Wednesday, September 30, 2009

Prescriptions now biggest cause of fatal drug overdoses

Debra Jones didn't begin taking painkillers to get high.
Jones, 50, was trying to relieve chronic pain caused by rheumatoid arthritis.

Yet after taking the painkiller Percocet safely for 10 years, the stay-at-home mother of three became addicted after a friend suggested that crushing her pills could bring faster relief. It worked. The rush of medication also gave her more energy. Over time, she began to rely on that energy boost to get through the day. She began taking six or seven pills a day instead of the three to four a day as prescribed.

"I wasn't trying to abuse it," says Jones, from Holly Springs, N.C., who has since recovered from her battle with addiction. "But after 10 years, I couldn't help what it did to my body or my brain. It was hard to work without it."

Addiction to prescription painkillers — which kill thousands of Americans a year — has become a largely unrecognized epidemic, experts say. In fact, prescription drugs cause most of the more than 26,000 fatal overdoses each year, says Leonard Paulozzi of the Centers for Disease Control and Prevention.

READ MORE @ USA TODAY

Tuesday, September 29, 2009

Drug Combo May Offer Best Relief for Nerve Pain

People with nerve pain respond better to a combination treatment using the anticonvulsant gabapentin and antidepressant nortriptyline than to treatment with either drug alone, according to Canadian researchers.

The study findings suggest that combination treatment could be used to help people who only partially respond to one drug or the other.

Nerve, or neuropathic, pain -- which affects 2 to 3 percent of the population -- is "initiated or caused by a primary lesion or dysfunction in the nervous system," according to a news release from The Lancet, which is publishing the study online Sept. 29. Conditions that cause neuropathic pain include nerve problems in the spine, diabetes-related nerve damage and postherpetic neuralgia (PHN), which is nerve pain caused by the varicella zoster virus that can follow an outbreak of shingles.

ATLANTA JOURNAL CONSTITUTION

Monday, September 28, 2009

Many Kids Suffer Medication Side Effects: Study

More than half a million kids a year are treated for medication side effects in American outpatient clinics and emergency rooms, according to new data.

Researchers at Children's Hospital Boston analyzed National Center for Health Statistics outpatient data between 1995 and 2005. Among children up to age 18, there were 585,922 visits a year for adverse drug events (ADEs). Most visits were to outpatient clinics, but 22 percent were to hospital emergency departments.

"We found that there are as many as 13 outpatient visits for adverse drug events per 1,000 children, indicating that they are a common complication of pediatric care," study leader Dr. Florence Bourgeois, of Children's division of emergency medicine, said in a news release.

The majority of visits were by children 4 and younger (43 percent), followed by youngsters aged 15 to 18 (23 percent). Skin-related (45 percent) and gastrointestinal (16.5 percent) were the most common types of side effects, and 52 percent of the children had symptoms that suggested an allergic reaction.

READ MORE @ ATLANTA JOURNAL CONSTITUTION

Sunday, September 27, 2009

Lilly Reaches Zyprexa Agreement With Seven States (Update2)

Eli Lilly & Co. agreed to settle, on confidential terms, lawsuits filed by seven states alleging the company improperly marketed its antipsychotic drug Zyprexa, a court-appointed official said.

“All of the states have essentially settled for the same” non-monetary arrangements, said Michael Rozen, special master appointed by the court to help settlement negotiations. The money terms, which weren’t disclosed, “have fallen roughly in line,” he said at a hearing today in federal court in Brooklyn, New York.

Lawyers told U.S. District Judge Jack B. Weinstein, who is overseeing the cases, that finishing the settlements may be delayed while the parties determine how much money the U.S. government plans to claim in compensation for federal dollars spent on Zyprexa through state Medicaid programs.

If completed and approved in court, the settlements would leave four suits filed by states pending against Lilly.

READ MORE @ BLOOMBERG

Saturday, September 26, 2009

Can depression cause osteoporosis?

[Studies indicate that a link exists and that the risk of bone disease is further increased by behaviour and medication, "One theory is that stress hormones released during depression may play a role ... The other theory is that if you suffer a bone fracture, your quality of life goes down. The question is, is it causal?" ]

In the feel-good French movie Amélie, audiences are introduced to an eccentric old character held hostage by his home and his own body. He's dubbed "The Glass Man."

Raymond Dufayel was born with bones as brittle as crystal. All the furniture in his Parisian apartment is padded, explains the narrator, and a simple handshake could crush his fingers. He's been trapped inside his home for 20 years and leads a small, lonely life.

In the 2000 thriller Unbreakable, a comic book specialist played by Samuel L. Jackson, nicknamed "Mr. Glass," is convinced he's found a real-life superhero in an unremarkable security guard played by Bruce Willis. His obsession is fuelled by his own crystalline skeleton and a villainous drive to find purpose for his lonesome, handicapped life.

Tall tales from cinematic imaginations? Of course. Entirely without foundation? Not so for those suffering from osteoporosis.

When Debbie Howe suffered a spinal fracture after bending over to pick up her baby, she was housebound for six months, and told she had the bones of 75-year-old woman. Six weeks later, she broke another vertebra from raising her arms over her head to shampoo her hair. She was 36 at the time.

"Those were some pretty grey days," Howe, now 57, said in her King City home.

Over the last decade or so, the relationship between depression, the use of antidepressants and osteoporosis has been the subject of a growing body of research.

READ MORE @ TORONTO STAR

Friday, September 25, 2009

Drugmaker Glaxo cuts back on seminars for doctors

* Company cuts out commercial medical education companies

* Only about 20 accredited providers will get grants

Drugmaker GlaxoSmithKline (GSK.L) said on Monday it will pare back funding for continuing medical education seminars.

While the company did not link its decision to political developments, pressure has been mounting in Congress and among some medical journal editors to limit the drug industry's influence over doctors.

Deirdre Connelly, president of Glaxo's operations in North America, said in a statement that starting in 2010, the company will limit its support for medical education programs, funding only independent programs with "the greatest potential to improve patient health."

The company said it will cut out education programs put on by commercial providers, and will only pay for programs from about 20 medical education providers with a track record of quality.

READ MORE @ REUTERS

Thursday, September 24, 2009

Bipolar Disorder Amongst Children And Adolescents Receive Late Diagnosis

A new study finds that 75% of the cases of paediatric bipolar disorder are diagnosed late – up to 18 months – due to the symptoms manifesting themselves in a different manner depending on whether the patient is a child or adult. Moreover, 25% of sufferers have a delay in their medical diagnoses of up to three years and four months, according to a study by the Department of Psychiatry and Medical Psychology at the University Hospital of Navarra, in collaboration with the Paediatric Psychopharmacology Unit at the Massachusetts General Hospital at Harvard University (Boston, United States).

As Dr. Inmaculada Escamilla Canales, specialist at the Madrid-based Child and Adolescent Psychiatry Unit of the University Hospital of Navarra explained, the research was based on an article previously published by her department in 2005 in which the perspectives of bipolar disorder amongst children outside the USA were reviewed. A very low incidence was observed in Europe compared to the North American samples, especially amongst certain countries. Also, in Great Britain, a study undertaken with a sufficiently representative sample concluded that the rate for this illness was non-existent.

READ MORE @ SCIENCE DAILY

Wednesday, September 23, 2009

EEOC Sees Mental Health Stereotypes at Work

The federal government is suing a North Carolina employer for what it calls a pervasive problem in the workplace: discrimination against employees with mental illness.

In the federal suit filed Sept. 21 in the Eastern District of North Carolina, the Equal Employment Opportunity Commission contends that the Smith International Truck Center relied upon "myths, fears and stereotypes about mental impairments" when it unlawfully terminated an employee who took leave for a mental health issue.

According to the suit, the employee, Stephen Kerns, took one week off from work to obtain medical treatment and get his dosage adjusted for medicine he took for what the complaint calls a mental impairment. The man then returned to work with no restrictions, but was fired shortly thereafter, according to the EEOC.

The agency asserts that his employer fired Kerns because of his perceived disability -- in violation of the Americans With Disabilities Act. "The employer just assumed, acting on stereotypes, that if he's getting treatment for any kind of mental impairment, that he must not be able to work, and that's the problem. They didn't look at his abilities," said Carol Miaskoff, assistant legal counsel to the EEOC.

READ MOLRE @ THE AMERICAN LAWYER

Tuesday, September 22, 2009

Brain Scans Link ADHD to Biological Flaw Tied to Motivation

For decades, attention-deficit hyperactivity disorder has sparked debate. Is it a biological illness, the dangerous legacy of genes or environmental toxins, or a mere alibi for bratty kids, incompetent parents and a fraying social fabric?

With 4.5 million U.S. children having received a diagnosis of the disorder -- and more than half of them taking prescription drugs to control it -- the question has divided doctors and patients, parents and teachers, and mothers and fathers.

Scientists maintain that they've been narrowing in on the origins and mechanics of disabling distraction, while gathering increasing evidence that ADHD is as real as such less controversial disorders as Down syndrome and schizophrenia. Their most recent progress is described in a Sept. 9 report in the Journal of the American Medical Association, based on a new study that indicates a striking difference in the brain's motivational machinery in people with ADHD symptoms.

READ MORE @ WASHINGTON POST

Monday, September 21, 2009

Dueling Intimidation Allegations Filed in Neurontin Litigation

The continuing litigation about whether Pfizer’s anti-seizure medication Neurontin is linked to suicidal behavior in some patients has been marred by allegations filed by attorneys on both sides accusing the other of using intimidation and strong-arm tactics.


Neurontin, known chemically as gabapentin, is an anti-epileptic medication (also called an anticonvulsant) taken by patients to reduce or eliminate seizures in adults and children as young as 12. The drug has been associated with serious side effects, most notably suicide.
Pfizer
Attorneys representing victims of Neurontin recently accused Pfizer’s counsel of trying to intimidate a potential key witness in the case. Pfizer’s attorneys then returned fire with a similar complaint against David Egilman, an expert witness for the plaintiffs.

READ MORE AT ATTORNEYATLAW.COM

Sunday, September 20, 2009

British doctor faces action over claims of 'ghost writing' for US drug company

Doctors have been agreeing to be named as authors on studies written by employees of the pharmaceutical industry, giving greater credibility to medical research, according to new evidence.

The Guardian has learned that one of Britain's leading bone specialists is facing disciplinary action over accusations that he was involved in "ghost writing".

The wider phenomenon has come to light through documents disclosed in the US courts which have revealed a culture in which doctors agree to "author" studies written by employees of drug firms. The doctors may have some input but do not have access to all the evidence from the drug trial on which the paper's conclusions are based, the documents showed.

The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he allowed his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study's conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures.

Saturday, September 19, 2009

Ziprasidone Plus Lithium or Divalproex Is More Effective Than Monotherapy in Bipolar Disorder: Presented at ECNP

Ziprasidone as adjunctive treatment of bipolar disorder yields better efficacy than monotherapy and does not have the side effect of weight gain, according to researchers here at the 22nd European College of Neuropsychopharmacology (ECNP) Congress.

Eduard Vieta, MD, Bipolar Disorders Program, Clinical Institute of Neuroscience, Barcelona, Spain, and colleagues investigated the efficacy of combining ziprasidone with standard mood stabilisers. Because few bipolar patients experience adequate symptom control with long-term lithium or divalproex therapy, the use of adjunctive treatment with atypical antipsychotics is being investigated.

READ MORE @ DOCTOR'S GUIDE

Friday, September 18, 2009

Drug-Drug Interactions, Other Factors Can Affect Antipsychotic Treatment Regimens: Presented at ECNP

Inhibitors or inducers of the cytochrome (CY) P450 system may affect the metabolism and activity of antipsychotic drugs, according to a study presented September 13 at the 22nd European College of Neuropsychopharmacology (ECNP) Congress.

Pierre Chue, MD, Department of Psychiatry, University of Alberta, Edmonton, Alberta, and colleagues performed an evidence-based review of all relevant literature to identify and define possible drug-drug interactions (DDIs) and other factors that may influence patient response to drug treatment.

Comorbidities such as smoking, alcohol, other substance-abuse disorders, infections, and metabolic disorders complicate the pharmacological management of psychotic patients. Additional factors such as genetic polymorphisms and environmental interactions (eg, DDIs and drug-food interactions) also influence drug efficacy. The researchers noted that clinicians need to consider these factors and others, along with patients' unique characteristics, when determining treatment.

EWAD MORE @ DOCTOR'S GUUIDE

Thursday, September 17, 2009

Treatment guidelines issued on depression during pregnancy

For women with serious conditions, medication may be the best route, but 'talk therapy' may alleviate suffering for others, according to a document prepared by two national physicians groups.

For the nearly one in four women who experience symptoms of depression during pregnancy, physicians on the front lines have long had little more than a prescription for antidepressants and a massive dose of uncertainty to offer.

The result: At last count, roughly 13% of pregnant women in the United States took antidepressant medications at some point in their pregnancy -- often with little to guide them in weighing the risks the drugs may pose to their fetus against the misery and dangers of untreated depression.

In a bid to resolve that conundrum, two of the nation's leading physicians groups have issued the first guidelines for the treatment of depression during pregnancy.

READ MORE @ LOS ANGELES TIMES

Wednesday, September 16, 2009

Metabolic Side Effects, Cardiovascular Risk Differs Among Antipsychotic Treatments for Schizophrenia: Presented at ECNP

The differences in metabolic side effects and cardiovascular risk resulting from antipsychotics make the initial choice of medication important in controlling long-term effects from treatments used for schizophrenia, researchers said here at the 22nd European College of Neuropsychopharmacology (ECNP) Congress.

W. Wolfgang Fleischhacker, MD, Biological Psychiatry Department, Medical University Innsbruck, Innsbruck, Austria, and colleagues analysed data from the European First Episode Schizophrenia Trial (EUFEST) study to determine the effects of several first- and second-generation antipsychotics on cardiovascular risk factors in patients with or without metabolic syndrome (MS) risk. Results of the study were presented on September 14.

READ MORE @ DOCTOR'S GUIDE

Tuesday, September 15, 2009

Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)

An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

READ MORE @ BLOOMBERG

Monday, September 14, 2009

The future of schizophrenia

Press conference at the 22nd Congress of the European College of Neuropsychopharmacology, Sept. 14, 2009, Istanbul, Turkey

Schizophrenia is a major public health problem. Affecting almost 1% of the world's population, it takes an enormous economic and social toll in addition to the distress, dysfunction, disability and mortality for those afflicted with this disease. Elements of the disease are present from birth, other aspects emerge during developmental years, and the illness becomes fully expressed in early adulthood with long-lasting implications for most patients.

Schizophrenia, which is seen as the paradigmatic psychiatric illness, presents different symptoms in multiple domains, whereby positive and negative phenomena can be separated (Falkai et al., 2005): Positive (psychotic) symptoms in a broader sense include delusions or delusional ideation, hallucinations, disturbance of association, catatonic symptoms, agitations as well as feelings of alien influence and suspiciousness. Negative symptoms include restricted range and intensity of emotional expression, limited thought and speech productivity, social withdrawal, and reduced initiation of goal-directed behaviour. These negative components are typically characterised as affective flattening, alogia, diminished drive, anhedonia and avolition. Furthermore, schizophrenia is associated with cognitive impairment, disorganised speech and behaviour, as well as poor attention. The primary advance in pharmacological treatment of schizophrenia was in 1952 with the introduction of dopamine antagonist antipsychotic drugs.

Paradigm shift in schizophrenia research: from single-disease entity to the paradigm of multiple domains

A century of work has been based on designs that conceptualise schizophrenia as a single disease entity, despite recognition that schizophrenia must have scientific status of a syndrome in the absence of proof of a single disease process (Carpenter et al., 1999). The implications are profound. Research based on the presumption that a single disease is present has produced weak findings that frequently fail confirmation in replication studies. The heterogeneity of patients receiving this diagnosis is substantial. Causal and neuropathological findings valid for some patients will not be found in others. Illness manifestations vary substantially between patients, and symptomatic components of illness are only weakly related to each other within individuals.

READ MORE @ EUREKALERT

Sunday, September 13, 2009

SSRI Use May Correlate With Lower Bone Mineral Density in Middle-Aged Women: Presented at ASBMR

A study presented at the 31st Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) found that use of some antidepressants may have a correlation with reduced bone mineral density (BMD) in women.

While data have been circulated since the late 1990s associating the use of selective serotonin reuptake inhibitors (SSRIs) with an increased risk of hip fractures, the studies have been in elderly women.

"They were based on database studies and were not able to control for important variables such as bone density and other health conditions," said Susan Diem, MD, University of Minnesota, Minneapolis, Minnesota, on September 12. "Basic science data in the last few years have also found that serotonin transcriptors may exist on bone cells. SSRIs, which block serotonin transcription, might then have an effect on bone density."
READ MORE @ DOCTOR'S GUIDE

Saturday, September 12, 2009

GlaxoSmithKline to Defend Paxil in Birth-Defect Case (Update1)

GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia next week in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects.

Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the risks of Paxil until forced to do so in 2005 by the U.S. Food and Drug Administration. In a trial set for Sept. 14, Michelle David blames the drug for causing life-threatening heart defects in her son Lyam Kilker, 3.

The London-based company faces two more such trials a month from October through January in state court in Philadelphia. The first group will show both sides how the rest of the lawsuits may fare, said David Logan, dean and professor of law at Roger Williams University in Bristol, Rhode Island.

“These cases are sort of like the canary in the coal mine,” Logan said in a phone interview. “The early cases set the parameters for any global settlement negotiations.”

Paxil, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company. Glaxo has settled other Paxil-related cases, including a suit brought by the New York Attorney General’s office accusing the company of withholding safety data about the antidepressant.

READ MORE @ BLOOMBERG

Ghost authors remain a chronic problem

Journal articles often list a long string of putative authors. I once counted 47 on a physics paper. But where journal articles in the natural sciences often appear overly conscientious about acknowledging all contributors, the opposite has become a nagging problem in biomedicine. Here, not all authors on a research project – or even, necessarily, the most important ones – may be identified as a contributor.

The existence of these ghost authors, as they’re called, evoked frustration and anger yesterday in a large share of the 400 journal editors and clinical research scientists taking part in a quadrennial international workshop on peer review and biomedical publication. This year’s venue: Vancouver, British Columbia.

The concern, speakers complained, is that ghost writers can be little more than hired guns. The expectation is that they will describe research findings in ways that aid their benefactors – drug or biomedical device companies that wish to avoid the appearance of directly influencing a clinical trial’s interpretation.

Often aiding and abetting the situation is another group of poseurs known as honorary authors. Their names show up on papers – despite their having done nothing – to lend credibility to research, to reward a friend of someone connected with the study, or to help hide the contributions of a ghost.

READ MORE @ SCIENCE NEWS

Thursday, September 10, 2009

Children with emotional difficulties at higher risk for adult obesity

Previous research has shown that low self-esteem and emotional problems are found in people who are overweight or obese– but not which influences which. Research published today in the open access journal BMC Medicine, sheds light on this issue showing that children with emotional difficulties are at higher risk for obesity in adult life.

Andrew Ternouth, David Collier and Barbara Maughan from the MRC Social, Genetic and Developmental Psychiatry Centre at the Institute of Psychiatry, King's College London, studied data from around 6,500 members of the 1970 British Birth Cohort Study who, as 10 year-olds, had been assessed for emotional problems, self-perceptions and BMI, and who reported on their BMI again at age 30. The researchers found that children with a lower self-esteem, those who felt less in control of their lives and those who worried often were more likely to gain weight over the next 20 years. They also found that girls were slightly more affected by these factors than boys.

READ MORE @ EUREKALERT

Wednesday, September 9, 2009

Depression After ACS Worsens Outcomes

Persistent depression after acute coronary syndrome continues to be a risk factor for early death for up to seven years, researchers said.

With a median of 6.7 years of follow-up, patients who encountered major depression after acute coronary syndrome -- and whose depression did not improve with treatment -- had a hazard ratio for death of 2.39 (95% CI 1.50 to 3.81) compared with those showing substantial improvement, according to Alexander Glassman, MD, of Columbia University, and colleagues.

The study involved patients in the randomized SADHART trial, which involved treatment with , sertraline (Zoloft) or placebo. Those who took their medications on schedule were more likely to show improvement in depression scores, the researchers wrote in the September issue of Archives of General Psychiatry.

Hence, they said, "physicians need to aggressively treat depression and be diligent in promoting adherence to guideline cardiovascular drug therapy."

The SADHART study (Sertraline Antidepressant Heart Attack Randomized Trial) began in 2000 with 369 patients hospitalized for acute coronary syndrome who were found to have major depression on screening.

READ MORE @ MEDPAGE TODAY

Tuesday, September 8, 2009

Brain Defect Implicated In Early Schizophrenia

In the first functional magnetic resonance imaging (fMRI) study of its kind, neurologists and psychiatrists at Columbia University have identified an area of the brain involved in the earliest stages of schizophrenia and related psychotic disorders.

Activity in this specific region of the hippocampus may help predict the onset of the disease, offering opportunities for earlier diagnosis and for the development of drugs for schizophrenia prevention.

Details of the findings were published in the September 7, 2009, issue of Archives of General Psychiatry.

In the study, the researchers scanned the brains of 18 high-risk individuals with "prodromal" symptoms, and followed them for two years. Of those individuals who went on to develop first-episode psychotic disorders such as schizophrenia, 70 percent had unusually high activity in this region of the hippocampus, known as the CA1 subfield.

SCIENCE DAILY

Monday, September 7, 2009

3 Genetic Variants Are Found to Be Linked to Alzheimer’s

Two teams of European scientists say they have discovered new genetic variants associated with Alzheimer’s disease. The variants account for about 20 percent of the genetic risk of the disease, and may lead to a better understanding of its biology, the scientists say.

One of the teams, led by Julie Williams of Cardiff University in Wales, scanned the genomes of about 19,000 patients, the largest study so far conducted on Alzheimer’s, and turned up two variants that have a statistically significant association with the disease. A second study, led by Philippe Amouyel of the University of Lille in France, also found two variants, one of which is the same as detected by the Cardiff team.

The fact that two studies could agree on at least one gene is an advance. More than 550 genes have been proposed in various small-scale studies as the cause of Alzheimer’s, but all have failed the test of replication by others, Dr. Amouyel said.

READ MORE @ NY TIMES

Saturday, September 5, 2009

Depressed Teens Continue to Suffer Those with mild depression more likely to suffer major episode later, researchers say

Mildly depressed teenagers
are more likely to have major depression, anxiety disorders and eating disorders as adults, a new study suggests.

In 1983, researchers interviewed 755 teenagers who were about age 16 about mood, anxiety and eating disorders, disruptive behaviors and substance abuse.

About 8 percent were found to have minor depression, defined as feeling down, losing interest in normal activities, and having insomnia or difficulty concentrating for two weeks or more. The symptoms
of minor depression are similar to, but less severe, than those of a major depressive episode.

Researchers followed up with the teens when they were in their early 20s and in their early 30s, and found that teenagers who had had minor depression were significantly more likely to have major depression in adulthood.

READ MORE @ U.S. NEWS & WORLD REPORT

Friday, September 4, 2009

More drug firms doing follow-ups than thought--FDA

More pharmaceutical companies have completed studies required by U.S. health regulators after their products were allowed on the market than previously thought, according to an analysis released on Thursday.

But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.

Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.

For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval.

A 2007 law gave the agency more power to require the follow-up studies and ordered the analysis, which found more drug companies than previously thought had completed their studies. Results of the audit by Booz Allen Hamilton Inc were given to the FDA.

"Most companies are doing these studies and they are submitting the reports," said Dr. John Jenkins, director of the FDA's Office of New Drugs.

READ MORE @ REUTERS

Thursday, September 3, 2009

Pfizer Pays $2.3 Billion to Settle Marketing Case

The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.

It was the largest health care fraud settlement and the largest criminal fine of any kind ever.

Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud.

“It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Kathleen Sebelius, secretary of health and human services.

Republicans and Democrats on Capitol Hill have accused the Obama administration of failing to crack down adequately on health care fraud, arguing that huge savings in government health programs could be found with better enforcement. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.

READ MORE @ NY TIMES

Wednesday, September 2, 2009

Pills and America's pursuit of happiness

Antidepressant use has soared during the recession but reaching for the pill bottle goes back decades.

Of all the bitter pills Americans are swallowing nowadays, from joblessness to home foreclosures to runaway national debt, it might come as no surprise that a pill of another sort is flying off the shelves at a recession-defying pace – the antidepressant.

It's an easy jump to conclude that hard times are turning the country comfortably numb, as the Washington Post suggested in a weekend report on the sales of the drug Cymbalta, up 14 per cent since the summer of 2008 and now among America's most popular happy pills.

Drill deeper and you will find that the U.S., though far and away a world leader with its $10-billion-a-year antidepressant habit, is not alone.

Over the summer, British politicians fretted over the impact of recession on mental health amid data showing a spike of 2.1 million antidepressant prescriptions last year, when the downturn took its first precipitous dive.

Same in India, where pharmaceutical firms reported a 20 per cent expansion of the antidepressant market in the year ending December 2008. And in New Zealand, where the global plunge was linked to reports of a near doubling in antidepressant prescriptions between 2002 and 2008.

But drill down deeper still and the story behind the flurry of cause-and-effect headlines is far more nuanced.

While many researchers acknowledge there is likely an uptick in med sales as a consequence of the poor economy, most say it is driven as much or more by trends decades in the making.

READ MORE @ TORONTO STAR

Tuesday, September 1, 2009

Depressed teens 'face adult risk'

Teenagers who have minor depression are at a higher risk of mental health problems later in life, a study says.

Psychiatrists at Columbia University and the New York State Psychiatric Institute spoke to 750 people.

Anxiety, severe depression and eating disorders were all far more common in 20 and 30-year-olds who had had minor depression as adolescents, they found.

The British Journal of Psychiatry report said further research was needed to unpick the reasons for the link.

UK charities said specialist services for young people were vital.

The study was based on interviews with 750 14 to 16-year-olds who were then assessed again as adults.

READ MORE @ BBC NEWS