Antidepressant linked to worsening white matter in elderly

The results of a study employing serial cranial MRI suggest that elderly adults who use tricyclic antidepressants may be at increased risk for progression of white matter lesions, which have been linked with late-life depression by previous studies.

Still, the progression of these lesions may be the indication for use, or certain side effects, such as hypotension, may be directly responsible.

Late-life depression has been tied to white matter lesions on MRI. The contribution of the various antidepressant agents to this finding has been unclear. Prior research has suggested that selective serotonin reuptake inhibitors (SSRI) inhibit platelet aggregation, which might be expected to slow progression of these lesions.

Dr. David C. Steffens, from Duke University Medical Center in Durham, North Carolina and associates addressed this topic by comparing the initial and five-year follow-up MRI scans in 1829 adults, 65 years or older, who were not using antidepressants at baseline.

The use of an antidepressant from any class during the study period hastened the progression of white matter disease, according to the report in the March issue of Stroke.

READ MORE @ MEDICEXCHANGE

Solving The US Drug Price Crisis, Experts Propose Solution

The mounting U.S. drug price crisis can be contained and eventually reversed by separating drug discovery from drug marketing and by establishing a non-profit company to oversee funding for new medicines, according to two MIT experts on the pharmaceutical industry.

Stan Finkelstein, M.D., senior research scientist in MIT's Engineering Systems Division, and Peter Temin, Elisha Gray II Professor of Economics, present their research and detail their proposal in their new book, "Reasonable Rx: Solving the Drug Price Crisis."

Finkelstein and Temin address immediate national problems--the rising cost of available medicines, the high cost of innovation and the 'blockbuster' method of selecting drugs for development--and predict worsening new ones, unless bold steps are taken.

"Drug prices in the United States are higher than anywhere else in the world. Right now, the revenues from those drugs finance research and development of new drugs. We propose to reduce prices, not at the expense of innovation, but by changing the way innovation is financed," said Temin, also the author of "Taking Your Medicine: Drug Regulation in the US."

READ MORE @ SCIENCE DAILY

Military Mental Health Policies Examined

Chris Scheuerman believes the military he served for 20 years failed his Army son Jason, who shot himself to death in his Iraq barracks almost three years ago.

Carefully choosing his words before a hushed congressional audience Friday, the father spoke of how the 20-year-old private's superiors largely ignored the soldier's signs of distress and his family's expressions of alarm in the days leading up to his suicide.

"I do not believe there is a safety net right now for those who fall through," Scheuerman, a veteran with service in Army medicine, told a House Armed Services subcommittee.

Scheuerman was one of several people who testified about their experiences with the military's mental health system. Military personnel, facing prolonged warfare and lengthy deployments, are under particular stress these days.

Army Chief Warrant Officer Richard Gutteridge, an Iraq war veteran treated for post-traumatic stress disorder, spoke of the military's prejudices toward service members with mental health problems. "PTSD sufferers are lepers without lesions," he said.

At the same time, Gutteridge and others cited improvements in the military's responses to the high levels of mental health problems and brain injuries among those serving in Iraq and Afghanistan.

Dr. S. Ward Casscells, assistant defense secretary for health affairs, and the surgeons general of the Army, Navy and Air Force also efforts to help address psychological issues. Steps include recruiting more mental health professionals, providing prompt care and extending outreach programs to military personnel and their families.

READ MORE @ ASSOCIATED PRESS

Statement from Eli Lilly and Company: Response to Today's New York Times Article, 'Lilly E-Mail Discussed Off-Label Drug Use'

See Friday, March 14, 2008 post.
Eli Lilly and Company today called the assertions in a New York Times online article 'flat out wrong.' The Times report in question focused on the State of Alaska v. Eli Lilly and Company trial that is underway and attempted to interpret a 2003 email from John C. Lechleiter, Ph.D., currently Lilly's president and chief operating officer. About this email and the Times report, the company makes the following statement:

READ MORE @ EARTHTIMES

Pharmaceuticals found in US drinking water - Trace quantities could endanger wildlife, humans

An array of pharmaceuticals - including antibiotics, anticonvulsants, mood stabilizers, and sex hormones - have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation found.

The concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. And utilities insist that their water is safe.

But the presence of so many prescription drugs - and over-the-counter medicines like acetaminophen and ibuprofen - in so much of our drinking water is heightening worries among scientists of long-term consequences to human health.

In the course of a five-month inquiry, the AP discovered that drugs have been detected in the drinking water supplies of 24 major metropolitan areas - from southern California to northern New Jersey, from Detroit to Louisville, Ky.

Water providers rarely disclose results of pharmaceutical screenings, unless pressed, the Associated Press found.

READ MORE @ BOSTON GLOBE

Lilly E-Mail Discussed Off-Label Drug Use

John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote e-mail in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators.

Dr. Lechleiter’s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.

The e-mail message was discussed earlier this week in an Anchorage courtroom in a lawsuit against Lilly by the state of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa. The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.

Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it “off label” for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug. In his e-mail message, Dr. Lechleiter discusses the use of Zyprexa by children and teenagers.

READ MORE @ NY TIMES

Researchers May Have Found Test For Depression

Researchers from the University of Illinois at Chicago College of Medicine have discovered that a change in the location of a protein in the brain could serve as a biomarker for depression, allowing a simple, rapid, laboratory test to identify patients with depression and to determine whether a particular antidepressant therapy will provide a successful response.

"This test could serve to predict the efficacy of antidepressant therapy quickly, within four to five days, sparing patients the agony of waiting a month or more to find out if they are on the correct therapeutic regimen," said Mark Rasenick, UIC distinguished university professor of physiology and biophysics and psychiatry.

Despite decades of research, the biological basis of depression is unknown, and the molecular and cellular targets of antidepressant treatment remain elusive, although it is likely that these drugs have one or more primary targets.

Rasenick said the discovery could help millions who suffer from undiagnosed depression or receive unsuccessful treatment.

READ MORE @ SCIENCE DAILY

Drugs giant attacked over dangers of anti-depressant drug

Health regulators have criticised drugs firm Glaxosmithkline (GSK) for withholding information over the risk of suicide relating to one of its anti-depressant drugs.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said today it remained concerned that GSK failed to raise the alarm earlier over the side-effects of Seroxat.

Government prosecutors have ruled that there is no realistic prospect of getting a conviction over the issue.

But new legislation ensuring drugs companies pass on results of clinical trials promptly is to be introduced, public health minister Dawn Primarolo told Parliament.

Seroxat is the most frequently-prescribed anti-depressant in the UK, but there have been complaints that it triggers suicidal feelings in some patients.

READ MORE @ THE INDEPENDENT

Depression After a Heart Attack Dangerous for Years

The increased risk of death associated with depression after a heart attack persists for at least five years, a study finds.

"We've known for a number of years that depression increases the risk of mortality as well as morbidity [illness] after a heart attack for at least three to six months," said study author Robert M. Carney, a professor of psychiatry at Washington University School of Medicine in St. Louis. "We assumed that we would find a decline in risk, but that was not what we found. The risk remained worse after five years."

Carney and his colleagues followed more than 750 people after their heart attacks, according to their report in the current online issue of theJournal of Affective Disorders. Using diagnostic interviews rather than the self-reporting common in most such studies, the researchers determined that 163 had major depression, and 195 had minor depression. Over the five-year study, the death rate was 87 percent higher for those with major depression and 76 percent higher for those with any form of depression.

READ MORE @ WASHINGTON POST

Troop Depression on Rise in Afghanistan

U.S. troop morale improved in Iraq last year, but soldiers fighting in Afghanistan suffered more depression as violence there worsened, according to an Army mental health report.

And in a recurring theme for a force strained by its seventh year at war, the annual battlefield study released Thursday found once again that soldiers on their third and fourth tours of duty had sharply greater rates of mental health problems than those on their first or second deployments.

The repositioning of troops closer to the Iraqi population last year, part of counterinsurgency tactics, made it harder for soldiers to get mental health treatment, the study found.

The report recommended longer home time between deployments, more focused suicide-prevention training and sending civilian psychologists and other mental health professionals to the warfront to add to the uniformed corps there. Officials said they've had some civilian volunteers.

The report was drawn from the work of a team of mental health experts who traveled to the wars last fall and surveyed more than 2,200 soldiers in Iraq and nearly 900 in Afghanistan. In the fifth such effort, the team also gathered information from more than 400 medical professionals, chaplains, psychiatrists, psychologists and other mental health workers serving with the troops — coming away with statistics on a range of issues such as marital problems, mental illness and troop ethics.

"They do show the effects of a long war," Col. Elspeth Ritchie, psychiatry consultant to Army Surgeon General Lt. Gen. Eric Schoomaker, said of the data.

READ MORE @ ASSOCIATED PRESS

FDA Warning of Suicidal Risk Associated with Antidepressants in Juveniles and Young Adults Reviewed at Recent ISCTM Meeting

The International Society for CNS Clinical Trials and Methodology (ISCTM) held its 2008 annual meeting in Washington, DC, February 25-27. This organization involves collaborative efforts among academic and research clinicians, representatives of the pharmaceutical industry, and governmental drug-regulatory bodies to improve methods for testing efficacy and safety of drugs used to treat psychiatric and neurological disorders. A half-day symposium explored FDA-required "black-box" drug safety warnings of evidence of increased risk of suicidal thoughts and actions during treatment with antidepressants in juvenile and young-adult patients as a case study. The symposium was chaired by FDA-advisor Andrew Leon, Ph.D. (Cornell Medical Center), and Ross J. Baldessarini, M.D. (Harvard Medical School). Other speakers were Neil Chayet, J.D. (Harvard Medical School), Thomas Laughren, M.D. (US FDA), James McNulty (Past-President, National Alliance on Mental Illness [NAMI]), and Sharon-Lise Normand, Ph.D. (Harvard School of Public Health).

Dr. Baldessarini noted: "Studies aimed at reducing risk of suicide remain far less well developed than many other treatments for psychiatric patients, despite the importance of the problem. Evidence of whether antidepressants increase or reduce risk of suicidal behaviors remains surprisingly inconsistent and inconclusive."

Symposium speakers reviewed evidence supporting the expanded safety warning for all drug products that are FDA-approved for the treatment of major depression, that involve 180-million prescriptions a year in the US. The FDA also is conducting a systematic review of suicidal risks associated with anti-epilepsy drugs and considering use of more systematic assessments of suicidal thinking and behaviors to replace current incidental patient and clinician reporting of adverse events during trials.

READ MORE @ EARTH TIMES

A Chilly Court: Alaska Attacks Lilly Over Zyprexa

This is the Zyprexa trial we’re talking about. The state, you may recall, sued Lilly in 2006, alleging the drugmaker failed to warn of weight gain and diabetes caused by Zyprexa, and wants Lilly to cover treatment costs of Medicaid patients who suffered serious health problems.

The civil suit is being closely watched by state and federal prosecutors investigating the drugmaker, because this is the first lawsuit filed by a state against Lilly to make it to trial. The outcome - and even the evidence - could, therefore, influence settlement talks under way with the US Attorney in Phildelphia and state attorneys general. An unfavorable verdict could also prompt other states to file lawsuits, although eight others already have done so. (By the way, if you want to read the controversial Zyprexa documents, visit Furious Seasons).

For its part, Lilly argues the state has two irreconcilable positions - at the same time Alaska is suing the drugmaker, the state continues to seek court orders to force mental patients to take the very drug it says is harmful. These are the slides Lilly’s lawyers used in court.

READ MORE @ PHARMALOT

Low Risk, Heavy Drugs - State's Nursing Homes Might Be Overusing Antipsychotics

Connecticut's nursing homes dole out antipsychotic drugs to residents who do not have psychotic disorders at one of the highest rates in the country, raising questions about whether the medications are being used to subdue agitated patients because of a lack of staffing and attention to alternate treatments.

Federal data from the Centers for Medicare & Medicaid Services show that since 2005, Connecticut has consistently ranked in the top four states in the prevalence of antipsychotic drugs dispensed to nursing home residents who have no psychotic or related conditions. In the most recent quarterly report, through September 2007, only Louisiana had a higher prevalence rate than Connecticut, where more than 26 percent of residents who lacked an appropriate psychiatric diagnosis were prescribed antipsychotics.

Nationally, the prevalence rate is 19.8 percent, with several states, such as Florida, Pennsylvania and New Jersey, well below that average.

"This is not a good indicator" for Connecticut, said Charlene Harrington, an expert on nursing home quality and professor of sociology and nursing at the University of California-San Francisco. "One of the main factors [for a high medication rate] is not having enough staff. If patients are having behavioral problems, it's easier to give them a pill to keep them quiet" than to hire more staff. "It's cheaper. They'll sleep a lot."

READ MORE @ HARTFORD COURANT

House Approves Bill on Mental Health Parity

After more than a decade of struggle, the House on Wednesday passed a bill requiring most group health plans to provide more generous coverage for treatment of mental illnesses, comparable to what they provide for physical illnesses.

The vote was 268 to 148, with 47 Republicans joining 221 Democrats in support of the measure.

The Senate has passed a similar bill requiring equivalence, or parity, in coverage of mental and physical ailments. Federal law now allows insurers to discriminate, and most do so, by setting higher co-payments or stricter limits on mental health benefits.

“Illness of the brain must be treated just like illness anywhere else in the body,” said Speaker Nancy Pelosi, Democrat of California. Supporters of the House bill, including consumer groups and the American Psychiatric Association, said it would be a boon to many of the 35 million Americans who experience disabling symptoms of mental disorders each year.

READ MPRE @ NY TIMES

ADHD Drugs Won't Raise Risk of Substance Abuse

Parents of children who are prescribed psychostimulants for attention deficit-hyperactivity disorder (ADHD) might have one less thing to worry about now that a new study concludes these kids are no more likely than their peers to abuse drugs and alcohol as young adults.

The report, which was funded by the National Institutes of Health, is published in the March issue of the American Journal of Psychiatry.

"The results should reassure clinicians who might be hesitant to treat ADHD because of concerns about future substance abuse," said study co-author Michael C. Monuteaux, assistant director of research at the pediatric psychopharmacology program at Massachusetts General Hospital.

Past research looking for a link between ADHD medications and substance abuse has produced conflicting conclusions.

"Some previous studies showed an increased risk of substance abuse associated with stimulant treatment, and other studies showed both no association and also a protective effect from treatments," Monuteaux said. "But those studies had some methodological limitations, and not all of them followed their samples well into late adolescence and early adulthood."

READ MORE @ US NEWS & WORLD REPORT

Comparison of antipsychotic treatments in adolescents with schizophrenia

There is a wealth of scientific literature available on the treatment of adults diagnosed with schizophrenia. However, there is a paucity of data to guide the treatment of children and adolescents with schizophrenia. “Although the U.S. Food and Drug Administration (FDA) has recently approved the use of aripiprazole and risperidone for adolescents with schizophrenia, few controlled data are available to help guide clinicians regarding the management of children and adolescents with schizophrenia who fail to respond to these standard 'first-line' antipsychotic treatments,” according to Dr. Sanjiv Kumra. Dr. Kumra is one of the authors of a new study to be published in the March 1st issue of Biological Psychiatry, which was undertaken to help fill this gap in knowledge.

The authors recruited 39 children, 10-18 years of age, who had already failed to respond to at least two antipsychotic treatments, to participate in a 12-week, double-blind, randomized study – the most rigorous of clinical trial designs. After initial assessments, the patients received treatment with either clozapine or “high-dose” olanzapine (doses that exceed the package insert recommendations) and were monitored for improvement in their symptoms. The researchers discovered that clozapine was approximately twice as likely to produce a treatment response as olanzapine. Both positive symptoms (psychosis) and negative symptoms (blunted emotional response, reduced motivation) responded better to clozapine. John H. Krystal, M.D., Editor of Biological Psychiatry and affiliated with both Yale University School of Medicine and the VA Connecticut Healthcare System, comments on the findings: “Olanzapine is among the most effective antipsychotic medications, so the distinctive effectiveness of clozapine in this study could be very important.”

READ MORE @ EUREKALERT

Depressed Teens More Likely To Get Better With Switch To Combination Therapy

More than half of teenagers with the most debilitating forms of depression that do not respond to treatment with selective serotonin reuptake inhibitors (SSRIs) show improvement after switching to a different medication combined with cognitive behavioral therapy, researchers at UT Southwestern Medical Center and their colleagues in a multicenter study have found.

Dr. Graham Emslie, professor of psychiatry and pediatrics at UT Southwestern and chief of child and adolescent psychiatry at Children's Medical Center Dallas, was a principal investigator in the study appearing in the Journal of the American Medical Association.

Adolescents with treatment-resistant depression have unique needs, for which standard treatments do not always work. "If an adolescent hasn't responded to an initial treatment, go ahead and switch treatments," said Dr. Emslie. "Our results should encourage clinicians to not let an adolescent stay on the same medication and still suffer."

The 334 study participants suffered from depression on average for about two years. The teenagers involved exhibited moderate to severe major depressive disorder, many with suicidal ideation. Historically, these types of patients have the worst treatment outcomes.

READ MORE @ SCIENCE DAILY

Shape Abnormalities Found In Thalamus Of Siblings Of Schizophrenia Patients

Subtle malformations in the shape of the thalamus in the brain are generally found in schizophrenic patients -- and their healthy siblings appear to display the same abnormalities, according to a study published on June 6, 2007 in The Journal of Neuroscience.

Scientists at the Silvio Conte Center for the Neuroscience of Mental Disorders at Washington University School of Medicine in St. Louis performed MRI scans of the brains of 25 patients with schizophrenia, as well as their non-affected siblings. These scans were compared to those of 40 healthy volunteers and their siblings. A process that converts the two-dimensional images of the scan into three-dimensional models of brain anatomy, also known as high-dimensional brain mapping, was used to detect tiny differences in the anatomy of the brain.

"We're interested in the thalamus because it has a lot of connections to the prefrontal cortex," states Michael P. Harms, Ph.D., senior scientist at the Conte Center. " In addition to psychosis, schizophrenia is characterized by other difficulties, such as issues with working memory and decreased cognitive performance. Those symptoms are believed to involve the cortex, and since the thalamus projects throughout the cortex, it's conceivable abnormalities in the thalamus may be related to those symptoms."

READ MORE @ MEDICAL NEWS TODAY

F.D.A. Approves Wyeth Antidepressant

Faced with the looming loss of patent protection for its top-selling drug, the antidepressant Effexor XR, Wyeth received federal approval on Friday for a successor drug, Pristiq, which the company hopes will also become a blockbuster.

With the Food and Drug Administration’s approval of Pristiq, Wyeth said the company planned a big sales effort to introduce the product to psychiatrists and primary care doctors.

Wyeth needs a product that will replace some of the revenue expected to be lost to generic competitors of Effexor XR, whose patent protection expires in 2010. Sales of Effexor XR last year were $3.8 billion.

Dr. Philip Ninan, a Wyeth vice president for neuroscience, said he thought that Pristiq, which is chemically similar to Effexor, would have similar benefits in treating major depression. But the company said the drug had distinct advantages over its existing product.

Among them are that patients can start taking Pristiq at the therapeutic dose of 50 milligrams. Frequently, antidepressants must be started at a low dose, then ramped up to the therapeutic dose, to test whether patients can tolerate the drug and to determine the correct dose for the individual. Another advantage is that Pristiq does not have to be broken down by the liver, Dr. Ninan said, so it is not likely to interact with other medications metabolized by the liver.

READ MORE @ NY TIMES

Antidepressant drugs don't work – official study

They are among the biggest-selling drugs of all time, the "happiness pills" that supposedly lift the moods of those who suffer depression and are taken by millions of people in the UK every year.

But one of the largest studies of modern antidepressant drugs has found that they have no clinically significant effect. In other words, they don't work.

The finding will send shock waves through the medical profession and patients and raises serious questions about the regulation of the multinational pharmaceutical industry, which was accused yesterday of withholding data on the drugs.

REAS MORE @ THE INDEPENDENT