Co-Payments Go Way Up for Drugs With High Prices

Health insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dollars for prescriptions for medications that may save their lives or slow the progress of serious diseases.
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With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug’s actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month.

The system means that the burden of expensive health care can now affect insured people, too.

No one knows how many patients are affected, but hundreds of drugs are priced this new way. They are used to treat diseases that may be fairly common, including multiple sclerosis, rheumatoid arthritis, hemophilia, hepatitis C and some cancers. There are no cheaper equivalents for these drugs, so patients are forced to pay the price or do without.

Insurers say the new system keeps everyone’s premiums down at a time when some of the most innovative and promising new treatments for conditions like cancer and rheumatoid arthritis and multiple sclerosis can cost $100,000 and more a year.

READ MORE @ NY TIMES

Task Force Proposes New Bipolar Guidelines

An international team of experts recently proposed expanding the diagnostic criteria for several subtypes of bipolar disorder, adding a pediatric bipolar disorder category and eliminating the schizoaffective disorder category.

The Diagnostic Guidelines Task Force of the International Society for Bipolar Disorder (ISBD) has been examining diagnostic issues since 2004 and recently presented its recommendations at ISBD's third biennial meeting in India and in the society's journal, Bipolar Disorders (February, part 2).

Task force chairman S. Nassir Ghaemi, MD, MPH, told Psychiatric Times that the task force brought together some of the world's clinical experts on bipolar disorder and key researchers with the goal of having them develop a more systematic and coherent set of diagnostic guidelines.

The task force's charge, originally developed by then ISBD president Samuel Gershon, MD, was to evaluate current diagnostic systems, identify key similarities and differences among them, reconcile the data, provide an organizational schema for diagnosis of bipolar disorder across cultures, and highlight continuing differences for further research.

READ MORE @ PSYCHIATRIC TIMES

FDA looks at link between medications, depression

Federal regulators warn that an array of drugs could play a role in spurring thoughts of suicide or other psychiatric symptoms.

As symptoms of depression go, there is none much clearer than having thoughts of suicide.

But a spate of recent announcements from federal health officials suggests a surprising new interpretation of suicidal fantasies and the depression they are thought to signal: Sometimes, sadness, anxiety and self-destructive thoughts are not symptoms but side effects -- of medicine.

In this year alone, federal regulators have warned that a surprising array of drugs could play a role in spurring thoughts of self-destruction. Medicines that treat epilepsy, asthma and influenza are now under suspicion, as is one that helps smokers kick the tobacco habit.

The FDA stresses that it has established no direct causal link between these medications and suicidal thoughts in patients taking them. But in all the cases, regulators acknowledge they had one of two indicators of potential trouble.

In some cases, a review of a drug's early clinical trials turned up increased rates of suicidal thinking among subjects taking the medicine. In others, the tip-off came when the FDA observed an uptick of reports that patients taking a medication for some other condition developed symptoms of depression.

READ MORE @ LOS ANGELES TIMES

Treatment With An Anti-psychotic Drug Found To Cause Changes In Metabolism Earlier Than Expected

Schizophrenia is a complex type of psychotic mental illness characterized by thoughts that are uncoupled from reality. Huge gains in the effective treatment of individuals with the disease began in the 1950s with the development of the first generation of antipsychotic drugs. The medications allowed physicians to treat the “positive” effects of the illness (delusions and hallucinations) and, to a lesser extent, the “negative” symptoms (apathy). The second generation of antipsychotics – known as atypical antipsychotics (AAP) – began in 1990. These newer medicines have proven as effective in treating the positive aspects of the disease and more effective in combating the negative ones.

As is the case with nearly all medications, antipsychotics have side affects, including weight gain and some other risk factors of metabolic syndrome, which puts an individual at greater risk of heart disease and type 2 diabetes. Physicians are concerned that these side effects may cause their patients to stop taking their medicine.

A team of French researchers has found, in an animal model, that the consumption of at least one atypical antipsychotic exhibits some of the risks for metabolic syndrome in humans. This model allows researchers to explore the sequence of early metabolic events that may result from atypical medications.

READ MORE @ SCIENCE DAILY

Injectable Risperidone Demonstrates Response, Lowers Relapse

With medication compliance is a significant issue in some people who grapple with schizophrenia, drug companies often look toward injectable forms of their psychiatric medications to help with this issue. A new study suggests that an atypical antipsychotic in injectable form looks to be just as effective as its non-injectable counterpart. Patients with psychosis treated early on in the course of their illness with risperidone long-acting injection demonstrated high response and remission rates with low relapse rates according to the study.

A reduction of the Positive and Negative Syndrome Scale (PANSS) total score of at least 50% was experienced by 84% of the 51 patients included in the study, with only four of these patients relapsing by the study endpoint. During the two-year trial period, the study also showed 64% of patients achieved remission.

Non-compliance or partial compliance remain key barriers in the management of schizophrenia and are often significant contributing factors in relapse. Relapse is associated with increased risk of hospitalization and a dramatically poorer quality of life. Patients experiencing numerous relapses are at high risk of never regaining previous levels of functioning.

READ MORE @ PSYCHCENTRAL

Link Between Insomnia And Depression In Young Adults - New Study In The Journal SLEEP

A study published in the April 1 issue of the journal SLEEP confirms the persistent nature of insomnia and the increased risk of subsequent depression among individuals with insomnia.

The study, conducted by Jules Angst, MD, of Zurich University Psychiatric Hospital in Switzerland, focused on 591 young adults, whose psychiatric, physical, and sleep symptoms were assessed with six interviews spanning 20 years. Four duration-based subtypes of insomnia were distinguished: one-month insomnia associated with significant distress, two-to-three-week insomnia, recurrent brief insomnia, and occasional brief insomnia.

According to the results, the annual prevalence of one-month insomnia increased gradually over time, with a cumulative prevalence rate of 20 percent and a greater than two-fold risk among women. In 40 percent of subjects, insomnia developed into more chronic forms over time. Insomnia either with or without comorbid depression was highly stable over time. Insomnia lasting two weeks or longer predicted major depressive episodes and major depressive disorder at subsequent interviews. Seventeen to 50 percent of subjects with insomnia lasting two weeks or longer developed a major depressive episode in a later interview. "Pure" insomnia and "pure" depression were not longitudinally related to each other, whereas insomnia comorbid with depression was longitudinally related to both.

READ MORE @ MEDICAL NEWS TODAY

2.5m children on drugs in US

Antipsychotic drugs for children have taken off in the US on the back of a willingness to diagnose those with behavioural problems as having manic depression. Even children barely out of babyhood are getting a diagnosis of bipolar disorder, the modern term for the condition.

The chief symptoms are mood swings, which, however, are common in children of any age.

David Healy, an expert on bipolar disorder, said there were now 2.5 million American children on antipsychotics. However, the UK guidelines on the disorder, from the National Institute for Health and Clinical Excellence, urge caution.

One drug which prompted concern was Risperdal, originally to be sold for children with "irritability" or difficult behaviour in autism. It was reviewed by experts for the Medicines and Healthcare products Regulatory Agency because of "concern about the potential misuse of [it] as ... long-term chemical control". The drug's maker, Janssen-Cilag, though it won a licence for it, withdrew its application, citing differences with the authority.

READ MORE @ GUARDIAN

Drug Makers Near Old Goal: A Legal Shield

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

READ MORE @ NY TIMES

Restrictive Prescription Drug Policies Hurt Schizophrenics

Harvard study found program made patients 29% more likely to stop, disrupt their meds

Restrictive prescription drug policies can cause schizophrenia patients to stop taking their medications, a Harvard Medical School study suggests.

Researchers looked at Medicare beneficiaries with schizophrenia in Maine before, during and after a policy that required patients to use an authorized medication (step treatment) before they were permitted to be prescribed drugs not on the preferred list. They were compared to Medicare beneficiaries with schizophrenia in New Hampshire, where there was no such regulation.

The study found that the Maine patients were 29 percent more likely to stop or disrupt medication when subject to the tightened policy. In addition, the restrictive drug policy -- originally designed to reduce costs -- provided only minimal savings.

READ MORE @ US NEWS & WORLD REPORT

New Findings in Early-Onset Schizophrenia

The Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) study, funded by the NIMH, was a multicenter, controlled treatment trial of children and adolescents.1 The aim of the TEOSS study was to compare the efficacy and safety of risperidone and olanzapine with that of a traditional antipsychotic agent—molindone.

In this double-blind, parallel-group study, patients were randomized to receive risperidone, olanzapine, or molindone for 8 weeks followed by a 44-week, double-blind maintenance phase for responders. A total of 119 children and adolescents were randomized in the study. The results of the study, which should be reported in the near future, will provide needed information about the safety and tolerability of antipsychotic medications in youths with schizophrenia spectrum disorders.

The clinical characteristics of this large sample were recently reported and provide important information about the demographics and severity of illness in children and adolescents with early-onset schizophrenia and schizoaffective disorder.2 The mean age of onset of illness was 11.1 years. At the time of enrollment, the mean age of the patients was 13.8 years. The sex distribution was 66% male and 34% female. The racial breakdown was 62% white, 31% African Amer-ican, 3.4% Asian, 2.5% mixed, and 0.8% Pacific Islander. The average IQ of the sample was 93. Most of the youths lived with their family, 4% were hospitalized, and 7% lived in a group home or residential facility.

READ MORE @ PSYCHIATRIC TIMES

Medication 'worsens Alzheimer's

Anti-psychotic drugs commonly given to Alzheimer's patients often make their condition worse, a UK study suggests.

Neuroleptics provided no benefit for patients with mild behavioural problems, but were associated with a marked deterioration in verbal skills.

The research focused on 165 people with advanced Alzheimer's who were living in nursing homes in four British cities.

Up to 60% of Alzheimer's patients in nursing homes are given the drugs to control behaviour such as aggression.

The study appears in the journal Public Library of Science Medicine.

The researchers, from Kings College London and the Universities of Oxford and Newcastle, found the drugs offered no long-term benefit for most patients with mild symptoms of disturbed behaviour.

But just six months of treatment was enough for patients to show a marked deterioration in their verbal fluency.

READ MORE @ BBC

Psychiatric drugs causing weight gain: doctors

The very drugs millions of Canadians are taking to get through their day can cause dramatic weight gain, doctors are warning.

Psychiatric drug-related weight gain "is a huge problem," says Dr. David Lau, chair of the diabetes and endocrine research group at the University of Calgary and president of Obesity Canada.

"You can see patients gaining 10, 20, 30, 40 pounds," Lau says.
Not everyone taking antidepressants, mood stabilizers or newer generation antipsychotics will gain weight, he stressed. What's more, he said new antipsychotics, so-called "atypical antipsychotics" have been "tremendous in terms of bringing back the functionality of people with schizophrenia, bipolar disorders and depression."

But Harvard University psychologist Paula Caplan warns of a vicious cycle, where patients who experience weight gain after taking psychotropic drugs are reluctant to discontinue their use.

"If they gain weight, they think 'I can avoid fast foods, or I can take smaller portion sizes or I can exercise more.' But to think, 'go off my medication that I believe is responsible for my being able to function, is too scary.'"

READ MORE@ VANCOUVER SUN

Second-Generation Antipsychotics Are No Better Than First-Generation Drugs for Schizophrenia

Second-generation antipsychotic drugs are not necessarily better than the first-generation drug haloperidol at treating a first episode of schizophrenia. This is the conclusion of authors of an article published in this week's issue of The Lancet.

Second-generation drugs, introduced over a decade ago, are purported to be more effective and less likely to induce motor side effects, such as stiffness and tremors, than first-generation drugs. However, results from studies comparing the 2 types of drugs have not been reliable -- studies have over-represented men and under-represented those with other issues such as drug abuse. Moreover, these trials were often too short. The question of which drugs are more effective is an important one, as many of the newer drugs are more expensive.

READ MORE @ DOCTOR'S GUIDE

Combination of Antidepressants Linked to Risk of Diabetes

The use of two types of antidepressants at the same time was associated with an increased risk for type 2 diabetes, a nested case-control study showed.

Patients taking both a tricyclic antidepressant and a selective serotonin reuptake inhibitor (SSRI) were nearly twice as likely to develop type 2 diabetes as those taking a tricyclic antidepressant alone, Jeffrey Johnson, Ph.D., of the University of Alberta, and colleagues reported in the January issue of Diabetes Research and Clinical Practice.

"If our findings are confirmed by others," they concluded, "it could be that antidepressant therapy will need to be tailored to depressed individuals' risk of developing diabetes, and that patients on combination therapy will require vigilance regarding the development of glucose intolerance."

The increased risk of diabetes in depressed patients is well-documented, the researchers said, but the mechanisms are unknown.

READ MORE @ MEDPAGE TODAY

Study Hints of Gene Link to Risk of Schizophrenia

A new study has found that rare and previously undetectable genetic variations may significantly increase the risk that a person will develop schizophrenia.

Experts said the study, while not identifying the cause of the disorder, provided a striking demonstration of how new gene-scanning technology can open a new frontier in the quest to understand the biology of mental disorders.

Until now, researchers had focused on finding common and known genetic variations that, when acting in some combination, might increase the risk for schizophrenia. They have had little success. The new analysis, being published Friday in the journal Science, detected extremely rare and unknown mutations that turned up three to four times as often in people with schizophrenia as in those without it.

The findings point scientists to previously unappreciated developmental problems that may help them develop more effective treatments, experts said.

READ MORE @ NY TIMES

Clozapine Better Than "High-Dose" Olanzapine for the Treatment of Adolescents With Schizophrenia

The results of a 12-week, double-blind, randomised study published in the March issue of Biological Psychiatry suggest that clozapine is more effective than "high-dose" olanzapine for the treatment of children and adolescents with schizophrenia who do not respond to standard, first-line antipsychotic treatment.

There is a wealth of scientific literature available on the treatment of adults with schizophrenia. However, there is a paucity of data to guide the treatment of children and adolescents with schizophrenia.

"Although the US Food and Drug Administration 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, University of Minnesota, Minneapolis, Minnesota, one of the authors of the study.

READ MORE @ DOCTOR'S GUIDE

Drug bill would give doctors unbiased details on medication

Imagine our doctors getting an unbiased education on the medications they prescribe instead of having to rely on drug company sales reps to tell them what's on the market and how well it works.

That's already happening in other countries -- Australia, England, the Netherlands and some provinces of Canada. It's happening -- or about to -- in some parts of the United States, too, including Maine, Pennsylvania, South Carolina, Vermont and Washington, D.C.

Ohio and the rest of the nation could see the same thing if a couple of U.S. senators get their way.

Democrats Herb Kohl of Wisconsin and Dick Durbin of Illinois are writing a bill that would provide accurate and objective drug information to any doctor in America who wants it.

Government-funded pharmacists and nurses who've studied the drugs -- all of them, even generics and over-the-counter ones -- and who understand their pros and cons would prepare the information and present it to doctors interested in having it. And the information would be available to consumers, those of us who end up having to take this stuff.

READ MORE @ THE PLAIN DEALER

The Increasing Use Of Antidepressants: Some Reasons For Concern

Two articles in the March issue of the European Journal Psychotherapy and Psychosomatics raise serious concern about the increasing use of antidepressant medications. In the first article, David Healy and collaborators (University of Cardiff) formulate a critique of many studies which try to support the use of antidepressants on the basis of variations in suicide rates.

The Authors compare suicide rates in the Nordic countries with autopsy and ill-defined death rates, and antidepressant sales, during the period 1961 through to 2003, finding a close correlation between suicide rates and both autopsy and ill-defined death rates.The Authors conclude that the role of autopsies and other factors in the registration of a death as a suicide appear to need further clarification.

In another article Mojtabai and collaborators analyze the increase in antidepressant medication in the US in the past decade in two US general population surveys.

READ MORE @ MEDICAL NEWS TODAY

Know Suicide's Warning Signs - More people likely to take their lives in the spring, doctors say

While many people view spring as a time of renewal and hope, the greatest number of suicides in the United States occur each year in April and May, notes the American College of Emergency Physicians.

It's not clear why suicide rates spike in the spring, said ACEP President Dr. Linda L. Lawrence. But "we do know that suicide is the 11th leading cause of death for all ages in the United States, with one suicide occurring every 16 minutes or about 11 suicides per 100,000 people," she said in a prepared statement.

"Moreover, suicide is the second leading cause of death among 25- to 34-year-olds and the third leading cause of death among 15- to 24-year-olds. Men take their own lives nearly four times more often than women, with men ages 75 and older having the highest rate of suicide, although over a lifetime, women attempt suicide two to three times as often as men," Lawrence said.

READ MORE @ US NEWS & WORLD REPORT

Seriously Depressed Teens Respond to Combined Therapy

"If at first..." Many high-risk teenagers with depression show improvement on treatment combining medication with cognitive-behavioral therapy.

Over half of adolescents who don't respond to a first antidepressant improve when switched to a combination of a different antidepressant and cognitive-behavioral therapy (CBT). This is a key finding of an NIMH-funded clinical trial, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA).

Previous trials have shown that SSRI antidepressants or CBT or the combination can produce an adequate clinical response in up to 60 percent of treated adolescents, the authors noted, but, "There are no empirical studies to guide clinicians regarding the management of adolescents with depression not responsive to an initial treatment with an SSRI."

Previously, the Treatment of Adolescent Depression Study (TADS) demonstrated a similar benefit for combined therapy, but it tested a treatment-naïve group of depressed adolescents. TORDIA differed in two ways from TADS. It was aimed at youth who had not responded to a first round of treatment, and it included more chronically depressed adolescents (averaging two years) and more with suicidal ideation (59 percent)—groups often excluded from clinical trials, said lead author David Brent, M.D., in an interview with Psychiatric News.

READ MORE @ PSYCHIATRIC NEWS