JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives of Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.
THIS WEEK'S CONTENTS
ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), Monday, October 2, 2006)
ONE-THIRD OF U.S. YOUTH NOT PHYSICALLY FIT
LOW BIRTH WEIGHT INFANTS MAY HAVE COGNITIVE AND PHYSICAL PROBLEMS WHEN THEY REACH ADOLESCENCE
ADHD COSTLY BEFORE AND AFTER DIAGNOSIS
ARCHIVES OF GENERAL PSYCHIATRY NEWS RELEASES
Embargoed Until: 3 P.M. (CT), Monday, October 2, 2006
SECOND-GENERATION ANTIPSYCHOTIC MEDICATIONS APPEAR TO OFFER LITTLE ADVANTAGE OVER OLDER DRUGS FOR PATIENTS REQUIRING CHANGE IN TREATMENT
EFFECTS OF NEW SLEEP MEDICATION APPEAR UNLIKELY TO HAVE POTENTIAL FOR ABUSE OR COGNITIVE IMPAIRMENT
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, October 2, 2006
Media Advisory: To contact Russell R. Pate, Ph.D., call Karen Petit or Margaret Lamb at 803-777-5400.
ONE-THIRD OF U.S. YOUTH NOT PHYSICALLY FIT
CHICAGO—Approximately one-third of boys and girls age 12 to 19 in the United States do not meet standards for physical fitness, according to a report in the October issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.
The more physically fit a young person, the less likely he or she is to have high blood pressure, high cholesterol levels or a number of other risk factors for chronic diseases, according to background information in the article. Between the 1950s and the 1980s, regular surveys of youth physical fitness were conducted in the United States. An increasing proportion of children have become obese since the 1980s, which may be explained by a decrease in physical activity. If so, it is likely that average physical fitness has also declined among youth in the same time period, since the last national survey.
Russell R. Pate, Ph.D., Arnold School of Public Health, University of South Carolina, Columbia, and colleagues assessed the physical fitness of 3,287 individuals age 12 to 19 who participated in the government-conducted National Health and Nutrition Examination Survey between 1999 and 2002. The participants were interviewed in their home and then visited a mobile examination center, where they performed a treadmill exercise test consisting of a two-minute warm-up, two three-minute periods of exercise and a two-minute cool-down. During the test, researchers measured blood pressure, heart rate and rate of perceived exertion, determined by asking participants to rate how hard they feel their bodies are working. Heart rate readings during the three-minute periods of exercise were used to estimate maximal oxygen uptake (VO2max), the amount of oxygen consumed by the body during maximum exertion; the higher the VO2max, the better the individual’s fitness level.
Estimated VO2max, and therefore physical fitness levels, were higher on average in males than in females and in youth of normal weight compared with overweight youth but were no different across racial or ethnic groups. Older males were more physically fit than younger males, while the opposite was true for females. Participants who reported more sedentary behavior, such as watching television or playing video games, and those who spent less time being physically active were more likely not to be physically fit.
Based on standards developed by experts and used by schools and school districts nationally, about 65 percent of youth met criteria for being physically fit. “This represents a significant public health problem because low physical fitness during adolescence tends to track into adulthood, and low-fit adults are at substantially increased risk for chronic disease morbidity [illness] and mortality [death],” the authors write. Because active youth tend to be more physically fit, experts recommend that physicians counsel children and parents about guidelines for physical activity, they conclude.
(Arch Pediatr Adolesc Med. 2006;160:1005-1012. Available to the media pre-embargo at www.jamamedia.org)
Editor's Note: This study was funded by a grant from the National Heart, Lung and Blood Institute and a grant from the National Institute of Child Health and Human Development. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, October 2, 2006
Media Advisory: To contact Agnes H. Whitaker, M.D., call Elizabeth Streich at 212-305-6535.
LOW BIRTH WEIGHT INFANTS MAY HAVE COGNITIVE AND PHYSICAL PROBLEMS WHEN THEY REACH ADOLESCENCE
CHICAGO—Sixteen-year-olds who weighed less than 2,000 grams (about 4.5 pounds) at birth and are not disabled are still more likely than the average teenager to have physical and mental difficulties, according to a report in the October issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.
Low birth weight is known to increase the risk for major disabilities such as cerebral palsy and mental retardation, but researchers now suspect that low birth weight may also contribute to minor difficulties in motor skills and in thinking, learning and memory (cognitive abilities). These problems may last into adolescence, according to background information in the article.
Agnes H. Whitaker, M.D., Columbia University and New York State Psychiatric Institute, New York, and colleagues studied 474 non-disabled adolescents who were born at or admitted to one of three New Jersey hospitals between 1984 and 1987 and weighed less than 2,000 grams at birth. The participants, who had an average age of 16 at the time of assessment for this study, underwent intelligence and motor tests in their homes.
Compared with the standardization sample, or the large group of teens used to provide a reference point for the assessments, the adolescents with low birth weight had more motor problems. Their IQ scores were within the normal range, but on average were significantly lower than the average for their age group. Those who were male, who had injuries to the white matter (nerve tissue) of the brain on neonatal ultrasound and who spent more days on a ventilator as an infant were more likely to have motor difficulties. Social disadvantages, a lower fetal growth ratio (calculated by dividing birth weight by the median weight for the infant’s age) and white matter injury also predicted lower IQ scores.
“The finding that, independent of social risk, specific prenatal, perinatal and neonatal biological risk factors are associated with cognitive and motor outcomes as late as adolescence runs counter to the view that, absent severe disability, early biological risk factors are of little importance in later life,” the authors conclude. “The prevention of white matter injury and the need for mechanical ventilation may be key to improving motor outcomes, whereas the prevention of intrauterine growth retardation (or perhaps impaired head growth) and white matter injury may be key to improving cognitive outcomes. Taken together, these findings suggest that enhanced maternal-fetal and neonatal care have the potential to substantially improve cognitive and motor outcomes for non-disabled low birth weight adolescents.”
(Arch Pediatr Adolesc Med. 2006;160:1040-1046. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This study was supported by a grant from the National Institute of Mental Health and a grant from the March of Dimes. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, October 2, 2006
Media Advisory: To contact G. Thomas Ray, M.B.A., call Maureen McInaney at 510-987-4779.
ADHD COSTLY BEFORE AND AFTER DIAGNOSIS
CHICAGO—Children with attention-deficit/hyperactivity disorder (ADHD) use more health services in the two years before and two years after they are diagnosed than do children without ADHD, with white children accumulating more expenses than those of other ethnicities, according to a report in the October issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.
Approximately 8 percent of children age 4 to 17 have ADHD, according to background information in the article. The condition affects social behaviors and achievement at school and work. Treatment can include medications and behavioral approaches and is often expensive, and costs can begin to add up before treatment starts. “Excess use of services prior to an ADHD diagnosis may signal an existing problem for which the family may be seeking a diagnosis and may indicate that assessment protocols are not identifying these children early enough,” the authors write.
G. Thomas Ray, M.B.A., Kaiser Permanente Medical Care Program, Northern California Region, Oakland, and colleagues used health plan records to identify 3,122 children between the ages of 2 and 10 who had been diagnosed with ADHD between 1996 and 2004. They compared health care costs, including pharmacy expenses, for these children to those of 15,899 control children who were the same age and sex but did not have ADHD. Approximately six children without ADHD were matched to every one child with ADHD and also were assigned an index date that corresponded to the child with ADHD’s diagnosis date.
The average age at ADHD diagnosis was 6.7. Compared with children without ADHD, those with ADHD had average health care costs that were $488 higher in the second year before diagnosis, $678 higher in the year before diagnosis, $1,328 higher in the year following diagnosis and $1,040 higher in the second year after diagnosis. Among children with ADHD, Asian Americans, African Americans and Hispanic Americans had lower yearly costs for ADHD medications compared with white Americans, and Asian Americans had overall lower spending on ADHD services than white Americans ($221 or 30 percent lower).
“Parents commonly state that behavioral problems predate their child’s ADHD diagnosis, often by several years, and these problems may affect their use of health services,” the authors write. “In our study sample, costs were significantly higher in the two years before the index date among children subsequently diagnosed with ADHD, and costs remained higher for at least two years following the initial ADHD diagnosis. Much of the excess cost was due to increased pediatric and psychiatric services, which were higher in the first year after diagnosis than in the second year.”
Differences in costs and use of ADHD medications by ethnicity could be related to cultural acceptance of diagnosis and treatment, they continue. “Future studies, particularly those involving interviews of the parents of children with ADHD and their health care providers, could shed light on the reasons for these differences.”
(Arch Pediatr Adolesc Med. 2006;160:1063-1069. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This study was funded by a grant from the National Institute of Mental Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, October 2, 2006
Media Advisory: To contact Peter B. Jones, M.D., Ph.D., e-mail pbj21{at}cam.ac.uk.
SECOND-GENERATION ANTIPSYCHOTIC MEDICATIONS APPEAR TO OFFER LITTLE ADVANTAGE OVER OLDER DRUGS FOR PATIENTS REQUIRING CHANGE IN TREATMENT
CHICAGO—Among patients with schizophrenia whose medication is changed because of ineffectiveness or harmful side effects, second-generation antipsychotic drugs do not appear to offer significant benefits compared to first-generation antipsychotic drugs, according to a report in the October issue of Archives of General Psychiatry, one of the JAMA/Archives journals. The findings run contrary to the widely held perception that second-generation antipsychotic agents are safer and more effective in treating patients with schizophrenia than the less-expensive first-generation class of medications.
For almost 50 years, antipsychotic medications have been the primary method of treating schizophrenia, a psychiatric disorder that causes a disconnect from reality and severe disturbances in thought, mood and behavior. Patients taking first-generation antipsychotics—so called because they were developed first—often relapse or develop severe side effects, including sedation (feeling tranquilized) and involuntary muscle movements, according to background information in the article. The development of second-generation antipsychotics was thought to be a major advance primarily because the drugs reduced such side effects. Claims that second-generation drugs are more effective than first-generation drugs have shifted treatment patterns away from first-generation medications, although research comparing the drug classes has had mixed results.
Peter B. Jones, M.D., Ph.D., University of Cambridge and Cambridgeshire and Peterborough Mental Health NHS Trust, Cambridge, England, and colleagues studied 227 individuals age 18 to 65 with schizophrenia. “The key question was whether the additional acquisition costs of second-generation antipsychotics over first-generation antipsychotics would be offset by improvements in health-related quality of life or savings in the use of other health and social care services in people with schizophrenia for whom a change in drug treatment was being considered for clinical reasons, most commonly suboptimal efficacy or adverse effects,” the authors write. The participants were randomly assigned to receive one class of drug or the other. Physicians determined which of the many first- or second-generation medications would be best for each patient. Participants were assessed before and 12, 26 and 52 weeks after the change in treatment using a quality of life scale, with higher scores reflecting a better quality of life. The researchers estimated that second-generation antipsychotics would produce a five-point improvement in quality of life scores compared with first-generation antipsychotics. Symptoms, side effects, treatment costs and satisfaction with the drug also were measured.
Of the 227 patients, 118 (52 percent) were randomly assigned to take first-generation medications and 109 (48 percent) to second-generation medications. After 12 weeks, quality of life scores averaged 49.2 for the first-generation group and 46.6 for the second-generation group; after 26 weeks, 49.2 for first-generation and 50.4 for second-generation; and after one year, 53.2 for first-generation and 51.3 for second-generation. “Participants in the first-generation antipsychotic arm showed a trend toward greater improvements in Quality of Life Scale and symptom scores,” the authors write. “Participants reported no clear preference for either drug group; costs were similar.”
Although surprising, these results align with other recent studies performed in the United States, they continue. “All the data suggest that careful prescribing of first-generation antipsychotics, at least in the context of a trial, is not associated with poorer efficacy or a greater adverse effect burden, both of which would translate into lower quality of life in the medium term,” the authors conclude. “This suggests that despite recent policy statements and prescribing patterns, further randomized and other evaluations of second-generation antipsychotics would still be useful in establishing their role in the long-term management of schizophrenia and, likewise, the continued role of older drugs.”
(Arch Gen Psychiatry. 2006;63:1079-1087. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
COMMENTARY: NEW THERAPIES FOR SCHIZOPHRENIA NEEDED
These and other recent findings suggest that despite their tremendous advantage in market share, second-generation antipsychotic drugs may not be much more effective than first-generation antipsychotic agents, writes Jeffrey A. Lieberman, M.D., College of Physicians and Surgeons, Columbia University, New York, in an accompanying commentary.
An objective view “must lead to the conclusion that with the possible exception of clozapine, the second-generation antipsychotics are not the great breakthrough in therapeutics they were once thought to be; rather, they represent an incremental advance at best,” Dr. Lieberman writes. “This underscores the urgent need for greater progress in developing novel therapeutics for schizophrenia and related psychotic disorders.”
(Arch Gen Psychiatry. 2006;63:1069-1072. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: Please see the article for additional information, including author contributions and affiliations, financial disclosures, funding and support, etc.
COMMENTARY: CHANGES TO SCHIZOPHRENIA TREATMENT SHOULD BE OPENLY DEBATED
Newly raised questions about the superiority of second-generation antipsychotics should not be used to justify a large, sudden change in treatment recommendations, warns Robert A. Rosenheck, M.D., Department of Veterans Affairs Connecticut Health Care System, West Haven, in an second related commentary.
Most patients with schizophrenia are unemployed and rely on public assistance; almost 90 percent of schizophrenics currently receive second-generation antipsychotics at a cost of $10 billion annually, 70 percent of which is paid through Medicaid. Although they are more expensive, most expert panels recommend using second-generation medications first in the treatment of schizophrenia, and current health policy supports open access to both first- and second-generation drugs.
This new information should not encourage changes that would mandate the use of less-expensive, first-generation drugs first, Dr. Rosenheck writes. “Data from clinical trials are only one type of information of relevance to public discourse,” he continues. “A comprehensive public dialogue is needed prior to policy action and should involve patients, health care professionals, researchers, industry representatives and other stakeholders. Policy change may eventually be warranted, but potentially polarizing decisions are best delayed until thoughtful public deliberation gives a chance for comprehensive review, consensus building and shared understanding.”
(Arch Gen Psychiatry. 2006;63:1074-1076. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, October 2, 2006
Media Advisory: To contact corresponding author Roland R. Griffiths, Ph.D., call Eric Vohr at 410-955-8665.
EFFECTS OF NEW SLEEP MEDICATION APPEAR UNLIKELY TO HAVE POTENTIAL FOR ABUSE OR COGNITIVE IMPAIRMENT
CHICAGO—In a study of 14 adults with histories of sedative abuse, the newly approved sleep medication ramelteon does not appear to have effects that indicate potential for abuse or motor or cognitive impairment, according to a report in the October issue of Archives of General Psychiatry, one of the JAMA/Archives journals.
About 10 to 15 percent of adults regularly experience chronic insomnia, difficulty sleeping that causes distress or impaired daytime functioning, according to background information in the article. Some of the medications most commonly used to treat the condition (known as benzodiazepine receptor agonists) have a number of problematic side effects. These include a risk for abuse, especially by those with histories of substance abuse; difficulties with cognition (thinking, learning and memory), including a type of amnesia that blocks the formation of new memories; and motor impairments that may make driving dangerous and contribute to falls among older adults. In addition, those who use benzodiazepine receptor agonists long-term may experience withdrawal symptoms—including anxiety, irritability and even seizures—if they stop taking the drugs. Ramelteon, a drug recently approved for treatment of insomnia, works through a different pathway in the brain involving melatonin receptors and therefore may be less likely to cause such effects.
Matthew W. Johnson, Ph.D., and colleagues at The Johns Hopkins School of Medicine, Baltimore, evaluated the potential for abuse and cognitive effects of ramelteon compared with placebo and with triazolam, a benzodiazepine, among 14 adults with histories of abusing sedatives. During approximately 18 days, participants stayed at a residential research unit and received one of the following doses of drugs each day in random order: 16, 80 or 160 milligrams of ramelteon (the recommended treatment dosage is 8 milligrams); .25, .5 or .75 milligrams of triazolam; and placebo. The patients, including one woman and 13 men with an average age of 28, were assessed thirty minutes before taking each drug and repeatedly for the next 24 hours. They answered questions about how much they liked each drug, how strong the drug was and how alert or sleepy they felt, and also underwent cognitive and motor function tests. Trained research staff members also rated the participants’ behavior, including how sedated and impaired they seemed and how much they slept.
None of the three doses of ramelteon showed any differences from placebo in effects reported by the participants, measured by performance tests or recorded by research observers. “In contrast, triazolam showed dose-related effects on a wide range of subject-rated, observer-rated and motor and cognitive performance measures, consistent with its profile as a sedative drug with abuse liability,” the authors write. When asked the next day about the drug they had taken the day before, 11 of the 14 participants (79 percent) classified the highest dose of ramelteon as a placebo, compared with two (14 percent) who categorized the highest dose of triazolam as placebo and 12 (86 percent) who classified placebo as placebo.
The findings, along with previous clinical trials indicating ramelteon’s effectiveness, suggest that it “may fill an unmet need in the treatment of insomnia,” the authors write. “Although further clinical trials are warranted, ramelteon may be particularly useful for the treatment of insomnia in individuals with histories of substance abuse, in older subjects (who are especially susceptible to the impairing effects of benzodiazepine receptor agonists), and in persons requiring minimal interference with arousal response (e.g., on-call workers and patients with chronic obstructive pulmonary disease). Furthermore, ramelteon may be a safe first-line medication even in individuals not reporting substance abuse, given that some individuals may not admit to such misuse.” Future research on sleep medications should explore the effectiveness of other drugs that work on the same pathway as ramelteon, they conclude.
(Arch Gen Psychiatry. 2006;63:1149-1157. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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