Judge OKs Zyprexa Class Action, Unseals Documents

A federal judge has granted class action status to a Zyprexa lawsuit that claimed Eli Lilly hid the drug’s serious side effects. The decision by Judge Jack B. Weinstein of Federal District Court in Brooklyn also unseals confidential documents relating to the antipsychotic medication. Eli Lily

The Zyprexa lawsuit in question was brought by insurance companies, pension funds and unions that want repaid for the money the they spent on the drug. The plaintiffs contend that Eli Lilly knew that Zyprexa had caused excessive weight gain and diabetes, and that the company marketed it for unapproved uses. In July, Judge Weinstein urged Lilly to settle, but the case will now proceed to a jury trial.

The judge also unsealed hundreds of pages of confidential documents that were produced by Eli Lilly in relation to a lawsuit filed by patients. They were placed under a protective court order soon after that suit was filed in 2004.

READ MORE @ NEWS INFERNO

Cognitive and Global Outcome in Schizophrenia Patients Related to Course of Disease, Not Antipsychotic Type: Presented at ECNP

In patients with chronic schizophrenia, the type of antipsychotic treatment (typical or atypical) is not as important for long-term cognitive and social functioning, according to the results of a study presented here at the 21st European College of Neuropsychopharmacology Congress (ECNP).

Research in the field of neuropsychopharmacology has been indicating a beneficial influence of atypical antipsychotic treatment on cognitive function of patients with schizophrenia, but there have been contradictory findings as well.

"In our study, we compared the patients' functioning with their present medication," explained Agnieszka Kalwa, PhD student, Independent Pharmacotherapy Unit, Institute of Psychiatry and Neurology, Warsaw, Poland, at a poster presentation on September 2.

The study assessed the relationship between the type of current antipsychotic therapy and the cognitive, clinical, and global social outcome in 30 patients with a duration of disease ranging from 29 to 36 years.

READ MORE @ DOCTOR'S GUIDE

Youth Suicides Continue to Rise in U.S. - One reason may be reluctance to prescribe antidepressants, study suggests

Suicides among U.S. children appear to be on the rise after a 15-year decline, and the trend may owe, in part, to fewer teens being prescribed antidepressants, a new study suggests.

Researchers thought a spike in youth suicides in 2004 may have been an anomaly. But the new study found the increase in suicides continued during 2005.

Looking at suicide trends among youngsters over a 15-year period, Jeff Bridge, from Nationwide Children's Hospital in Columbus, Ohio, found the rates of suicide among youths aged 10 to 19 were higher in 2004 and 2005 than would have been expected, based on suicide rate trends from 1996 to 2003.

"This is significant, because pediatric suicide rates in the U.S. had been declining steadily for a decade until 2004, when the suicide rate among U.S. youth younger than 20 years of age increased by 18 percent, the largest single-year increase in the past 15 years," said Bridge, an investigator in the Center for Innovation in Pediatric Practice.

READ MORE @ U.S. NEWS & WORLD REPORT

Risks and benefits of antipsychotics in children and adolescents

Many of the psychiatric disorders observed in adults have their onset in childhood or adolescence. In fact some studies show that at least 20% of children and adolescents will fulfil a diagnostic criterion for a mental disorder before reaching adulthood. The presence of a major mental illness is certainly no less serious in children than in adults – in fact, childhood onset of several psychiatric disorders predicts a worse illness course. Early manifestations of mental disorders may substantially impact the child´s academic performance and achievement as well as his/her ability to develop age-appropriate social skills. Thus, appropriate identification and treatment of signs and symptoms of psychiatric illnesses during childhood and adolescence is critical for minimizing continued or additional psychiatric problems that put these children at risk later in life.

For many years old antipsychotics have been used for the treatment of conditions such as severe conduct disorders, Tourette syndrome, bipolar disorder and schizophrenia in children and adolescents. Treatment advances, particularly with the introduction of new-generation antipsychotic medications, have created a lot of expectations in the search for long-term, clinically effective treatments for this young population. The prescription of new-generation antipsychotics has become a widely accepted practice in the treatment of children and adolescents with psychotic disorders (Armenteros & David, 2006) and many other psychiatric conditions (Findling et al., 2005; Olfson et al., 2006). In fact, prescribing of new-generation antipsychotics has increased dramatically in recent years in the paediatric population (160% in the USA between 1990 and 2000) (Patel et al., 2005).

READ MORE @ EUREKALERT

Brain's Serotonin May Explain Seasonal Mood Changes

Fluctuations in the actions of the serotonin transporter, which helps regulate the mood-altering neurotransmitter serotonin, may help explain seasonal affective disorder and related mood changes, researchers say.

In places where the weather changes with the seasons, people commonly feel happier and more energetic when the days are bright and sunny and more depressed and fatigued during the dark of winter. Scientists believe this is related to variations in brain levels of serotonin, a neurotransmitter involved in regulating functions such as mating, feeding, energy balance, and sleep.

READ MORE @ WASHINGTON POST

Variations In Antidepressant Prescribing Suggest Disparities In Provision Of Care

GPs prescribe lower volumes of antidepressants in areas with more Black or South Asian people, suggesting possible disparities in the provision of care.

The study, published in the September issue of the British Journal of Psychiatry, also reveals that higher volumes of antidepressants are prescribed by general practices in economically deprived areas, and by practices serving areas with a high prevalence of chronic illness.

Researchers from King's College London set out to explore the relationship between physical illness, social deprivation, ethnicity, practice characteristics and the volume of antidepressants prescribed in primary care.

READ MORE @ MEDICAL NEWS TODAY

Long-Term Antidepressant Treatment Without Active Management Hardly Induces Remission: Presented at ECNP

A Scottish study identified a group of patients in primary care who are on long-term and stable treatment with selective serotonin reuptake inhibitors (SSRIs). A substantial proportion of patients displayed prevailing residual depressive and anxiety symptoms as well as sleep problems in spite of their treatment.

Alan Wade, MD, CPS Clinical Research Centre, Glasgow, Scotland, presented the study at a poster session on September 1 here at the 21st European College of Neuropsychopharmacology (ECNP) Congress.

Patients who were prescribed standard doses of antidepressants by their general practitioners without active management due to repeat prescriptions were identified from prescribing records in the West of Scotland.

READ MORE @ DOCTOR'S GUIDE

Antidepressants in suicide prevention

Antidepressants are the cornerstone of treatment of depressive disorders in health care. Their efficacy in treating depression is undisputable, although it leaves room for improvement. However, recent reports also suggest that antidepressants might, in some rare cases, actually worsen suicidal tendencies instead of alleviating them. As a consequence, research has intensified to clarify this issue, and regulatory authorities in many countries have reconsidered their cost-benefit ratio. While there is no doubt that such potential side-effects of antidepressant therapy are a very serious issue, it is important to obtain a balanced view of all the clinical and epidemiological facts pertaining the effect of antidepressant therapy in relation to suicidal behaviour.

READ MORE @ EUREKALERT

Sex Differences Seen in Response to Common Antidepressant

Women with depression may be much more likely than men to get relief from a commonly used, inexpensive antidepressant drug, a new national study finds. But many members of both sexes may find that it helps ease their depression symptoms.

The persistence of a gender difference in response to the drug — even after the researchers accounted for many complicating factors — suggests that there’s a real biological difference in the way the medication affects women compared with men. The reasons for that difference are still unclear, but further studies are now examining hormonal variations that may play a role.

The study involved citalopram, a commonly used antidepressant that is available both as a generic drug and under the brand name Celexa.

Researchers from the University of Michigan Depression Center and their colleagues from around the country tested the drug’s ability to help depression patients achieve remission, or total relief from their symptoms, in a multi-year study called STAR*D.

The gender differences emerged from a detailed analysis of data from 2,876 men and women who had a clear diagnosis of major depression, and took citalopram over a number of weeks, with the doses increasing over time.

In the end, women were 33 percent more likely to achieve a full remission of their depression, despite the fact that women in the study were more severely depressed than the men when the study began.

READ MORE @ NEWSWISE

Antipsychotic drug 'stroke risk'

More people than previously thought could be at higher risk of having a stroke caused by their antipsychotic drugs, say UK scientists.

Previous research suggested only some types of the drug increased the risk, particularly for people with dementia.

However a study published in the British Medical Journal says all forms of antipsychotics boost the risk, in all patients.

A mental health charity said patients on the drugs must be closely monitored.

Antipsychotic drugs are generally used to control psychotic symptoms in patients with disorders such as schizophrenia, and some severe forms of depression.

They are also thought to be widely used to control symptoms of dementia such as aggression, leading to accusations they were being used unnecessarily as a "chemical cosh" in some circumstances.

READ MORE @ BBC

Antidepressants need new nerve cells to be effective, UT Southwestern researchers find

Researchers at UT Southwestern Medical Center have discovered in mice that the brain must create new nerve cells for either exercise or antidepressants to reduce depression-like behavior.

In addition, the researchers found that antidepressants and exercise use the same biochemical pathway to exert their effects.

These results might help explain some unknown mechanisms of antidepressants and provide a new direction for developing drugs to treat depression, said Dr. Luis Parada, chairman of developmental biology and senior author of a study in the Aug. 14 issue of the journal Neuron.

In animals, it was already known that long-term treatment with antidepressants causes new nerve cells to be generated in a part of the brain called the dentate gyrus. Exercise, which can also relieve the symptoms of depression, stimulates the generation of new nerve cells in the same area.

READ MORE @ EUREKALERT

Antidepressant Medications May Have Alternate Use

A new study published in the August 15th issue of Biological Psychiatry finds that hippocampal neurogenesis (neuron birth in the hippocampus part of the brain) might be used by the monoaminergic antidepressants (related to the secretion of monoamine neurotransmitters such as dopamine and serotonin) to counteract the effects of stress, whereas similar effects could be achieved by directly targeting the hypothalamo-pituitary-adrenal (HPA) axis and related neuropeptides (amino acid chains).

READ MORE @ MEDICAL NEWS TODAY

Anti-psychotic drug use in the elderly increases despite drug safety warnings

Three regulatory warnings of serious adverse events slowed the growth of use of atypical antipsychotic drugs among elderly patients with dementia, but they did not reduce the overall prescription rate of these drugs, found a research analysis of prescription drug claims data in Ontario http://www.cmaj.ca/press/pg438.pdf. The rate of use of these drugs actually increased 20% from the month prior to the first warning in September 2002 to the end of the study period in February 2007.

About 70% of people receiving antipsychotic drugs lived in nursing homes, and approximately 40% were aged 85 or older.

READ MORE @ EUREKALERT

Stigmatising attitude of medical students towards a psychiatry label

The aim of this study is to evaluate the effect of a psychiatric label attached to an apparently normal person on the attitude of final year medical students at a Nigerian university.

Methods: A questionnaire with sections on demographic information, a single-paragraph case description illustrating a normal person, a social distance scale and questions on expected burden was used to elicit responses from 144 final year medical students who have had previous exposure to psychiatric posting.

The students consisted of two randomly assigned groups; group A received a case description with a psychiatric label attached while group B received the same case description but without a psychiatric label.

READ MORE @ 7TH SPACE INTERACTIVE

Looking beyond the drug receptor for clues to drug effectiveness

Antipsychotic drugs that are widely used to treat schizophrenia and other problems may not work as scientists have assumed, according to findings from Duke University Medical Center researchers that could lead to changes in how these drugs are developed and prescribed.

Scientists have known that all antipsychotic drugs target the D2 receptor inside cells. New tests developed at Duke reveal that the biochemical pathways linked to this receptor – the pathways along which the drugs deliver their therapeutic effects – may function differently than previously understood.

The Duke team developed specialized tests and studied two main pathways that stem from the receptor. The first is the G-protein-dependent signaling pathway, and the other is the beta arrestin pathway.

Most antipsychotic drugs in use today were developed to target the G-protein signaling that occurs at the receptor. Only recently, beta-arrestin, a protein known as an "off-switch" for G-protein receptors, has been shown to also play a role in directing other cellular activities.

The tests uncovered surprising results. "Our work showed that all nine antipsychotic drugs we examined uniformly and more potently block the beta-arrestin pathway downstream of the D2 dopamine receptor," said Bernard Masri, Ph.D., lead author and postdoctoral researcher in the Duke Department of Cell Biology.

READ MORE @ EUREKALERT

Adding insult to surgical injury

MY WIFE Wendy recently underwent a routine colonoscopy at a teaching hospital in the Boston area. This effective and sometimes lifesaving procedure can locate and remove cancerous polyps in the colon (intestine). But Wendy was unlucky and experienced a medical injury that only occurs in one of 1,000 patients.

And as the hospital staff struggled to deal with the consequences of that injury, my wife and I got a first-hand look at the difficulty healthcare providers have in controlling patients' pain.

During her procedure, the colonoscope - a long, flexible, lighted tube - broke through the wall of her colon, creating a nickel-sized tear in the intestine. The injury could be seen immediately on the monitor. Wendy's doctor explained what had happened, apologized, and rushed her to the operating room for emergency surgery to prevent dangerous internal infections. The two-hour surgery was successful, and left Wendy with a 4-inch abdominal incision.

EWAD MORE @ BOSTON GLOBE

3.4 Million Seniors Hit Medicare 'Doughnut Hole'

In 2007, about 3.4 million Americans enrolled in the Medicare Part D drug plan reached a gap in their prescription coverage known as the "doughnut hole," leading some of them to stop taking prescribed drugs, says a Kaiser Family Foundation study released Thursday.

The analysis of data found that 26 percent of Part D enrollees who filled any prescriptions in 2007 reached the coverage gap. This includes 22 percent who were stuck in the gap for the remainder of the year and 4 percent who eventually received catastrophic coverage.

When they applied this estimate to the all Part D enrollees, the study authors concluded that last year about 3.4 million beneficiaries (14 percent of all Part D enrollees) reached the coverage gap and faced paying full cost for their prescriptions.

READ MORE @ FORBES

Psychedelic drugs could heal thousands

New research into the benefits of hallucinogens alongside psychotherapy is welcome: in my experience they change lives

There is a horrible sense of meaninglessness and chaos that comes from the extreme loneliness of being cut off. Trauma, whether sustained in the family, or in the military during combat, renders millions feeling unsafe, insecure, mistrustful, and in the end isolated, lonely and desperate. Judith Lewis Herman, who wrote the definitive book on trauma and recovery, stated that all so-called mental illness and suffering could be seen as a person's misguided attempt to survive trauma. Fear separates, love unites. We all wish to grow to freedom, to belong, to participate. Hatred is like gangrene, shame is deadly. Forgiveness is but a faint hope.

Sandoz began to market LSD in 1947 as a psychiatric panacea, the cure for everything from schizophrenia to criminal behaviour, sexual perversions, alcoholism, and other addictions. During a 15-year period beginning in 1950, research on LSD and other hallucinogens generated over 1,000 scientific papers, several dozen books and six international conferences, and LSD was prescribed as an adjunct of psychotherapy to over 40,000 patients. The current research using psychedelics heralds a reawakening to the magnificent healing possibilities of these now prohibited substances. After over 40 years of repression or oppression, Rick Doblin of Multidisciplinary Association for Psychedelic Studies (Maps), and others are spearheading a more enlightened, less hysterical and terrified approach to the use of these substances. I am participating in what hopefully will be Canada's first government approved clinical trials in 40 years, sponsored and organised by Maps, evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder.

READ MORE @ THE GUARDIAN

Redundancy and a depression

Philip Joslin, a senior clinician at Lifeworks, a private clinic in London dealing with addictions and depression, believes redundancy “is not just a matter of economic survival. It threatens people’s very identity”.

As the economy slows and jobs are cut, psychiatric practices based in London’s financial centre are reporting a rise in referrals. Mark Beadle, chief executive of Capio Nightingale Hospitals, a provider of private psychiatric treatment, says the number of City workers coming to his clinics with depression or anxiety has risen by 30 to 40 per cent.

The psychological impact of redundancy goes beyond those whose jobs are cut, however. Christine Martin, therapist and partner at Haswell, Martin & Rose, a private practice based in central London, says: “Redundancy raises a wide range of issues – for the person losing their job, for the ‘survivor’ who hasn’t been made redundant and also the people managing the process such as human resources professionals.”

READ MORE @ FINANCIAL TIMES

FDA’s off-label policing criticized - GAO says agency moves too slowly

When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot.

When federal regulators catch a drug company peddling prescription drugs for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. During that time, a lot prescriptions can be written.

The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as “off-label” prescribing.

Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting money. Some people have been harmed by unexpected side effects.

What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.

READ MORE @ MILWAUKEE JOURNAL SENTINEL