain disorders in the EU is immense, and has so far been underestimated," as Prof. Dr. Hans Ulrich Wittchen emphasized at the Official Press Conference to the 20th ECNP Congress for Neuropsychopharmacology in Vienna (October 13-17, 2007).
Increasing Lifetime Risk -- Unmet Needs
Mental disorders such as anxiety and depressive disorders are disorders of the brain and involve complex patterns of disturbances of cognition (such as perception, attention, memory), affect and emotion (such as depressed mood, panic), somatic functioning (e.g. appetite, heart rate variability) and behaviour. These patterns and disturbances are all associated with disturbances in the transmitter systems of the brain and the central nervous system. What is special about most mental disorders is that they predominantly manifest early in life, before the age of 20. They are also associated across the life span with a high risk of developing complications and other -- so called comorbid -- disorders.
READ MORE @ SCIENCE DAILY
The size, the burden and cost of brain disorders in the EU is immense, and has so far been underestimated," as Prof. Dr. Hans Ulrich Wittchen emphasized at the Official Press Conference to the 20th ECNP Congress for Neuropsychopharmacology in Vienna (October 13-17, 2007).
Increasing Lifetime Risk -- Unmet Needs
Mental disorders such as anxiety and depressive disorders are disorders of the brain and involve complex patterns of disturbances of cognition (such as perception, attention, memory), affect and emotion (such as depressed mood, panic), somatic functioning (e.g. appetite, heart rate variability) and behaviour. These patterns and disturbances are all associated with disturbances in the transmitter systems of the brain and the central nervous system. What is special about most mental disorders is that they predominantly manifest early in life, before the age of 20. They are also associated across the life span with a high risk of developing complications and other -- so called comorbid -- disorders.
READ MORE @ SCIENCE DAILY
Monday, October 15, 2007
Depressed at work? Get a new career
Child care workers, home health care aides and other people who provide personal services have the highest rates of depression among U.S. workers, according to a new survey to be published on Monday.
It found that 10.8 percent of personal care and service workers and 10.3 percent of food preparation and serving workers -- both usually low-paying jobs -- experienced one or more major depressive episodes in the past year.
The least depressing careers appear to lie in architecture, engineering, the sciences and in the installation, maintenance and repair fields, the survey from the Substance Abuse and Mental Health Services Administration found.
READ MORE @ REUTERS
It found that 10.8 percent of personal care and service workers and 10.3 percent of food preparation and serving workers -- both usually low-paying jobs -- experienced one or more major depressive episodes in the past year.
The least depressing careers appear to lie in architecture, engineering, the sciences and in the installation, maintenance and repair fields, the survey from the Substance Abuse and Mental Health Services Administration found.
READ MORE @ REUTERS
Sunday, October 14, 2007
A dark age for mental health - A therapy last used on a mass scale in China's cultural revolution is to be unleashed on the NHS
It looks like good news. In an era where psychological problems are increasingly explained in terms of biological deficits, the government has announced that it will spend £170m by 2010 on talking therapies for depression and anxiety. The scheme should pay for itself as better mental health will mean fewer sick days and benefits - £170m isn't much compared with an annual £12bn cost to the economy. But will it really help?
The answer, sadly, is negative. Talking therapy means not psychotherapy, but cognitive behavioural therapies (CBTs). These aim at the removal of symptoms and the return to work of sufferers, who will have learned to identify and manage patterns of undesirable behaviour. However, clinicians know that patients are likely to be back on a waiting list within a year to 18 months. Their underlying problems will not have been resolved, resulting in new symptoms or the return of old ones.
READ MORE @ THE GUARDIAN
The answer, sadly, is negative. Talking therapy means not psychotherapy, but cognitive behavioural therapies (CBTs). These aim at the removal of symptoms and the return to work of sufferers, who will have learned to identify and manage patterns of undesirable behaviour. However, clinicians know that patients are likely to be back on a waiting list within a year to 18 months. Their underlying problems will not have been resolved, resulting in new symptoms or the return of old ones.
READ MORE @ THE GUARDIAN
Saturday, October 13, 2007
Report questions generic antidepressant - ConsumerLab.com finds cheaper drug may not work the same as brand
For seven years Linda Douglas has been treating her depression with the antidepressant Wellbutrin, first with a twice-a-day version and then later with a more convenient once-a-day pill called Wellbutrin XL. The drug, she says, "renewed my joy for living."
All that changed earlier this year when she switched to a generic version of Wellbutrin XL 300 milligrams to save money. Instead of paying $250 for a three-month supply of the brand drug, she was paying just $53. The cost savings were welcome, but Douglas, 48, a telecommunications project manager in Columbia, Md., says the depression returned during the six months she took the generic antidepressant.
READ MORE @ MSNBC
All that changed earlier this year when she switched to a generic version of Wellbutrin XL 300 milligrams to save money. Instead of paying $250 for a three-month supply of the brand drug, she was paying just $53. The cost savings were welcome, but Douglas, 48, a telecommunications project manager in Columbia, Md., says the depression returned during the six months she took the generic antidepressant.
READ MORE @ MSNBC
Friday, October 12, 2007
Antidepressants Emerge as Coolant for Hot Flashes
Doctors are writing a new prescription for menopause: the antidepressant.
It’s not that all menopausal women are depressed. Instead, the antidepressant has emerged as the drug of choice among women searching for new ways to cool the hot flash.
There is no way to track how often antidepressants are prescribed to treat hot flashes, the unpredictable, sticky wave of heat that for many women is the defining symptom of menopause. None are specifically approved for hot flashes, and doctors who prescribe them are doing so “off label.”
READ MORE @ NY TIMES
It’s not that all menopausal women are depressed. Instead, the antidepressant has emerged as the drug of choice among women searching for new ways to cool the hot flash.
There is no way to track how often antidepressants are prescribed to treat hot flashes, the unpredictable, sticky wave of heat that for many women is the defining symptom of menopause. None are specifically approved for hot flashes, and doctors who prescribe them are doing so “off label.”
READ MORE @ NY TIMES
Thursday, October 11, 2007
The Politics Behind Despair and Depression
On September 14, 2007, New York Times reporters Alex Berenson and Benedict Carey foiled, at least temporarily, Big Pharma and its psychiatry allies' attempt to eliminate the U.S. Food and Drug Administration warning label about increased suicidal thoughts and behaviors in minors using antidepressants.
Berenson and Carey refuted a September 2007 American Journal of Psychiatry article that had claimed an increase in the youth suicide rate in 2004 was related to declining antidepressant prescriptions for that group (caused by the FDA warning). Berenson and Carey reported that, in fact, in 2004 the "number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially." The New York Times did not, however, report that the lead author of the American Journal of Psychiatry article had served as an expert witness for Wyeth Pharmaceuticals, makers of the antidepressant Effexor.
While the recent smoke and mirrors of Big Pharma and the American Journal of Psychiatry was detected by The New York Times, the media, once again, is losing sight of a more important revelation: scientists currently agree that "the neurotransmitter-deficiency theory of depression"--the rationale for antidepressants--has no validity.
READ MORE @ HUFFINGTON POST
Berenson and Carey refuted a September 2007 American Journal of Psychiatry article that had claimed an increase in the youth suicide rate in 2004 was related to declining antidepressant prescriptions for that group (caused by the FDA warning). Berenson and Carey reported that, in fact, in 2004 the "number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially." The New York Times did not, however, report that the lead author of the American Journal of Psychiatry article had served as an expert witness for Wyeth Pharmaceuticals, makers of the antidepressant Effexor.
While the recent smoke and mirrors of Big Pharma and the American Journal of Psychiatry was detected by The New York Times, the media, once again, is losing sight of a more important revelation: scientists currently agree that "the neurotransmitter-deficiency theory of depression"--the rationale for antidepressants--has no validity.
READ MORE @ HUFFINGTON POST
Wednesday, October 10, 2007
Reported suicides – more than 80 percent got psychiatric drugs, well over 50 percent got antidepressants
Health care providers in Sweden are per a new law required to report all suicides committed in health care and up to four weeks after last health care visit. The reports are sent to the National Board of Health and Welfare for investigation.
367 suicides were reported per this law for 2006.
Data gotten via FOIA requests show: More than 80 percent of persons committing suicide were “treated” with psychiatric drugs; in well over 50 percent of the cases the persons got antidepressants, in more than 60 neuroleptics or antidepressants.
This information has been concealed by senior (psychiatric) officials at the National Board of Health and Welfare. It was contrary to the best interests of Big Pharma and biological psychiatrists. It blew the myths of antidepressants and neuroleptics as suicide protecting drugs to pieces. It would also have hurt the career of many medical journalists to take up this subject; journalists who for years have made their living by writing marketing articles about new antidepressant drugs. So nothing has been written about this in major media in Sweden.
READ MORE @ TRANSWORLDNEWS
367 suicides were reported per this law for 2006.
Data gotten via FOIA requests show: More than 80 percent of persons committing suicide were “treated” with psychiatric drugs; in well over 50 percent of the cases the persons got antidepressants, in more than 60 neuroleptics or antidepressants.
This information has been concealed by senior (psychiatric) officials at the National Board of Health and Welfare. It was contrary to the best interests of Big Pharma and biological psychiatrists. It blew the myths of antidepressants and neuroleptics as suicide protecting drugs to pieces. It would also have hurt the career of many medical journalists to take up this subject; journalists who for years have made their living by writing marketing articles about new antidepressant drugs. So nothing has been written about this in major media in Sweden.
READ MORE @ TRANSWORLDNEWS
Tuesday, October 9, 2007
Anti-depressants And Painkillers Combined Linked To Gastrointestinal Bleeding
New research shows that selective serotonin reuptake inhibitors (SSRIs), a group of drugs commonly used to treat depression, may double the risk of gastrointestinal bleeding, according to researchers from Wake Forest University School of Medicine and colleagues. When the drugs are taken with aspirin and other similar pain medications, the risk is more than 600 percent higher.
Painkillers such as ibuprofen are widely used by the public and can be purchased from supermarkets and pharmacies without prescription.
"Clinicians who prescribe these medications should be aware of the potential risk and may need to consider alternatives," said Sonal Singh, M.D., senior researcher and an assistant professor of internal medicine. "In addition, regulatory authorities should consider revising existing package inserts to highlight the magnitude of the risk."
READ MORE @ SCIENCE DAILY
Painkillers such as ibuprofen are widely used by the public and can be purchased from supermarkets and pharmacies without prescription.
"Clinicians who prescribe these medications should be aware of the potential risk and may need to consider alternatives," said Sonal Singh, M.D., senior researcher and an assistant professor of internal medicine. "In addition, regulatory authorities should consider revising existing package inserts to highlight the magnitude of the risk."
READ MORE @ SCIENCE DAILY
Monday, October 8, 2007
New Medication For The Treatment Of Schizophrenia Significantly Reduces Symptoms And Improves Patients’ Daily Lives(1,2)
INVEGA™ controls symptoms around the clock and may reduce the risk of some drug interactions, which can be a problem in the treatment of schizophrenia
Toronto, ON .- Health Canada has approved INVEGA™ (paliperidone) for the treatment of schizophrenia.1 INVEGA™ is the only once-daily oral treatment for schizophrenia that uses a unique OROS® technology designed to deliver and sustain a controlled level of medication throughout the day.1 Moreover, INVEGA™ is not extensively metabolized in the liver, which may mean fewer drug interactions for patients.1,3
People with schizophrenia are often on more than one medication (called polypharmacy) for conditions including anxiety disorders, depression, cardiovascular disease, diabetes, HIV and hepatitis C.3 In fact, studies have shown that 43 per cent of patients on an atypical antipsychotic are on five or more other medications.4 Taking several drugs along with antipsychotic medication can alter the potency of the medication and may lead to serious and potentially life-threatening adverse events.3 Thus, reducing the risk of drug interactions in the treatment of schizophrenia is an important consideration.
READ MORE @ WEBWIRE
Toronto, ON .- Health Canada has approved INVEGA™ (paliperidone) for the treatment of schizophrenia.1 INVEGA™ is the only once-daily oral treatment for schizophrenia that uses a unique OROS® technology designed to deliver and sustain a controlled level of medication throughout the day.1 Moreover, INVEGA™ is not extensively metabolized in the liver, which may mean fewer drug interactions for patients.1,3
People with schizophrenia are often on more than one medication (called polypharmacy) for conditions including anxiety disorders, depression, cardiovascular disease, diabetes, HIV and hepatitis C.3 In fact, studies have shown that 43 per cent of patients on an atypical antipsychotic are on five or more other medications.4 Taking several drugs along with antipsychotic medication can alter the potency of the medication and may lead to serious and potentially life-threatening adverse events.3 Thus, reducing the risk of drug interactions in the treatment of schizophrenia is an important consideration.
READ MORE @ WEBWIRE
Sunday, October 7, 2007
Cognitive Behavioral Therapy Reduces Risks of Teen Antidepressant Use
The combination of fluoxetine (Prozac) and cognitive behavior therapy for depressed teens may accelerate treatment response and protect against suicidality.
In a randomized trial, combination therapy was not superior to fluoxetine or cognitive behavior therapy after 36 weeks, reported John S. March, M.D., M.P.H., of Duke here, and colleagues, in the October issue of Archives of General Psychiatry.
But a previously published analysis of the same patients, which showed an early advantage in response rate at 12 weeks with combination therapy (73% versus 62% and 48%), suggests that it may be a superior strategy, they said.
"Because accelerating symptom reduction by using medication is an important clinical outcome in psychiatry, as it is in other areas of medicine, use of fluoxetine should be made widely available, not discouraged," they wrote.
READ MORE @ MEDPAGE TODAY
In a randomized trial, combination therapy was not superior to fluoxetine or cognitive behavior therapy after 36 weeks, reported John S. March, M.D., M.P.H., of Duke here, and colleagues, in the October issue of Archives of General Psychiatry.
But a previously published analysis of the same patients, which showed an early advantage in response rate at 12 weeks with combination therapy (73% versus 62% and 48%), suggests that it may be a superior strategy, they said.
"Because accelerating symptom reduction by using medication is an important clinical outcome in psychiatry, as it is in other areas of medicine, use of fluoxetine should be made widely available, not discouraged," they wrote.
READ MORE @ MEDPAGE TODAY
Saturday, October 6, 2007
Antidepressant response may predict cardiac event
Among patients who have had a heart attack and subsequently develop depression, a lack of response to antidepressant treatment signals a high risk of another cardiac episode, according to a secondary analysis of data from Myocardial Infarction and Depression-Intervention Trial (MIND-IT).
MIND-IT involved 2,177 patients who were hospitalized with an acute heart attack. During follow-up, 375 patients developed post-heart attack depression. Two hundred nine of these patients were randomly assigned to receive mirtazapine, sold under the trade name Remeron, or to "care as usual."
If there was an inadequate response to mirtazapine after 8 weeks, the patients were switched to citalopram, sold under the trade name Celexa, according to the report in the American Journal of Psychiatry
READ MORE @ REUTERS
MIND-IT involved 2,177 patients who were hospitalized with an acute heart attack. During follow-up, 375 patients developed post-heart attack depression. Two hundred nine of these patients were randomly assigned to receive mirtazapine, sold under the trade name Remeron, or to "care as usual."
If there was an inadequate response to mirtazapine after 8 weeks, the patients were switched to citalopram, sold under the trade name Celexa, according to the report in the American Journal of Psychiatry
READ MORE @ REUTERS
Friday, October 5, 2007
Lilly Adds Label Warnings for Mental Illness Drug
Eli Lilly today added strong warnings to the label of Zyprexa, its best-selling medicine for schizophrenia, citing the drug’s tendency to cause weight gain, high blood sugar, high cholesterol and other metabolic problems.
For the first time, Zyprexa’s label now acknowledges that the drug causes high blood sugar more than some other medicines for schizophrenia and bipolar disorder, called atypical antipsychotics.
Lilly previously argued that Zyprexa had not been proven to cause high blood sugar at a more frequent rate than its competitors.
Concern about Zyprexa’s side effects has been increasing since at least 2004, and Zyprexa’s prescriptions and market share have fallen sharply over the same period. As a result, the new warnings may have only a moderate impact among doctors and patients, said S. Nassir Ghaemi, director of the Bipolar Disorder Research Program at Emory University.
READ MORE @ NY TIMES
For the first time, Zyprexa’s label now acknowledges that the drug causes high blood sugar more than some other medicines for schizophrenia and bipolar disorder, called atypical antipsychotics.
Lilly previously argued that Zyprexa had not been proven to cause high blood sugar at a more frequent rate than its competitors.
Concern about Zyprexa’s side effects has been increasing since at least 2004, and Zyprexa’s prescriptions and market share have fallen sharply over the same period. As a result, the new warnings may have only a moderate impact among doctors and patients, said S. Nassir Ghaemi, director of the Bipolar Disorder Research Program at Emory University.
READ MORE @ NY TIMES
Wednesday, October 3, 2007
Anti-Anxiety Medications For Treating Anxiety Disorders
Everyone suffers a bit of anxiety on occasion. But does that mean you need anti-anxiety medication? Not necessarily.
Your palms begin to sweat and your stomach begins to flutter but you're fine. You're experiencing simple cases of nervousness and your body is responding in ways that are manageable. But, anxiety can explode into a serious problem.
Anxiety disorders, in addition to generalized anxiety, include phobias, panic disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. For millions of sufferers anxiety disorders are disruptive, debilitating and often the reason for loss of job and serious problems in family relationships. So what can be done to control anxiety disorders?
READ MORE @ AMERICAN CHRONICLE
Your palms begin to sweat and your stomach begins to flutter but you're fine. You're experiencing simple cases of nervousness and your body is responding in ways that are manageable. But, anxiety can explode into a serious problem.
Anxiety disorders, in addition to generalized anxiety, include phobias, panic disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. For millions of sufferers anxiety disorders are disruptive, debilitating and often the reason for loss of job and serious problems in family relationships. So what can be done to control anxiety disorders?
READ MORE @ AMERICAN CHRONICLE
Tuesday, October 2, 2007
Drug firm, subsidiary settle suits for $515m - Pricing schemes, fraud alleged
Bristol-Myers Squibb and a subsidiary have agreed to pay more than $515 million to settle civil suits over fraudulent drug marketing and pricing schemes, including illegally promoting an anti-psychotic drug to children and the elderly, US Attorney Michael J. Sullivan said yesterday.
The settlement between the federal government and Bristol-Myers Squibb and Apothecon Inc. is the third-largest between a pharmaceutical company and the US Attorney's Office in Massachusetts, which has obtained more than $4 billion in healthcare fraud settlements since 2000 and acquired a national reputation for pursuing such cases.
As with many of the earlier settlements, the agreement came after several employees of the pharmaceutical giant turned whistleblowers and filed federal suits in Massachusetts, enticed in part by the track record of federal prosecutors here.
The agreement says Bristol-Myers Squibb gave kickbacks to physicians and healthcare providers from 2000 through mid-2003 to get them to prescribe the company's drugs. The kickbacks came in several forms, including consulting fees and trips to luxury resorts.
READ MORE @ BOSTON GLOBE
The settlement between the federal government and Bristol-Myers Squibb and Apothecon Inc. is the third-largest between a pharmaceutical company and the US Attorney's Office in Massachusetts, which has obtained more than $4 billion in healthcare fraud settlements since 2000 and acquired a national reputation for pursuing such cases.
As with many of the earlier settlements, the agreement came after several employees of the pharmaceutical giant turned whistleblowers and filed federal suits in Massachusetts, enticed in part by the track record of federal prosecutors here.
The agreement says Bristol-Myers Squibb gave kickbacks to physicians and healthcare providers from 2000 through mid-2003 to get them to prescribe the company's drugs. The kickbacks came in several forms, including consulting fees and trips to luxury resorts.
READ MORE @ BOSTON GLOBE
Monday, October 1, 2007
Drug Makers Seek Clues to Side Effects in Genes
Seven of the largest pharmaceutical companies have formed a group to develop genetic tests to determine which patients would be at risk from dangerous drug side effects.
The new group, the International Serious Adverse Events Consortium, is one of a wave of cooperative research efforts sweeping the drug industry, as companies come under pressure to cut costs and increase their success rates in developing medications. The Food and Drug Administration has encouraged the formation of such groups.
If drugs could be withheld from patients who have a genetic risk for serious side effects, it could not only protect the patients but might help manufacturers get their drugs approved or avoid having to remove them from the market.
READ MORE @ NY TIMES
The new group, the International Serious Adverse Events Consortium, is one of a wave of cooperative research efforts sweeping the drug industry, as companies come under pressure to cut costs and increase their success rates in developing medications. The Food and Drug Administration has encouraged the formation of such groups.
If drugs could be withheld from patients who have a genetic risk for serious side effects, it could not only protect the patients but might help manufacturers get their drugs approved or avoid having to remove them from the market.
READ MORE @ NY TIMES
Sunday, September 30, 2007
Zyprexa may get OK for teen use - Senior regulator overrules peers on drug's benefits for adolescents
Eli Lilly and Co.'s best-selling schizophrenia drug Zyprexa is poised to get U.S. approval for treating adolescents diagnosed with mental illness after a senior government regulator overruled his colleagues.
A three-member Food and Drug Administration team initially urged rejecting the drug for pediatric use because of inconsistent data from studies in U.S. and Russian teens. In an April 29 memo posted on the FDA's Web site, Thomas Laughren, head of the agency's psychiatry division, said the drug's benefits in some studies outweighed the reviewers' concerns.
Zyprexa, with $4.4 billion in global sales in 2006, is Lilly's biggest revenue producer and the best-seller among five drugs known as atypical antipsychotics.
The drug's market leadership has slipped because of surging pediatric prescriptions for competing products and side effects linked to Zyprexa. Johnson & Johnson's Risperdal last month became the only drug in the class cleared for pediatric use though doctors long have prescribed the pills to children, according to market research.
READ MORE @ Indianapolis Star
A three-member Food and Drug Administration team initially urged rejecting the drug for pediatric use because of inconsistent data from studies in U.S. and Russian teens. In an April 29 memo posted on the FDA's Web site, Thomas Laughren, head of the agency's psychiatry division, said the drug's benefits in some studies outweighed the reviewers' concerns.
Zyprexa, with $4.4 billion in global sales in 2006, is Lilly's biggest revenue producer and the best-seller among five drugs known as atypical antipsychotics.
The drug's market leadership has slipped because of surging pediatric prescriptions for competing products and side effects linked to Zyprexa. Johnson & Johnson's Risperdal last month became the only drug in the class cleared for pediatric use though doctors long have prescribed the pills to children, according to market research.
READ MORE @ Indianapolis Star
Saturday, September 29, 2007
Genes Tied to Bad Reactions to Antidepressant Drug
Variations in two genes may increase the likelihood that a person will report suicidal thoughts after taking an antidepressant, researchers reported yesterday. The finding could help doctors develop tests to predict which patients will do well on such medications and which will react badly.
The authors of the study, which was released to reporters yesterday and will appear in The American Journal of Psychiatry on Monday, said that the findings were preliminary and would need to be verified by further testing.
The study focused on reactions to only one drug, Celexa from Forest Laboratories, and found no link between the gene variations and dangerous behavior like suicide attempts.
READ MORE @ NY TIMES
The authors of the study, which was released to reporters yesterday and will appear in The American Journal of Psychiatry on Monday, said that the findings were preliminary and would need to be verified by further testing.
The study focused on reactions to only one drug, Celexa from Forest Laboratories, and found no link between the gene variations and dangerous behavior like suicide attempts.
READ MORE @ NY TIMES
Friday, September 28, 2007
Report Assails F.D.A. Oversight of Clinical Trials
The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.
The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.
READ MORE @ NY TIMES
In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.
The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.
READ MORE @ NY TIMES
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