Atypical Antipsychotics Increase Cardiometabolic Risk in Children

A study of the adverse effects of 4 second-generation antipsychotics in children and adolescents documented substantial weight gain during 11 weeks of treatment with each agent, with the increased abdominal fat that has been associated with development of metabolic syndrome in adults. Metabolic abnormalities emerged with 3 of the 4 agents, differing in type and severity with the agent and, in some cases, with the dose.

In this analysis from the Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth (SATIETY) study, 10% to 36% of 272 patients between 4 and 19 years of age (mean, 13.9 years) who had not previously received antipsychotic medication became overweight or obese. There was minimal weight change in a comparison group of patients who had refused the agent, or who discontinued it within 4 weeks.1

Christoph Correll, MD, Zucker Hillside Hospital, Glen Oaks, NY, and colleagues conducted this observational cohort study as the largest to date of adverse experiences with second-generation antipsychotics in antipsychotic treatment–naive children. The researchers noted that there has been increasing use of these agents in younger patients for psychotic and bipolar disorders as well as nonpsychotic disorders, despite little available age-specific data on adverse reactions.

READ MORE @ PSYCHIATRIC TIMES

Cognitive-Behavioral Therapy for Childhood Anxiety and Depression

For both depression and anxiety disorders in youths, there is increasing evidence of clinical benefit from cognitive-behavioral therapy (CBT).

Anxiety disorders

Both SSRIs and CBT individually have been shown to be effective in the treatment of children with anxiety disorders. A recent large randomized controlled trial examined the combined efficacy of these treatments in 488 children and adolescents (aged 7 to 17 years) who had anxiety disorder (separation anxiety disorder, social phobia, or generalized anxiety disorder).1

Patients were randomized to receive sertraline, CBT, sertraline and CBT, or placebo for 12 weeks. Combination treatment was significantly superior to either sertraline or CBT alone. Response rates were 81% for combination treatment, 60% for CBT, 55% for sertraline, and 24% for placebo. The effect size for combination treatment was 0.86 compared with 0.45 for sertraline and 0.31 for CBT. The investigators concluded that children and adolescents who receive combination treatment for anxiety disorders can consistently expect a significant reduction in anxiety severity.

Is CBT effective for young children with anxiety disorders? Typically, anxiety studies include children older than 8 years. Recently, Freeman and colleagues2 compared the efficacy of family-based CBT with family-based relaxation treatment for children aged 5 to 8 years who have ob-sessive-compulsive disorder (OCD). The 12-session CBT treatment was tailored to younger children to address their developmental stage. CBT had a moderate treatment effect (0.53). Half of the children who received CBT obtained clinical remission compared with 20% in the relaxation treatment group. The authors recommended family-based CBT as an important component when addressing early childhood–onset OCD.

READ MORE @ PSYCHIATRIC TIMES

Mental health isn't the issue - stigma is

Mark Dayton at his campaign headquarters in downtown Minneapolis.

Many politicians have overcome admissions of addiction or depression, thanks to better understanding of the manageable diseases. Can Dayton, too?

There was a time when the public admission of mental illness could derail a candidate's political career.

That could still happen to Mark Dayton, the Democratic candidate for governor who went public this week with his history of depression. But if so, experts say, it's the stigma -- not the disease itself -- that would sabotage his run for office.

Today, more than a decade into Prozac Nation, there is no reason why someone being treated for mild to moderate depression shouldn't hold a job with enormous responsibility, doctors say. Abraham Lincoln and Winston Churchill both suffered from depression, they say, and that was long before Prozac and even more effective medications that are available now.

READ MOE @ Minneapolis Star Tribune

Schizophrenia Mouse Model Should Improve Understanding and Treatment of the Disorder

Scientists have created what appears to be a schizophrenic mouse by reducing the inhibition of brain cells involved in complex reasoning and decisions about appropriate social behavior.

Findings by Medical College of Georgia scientists, published Dec. 28 in the Proceedings of the National Academy of Sciences, elucidate the critical balance between excitation and inhibition of these cells that appears to go awry in schizophrenia. They also provide the first animal model for studying the disabling psychiatric disorder that affects about 1 percent of the population.

"We believe the mouse, which exhibits some of the same aberrant behavior as patients with this disorder, will help identify better therapies," said Dr. Lin Mei, a developmental neurobiologist who directs MCG's Institute of Molecular Medicine and Genetics. "We are doing testing to see if antipsychotic drugs already on the market are effective in treating the mouse."

MCG scientists made the mouse by deleting a candidate gene for schizophrenia, ErbB4, from interneurons, which are brain cells that help shower larger decision-making neurons, called pyramidal cells, with inhibition.

READ MORE @ SCIENCE DAILY

A happy Christmas – alone Before we universally condemn loneliness we should ensure we understand its roots, and that sometimes solitude can be sweet

The meaning of Christmas, and its supposed power to bring friends and family together, is again in evidence this year. Jonathan Freedland admirably called for an end to loneliness, and urged social policy to address it – a sentiment echoed by a Guardian leader.

I do not wish to detract from the importance of addressing chronic loneliness, particularly in the elderly. Many people end up alone, not just over the festive season, but for significantly longer periods, for want of company, and not of their own volition. It is easy to pity them (which is just offensive) and say that we must do more as a society to help them. What is significantly harder is to understand the nature of, and the causes behind, loneliness in various sections of society, and ask whether and where society should act.

Recently, we have begun to regard loneliness, and not just in the elderly, as a purely social problem. In fact, there can be plenty of individual factors that underlie feelings of loneliness – from bereavement to serious medical illnesses. Therefore, trying to address it through political policy without adequate consultation is a cause for concern. After all, do we know that loneliness is largely a social problem? If so, is it just in the elderly or even among younger generations? What engenders it? Apart from a few intuitive ideas invoking the alienation triggered by online worlds, our obsession with communicating via screens, and the intrusiveness of corporate chains, we frankly do not know.

READ MORE @ THE GUARDIAN

Stress speeds mental decline in impaired elders

Chronic stress can speed up memory decline in older people who already have some impairment in their mental function, a new study in the American Journal of Psychiatry shows.

But being stressed doesn't appear to affect memory in older people without such impairment, Dr. Guerry M. Peavy of the University of California San Diego and colleagues found.

Research suggests a "strong relationship" between increased stress and memory loss, the researchers note, but few investigators have looked at stress and memory over time. Chronic stress may affect memory by causing prolonged release of so-called "stress hormones," such as cortisol, resulting in damage to the brain.

To investigate, the researchers followed 52 people 65 to 97 years old for up to three years. Twenty-five had no loss of mental function at the beginning of the study, while the remaining 27 showed evidence of mild mental impairment.

To measure stress, the researchers asked study participants about whether they had experienced stressful life events in the previous year or six months, such as being hospitalized or having a death in the family. A person was considered to have "high stress" if they reported at least one such event in a given period.

READ MORE @ REUTERS

Antidepressants cut risk of hospital readmission for suicidal youth

Suicidal adolescents who were prescribed an antidepressant medication during inpatient psychiatric hospital treatment were 85 percent less likely than others to be readmitted within a month after discharge, a new study found.

The results provide additional evidence that antidepressants may play a key role in helping improve the mental health of suicidal youth, said Cynthia Fontanella, co-author of the study and assistant professor of social work at Ohio State University.

The findings are especially important now, because antidepressant use dropped in 2003 after the Food and Drug Administration issued a black box warning that some antidepressants may increase the risk of suicidal behavior for pediatric patients. A black-box warning is the most serious type of warning in prescription drug labeling.

"We found that antidepressant treatment had a protective effect on readmission," Fontanella said. "Although the findings are preliminary, our results should be reassuring to child psychiatrists who may have been concerned about prescribing antidepressants since the FDA warning."

But another key finding from the study showed that hospitalized youth who were prescribed three or more medications from different drug classes for mental health issues had a 3-fold increased risk of being readmitted within a month of discharge.

READ MORE @ SCIENCE BLOG

Not All Drugs Are the Same After All

LET me start by saying I’m a fan of generic drugs. They save Americans billions of dollars each year and give us access to wonderful drugs at affordable prices. I’ve recommended generics in this column many times and use them myself when possible.

But there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts. The problem is not pervasive, but it’s something consumers should be aware of — especially now that more insurers insist that patients take generic medications when they are available.

Let me also prepare the groundwork for what I hope will be full and frank reader comments, by acknowledging that this issue is controversial.

Joe Graedon, who has been writing about pharmaceuticals for three decades and runs a consumer advocacy Web site, the People’s Pharmacy (peoplespharmacy.com), was 100 percent behind generics for many years.

“We were the country’s leading generic enthusiasts,” he told me recently. But over the last eight or nine years, Mr. Graedon began hearing about “misadventures” from people who read his syndicated newspaper column, also called The People’s Pharmacy.

READ MORE @ NY TIMES

This blog resumes its posts as of Sunday, December 20, 2009 after a 2 week hiatus

SSRIs May Prolong Seizure Duration but Shorten Post-Seizure Depression in Patients With Epilepsy: Presented at AES

Use of selective serotonin reuptake inhibitors (SSRIs) appears to be associated with longer seizures in patients with epilepsy, confounding basic science results suggesting SSRIs reduce the frequency of epileptic seizures in animal models, according to a study presented here at the American Epilepsy Society (AES) 63rd Annual Meeting.

"What we found was not necessarily a causal relationship, but an association, between SSRI use and longer seizures," study presenter Eugen Trinka, MD, MSc, Innsbruck Medical University, Innsbruck, Austria. "Based on our study, we cannot conclude that SSRIs prolong seizures." However, "doctors should use caution in using SSRIs in patients with epilepsy," Dr. Trinka added during his poster presentation held on December 5.

The study found that epilepsy seizures in those on SSRIs lasted a median 132 seconds, compared with 85 seconds in those not using SSRIs.

READ MORE @ DOCTOR;S GUIDEssris,

US FDA Approves SEROQUEL XR(R) For Add-On Treatment Of Major Depressive Disorder

AstraZeneca (NYSE: AZN) announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD). SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy.(1)(2)

MDD affects approximately 14.2 million American adults in a given year, and today it is often treated with antidepressants(3). Selective serotonin reuptake inhibitors, or SSRIs, are among the most commonly prescribed class of antidepressant medications for depression; however, in many cases patients fail to respond adequately to treatment(4). Results from a National Institute of Mental Health study, STAR*D, showed that approximately 63% of patients did not achieve remission with the SSRI citalopram when used as a first-line treatment(4). Additionally, this study reported that overall approximately one-third of patients with MDD failed to achieve study defined remission(4). This approval for SEROQUEL XR provides physicians with a new adjunctive treatment option for patients with MDD who have an inadequate response to their current antidepressant.

READ MORE @ MEDICAL NEWS TODAY

Why Psychiatry May Sometimes Need “Fuzzy” Diagnoses

“Well, while I’m here, I’ll do the work—and what’s the work? To ease the pain of living . . .”
—Allen Ginsberg


"Many words . . . don't have a strict meaning. But this is not a defect. To think it is would be like saying that the light of my reading lamp is no real light at all, because it has no sharp boundary."
—Ludwig Wittgenstein, The Blue and Brown Books


As a general proposition, most scientists and physicians prefer sharpness to fuzziness, at least when it comes to defining terms. I generally share this view, as regards psychiatric diagnosis, but only up to a point. That point is defined by the well-being of my patient—and sometimes this may call for a “fuzzy” diagnosis.

To understand why this is so, consider the following thought experiment. Imagine that we have a set of psychiatric signs and symptoms, designated as A through F. Suppose that if we select “A,B,C,D,E” as constituting our identified “Syndrome X,” we can correlate it with a specific pathophysiology and even with a specific genetic anomaly. Sounds terrific, right? And all so very “scientific”! But suppose that the syndrome, so defined, corresponds poorly to our patients’ subjective experience of distress; and furthermore, that the “ABCDE” syndrome does not lend itself well to any effective treatment.

Now imagine we start with the same A through F signs and symptoms, but we decide to group them as either “A,B,C,D,E” or as “B,C,D,E, F.” We are, in other words, making our definition of Syndrome X “fuzzier.” We now find that Syndrome X no longer corresponds as well to a particular pathophysiology or genetic defect, but that it better captures our patients’ subjective experience, and also lends itself to an effective treatment. In short, the fuzzier syndrome allows us to reduce our patients’ degree of suffering and incapacity to a greater extent than did the “sharp” ABCDE category. Which syndrome is more “real”—the “sharp” or the “fuzzy” one? Which is more pragmatically useful? And which syndrome leads us to more humane medical care, consistent with our ethical responsibilities as physicians?

READ MORE @ PSYCHIATRIC TIMES

New Safety Concern Related to Antipsychotic Treatment

Overall, antipsychotic medications are reasonably effective, and fairly well tolerated treatments for mood and psychotic disorders. However, treatment with a number of antipsychotic medications is associated with weight gain, and for some, hyperglycemia and hyperlipidemia. In the current issue of Biological Psychiatry, published by Elsevier, researchers discuss this cluster of metabolic side effects and how it may contribute to the risk for diabetes, hypertension, and other medical disorders associated with heart disease. This is of particular concern because there is a higher cardiovascular mortality among the severely mentally ill compared to the general population.

Researchers already know that differences exist between antipsychotics in their effect on clinical measures associated with cardiovascular risk, namely weight, lipids and glucose. Systemic inflammation has recently emerged as an important marker of cardiovascular risk, but the effects of antipsychotics on inflammatory markers in the blood have not been extensively studied until now.

READ MORE @ SCIENCE DAILY

The Doctors Were Real, the Patients Undercover

It had all the markings of a television detective show. Posing as patients, three undercover observers got themselves admitted as patients to a locked psychiatric ward to investigate conditions on the inside.

Each undercover patient had rehearsed an extensive back story, and the supposed family members who visited them were professional actors. A remote team monitored the project via hidden cameras and microphones from a command center in a nearby hotel.

The project, which took place this spring in De Gelderse Roos, a psychiatric complex about 40 miles from Amsterdam, was not a sting operation. The staff was told there would be mystery shoppers, of a sort, in the facility over a couple of months.

“We didn’t go in there like cowboys,” said Menko Soeters, a partner at Clearfields, a consulting firm that developed the project with De Gelderse Roos. “But we did use an unorthodox instrument for psychiatric care.”

Surrounded by manicured greenery, the closed-off ward of the complex, known as De Riethorst, recalls a suburban dental clinic, and its sunny gymnasium and carpeted hallways do little to suggest that it houses up to a dozen acute psychiatric patients, many of whom are there involuntarily.

And that is why the undercover participants were all experienced psychiatric nurses. “You couldn’t have done it otherwise,” said Edo De Vries, the director of De Gelderse Roos, which released the results of the project last summer.

READ MORE @ NY TIMES

Antidepressants can be helpful but risky

Feelings of unhappiness, decreased energy, insomnia and irritability are all symptoms of depression. And antidepressants can help relieve depression.

But for some people, these drugs may also have dangerous or troubling side effects -- drowsiness, feelings of panic, nervousness, sexual problems, thoughts of suicide or weight gain -- and should be taken only by people who really need them. So it's alarming that a new study shows antidepressant use has nearly doubled in the United States since the mid-1990s.

In the study, published in the August issue of Archives of General Psychiatry, researchers analyzed data from a national survey of antidepressant use conducted in 1996 and again in 2005. The survey included people age 6 and older.

Between 1996 and 2005, the rate of those reporting that they had used antidepressants in the past year jumped from 5.8 percent to 10.1 percent. This translates to an increase from about 13.3 million people to 27 million. The change was more dramatic among whites than African Americans or Hispanics.

READ MORE @ WASHINGTON POST

Should Drug Companies Carry Out Their Own Clinical Trials?

Two experts question on bmj.com today whether the conflict of interest is unethical when drug companies perform clinical trials on their own medicines.

Their opinions come as new guidance on the obligatory standards for communicating company sponsored medical research.

Vincent Lawton is a healthcare consultant and non-executive director at the Medicines and Healthcare products Regulatory Agency in London. He argues that after having invested billions of pounds in medicine development, it is unrealistic to expect the drug industry to "surrender its intellectual property." He comments that withdrawing research from pharmaceutical companies will lead to delays, ineffectiveness and a deficiency in innovation.

MEDICAL NEWS TODAY

Patient advocates ill at ease with Rx data mining Patient advocates see sales tactic as medical meddling

When your doctor writes you a prescription, that's just between you, your doctor and maybe your health insurance company, right?

Wrong. The pharmaceutical companies that make those prescription drugs are also looking over the doctor's shoulder, keeping track of how many prescriptions for which drugs the physician is writing.

And that data on the prescribing habits of thousands of doctors has become a powerful sales and marketing tool for the pharmaceutical industry, but also a source of growing concern among some elected officials, health care advocates and legal authorities.

The identity of patients is not disclosed, but knowing in detail what doctors are prescribing enables drugmakers to fine-tune their messages when sales reps call on doctors. They can lobby for use of an alternative drug made by their own company, for instance, bolstering the pitch with specially selected research data or free samples.

What worries some government officials and patient advocates is that sales tactics keyed to a doctor's prescribing preferences may distort decision-making. That's especially likely, the critics say, when many doctors have trouble finding time to examine a plethora of studies and weigh the results carefully. And, given the concern over costs, they say, free samples or other inducements could influence decisions for nonmedical reasons.

The practice is known as "prescription data mining." Medical data firms annually blend several billion prescription records -- purchased from pharmacies and health insurers -- with physician data from the American Medical Association and other sources and sell the results to drug companies.

READ MORE @ CHICAGO TRIBUNE

Focus on Pharmacotherapy Studies in Elderly

The NIMH-sponsored New Clinical Drugs Evaluation Unit (NCDEU) meeting is a favored venue for reports and reviews of NIH-funded psychopharmacological studies, and this was true of the recent annual meeting in Hollywood, Fla. The meeting included a workshop on new investigations of antidepressant use in Alzheimer disease and a panel session on the safety of pharmacotherapy in older adults.

Two studies were developed, in part, in response to growing concern about both safety and lack of efficacy of antipsychotics for behavior symptoms in patients with dementia. These were the Depression in Alzheimer’s Disease Study–2 (DIADS-2) sertraline (Zoloft) trial, the citalopram (Celexa) versus antipsychotics nested study in the Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimer’s Disease (CATIE-AD), and the recently initiated Citalopram for Agitation in Alzheimer’s Disease (CITAD).

In describing the rationale and design of the CITAD study, Bruce Pollock, MD, Center for Addiction and Mental Health, questioned the premise for using antipsychotics in this population. “The neuropharmacologic rationale for using dopamine antagonists in elders with dopaminergic deficits is questionable,” Pollock indicated. “Agitation in Alzheimer disease is commonly derived from anxious, impulsive, and compulsive symptoms, which may be responsive to serotonergic agents.”

READ MORE @ PSYCHIATRIC TIMES

'Doctors should stop pushing drugs at depressed people'

Despite a large increase in cognitive behaviour therapy (CBT) doctors are still pushing drugs at patients, according to Dr Jennifer Wild, a senior lecturer at the Institute of Psychiatry.
In this week's Scrubbing Up, she argues that GPs need to understand that psychological therapies like CBT work and should choose to offer them.

People with depression often get better when they change the way they think.
Since therapy is more likely to achieve this with longer-lasting results than drugs, doctors need to stop pushing pills and start pushing treatments that work.

Depressed people feel low, worthless, and often suicidal. They need treatment.
Six million people suffer from depression and anxiety in the UK, and surveys show that most do not want to take drugs.

They want a treatment with long-lasting results.

READ MORE @ BBC NEWS"

'Distorted thinking'

This treatment is cognitive behavioural therapy (CBT).
CBT is based on a well-supported theory of how depression starts and what keeps it going: distorted thinking patterns.
Change people's thoughts and recovery occurs.

Ziprasidone Okayed for Bipolar Disorder

The FDA has cleared ziprasidone (Geodon) for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.

It joins several other antipsychotic drugs -- including quetiapine (Seroquel), aripiprazole (Abilify), and olanzapine (Zyprexa) -- approved for this indication.

Ziprasidone is also approved for acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for schizophrenia.

The approval as bipolar maintenance therapy follows a a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder, according to the drug's manufacturer, Pfizer.

READ MORE @ MEDPAGE TODAY

Psychiatrist Helped Demonstrate Psychotherapy Is Cost-Effective

Whether psychotherapy is cost-effective was an important question during President Clinton's health care reform effort. Lessons from that era remain relevant during current health reform debates.

If psychotherapy has a place in the American health care system of tomorrow, give some credit to psychiatrist Susan Lazar, M.D., and other clinician-researchers who helped establish the evidence base for the cost-effectiveness of psychotherapy beginning more than 16 years ago.

That was when Hillary Rodham Clinton's Health Care Task Force was at work. Though the exact content of health insurance benefit packages hasn't yet been a focus of today's health care debates, a decade and a half ago task force members were weighing the relative value of any health care service as a criterion for inclusion in mandated benefits.

And “value” meant cost-effectiveness—the cost of providing the service compared with the benefits derived from the service.

READ MORE @ PSYCHIATRIC NEWS

Psychotropic Drugs Boost Fall Risk in the Elderly

A new analysis of studies including nearly 80,000 people aged 60 and older confirms that certain types of widely prescribed drugs, such as antidepressants and sedatives, can increase their risk of falling.

Falls often have serious consequences for older people, such as injuries leading to disability and admission to a nursing home, or even death.

While prescription drugs are recognized as contributing to fall risk among older people --who are likely to be on lots of medications -- discovering just which drugs are the problem is still a "challenge," Dr. Carlo A. Marra of the University of British Columbia in Vancouver and colleagues note in the Archives of Internal Medicine.

To update a review of studies on this subject published in 1996, Marra and his team identified 22 studies published between 1996 and 2007 including 79,081 people 60 and older, some of whom lived independently, and some of whom were institutionalized. They analyzed the risk of falling associated with nine classes of drugs.

Three classes turned out to significantly boost fall risk: sedatives and hypnotics, typically prescribed as sleeping aids; antidepressants; and benzodiazepines, which include tranquilizers like Xanax and Valium.

READ MORE @ ABC NEWS

The stigma of mental illness The suicides of a German footballer and two of my colleagues show how destructive is the stigma of psychiatric ill-health

Last week's suicide of the German goalkeeper Robert Enke revealed more than the terrible news of one man's death, the cruelty of depression and the pressures on sportsmen to protect the public's idealised view of them; it also exposed the ongoing shame and stigma of mental illness. For years he had been struggling with depression, kept secret from the public and his colleagues for fear of a vicious backlash that could, he apparently feared, raise questions about his capacity to care for his adopted baby girl and play for his nation.

Rather than risk this, and perhaps further despairing under the force of these private terrors, he chose the solution of death. That this seemed preferable to risking public awareness of his depression and the imagined consequences of personal shame, family destruction and exclusion from his nation's crucial sporting event, demonstrates something of the huge level of hatred that mental illness still evokes in the public imagination. The stigma only worsens the burden on those with mental health problems, typically reported as one in four of the adult population in the UK.

When people die by their own hand, a response of shocked disbelief, of the sense of an awful secret that has been starkly exposed, occurs all too often. How is it in this advanced age of emotional literacy, psychological self-help and media shrinks that the shame of depression and other mental illness causes people to desperately try to hide their problems rather than challenge society to accept that they, like so many others, are vulnerable?

READ MORE @ THE GUARDIAN

Healthcare lobby set for record spending this year

It's not just spending on U.S. healthcare that is breaking records. Drugmakers, insurers and industry groups are on track to spend an all-time high of more than $500 million this year to influence Congress' revamp of the healthcare system.

Lobbyists for the healthcare sector will likely smash previous spending records by tens of millions of dollars this year as Democratic lawmakers try to reshape the industry by expanding coverage and shaving costs.

"If current trends continue, the health sector is likely to spend more than a half-billion dollars on lobbying in 2009," said The New England Journal of Medicine's Dr. Robert Steinbrook.

As Congress makes a final push for a bill to overhaul the $2.5 trillion healthcare system that fuels one-sixth of the U.S. economy, health companies and industry groups are trying to shape the outcome.

READ MORE @ REUTERS

Rising Prices of Drugs Lead to Call for Inquiry

Democrats in Congress asked for two separate investigations of drug industry pricing Wednesday as they continue working on legislation to overhaul the nation’s health care system.

Responding to news reports of unusually high wholesale price increases in brand-name prescription drugs, four House leaders and one senator asked for government reviews of the pricing practices.

Although drug makers challenge the theory, some experts say the run-up in wholesale prices may be partly related to the industry’s concerns about future cost containment under any health care legislation.

“Recent studies have indicated that the industry may be artificially raising prices for certain pharmaceutical products in expectation of new reforms,” the House Democrats wrote in a letter to the Government Accountability Office, a nonpartisan investigative arm of Congress. “Any price gouging is unacceptable, but anticipatory price gouging is especially offensive,” the letter added, asking the G.A.O. to conduct an expedited review of the price increases.

READ MORE @ NY TIMES

US Army suicides on track to hit new high in 2009

US Army is short on mental health professionals as it tries to stem rising number of Army suicides.

The US Army is short as many as 300 substance-abuse counselors and 800 mental health professionals as it attempts to stem the rise of soldier suicides, which is expected to break new records again this year.

As of Monday, there were 140 confirmed suicides in 2009 among the active-duty Army and another 71 from the Reserve and National Guard, said Army Gen. Pete Chiarelli, the service's vice-chief of staff. This year will probably be worse than last year, in which 140 suicides were confirmed, he said. That would represent the fifth straight year suicides increased in the Army.

"This is horrible, and I do not want to downplay the significance of this in any way," said Chiarelli, noting that the rising number of suicides is probably the "toughest challenge" he's ever had to tackle.

The Marine Corps is seeing a similar trend: Last year it confirmed 42 suicides and has counted 42 already this year.

Too few mental health experts are available to address the problem – reflecting a shortage of such experts across the country, not just in the military.

READ MORE @ CHRISTIAN SCIENCE MONITOR

Drug ads get scrutiny from the FDA

When patients are diagnosed with an illness, the Web is fast becoming the first place they look for information, treatment options and support groups.

Drug companies want to be part of that conversation. But they are wary of advertising online because of the Food and Drug Adminstration's vague rules about ad content and disclaimer information for Internet marketing. Afraid of violating those rules, most pharmaceutical makers have shied away from advertising specific products online, instead relying on traditional media such as TV and print ads, for which there are strict guidelines.

The online advertising industry says the lack of clarity around the rules is costing millions in potential ad revenue and is actually resulting in less information getting to consumers.

The FDA is hosting a two-day workshop, which concludes today, to discuss how drug companies should be allowed to advertise on Web sites, search engines and social media sites. (The Wall Street Journal and NPR both wrote stories on the workshop.)

READ MORE @ THE HILL

Medical Schools Quizzed on Ghostwriting

Senator Charles E. Grassley wrote to 10 top medical schools Tuesday to ask what they are doing about professors who put their names on ghostwritten articles in medical journals — and why that practice was any different from plagiarism by students.

Mr. Grassley, of Iowa, the ranking Republican on the Senate Finance Committee, sent the letters as part of his continuing investigation of so-called medical ghostwriting. The term refers to publication of medical journal articles in which an outside writer — sometimes paid by a drug or medical devices company whose product is being studied — has done extensive work on the article without being named on the publication. Instead, one or more academic researchers may receive author credit.

Mr. Grassley said ghostwriting had hurt patients and raised costs for taxpayers because it used prestigious academic names to promote medical products and treatments that might be expensive or less effective than viable alternatives.

Va href="http://www.nytimes.com/2009/11/18/business/18ghost.html?_r=1&ref=health">READ MORE @ NY TIMES

New Treatment for Autism 'Holds Promise'

A new treatment for autism appears to normalize brain function, according to Nashville physician Fred S. Starr, MD, FAACAP, BCIA-EEG.
In addition to high serotonin levels, autistic children have a characteristically common "u" EEG pattern reflecting impaired brain function, particularly in areas of the brain responsible for social interaction, communication, speech and bonding.
However, Quantitative EEG's conducted by Dr. Starr on autistic children after three weeks on the medication Respen-A showed that the children's brain patterning changed to "normal" patterning. Starr says that behavioral improvement was also "evident". "Speech, interaction and social skills improved markedly in patients using Respen-A, and displays of frustration and anger markedly diminished," Starr said.
The theory behind the use of Respen-A was developed by private researcher Elaine DeLack, Stanwood, WA. Unlike theories that center on negative reaction to vaccinations, DeLack looked at exposure to a commonly used drug used during delivery, and at brain enzymes that affect the brain both at birth, and again as the child enters childhood.

READ MORE @ EARTHTIMES

UK study warns against anti-psychotics for dementia

* Most dementia patients given anti-psychotics needlessly

* Report could inform clinical practice around the world

* Global dementia cases seen doubling to 66 mln by 2030

More than 140,000 dementia patients in Britain are given anti-psychotic drugs needlessly and overprescribing of the medicines is linked to an extra 1,800 deaths in elderly people each year, a report said on Thursday.

The government-backed review showed that only around 36,000 of around 180,000 dementia patients prescribed anti-psychotics got any benefit from them -- findings it said could affect clinical practice in dementia across the world.

"Anti-psychotics are used too often in dementia," Sube Banerjee, the report's author and a professor of mental health and ageing at the Institute of Psychiatry at King's College London, said in a statement.

He said use of anti-psychotics drugs for dementia should be cut to a third of current levels in Britain and said his study would "provide international leadership in this complex clinical area."

Alzheimer's Disease International predicted in September that more than 35 million people around the world will suffer from dementia in 2010. That number is expected to almost double every 20 years, to 66 million in 2030 and more than 115 million in 2050. [ID:nN20262573]

READ MORE @ REUTERS

Web-based counseling service Vets Prevail offered to veterans

Veterans in need of counseling, support or information to deal with mental and emotional issues can now turn to an online, interactive program called Vets Prevail. The services are provided confidentially and free of charge.

The website allows veterans to connect with other vets through forums, blogs and multimedia content. Vets can also sign up for a six-week online mental health program tool designed to help them build resilience and readjust to life after deployment. The aim of the training is to help vets tackle negative emotions and keep the trauma of the battlefield from affecting daily life and relationships.

About 500 veterans will be able to access the training program based on funds provided by Major League Baseball and the McCormick Foundation. However, organizers aim to continue the service with additional funding.

READ MORE @ LS ANGELES TIMES

Drugmaker Paid Psychiatrist Nearly $500,000 to Promote Antipsychotic, Despite Doubts About Research

This story was co-published with the Chicago Tribune.

Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.

On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.

On the other, some worried that his research findings might be too good to be true.

As Reinstein grew irritated with what he perceived as the company's slights, a top executive outlined the scenario in an e-mail to colleague

"If he is in fact worth half a billion dollars to (AstraZeneca)," the company's U.S. sales chief wrote in 2001, "we need to put him in a different category." To avoid scaring Reinstein away, he said, the firm should answer "his every query and satisfy any of his quirky behaviors."

Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of indigent, mentally ill residents in Chicago-area nursing homes.

During this period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.

READ MORE @ PRO PUBLICA

Widespread Generic Erosion of Atypical Antipsychotics Will Cause the Bipolar Disorder Drug Market to Decline By More Than $1 Billion Through 2018

Decision Resources, one of the world's
leading research and advisory firms for pharmaceutical and healthcare issues,
finds that widespread generic erosion of branded atypical antipsychotics will
cause the bipolar disorder drug market to decline from $6.3 billion in 2008 to
approximately $5 billion in 2018 in the United States, France, Germany, Italy,
Spain, the United Kingdom and Japan.

The new Pharmacor report entitled Bipolar Disorder finds that the market will
be constrained over the next several years by the patent expiries and
subsequent generic erosion of key antipsychotic agents such as AstraZeneca's
Seroquel, Eli Lilly's Zyprexa, Bristol-Myers Squibb/Otsuka's Abilify and
Pfizer's Geodon. In 2008, sales of atypical antipsychotics exceeded $4 billion
but generic competition, beginning in 2011, will cause sales of these agents
to decline to just under $3 billion by 2018, according to the report.
Additionally, patent expiries of branded antidepressants that include Wyeth's
(now Pfizer's) Effexor XR, Eli Lilly's Cymbalta/Xeristar and Forest/Lundbeck's
Lexapro/Cipralex will further constrain the market.

READ MORE @ REUTERS

Adjunctive Psychotherapy for Depression Studied Findings suggest addition of psychotherapy does not increase remission over medication alone

Adjunctive psychotherapy added to antidepressant medications for patients with chronic depression did not increase the proportion of patients achieving remission, according to a study in the November issue of the Archives of General Psychiatry.

James H. Kocsis, M.D., of Weill Cornell Medical College in New York City, and colleagues treated chronically depressed patients using a two-phase treatment protocol with phase one consisting of an antidepressant medication used in accordance with a pharmacotherapy algorithm. After phase one, patients not achieving remission were randomized to 12 weeks of either continued medication and the addition of the cognitive behavioral analysis system of psychotherapy, continued medication and the addition of brief supportive psychotherapy, or optimized medication alone.

READ MORE @ MODERN MEDICINE

Genetic 'breakthroughs' in medicine are often nothing of the sort

During the second world war, the physicist Enrico Fermi asked General Leslie Groves of the US Army how many generals might be called "great" and why. Groves replied that any general who won five major battles in a row might be called great, and that about three in every hundred would qualify.

Fermi countered that if opposing forces are roughly equal, the odds are one in two that a general will win one battle, one in four that he will win two battles in a row, one in eight for three battles, one in 16 for four battles, and one in 32 for five battles in a row. "So you are right, General, about three in a hundred. Mathematical probability, not genius."1

There's an analogue of Fermi's "great general": the "great scientific discovery", or at least, as a case study, "the great genetic scientific discovery" as reported in the press. The discovery of genes for a certain behaviour, for schizophrenia, for happiness, always get good press coverage, usually based on publication in a respected scientific journal such as Science or Nature.

The research paper will include a statistic: the probability that the finding could have occurred by chance. The probability will have been sufficiently low that a reviewer for the journal was impressed and therefore recommended publication. Typically this probability or "P-value" will be less than 0.05, or 5%, which means the odds are less than one in 20 that the observed genetic correlation could have occurred by chance.

READ MORE @ GUARDIAN"

Chronically Depressed? What to Do When Antidepressants Don't Work

The range of options includes cognitive behavioral therapy and brain stimulation techniques like ECT.

Last winter, confined to bed by intense sadness, exhaustion, and headaches, the University of Kansas student found herself considering suicide. Desperate after a years-long struggle with depression, she sought a treatment she had once viewed as extreme: electroconvulsive therapy. After a few sessions, "I literally went from almost unable to function—feeling suicidal—to a 180-degree change," she says.

The student, who still contends with depression, is one of the many people chronically in its grip who, disappointed by antidepressants, are finding some relief in therapies ranging from exercise to various forms of high-tech brain stimulation. Some 27 million Americans were taking an antidepressant in 2005, more than twice the number almost 10 years earlier, thanks largely to the arrival of Prozac and other effective antidepressants with fewer side effects. But a groundbreaking 2006 trial known as STAR*D revealed that about one third of people found total relief with their first drug, and around a third were not helped even after trying several drugs and combinations. ECT, which has been controversial since the days when it was performed without anesthesia and sometimes without proper consent, has evolved considerably in recent years; by inducing a seizure, it is thought to reset dysfunctional brain circuitry. It "is the most effective and rapidly acting treatment for severe depression," says Sarah Lisanby, a professor of clinical psychiatry at Columbia University Medical Center who is a leading brain stimulation researcher.

READ MORE @ U.S. NEWS & WORLD REPORT

FDA initiative targets drug prescription, dosing errors

The Food and Drug Administration wants to reduce the misuse of medications, saying that at least 50,000 hospitalizations a year could be prevented if physicians, pharmacists, patients and parents used greater care in dispensing and taking drugs.

"When I first started looking at this, I was stunned at the scope of the problem," FDA commissioner Margaret A. Hamburg said Wednesday as she announced the new "Safe Use" program.

The Institute of Medicine estimates that at least 1.5 million preventable injuries and deaths result each year from overdosing, mix-ups and unintended exposure to prescription drugs. Children are often the victims -- one study found that, between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs such as codeine and morphine.

The cost of these preventable injuries is estimated at about $4 billion annually by the Institute of Medicine.

READ MORE @ WASHINGTON POST

Genes And Environment May Interact To Influence Risk For Post-traumatic Stress Disorder

Individuals who experience both childhood adversity and traumatic events in adulthood appear more likely to develop post-traumatic stress disorder than those exposed to only one of these types of incidents, according to a report in the November issue of Archives of General Psychiatry, one of the JAMA/Archives journals. In addition, the risk was further increased in individuals with a certain genetic mutation.

Although 40 percent to 70 percent of Americans have experienced traumatic events, only about 8 percent develop PTSD during their lifetimes, according to background information in the article. PTSD is a complex anxiety disorder that involves re-experiencing, avoidance and increased arousal following exposure to a life-threatening event. "In addition to the obvious effect of environmental factors, PTSD has a heritable component," the authors write. Recent studies estimate that genetic factors account for approximately 30 percent of the difference in PTSD symptoms.

READ MORE @ SCIENCE DAILY

Depression, drugs linked to preterm birth

Pregnant women with a history of depression who used psychiatric medication have triple the risk of premature child delivery, U.S. researchers found.

Researchers at the University of Washington, University of Michigan and Michigan State University found that a combination of medication use and depression -- either before or during pregnancy was strongly linked to delivery before 35 weeks' gestation.

Lead author Amelia Gavin of the University of Washington said the findings highlight the need for carefully planned studies that can clarify associations between depression, psychiatric medications and preterm delivery.

READ MORE @ UPI

The Role of Antidepressants for the Treatment of Bipolar Depression

Although rapid-cycling bipolar disorder has been linked to the use of antidepressants, these treatments may still have a role in the management of patients with bipolar depression, said Stephen V. Sobel, MD, clinical instructor at the University of California, San Diego School of Medicine, in a presentation at the U.S. Psychiatric and Mental Health Congress is Las Vegas. Patients with bipolar disorder spend most of their time in depression, and antidepressants can alleviate these symptoms, said Sobel. “That’s why it’s so tempting to treat these patients with an antidepressant. But it’s important to be familiar with recent studies on the development of rapid-cycling bipolar disorder and to weigh the risks and benefits,” he said.

The use of antidepressants may increase a patient’s risk of rapid-cycling bipolar disorder. The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) included 1742 patients treated with a variety of approved medications for bipolar I and bipolar II disorder, and 32% reported having rapid-cycling at baseline. After 2 years of treatment, 5% still had rapid-cycling bipolar disorder. Those who were treated with an antidepressant were 3.8 times more likely to have rapid-cycling bipolar disorder.1

READ MORE @ PSYCHIATRIC TIMES

Regimens: A Supplement Didn’t Help Heart Patients

Patients with heart disease are at greater risk of dying if they are depressed. And both depression and heart disease are characterized, among other things, by low levels of omega-3 fatty acids.

So scientists wondered whether heart patients with depression might benefit from a dose of omega-3s in their antidepressant medicine. In a clinical trial, two groups of heart patients taking the antidepressant sertraline (Zoloft) were randomly assigned to receive a supplement of either omega-3s or a corn oil placebo.

READ MORE @ NY TIMES

What “Meaningful Use” of Electronic Health Records May Mean to Psychiatrists

With billions of dollars for electronic health record (EHR) technology purchases hanging in the balance, psychiatrists need to be paying attention to the Department of Health and Human Services (HHS) deliberations on the definition of “meaningful use.” HHS Secretary Kathleen Sebelius is supposed to set an interim definition in a few months. This is important to all office-based physicians because it will set the requirements they will have to meet for proving they are making meaningful use of EHR software and hardware they previously purchased. If they can make the case, starting in 2011, they would qualify for federal grants to partially compensate them for those previous software and hardware purchases.

Those grants are available for 5 years, and if obtained starting in 2011, they could amount to as much as $64,000 per practice for psychiatrists whose patient mix is at least 30% Medicaid recipients. That figure falls to $44,000 for physicians who cannot meet the Medicaid percentage and who see Medicare patients, with no specific percentage of the latter being designated.

There is also a penalty for physicians who do not meet the meaningful use definition. It comes into play after 2016; the Medicare fee schedule for professional services is reduced by 1% in 2015, by 2% in 2016, by 3% for 2017, and by between 3% to 5% in subsequent years.

The grants were authorized by the American Recovery and Reinvestment Act (ARRA)—which is the stimulus bill Congress passed last winter. Sebelius will set interim requirements based on recommendations from 2 new advisory committees that were established by the ARRA: a health information technology policy and a standards committee. The meaningful use requirements will be different, in part, for office-based physicians and hospitals, but they will have escalating requirements in 2011, 2013, and 2015.

READ MORE @ PSYVHIATRIC TIMES

Long, hard road to marketplace for Vanda drug

Early next year, if all goes according to plan, doctors will be able to prescribe a new antipsychotic drug for patients with schizophrenia. When that happens, investors in a local pharmaceutical firm will surely breathe a sigh of relief.

While it's almost certain that the compound known as Fanapt will reach pharmacy shelves, the drug's future was anything but clear for most of its 13-year existence. Rockville-based Vanda Pharmaceuticals toiled for years on its development, even after larger drugmakers lost interest and the Food and Drug Administration gave the product a thumbs-down.

"Last year at this time, nobody believed in the company, and nobody believed in the compound," said Mihael H. Polymeropoulos, Vanda's president and chief executive. Today, the company has a deal for Fanapt worth nearly half a billion dollars.

READ MORE @ WASHINGTON POST

Surgery, Illness Not Linked to Mental Decline in Seniors New findings contradict previous reports of increased risks of dementia

Illness and surgery don't contribute to long-term cognitive decline in seniors and don't accelerate progression of dementia, researchers say.

The findings of a new study, published in the November issue of Anesthesiology, challenge the widely held belief that elderly patients suffer major deterioration in mental function after surgery.

"The concerns surrounding postoperative cognitive decline (POCD) following surgery certainly will not evaporate following publication of this study," researcher Michael S. Avidan, of the Washington University School of Medicine, said in a news release from the American Society of Anesthesiologists. "The important message to take from these findings is that persistent cognitive deterioration following surgery might not be a major public health problem. The decision to proceed with surgery should presently be made based on a person's general health and the specific risks and benefits of the procedure."

For the study, Avidan and colleagues looked at 575 patients tested annually at Washington University's Alzheimer Disease Research Center. At the start of the study, 361 patients had very mild or mild dementia and 214 were dementia-free. The patients were divided into three groups -- those who'd undergone non-cardiac surgery, those with illness, and those with neither.

READ MORE @ U.S. NEWS & WORLD REPORT

Patients with long-term diseases to be assessed for depression

GPs must assess people with chronic diseases to see whether they are suffering from depression, under new guidelines.

GPs must assess all patients with long-term diseases such as cancer to see whether they are suffering from depression, under new guidelines published today.

Too many doctors and patients assume that fatigue and weight loss are a result of the disease or the medicines they are taking, according to experts who formulated the guidelines for the National Institute for Healthcare and Clinical Excellence (NICE).

Depression affects one in six people at some point, but is three times more common in people with chronic diseases than in the rest of the population.

John Hindle, a consultant physician with the Betsi Cadwaladr University local health board, who was on the guideline development group, said that improving people's mood may even make them physically better.

"We should give everybody with physical disease the opportunity to be asked about the symptoms of depression," he said.

GPs should be asking two key questions, the guidelines say: during the last month, has the patient been bothered by feeling down, depressed or hopeless in the last month or by having little interest or pleasure in doing things?

READ MORE @ THE GUARDIAN

Weight Gain Associated With Antipsychotic Drugs

Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs.

The study, to be published Wednesday in The Journal of the American Medical Association, found that 257 young children and adolescents in New York City and on Long Island added 8 to 15 percent to their weight after taking the pills for less than 12 weeks.

The patients, ages 4 to 19, added an average of one to one-and-a-half pounds a week.

“The degree of weight gain is alarming,” said Dr. Wayne K. Goodman, head of a Food and Drug Administration advisory panel on the drugs last summer and chairman of psychiatry at Mount Sinai School of Medicine in Manhattan. “The magnitude is stunning,” he said.

Although the drugs’ influence on weight and metabolism had been previously detected, Dr. Goodman, who was not involved in the study, said the speed and magnitude of the effects found in the study were greater than previously reported — findings he said were made possible by looking exclusively at new patients.

READ MORE @ NY TIMES

Prescribing drugs 'off-label': an ethical prescription

More than one in five of the prescriptions U.S. doctors write for 160 common drugs is for a use other than that approved by the Food and Drug Administration. The practice is perfectly legal, though patients are largely in the dark about what "indications" or uses the FDA has approved for different prescription medications. (You can, however, always check the FDA-approved product labels for a prescription drug here.).

These "off-label uses" have not been scrutinized by the FDA for safety and effectiveness. It's not legal for drug companies actively to promote a drug for "off-label" purposes. But the practice means big money for drug makers, and some do it anyway (just last month, Pfizer agreed to plead guilty to promoting off-label uses for some of its medications and was fined $2.3 billion by the Justice Department, according to the Justice Department website).

So, while it's legal, the practice is controversial.

That leaves doctors, who often feel immense pressure to offer something--anything--to relieve a patient's suffering, in uncharted ethical waters. In some cases, the "off-label" use of a drug might be just the treatment the patient needed. But it might just as likely be a waste of time and money--or worse, pose unpredictable dangers to the patient. When "everybody's doing it" (and, yes, even physicians say stuff like that sometimes), what's a physician to do?

READ MORE @ LOS ANGELES TIMES

Antidepressants 'work instantly'

Antidepressants get to work immediately to lift mood, contrary to current belief, UK researchers say.

Although patients may not notice the effects until months into the therapy, the team say they work subconsciously.

The action is rapid, beginning within hours of taking the drugs, and changes negative thoughts, according to the Oxford University researchers.

These subtle, positive cues may add up over time to lift the depression, the American Journal of Psychiatry reports.

It may also explain why talking therapies designed to break negative thought cycles can also help.

Psychiatrist Dr Catherine Harmer and her team at Oxford University closely studied the reactions of 33 depressed patients and 31 healthy controls given either an antidepressant or a dummy drug.

The depressed patients who took the active drug showed positive improvements in three specific measures within three hours of taking them.

These patients were more likely to think about themselves in a positive light, rather than dwelling on their bad points, the researchers said.

They were also more likely to see the positive in others. For example, if they saw a grumpy person they no longer internalised this to think that they must have done something wrong to upset the person.

READ MORE @ BBC NEWS

Purging the stigma of mental illness

Joseph Rochford, associate professor of psychiatry at McGill and a director at the Douglas Hospital, hopes the hospital's Mini-Psych School will help debunk myths surrounding people suffering from mental disorders.

"Molecular biologists and geneticists are like the engineers who develop a new Formula One racing car. We're the ones who test drive it and then go back and say 'this is how it behaves.' "

That's Joseph Rochford, associate professor of psychiatry at McGill University and director of the Douglas Hospital Research Centre, on what a behaviour pharmacologist does.

The head of the neurophenotyping centre at the Douglas Institute studies how drugs used for treating mental disorders affect behaviour.

Starting this week, Rochford - also the director of academic affairs - will launch the Douglas's Mini-Psych School by giving the first session on the myths of mental illness. The purpose of the six-week course is to educate and sensitize the public to mental health issues.

READ MOEW @ MONTREAL GAZETTE

New Pfizer unit to take on autism

Diane Stephenson of Groton has three tangible reasons for wanting to know as much as possible about autism.

Stephenson, associate research fellow at Pfizer Inc.'s Groton laboratories who helped start an autism research unit there earlier this year, has two nephews and a niece with the neurological disorder, which is often accompanied by language difficulties, behavioral problems, sleep interruptions, poor eye contact and low social skills.

Her sister's son Thomas, 23, has never spoken a word. And two of her brother's children, Clarise, 5, and Craig, 2, also have been diagnosed with autism.

Autism is believed to be caused by a combination of environmental and genetic factors, but there is little doubt the disorder tends to run in families. Stephenson said couples who have one autistic child are 30 times more likely than others to have a second with the same disorder.

"Everyone wants a cure," said Stephenson, who has worked at the Groton labs for six years. "I felt there was something I could do."

So Stephenson, along with Pfizer colleague Howie Mayer, who has two children with autism, worked behind the scenes for a year with the idea of forming a separate research unit focusing on autism. They later added another colleague, Larry Fitzgerald, as the group put the finishing touches on its proposal, contacting key experts outside Pfizer who had a grasp on the latest breakthroughs in autism research.

READ MORE @ HARTFORD COURANT

Increase In Long-term Antidepressant Drug Use, UK Study Reveals

A dramatic rise in antidepressant prescriptions issued by GPs has been caused by a year on year increase in the number of people taking antidepressant drugs on a long-term basis, according to researchers from the University of Southampton.


In a paper, published in the printed edition of British Medical Journal (BMJ), scientists found that despite a drop in the number of new patients diagnosed with depression over 11 years, the number of prescriptions doubled.

"We estimate that more than 2 million people are now taking antidepressants long-term over several years, in particular women aged between 18 and 30," comments Tony Kendrick, a professor in Primary Medical Care of the University's School of Medicine, who led the study.

The number of prescriptions issued per patient rose from 2.8 in 1993 to 5.6 in 2004.

Prescription Pricing Authority data shows that more than 30 million prescriptions for SSRIs (selective serotonin reuptake inhibitors) such as Prozac and Seroxat, are now issued per year, twice as many as the early 1990s. Researchers at the University of Southampton found 90 per cent of people diagnosed with depression are now taking SSRIs either continuously or as repeated courses over several years.

RED MORE @ SCIENCE DAILY

Why antidepressants don't work for so many Northwestern research finds drugs aim at wrong target

More than half the people who take antidepressants for depression never get relief.

Why? Because the cause of depression has been oversimplified and drugs designed to treat it aim at the wrong target, according to new research from the Northwestern University Feinberg School of Medicine. The medications are like arrows shot at the outer rings of a bull's eye instead of the center.

A study from the laboratory of long-time depression researcher Eva Redei, presented at the Neuroscience 2009 conference in Chicago this week, appears to topple two strongly held beliefs about depression. One is that stressful life events are a major cause of depression. The other is that an imbalance in neurotransmitters in the brain triggers depressive symptoms.

Both findings are significant because these beliefs were the basis for developing drugs currently used to treat depression.

Redei, the David Lawrence Stein Professor of Psychiatry at Northwestern's Feinberg School, found powerful molecular evidence that quashes the long-held dogma that stress is generally a major cause of depression. Her new research reveals that there is almost no overlap between stress-related genes and depression-related genes.

READ MORE @ EUREKALERT

Texas Lawsuit Blames Antipsychotic Seroquel for Woman’s Diabetes

Taking Seroquel to treat a mental disorder caused a Texas woman to develop diabetes and she wouldn’t have taken the drug if she knew of the risks, according to a lawsuit filed in Texas federal court.


Misty Peters claims she took the atypical antipsychotic drug, which is approved for treating schizophrenia and bipolar disorder but also is widely used by physicians to treat other unapproved “off-label” conditions, according to a report in the Southeast Texas Record.

Peters’ product liability lawsuit, filed last week in the Beaumont Division of the Eastern District of Texas, accuses Seroquel’s maker, Astra Zeneca Pharmaceuticals, and others of promoting the drug’s benefits and downplaying its risks while knowing it could cause users to develop diabetes and other medical problems.


Seroquel Linked to Diabetes, Other Blood-Sugar Disorders
Seroquel was approved by the Food and Drug Administration in 1997 as a member of a newer class of drugs called atypical antipsychotics. The drugs, which control levels of dopamine in the brain, are billed as being just as effective as older antipsychotic drugs like Haldol with fewer side effects, but more recent research has found a link between taking Seroquel and developing diabetes and other blood-sugar disorders.

READ MORE @ ATORNEY AT LAW

In praise of 'electroshock'

What does it feel like to be profoundly depressed?

“Sometimes you feel like your head is going to explode,” Richard Braudo explains. “There were times I was so depressed, I was comatose. You can reach the point where you don't want to live – the pain is too much.”

Mr. Braudo knows. His diagnosis: treatment-resistant bipolar affective disorder.

The Toronto lawyer and management consultant has survived 30 bouts of severe depression, each lasting many months, not to mention a couple of suicide attempts.

But, at the age of 55, he has finally achieved “stable wellness.”

Mr. Braudo credits electroconvulsive therapy for his recovery. He has undergone 10 courses of ECT since 1991, the last about 18 months ago – the longest period, by far, in his adult life that he has gone without a bout of depression.

He has chosen to tell his story to help counter the negative public image of ECT as barbaric and painful and to underscore that prescription drugs are not the be-all and end-all for people with psychiatric illnesses.

READ MORE @ GLOBE AND MAIL

MENTAL DISORDERS DON'T HINDER HEADACHE TREATMENT

Contrary to long-standing thinking, medications may offer comparable headache relief to those with and without mental disorders.

For an especially miserable time, mix recurring headaches with depression, anxiety or both. But people in such a fix have cause for optimism, courtesy of a team led by psychologist Bernadette Heckman of Ohio University in Athens.

Drug treatments for headaches work just as well for patients with these psychiatric disorders as for those with no such problems, Heckman and her colleagues report in the November Pain.

Researchers and clinicians generally assume that the presence of one or more psychiatric ailments worsens headache symptoms and thus the prospects for successful treatment. Heckman and her colleagues conducted one of the few prospective studies to test that conviction.

“Contrary to conventional clinical wisdom, many patients with psychiatric disorders responded favorably to headache treatment,” Heckman says.

The team found that, during six months of treatment at any of four outpatient headache clinics, rates of improvement in headache frequency and intensity were about the same for patients with depression, anxiety, a combination of the two or no psychiatric disorders.

In a comment published with the new study, psychologist Todd Smitherman of the University of Mississippi in Oxford and psychiatrist Donald Penzien of the University of Mississippi Medical Center in Jackson say that the new findings “give us pause to reconsider our earlier predictions” that people with mental disorders respond poorly to headache treatment.

READ MORE @ SCIENCE NEWS

Men on Tricyclic Antidepressant More Likely to Think of Suicide

All antidepressants may not be created equal when it comes to worsening of suicidal ideation during treatment, researchers found.

Men taking nortriptyline (Aventyl, Pamelor) were 2.4 times more likely to have an increase in suicidal thoughts than were those taking escitalopram (Lexapro), Nader Perroud, MD, of King's College London, and colleagues reported online in BMC Medicine.

Nortriptyline, a tricyclic antidepressant, was also associated with a 9.8-fold higher risk of new onset of suicidal ideation compared with the selective serotonin reuptake inhibitor (SSRI) in the prospective open-label trial.

The reason behind the difference may be that nortriptyline acts predominantly on the noradrenergic system, which, when overactive, is associated with anxiety and agitation.
Because "suicidal ideation is more common in agitated and irritable types of depression," the researchers said, "it is possible that nortriptyline may induce or worsen suicidal thoughts in some male subjects possibly through an induction of this more agitated type of depression."

Another possibility is that nortriptyline is less effective against mood symptoms, they noted.

All antidepressants now carry black box warnings of suicidality risk, particularly in children and young adults, and especially early in treatment, but whether this risk differs between agents or by gender has been debated.

READ MORE @ MEDPAGE TODAY

'ECG for the mind' could diagnose depression in an hour

An innovative diagnostic technique invented by a Monash University researcher could dramatically fast-track the detection of mental and neurological illnesses.

Monash biomedical engineer Brian Lithgow has developed electrovestibulography which is something akin to an 'ECG for the mind'. Patterns of electrical activity in the brain's vestibular (or balance) system are measured against distinct response patterns found in depression, schizophrenia and other Central Nervous System (CNS) disorders.

The vestibular system is closely connected to the primitive regions of the brain that relate to emotions and behaviour, so Lithgow saw the diagnostic potential of measuring and comparing different patterns of electrovestibular activity.

Working with psychiatry researchers at Monash University's Alfred Psychiatry Research Centre (MAPrc) in Melbourne, Australia, he tested volunteers and found distinct response patterns, or "biomarkers", that distinguished different CNS diseases from each other and from regular electrovestibular activity.

READ MORE @ EUREKALERT"

Should Michigan repeal immunity law for drug industry? Even after a felony plea, residents can't sue

Recently we learned that the Department of Justice will fine Pfizer $2.3 billion in civil and criminal penalties for its illegal marketing of the drugs Bextra, Zyvox, Geodon and Lyrica. This is not only the largest penalty ever levied against a drug company. It is the largest penalty ever levied against any company in American history.

That is saying something.

Pfizer and its subsidiary entities -- the former Upjohn and Pharmacia -- not only promoted these drugs for uses that were not approved by the FDA. They also marketed the drugs for uses that were explicitly rejected by the FDA, primarily because of safety concerns. To the degree that patients were killed or injured as a result, Pfizer's off-label marketing scheme amounts to negligent homicide.

That is probably why Pfizer was compelled to plead guilty to felony charges, which is also unprecedented in such contexts. In most instances, companies plea-bargain to misdemeanor admissions, fines are levied, and that is the end of it.

READ MORE @ DETROT FREE PRESS

Response to Nortriptyline and Paroxetine Linked to Level of Neuropsychological Impairment in Patients With Parkinson's Disease: Presented at ANA

The use of nortriptyline and paroxetine in the treatment of depression does not affect cognitive functioning in patients with Parkinson's disease (PD); however, the higher the baseline performance on measures of executive functioning, speed of processing, and verbal memory, the better the response to antidepressant treatment, according to results presented here at the American Neurological Association (ANA) 134th Annual Meeting.

"This is one of the few studies to examine the impact of antidepressant treatment on cognition in PD patients with depression," said Roseanne D. Dobkin, PhD, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, New Jersey.

More than 1 million people are affected by PD in the United States alone. It is the second most common neurodegenerative disease in the country, said Dr. Dobkin on October 10.

"Depression is one of the most common nonmotor symptoms of PD, affecting as many as half of these patients," she added.

READ MORE @ DOCTOR'S GUIDE"

Older antidepressant spurs more suicidal thinking in men than newer medication

The largest clinical trial to date comparing an older, tricyclic antidepressant with a newer antidepressant of the selective serotonin reuptake inhibitor (SSRI) class has found that the emergence of suicidal thinking was almost 10 times more common in men taking the older drug than in those taking the newer medication.

The study also found that for men and women taking either medication, suicidal thinking was spread over the first six weeks of treatment, but peaked at roughly the fifth week before declining significantly after week six. Taking place at academic medical institutions across Europe, the trial, called Genome-Based Therapeutic Drugs for Depression--or GENDEP--gauged the responses to antidepressants of 811 persons ranging from 18 to 72 with depression.

READ MORE @ LOS ANGELES IMES

Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia

-- Fanapt (iloperidone), an antipsychotic therapy, is indicated in US for the acute treatment of schizophrenia in adults, set for US launch in early 2010

-- Addition of Fanapt will strengthen Novartis psychiatry portfolio and build on history in schizophrenia

-- Schizophrenia is a chronic, severe and disabling psychiatric disorder estimated to affect more than two million adults in the US and nearly 250,000 Canadians

-- Rights to Fanapt acquired from Vanda Pharmaceuticals Inc. for upfront payment of USD 200 million; Vanda eligible for milestones and sales royalties

Novartis Pharma AG has entered into an agreement for exclusive US and Canadian rights to Fanapt(TM) (iloperidone), a new oral medication that is approved by the US Food and Drug Administration (FDA) for the acute treatment of adults with schizophrenia. Novartis plans to launch Fanapt in the US in early 2010.
As part of the agreement with Vanda Pharmaceuticals Inc., Novartis will have exclusive commercialization rights to the oral formulation of this medicine in the US and Canada as well as exclusive rights to develop and commercialize a long-acting injectable (or "depot") formulation of this medicine for these markets.
Schizophrenia is a severe psychiatric disorder that is estimated to affect more than 2 million adults in the US and nearly 250,000 Canadians. Fanapt belongs to a class of medication for schizophrenia known as atypical antipsychotics.

READ MORE @ PR NEWSWIRE

Dementia's effects vary with cause

Dementia is an illness characterized by significant impairment of one or more areas of higher cognitive functioning, such as memory or ability to calculate. Dr. Mel Daly, a geriatrician at Greater Baltimore Medical Center Greater Geriatrics Group, discusses symptoms and treatment for dementia.

•About one in five people over age 80 have some form of dementia. Close relatives of people with early onset (before age 60) Alzheimer's disease have a greater chance of getting the disease. Those with genes from a group called ApoE are at increased risk for developing Alzheimer's disease. All persons with Down syndrome will eventually get Alzheimer's if they live long enough, and about half of patients with Parkinson's disease will develop a dementia similar to Alzheimer's. Head trauma or repeated blows to the head are also risk factors.

•Chronic alcoholism often results in dementia. Persons with high blood pressure, diabetes mellitus, cigarette smokers, high cholesterol levels, and atrial fibrillation are at risk for strokes that impair higher cognitive functioning.

Dementia can occur in patients with AIDS. Rarely, dementia is caused by other infections such as tertiary syphilis and viruses (Jacob-Creutzfeld disease).

READ MORE @ BALTIMORE SUN

Clemson bioengineer uses nanoparticles to target drugs

Clemson bioengineer Frank Alexis is designing new ways to target drugs and reduce the chances for side effects.

Pharmaceutical commercials can cause the unsettling feeling that if the disease doesn't kill, the cure will, what with a drug's long list of side effects and warnings. Many therapeutic drugs administered by pill, cream, syringe, IV or liquid can be a hit or miss delivery system. Researchers report that only 1 of 100,000 molecules of an intravenous drug make it to the intended spot in the body.

"The big issues for making medicines more effective are getting drugs to where they are needed and keeping them from breaking down as they circulate through the body," said Alexis. "A way to improve targeting a drug and preventing it from being passed out of the body is putting it in envelopes — putting the drug inside something to protect it until it's at the right spot."

The envelopes Alexis uses are nanoparticles. Think of an M&M, with the nanoparticle being the hard outer candy shell and the chocolate being the medicine. The goal would be the same as for an M&M — to melt in the right place.

Nanotechnology operates on the molecular level. It involves engineering materials on such a small scale that the results can be seen only with electron and atomic force microscopes. Nano-engineers take advantage of natural forces — positive and negative electrical charges, attraction and repulsion, surface texture — to have materials self assemble.

READ MORE @ CLEMSON UNIVERSITY NEWSROOM

FDA Eases Rules on Access to Investigational Psychotropic Drugs

The FDA’s new rule on “expanded access programs” would allow pharmaceutical companies to give seriously ill patients broader access to investigational drugs outside of clinical trials. A limited number of expanded access programs were created in the past under sketchy FDA rules; the 2 new allied rules—one on the conditions drug companies must meet to create a program, the other on how they can charge for the drugs—ostensibly give pharma a wider berth. Moreover, psychotropic drugs can be provided under the clarified policy.

When the FDA was considering changes to its policy (in part prompted by a lawsuit), it contended with the issue of whether the use of psycho-tropic drugs fits in the definition of “serious medical condition”—with which a patient must be afflicted before a drug company can make an investigational agent available outside a clinical trial. The health insurance industry made an effort to convince the FDA to exclude mental health conditions from serious medical conditions.

In her comments to the FDA after the agency proposed a rule in March 2007, Karen Ignagni, president and CEO of America’s Health Insurance Plans (AHIP), pressed the agency to include a definition in the final rule that said, “A serious disease or condition is one which is persistent, substantially disabling, progressive, and likely to result in death within 6 to 12 months.” She noted that schizophrenia and chronic depression are among the conditions that “cause disabling health effects and suffering for a period of time without death occurring prematurely or in a matter of months.” AHIP was concerned about exposure of its insurance company members to wide claims from policy holders for reimbursement for expensive, investigational drugs obtained through expanded access programs, which might multiply because of the FDA rule liberalization.

READ MORE @ PSYCHIATRIC TIMES

Antidepressant Use in Children With Cancer What We Now Know (and Need to Know) About the Use of Antidepressants

In 2007, cancer was diagnosed in 10,400 children and adolescents under the age of 15 years.1 While cancer remains the second leading cause of death in children, increasing numbers of children with cancer are surviving into adulthood.2 Over the past 30 years, 5-year survival rates for children with cancer have significantly improved, from 59% in 1975 to 1977 to 80% in 1996 to 2004.3 Pediatric cancer, increasingly considered a chronic rather than an acute condition, is an intense emotional and physical experience for patients and their families.4

Comprehensive psychiatric assessment of these children is complicated by symptoms of medical comorbidities that overlap mental health conditions. Few resources exist to guide clinicians in the psychiatric treatment of children with cancer. This article describes the sparse research from small clinical studies on the extent of psychiatric treatment in children with cancer and evidence from outcome studies of medication use in these children. Minimal knowledge on the role of antidepressants in such children motivated us to examine the question in a broad population-based approach.

Psychopathology

One area of interest in caring for children with cancer is the prevalence of psychiatric diagnoses. Assessment of psychiatric disorders in these children from either research or community settings is difficult because of the complex medical and emotional presentation of illness.5,6 DSM-IV criteria for mood disorders, for example, include both somatic and cognitive symptom criteria, and clinicians must decide which symptoms are caused by the illness and treatment and which are related to a separate psychiatric diagnosis.7

In addition, doctors and nurses may overestimate psychosocial distress and symptoms in children and adolescents with cancer.6 Assessment tools for psychiatric disorders are not often validated in children with medical illnesses, which may lead in part to the varying research prevalence of psychiatric disorders in this population.8

Reports of psychiatric illness in children with cancer range from a high of 17% to rates that do not differ significantly from those for the general population.9 Specific cancers and their treatments may also contribute to the variable rates of depression. Without more precise estimates that generalize to large youth populations, it is unclear whether children with cancer are at higher risk for a psychiatric disorder than children who are not medically ill.

READ MORE @ PSYCHIATRIC TIMES

Psychiatric Symptoms May Predict Internet Addiction In Adolescents

Adolescents with psychiatric symptoms such as attention-deficit/hyperactivity disorder (ADHD), social phobia, hostility and depression may be more likely to develop an Internet addiction, according to a report in the October issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.

Although the Internet has become one of the most significant information resources for adolescents, addiction to the Internet can negatively impact school performance, family relationships and adolescents' emotional state, according to background information in the article. "This phenomenon has been described as Internet addiction or problematic Internet use and classified as a possible behavior addiction," the authors write. Previous studies report that 1.4 percent to 17.9 percent of adolescents are addicted to the Internet in both Western and Eastern societies; therefore, there have been suggestions to add Internet and gaming addictions to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders. "Identification of the risk factors for Internet addiction is therefore of clinical significance for the prevention of, and early intervention into, Internet addiction in adolescents."

READ MORE @ SCIENCE DAILY

Government under pressure to publish antipsychotic review

10 leading dementia organizations, including the Alzheimer’s Research Trust, are demanding that the government publishes its long-delayed review into the widespread misuse of antipsychotic – or ‘chemical cosh’ – drugs.

Earlier this year, an Alzheimer’s Research Trust-funded study published in Lancet Neurology found that antipsychotic drugs double risk of death for many patients if used over a three year period. As many as 100,000 people with dementia are routinely prescribed antipsychotics in UK care homes. This could mean 23,500 people dying prematurely, according to a 2008 report by Paul Burstow MP.

The issue will be discussed by Rebecca Wood, Chief Executive of the Alzheimer’s Research Trust, at a Conservative Party Conference fringe event on dementia research with Shadow Health Minister Stephen O’Brien MP, and the author of the Lancet Neurology study Prof Clive Ballard of King’s College London and Alzheimer’s Society (‘Dementia Decade: a cure by 2020?’, Wednesday, 12.45, Marquee 2, MICC, Manchester).

Rebecca Wood, Chief Executive of the Alzheimer’s Research Trust, said:

"While the Department of Health prevaricates, thousands of people are being put at risk through the misuse of antipsychotics. After so many delays, the government must take swift and decisive action."

READ MORE @ ALZHEIMER'S RESEARCH TRUST

From War to Home: Psychiatric Emergencies of Returning Veterans

Since the time of Homer, warriors have returned from battle with wounds both physical and psychological, and healers from priests to physicians have tried to relieve the pain of injured bodies and tormented minds.1 The "soldier’s heart" of the American Civil War and the shell shock of World War I both describe the human toll of combat that since Vietnam has been clinically recognized as posttraumatic stress disorder (PTSD).2 The veterans of Operation Iraqi Freedom (OIF) and of Operation Enduring Freedom (OEF) share with their brothers and sisters in arms the high cost of war. As of August 2009, there have been 4333 confirmed deaths of US service men and women and 31,156 wounded in Iraq. As of this writing, 796 US soldiers have died in the fighting in Afghanistan.3

Yet, there are also unique aspects of the combat experience of these veterans that influence their psychiatric presentations in acute settings.

First, far more of the troops (up to 45%) are reserve or National Guard rather than active duty compared with earlier wars.4 Their combat exposure, severity of PTSD, and impairments in interpersonal functioning are more similar to those experienced by career military.5 These individuals are most likely to appear in crises in community emergency departments (EDs); they may present with problems that may be different from veterans of previous wars or from soldiers in active military duty.

Typical presenting symptoms are marital stress from unexpectedly long deployments of 15 months (rather than the standard 12), employment concerns, financial stresses, and overall difficulty in reintegrating into civilian life. The absence of a strong military identity and cohesion, geographical separation from comrades, greater stigma, and misunderstanding from communities without exposure to the military or combat trauma serve as formidable barriers to care for these citizen-soldiers.

READ MORE @ PSYCHIATRIC TIMES

Depression Is a Dilemma for Women in Pregnancy

When Sherean Malekzadeh Allen of Marietta, Ga., learned she was pregnant, she was 43, had been married for two years, had gone through two miscarriages and had all but given up hope of having a baby.

But instead of being overjoyed, Ms. Allen was immobilized: panic-ridden, nauseated, listless and thoroughly depressed. She could not rouse herself to go to work in the marketing business she founded and ran, or even get through the newspaper.

And she faced the pregnant woman’s quintessential dilemma: take drugs that might pose a risk to the developing baby, or struggle through an anguishing pregnancy that could harm the baby in other ways?

“Every single thing you put in your body when you’re pregnant, you wonder, ‘Oh, my God, am I growing my baby an extra finger?’ ” Ms. Allen said. “I was worried that I would hurt the baby if I took the pills, and I was worried I would hurt the baby if I didn’t.”

READ MORE @ NY TIMES

Statement emphasizes link between severe mental illness, CVD, diabetes

European organizations are calling for improved care and screening for CVD, diabetes in those with mental illnesses.

People with severe mental illnesses, such as schizophrenia, depression and bipolar disorder, die about 10 to 20 years prematurely compared with the general population, and the most common cause of death is cardiovascular disease, experts said at a press conference on Wednesday.

A joint statement issued by the European Association for the Study of Diabetes, European Society of Cardiology and European Psychiatric Association emphasizes the link between mental illness and CVD, with the goal of increasing awareness, improving care and initiating cooperation and screening.

“In addition to having the devastating effects of severe mental illness, people with schizophrenia and bipolar disorder die prematurely,” Richard Holt, MD, PhD, from the University of Southampton, United Kingdom, said during a press conference.

People with mental illness find it much harder to access physical health services, Holt noted. “Rates of screening for both diabetes and CVD are significantly less than in the general population,” he said. “While maybe 20% of cases of diabetes are unknown in the general population, among people with mental illness, as many as 70% are undiagnosed.”

READ MORE @ ENDOCRINE TODAY

Antidepressant and placebo are equally effective in child pain relief

When used "off-label," the antidepressant amitriptyline works just as well as placebo in treating pain-predominant gastrointestinal disorders in children, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute. To view this article's video abstract, go to the AGA's YouTube Channel at www.youtube.com/AmerGastroAssn.

"Many pharmaceutical products are prescribed for off-label use in children due to the lack of clinical trials testing the efficacy of the drugs in children and adolescents. Therefore, the pediatric gastroenterologist frequently has to make treatment decisions without the evidence of how drugs work in children," said Miguel Saps, MD, of Children's Memorial Hospital and lead author of the study. "The high placebo effect we identified in this study suggests that further studies of the use of certain antidepressants in children with functional bowel disorders are needed. While several trials have demonstrated a beneficial effect of antidepressants, including amitriptyline, for the treatment of irritable bowel syndrome (IBS) in adults, more research is needed to determine how effective this drug is, if at all, in children."

READ MORE @ EUREKALERT

Oops, They Did It Again - What Integrity Means to Pfizer

The satire was biting:

"Thanks for making time to see me today," posted a rep on cafepharma about a fictitious sales meeting with a psychiatrist. "Now, I know that you used Neurontin in the past for every condition under the sun. Pfizer knows very well that you guys were and still continue to be the largest writers of off-label Lyrica and so, in the spirit of Bextra [withdrawn in 2004] will you please write Lyrica as much as possible? Remember Dr, this is Pfizer. The company that never met an off-label sale that it wouldn't cover-up."

Don't forget, writes the next poster on the pharma site, the psychiatrist answers, "Great! and I also heard that it is about to be approved on state Medicaid and I can write it for anything. Is this true?" to which the rep assents in defiance of, "that nice little 2004 CIA agreement."

Pfizer's nice little 2004 "CIA" or Corporate Integrity Agreement in which a company promises to sin no more to which the poster refers was for fraudulent marketing of seizure drug Neurontin. It was preceded by a CIA for fraud related to Pfizer's cholesterol drug, Lipitor, in 2002.

And this month it's followed by a CIA for mis-marketing pain drug Bextra, antipsychotic Geodon, seizure drug Lyrica and antibiotic Zyvox.

Pfizer's $2.3 billion health care fraud settlement with the government announced this month by the US Department of Justice adds some firsts to the world's biggest pharmaceutical company.

It is the largest health care fraud settlement in the history of the Department of Justice "to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products,"--and the largest criminal fine ever imposed in the United States. It covers Pfizer's kickbacks to health care providers and false claims submitted to government health care programs, also known as our tax dollars, in violation of the Food, Drug and Cosmetic Act. Forty-three states will share in the "give backs."

But it is not exhaustive.

READ MORE @ COUNTERPUNCH

Rx America: Drug companies want patent protection in health care overhaul

As Congress debates a health-care insurance overhaul, the pharmaceutical industry is lobbying heavily for expanded patent protections that its lobbyists say are necessary to protect the industry’s investments and encourage future developments.

The question is how long a period a drug developer will have exclusive rights to a certain kind of drug – called biologics – before competitors can be allowed into the market with generic versions.

Biologics are costly drugs produced from living organisms, not from chemicals as the more common small molecule drugs are composed. Americans spend an estimated $40 billion per year on the drugs, which comprise almost a third of Medicare Part B spending.

PhRMA – the lobbying arm of the industry headed by former Louisiana Congressman Billy Tauzin – wants at least 12 years of protection from competition, saying that’s about what it would take, on average, to recoup the initial research and development investment of getting a drug to the marketplace.

READ MORE @ NEW ORLEANS PICAYUNE