Monday, August 31, 2009

Generic versions of biologic medications are coming Companies most likely to produce biogenerics

The days of market exclusivity could soon come to an end for the biotech industry if Congress moves forward with plans to finally allow generic biologics on the U.S. market.

Because of their eye-popping price tags, pressure to rein in the cost of biologics has been mounting on Capitol Hill for some time. A process for approving generic versions of traditional chemical medications has been in place for more than a decade, but Congress has yet to establish a similar legal pathway for biologics.

But all that could change in the next few months. Currently, almost all of the leading healthcare reform bills circulating on the Hill call for allowing the Food and Drug Administration to establish an approval process for generic biologics, also known as biogenerics or biosimilars.

Unlike traditional drugs, which are comprised of chemicals, biologics use living cells to treat diseases and disorders. The drug category includes some of the most popular therapies on the market: Cancer treatments such as Roche's /quotes/comstock/11i!rhhby (RHHB.Y 39.12, -0.72, -1.81%) Avastin and Herceptin; rheumatoid arthritis drugs such as Amgen Inc.'s /quotes/comstock/15*!amgn/quotes/nls/amgn (AMGN 58.98, -0.80, -1.34%) and Wyeth's /quotes/comstock/13*!wye/quotes/nls/wye (WYE 47.79, -0.06, -0.13%) Enbrel, Johnson & Johnson's /quotes/comstock/13*!jnj/quotes/nls/jnj (JNJ 59.94, -0.50, -0.83%) and Schering-Plough Corp.'s /quotes/comstock/13*!sgp/quotes/nls/sgp (SGP 27.79, -0.39, -1.38%) Remicade, and Abbott Laboratories' /quotes/comstock/13*!abt/quotes/nls/abt (ABT 45.12, -0.11, -0.24%) Humira; and multiple sclerosis therapies such as Biogen Idec's /quotes/comstock/15*!biib/quotes/nls/biib (BIIB 49.24, -0.96, -1.91%) Avonex.

READ MORE @ MARKET WATCH

Sunday, August 30, 2009

Antidepressants Vary More in Side Effects, Not Efficacy

Summary

[SIDE EFFECTS] The main differences among the newer antidepressants are side effects and drug interactions. See the Commentary for a drug-by-drug list of these key differences. [PCP's] This review comes from a group of primary care docs, which is important because most depression is treated by PCPs. [FOLLOW-UP] It emphasizes the need for follow-up 1-2 weeks after initial prescription, which is KEY to improving adherence and addressing new side effects.

READ MORE @ GERSON LEHMAN GROUP

Saturday, August 29, 2009

Depression and The Recession: Cymbalta Sales Are on the Rise

During a downturn, we tend to seek the "bright spots" -- sectors or products that are doing well when all the rest are struggling. For example, there were plenty of reports over the past year about retail items -- lipstick, chocolate, and macaroni and cheese -- that were bucking downward trends and selling well during the slump. While these stories were cautiously upbeat, news of an uptick in antidepressant sales despite -- or perhaps because of -- the recession was just plain depressing.

Helplessness, pessimism and persistent sadness -- the main symptoms of depression -- didn't seem to abate as the economy crumbled. About 164 million antidepressant prescriptions were written in 2008, 4 million more than in 2007, according to IMS Health, a health-care information and consulting company.

Antidepressants were the third most prescribed type of drug in 2008, hitting $9.6 billion in sales, up from $9.4 billion the year before. Last month, Eli Lilly reported that second-quarter sales for Cymbalta -- which is on the verge of surpassing Effexor as the nation's best-selling antidepressant -- increased 14 percent over the past year. Our national reliance on these drugs is a stubborn trend. A study published in the August issue of Archives of General Psychiatry found that from 1996 to 2005, antidepressant use in the United States doubled.

READ MORE @ WASHINGTON POST

Friday, August 28, 2009

New Antipsychotic Eases Schizophrenia Symptoms

The novel antipsychotic lurasidone appears to improve acute schizophrenia symptoms without the weight gain or metabolic problems common among second generation agents, according to a preliminary report from the drug's second pivotal trial.

Patients treated with the 40 and 120 mg doses of the drug had reductions of 25.7 and 23.6 points on the Positive and Negative Syndrome Scale (PANSS) total score, significantly greater than the 16.0 decline among placebo treated patients, according to data released by drug developer Dainippon Sumitomo Pharma.

In the phase III PEARL 2 (Program to Evaluate the Antipsychotic Response to Lurasidone) trial, 53% of patients on the lower dose and 47% on the higher dose had at least a 30% improvement on symptom score from baseline whereas only 38% on placebo did.

The company press release also announced that lurasidone met key secondary efficacy endpoints at both doses in the trial, including change from baseline on the Clinical Global Impressions Severity scale (-1.5 and -1.4 versus -1.1, respectively).

The results are expected to be reported in greater detail at the American College of Neuropsychopharmacology meeting later this year.

aread more @ medpage today

Thursday, August 27, 2009

Antidepressants: Selective Serotonin And Norepinephrine Reuptake Inhibitor Drugs Show Benefits In German Study

The Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether patients with depression benefit from taking drugs belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) drug class. Up till now, 2 of these drugs have been approved as antidepressants in Germany: venlafaxine and duloxetine. The Institute published its final report on 18 August. According to this report, the benefit of both drugs has been proven compared to a sham drug (placebo): patients respond better to the therapy and suffer less from the symptoms of depression. Moreover, there are indications that both drugs protect against relapse in addition to alleviating symptoms.

Interplay of biological and psycho-social factors

There are various assumptions about when and how depression occurs. The possible causes and influencing factors are manifold. What is not disputed is that the complete clinical picture of depression is the result of a complex interplay of biological and psycho-social factors. There are indications that a modification or reduction in the transfer of certain messenger substances in the central nervous system plays a part. This is where most drug therapies start their effect. The comparatively new SNRI drug class is intended to influence two of these messenger substances (neurotransmitters) by inhibiting the reuptake of serotonin and norepinephrine.

READ MORE @ SCIENCE DAILY

Wednesday, August 26, 2009

Abuse of ADHD Drugs on the Rise

As more and more prescriptions are being written for medications to treat attention-deficit hyperactivity disorder (ADHD), more and more children are abusing these drugs.

That's the conclusion of new research in the September issue of Pediatrics that found the rate of ADHD medication abuse was up 76 percent from 1998 to 2005, and at the same time, the rates of prescriptions for these medications rose about 80 percent.

"We looked at all the poison control centers across the nation and found a significant increase in the number of calls for ADHD medication abuse that parallels the amount of prescriptions being written," said Dr. Jennifer Setlik, an emergency physician at Cincinnati Children's Hospital Medical Center in Ohio and a study author.

What's more, Setlik said, is that this study is "not an estimate of the total problem" because it looks only at data from poison control centers, but it gives doctors and parents a snapshot of the trend toward rising abuse of these medications with increasing availability.

ADHD affects between 8 percent and 12 percent of children, and as many as 4 percent of adults worldwide, according to background information in the study. The disorder is commonly treated with stimulant medications, which have a seemingly paradoxical effect on people with ADHD, allowing them to concentrate and function more effectively. The drugs most often prescribed are mixed amphetamine salts (Adderall) and methylphenidate (Ritalin, Concerta), according to the study.

READ MORE @ ATLANTA JOURNAL CONSTITUTION

Tuesday, August 25, 2009

Iloperidone Approved as “Second-Generation” Benefits Debated

The FDA recently approved iloperidone (Fanapt, Vanda Pharmaceuticals) for the treatment of schizophrenia, reversing a July 2008 determination that the New Drug Application (NDA) was “not approvable.” An FDA spokesperson explained in an interview in Forbes (May 8), “Vanda provided the FDA with additional data and arguments that led us to reinterpret results of several of their studies.”

The favorable judgment culminated a circuitous product development path. The compound had been developed by Hoechst Marion Roussel, but the rights were sold to Titan Pharmaceuticals in 1997, and then to Novartis in 1998, before Vanda Pharmaceuticals acquired them in 2004. Vanda succeeded in garnering regulatory approval, in large part by redesigning the clinical trials supporting the NDA.

Rather than comparing the efficacy of iloperidone with risperidone and haloperidol, which had not previously favored iloperidone, the new trials compared iloperidone with placebo and used ziprasidone as an active control. In this design, the active agents were shown to have comparable efficacy in improving symptoms measured on the 30-item Positive and Negative Syndrome Scale (PANSS) and were both statistically superior to placebo.

READ MORE @ PSYCHIATRIC TIMES

Monday, August 24, 2009

Touted "Depression Risk Gene" May Not Add to Risk After All

A gene variation long thought to increase a person’s risk for major depression when paired with stressful life events may actually have no effect, according to a new analysis. The result challenges a common approach to studying depression risk factors.

Most mental disorders are thought to be caused by a combination of many genetic risk factors interacting with environmental triggers. Finding the exact combinations of factors, however, has been a significant challenge. Advances during the past decade have led to powerful tools for studying how genes and the environment interact to affect the risk for disease. In 2003, these advances allowed scientists to show that variation in a gene called the serotonin transporter gene affected the risk of major depression in people who had a number of stressful life events over a 5-year period.

Serotonin is a chemical messenger that helps brain cells communicate. The serotonin transporter directs serotonin from the space between brain cells back into the cell for reuse. Since the most widely prescribed class of medication for treating major depression acts by blocking this protein, it’s been a prime suspect in mood and anxiety disorders.

READ MORE @ NIH Research Matters

Sunday, August 23, 2009

Cymbalta's waning patent and generic rivals soon could threaten Lilly's sales

Eli Lilly has enjoyed a wave of success with antidepressants, but analysts say such expertise must now bring new revenue growth.

Eli Lilly and Co. built a large part of its fortune selling medications for gloom, anxiety and withdrawal.

Now the question is: Can the Indianapolis drug maker keep riding the antidepressant wave? Can it find its next Prozac, its next Cymbalta?

Use of antidepressants in the U.S. doubled from 1996 to 2005, as more people sought out treatment and the stigma of depression has fallen, according to a study published in the August issue of the Archives of General Psychiatry. All told, about 10 percent of Americans, or 27 million people, were prescribed an antidepressant in 2005, up sharply from 13 million people a decade earlier.

"There's a huge increase in the recognition of depression and its symptoms," said Dr. Jim Martinez, an Indianapolis psychiatrist and adviser to Lilly. "And I think we've seen a growing improvement in public attitudes around seeking care for this disease."

But in recent years, the market has faced growing headwinds. Industry sales from antidepressants dipped nearly 14 percent in the past four years, even as the number of prescriptions dispensed for the pills has continued to climb. Medco Health Solutions, a huge pharmacy company that studies drug trends, is forecasting that use of antidepressants is likely to grow slowly over the next three years.

READ MORE @ INDIANAPOLIS STAR

Saturday, August 22, 2009

Online Psychiatric Counseling Appears Effective New Study Shows Remote Counseling Online Can Have Mental Health Benefits

If you're feeling depressed but can't see a shrink in person, the next best thing may be instant messaging, according to a new British study.

Online cognitive behavioral therapy for depression -- with patients and therapists communicating in real time via instant messaging, or IM -- was not only effective, but could broaden access to treatment, researchers reported in the Aug. 22 issue of The Lancet.

After four months, 38 percent of patients who had participated in the Internet-based therapy program had recovered from depression, compared with 24 percent of those in a control group, according to Dr. David Kessler of the University of Bristol.

After eight months' follow-up, 42 percent of the treatment group -- but only 26 percent of controls -- had recovered.

READ MORE @ ABC NEWS

Friday, August 21, 2009

Pregnant, depressed and confused? New guidelines clarify antidepressant risks, benefits

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Pregnant, depressed and confused? New guidelines clarify antidepressant risks, benefits
August 21, 2009 | 5:00 pm

Depression hits women in the childbearing years more than any other demographic, but how to deal with this most common of mental afflictions poses a conundrum: antidepressant medications have become the first line of defense against depression; but there's growing research evidence that they pose risks to a developing fetus.

It's a tightrope that obstetricians on the front lines of patient care have walked for years without guidance from their own leaders or the profession of psychiatry. Busy, concerned but operating in unfamiliar terrain, many obstetricians have pulled out their pads, written a prescription for an antidepressant, and hoped for the best. No surprise, then, that by 2003, 13% of pregnant women had taken an antidepressant at some point in their http://latimesblogs.latimes.com/booster_shots/2009/08/pregnant-depressed-and-confused-new-guidelines-clarify-antidepressant-risks-benefits.html -- twice the rate that was seen in 1999.

But on Friday, the American Psychiatric Assn. and the American College of Obstetricians and Gynecologists put a safety net under obstetricians and the pregnant women they treat. In a first-ever set of guidelines, the two physician groups offered obstetricians and their patients a set of clear road maps for treating depression in pregnancy.

The guidelines were published simultaneously in the ACOG journal Obstetrics and Gynecology and in the APA's journal, General Hospital Psychiatry.

READ MORE @ LOS ANGELES TIMES

Thursday, August 20, 2009

Senator Moves to Block Medical Ghostwriting

A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.

Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.

With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting. Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.

READ MORE @ NY TIMES

Tuesday, August 18, 2009

Treatment-Resistant Schizophrenia Strategies for Recognizing Schizophrenia and Treating to Remission

Since the introduction of chlorpromazine, the first antipsychotic drug, it has been evident that a large number of patients have schizophrenia that is treatment resistant. It is estimated that between 20% and 60% of patients have schizophrenia that is resistant to treatment.1,2

The relationship between treatment-resistant and treatment-responsive schizophrenia is not strictly black and white. No particular psychopathology of schizophrenia specifically suggests treatment-resistant disease. Brenner and Merlo3 proposed that treatment-resistant schizophrenia be considered at one end of a spectrum of antipsychotic drug response rather than being clearly differentiated from treatment-responsive schizophrenia. However, patients with treatment-resistant schizophrenia do tend to have prominent negative and cognitive symptoms and more severe psychopathology than patients whose condition responds to antipsychotic drugs.

Chronicity has often been confused with treatment-resistant schizophrenia. Schizophrenia is a chronic disorder that progresses to various levels of clinical deterioration without sustained remission or full recovery. In contrast with treatment-resistant schizophrenia, chronicity is associated with a favorable response to drug treatment, in which schizophrenic features are largely under control for 6 months or longer or there is partial recovery to the premorbid level of functioning.4,5

READ MORE @ PSYCHIATRIC TIMES

Monday, August 17, 2009

Mental Stress Training Is Planned for U.S. Soldiers

The Army plans to require that all 1.1 million of its soldiers take intensive training in emotional resiliency, military officials say.

The training, the first of its kind in the military, is meant to improve performance in combat and head off the mental health problems, including depression, post-traumatic stress disorder and suicide, that plague about one-fifth of troops returning from Afghanistan and Iraq.

Active-duty soldiers, reservists and members of the National Guard will receive the training, which will also be available to their family members and to civilian employees.

The new program is to be introduced at two bases in October and phased in gradually throughout the service, starting in basic training. It is modeled on techniques that have been tested mainly in middle schools.

READ MORE @ NY TIMES

Sunday, August 16, 2009

Breakthrough in Alzheimer's research

A combination of proteins in the cerebrospinal fluid can reliably identify which patients with early symptoms of dementia will subsequently develop full-blown Alzheimer's disease, a research team at the University of Gothenburg, Sweden, has found in a major international study. The results were published in this week's edition of the Journal of the American Medical Association (JAMA).

Alzheimer's is one of the most common dementia disorders. Around 160,000 people in Sweden currently suffer from dementia, and an estimated 60 per cent of them have Alzheimer's.

"There is currently no medication that can alter the course of the disease, but the medicines currently under development will probably have the greatest effect if they are used from an early stage, so methods are needed for early diagnosis of the disease," says Dr Niklas Mattsson, a member of Kaj Blennow's group at the Institute of Neuroscience and Physiology at the University of Gothenburg's Sahlgrenska Academy.

READ MORE @ EUREKALERT

Saturday, August 15, 2009

National Academy Urges Changes in Screening and Treatment of Depression

A National Academy of Sciences (NAS) report urging a more coordinated approach to prevention and treatment of depression in parents—because of its impact on children—hit the streets just as Congress began considering legislation to reform the US health insurance system. The NAS report made a number of recommendations for changing the approach of both public and private health insurers toward depression, although the front-line troops expected to deal with the problem are primary care physicians, who already treat 70% of patients with depression.

According to the report, conventional screening does not consider the impact of a parent’s mental health status on the health and development of the children, nor have models that incorporate multiple interventions (eg, collaborative care) for adults been tested for their effectiveness in serving parents. “In short, parental depression is prevalent, but a comprehensive strategy to treat the depressed adults and to prevent problems in the children in their care is absent.”

READ MORE @ PSYCHIATRIC TIMES

Friday, August 14, 2009

Schering-Plough Gets FDA Approval for Saphris

Schering-Plough Corp.'s new drug for schizophrenia and bipolar disorder, Saphris, has been approved by the Food and Drug Administration.

The pill, taken twice a day, is the first mind-altering medication to get simultaneous approval for treating both conditions, but it will face significant competition in a crowded market.

For now, it is only specifically approved for short-term use for acute problems, such as when patients have a psychotic episode. However, the drug's label, or detailed package insert, recommends patients responding well to Saphris should continue on it.

Kenilworth, N.J.-based Schering-Plough has completed some studies and is finishing up others on the long-term safety and effectiveness of the drug, spokesman Robert Consalvo said Friday. The company plans to eventually seek official approval for ''maintenance treatment.''

READ MORE @ NY TIMES

Thursday, August 13, 2009

Some Conditions Misdiagnosed as Bipolar Disorder

A study published last year suggested that bipolar disorder may be over diagnosed in people seeking mental health care. Now new findings shed light on which disorders many of these patients actually have.

Bipolar disorder, also known as manic depression, involves dramatic swings in mood -- ranging from debilitating depression to euphoric recklessness.

In the original 2008 study, researchers at Brown University School of Medicine found that of 145 adults who said they had been diagnosed with bipolar disorder, 82 (57 percent) turned out not to have the condition when given a comprehensive diagnostic interview.

In this latest study, published in the Journal of Clinical Psychiatry, the researchers used similar standardized interviews to find out which disorders those 82 patients might have.

Overall, they found, nearly half had major depression, while borderline personality disorder, post-traumatic stress disorder (PTSD), generalized anxiety and social phobia were each diagnosed in roughly one-quarter to one-third.

READ MORE @ ABC NEWS

Wednesday, August 12, 2009

Anti-psychotic drugs could help fight cancer

The observation that people taking medication for schizophrenia have lower cancer rates than other people has prompted new research revealing that anti-psychotic drugs could help treat some major cancers.

A preliminary finding in the current online issue of the International Journal of Cancer reports that the anti-psychotic drug, pimozide, kills lung, breast and brain cancer cells in in-vitro laboratory experiments.

Several epidemiological studies have noted the low rate of cancer among schizophrenic patients. These studies found, for example, that these patients have lower rates of lung cancer than other people, even though they are more likely to smoke.

Genetic factors and the possibility of reduced cancer detection in patients have been considered and over the past decade anti-psychotic drugs have been suggested as possible mediators of this effect.

In the new study, pimozide was the most lethal of six anti-psychotic drugs tested by a team from UNSW and the University of Queensland. Rapidly-dividing cancer cells require cholesterol and lipids to grow and the researchers suspect that pimozide kills cancer cells by blocking the synthesis or movement of cholesterol and lipid in cancer cells.

Analysis of gene expression in test cancer cells showed that genes involved in the synthesis and uptake of cholesterol and lipids were boosted when pimozide was introduced.

READ MORE @ EUREKALERT

Tuesday, August 11, 2009

Antidepressant suicide risk varies by age: FDA

People under age 25 who take antidepressants have a higher risk of suicide, but adults older than that do not, an analysis by U.S. Food and Drug Administration researchers released on Tuesday showed.

The report by the FDA scientists confirms earlier studies and supports the agency's age-related warnings on the drugs' labeling.

U.S. and European regulators have been sounding alarms on the use of antidepressant drugs since 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in those under age 18.

In February 2005, the FDA added a so-called black box warning -- the agency's strongest warning -- on the use of all antidepressants in young children and teens to draw attention to the possible risks of these medications. In May 2007, it extended the warnings to young adults aged 18 to 24.

Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment for depression, the leading cause of suicide. In fact, recent studies have suggested the warnings triggered an 8 percent rise in suicide among youth and teens in 2004, the biggest one-year gain in 15 years.

READ MORE @ REUTERS

Monday, August 10, 2009

Certain drugs may increase risk of falling

In elderly men and women, certain medications can increase the risk of falling, new research shows.

Findings from a 4-year study conducted in France suggest the risk of falling is 1.4 times greater among elderly men and women taking a long-acting benzodiazepine, compared with age-matched men and women not using this type of anti-anxiety medication.

Dr. Annick Alperovitch, at INSERM in Paris, and colleagues also found a moderately increased risk of falling among elderly men and women who regularly used mood- and behavior-altering "psychotropic" medications.

Their findings, reported in the journal BMC Geriatrics, identified similar risk among elderly individuals reporting regular use of tranquilizers, muscle relaxants and anti-spasmodics, and some antihistamines that block nerve responses (so-called "anticholinergics").

READ MORE @ REUTERS

Sunday, August 9, 2009

Psychosocial Therapy With Antidepressants More Effective In Helping Depressed Stroke Patients

Psychosocial therapy combined with medication can effectively improve depression and recovery in stroke patients, according to a new study reported in Stroke: Journal of the American Heart Association.

In the first long-term study of psychosocial/behavioral therapy in combination with antidepressants, researchers found that adding psychosocial therapy improved depression scores short term and those improvements were sustained long term. At one year:

* Depression scores dropped 47 percent in patients treated with eight weeks of psychosocial/behavioral therapy and antidepressants.
* Scores dropped 32 percent among those having usual care, which included taking antidepressants.

The results are clinically and statistically significant, researchers said. Patients with improved depression perceived their recovery as significantly greater and also felt their physical condition and social participation were better than those with lesser improvement in depression.

<READ MORE @ SCIENCE DAILY

Saturday, August 8, 2009

Antidepressants once seen as miracle drugs: now risks are becoming evident

Since the horror of the Thalidomide scandal in the 1960s, pharmaceutical companies and medicines regulators have been acutely aware of the dangers drugs may pose to the unborn child.

Establishing what the effect of a drug may be on a foetus, however, is no simple task. Companies must rely on animal studies in the early stages of research and hope that the drug will behave in humans in the same way. Trials on pregnant women are rarely carried out, for obvious reasons.

Depression and anxiety became big business for the pharmaceutical industry in the 1990s as doctors became better at diagnosing the problems, exposing a population of over-achieving, highly-stressed, worried-well.

Women, always more willing to see a doctor than men, were a large proportion of those diagnosed and put on SSRIs (selective serotonin reuptake inhibitors) such as Prozac and the British drug Seroxat, known as Paxil in the US. For a while, these seemed to be the new miracle drugs. They were safer than older antidepressants because the severely depressed could not overdose on them.

But in court cases about to begin in the US, it will be argued that insufficient attention was paid to the possible dangers for young women who were pregnant or might become pregnant and more particularly, for their babies.

READ MORE @ GUARDIAN

Friday, August 7, 2009

Psychologists: Gays shouldn't be advised to change

The American Psychological Association declared Wednesday that mental health professionals should not tell gay clients they can become straight through therapy or other treatments.

Instead, the APA urged therapists to consider multiple options — that could range from celibacy to switching churches — for helping clients whose sexual orientation and religious faith conflict.

FAITH & REASON: 'Be straight or go away'
YOUNG ADULTS: 'Don't want to be defined by gender, orientation'

In a resolution adopted on a 125-to-4 vote by the APA's governing council, and in a comprehensive report based on two years of research, the 150,000-member association put itself firmly on record in opposition of so-called "reparative therapy" which seeks to change sexual orientation.

No solid evidence exists that such change is likely, says the report, and some research suggests that efforts to produce change could be harmful, inducing depression and suicidal tendencies.

READ MORE @ USA TODAY

Thursday, August 6, 2009

FDA Okays First Monthly Antipsychotic Drug

The FDA has approved the injectable maintenance drug paliperidone palmitate (Invega Sustenna), making it the first once-monthly, atypical antipsychotic for schizophrenia.

The long-acting drug is approved for both acute and maintenance treatment.

The parent drug -- paliperidone in a once-daily tablet -- is an active metabolite of an old pharmaceutical, the atypical antipsychotic risperidone (Risperdal). (See Invega (paliperidone), Son of Risperdal (risperidone), Wins FDA Okay for Schizophrenia)

Researchers see once-monthly dosing as a potential solution for the medication adherence problems common in schizophrenia, noted Henry A. Nasrallah, MD, of the University of Cincinnati, an investigator in the paliperidone palmitate clinical trials.

"Inconsistent compliance with medications is arguably one of the single greatest impediments to managing the symptoms of schizophrenia and delaying the time to relapse," he said in a prepared statement.

READ MORE @ MEDPAGE TODAY

Wednesday, August 5, 2009

CCHRINT Announces FDA Reported Psychiatric Drug Side Effects Search Engine

Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone.

For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).

The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.

The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.

The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).

It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.

READ MORE @ PR WEB

Tuesday, August 4, 2009

After Combat, Victims of an Inner War

Sgt. Jacob Blaylock flipped on the video camera he had set up in a trailer at the Tallil military base, southeast of Baghdad.

He lit a cigarette, inhaled deeply, blew the smoke upward.

“Hey, it’s Jackie,” he said. “It’s the 20th of April. We go home in six days. I lost two good friends on the 14th. I’m having a hard time dealing with it.”

For almost a year, the soldiers of the 1451st Transportation Company had been escorting trucks full of gasoline, building materials and other supplies along Iraq’s dark, dangerous highways. There had been injuries, but no one had died.

Their luck evaporated less than two weeks before they were to return home, in the spring of 2007. A scout truck driving at the front of a convoy late at night hit a homemade bomb buried in the asphalt. Two soldiers, Sgt. Brandon Wallace and Sgt. Joshua Schmit, were killed.

The deaths stunned the unit, part of the North Carolina National Guard. The two men were popular and respected — “big personalities,” as one soldier put it. Sergeant Blaylock, who was close to both men, seemed especially shaken. Sometime earlier, feeling the strain of riding the gunner position in the exposed front truck, he had switched places with Sergeant Wallace, moving to a Humvee at the rear.

READ MORE @ NY TIMES

Monday, August 3, 2009

Antidepressant Use in U.S. Has Almost Doubled Study also finds increases in use of other psychotropic medications

Antidepressant use among U.S. residents almost doubled between 1996 and 2005, along with a concurrent rise in the use of other psychotropic medications, a new report shows.

The increase seemed to span virtually all demographic groups.

"Over 10 percent of people over the age of 6 were receiving anti-depression medication. That strikes me as significant," said study author Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University/New York State Psychiatric Institute in New York City.

According to background information in the study, antidepressants are now the most widely prescribed class of drugs in the United States. The expansion in use dates back to the 1980s, with the introduction of the antidepressant Prozac (fluoxetine).

The study found that 5.84 percent of U.S. residents aged 6 and over were using antidepressants in 1996, compared with 10.12 percent in 2005. That's 13.3 million people, up to 27 million people.

"This is a 20-year trend and it's very powerful," remarked Dr. Eric Caine, chair of the department of psychiatry and co-director of the Center for the Study of Prevention of Suicide at the University of Rochester Medical Center.

This happened despite a "black box" warning mandated for many antidepressant medications by the U.S. Food and Drug Administration in 2004, the study authors noted.

READ MORE @ U.S. NEWS & WORLD REPORT

Sunday, August 2, 2009

New link between depression and heart disease

Researchers have identified an enzyme that may trigger depressive symptoms in patients with heart disease and may help to explain why general antidepressants are often not as effective for these specific patients.

"Our study confirms that depressive symptoms are associated with inflammation in patients with heart disease and suggests a mechanism by which the brain might be affected," says Walter Swardfager, lead author of a new study and PhD candidate in the Neuropsychopharmacology Research Program at Sunnybrook Health Sciences Centre.

The research focuses on an enzyme that is part of the inflammatory process in patients with coronary artery disease (CAD). The enzyme breaks down the amino acid tryptophan and it is associated with damage to brain cells. Findings show a significant association between activation of this enzyme and the degree of depressive symptoms in these patients. They also identify a trend towards even higher levels in those suffering from clinical depression.

"This enzyme makes 'brain unfriendly' chemicals," says Dr. Krista Lanctôt, principal investigator and head of the Neuropsychopharmacology Research Program at Sunnybrook. "We are trying to chase down a treatment for patients with CAD that will block the enzyme and/or prevent the inflammatory process in the first place."

Saturday, August 1, 2009

Popular Breast Cancer Drug Used with Certain Antidepressants Puts New Jersey Women at Risk

A new analysis finds that women in New Jersey who take the breast cancer drug tamoxifen in conjunction with certain popular antidepressants may be at a higher risk for a breast cancer recurrence.

In May, Medco Health Solutions, Inc. (NYSE: MHS) and Indiana University School of Medicine released a study revealing that women using tamoxifen to prevent a recurrence of breast cancer who also use certain selective serotonin reuptake inhibitors (SSRI), for example Prozac(R) (fluoxetine), Paxil(R) (paroxetine) and Zoloft(R) (sertraline), have up to twice the chance of having a recurrence of the disease.

In a separate New Jersey-specific analysis, Medco found that among nearly 2,000 tamoxifen patients in the state during 2008, 12 percent were also taking SSRIs, including those that could put them in the at-risk population.

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