Thursday, February 26, 2009

Seroquel Case: Must AstraZeneca Tell All?

In more lawsuits, companies are being forced to reveal internal information during the pretrial discovery phase that otherwise would be kept private

A showdown is looming in a Florida courtroom over an issue that has long bedeviled business: How much internal information can a company be forced to make public simply because it has become a defendant in a lawsuit?

In federal court in Orlando, drugmaker AstraZeneca (AZN) is battling to keep confidential thousands of pages of correspondence, studies, and other material related to its blockbuster antipsychotic drug Seroquel. On Feb. 13, Bloomberg News, invoking "the public's right of access to judicial documents," asked the court to unseal selected filings. A hearing on the request is scheduled for Feb. 26.

The battle grows out of claims by consumers who allege that AstraZeneca didn't adequately disclose that Seroquel can trigger serious weight gain and diabetes. There is also an unusual allegation of sexual misconduct that AstraZeneca is trying to keep contained by arguing that it is irrelevant and should be kept from a jury. More than 6,000 Seroquel cases have been consolidated in the Florida case.

READ MORE @ BUSINESS WEEK

Wednesday, February 25, 2009

Diabetic pregnant women at risk for depression

Low-income pregnant women and new mothers with diabetes are nearly twice as likely as those without diabetes to be diagnosed with depression during and after pregnancy, new research indicates.

Depression during the last several months of pregnancy and the year following childbirth -- the so-called perinatal period -- affects at least 10 percent to 12 percent of new mothers, and approximately 2 percent to 9 percent of pregnancies are complicated by diabetes, the researchers note. Past research has established an association between diabetes and depression in the general adult population.

In the current study, Dr. Bernard L. Harlow, at the University of Minnesota, Minneapolis, and colleagues examined the association between diabetes and depression in the perinatal period among approximately 11,000 low-income women enrolled in Medicaid who gave birth between 2004 and 2006.

They found that women with diabetes had nearly double the odds of having a diagnosis of depression or taking an antidepressant during the perinatal period compared with women without diabetes (15.2 percent versus 8.5 percent).

READ MORE @ REUTERS

Tuesday, February 24, 2009

Agomelatine Approved in EU for Major Depressive Episodes

The European Commission has granted marketing authorisation for agomelatine (Valdoxan) for the treatment of adult patients with major depressive episodes.

The approval is based on both short-term and long-term results from a large, comprehensive, international development programme including almost 6,000 adult patients with depression.

The results demonstrated the superior efficacy of agomelatine as compared with placebo, selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitor (SNRI) treatments.

READ MORE @ DOCTOR'S GUIDE

Monday, February 23, 2009

Aging: Vitamin D Levels Tied to Dementia Risk

Low blood levels of vitamin D may be associated with an increased risk for dementia, a British study has found.

Scientists measured blood levels of the vitamin in a representative sample of 1,766 people over 65 and assessed their mental functioning with a widely used questionnaire. About 12 percent were cognitively impaired, and the lower their vitamin D level, the more likely they were to be in that group. Compared with those in the highest one-quarter for serum vitamin D, those in the lowest were 2.3 times as likely to be impaired, even after statistically adjusting for age, sex, education and ethnicity. Men showed the effect more strongly than women.

READ MORE @ NY TIMES

Saturday, February 21, 2009

There's help to rein in drug costs Generics and mail order among the best ways to save

These days the price of prescription drugs can seem harder to swallow than the pills themselves. Operators of health-related hot lines say they've been swamped with calls from consumers looking for cheaper alternatives. For young families and seniors - two groups that tend to use more medications - the costs can be eye-popping. While there may not be a ready cure for the nation's soaring healthcare costs, there are a number of cost-cutting tips to ease the pain. Here are some favorites from pharmacists who help callers at MassMedLine, 866-633-1617 or www.massmedline.com, a free information service run by the Massachusetts College of Pharmacy and Health Sciences.

READ MORE @ BOSTON GLOBE

Wednesday, February 18, 2009

It's the Cymbalta Stupid

Many are outraged that Eli Lilly gave nonprofits $3.9 million in grants last year for medical courses to "educate" doctors about the pain-and-fatigue ailment fibromyalgia--more than it spent for diabetes and Alzheimer's which people already know they have.

But finding new diseases to justify a drug's existence is the normal way pharma operates.

Especially Lilly who agreed to pay $1.42 billion for illegal marketing of its anti-psychotic Zyprexa last month--$615 million for criminally promoting it for dementia--another $62 million to 32 states for illegal pediatric marketing and agreed to resolve Medicaid fraud investigations into "rebates" at the same time. (And how was your year?)

And whose diabetes treatment Byetta is tanking since reports last summer of six deaths, at least two from pancreatitis.

But Lilly's fibromyalgia-fighting drug, Cymbalta (duloxetine)--its second best seller after Zyprexa--is anything but normal.

Starting with the death of 19-year-old Cymbalta test subject Traci Johnson in 2004--who hanged herself in the Lilly Clinic in Indianapolis and had no history of mental problems--it has been beset by reports of baffling, rapid, unprovoked, and out of character suicides and suicide attempts.

READ MORE @ COUNTERPUNCH

Tuesday, February 17, 2009

Listen without prejudice

People with mental health problems deal with bigotry daily. What training is being offered to public sector workers to address this?

At any one time, one in six of us will have a mental health problem. The majority of us will surely have had some contact with someone who has personal experience of mental ill health. Yet stigma and discrimination are widespread and stop many people from admitting to mental health problems and doing things that the rest of us take for granted: applying for jobs; going out and meeting new friends; going to clubs and the shops; and even using public services like buses and libraries.

Every year the Department of Health carries out a public attitudes survey to gauge beliefs and attitudes towards people with mental illness. The 2008 survey found that one in eight people would not want to live next door to someone with a mental health problem, while a third thought those with mental health problems should not have the same rights to a job as everyone else.

The new statutory disability equalities duty (part of the Disability Discrimination Act) and the government-led social inclusion agenda are spurring public services to ensure people with mental health problems have equal access to mainstream services, from housing and transport through to education, arts, health and sport.

READ MORE @ THE GUARDIAN

Monday, February 16, 2009

Bipolar disorder increases risk of disease

Bipolar disorder, like smoking, increases the risk of early death from medical illnesses, a U.S. review found.

The review of 17 studies, published in Psychiatric Services, involving more than 331,000 patients suggested that people with bipolar disorder have a higher mortality from natural causes compared with people in the general population of similar age and gender but without mental illness.

"The review of data gathered from large population studies suggests that having bipolar disorder is similar to being a smoker in terms of increasing a person's risk of early death," Dr. Wayne Katon of the University of Washington in Seattle, co-author of the review, said in a statement.

People with bipolar disorder tend to have both manic phases that can include sleepless periods and depressed phases that can even leave them immobilized. There are many possible factors that may account for the higher risk of premature death.

READ MORE @ UPI

Sunday, February 15, 2009

Drug giant GlaxoSmithKline pledges cheap medicine for world's poor Head of GSK shocks industry with challenge to other 'big pharma' companies

The world's second biggest pharmaceutical company is to radically shift its attitude to providing cheap drugs to millions of people in the developing world.

In a major change of strategy, the new head of GlaxoSmithKline, Andrew Witty, has told the Guardian he will slash prices on all medicines in the poorest countries, give back profits to be spent on hospitals and clinics and – most ground-breaking of all – share knowledge about potential drugs that are currently protected by patents.

Witty says he believes drug companies have an obligation to help the poor get treatment. He challenges other pharmaceutical giants to follow his lead.

Pressure on the industry has been growing over the past decade, triggered by the Aids catastrophe.

Drug companies have been repeatedly criticised for failing to drop their prices for HIV drugs while millions died in Africa and Asia. Since then, campaigners have targeted them for defending the patents, which keep their prices high, while attempting to crush competition from generic manufacturers, who undercut them dramatically in countries where patents do not apply.
READ MORE @ THE GUARDIAN

Saturday, February 14, 2009

Manic Symptoms in Bipolar Depression Linked to Drug-Induced Mood Cycling

Patients with bipolar disorder who are on antidepressants may be at increased risk of rapid mood switches when even minimal manic symptoms are present, researchers found.

Bipolar patients with even low scores for symptoms of racing thoughts, distractibility, psychomotor agitation, and pressured speech were significantly more likely to develop treatment-emergent mania when started on antidepressants, Mark A. Frye, M.D., of the Mayo Clinic here, and colleagues reported in the February issue of the American Journal of Psychiatry.

These findings are the first prospective, controlled data supporting heightened risk of mood cycling and add to mounting evidence against antidepressants in bipolar disorder, noted Christopher D. Schneck, M.D., of the University of Colorado, in an accompanying editorial.

By re-emphasizing the importance of evaluating these symptoms, he wrote, "clinicians may be able to better predict which patients have an underlying bipolar diathesis and thereby avoid giving them antidepressants."

READ MORE @ MEDPAGE TODAY

Friday, February 13, 2009

High Level Of Adverse Drug Reactions In Hospitals Found

In a study of more than 3,000 patients, researchers at the University of Liverpool have found that one in seven admitted to hospital experience adverse drug reactions to medical treatment.

Adverse drug reactions (ADRs) are a major cause of hospital admissions, but recent data on ADRs that develop following hospital treatment is lacking. To further understanding of the clinical characteristics of ADRs, researchers at Liverpool assessed drug reactions of patients on 12 hospital wards over a six-month period.

Researchers found that 15% of patients admitted to hospital experienced one or more adverse reactions, which included constipation, confusion, renal problems, bleeding and infection with Clostridium difficle. Drugs most commonly associated with ADRs were anticoagulants, analgesics and diuretics.

The team also found that ADRs increased the length of a patient's hospital stay by an average of 0.25 days, and that those most susceptible were elderly patients on a number of different medications.

READ MORE @ SCIENCE DAILY

Thursday, February 12, 2009

Economy triggering depression, anxiety

n his stirring inauguration speech, President Barack Obama urged Americans to choose hope over fear.

While Obama's election clearly has given some people a lift, rhetoric alone isn't comforting those hit hardest by the country's economic downturn.

As people lose jobs or watch their retirement savings dry up, some local psychiatrists say they are seeing an increasing number of new patients with depression or anxiety, and that the symptoms of some current patients have worsened.

Beyond that, these doctors say, many who need treatment aren't receiving it because they cannot pay, having lost their jobs or their insurance.

Psychiatrist Bhawani Ballamudi, who practices at Dean Clinic East, said she is seeing a lot of depression.

"They just lost their job and have a family to feed, and they are trying to figure out how to do that, and that has caused a lot of stress," she said.

According to a Jan. 31 story in the New York Times, cries for help have increased nationwide. The National Suicide Prevention Lifeline reported a 36 percent jump in calls over the last year, to 545,851 from 402,167. Richard McKeon, a psychologist and federal public health expert, said crisis centers were reporting "a significant increase in the number of people who are giving economic reasons" for calling, whether it is "the loss of a job, loss of a home, or fear of that."

READ MORE @ THE CAPITAL TIMES

Wednesday, February 11, 2009

Use of Atypical Antipsychotic Drugs Increases Risk of Sudden Cardiac Death

Patients aged 30 to 74 years who took atypical antipsychotics such as risperidone (Risperdal), quetiapine (Seroquel), olanzapine (Zyprexa), and clozapine (Clozaril) had a significantly higher risk of sudden death from cardiac arrhythmias and other cardiac causes than patients who did not take these medications, according to a study published in the January 15 issue of the New England Journal of Medicine.

"This study provides critical information about the safety of atypical antipsychotics that can be used to make important treatment decisions for patients," said Carolyn M. Clancy, MD, Agency for Healthcare Research & Quality, Rockville, Maryland.

"These findings will help clinicians and patients weigh the risks versus the benefits of these drugs before prescribing them for treatment of depression or other off-label uses for other conditions."

READ MORE @ DOCTOR'S GUIDE

Tuesday, February 10, 2009

Psychiatrists may cut some ties to drug firms

Dr. Daniel Carlat knows all too well how easy it is for doctors to be seduced by drug industry money.

In 2002, he earned $30,000 in speaking fees to promote Wyeth's antidepressant Effexor XR to fellow doctors.

"I quit doing it because I felt I was beginning to push some ethical boundaries in terms of what I was saying and what I was not saying," said Carlat, a psychiatry professor at Tufts University in Boston who believes doctors need to cut their financial ties with drug companies.

"My own story was really nothing special," he said in a telephone interview. "I made $30,000 for the year, which is less than some of these doctors make in a weekend."

Carlat and other psychiatrists have been studying the issue and have proposed that the American Psychiatric Association cut back on medical education seminars funded by drug companies.

READ MORE @ REUTERS

Monday, February 9, 2009

AP IMPACT: Drugmakers' push boosts 'murky' ailment

Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills recently approved as treatments and drowning out unresolved questions — including whether it's a real disease at all.

Key components of the industry-funded buzz over the pain-and-fatigue ailment fibromyalgia are grants — more than $6 million donated by drugmakers Eli Lilly and Pfizer in the first three quarters of 2008 — to nonprofit groups for medical conferences and educational campaigns, an Associated Press analysis found.

That's more than they gave for more accepted ailments such as diabetes and Alzheimer's. Among grants tied to specific diseases, fibromyalgia ranked third for each company, behind only cancer and AIDS for Pfizer and cancer and depression for Lilly.

Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments.

READ MORE @ ASSOCIATED PRESS

Sunday, February 8, 2009

Strategies for Saving on Prescription Drugs

Drugs have never been so expensive — or so cheap

News reports and anecdotal evidence indicate that the recession is prompting many people to skimp on prescription drugs, putting their health at risk now and setting them up for higher medical expenses in the long term. So now is a good time to take a hard look at what you spend on prescriptions and figure out how you can make that money go farther.

The average brand-name prescription cost an eye-popping $120 in 2007, according to the most recent data from the Kaiser Family Foundation. That was up from $111 the year before. The average generic in 2007 was a mere $34, according to Kaiser. These days you can buy many generic drugs for as little as $4 for a 30-day supply at WalMart or Target, and many other retailers are offering steep discounts.

Switching to generics is obviously one of the best options, if your doctor approves. But generics aren’t the answer in every case. So before you go to the pharmacy, or your drug Web site, consider these strategies for lowering your prescription bills.

READ MORE @ NY TIMES

Saturday, February 7, 2009

SSRIs as Antihypertensives in Patients With Autonomic Panic Disorder Is There a Link Between Panic Disorder and Hypertension?

We would like provisionally to name it serotonin, which indicates that its source is serum and its activity is one of causing constriction.
Rapport M, et al

The cardiovascular properties of serotonin (5-HT) have been known for some time—its name reflects its presence in serum and its action in increasing vascular tone. Serotonergic medications are routinely used to treat depressive and anxiety disorders, and the association of depression with cardiovascular disease has become well established.2 Recent studies have confirmed the colloquial wisdom that anxiety (especially panic) and hypertension are linked.

In this article, we examine the trinity of serotonin—serotonergic dysfunction, autonomic panic, and normal-weight essential hypertension— and the evidence that hypertensive individuals who experience panic with autonomic symptoms may be a group of patients in whom serotonergic dysfunction plays a key role. We discuss implications of this model, including the potential utility of SSRIs as antihypertensives in this cohort.

READ MORE @ PSYCHIATRIC TIMES

Friday, February 6, 2009

Can Anticonvulsants Help Patients With Anxiety Disorders? What Does the Evidence Show?

Anxiety disorders are chronic conditions that follow a relapsing/remitting course.1 The evidence to support this view comes primarily from cross-sectional and retrospective assessments of duration of illness and, in part, from prospective studies. The waxing and waning nature of panic disorder and generalized anxiety disorder (GAD), for example, has been clearly demonstrated. Much less information is available about the course of illness of social phobia. However, both community studies and patient samples suggest an age of onset of social phobia in mid to late teens with a chronicity that is equal to or greater than that of panic disorder.2 Nevertheless, this recognition has not reshaped our basic treatment approach, which focuses almost entirely on the acute control of symptoms and only secondarily acknowledges relapse prevention.

In addition, the natural history of anxiety disorders is frequently complicated by Axis I and Axis II comorbidity that seems to be significantly higher among patients who seek treatment than in persons in the community who are not in treatment.1 In fact, it has been estimated that 73% of patients with panic disorder had other comorbid conditions that ranged from major depression to substance abuse until the onset of the Axis II disorders, mostly cluster C type 1 to 2. It is, therefore, evident that any long-term anxiolytic treatment strategy must take account of these high rates of comorbidity that appear to develop during the longitudinal phase of the anxiety disorder.

READ MORE @ PSYCHIATRIC TIMES

Thursday, February 5, 2009

Dementia strategy criticised by Alzheimer's trust

The first-ever national dementia strategy, intended to transform the care of the rising number of sufferers and their families, was launched by the government yesterday with funding of £150m and the promise of a string of memory clinics and advisors across the country.

But while the much-delayed strategy was welcomed by many in the field, it was criticised for failing to deliver on two crucial issues – research into the causes and potential treatments of dementia and the drugging of elderly people in care homes. A review of antipsychotic drugs – the so-called "chemical cosh" used in care homes to sedate people whose dementia makes them angry or distressed – has been postponed until the spring.

"This strategy is only the first step to tackling our dementia crisis, and it is a huge let-down that so much has been left out," said Rebecca Wood, chief executive of the Alzheimer's Research Trust.

"It is astonishing that dementia research is not a fundamental component of this strategy, and disappointing that the review of antipsychotic drugs has been delayed yet again," she added.

READ MORE @ GUARDIAN

Wednesday, February 4, 2009

Common antidepressants cut adult suicide risk -study

Common antidepressants suspected of raising suicide risk among children reduce the risk for adults, Italian scientists reported on Monday.

The findings that the drugs cut suicide risk by more than 40 percent among adults and over 50 percent for elderly people should reassure doctors, the researchers said.

But the study confirmed the drugs seriously raise the suicide risk for children, Corrado Barbui of the University of Verona and colleagues reported in the Canadian Medical Journal.

READ MORE @ REUTERS

Tuesday, February 3, 2009

Mental Illness Doesn't Predict Violent Behavior - Even when combined with substance abuse, psychiatric woes rank low as risk factor, study finds

Mental illness alone is not a predictor of future violent behavior, but mental illness combined with substance abuse or dependence does increase the risk, according to U.S. researchers who analyzed data collected from nearly 35,000 people.

People who have a severe mental illness but no substance abuse or a history of violence weren't any more likely than any other person in the general population to be violent over a period of three years, the study found. But the risk for future violence reached the level of statistical significance when mental illness was combined with substance abuse.

Still, the mental illness/substance abuse combination only ranked ninth on the study's list of the top 10 predictors of future violence. The predictors, listed from first to tenth, were: age (younger people are more likely to commit violence); history of violence; gender (males are more prone to violence); history of juvenile detention; divorce or separation in the past year; history of physical abuse; parental criminal history; unemployment in the past year; mental illness with substance abuse; and victimization in the past year.

RERAD MORE @ U.S. NEWS & WORLD REPORT

Monday, February 2, 2009

Bipolar Disorder Linked to Higher Mortality from Medical Illnesses

Bipolar disorders appear to increase the risk of early death from a medical illness, according to a literature review study published as the lead article this week in the journal Psychiatric Services.

The researchers comprehensively reviewed 17 studies involving more than 331,000 patients. Evidence suggested that people with bipolar disorder have a higher mortality from natural causes compared to people in the general population of similar age and gender but without mental illness. The various studies indicated that the risk was from 35 percent to 200 percent higher. The risk is the same for men and women. The most common conditions leading to premature death were heart disease, respiratory diseases, stroke, and endocrine problems such as diabetes.

"The review of data gathered from large population studies suggests that having bipolar disorder is similar to being a smoker in terms of increasing a person's risk of early death," said Dr. Wayne Katon, a University of Washington (UW) professor of psychiatry. He co-authored the study with third-year UW psychiatry resident Babak Roshanaei-Moghaddam. The article is titled, "Premature Mortality from General Medical Illnesses Among Persons with Bipolar Disorder: A Review." Katon is a noted researcher on the interplay between life-shortening medical conditions and mood disorders.

People with bipolar disorder tend to have manic phases and depressed phases in their lives. During mania, they might be too wound up to sleep, their thoughts might race, and they might have boundless energy. During depression, they might feel painfully sad, hopeless, and immobilized.

READ MORE @ NEWSWISE

Sunday, February 1, 2009

Bitter Pill

Created to treat schizophrenia, Zyprexa wound up being used on misbehaving kids. How the pharmaceutical industry turned a flawed and dangerous drug into a $16 billion bonanza

In June 1992, not long after the place closed down, a Harvard-trained psychologist named Sergio Pirrotta walked out of Danvers State Hospital for the last time. The psychiatric facility, at this late date, was a baggy old thing, rectangled into a field just north of Boston; whole wings were barely occupied, and vandals had already begun to rip out the mantelpieces and furniture. The hospital had been slowly, incrementally shutting down for a decade, and the patients that remained were the hardest cases, mostly schizophrenics and those with disorders too dense and weird to classify. But now, as Pirrotta took a walk around the campus, even those patients were gone: released into the larger world to fend for themselves or bused to hospitals where the staffs had little psychiatric training.

Pirrotta had come to Danvers in the mid-1970s to rehabilitate children whom the courts had declared insane. Back then the place was overpopulated, the halls packed with madmen who would wander around smoking cigarettes, leering and lunging at the kids. In those days, the drugs used to treat mental illness were crude and ugly things. Thorazine was the best, and it made you into a ghouled and lifeless ogre — your face seized up involuntarily, you kept shuffling around, you were an emotional drone. But gradually the medications got a little bit better, the pharmacology more precise. First there was haloperidol, similar to Thorazine but with less-vivid side effects. Then clozapine, which had at first seemed a wonder drug, before it turned out to trigger a potentially fatal immune deficiency in two cases out of a hundred.

READ MORE @ ROLLING STONE