http://prescriptions.blogs.nytimes.com/2010/01/14/biologic-drugs-may-get-less-protection/ May Get Less Protection

President Obama is pushing for a last-minute change in the final health care bill that would shorten the time that expensive biotechnology drugs would be shielded from generic competition, pharmaceutical industry officials said Thursday.

Any White House intervention would be welcome news to generic pharmaceutical companies, as well as to some consumer groups, insurers and big employers, which have complained that the proposed House and Senate bills would not allow for robust competition.

But it could throw another wrench into negotiations. At a time when Congressional leaders are trying to resolve differences in the House and Senate bills, the issue of biotech drugs is one aspect on which both bills agree.

Both the House and Senate bills would for the first time create rules by which so-called biologic drugs, which are made in living cells, would be subject to copycat competition, saving the health care system billions of dollars over 10 years.

The drugs, which include big sellers like the cancer drug Avastin and the arthritis drug Enbrel, can cost tens of thousands of dollars a year. Biologics are not governed by the Hatch-Waxman Act, which covers generic competition for more conventional drugs made from chemicals, like Prozac or Lipitor. After the patent on a biologic drug expires, competitors may produce similar products, but they are treated by the health care system as if they were entirely new drugs, not substitutes like generics.

READ MORE @ NY TIMES

Morphine shows promise against post-traumatic stress disorder

Studies find that troops who got the powerful painkiller when injured were about 50% less likely to develop PTSD than those who didn't. The findings offer hope for preventive treatment.

Early administration of morphine to military personnel wounded on the front lines during Operation Iraqi Freedom appears to have done more than relieve excruciating pain. Scientists believe it also prevented hundreds of cases of post-traumatic stress disorder, the debilitating condition that plagues 15% of those who have served in Iraq and Afghanistan.

That conclusion is based on findings published today in the New England Journal of Medicine. They suggest that a simple treatment can stop a single horrifying event from escalating into a chronic, incapacitating illness.

Small clinical trials and observational studies have hinted that opiates and other medications could disrupt the way the brain encodes traumatic memories, thus preventing the incidents from being recorded with too much intensity. The new findings -- troops who received morphine within a few hours of their injuries were about 50% less likely to develop PTSD than those who didn't get the powerful painkiller -- are a strong endorsement of that theory.

The results underscore the potential for preemptive treatment not just for soldiers, but for victims of war, natural disasters, physical abuse, violent crimes such as rape, and traumatic accidents.

READ MORE @ LOS ANGELES TIMES

Breast feeding for over six months could aid mental health

Children who are breastfed for longer than six months could be at lower risk of mental health problems later in life, according to Australian research.

A study by the Telethon Institute for Child Health Research in Perth looked at 2,366 children born to women enrolled in a pregnancy study in the state of Western Australia.

Each of the children underwent a mental health assessment when they were aged two, five, eight, 10, and 14.

The researchers found that breastfeeding could help babies cope better with stress and may signal a stronger mother-child attachment which could provide lasting benefits.

"Breastfeeding for a longer duration appears to have significant benefits for the onward mental health of the child into adolescence," researcher Dr. Wendy Oddy, who led the study, wrote in The Journal of Pediatrics.

READ MORE @ REUTERS

Some blood pressure drugs may cut risk of dementia

Medicines commonly used to treat high blood pressure and heart disease may cut the risk of developing Alzheimer's disease and dementia, U.S. scientists said on Wednesday.

Researchers from Boston found that older people taking a certain type of blood pressure medication known as angiotensin receptor blockers (ARBs) were significantly less likely to develop the brain-wasting illnesses.

Dementia affects some 35 million people around the world and the number of cases -- and their impact on health policy and the economic and social costs of healthcare -- is set to grow dramatically as populations age.

Despite decades of research, doctors still have few effective weapons against dementia and experts commenting on the latest study said it could have major implications.

READ MORE @ REUTERS

Impact of FDA Safety Warnings Examined

A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA's system of communicating these warnings is sufficiently targeted and effective.

A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA’s system of communicating these warnings is sufficiently targeted and effective.

“Because this medication class has limited evidence of benefit among the elderly with dementia and significantly increases their risk of death, the ‘right’ magnitude of decline in usage is not clear,” said University of Rochester Medical Center neurologist Ray Dorsey, M.D., the study’s lead author. “More generally, the study raises larger issues about appropriate prescribing, particularly among the elderly, and the need to improve risk communication to patients and providers.”


Safety issues frequently emerge after a drug has been introduced to the market. These concerns arise either through ongoing clinical research or adverse events reported by post-market surveillance of the drug. The FDA can act upon this information in a number of ways. It can choose to remove the drug from the market or it can issue an advisory to physicians, the strongest of which is a “black box” warning which appears on the drug label.

The authors examined the impact of these warnings on a class of drugs called atypical antipsychotics. In April 2005, the FDA issued an advisory warning that elderly patients with dementia treated with these drugs were at increased risk of death.

READ MORE @ MEDIA-NEWSWIRE

'Big Pharma' feed biotech startups record funds

The biotech industry raised a record $55.8 billion in 2009 despite hesitant stock and venture capital markets, as drug-company partnerships fed the cash-burning startups that develop new therapies.

That represents a jump of 85 percent over the $30.1 billion recorded in 2008, according to Steve Burrill, whose San Francisco firm Burrill & Co. is both an industry investor and analyst.

He said the 2009 results were driven by $37 billion in financial partnerships through which large drug companies license technologies or experimental remedies from biotech startups, a dynamic that enabled many small firms to survive a tough year. But it may ultimately limit their growth if they were forced to cede control over their most promising developments.

"You're not going to grow a lot more Genentechs or Amgens," Burrill said, painting a picture of a biotech industry that is increasingly the farm team that develops remedies that will ultimately be licensed and sold by the major league drug companies, also known as "Big Pharma."

That's the snapshot of the industry that emerges as 6,500 scientists, executives and financiers converge on San Francisco this week for the JP Morgan Healthcare Conference.

READ MORE @ S.F. CHRONICLE

Few depressed Americans treated appropriately: study

Most Americans with major depression go untreated or under treated using a benchmark of American Psychiatric Association guidelines, according to a national study released this week.

Mexican Americans and African Americans are the least likely to receive treatment, especially treatment consistent with the guidelines, the study found. Those racial and ethnic disparities persisted regardless of health insurance coverage.

"Our findings support the conclusion that the U.S. mental health system is broken," Dr. Hector M. Gonzalez of Wayne State University, Detroit, and first author of the study, told Reuters Health by email.

The findings stem from interviews conducted between 2001 and 2003 with a diverse group of more than 15,000 Americans aged 18 and older.

A little more than 8 percent of the sample suffered from major depression, researchers found, including roughly 8 percent of Mexican Americans, Caribbean blacks, and non-Latino whites, and nearly 12 percent of Puerto Rican Americans.

Overall, only about half of those with depression received some type of treatment in the past year and less than a quarter had received "guideline-based" treatment, according to a report in the Archives of General Psychiatry.

READ MORE @ REUTERS

Old Antidepressant Offers Promise in Treating Heart Failure

A team of Johns Hopkins and other researchers have found in animal experiments that an antidepressant developed over 40 years ago can blunt and even reverse the muscle enlargement and weakened pumping function associated with heart failure.

In a report to be published in the Jan. 8 edition of the journal Circulation Research, the international team of U.S. and Italian heart experts describes in a dozen key laboratory experiments in rodents how the antidepressant clorgyline, which is no longer in use in humans, blocks the action of enzyme monoamine oxidase-A (MAO-A) and stops its breakdown of a key neurohormone. Norepinephrine, as it is called, controls the pace of blood pumping and makes the heart pump harder and faster in response to stress.

The latest study results, they say, are believed to be the first evidence showing how elevated MAO-A activity biochemically drives heart failure and that its dangerous downstream effects can be stalled by drug therapy.

READ MORE @ NEWSWISE

Lawsuits filed over drug side effects

A Philadelphia law firm today said it filed 10 lawsuits on behalf of boys and young men who developed serious side effects - including the growth of breasts - while taking the antipsychotic medications Risperdal and Invega.

The suits were filed in Philadelphia Court of Common Pleas. Lawyer Stephen Sheller said he expected to file an additional 20 to 30 similar cases in Philadelphia in the next two months. His firm also has 10 cases involving boys who took Risperdal and another medication pending in New Jersey.

The drugs in the Philadelphia cases are made by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson. All of the companies, which are named in the suits, are based in New Jersey, but Ortho-McNeil-Janssen is incorporated in Pennsylvania, Sheller said.

Only one of the plaintiffs, a young man who took Risperdal in his teens, is from Philadelphia. He could not be reached for comment. The suit says he experienced rapid weight gain and developed breasts that will require surgical removal. The side effects caused him to suffer "mental anguish" and "embarrassment," the suit said.

Sheller said some of his already-troubled clients grew significant bosoms, a fact their doctors may not have taken seriously enough because of the weight gain. "I would say 38D, some of them," Sheller said. "No boy wants to have a B cup, certainly not a D."

Janssen declined to comment. "We have not received details of the cases and are therefore unable to comment at this time," spokeswoman Kara Russell said.

The suits also named Excerpta Medica Inc., of Bridgewater, N.J., and its parent, Elsevier Science Publishing Co. Inc., of New York. Sheller said the companies were involved in publishing ghostwritten studies they should have known were misleading or exaggerated. An Elsevier spokesman said the company had not had time to evaluate the suits.

READ MORE @ PHILADELPHIA INQUIRER

Metabolic risks remain largely unmonitored in Medicaid patients taking antipsychotics

Despite government warnings and professional recommendations about diabetes risks associated with second-generation antipsychotic drugs, fewer than one-third of Medicaid patients who are treated with these medications undergo blood glucose or lipid tests, according to a new report.

Researchers studied laboratory claims data from the Medicaid populations of California, Missouri and Oregon between 2002 and 2005. They compared metabolic testing rates between a group of 109,451 patients receiving second-generation antipsychotics (aripiprazole, olanzapine, olanzapine/fluoxetine, quetiapine, risperidone or ziprasidone) and a control group of 203,527 patients who began taking albuterol but not an antipsychotic.

Initial testing rates for patients treated with second-generation antipsychotics were low — 27% underwent glucose testing and 10% underwent lipid testing.

In 2003, the FDA started requiring a warning on labels of second-generation antipsychotics, including olanzapine, fluoxetine and risperidone, describing an increased risk for hyperglycemia and diabetes. The warning stated that glucose levels should be monitored in patients with diabetes, at risk for the disease or with symptoms of hyperglycemia. At the same time, the American Diabetes Association and American Psychiatric Association published a consensus statement describing the metabolic risks associated with second-generation antipsychotics and specifying a monitoring protocol for all patients receiving these medications.

READ MORE @ ENDOCRINE TODAY

Study finds medication of little help to patients with mild, moderate depression

Only people with severe depression benefit from antidepressants, says research published in the Journal of the American Medical Assn. Others do better with nonmedical approaches.

Antidepressant medications probably provide little or no benefit to people with mild or moderate depression, a new study has found. Rather, the mere act of seeing a doctor, discussing symptoms and learning about depression probably triggers the improvements many patients experience while on medication.

Only people with very severe depression receive additional benefits from drugs, said the senior author of the study, Robert J. DeRubeis, a University of Pennsylvania psychology professor. The research was released online Tuesday and will be published today in the Journal of the American Medical Assn.

Hundreds of studies have attested to the benefits of antidepressants over placebos, DeRubeis said. But many studies involve only participants with severe depression. Confusion arises, he said, "because there is a tendency to generalize the findings to mean that all depressed people benefit from medications."

The current analysis attempted to quantify how much of antidepressants' benefit is attributable to chemical effects on the brain and how much can be explained by other factors, such as visiting a doctor, taking action to feel better or merely the passage of time.

READ MORE @ LOS ANGELES TIMES

More US patients receive multiple psychotropic medications

An increasing number of U.S. adults are being prescribed combinations of antidepressants and antipsychotic medications, according to a report in the January issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

In some clinical situations, evidence suggests that more than one psychotropic (affecting the brain or mind) medication may be beneficial, according to background information in the article. For instance, a patient with depression who does not respond to one medication alone might require a second antidepressant, or an individual who has depression with psychotic features might respond to a combination of an antidepressant and an antipsychotic. "In routine psychiatric practice, however, patients often receive psychiatric medication combinations that are not well supported by controlled clinical trials," the authors write.

To examine patterns and trends in psychotropic polypharmacy—or the prescription of more than one psychiatric medication—Ramin Mojtabai, M.D., Ph.D., M.P.H., of Bloomberg School of Public Health, Johns Hopkins University, Baltimore, and Mark Olfson, M.D., M.P.H., of Columbia University Medical Center and the New York State Psychiatric Institute, New York, analyzed data collected from a national sample of office-based psychiatry practices. The number of medications prescribed and specific medication combinations were assessed from a total of 13,079 office visits to psychiatrists by adults (18 years or older) between 1996 and 2006.

READ MORE @ EUREKALERT

Many antipsychotic users not getting needed tests

People who take newer drugs for Cand other psychotic conditions are supposed to have their blood sugar and cholesterol levels checked regularly but many don't, according to a study released today.

These so-called "second-generation" antipsychotic drugs, which include olanzapine (Zyprexa), risperidone (Risperdal) and aripiprazole (Abilify), were developed because older antipsychotics have significant side effects. However, the newer drugs are known to significantly increase blood sugar and cholesterol levels, raising the risk for diabetes and heart disease.

In a study, researchers found that less than one-third of low-income Medicaid patients who are treated with these drugs have their blood sugar and cholesterol levels checked.

And perhaps even more concerning, say the researchers, screening rates did not increase following government warnings and recommendations calling for increased blood sugar and cholesterol monitoring.

The findings are consistent with others from non-Medicaid populations, Dr. Elaine H. Morrato of the University of Colorado, Denver, who was involved in the study, told Reuters Health.

She has this advice: "If you are taking second-generation antipsychotic drugs, then you should be screened for diabetes and (high cholesterol and fats in the blood) and monitored for potential adverse drug effects. This is important so that you can receive appropriate preventive care and treatment."

READ MORE @ REUTERS

Combination Therapy Better Than Leading Drug for Bipolar Disorder, Study Suggests

People with bipolar disorder are less likely to suffer a relapse if they are taking both lithium and sodium valproate rather than the drug valproate alone, an Oxford University study has shown.

Sodium valproate (available as Depakote) has been increasingly prescribed over lithium (Priadel) as a long-term therapy for bipolar disorder, particularly in North America. But the findings of the randomised trial, published in the medical journal The Lancet, suggest that those who have been prescribed valproate would fare better if lithium was added to their therapy, or if they changed to lithium alone.
'Our study indicates that a combination therapy of lithium plus valproate may be preferable for people with bipolar disorder over valproate alone, as there were significantly fewer relapses among those on both drugs over the two year period of the trial,' says Professor John Geddes of the Department of Psychiatry at the University of Oxford, who led the research.
About 1 in 100 people are diagnosed as having bipolar disorder (also known as manic depression), a mood disorder characterised by swings in a person's mood, including depression and mania. During a severe depressive episode, people may have feelings of hopelessness and despair, and have difficulty in carrying on with daily activities and work. In the manic phase, people may be overactive, lose judgement, become sexually uninhibited, and have grandiose ideas or delusions.

READ MORE @ SCIENCE DAILY

Genetic Studies Offer Clues about Addiction Risks, Treatments

The social and health tolls of alcohol abuse, nicotine dependence, and drug addiction have been known for some time. But the genetic patterns that make some individuals more susceptible to abusing these substances — as well as those influencing their ability to quit — are less well understood.

Even so, a growing body of evidence is starting to unravel how genetics and epigenetics contribute not only to an individual's predisposition for becoming hooked on alcohol, nicotine, or other drugs, but also their ability to kick such habits. And experts say genetics is poised to impact clinical treatments for addiction in the not-too-distant future, with researchers already identifying genetic variants that may eventually help guide smoking-cessation therapy.

"[T]he rapid advances in the genetics of addiction hold great promise for developing treatments for addiction and reducing the enormous health burden of addiction," Jonathon Pollock, chief of the National Institute of Drug Abuse's genetics and molecular neurobiology research branch, and Trinity College geneticist Mani Ramaswami wrote in a preface to a special issue of the Journal of Neurogenetics earlier this year.

The issue contains numerous papers and reviews stemming from a NIDA short course on the genetics and epigenetics of addiction held in the spring of 2008.

READ MORE @ GENOME WEB DAILY NEWS

Atypical Antipsychotics Increase Cardiometabolic Risk in Children

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

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

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

READ MORE @ PSYCHIATRIC TIMES

Cognitive-Behavioral Therapy for Childhood Anxiety and Depression

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

Anxiety disorders

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

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

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

READ MORE @ PSYCHIATRIC TIMES

Mental health isn't the issue - stigma is

Mark Dayton at his campaign headquarters in downtown Minneapolis.

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

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

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

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

READ MOE @ Minneapolis Star Tribune

Schizophrenia Mouse Model Should Improve Understanding and Treatment of the Disorder

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

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

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

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

READ MORE @ SCIENCE DAILY

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

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

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

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

READ MORE @ THE GUARDIAN