A head-to-head study,
published in the June Journal of Child and Adolescent Psychopharmacology,
confirms that Focalin(R) XR (dexmethylphenidate HCl) extended-release
capsules offer greater improvements in managing symptoms of Attention
Deficit/Hyperactivity Disorder compared with Concerta(R) (d,l-
methylphenidate HCl) extended-release tablets at two hours post-dose, the
primary study endpoint.
Focalin XR 20 mg and 30 mg2 also demonstrated better symptom control
versus Concerta 36 mg and 54 mg respectively, from 30 minutes to 6 hours.
Symptom control was demonstrated as early as 30 minutes post-dose with
Focalin XR 20 mg and 30 mg versus placebo. Neither dose of Concerta was
effective versus placebo at 30 minutes. Novartis is seeking revised
labeling to reflect the 30-minute onset of action.
"There are many things to consider when determining which treatment is
best for a patient, including lifestyle implications," said Alice Mao,
M.D., Associate Professor of Psychiatry at the Baylor College of Medicine.
"The results of this study demonstrate the benefits of Focalin XR during
the early part of the day, which may be better for children who need their
medication to begin working before they leave for school and continue
working throughout the day."
Attention Deficit/Hyperactivity Disorder affects approximately three to
seven percent of children in the United States, and its symptoms --
inattention, hyperactivity and impulsivity -- can significantly impact a
child's ability to focus and learn in an educational setting. The study
included children between the ages of 6 and 12 and examined their response
to Focalin XR compared to Concerta as well as placebo in a classroom
setting.
Similar efficacy was observed between Focalin XR and Concerta at eight
hours post-dose. Only at 10 to 12 hours and 11 to 12 hours post-dose did
Concerta 36 mg and 54 mg demonstrate symptom improvement over Focalin XR 20
mg and 30 mg respectively.
"Focalin XR helps children with ADHD optimize their natural cycle of
the day because its drug delivery system allows for a quick onset in the
morning, effective symptom management during the day, and then tapers off
in the evening," said Rafael Muniz, MD, Senior Medical Director, Novartis
Pharmaceuticals Corporation.
Focalin XR uses the proprietary SODAS(R) (Spheroidal Oral Drug
Absorption System) technology developed by Elan Corporation, where 50% of
the dose is released immediately and the remaining 50% is released after
approximately four hours, resulting in a maximum peak at about 1.5 hours
and a second peak at about 6.5 hours. Concerta is formulated to release 22%
of the drug initially, with the remainder released through a controlled
osmotic process.
In addition, Focalin XR and Concerta have chemical differences. Focalin
XR isolates the active d-isomer of d,l-methylphenidate. Therefore, only
half the dose of methylphenidate is required. Concerta is a
d,l-methylphenidate.
Study Results
The randomized, multi-center, double-blind, five-period, crossover
study was conducted in 84 children with ADHD with 6-12 years of age,
stabilized on methylphenidate and randomized to different treatment
sequences for comparison. The study was conducted in a laboratory classroom
setting over a 12 hour period. The crossover design exposed each child to
five treatments: Focalin XR (20 mg/day and 30 mg/day), Concerta (36 mg/day
and 54 mg/day) and placebo.
Primary efficacy was measured by the change from pre-dose in the
Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale-Combined
scores at two hours post-dose with Focalin XR 20 mg compared with Concerta
36 mg. The SKAMP rating scale is a standard assessment tool used in
laboratory classroom clinical trials to evaluate attention and behavior.
Both doses of Focalin XR showed significantly greater improvement in
SKAMP-Attention and -Deportment scores when compared with placebo at all
measured time-points (30 minutes to 12 hours post-dose), except for 10-12
hours post-dose with 20 mg. Concerta 36 mg and 54 mg demonstrated efficacy
at measured time-points 1-12 hours post-dose, but were no different to
placebo at 30 minutes.
Because of the differences in release profiles, the investigators also
studied overall efficacy during the 12 hour study period using an area
under the curve analysis (AUC0-12) of the SKAMP combined scores. All doses
of the active medication were significantly better than placebo. There was
no difference between Focalin XR 20 mg and 30 mg when compared to both
Concerta 36 mg and 54 mg, respectively, observed overall across the 12-hour
day.
In general, both treatments were well tolerated and no patients
discontinued or had a reduction in study drug dose due to an adverse event.
A total of 81 children completed the study (three withdrew consent for
reasons not related to study medications).
A previous head-to-head study comparing Focalin XR and Concerta
published in the April 2008 Psychopharmacology Bulletin found similar
efficacy and safety results to the present study.
About Focalin XR
Focalin XR (dexmethylphenidate HCl) extended-release capsules are
indicated for the treatment of Attention Deficit/Hyperactivity Disorder
(ADHD) in adults, adolescents and children six years and older. Focalin XR
is indicated as an integral part of a total treatment program for ADHD that
may include other measures (e.g., psychological, educational, social) for
patients with this syndrome.
Important Safety Information
The most common adverse events seen with Focalin XR were dyspepsia,
decreased appetite, headache and anxiety in pediatric studies; and dry
mouth, dyspepsia, feeling jittery, dizziness, headache and anxiety in adult
studies.
Focalin XR is contraindicated in patients with marked anxiety, tension
and agitation since the drug may aggravate these symptoms; in patients
known to be hypersensitive to methylphenidate or other components of the
product; in patients with glaucoma; in patients with motor tics or with a
family history or diagnosis of Tourette's syndrome; and during or following
treatment with monoamine oxidase inhibitors.
Stimulants should generally not be used in children, adolescents or
adults with known serious structural cardiac abnormalities, cardiomyopathy,
serious heart-rhythm abnormalities or other serious cardiac problems. Use
with caution in treating patients with underlying medical conditions that
might be compromised by increases in blood pressure or heart rate, such as
those with pre-existing hypertension, heart failure, recent myocardial
infarction or ventricular arrhythmia. Before initiating treatment, patients
should have careful history and physical exam to assess for presence of
cardiac disease.
Use with caution in psychosis or bipolar disorder. Discontinuation of
treatment may be appropriate in the presence of treatment-emergent
psychotic or manic symptoms. While aggressive behavior is often observed in
children or adolescents with ADHD, patients beginning treatment should be
monitored for the appearance of or worsening of aggressive behavior or
hostility.
Suppression of growth has been reported with long-term use of
stimulants. Stimulants should be used with caution in patients with a prior
history of seizures or EEG abnormalities. Difficulties with accommodation
and blurring of vision have been reported with stimulant treatment. (See
WARNINGS.)
Focalin XR should be given cautiously to patients with a history of
drug dependence or alcoholism. Chronic abusive use can lead to marked
tolerance and psychological dependence with varying degrees of abnormal
behavior. Frank psychotic episodes can occur, especially with parenteral
abuse. Careful supervision is required during drug withdrawal from abusive
use since severe depression may occur. Withdrawal following chronic
therapeutic use may unmask symptoms of the underlying disorder that may
require follow-up.
For further information, please visit FocalinXR.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "suggests," "can," "is seeking," "may,"
or similar expressions, or by express or implied discussions regarding
potential additional labeling or indications or potential future sales of
Focalin XR. Such forward-looking statements reflect the current views of
Novartis regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that
Focalin XR will be approved for any additional labeling or indications in
any country. Nor can there be any guarantee that Focalin XR will reach any
particular sales levels. In particular, management's expectations regarding
Focalin XR could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; unexpected clinical
trial results, including unexpected new clinical data, and unexpected
additional analysis of existing clinical data; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; competition in general; increased government, industry, and
general public pricing pressures; and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the U.S. Securities and
Exchange Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those anticipated, believed, estimated or
expected. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of
new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company's mission is to improve people's lives
by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which provides
healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic
tools, and consumer health products. Novartis is the only company with
leading positions in these areas. In 2007, the Group's continuing
operations (excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4 billion
was invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately 98,000
full-time associates and operate in over 140 countries around the world.
For more information, please visit novartis.
Novartis Partnerships
Celgene Corporation (Nasdaq: CELG) of Summit, New Jersey granted
Novartis Pharma AG an exclusive worldwide (excluding Canada) license
covering its intellectual property rights associated with Focalin XR.
Pursuant to an agreement between Novartis Pharma AG and Novartis
Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets
Focalin XR in the U.S.
Focalin XR was developed with SODAS(R) technology (spheroidal oral drug
absorption system), a multiparticulate drug delivery system of Elan
Corporation, plc (NYSE: ELN). Focalin XR is being supplied to Novartis
under an exclusive worldwide (except Canada) royalty and manufacturing
agreement between Elan Corporation, plc, and Novartis Pharma AG.
References
1. Concerta(R) is a registered trademark of ALZA Corporation.
2. The 30 mg dose of Focalin XR is not an FDA-approved dosage strength.
Novartis Pharmaceuticals Corporation
novartis
View drug information on Concerta; Focalin.
воскресенье, 19 июня 2011 г.
суббота, 18 июня 2011 г.
In ADHD The Brain Matures A Few Years Late But Follows Normal Pattern
In youth with attention deficit hyperactivity disorder (ADHD), the brain matures in a normal pattern but is delayed three years in some regions, on average, compared to youth without the disorder, an imaging study by researchers at the National Institutes of Health's (NIH) National Institute of Mental Health (NIMH) has revealed. The delay in ADHD was most prominent in regions at the front of the brain's outer mantle (cortex), important for the ability to control thinking, attention and planning. Otherwise, both groups showed a similar back-to-front wave of brain maturation with different areas peaking in thickness at different times.
"Finding a normal pattern of cortex maturation, albeit delayed, in children with ADHD should be reassuring to families and could help to explain why many youth eventually seem to grow out of the disorder," explained Philip Shaw, M.D., NIMH Child Psychiatry Branch, who led research team.
Previous brain imaging studies failed to detect the developmental lag because they focused on the size of the relatively large lobes of the brain. The sharp differences emerged only after a new image analysis technique allowed the researchers to pinpoint the thickening and thinning of thousands of cortex sites in hundreds of children and teens, with and without the disorder.
"If you're just looking at the lobes, you have only four measures instead of 40,000," explained Shaw. "You don't pick up the focal, regional changes where this delay is most marked."
Among 223 youth with ADHD, half of 40,000 cortex sites attained peak thickness at an average age of 10.5, compared to age 7.5 in a matched group of youth without the disorder.
Shaw, Judith Rapoport, M.D., of the NIMH Child Psychiatry Branch, Alan Evans, M.D., of McGill University, and colleagues report on their magnetic resonance imaging (MRI) study during the week of November 12, 2007, in the online edition of the Proceedings of the National Academy of Sciences.
The researchers scanned most of the 446 participants -- ranging from preschoolers to young adults -- at least twice at about three-year intervals. They focused on the age when cortex thickening during childhood gives way to thinning following puberty, as unused neural connections are pruned for optimal efficiency during the teen years.
In both ADHD and control groups, sensory processing and motor control areas at the back and top of the brain peaked in thickness earlier in childhood, while the frontal cortex areas responsible for higher-order executive control functions peaked later, during the teen years. These frontal areas support the ability to suppress inappropriate actions and thoughts, focus attention, remember things from moment to moment, work for reward, and control movement -- functions often disturbed in people with ADHD.
Circuitry in the frontal and temporal (at the side of the brain) areas that integrate information from the sensory areas with the higher-order functions showed the greatest maturational delay in youth with ADHD. For example, one of the last areas to mature, the middle of the prefrontal cortex, lagged five years in those with the disorder.
The motor cortex emerged as the only area that matured faster than normal in the youth with ADHD, in contrast to the late-maturing frontal cortex areas that direct it. This mismatch might account for the restlessness and fidgety symptoms common among those with the disorder, the researchers suggested.
They also noted that the delayed pattern of maturation observed in ADHD is the opposite of that seen in other developmental brain disorders like autism, in which the volume of brain structures peak at a much earlier-than-normal age.
The findings support the theory that ADHD results from a delay in cortex maturation. In future studies, the researchers hope to find genetic underpinnings of the delay and ways of boosting processes of recovery from the disorder.
"Brain imaging is still not ready for use as a diagnostic tool in ADHD," noted Shaw. "Although the delay in cortex development was marked, it could only be detected when a very large number of children with the disorder were included. It is not yet possible to detect such delay from the brain scans of just one individual. The diagnosis of ADHD remains clinical, based on taking a history from the child, the family and teachers."
Also participating in the research were: Kristen Eskstrand, Wendy Sharp, Jonathan Blumenthal, Dede Greenstein, Liv Clasen, and Jay Giedd, M.D., NIMH.
The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website, nimh.nih.gov/.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih.gov/.
Source: Jules Asher
NIH/National Institute of Mental Health
"Finding a normal pattern of cortex maturation, albeit delayed, in children with ADHD should be reassuring to families and could help to explain why many youth eventually seem to grow out of the disorder," explained Philip Shaw, M.D., NIMH Child Psychiatry Branch, who led research team.
Previous brain imaging studies failed to detect the developmental lag because they focused on the size of the relatively large lobes of the brain. The sharp differences emerged only after a new image analysis technique allowed the researchers to pinpoint the thickening and thinning of thousands of cortex sites in hundreds of children and teens, with and without the disorder.
"If you're just looking at the lobes, you have only four measures instead of 40,000," explained Shaw. "You don't pick up the focal, regional changes where this delay is most marked."
Among 223 youth with ADHD, half of 40,000 cortex sites attained peak thickness at an average age of 10.5, compared to age 7.5 in a matched group of youth without the disorder.
Shaw, Judith Rapoport, M.D., of the NIMH Child Psychiatry Branch, Alan Evans, M.D., of McGill University, and colleagues report on their magnetic resonance imaging (MRI) study during the week of November 12, 2007, in the online edition of the Proceedings of the National Academy of Sciences.
The researchers scanned most of the 446 participants -- ranging from preschoolers to young adults -- at least twice at about three-year intervals. They focused on the age when cortex thickening during childhood gives way to thinning following puberty, as unused neural connections are pruned for optimal efficiency during the teen years.
In both ADHD and control groups, sensory processing and motor control areas at the back and top of the brain peaked in thickness earlier in childhood, while the frontal cortex areas responsible for higher-order executive control functions peaked later, during the teen years. These frontal areas support the ability to suppress inappropriate actions and thoughts, focus attention, remember things from moment to moment, work for reward, and control movement -- functions often disturbed in people with ADHD.
Circuitry in the frontal and temporal (at the side of the brain) areas that integrate information from the sensory areas with the higher-order functions showed the greatest maturational delay in youth with ADHD. For example, one of the last areas to mature, the middle of the prefrontal cortex, lagged five years in those with the disorder.
The motor cortex emerged as the only area that matured faster than normal in the youth with ADHD, in contrast to the late-maturing frontal cortex areas that direct it. This mismatch might account for the restlessness and fidgety symptoms common among those with the disorder, the researchers suggested.
They also noted that the delayed pattern of maturation observed in ADHD is the opposite of that seen in other developmental brain disorders like autism, in which the volume of brain structures peak at a much earlier-than-normal age.
The findings support the theory that ADHD results from a delay in cortex maturation. In future studies, the researchers hope to find genetic underpinnings of the delay and ways of boosting processes of recovery from the disorder.
"Brain imaging is still not ready for use as a diagnostic tool in ADHD," noted Shaw. "Although the delay in cortex development was marked, it could only be detected when a very large number of children with the disorder were included. It is not yet possible to detect such delay from the brain scans of just one individual. The diagnosis of ADHD remains clinical, based on taking a history from the child, the family and teachers."
Also participating in the research were: Kristen Eskstrand, Wendy Sharp, Jonathan Blumenthal, Dede Greenstein, Liv Clasen, and Jay Giedd, M.D., NIMH.
The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website, nimh.nih.gov/.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih.gov/.
Source: Jules Asher
NIH/National Institute of Mental Health
пятница, 17 июня 2011 г.
Positive study results for methylphenidate transdermal system
Shire announced at the US Psychiatric and Mental Health Congress in Las Vegas, Nevada, that its investigational methylphenidate transdermal system (MTS) demonstrated statistically significant reductions in the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) and was generally well tolerated in patients aged 6 to 12 in two clinical trials.
"Children who have ADHD must cope with symptoms throughout the day and in a number of environments, including in the classroom, during extra-curricular activities, or while at home," explained Frank Lopez, MD, developmental pediatrician at the Children's Developmental Center, Maitland, Florida. "While oral methylphenidate has long been a first-line treatment for patients with ADHD symptoms, if approved, this transdermal patch formulation would provide parents and health care professionals the first and only non-oral medication for children with ADHD."
The MTS patch was developed by Noven Pharmaceuticals, Inc. and combines the active ingredient of methylphenidate with transdermal technology. This transdermal delivery?Noven's patented DOT Matrix system was designed to provide continuous medication release throughout the day. The transdermal system releases medication that passes through the skin and directly into the blood stream. The patch is water-resistant.
Data from phase II and phase III clinical trials presented this week in Las Vegas demonstrated statistically significant improvements in the primary and secondary endpoints analyzed for children treated with MTS compared to children treated with placebo.
The phase II analog classroom study included 79 children with ADHD. The patch was worn for nine hours, and efficacy was assessed throughout the day for twelve hours. MTS demonstrated statistically significant improvement over placebo on the measures tested. Behavior, which was measured using the Swanson, Kotkin, Agler, M-Flynn, and Pelham -Deportment (SKAMP-D) scale, was improved with MTS overall (mean score 3.2 for MTS versus 8.0 for placebo) and at all time points throughout the day (P < 0.001).
Children taking MTS also completed more math problems correctly on the Permanent Product Measure of Performance (PERMP) scale than did those taking placebo (110 versus 81, respectively).
In the phase III naturalistic trial with 270 participants, investigators found that MTS worn for nine hours reduced the children's overall symptoms of ADHD, compared to a placebo (P < 0.0001), as measured by scores on the ADHD Rating Scale (ADHD-RS). By the study's end, mean ADHD-RS scores declined -24.2 points (56%) from baseline for children treated with MTS versus a decline of -9.9 (24%) for those treated with placebo (P < 0.0001). ADHD-RS assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(TM), a publication of the American Psychiatric Association.
In both studies, MTS was generally well tolerated during both the dose optimization and double-blind phases. Adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate. The most common adverse events reported by patients who received MTS in clinical trials were: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite, affect lability, insomnia, tic, and nasal congestion.
Shire and Noven provided funds for both studies.
Noven and Shire are seeking approval for MTS and the application is currently under review by the FDA. The trade name DAYTRANA(TM) has been proposed to the FDA and is currently under review.
About MTS
MTS is not intended to be administered to patients with: marked anxiety, tension or agitation; allergies to methylphenidate or other ingredients in MTS; skin sensitivities to soaps, lotions, cosmetics or adhesives; eczema, psoriasis, dermatitis or sensitive skin syndrome. MTS has not been studied in children under 6 years of age. Patients will be advised to avoid direct external heat to the patch application site. MTS will need to be stored in a safe place, out of the reach of children.
Methylphenidate should not be administered to patients with:
glaucoma; tics, Tourette's syndrome or a family history of Tourette's syndrome; current or recent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse of methylphenidate may lead to dependence and careful supervision following withdrawal from abuse is warranted. Methylphenidate should not be given to patients with a history of drug dependence or alcoholism. Methylphenidate should not be used for the prevention or treatment of severe depression or normal fatigue states. Growth should be monitored in patients treated with methylphenidate. Use with caution in patients with psychosis, history of seizures or EEG abnormalities, hypertension, and history of drug dependence or alcoholism. Rare cases of visual disturbances have been reported with methylphenidate use. Hematologic monitoring is advised during prolonged therapy.
About ADHD
ADHD affects approximately 7.8 percent of all school-age children, more than 4 million in the United States. ADHD is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. If untreated, ADHD can acutely affect a child's life, leading to problems with family members, friends, sports, after-school activities and academics.
Shire Pharmaceuticals Group plc
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system (CNS), gastrointestinal (GI), general products (GP) and human genetic therapies (HGT) - all being areas in which Shire has a commercial presence. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. This approach aims to deliver increased returns and lower risks. Shire's in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: shire
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including, but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including, but not limited to, the expected product approval dates of DAYTRANA (MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), MESAVANCE (SPD476) (ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to benefit from its acquisition of Transkaryotic Therapies, Inc.; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year to December 31, 2004.
A high-resolution image is available at: hispanicprwire/home.php?l=in
Matthew Cabrey
484-595-8248B
Media Relations
Brian Piper
484-595-8252
Investor Relations
Shire Pharmaceuticals Group
shire/shire/index.jsp
"Children who have ADHD must cope with symptoms throughout the day and in a number of environments, including in the classroom, during extra-curricular activities, or while at home," explained Frank Lopez, MD, developmental pediatrician at the Children's Developmental Center, Maitland, Florida. "While oral methylphenidate has long been a first-line treatment for patients with ADHD symptoms, if approved, this transdermal patch formulation would provide parents and health care professionals the first and only non-oral medication for children with ADHD."
The MTS patch was developed by Noven Pharmaceuticals, Inc. and combines the active ingredient of methylphenidate with transdermal technology. This transdermal delivery?Noven's patented DOT Matrix system was designed to provide continuous medication release throughout the day. The transdermal system releases medication that passes through the skin and directly into the blood stream. The patch is water-resistant.
Data from phase II and phase III clinical trials presented this week in Las Vegas demonstrated statistically significant improvements in the primary and secondary endpoints analyzed for children treated with MTS compared to children treated with placebo.
The phase II analog classroom study included 79 children with ADHD. The patch was worn for nine hours, and efficacy was assessed throughout the day for twelve hours. MTS demonstrated statistically significant improvement over placebo on the measures tested. Behavior, which was measured using the Swanson, Kotkin, Agler, M-Flynn, and Pelham -Deportment (SKAMP-D) scale, was improved with MTS overall (mean score 3.2 for MTS versus 8.0 for placebo) and at all time points throughout the day (P < 0.001).
Children taking MTS also completed more math problems correctly on the Permanent Product Measure of Performance (PERMP) scale than did those taking placebo (110 versus 81, respectively).
In the phase III naturalistic trial with 270 participants, investigators found that MTS worn for nine hours reduced the children's overall symptoms of ADHD, compared to a placebo (P < 0.0001), as measured by scores on the ADHD Rating Scale (ADHD-RS). By the study's end, mean ADHD-RS scores declined -24.2 points (56%) from baseline for children treated with MTS versus a decline of -9.9 (24%) for those treated with placebo (P < 0.0001). ADHD-RS assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(TM), a publication of the American Psychiatric Association.
In both studies, MTS was generally well tolerated during both the dose optimization and double-blind phases. Adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate. The most common adverse events reported by patients who received MTS in clinical trials were: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite, affect lability, insomnia, tic, and nasal congestion.
Shire and Noven provided funds for both studies.
Noven and Shire are seeking approval for MTS and the application is currently under review by the FDA. The trade name DAYTRANA(TM) has been proposed to the FDA and is currently under review.
About MTS
MTS is not intended to be administered to patients with: marked anxiety, tension or agitation; allergies to methylphenidate or other ingredients in MTS; skin sensitivities to soaps, lotions, cosmetics or adhesives; eczema, psoriasis, dermatitis or sensitive skin syndrome. MTS has not been studied in children under 6 years of age. Patients will be advised to avoid direct external heat to the patch application site. MTS will need to be stored in a safe place, out of the reach of children.
Methylphenidate should not be administered to patients with:
glaucoma; tics, Tourette's syndrome or a family history of Tourette's syndrome; current or recent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse of methylphenidate may lead to dependence and careful supervision following withdrawal from abuse is warranted. Methylphenidate should not be given to patients with a history of drug dependence or alcoholism. Methylphenidate should not be used for the prevention or treatment of severe depression or normal fatigue states. Growth should be monitored in patients treated with methylphenidate. Use with caution in patients with psychosis, history of seizures or EEG abnormalities, hypertension, and history of drug dependence or alcoholism. Rare cases of visual disturbances have been reported with methylphenidate use. Hematologic monitoring is advised during prolonged therapy.
About ADHD
ADHD affects approximately 7.8 percent of all school-age children, more than 4 million in the United States. ADHD is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. If untreated, ADHD can acutely affect a child's life, leading to problems with family members, friends, sports, after-school activities and academics.
Shire Pharmaceuticals Group plc
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system (CNS), gastrointestinal (GI), general products (GP) and human genetic therapies (HGT) - all being areas in which Shire has a commercial presence. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. This approach aims to deliver increased returns and lower risks. Shire's in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: shire
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including, but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including, but not limited to, the expected product approval dates of DAYTRANA (MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), MESAVANCE (SPD476) (ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to benefit from its acquisition of Transkaryotic Therapies, Inc.; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year to December 31, 2004.
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Matthew Cabrey
484-595-8248B
Media Relations
Brian Piper
484-595-8252
Investor Relations
Shire Pharmaceuticals Group
shire/shire/index.jsp
четверг, 16 июня 2011 г.
Is There A Gender Difference Related To Movement In ADHD
Attention deficit hyperactivity disorder (ADHD) appears to affect movement in boys more than it does in girls, according to a study published in the November 4, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology. ADHD is one of the most common mental disorders found in children. Symptoms include impulsiveness, hyperactivity, such as not being able to sit still, and inattention or constant daydreaming. Few studies have been done that compare ADHD and movement in both boys and girls.
Researchers tested the movement abilities of 132 boys and girls with ADHD and 136 without the disorder. The children were between the ages of seven and 15 years and were tested for how fast and how well they could tap their toes, walk on their heels, maintain balance and keep a steady rhythm during a task compared to scores typical for their age.
The study found that girls with ADHD and the control group of children without ADHD were twice as likely to be able to control their movements for their age compared to boys with ADHD, who showed continued difficulties.
"Our findings suggest that the differences between boys and girls with ADHD show up not only in behavior and symptoms but also in development of movement control, likely because girls' brains mature earlier than boys' brains," said study author E. Mark Mahone, PhD, with the Kennedy Krieger Institute and Johns Hopkins University School of Medicine in Baltimore, MD.
"More studies related to ADHD and movement are needed that look at boys and girls separately and at younger ages," said Mahone.
The study was supported by the National Institute of Neurological Disorders and Stroke, Kennedy Krieger Institute's Developmental Disabilities Research Center and the Johns Hopkins University School of Medicine Institute for Clinical and Translational Research.
The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer's disease, epilepsy, Parkinson's disease, and multiple sclerosis.
For more information about the American Academy of Neurology, visit http:/aan/.
Source: Rachel Seroka
American Academy of Neurology
Researchers tested the movement abilities of 132 boys and girls with ADHD and 136 without the disorder. The children were between the ages of seven and 15 years and were tested for how fast and how well they could tap their toes, walk on their heels, maintain balance and keep a steady rhythm during a task compared to scores typical for their age.
The study found that girls with ADHD and the control group of children without ADHD were twice as likely to be able to control their movements for their age compared to boys with ADHD, who showed continued difficulties.
"Our findings suggest that the differences between boys and girls with ADHD show up not only in behavior and symptoms but also in development of movement control, likely because girls' brains mature earlier than boys' brains," said study author E. Mark Mahone, PhD, with the Kennedy Krieger Institute and Johns Hopkins University School of Medicine in Baltimore, MD.
"More studies related to ADHD and movement are needed that look at boys and girls separately and at younger ages," said Mahone.
The study was supported by the National Institute of Neurological Disorders and Stroke, Kennedy Krieger Institute's Developmental Disabilities Research Center and the Johns Hopkins University School of Medicine Institute for Clinical and Translational Research.
The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer's disease, epilepsy, Parkinson's disease, and multiple sclerosis.
For more information about the American Academy of Neurology, visit http:/aan/.
Source: Rachel Seroka
American Academy of Neurology
среда, 15 июня 2011 г.
Vaccinated Children Two And A Half Times More Likely To Have Neurological Disorders Like ADHD And Autism, New Survey In California And Oregon Finds
As the first trial
in Vaccine Court explores the relationship between vaccines and autism, a
new survey released today indicates a strong correlation between rates of
neurological disorders, such as ADHD and autism, and childhood
vaccinations.
The survey, commissioned by Generation Rescue, compared vaccinated and
unvaccinated children in nine counties in Oregon and California. Among more
than 9,000 boys age 4-17, the survey found vaccinated boys were two and a
half times (155%) more likely to have neurological disorders compared to
their unvaccinated peers. Vaccinated boys were 224% more likely to have
Attention Deficit Hyperactivity Disorder (ADHD), and 61% more likely to
have autism.
For older vaccinated boys in the 11-17 age bracket, the results were
even more pronounced. Vaccinated boys were 158% more likely to have a
neurological disorder, 317% more likely to have ADHD, and 112% more likely
to have autism. Complete survey results are available at
GenerationRescue.
Generation Rescue commissioned the phone survey. Data was gathered by
SurveyUSA, a national market research firm, which surveyed parents by phone
on more than 17,000 children, ages 4-17, in five counties in California
(San Diego, Sonoma, Orange, Sacramento, and Marin) and four counties in
Oregon (Multnomah, Marion, Jackson, and Lane).
The survey asked parents whether their child had been vaccinated, and
whether that child had one or more of the following diagnoses: Attention
Deficit Disorder (ADD), ADHD, Asperger's Syndrome, Pervasive Development
Disorder -- Not Otherwise Specified (PDD-NOS), or Autism. The phone survey
was chosen to mirror the methodology the Centers for Disease Control (CDC)
uses to establish national prevalence for neurological disorders in their
national phone survey.
Timed to the release of the survey results, Generation Rescue also ran
full-page advertisements in Washington's Roll Call, The Oregonian, and The
Orange County Register today. The ad compares the 36 pediatric vaccines the
CDC recommends today to the 10 recommended in 1983, and asks, "Are We Over-
Vaccinating Our Kids?"
"No one has ever compared prevalence rates of these neurological
disorders between vaccinated and unvaccinated children," said J.B. Handley,
co-founder of Generation Rescue, whose son was diagnosed with autism. "The
phone survey isn't perfect, but these numbers point to the need for a
comprehensive national study to gather this critical information."
In Washington, Congresswoman Carolyn Maloney (D-NY) has been advocating
for such a survey. Co-sponsored by Rep. Maurice Hinchey (D-NY) and Rep. Ron
Paul (R-TX), the "Comprehensive Comparative Study of Vaccinated and
Unvaccinated Population Act of 2006," or H.R. 2832, was introduced on June
22, and would require the National Institutes of Health to complete this
research.
"Generation Rescue's study is impressive and forcefully raises some
serious questions about the relationship between vaccines and autism. What
is ultimately needed to resolve this issue one way or the other is a
comprehensive national study of vaccinated and unvaccinated children," said
Congresswoman Maloney. "The parents behind Generation Rescue only want
information. These parents deserve more than road blocks, they deserve
answers. We can and should move forward in search of those answers. That's
why I've introduced a common sense bill that would require the National
Institutes of Health (NIH) to conduct a comprehensive, comparative study on
the possible link between autism and thimerosal."
From 1983 to 2007, autism rates have climbed from 1 in 10,000 children
to 1 in 150 children, a growth rate of 6,000% (boys are significantly more
affected by neurological disorders, accounting for approximately 80% of all
cases). ADHD currently affects 1 in 13 children. In the same period, the
CDC's recommended vaccine schedule more than tripled. The simmering debate
over the cause of childhood neurological disorders shows no sign of
cooling, but no study had ever been done to look at unvaccinated children.
Lisa Handley, co-founder of Generation Rescue, adds, "Everyone working
with autism wants to identify the cause so we can focus on treatment and
prevention. A national study like HR 5940 could help end this debate and
focus all of our resources on helping our kids. Its time has come, and we
hope Congress will choose to put our children first."
About Generation Rescue
Generation Rescue was formed by parents of children who have been
diagnosed with childhood neurological disorders (NDs), and is dedicated to
examining the causes and biomedical treatments for Autism, Asperger's,
ADHD, ADD, PDD-NOS, and other learning disabilities. Visit
GenerationRescue for more information and to see complete survey
results.
Generation Rescue
GenerationRescue
in Vaccine Court explores the relationship between vaccines and autism, a
new survey released today indicates a strong correlation between rates of
neurological disorders, such as ADHD and autism, and childhood
vaccinations.
The survey, commissioned by Generation Rescue, compared vaccinated and
unvaccinated children in nine counties in Oregon and California. Among more
than 9,000 boys age 4-17, the survey found vaccinated boys were two and a
half times (155%) more likely to have neurological disorders compared to
their unvaccinated peers. Vaccinated boys were 224% more likely to have
Attention Deficit Hyperactivity Disorder (ADHD), and 61% more likely to
have autism.
For older vaccinated boys in the 11-17 age bracket, the results were
even more pronounced. Vaccinated boys were 158% more likely to have a
neurological disorder, 317% more likely to have ADHD, and 112% more likely
to have autism. Complete survey results are available at
GenerationRescue.
Generation Rescue commissioned the phone survey. Data was gathered by
SurveyUSA, a national market research firm, which surveyed parents by phone
on more than 17,000 children, ages 4-17, in five counties in California
(San Diego, Sonoma, Orange, Sacramento, and Marin) and four counties in
Oregon (Multnomah, Marion, Jackson, and Lane).
The survey asked parents whether their child had been vaccinated, and
whether that child had one or more of the following diagnoses: Attention
Deficit Disorder (ADD), ADHD, Asperger's Syndrome, Pervasive Development
Disorder -- Not Otherwise Specified (PDD-NOS), or Autism. The phone survey
was chosen to mirror the methodology the Centers for Disease Control (CDC)
uses to establish national prevalence for neurological disorders in their
national phone survey.
Timed to the release of the survey results, Generation Rescue also ran
full-page advertisements in Washington's Roll Call, The Oregonian, and The
Orange County Register today. The ad compares the 36 pediatric vaccines the
CDC recommends today to the 10 recommended in 1983, and asks, "Are We Over-
Vaccinating Our Kids?"
"No one has ever compared prevalence rates of these neurological
disorders between vaccinated and unvaccinated children," said J.B. Handley,
co-founder of Generation Rescue, whose son was diagnosed with autism. "The
phone survey isn't perfect, but these numbers point to the need for a
comprehensive national study to gather this critical information."
In Washington, Congresswoman Carolyn Maloney (D-NY) has been advocating
for such a survey. Co-sponsored by Rep. Maurice Hinchey (D-NY) and Rep. Ron
Paul (R-TX), the "Comprehensive Comparative Study of Vaccinated and
Unvaccinated Population Act of 2006," or H.R. 2832, was introduced on June
22, and would require the National Institutes of Health to complete this
research.
"Generation Rescue's study is impressive and forcefully raises some
serious questions about the relationship between vaccines and autism. What
is ultimately needed to resolve this issue one way or the other is a
comprehensive national study of vaccinated and unvaccinated children," said
Congresswoman Maloney. "The parents behind Generation Rescue only want
information. These parents deserve more than road blocks, they deserve
answers. We can and should move forward in search of those answers. That's
why I've introduced a common sense bill that would require the National
Institutes of Health (NIH) to conduct a comprehensive, comparative study on
the possible link between autism and thimerosal."
From 1983 to 2007, autism rates have climbed from 1 in 10,000 children
to 1 in 150 children, a growth rate of 6,000% (boys are significantly more
affected by neurological disorders, accounting for approximately 80% of all
cases). ADHD currently affects 1 in 13 children. In the same period, the
CDC's recommended vaccine schedule more than tripled. The simmering debate
over the cause of childhood neurological disorders shows no sign of
cooling, but no study had ever been done to look at unvaccinated children.
Lisa Handley, co-founder of Generation Rescue, adds, "Everyone working
with autism wants to identify the cause so we can focus on treatment and
prevention. A national study like HR 5940 could help end this debate and
focus all of our resources on helping our kids. Its time has come, and we
hope Congress will choose to put our children first."
About Generation Rescue
Generation Rescue was formed by parents of children who have been
diagnosed with childhood neurological disorders (NDs), and is dedicated to
examining the causes and biomedical treatments for Autism, Asperger's,
ADHD, ADD, PDD-NOS, and other learning disabilities. Visit
GenerationRescue for more information and to see complete survey
results.
Generation Rescue
GenerationRescue
вторник, 14 июня 2011 г.
ADHD - Important Strattera(R) Label Update Regarding Uncommon Reports of Suicidal Thoughts Among Children and Adolescents
Eli Lilly and Company announced that it will update the product label globally for
its attention-deficit/hyperactivity disorder (ADHD) medication, Strattera, to
communicate new information regarding uncommon reports of suicidal thoughts
among children and adolescents.
In conjunction with a request from the U.S.
Food and Drug Administration (FDA), Lilly submitted to regulatory agencies an
analysis of adverse event data from its Strattera clinical trials database
that identified a small but statistically significant increased risk of
suicidal thoughts among Strattera-treated children and adolescents (5 cases
out of 1357 patients or 0.4 percent vs. 0 cases out of 851 patients taking
placebo).
There also was one case of a suicide attempt in a patient taking
the medication (out of 1357 patients). There were no suicides among children,
adolescents or adults on the medication during any Strattera clinical trials,
and there was no indication of an increased risk of suicidal thinking in the
adult population. As part of the FDA's continuing focus on patient safety,
the agency and its Pediatric Advisory Committee plan to complete an ongoing
review of adverse event data for all ADHD medications by early 2006.
In the United States, Lilly will add a boxed warning to the product label
and is working with the FDA to finalize the product label content as well as
information for healthcare professionals. Lilly is also working with other
regulatory agencies where the product is currently approved regarding this
safety information. In Europe, the information will be provided under the
special warnings and precautions section of the product label. In Australia,
it will appear as a precaution.
"Lilly's top priority is to help doctors, patients and their families make
informed treatment decisions, so we are reaching out extensively to educate
physicians and the public about this product label change," said Alan Breier,
M.D., vice president and chief medical officer at Lilly. "While suicidal
thinking was uncommon in patients on the medication during clinical trials, it
is important for parents to be aware it can occur, and to discuss any unusual
symptoms with a physician. Also important for parents to know," he said, "is
that Lilly continues to view Strattera as a safe and effective treatment
option, and those doing well on the medication should be able to continue
their treatment with confidence."
Investor Information
Lilly is confirming its prior sales and earnings guidance for the year.
Lilly expects reported full-year 2005 earnings per share of $1.90 to $1.96.
Eliminating the second-quarter 2005 product liability charge of $.90 per
share, the adjusted full-year 2005 earnings per share would be $2.80 to $2.86.
For the full year of 2005, the company continues to expect sales growth of
6 to 8 percent.
ADHD and Suicide
ADHD affects 3-7 percent of school-age children and manifests itself in
levels of attention, concentration, activity, distractibility and impulsivity
that are inappropriate to the child's age.(1) ADHD is a serious disorder that
can have lifelong consequences, including poor peer relations, poor academic
and work performance and increased risk-taking behaviors such as substance
abuse.(2,3,4) Sixty percent of children with the disorder carry their
symptoms into adulthood.(5) Experts estimate 4 percent of adults in the
United States, more than 8 million people, have ADHD.(6,7)
"ADHD is a complex disorder and many patients who are managing it are
often dealing with other co-existing psychiatric disorders," said Christopher
Kratochvil, M.D., associate professor of psychiatry at the University of
Nebraska Medical Center. "As a physician, I believe strong communication
between the doctor, parents, caregivers and patients is vital to successful
mental health treatment."
The FDA's request for clinical trial data is part of the agency's ongoing
review of psychiatric medicines, reflecting the scientific community's growing
understanding of suicide-related behaviors and how to analyze them. The
analysis was based on criteria developed by Columbia University and the FDA
last year, and uses a rigorous classification system to assess any risk of
suicide-related events in clinical trials.
According to the World Health Organization, suicidal thoughts or behaviors
have a large number of complex, underlying causes that can make it difficult
to determine why some people experience these feelings. Suicidal thoughts
occur in children and adolescents and are not always associated with other
features of mental illness. There is evidence that those suffering from ADHD
are at greater risk of suicide than the general population.(8,9)
Information for Patients and Physicians
Lilly is working in concert with regulatory agencies worldwide to notify
physicians about this important update. In addition, the company is notifying
consumer advocacy and professionally focused associations about these findings
so they can provide important information to patients. In the U.S., Lilly's
outreach efforts will include a "Dear Healthcare Professional" letter, sales
force communications to prescribers and updated label information on the
product web site, strattera.
All medications have side effects. No medication works for everyone. As
with any medication, patients or parents should consult their doctors with any
questions or concerns regarding treatment. This allows physicians and
patients to make the most informed treatment decisions. Patients or
caregivers with questions may also call the Lilly Answers Center at
1-800-LillyRx.
About Strattera
Strattera, a selective norepinephrine reuptake inhibitor, is the first
FDA-approved non-stimulant to treat ADHD and provide full-symptom relief. It
is not known precisely how Strattera reduces ADHD symptoms, but scientists
believe it works by blocking or slowing reabsorption of norepinephrine, a
chemical in the brain considered important in regulating attention,
impulsivity and activity levels. This keeps more norepinephrine at work in
the spaces between neurons in the brain. Improved efficiency in the
norepinephrine system is associated with improvement in symptoms of ADHD
(Pliska, 1996).
Strattera should not be taken at the same time as, or within two weeks of
taking, a monoamine oxidase inhibitor (MAOI) or by patients with narrow angle
glaucoma. Patients with a history of high or low blood pressure, increased
heart rate, or any heart or blood vessel disease should tell their doctor
before taking Strattera. Strattera has not been tested in children less than
6 years of age or in geriatric patients. Some children may lose weight when
starting treatment with Strattera. As with all ADHD medications, growth
should be monitored during treatment. Strattera can cause liver damage in
rare cases. Patients should tell their doctor right away if they have
itching, dark urine, yellow skin/eyes, upper right-sided abdominal tenderness,
or unexplained "flu-like" symptoms.
Most people in clinical studies who experienced side effects were not
bothered enough to stop using Strattera. The most common side effects in
children and adolescents in medical studies were upset stomach, decreased
appetite, nausea and vomiting, dizziness, tiredness and mood swings. In
adults, the most common side effects were constipation, dry mouth, nausea,
decreased appetite, dizziness, problems sleeping, sexual side effects,
problems urinating and menstrual cramps.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs. Additional
information about Lilly is available at lilly.
For full prescribing information visit strattera.
This press release contains forward-looking statements about the use of
Strattera for the treatment of ADHD and reflects Lilly's current beliefs.
However, as with any pharmaceutical product, there are substantial risks and
uncertainties, including risk of side effects and other safety concerns; and
there is no guarantee regarding the future commercial success of the product.
The company's results may also be affected by such factors as competitive
developments affecting current products; rate of sales growth of recently
launched products; the timing of anticipated regulatory approvals and launches
of new products; other regulatory developments and government investigations;
patent disputes and other litigation involving current and future products;
the impact of governmental actions regarding pricing, importation, and
reimbursement for pharmaceuticals; changes in tax law; and the impact of
exchange rates. For additional information about the factors that affect the
company's business, please see Exhibit 99 to the company's latest Form 10-Q
filed August 2005. The company undertakes no duty to update forward-looking
statements.
(1) American Psychiatric Association: Diagnostic and Statistical Manual
of Mental Disorders, fourth edition, text revision, Washington, DC, American
Psychiatric Association, 2000.
(2) Greenhill LL. Diagnosing attention-deficit/hyperactivity disorder in
children. J Clin Psychiatry 1998; 59 (Suppl 7): 31-41.
(3) Faraone S, Biederman J, et al. ADHD in adults: an overview. Biol
Psychiatry 2000; 48:9-20.
(4) Barkley. ADHD: A Handbook for Diagnosis and Treatment. New York:
Guilford Press; 1998.
(5) Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med
Clin of North Am. 2001; 85(3): 757-777
(6) Murphy K, Barkley, RA. J Atten disord. 1996; 1:147-161.
(7) United States Census Summary File; 2000.
(8) Swensen A, Kruesi M, Allen A, et al. Self injury and suicide in
patients with attention deficit hyperactivity disorder. Program and abstracts
of the American Academy of Child and Adolescent Psychiatry 49th Annual
Meeting; October 22-27, 2002; San Francisco, California. New Research F27.
(9) James A, Lai FH, Dahl C. Attention deficit hyperactivity disorder and
suicide: a review of possible associations. Acta Psychiatr Scand
2004;110:408-415.
lilly
View drug information on Strattera.
its attention-deficit/hyperactivity disorder (ADHD) medication, Strattera, to
communicate new information regarding uncommon reports of suicidal thoughts
among children and adolescents.
In conjunction with a request from the U.S.
Food and Drug Administration (FDA), Lilly submitted to regulatory agencies an
analysis of adverse event data from its Strattera clinical trials database
that identified a small but statistically significant increased risk of
suicidal thoughts among Strattera-treated children and adolescents (5 cases
out of 1357 patients or 0.4 percent vs. 0 cases out of 851 patients taking
placebo).
There also was one case of a suicide attempt in a patient taking
the medication (out of 1357 patients). There were no suicides among children,
adolescents or adults on the medication during any Strattera clinical trials,
and there was no indication of an increased risk of suicidal thinking in the
adult population. As part of the FDA's continuing focus on patient safety,
the agency and its Pediatric Advisory Committee plan to complete an ongoing
review of adverse event data for all ADHD medications by early 2006.
In the United States, Lilly will add a boxed warning to the product label
and is working with the FDA to finalize the product label content as well as
information for healthcare professionals. Lilly is also working with other
regulatory agencies where the product is currently approved regarding this
safety information. In Europe, the information will be provided under the
special warnings and precautions section of the product label. In Australia,
it will appear as a precaution.
"Lilly's top priority is to help doctors, patients and their families make
informed treatment decisions, so we are reaching out extensively to educate
physicians and the public about this product label change," said Alan Breier,
M.D., vice president and chief medical officer at Lilly. "While suicidal
thinking was uncommon in patients on the medication during clinical trials, it
is important for parents to be aware it can occur, and to discuss any unusual
symptoms with a physician. Also important for parents to know," he said, "is
that Lilly continues to view Strattera as a safe and effective treatment
option, and those doing well on the medication should be able to continue
their treatment with confidence."
Investor Information
Lilly is confirming its prior sales and earnings guidance for the year.
Lilly expects reported full-year 2005 earnings per share of $1.90 to $1.96.
Eliminating the second-quarter 2005 product liability charge of $.90 per
share, the adjusted full-year 2005 earnings per share would be $2.80 to $2.86.
For the full year of 2005, the company continues to expect sales growth of
6 to 8 percent.
ADHD and Suicide
ADHD affects 3-7 percent of school-age children and manifests itself in
levels of attention, concentration, activity, distractibility and impulsivity
that are inappropriate to the child's age.(1) ADHD is a serious disorder that
can have lifelong consequences, including poor peer relations, poor academic
and work performance and increased risk-taking behaviors such as substance
abuse.(2,3,4) Sixty percent of children with the disorder carry their
symptoms into adulthood.(5) Experts estimate 4 percent of adults in the
United States, more than 8 million people, have ADHD.(6,7)
"ADHD is a complex disorder and many patients who are managing it are
often dealing with other co-existing psychiatric disorders," said Christopher
Kratochvil, M.D., associate professor of psychiatry at the University of
Nebraska Medical Center. "As a physician, I believe strong communication
between the doctor, parents, caregivers and patients is vital to successful
mental health treatment."
The FDA's request for clinical trial data is part of the agency's ongoing
review of psychiatric medicines, reflecting the scientific community's growing
understanding of suicide-related behaviors and how to analyze them. The
analysis was based on criteria developed by Columbia University and the FDA
last year, and uses a rigorous classification system to assess any risk of
suicide-related events in clinical trials.
According to the World Health Organization, suicidal thoughts or behaviors
have a large number of complex, underlying causes that can make it difficult
to determine why some people experience these feelings. Suicidal thoughts
occur in children and adolescents and are not always associated with other
features of mental illness. There is evidence that those suffering from ADHD
are at greater risk of suicide than the general population.(8,9)
Information for Patients and Physicians
Lilly is working in concert with regulatory agencies worldwide to notify
physicians about this important update. In addition, the company is notifying
consumer advocacy and professionally focused associations about these findings
so they can provide important information to patients. In the U.S., Lilly's
outreach efforts will include a "Dear Healthcare Professional" letter, sales
force communications to prescribers and updated label information on the
product web site, strattera.
All medications have side effects. No medication works for everyone. As
with any medication, patients or parents should consult their doctors with any
questions or concerns regarding treatment. This allows physicians and
patients to make the most informed treatment decisions. Patients or
caregivers with questions may also call the Lilly Answers Center at
1-800-LillyRx.
About Strattera
Strattera, a selective norepinephrine reuptake inhibitor, is the first
FDA-approved non-stimulant to treat ADHD and provide full-symptom relief. It
is not known precisely how Strattera reduces ADHD symptoms, but scientists
believe it works by blocking or slowing reabsorption of norepinephrine, a
chemical in the brain considered important in regulating attention,
impulsivity and activity levels. This keeps more norepinephrine at work in
the spaces between neurons in the brain. Improved efficiency in the
norepinephrine system is associated with improvement in symptoms of ADHD
(Pliska, 1996).
Strattera should not be taken at the same time as, or within two weeks of
taking, a monoamine oxidase inhibitor (MAOI) or by patients with narrow angle
glaucoma. Patients with a history of high or low blood pressure, increased
heart rate, or any heart or blood vessel disease should tell their doctor
before taking Strattera. Strattera has not been tested in children less than
6 years of age or in geriatric patients. Some children may lose weight when
starting treatment with Strattera. As with all ADHD medications, growth
should be monitored during treatment. Strattera can cause liver damage in
rare cases. Patients should tell their doctor right away if they have
itching, dark urine, yellow skin/eyes, upper right-sided abdominal tenderness,
or unexplained "flu-like" symptoms.
Most people in clinical studies who experienced side effects were not
bothered enough to stop using Strattera. The most common side effects in
children and adolescents in medical studies were upset stomach, decreased
appetite, nausea and vomiting, dizziness, tiredness and mood swings. In
adults, the most common side effects were constipation, dry mouth, nausea,
decreased appetite, dizziness, problems sleeping, sexual side effects,
problems urinating and menstrual cramps.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs. Additional
information about Lilly is available at lilly.
For full prescribing information visit strattera.
This press release contains forward-looking statements about the use of
Strattera for the treatment of ADHD and reflects Lilly's current beliefs.
However, as with any pharmaceutical product, there are substantial risks and
uncertainties, including risk of side effects and other safety concerns; and
there is no guarantee regarding the future commercial success of the product.
The company's results may also be affected by such factors as competitive
developments affecting current products; rate of sales growth of recently
launched products; the timing of anticipated regulatory approvals and launches
of new products; other regulatory developments and government investigations;
patent disputes and other litigation involving current and future products;
the impact of governmental actions regarding pricing, importation, and
reimbursement for pharmaceuticals; changes in tax law; and the impact of
exchange rates. For additional information about the factors that affect the
company's business, please see Exhibit 99 to the company's latest Form 10-Q
filed August 2005. The company undertakes no duty to update forward-looking
statements.
(1) American Psychiatric Association: Diagnostic and Statistical Manual
of Mental Disorders, fourth edition, text revision, Washington, DC, American
Psychiatric Association, 2000.
(2) Greenhill LL. Diagnosing attention-deficit/hyperactivity disorder in
children. J Clin Psychiatry 1998; 59 (Suppl 7): 31-41.
(3) Faraone S, Biederman J, et al. ADHD in adults: an overview. Biol
Psychiatry 2000; 48:9-20.
(4) Barkley. ADHD: A Handbook for Diagnosis and Treatment. New York:
Guilford Press; 1998.
(5) Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med
Clin of North Am. 2001; 85(3): 757-777
(6) Murphy K, Barkley, RA. J Atten disord. 1996; 1:147-161.
(7) United States Census Summary File; 2000.
(8) Swensen A, Kruesi M, Allen A, et al. Self injury and suicide in
patients with attention deficit hyperactivity disorder. Program and abstracts
of the American Academy of Child and Adolescent Psychiatry 49th Annual
Meeting; October 22-27, 2002; San Francisco, California. New Research F27.
(9) James A, Lai FH, Dahl C. Attention deficit hyperactivity disorder and
suicide: a review of possible associations. Acta Psychiatr Scand
2004;110:408-415.
lilly
View drug information on Strattera.
понедельник, 13 июня 2011 г.
ADHD And Sleep Problems In Adolescents Linked By Study
A study in the May 1 issue of the journal SLEEP shows that adolescents with a childhood diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) are more likely to have current and lifetime sleep problems and disorders, regardless of the severity of current ADHD symptoms. Authors suggest that findings indicate that mental health professionals should screen for sleep problems and psychiatric comorbidities among all adolescents with a childhood diagnosis of ADHD.
Results indicate that adolescents with a childhood diagnosis of ADHD, regardless of persistent ADHD were more likely to have current sleep problems and sleep disorders such as insomnia, sleep terrors, nightmares, bruxism and snoring. Of the total sample, 17 percent of children with ADHD were currently suffering from primary insomnia, versus 7 percent of controls; lifetime primary insomnia occurred in 20 percent of children with ADHD, compared to 10 percent of controls. Nightmare disorder affected 11 percent of children with ADHD and lifetime nightmare disorder affected 23 percent, versus 5 and 16 percent of controls. The presence of at least one psychiatric comorbid condition increases the risks for insomnia and nightmares.
According to principal investigator Susan Shur-Fen Gau, MD, PhD, associate professor at the College of Medicine and Public Health, National Taiwan University, symptoms and consequences of ADHD and sleep problems in children often overlap. Some primary sleep disorders are found to be associated with inattention, hyperactivity, behavioral problems and impaired academic performance, which are often mistaken for symptoms of ADHD.
"In some patients with ADHD, symptoms are caused or exaggerated by primary sleep disorders, and therefore treatment of the sleep disorder will improve ADHD symptoms," said Gau.
Data were collected from 281 consecutive patients (86.2 percent male) between the ages of 10 to 17 years who had been diagnosed with ADHD according to DSM-IV criteria at a mean age of 6.7 years, and 185 controls who did not have ADHD as a child or teen. Diagnosis of ADHD was made based on information obtained from parent and child interviews, observation of the child's behaviors, and rating scales reported by parents and teachers.
Findings of the study indicated that the rates of nightmare and lifetime nightmare disorder were more prevalent in girls and snoring was more prevalent in boys. Snoring may be more prevalent in boys due to an increased rate of sleep-disordered breathing in boys. Mothers were found to be more aware of symptoms related to ADHD in the presence of primary insomnia, sleep terror disorder or sleepwalking disorder, whereas teachers may be more sensitive to ADHD symptoms in the presence of primary hypersomnia and nightmare disorder.
According to the study, sleep problems in children with ADHD may be caused by a variety of factors, including internet addiction, hyperactivity, use of stimulants and the presence of other psychiatric disorders. Authors of the study state that the etiology of sleep problems and disorders need to be identified in children with ADHD, in order to create a modified treatment regime for sleep disorders and ADHD symptoms.
The study: "Sleep Problems and Disorders among Adolescents with Persistent and Subthreshold Attention-deficit/Hyperactivity Disorders,"
Source:
Kelly Wagner
American Academy of Sleep Medicine
Results indicate that adolescents with a childhood diagnosis of ADHD, regardless of persistent ADHD were more likely to have current sleep problems and sleep disorders such as insomnia, sleep terrors, nightmares, bruxism and snoring. Of the total sample, 17 percent of children with ADHD were currently suffering from primary insomnia, versus 7 percent of controls; lifetime primary insomnia occurred in 20 percent of children with ADHD, compared to 10 percent of controls. Nightmare disorder affected 11 percent of children with ADHD and lifetime nightmare disorder affected 23 percent, versus 5 and 16 percent of controls. The presence of at least one psychiatric comorbid condition increases the risks for insomnia and nightmares.
According to principal investigator Susan Shur-Fen Gau, MD, PhD, associate professor at the College of Medicine and Public Health, National Taiwan University, symptoms and consequences of ADHD and sleep problems in children often overlap. Some primary sleep disorders are found to be associated with inattention, hyperactivity, behavioral problems and impaired academic performance, which are often mistaken for symptoms of ADHD.
"In some patients with ADHD, symptoms are caused or exaggerated by primary sleep disorders, and therefore treatment of the sleep disorder will improve ADHD symptoms," said Gau.
Data were collected from 281 consecutive patients (86.2 percent male) between the ages of 10 to 17 years who had been diagnosed with ADHD according to DSM-IV criteria at a mean age of 6.7 years, and 185 controls who did not have ADHD as a child or teen. Diagnosis of ADHD was made based on information obtained from parent and child interviews, observation of the child's behaviors, and rating scales reported by parents and teachers.
Findings of the study indicated that the rates of nightmare and lifetime nightmare disorder were more prevalent in girls and snoring was more prevalent in boys. Snoring may be more prevalent in boys due to an increased rate of sleep-disordered breathing in boys. Mothers were found to be more aware of symptoms related to ADHD in the presence of primary insomnia, sleep terror disorder or sleepwalking disorder, whereas teachers may be more sensitive to ADHD symptoms in the presence of primary hypersomnia and nightmare disorder.
According to the study, sleep problems in children with ADHD may be caused by a variety of factors, including internet addiction, hyperactivity, use of stimulants and the presence of other psychiatric disorders. Authors of the study state that the etiology of sleep problems and disorders need to be identified in children with ADHD, in order to create a modified treatment regime for sleep disorders and ADHD symptoms.
The study: "Sleep Problems and Disorders among Adolescents with Persistent and Subthreshold Attention-deficit/Hyperactivity Disorders,"
Source:
Kelly Wagner
American Academy of Sleep Medicine
воскресенье, 12 июня 2011 г.
A Silent Pandemic: Industrial Chemicals Are Impairing The Brain Development Of Children Worldwide
Fetal and early childhood exposures to industrial chemicals in the environment can damage the developing brain and can lead to neurodevelopmental disorders (NDDs)--autism, attention deficit disorder (ADHD), and mental retardation. Still, there has been insufficient research done to identify the individual chemicals that can cause injury to the developing brains of children.
In a new review study, published online in The Lancet on November 8, 2006, and in an upcoming print issue of The Lancet, researchers from the Harvard School of Public Health and the Mount Sinai School of Medicine systematically examined publicly available data on chemical toxicity in order to identify the industrial chemicals that are the most likely to damage the developing brain.
The researchers found that 202 industrial chemicals have the capacity to damage the human brain, and they conclude that chemical pollution may have harmed the brains of millions of children worldwide. The authors conclude further that the toxic effects of industrial chemicals on children have generally been overlooked.
To protect children against industrial chemicals that can injure the developing brain, the researchers urge a precautionary approach for chemical testing and control. Such an approach is beginning to be applied in the European Union. It puts in place strong regulations, which could later be relaxed, if the hazard were less than anticipated, instead of current regulations that require a high level of proof. At present in the U.S., requirements for toxicity testing of chemicals are minimal.
"The human brain is a precious and vulnerable organ. And because optimal brain function depends on the integrity of the organ, even limited damage may have serious consequences," says Philippe Grandjean, adjunct professor at Harvard School of Public Health and the study's lead author.
One out of every six children has a developmental disability, usually involving the nervous system. Treating NDDs is difficult and costly to both families and society. In recent decades, a gathering amount of evidence has linked industrial chemicals to NDDs. Lead, for example, was the first chemical identified as having toxic effects to early brain development, though its neurotoxicity to adults had been known for centuries.
A developing brain is much more susceptible to the toxic effects of chemicals than an adult brain. During development, the brain undergoes a highly complex series of processes at different stages. An interference--for example, from toxic substances--that disrupts those processes, can have permanent consequences. That vulnerability lasts from fetal development through infancy and childhood to adolescence. Research has shown that environmental toxicants, such as lead or mercury, at low levels of exposure can have subclinical effects--not clinically visible, but still important adverse effects, such as decreases in intelligence or changes in behavior.
Grandjean and co-author Philip J. Landrigan, Professor at Mount Sinai School of Medicine, compiled a list of 202 environmental chemicals known to be toxic to the human brain using the Hazardous Substances Data Bank of the National Library of Medicine and other data sources. (The authors note that the list should not be regarded as comprehensive; for example, the number of chemicals that can cause neurotoxicity in laboratory animal tests exceeds 1,000.)
The authors then examined the published literature on the only five substances on the list--lead, methylmercury, arsenic, PCBs and toluene--that had sufficient documentation of toxicity to the developing human brain in order to analyze how that toxicity had been first recognized and how it led to control of exposure. They found a similar pattern in how the risks of each substance were documented: first, a recognition of adult toxicity and episodes of poisoning among children, followed by a growing body of epidemiological evidence that exposure to lower levels of the substances caused neurobehavioral deficits in children.
"Even if substantial documentation on their toxicity is available, most chemicals are not regulated to protect the developing brain," says Grandjean. "Only a few substances, such as lead and mercury, are controlled with the purpose of protecting children. The 200 other chemicals that are known to be toxic to the human brain are not regulated to prevent adverse effects on the fetus or a small child."
Grandjean and Landrigan conclude that industrial chemicals are responsible for what they call a silent pandemic that has caused impaired brain development in millions of children worldwide. It is silent because the subclinical effects of individual toxic chemicals are not apparent in available health statistics. To point out the subclinical risk to large populations, the authors note that virtually all children born in industrialized countries between 1960 and 1980 were exposed to lead from petrol, which may have reduced IQ scores above 130 (considered superior intelligence) by more than half and increased the number of scores less than 70. Today, it's estimated that the economic costs of lead poisoning in U.S. children are $43 billion annually; for methylmercury toxicity, $8.7 billion each year.
"Other harmful consequences from lead exposure include shortened attention spans, slowed motor coordination and heightened aggressiveness, which can lead to problems in school and diminished economic productivity as an adult. And the consequences of childhood neurotoxicant exposure later in life may include increased risk of Parkinson's disease and other neurogenerative diseases," says Landrigan.
The researchers believe that the total impact of the pandemic is much greater than currently recognized. In supplementary documentation (see below for a link), about half of the 202 chemicals known to be toxic to the brain are among the chemicals most commonly used.
Testing chemicals for toxicity is a highly efficient public health measure. However, less than half of the thousands of chemicals currently used in commerce have been tested to assess acute toxicity and, although new chemicals undergo more thorough testing, access to the data may be restricted because companies fear exposing proprietary information. Also, current toxicity testing rarely includes neurobehavioral functions.
"The brains of our children are our most precious economic resource, and we haven't recognized how vulnerable they are," says Grandjean. "We must make protection of the young brain a paramount goal of public health protection. You have only one chance to develop a brain."
To view supplementary documentation on industrial chemicals and risks of toxic effects on brain development, click here: hsph.harvard/neurotoxicant/appendix.doc
Support for this research was provided by the Danish Medical Research Council, the (U.S.) National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency.
See the latest news from the Harvard School of Public Health.
Harvard School of Public Health is dedicated to advancing the public's health through learning, discovery, and communication. More than 300 faculty members are engaged in teaching and training the 900-plus student body in a broad spectrum of disciplines crucial to the health and well being of individuals and populations around the world. Programs and projects range from the molecular biology of AIDS vaccines to the epidemiology of cancer; from risk analysis to violence prevention; from maternal and children's health to quality of care measurement; from health care management to international health and human rights. For more information on the school visit: hsph.harvard/
Contact: Todd Datz
Harvard School of Public Health
In a new review study, published online in The Lancet on November 8, 2006, and in an upcoming print issue of The Lancet, researchers from the Harvard School of Public Health and the Mount Sinai School of Medicine systematically examined publicly available data on chemical toxicity in order to identify the industrial chemicals that are the most likely to damage the developing brain.
The researchers found that 202 industrial chemicals have the capacity to damage the human brain, and they conclude that chemical pollution may have harmed the brains of millions of children worldwide. The authors conclude further that the toxic effects of industrial chemicals on children have generally been overlooked.
To protect children against industrial chemicals that can injure the developing brain, the researchers urge a precautionary approach for chemical testing and control. Such an approach is beginning to be applied in the European Union. It puts in place strong regulations, which could later be relaxed, if the hazard were less than anticipated, instead of current regulations that require a high level of proof. At present in the U.S., requirements for toxicity testing of chemicals are minimal.
"The human brain is a precious and vulnerable organ. And because optimal brain function depends on the integrity of the organ, even limited damage may have serious consequences," says Philippe Grandjean, adjunct professor at Harvard School of Public Health and the study's lead author.
One out of every six children has a developmental disability, usually involving the nervous system. Treating NDDs is difficult and costly to both families and society. In recent decades, a gathering amount of evidence has linked industrial chemicals to NDDs. Lead, for example, was the first chemical identified as having toxic effects to early brain development, though its neurotoxicity to adults had been known for centuries.
A developing brain is much more susceptible to the toxic effects of chemicals than an adult brain. During development, the brain undergoes a highly complex series of processes at different stages. An interference--for example, from toxic substances--that disrupts those processes, can have permanent consequences. That vulnerability lasts from fetal development through infancy and childhood to adolescence. Research has shown that environmental toxicants, such as lead or mercury, at low levels of exposure can have subclinical effects--not clinically visible, but still important adverse effects, such as decreases in intelligence or changes in behavior.
Grandjean and co-author Philip J. Landrigan, Professor at Mount Sinai School of Medicine, compiled a list of 202 environmental chemicals known to be toxic to the human brain using the Hazardous Substances Data Bank of the National Library of Medicine and other data sources. (The authors note that the list should not be regarded as comprehensive; for example, the number of chemicals that can cause neurotoxicity in laboratory animal tests exceeds 1,000.)
The authors then examined the published literature on the only five substances on the list--lead, methylmercury, arsenic, PCBs and toluene--that had sufficient documentation of toxicity to the developing human brain in order to analyze how that toxicity had been first recognized and how it led to control of exposure. They found a similar pattern in how the risks of each substance were documented: first, a recognition of adult toxicity and episodes of poisoning among children, followed by a growing body of epidemiological evidence that exposure to lower levels of the substances caused neurobehavioral deficits in children.
"Even if substantial documentation on their toxicity is available, most chemicals are not regulated to protect the developing brain," says Grandjean. "Only a few substances, such as lead and mercury, are controlled with the purpose of protecting children. The 200 other chemicals that are known to be toxic to the human brain are not regulated to prevent adverse effects on the fetus or a small child."
Grandjean and Landrigan conclude that industrial chemicals are responsible for what they call a silent pandemic that has caused impaired brain development in millions of children worldwide. It is silent because the subclinical effects of individual toxic chemicals are not apparent in available health statistics. To point out the subclinical risk to large populations, the authors note that virtually all children born in industrialized countries between 1960 and 1980 were exposed to lead from petrol, which may have reduced IQ scores above 130 (considered superior intelligence) by more than half and increased the number of scores less than 70. Today, it's estimated that the economic costs of lead poisoning in U.S. children are $43 billion annually; for methylmercury toxicity, $8.7 billion each year.
"Other harmful consequences from lead exposure include shortened attention spans, slowed motor coordination and heightened aggressiveness, which can lead to problems in school and diminished economic productivity as an adult. And the consequences of childhood neurotoxicant exposure later in life may include increased risk of Parkinson's disease and other neurogenerative diseases," says Landrigan.
The researchers believe that the total impact of the pandemic is much greater than currently recognized. In supplementary documentation (see below for a link), about half of the 202 chemicals known to be toxic to the brain are among the chemicals most commonly used.
Testing chemicals for toxicity is a highly efficient public health measure. However, less than half of the thousands of chemicals currently used in commerce have been tested to assess acute toxicity and, although new chemicals undergo more thorough testing, access to the data may be restricted because companies fear exposing proprietary information. Also, current toxicity testing rarely includes neurobehavioral functions.
"The brains of our children are our most precious economic resource, and we haven't recognized how vulnerable they are," says Grandjean. "We must make protection of the young brain a paramount goal of public health protection. You have only one chance to develop a brain."
To view supplementary documentation on industrial chemicals and risks of toxic effects on brain development, click here: hsph.harvard/neurotoxicant/appendix.doc
Support for this research was provided by the Danish Medical Research Council, the (U.S.) National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency.
See the latest news from the Harvard School of Public Health.
Harvard School of Public Health is dedicated to advancing the public's health through learning, discovery, and communication. More than 300 faculty members are engaged in teaching and training the 900-plus student body in a broad spectrum of disciplines crucial to the health and well being of individuals and populations around the world. Programs and projects range from the molecular biology of AIDS vaccines to the epidemiology of cancer; from risk analysis to violence prevention; from maternal and children's health to quality of care measurement; from health care management to international health and human rights. For more information on the school visit: hsph.harvard/
Contact: Todd Datz
Harvard School of Public Health
суббота, 11 июня 2011 г.
Popular ADHD Drug Safe And Effective For Pre-schoolers But Monitor Youngsters Closely For Side Effects, Researchers Caution
A new study by researchers from the Johns Hopkins Children's Center and five other medical centers concludes that carefully measured, low doses of methylphenidate (Ritalin) are safe and effective for attention-deficit and hyperactivity disorder (ADHD) in preschoolers. Investigators warn, however, that 3- to 5-year-olds appear more sensitive to the drug's side effects, which include irritability, insomnia and weight loss, than are older children with ADHD and require closer monitoring.
Children who took the drug also experienced somewhat slower growth rates. On average, children on the drug grew half an inch per year less than expected and gained 2.9 pounds less than expected. Researchers recommend that pediatricians weigh the risks of slowed growth rates against the benefits of treatment. Children on long-term treatment with methylphenidate should be monitored carefully several times a year to assess growth changes over time.
Methylphenidate is the most widely prescribed drug for the treatment of ADHD in children but is not approved by the Food and Drug Administration (FDA) for use in children younger than 6.
Results of the federally funded research, the first large-scale, long-term study of the safety and value of the drug in younger children, appear in a special section of the November issue of the Journal of the American Academy of Child and Adolescent Psychiatry.
"These results give us the missing links in the decision to prescribe a drug that's been widely used off-label in preschool-age children," says Mark Riddle, M.D., director of Child and Adolescent Psychiatry at the Children's Center and a co-author on the study, which followed 303 children between 3 and 5 over 70 weeks. "We were able to confirm what many already suspected-that even lower doses in preschoolers can safely achieve the desired therapeutic effect and indeed that low doses are often optimal."
Children in the study were started on a low-dose regimen of medication ranging from 3.75 mg total daily to 22.5 mg total daily. By comparison, the cumulative daily dose for older children ranges from 15 mg per day to 50 mg per day. The optimal dose needed to reduce symptoms ranged widely in preschool-age children, but on average, 14 mg daily was effective in reining in symptoms.
"One of the surprises was that in some cases, doses as low as even 3 to 4 mg a day were helpful to some preschoolers, which goes to show that lower doses need to be given a chance before higher doses are tried," Riddle explains.
About 11 percent of those enrolled in the study experienced side effects severe enough to drop out. These included weight loss, anxiety, skin picking, mood disturbances and insomnia.
"We want parents to know that trained professionals can make an accurate diagnosis and prescribe helpful and safe treatment in preschoolers with ADHD," Riddle says. "But do expect your prescribing physician to monitor side effects closely and regularly and to tweak the dose if necessary."
ADHD is characterized by a wide range of symptoms, including inability to concentrate, being easily distracted, fidgeting and restlessness, among others. Left untreated, ADHD can interfere with academic progress and social and emotional development. More than 4.4 million children in the United States have ADHD, according to estimates by the Centers for Disease Control and Prevention. About 2 percent of preschool-age children are believed to have ADHD.
Johns Hopkins Medicine Media Relations and Public Affairs October 23, 2006
Other Hopkins researchers included Elizabeth Kastelic, M.D., Golda Ginsburg, Ph.D., Margaret Schlossberg, Ph.D.., Alexander Scharko, M.D., now at the University of Wisconsin, and Jaswinder Ghuman, M.D., now at the University of Arizona. The study was led by Laurence Greenhill, M.D., of Columbia University and the New York State Psychiatric Institute. Other study sites included Duke University, New York University, the University of California-Los Angeles, and the University of California-Irvine.
Founded in 1912 as the children's hospital of the Johns Hopkins Medical Institutions, the Johns Hopkins Children's Center offers one of the most comprehensive pediatric medical programs in the country, from performing emergency trauma surgery, to finding causes and treatments for childhood cancers, to delivering a child's good bill of health. The Johns Hopkins Children Center's Pediatric Trauma Service is Maryland's only state-designated trauma center for children. With recognized Centers of Excellence in 20 pediatric subspecialties including cardiology, transplant, psychiatric illnesses and genetic disorders, Children's Center physicians, nurses and staff provide compassionate care to more than 90,000 children each year. For more information, please visit: hopkinschildrens/
Contact: Katerina Pesheva
Johns Hopkins Medical Institutions
View drug information on Ritalin LA.
Children who took the drug also experienced somewhat slower growth rates. On average, children on the drug grew half an inch per year less than expected and gained 2.9 pounds less than expected. Researchers recommend that pediatricians weigh the risks of slowed growth rates against the benefits of treatment. Children on long-term treatment with methylphenidate should be monitored carefully several times a year to assess growth changes over time.
Methylphenidate is the most widely prescribed drug for the treatment of ADHD in children but is not approved by the Food and Drug Administration (FDA) for use in children younger than 6.
Results of the federally funded research, the first large-scale, long-term study of the safety and value of the drug in younger children, appear in a special section of the November issue of the Journal of the American Academy of Child and Adolescent Psychiatry.
"These results give us the missing links in the decision to prescribe a drug that's been widely used off-label in preschool-age children," says Mark Riddle, M.D., director of Child and Adolescent Psychiatry at the Children's Center and a co-author on the study, which followed 303 children between 3 and 5 over 70 weeks. "We were able to confirm what many already suspected-that even lower doses in preschoolers can safely achieve the desired therapeutic effect and indeed that low doses are often optimal."
Children in the study were started on a low-dose regimen of medication ranging from 3.75 mg total daily to 22.5 mg total daily. By comparison, the cumulative daily dose for older children ranges from 15 mg per day to 50 mg per day. The optimal dose needed to reduce symptoms ranged widely in preschool-age children, but on average, 14 mg daily was effective in reining in symptoms.
"One of the surprises was that in some cases, doses as low as even 3 to 4 mg a day were helpful to some preschoolers, which goes to show that lower doses need to be given a chance before higher doses are tried," Riddle explains.
About 11 percent of those enrolled in the study experienced side effects severe enough to drop out. These included weight loss, anxiety, skin picking, mood disturbances and insomnia.
"We want parents to know that trained professionals can make an accurate diagnosis and prescribe helpful and safe treatment in preschoolers with ADHD," Riddle says. "But do expect your prescribing physician to monitor side effects closely and regularly and to tweak the dose if necessary."
ADHD is characterized by a wide range of symptoms, including inability to concentrate, being easily distracted, fidgeting and restlessness, among others. Left untreated, ADHD can interfere with academic progress and social and emotional development. More than 4.4 million children in the United States have ADHD, according to estimates by the Centers for Disease Control and Prevention. About 2 percent of preschool-age children are believed to have ADHD.
Johns Hopkins Medicine Media Relations and Public Affairs October 23, 2006
Other Hopkins researchers included Elizabeth Kastelic, M.D., Golda Ginsburg, Ph.D., Margaret Schlossberg, Ph.D.., Alexander Scharko, M.D., now at the University of Wisconsin, and Jaswinder Ghuman, M.D., now at the University of Arizona. The study was led by Laurence Greenhill, M.D., of Columbia University and the New York State Psychiatric Institute. Other study sites included Duke University, New York University, the University of California-Los Angeles, and the University of California-Irvine.
Founded in 1912 as the children's hospital of the Johns Hopkins Medical Institutions, the Johns Hopkins Children's Center offers one of the most comprehensive pediatric medical programs in the country, from performing emergency trauma surgery, to finding causes and treatments for childhood cancers, to delivering a child's good bill of health. The Johns Hopkins Children Center's Pediatric Trauma Service is Maryland's only state-designated trauma center for children. With recognized Centers of Excellence in 20 pediatric subspecialties including cardiology, transplant, psychiatric illnesses and genetic disorders, Children's Center physicians, nurses and staff provide compassionate care to more than 90,000 children each year. For more information, please visit: hopkinschildrens/
Contact: Katerina Pesheva
Johns Hopkins Medical Institutions
View drug information on Ritalin LA.
пятница, 10 июня 2011 г.
New Guidelines For GP's Revolutionise Treatment For Hyperactivity Disorders
New guidelines published this month (January 2007) in the Journal of Psychopharmacology will help to treat ADHD (Attention-Deficit/Hyperactivity Disorder), a condition that is traditionally associated with children but which is now increasing in adults. The guidelines will provide authoritative information to health professionals at a time when there is currently great uncertainty amongst GPs on how to treat the condition.
ADHD in the population is considered to be about four per cent making it a common disorder. There are no licensed drugs for managing ADHD specifically in adults, leading to uncertainty amongst health professionals on how best to treat these new cases. Yet drugs licensed for related conditions have proven to be effective.
The British Association of Psychopharmacology (BAP) guidelines provide the appropriate evidence and experience to permit health professionals to use unlicensed medicines if the clinical need cannot be met by licensed medicines, as advised by the British National Formulary (BNF).
"Treatment relieves suffering for the patient and family, and also alleviates social costs in unemployment, crime, incarceration, smoking, substance use and driving accidents", said Professor David Nutt from the BAP consensus group. "This information needs to be addressed by the NHS so that resources can be redirected to provide appropriate and evidence-based care for adults with ADHD."
The BAP guidelines on adult ADHD are based on expert opinion derived from childhood evidence. It is the first time that guidelines for ADHD in adults, and in adolescents in transition to adult services, have been published and arrive at a time when they can influence the new specialist services that the NHS is establishing in response to this growing need.
SAGE PUBLICATIONS
http://sagepub.co.uk/
ADHD in the population is considered to be about four per cent making it a common disorder. There are no licensed drugs for managing ADHD specifically in adults, leading to uncertainty amongst health professionals on how best to treat these new cases. Yet drugs licensed for related conditions have proven to be effective.
The British Association of Psychopharmacology (BAP) guidelines provide the appropriate evidence and experience to permit health professionals to use unlicensed medicines if the clinical need cannot be met by licensed medicines, as advised by the British National Formulary (BNF).
"Treatment relieves suffering for the patient and family, and also alleviates social costs in unemployment, crime, incarceration, smoking, substance use and driving accidents", said Professor David Nutt from the BAP consensus group. "This information needs to be addressed by the NHS so that resources can be redirected to provide appropriate and evidence-based care for adults with ADHD."
The BAP guidelines on adult ADHD are based on expert opinion derived from childhood evidence. It is the first time that guidelines for ADHD in adults, and in adolescents in transition to adult services, have been published and arrive at a time when they can influence the new specialist services that the NHS is establishing in response to this growing need.
SAGE PUBLICATIONS
http://sagepub.co.uk/
четверг, 9 июня 2011 г.
ADDA Kicks Off AD/HD Awareness Campaign With Regional Meeting On Oct. 20 In Atlanta, GA
The Attention Deficit Disorder
Association (ADDA) knows how difficult it can be for the 8 million adults
who live with Attention Deficit/Hyperactivity Disorder (AD/HD). Due to a
lack of awareness about AD/HD and the negative stigma surrounding this
disorder, 85 percent of these adults remain undiagnosed, leading to
difficulties with family and other relationships and educational and
employment problems.
In order to provide hope for these adults living in the dark, ADDA is
holding four regional meetings this fall to shed light on this disorder and
present effective strategies for handling these everyday challenges.
The next meeting is being held Oct. 20 in Atlanta, GA.
When: Saturday, October 20 from 8:00 a.m. to 6:30 p.m.
Where: Crowne Plaza Altanta-Buckhead, 3377 Peachtree Road, N.E.,
Atlanta, GA
A special networking event for AD/HD professionals will be held Friday,
October 19 from 5:00 p.m. to 8:30 p.m. at Crowne Plaza Atlanta-Buckhead.
Well-respected experts in the medical and mental health fields, as well
as AD/HD professionals will provide facts about AD/HD symptoms, diagnosis
and treatment, in addition to explaining how people can successfully cope
with AD/HD in all aspects of their lives. Sessions will also provide
coaches with insight into coaching for AD/HD.
Dr. Robert Doyle will give a keynote address on Diagnosing and Treating
the Adult AD/HD: Advances in Adult Arena, and Judith Goldberg and Yvonne
Pennington, PhD will also present at the meeting, along with other
well-known experts.
Bringing together a renowned group of AD/HD experts, the regional
meetings will provide unparalleled educational and networking opportunities
for a diverse audience. They are appropriate for adults with AD/HD, parents
with AD/HD children, educators, medical and mental health professionals,
other AD/HD professionals and interested members of the general public.
Registration is now open online at add. Workshop topics
will include:
-- Executive dysfunction
-- Time management
-- Associated disorders
-- Organization
About ADDA: The Attention Deficit Disorder Association (ADDA) is a
nonprofit organization working to provide information, resources and
networking to adults with AD/HD and to the professionals who work with
them. In doing so, ADDA generates hope, awareness, empowerment and
connections worldwide in the field of AD/HD. For more information visit:
add.
Attention Deficit Disorder Association
add
Association (ADDA) knows how difficult it can be for the 8 million adults
who live with Attention Deficit/Hyperactivity Disorder (AD/HD). Due to a
lack of awareness about AD/HD and the negative stigma surrounding this
disorder, 85 percent of these adults remain undiagnosed, leading to
difficulties with family and other relationships and educational and
employment problems.
In order to provide hope for these adults living in the dark, ADDA is
holding four regional meetings this fall to shed light on this disorder and
present effective strategies for handling these everyday challenges.
The next meeting is being held Oct. 20 in Atlanta, GA.
When: Saturday, October 20 from 8:00 a.m. to 6:30 p.m.
Where: Crowne Plaza Altanta-Buckhead, 3377 Peachtree Road, N.E.,
Atlanta, GA
A special networking event for AD/HD professionals will be held Friday,
October 19 from 5:00 p.m. to 8:30 p.m. at Crowne Plaza Atlanta-Buckhead.
Well-respected experts in the medical and mental health fields, as well
as AD/HD professionals will provide facts about AD/HD symptoms, diagnosis
and treatment, in addition to explaining how people can successfully cope
with AD/HD in all aspects of their lives. Sessions will also provide
coaches with insight into coaching for AD/HD.
Dr. Robert Doyle will give a keynote address on Diagnosing and Treating
the Adult AD/HD: Advances in Adult Arena, and Judith Goldberg and Yvonne
Pennington, PhD will also present at the meeting, along with other
well-known experts.
Bringing together a renowned group of AD/HD experts, the regional
meetings will provide unparalleled educational and networking opportunities
for a diverse audience. They are appropriate for adults with AD/HD, parents
with AD/HD children, educators, medical and mental health professionals,
other AD/HD professionals and interested members of the general public.
Registration is now open online at add. Workshop topics
will include:
-- Executive dysfunction
-- Time management
-- Associated disorders
-- Organization
About ADDA: The Attention Deficit Disorder Association (ADDA) is a
nonprofit organization working to provide information, resources and
networking to adults with AD/HD and to the professionals who work with
them. In doing so, ADDA generates hope, awareness, empowerment and
connections worldwide in the field of AD/HD. For more information visit:
add.
Attention Deficit Disorder Association
add
среда, 8 июня 2011 г.
St. John's Wort Similar To Placebo For ADHD Treatment
St. John's wort does not appear to improve the symptoms of
attention-deficit/hyperactivity disorder (ADHD) in children and teens
in comparison with a placebo, according to an article released on June
10, 2008 in JAMA.
Hypericum perforatum, also called St. John's wort,
is a flowering plant often used in alternative medicine to treat
depression. Many studies have been used to test its efficacy for this
and other indications. Its active chemical is called hypercin, and some
of its efficacy is attributed to this substance.
ADHD is a neurological disorder that generally appears in childhood,
presenting with symptoms of hyperactivity, forgetfulness, and being
easily distracted. This disease affects between 3-12% of children in
the United States, according to the background information in the
article. Up to 30% of these children have no response to medications,
or have adverse effects when taking them such as nausea, insomnia, or
weight loss. For these reasons, many parents seek complementary or
alternative
medicine for their children with ADHD. Complementary or alternative
medicine treatments used for pediatric ADHD include massage, dietary
changes, dietary supplements, and herbal treatments. In the United
States, the most common herbal treatments used by children with ADHD
are St John's wort, Echinacea species, and Ginkgo biloba," write the
authors.
To investigate St. John's wort as a remedy for the symptoms of ADHD,
Wendy Weber, N.D., Ph.D., M.P.H., of Bastyr University, Kenmore, Wash.,
and colleagues performed a trial of 54 children and adolescents with
ADHD between the ages of 6 and 17 years. Of these, 27 subjects were
randomly assigned to receive 300mg of H. perforatum
standardized to 0.3% hypercin, while the other 27 received a matched
placebo. Treatment was administered three times daily for eight weeks
while all other ADHD medications were forbidden.
No significant discrepancy was found between the two groups in terms of
ADHD rating scale scores related to inattentiveness and hyperactivity
in any of the 8 weeks of trials. There was also no difference found in
the proportion of participants rated either much or very much improved
in relation to ADHD symptoms on a second, different measurement scale
called the Clinical Global Impression Improvement Scale. Finally, no
statistically significant difference was found between the two groups
for adverse events, including rash, nausea/vomiting, headache, or
sunburn.
ing the trial.
The authors indicate that this means the efficacy of St. John's wort is
similar to that of a placebo. "To our knowledge, this is the first
placebo-controlled trial of H. perforatum in
children and adolescents. The results of this study suggest that
administration of H. perforatum has no additional
benefit beyond that of placebo for treating symptoms of child and
adolescent ADHD," they write.
Hypericum perforatum (St John's Wort) for
Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A
Randomized Controlled Trial
Wendy Weber; Ann Vander Stoep; Rachelle L. McCarty; Noel S. Weiss;
Joseph Biederman; Jon McClellan
JAMA. 2008; 299(22): 2633-2641.
Click Here For Journal
Written by Anna Sophia McKenney
attention-deficit/hyperactivity disorder (ADHD) in children and teens
in comparison with a placebo, according to an article released on June
10, 2008 in JAMA.
Hypericum perforatum, also called St. John's wort,
is a flowering plant often used in alternative medicine to treat
depression. Many studies have been used to test its efficacy for this
and other indications. Its active chemical is called hypercin, and some
of its efficacy is attributed to this substance.
ADHD is a neurological disorder that generally appears in childhood,
presenting with symptoms of hyperactivity, forgetfulness, and being
easily distracted. This disease affects between 3-12% of children in
the United States, according to the background information in the
article. Up to 30% of these children have no response to medications,
or have adverse effects when taking them such as nausea, insomnia, or
weight loss. For these reasons, many parents seek complementary or
alternative
medicine for their children with ADHD. Complementary or alternative
medicine treatments used for pediatric ADHD include massage, dietary
changes, dietary supplements, and herbal treatments. In the United
States, the most common herbal treatments used by children with ADHD
are St John's wort, Echinacea species, and Ginkgo biloba," write the
authors.
To investigate St. John's wort as a remedy for the symptoms of ADHD,
Wendy Weber, N.D., Ph.D., M.P.H., of Bastyr University, Kenmore, Wash.,
and colleagues performed a trial of 54 children and adolescents with
ADHD between the ages of 6 and 17 years. Of these, 27 subjects were
randomly assigned to receive 300mg of H. perforatum
standardized to 0.3% hypercin, while the other 27 received a matched
placebo. Treatment was administered three times daily for eight weeks
while all other ADHD medications were forbidden.
No significant discrepancy was found between the two groups in terms of
ADHD rating scale scores related to inattentiveness and hyperactivity
in any of the 8 weeks of trials. There was also no difference found in
the proportion of participants rated either much or very much improved
in relation to ADHD symptoms on a second, different measurement scale
called the Clinical Global Impression Improvement Scale. Finally, no
statistically significant difference was found between the two groups
for adverse events, including rash, nausea/vomiting, headache, or
sunburn.
ing the trial.
The authors indicate that this means the efficacy of St. John's wort is
similar to that of a placebo. "To our knowledge, this is the first
placebo-controlled trial of H. perforatum in
children and adolescents. The results of this study suggest that
administration of H. perforatum has no additional
benefit beyond that of placebo for treating symptoms of child and
adolescent ADHD," they write.
Hypericum perforatum (St John's Wort) for
Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A
Randomized Controlled Trial
Wendy Weber; Ann Vander Stoep; Rachelle L. McCarty; Noel S. Weiss;
Joseph Biederman; Jon McClellan
JAMA. 2008; 299(22): 2633-2641.
Click Here For Journal
Written by Anna Sophia McKenney
вторник, 7 июня 2011 г.
Consumer Reports To Parents: Think Twice About Free Prescription ADHD Drug Samples For Your Children
According to a new Consumer Reports Best Buy Drugs report, parents should be skeptical if their doctors offer them free prescription drug samples, especially for the treatment of attention deficit hyperactivity disorder (ADHD). Free samples can hook consumers on high-priced brand name drugs that are not any better or safer than less expensive generic medicines. In addition, when doctors give out free samples, they often fail to give patients information inserts that highlight important safety and side effect information.
Consumer Reports Best Buy Drugs found that two generic ADHD drugs, dextroamphetamine and methylphenidate, are as safe and effective as well- known drugs like Adderall XR, Concerta or Strattera. By switching to one of those two generic drugs, consumers could save roughly $3,000 a year off the retail price.
"Parents want to do what is best for their children," says Dr. John Santa, director of the Consumer Reports Health Ratings Center. "But free samples and clever advertising convince them they should be shelling out thousands of dollars a year for brand name prescription drugs when equally effective generics are available."
ADHD is one of the most common behavioral problems diagnosed among school-age children in the United States and about 7 percent (about 4.5 million in 2006) of children aged 4 to 17 have been diagnosed with the disorder. When ADHD needs to be treated with medication, parents may be presented with advertisements and free samples of expensive brand-name drugs.
Drug companies gave away an estimated $16 billion in free drug samples in 2004, and doctors routinely hand out these free samples to parents. In fact, according to one October 2008 study in the journal of Pediatrics; about 1 out of every 10 kids already taking a medication got a free drug sample. According to that study, which looked at data from 2004, the ADHD drug Strattera was the 4th most common free drug sample given to children; Adderall XR was in the top 15.
A recent poll by the Consumer Reports National Research Center revealed that 80 percent of Americans who take prescription drugs have received free samples from their physicians. "The use of free samples is extremely prevalent and insidious," said Santa. "And is likely not the best first-choice treatment for a patient's condition."
"Once the samples run out, consumers are likely to end up with sticker shock when they go to fill the prescription," explained Santa. Moreover, samples often do not contain a patient package insert, which describe important safety information.
Ensure a Correct ADHD Diagnosis
Consumer Reports Best Buy Drugs notes that many young patients who take ADHD drugs either do not have ADHD or have only mild symptoms. Before starting any drug treatment for ADHD, it's essential to get an accurate diagnosis by a medical professional.
"Few children present with symptoms of ADHD that can be easily diagnosed by simple observation," said Dr. Orly Avitzur, medical adviser, Consumers Union. "Most need to be evaluated with formal testing, and questionnaires answered by the parents and teachers. A complete history and physical examination should also be performed before medication is prescribed."
Children or teens with ADHD exhibit a persistent pattern, lasting six months or more, including impulsive behavior, hyperactivity, and/or lack of focus and inability to complete a task. A pediatrician, primary care doctor or mental-health professional should always begin by ruling out other possible reasons for their behavior. Parents should question a medical professional who diagnoses ADHD on the first visit and prescribes a drug on the spot.
ADHD Drugs May Only Work for a Few Years
And there is another hitch: a recent study shows that at least one ADHD stimulant drug, methylphenidate (Ritalin), may only work for a few years. There is little evidence proving a clear benefit beyond that. Long term studies have not been done on other ADHD drugs. Parents should routinely check in with their child's doctor about whether the drugs are still working since all stimulant drugs, along with Strattera (a non-stimulant), may have long-term risks, including possibly suppressing a child's growth and a rare risk of sudden death, stroke or heart attack.
Methodology
The Consumer Reports Best Buy Drugs report on drugs to treat ADHD is based on a systematic review of hundreds of research articles and studies, where the risks and benefits of one drug or many drugs against each other are evaluated. This kind of systematic review is known as comparative effectiveness and all Consumer Reports Best Buy Drugs reports use this process as the basis for their drug Ratings.
JULY 2009
(C) Consumers Union 2009. The material above is intended for legitimate news entities only; it may not be used for commercial or promotional purposes. Consumer Reports(R) is published by Consumers Union, an expert, independent nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. To achieve this mission, we test, inform, and protect. To maintain our independence and impartiality, Consumers Union accepts no outside advertising, no free test samples, and has no agenda other than the interests of consumers. Consumers Union supports itself through the sale of our information products and services, individual contributions, and a few noncommercial grants.
Source: Consumer Reports Health
View drug information on Adderall XR; Concerta; Ritalin LA.
Consumer Reports Best Buy Drugs found that two generic ADHD drugs, dextroamphetamine and methylphenidate, are as safe and effective as well- known drugs like Adderall XR, Concerta or Strattera. By switching to one of those two generic drugs, consumers could save roughly $3,000 a year off the retail price.
"Parents want to do what is best for their children," says Dr. John Santa, director of the Consumer Reports Health Ratings Center. "But free samples and clever advertising convince them they should be shelling out thousands of dollars a year for brand name prescription drugs when equally effective generics are available."
ADHD is one of the most common behavioral problems diagnosed among school-age children in the United States and about 7 percent (about 4.5 million in 2006) of children aged 4 to 17 have been diagnosed with the disorder. When ADHD needs to be treated with medication, parents may be presented with advertisements and free samples of expensive brand-name drugs.
Drug companies gave away an estimated $16 billion in free drug samples in 2004, and doctors routinely hand out these free samples to parents. In fact, according to one October 2008 study in the journal of Pediatrics; about 1 out of every 10 kids already taking a medication got a free drug sample. According to that study, which looked at data from 2004, the ADHD drug Strattera was the 4th most common free drug sample given to children; Adderall XR was in the top 15.
A recent poll by the Consumer Reports National Research Center revealed that 80 percent of Americans who take prescription drugs have received free samples from their physicians. "The use of free samples is extremely prevalent and insidious," said Santa. "And is likely not the best first-choice treatment for a patient's condition."
"Once the samples run out, consumers are likely to end up with sticker shock when they go to fill the prescription," explained Santa. Moreover, samples often do not contain a patient package insert, which describe important safety information.
Ensure a Correct ADHD Diagnosis
Consumer Reports Best Buy Drugs notes that many young patients who take ADHD drugs either do not have ADHD or have only mild symptoms. Before starting any drug treatment for ADHD, it's essential to get an accurate diagnosis by a medical professional.
"Few children present with symptoms of ADHD that can be easily diagnosed by simple observation," said Dr. Orly Avitzur, medical adviser, Consumers Union. "Most need to be evaluated with formal testing, and questionnaires answered by the parents and teachers. A complete history and physical examination should also be performed before medication is prescribed."
Children or teens with ADHD exhibit a persistent pattern, lasting six months or more, including impulsive behavior, hyperactivity, and/or lack of focus and inability to complete a task. A pediatrician, primary care doctor or mental-health professional should always begin by ruling out other possible reasons for their behavior. Parents should question a medical professional who diagnoses ADHD on the first visit and prescribes a drug on the spot.
ADHD Drugs May Only Work for a Few Years
And there is another hitch: a recent study shows that at least one ADHD stimulant drug, methylphenidate (Ritalin), may only work for a few years. There is little evidence proving a clear benefit beyond that. Long term studies have not been done on other ADHD drugs. Parents should routinely check in with their child's doctor about whether the drugs are still working since all stimulant drugs, along with Strattera (a non-stimulant), may have long-term risks, including possibly suppressing a child's growth and a rare risk of sudden death, stroke or heart attack.
Methodology
The Consumer Reports Best Buy Drugs report on drugs to treat ADHD is based on a systematic review of hundreds of research articles and studies, where the risks and benefits of one drug or many drugs against each other are evaluated. This kind of systematic review is known as comparative effectiveness and all Consumer Reports Best Buy Drugs reports use this process as the basis for their drug Ratings.
JULY 2009
(C) Consumers Union 2009. The material above is intended for legitimate news entities only; it may not be used for commercial or promotional purposes. Consumer Reports(R) is published by Consumers Union, an expert, independent nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. To achieve this mission, we test, inform, and protect. To maintain our independence and impartiality, Consumers Union accepts no outside advertising, no free test samples, and has no agenda other than the interests of consumers. Consumers Union supports itself through the sale of our information products and services, individual contributions, and a few noncommercial grants.
Source: Consumer Reports Health
View drug information on Adderall XR; Concerta; Ritalin LA.
понедельник, 6 июня 2011 г.
ADHD: NYU Child Study Center Offers Unique Summer Experience For Children With Attention-Deficit/Hyperactivity Disorder
As parents and teachers know, children with Attention-Deficit/Hyperactivity Disorder (ADHD) can thrive in a setting that emphasizes achievement and success and maintains consistency and, therefore, predictability. To that end, NYU Child Study Center created the Summer Program for Kids (SPK), New York's first all-day, therapeutic camp exclusively for children with ADHD, which is now in its eighth year. SPK combines traditional summer camp activities, such as swimming and arts and crafts, with academic and computer activities, in an effort to improve social skills and raise self-esteem of children ages 7 to 11.
"Often, we find that our campers felt out of place at other camps where there was not a real understanding of their needs," says Karen Fleiss, Psy.D., clinical director of the NYU Child Study Center Long Island Campus and the Summer Program for Kids. "Many of the children have a very low self-esteem, so we put a lot of attention on positive reinforcement and instilling a much-needed sense of confidence."
The staff to child ratio is 1 to 1.5, allowing the children to get the individualized attention they need. The SPK counselors are advanced psychology undergraduate majors or graduate students who undergo a month-long intensive training to gain an understanding of children with special needs and to learn behavioral strategies. The counselors help kids improve social behavior; friendship skills; academic competence; problem-solving skills; self-esteem; classroom behavior; sports competence; anger control; and rule following, among others.
The SPK format is based on the Summer Treatment Program, which was a behavior therapy component of the Multimodal Treatment Study of ADHD (MTA), the largest clinical trial of children with ADHD funded by the National Institute of Mental Health. The MTA study consisted of 579 children who were treated at six university medical centers across the United States and one in Canada. Each child was randomly assigned to one of four treatment conditions for 14 months - medication, usually Ritalin; behavior therapy; a combination of both behavior therapy and medication; or regular community care, which included in most cases Ritalin prescribed by community doctors instead of MTA staff.
"From this initial trial, we found that the two MTA treatment conditions that involved medication management were equivalent, and superior to the other treatments in reducing the symptoms of ADHD; that lower doses of medication were needed to obtain symptom reductions in the combined treatment condition; and that the effects of behavior therapy were roughly equivalent to medication treatment provided in the community," according to Howard Abikoff, Ph.D., a principal investigator of the MTA and director of the Institute for Attention Deficit/Hyperactivity and Behavior Disorders at the NYU Child Study Center. "We continued to monitor - although not treat - these children after the original study and found that at one-year follow-up the medication management and combined medication and behavior therapy treatment options maintained their superiority in reducing symptoms, indicating that initial treatment effects do continue."
Parents of the campers are encouraged to take part in weekly training sessions offered throughout the summer. These sessions tie together what kids are learning in the program to what is happening at home. Parents are able to share their experiences with each other and learn effective behavior management techniques that help encourage their children to follow the rules and promote independence and positive self-esteem.
Parents of children who participate in the camp report that the progress their kids make during the summer carries through to the school year. The full-day camp runs for eight weeks, beginning June 26 and ending August 18. The camp is located in Throggs Neck on the campus of SUNY Maritime.
ADHD is a group of related childhood problems that cause difficulties with behavior, academic performance, and peer relationships in about five percent of school-aged children. In the United States alone, it affects between one and two million children.
Watch "A Summer in Paradise" - a online video on the NYU Child Study Center's Summer Program for Kids - at http://mc-rms01.med.nyu/ramgen/realmedia/summer_paradise.rm. Learn more about SPK, ADHD, and the NYU Child Study Center at aboutourkids/.
NYU Child Study Center
The NYU Child Study Center is dedicated to the understanding, prevention and treatment of child and adolescent mental health problems. The Center offers expert psychiatric services for children and families with emphasis on early diagnosis and intervention. The Center's mission is to bridge the gap between science and practice, integrating the finest research with patient care and state-of-the-art training, utilizing the resources of the New York University School of Medicine. The NYU Child Study Center offers a variety of mental health services for children, adolescents, young adults and their families. Child and Family Associates is the clinical arm of the NYU Child Study Center and the point of entry for all clinical programs. Its goal is to bring together the most research-supported evaluations and treatments with an individualized and family-centered approach.
Contact: Kari Root
New York University Child Study Center
View drug information on Ritalin LA.
"Often, we find that our campers felt out of place at other camps where there was not a real understanding of their needs," says Karen Fleiss, Psy.D., clinical director of the NYU Child Study Center Long Island Campus and the Summer Program for Kids. "Many of the children have a very low self-esteem, so we put a lot of attention on positive reinforcement and instilling a much-needed sense of confidence."
The staff to child ratio is 1 to 1.5, allowing the children to get the individualized attention they need. The SPK counselors are advanced psychology undergraduate majors or graduate students who undergo a month-long intensive training to gain an understanding of children with special needs and to learn behavioral strategies. The counselors help kids improve social behavior; friendship skills; academic competence; problem-solving skills; self-esteem; classroom behavior; sports competence; anger control; and rule following, among others.
The SPK format is based on the Summer Treatment Program, which was a behavior therapy component of the Multimodal Treatment Study of ADHD (MTA), the largest clinical trial of children with ADHD funded by the National Institute of Mental Health. The MTA study consisted of 579 children who were treated at six university medical centers across the United States and one in Canada. Each child was randomly assigned to one of four treatment conditions for 14 months - medication, usually Ritalin; behavior therapy; a combination of both behavior therapy and medication; or regular community care, which included in most cases Ritalin prescribed by community doctors instead of MTA staff.
"From this initial trial, we found that the two MTA treatment conditions that involved medication management were equivalent, and superior to the other treatments in reducing the symptoms of ADHD; that lower doses of medication were needed to obtain symptom reductions in the combined treatment condition; and that the effects of behavior therapy were roughly equivalent to medication treatment provided in the community," according to Howard Abikoff, Ph.D., a principal investigator of the MTA and director of the Institute for Attention Deficit/Hyperactivity and Behavior Disorders at the NYU Child Study Center. "We continued to monitor - although not treat - these children after the original study and found that at one-year follow-up the medication management and combined medication and behavior therapy treatment options maintained their superiority in reducing symptoms, indicating that initial treatment effects do continue."
Parents of the campers are encouraged to take part in weekly training sessions offered throughout the summer. These sessions tie together what kids are learning in the program to what is happening at home. Parents are able to share their experiences with each other and learn effective behavior management techniques that help encourage their children to follow the rules and promote independence and positive self-esteem.
Parents of children who participate in the camp report that the progress their kids make during the summer carries through to the school year. The full-day camp runs for eight weeks, beginning June 26 and ending August 18. The camp is located in Throggs Neck on the campus of SUNY Maritime.
ADHD is a group of related childhood problems that cause difficulties with behavior, academic performance, and peer relationships in about five percent of school-aged children. In the United States alone, it affects between one and two million children.
Watch "A Summer in Paradise" - a online video on the NYU Child Study Center's Summer Program for Kids - at http://mc-rms01.med.nyu/ramgen/realmedia/summer_paradise.rm. Learn more about SPK, ADHD, and the NYU Child Study Center at aboutourkids/.
NYU Child Study Center
The NYU Child Study Center is dedicated to the understanding, prevention and treatment of child and adolescent mental health problems. The Center offers expert psychiatric services for children and families with emphasis on early diagnosis and intervention. The Center's mission is to bridge the gap between science and practice, integrating the finest research with patient care and state-of-the-art training, utilizing the resources of the New York University School of Medicine. The NYU Child Study Center offers a variety of mental health services for children, adolescents, young adults and their families. Child and Family Associates is the clinical arm of the NYU Child Study Center and the point of entry for all clinical programs. Its goal is to bring together the most research-supported evaluations and treatments with an individualized and family-centered approach.
Contact: Kari Root
New York University Child Study Center
View drug information on Ritalin LA.
воскресенье, 5 июня 2011 г.
Inconsistent Performance Speed Among Children With ADHD May Underlie How Well They Use Memory
Children with attention-deficit hyperactivity disorder (ADHD) show more variable or inconsistent responses during on 'working' or short-term, memory tasks when compared with typically developing peers, a study by UC Davis M.I.N.D. Institute Julie Schweitzer has found.
"We think poor working memory is a characteristic present in many children and adults with ADHD," said Schweitzer, an associate professor in the Department of Psychiatry and Behavioral Sciences.
"Our study helps explain why working memory may be fine at one moment and poor at another, just as one day a child with ADHD seems to be able to learn and focus in class and on another day seems distracted and not paying attention," Schweitzer said.
According to the national Centers for Disease Control and Prevention (CDC), an estimated 4.4 million youth, ages 4 to17, have been diagnosed with ADHD by a healthcare professional. In 2003 nearly 8 percent of school-aged children were reported to have an ADHD diagnosis by their parent. The current study, published online in February in the journal Child Neuropsychology, supports the idea that what underlies impaired working memory is a problem in how consistently a child with ADHD can respond during a working memory task.
"We have known for some time that children with ADHD vary in how fast they are able to complete working memory tasks when compared to normally developing control subjects," Schweitzer explained .
Previous studies have suggested that children with ADHD might be slower at responding to tasks. The current study took a closer look at their performance using a relatively newer statistical analytical approach, to determine whether the children with ADHD were indeed faster, slower, or if perhaps another, more complicated process was occurring. The hypothesis was that children with ADHD were actually mostly responding at the same rate as healthy children, but with more frequent very slow responses than the control subjects.
To test this hypothesis, the study authors presented 25 children with ADHD and 24 typically developing peers with the Visual Serial Addition Task, a computerized program that presents children with a number on one screen and then asks them to mentally add it to another number shown on a second screen. The children are then asked to decide whether or not a given sum is correct. From session to session, the task is presented at different speeds and at different levels of difficulty.
"We found that the children with ADHD were much less consistent in their response times," said Wendy Buzy, study lead author and a graduate student when the experiments were conducted.
Schweitzer and Buzy were both at the University of Maryland at the time. Buzy said that the children with ADHD had more frequent longer response times when compared with their typically developing peers, but the responses they did give were just as accurate.
"Once we controlled for omission errors, the accuracy of the two groups was the same," she said.
Buzy and Schweitzer pointed out that one of the unique things about their study was the way in which their data were analyzed. Previous studies compared only the range of reaction times and average reaction times for children with ADHD and controls. The method used in the current study allowed researchers to compare variation in response times within and between individuals, as well as within and between the two groups. The researchers also showed that working memory variability correlated with ADHD symptoms as scored by parent surveys (using the Conners' ADHD rating scale) prior to testing.
"We found that higher levels of hyperactivity and restlessness or impulsivity correlated with slower reaction times," Schweitzer said.
The current results led another Schweitzer laboratory member, postdoctoral fellow Catherine Fassbender, to design a study looking at variability in response time during a working memory task in the brains of children with ADHD using functional magnetic resonance imaging (fMRI).
"This study increases our understanding of what might be happening at a physiological level that underlies the inconsistency in responding in ADHD," she said.
Schweitzer also hopes to look at whether behavioral interventions and/or medications can help reduce the kind of variability observed in the current study. Variability in working memory, she said, means children cannot generalize what they learn in one situation to another.
"Improving consistency in how children with ADHD respond to the environment should help them generalize what they learn in clinical interventions improving their skills across situations."
The study was supported by grants from the National Institutes of Health and the University of Maryland. Deborah Medoff, Ph.D. from the University of Maryland, Baltimore also contributed to this study.
UC Davis Children's Hospital is the Sacramento region's only comprehensive hospital for children. From primary care offices to specialty and intensive care clinics, pediatric experts provide compassionate care to more than 100,000 children each year and conduct research on causes and improved treatments for conditions such as autism, asthma, obesity, cancer and birth defects. For more information, visit the UC Davis Children's Hospital Web site.The UC Davis M.I.N.D. Institute, in Sacramento, Calif., was founded in 1998 as a unique interdisciplinary research center where parents, community leaders, researchers, clinicians and volunteers collaborate to study and treat autism and other neurodevelopmental disorders.
Source
UC Davis Children's Hospital
"We think poor working memory is a characteristic present in many children and adults with ADHD," said Schweitzer, an associate professor in the Department of Psychiatry and Behavioral Sciences.
"Our study helps explain why working memory may be fine at one moment and poor at another, just as one day a child with ADHD seems to be able to learn and focus in class and on another day seems distracted and not paying attention," Schweitzer said.
According to the national Centers for Disease Control and Prevention (CDC), an estimated 4.4 million youth, ages 4 to17, have been diagnosed with ADHD by a healthcare professional. In 2003 nearly 8 percent of school-aged children were reported to have an ADHD diagnosis by their parent. The current study, published online in February in the journal Child Neuropsychology, supports the idea that what underlies impaired working memory is a problem in how consistently a child with ADHD can respond during a working memory task.
"We have known for some time that children with ADHD vary in how fast they are able to complete working memory tasks when compared to normally developing control subjects," Schweitzer explained .
Previous studies have suggested that children with ADHD might be slower at responding to tasks. The current study took a closer look at their performance using a relatively newer statistical analytical approach, to determine whether the children with ADHD were indeed faster, slower, or if perhaps another, more complicated process was occurring. The hypothesis was that children with ADHD were actually mostly responding at the same rate as healthy children, but with more frequent very slow responses than the control subjects.
To test this hypothesis, the study authors presented 25 children with ADHD and 24 typically developing peers with the Visual Serial Addition Task, a computerized program that presents children with a number on one screen and then asks them to mentally add it to another number shown on a second screen. The children are then asked to decide whether or not a given sum is correct. From session to session, the task is presented at different speeds and at different levels of difficulty.
"We found that the children with ADHD were much less consistent in their response times," said Wendy Buzy, study lead author and a graduate student when the experiments were conducted.
Schweitzer and Buzy were both at the University of Maryland at the time. Buzy said that the children with ADHD had more frequent longer response times when compared with their typically developing peers, but the responses they did give were just as accurate.
"Once we controlled for omission errors, the accuracy of the two groups was the same," she said.
Buzy and Schweitzer pointed out that one of the unique things about their study was the way in which their data were analyzed. Previous studies compared only the range of reaction times and average reaction times for children with ADHD and controls. The method used in the current study allowed researchers to compare variation in response times within and between individuals, as well as within and between the two groups. The researchers also showed that working memory variability correlated with ADHD symptoms as scored by parent surveys (using the Conners' ADHD rating scale) prior to testing.
"We found that higher levels of hyperactivity and restlessness or impulsivity correlated with slower reaction times," Schweitzer said.
The current results led another Schweitzer laboratory member, postdoctoral fellow Catherine Fassbender, to design a study looking at variability in response time during a working memory task in the brains of children with ADHD using functional magnetic resonance imaging (fMRI).
"This study increases our understanding of what might be happening at a physiological level that underlies the inconsistency in responding in ADHD," she said.
Schweitzer also hopes to look at whether behavioral interventions and/or medications can help reduce the kind of variability observed in the current study. Variability in working memory, she said, means children cannot generalize what they learn in one situation to another.
"Improving consistency in how children with ADHD respond to the environment should help them generalize what they learn in clinical interventions improving their skills across situations."
The study was supported by grants from the National Institutes of Health and the University of Maryland. Deborah Medoff, Ph.D. from the University of Maryland, Baltimore also contributed to this study.
UC Davis Children's Hospital is the Sacramento region's only comprehensive hospital for children. From primary care offices to specialty and intensive care clinics, pediatric experts provide compassionate care to more than 100,000 children each year and conduct research on causes and improved treatments for conditions such as autism, asthma, obesity, cancer and birth defects. For more information, visit the UC Davis Children's Hospital Web site.The UC Davis M.I.N.D. Institute, in Sacramento, Calif., was founded in 1998 as a unique interdisciplinary research center where parents, community leaders, researchers, clinicians and volunteers collaborate to study and treat autism and other neurodevelopmental disorders.
Source
UC Davis Children's Hospital
суббота, 4 июня 2011 г.
Curemark To Present At BioPharm America™ 2010
Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, will present at BioPharm America™ 2010, to be held September 15-17 in Boston at the Marriott Boston Copley Place, the company announced.
Dr. Joan Fallon, Curemark's founder and CEO, will provide an overview of the company's enzyme replacement therapy targeted to autism. Curemark is now in Phase III clinical trials for CM-AT, its autism treatment. She will also discuss the Investigational New Drug (IND) authorization Curemark recently received from the U.S. Food and Drug Administration (FDA) for the use of the company's compound CM-4612 to treat attention deficit hyperactivity disorder (ADHD). The FDA has given clearance to Curemark's Investigational New Drug (IND) application for a Phase III clinical trial to study the use of CM-4612 in the treatment of ADHD.
"We are very pleased to be able to give a presentation at this year's BioPharm America," Fallon said. "We welcome the opportunity to discuss our momentum with therapies that address neurological conditions for which there are currently no viable, physiologically-based treatments."
CM-AT, Curemark's autism treatment, targets enzyme deficiencies in autistic children that affect the availability of amino acids, the building blocks of chemicals essential for brain function. The company is currently conducting Phase III CM-AT trials at 13 sites nationwide with a planned total of 170 children. If approved, CM-AT, which has been granted Fast Track status from the FDA, will be one of the first therapies to address the underlying physiology of autism.
Organized by EBD Group, a leading partnering firm for the global life sciences industry, BioPharm America is intended as a forum where biotech and pharma executives from around the world can meet, and identify and enter strategic relationships. BioPharm America 2010 is the third annual international partnering conference.
Safe Harbor Statement
This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of CM-AT, its potential advantages, its potential for use in treating autism, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning CM-AT. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of CM-AT, our ability to finance our development of CM-AT, regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.
Source: Curemark, LLC
Dr. Joan Fallon, Curemark's founder and CEO, will provide an overview of the company's enzyme replacement therapy targeted to autism. Curemark is now in Phase III clinical trials for CM-AT, its autism treatment. She will also discuss the Investigational New Drug (IND) authorization Curemark recently received from the U.S. Food and Drug Administration (FDA) for the use of the company's compound CM-4612 to treat attention deficit hyperactivity disorder (ADHD). The FDA has given clearance to Curemark's Investigational New Drug (IND) application for a Phase III clinical trial to study the use of CM-4612 in the treatment of ADHD.
"We are very pleased to be able to give a presentation at this year's BioPharm America," Fallon said. "We welcome the opportunity to discuss our momentum with therapies that address neurological conditions for which there are currently no viable, physiologically-based treatments."
CM-AT, Curemark's autism treatment, targets enzyme deficiencies in autistic children that affect the availability of amino acids, the building blocks of chemicals essential for brain function. The company is currently conducting Phase III CM-AT trials at 13 sites nationwide with a planned total of 170 children. If approved, CM-AT, which has been granted Fast Track status from the FDA, will be one of the first therapies to address the underlying physiology of autism.
Organized by EBD Group, a leading partnering firm for the global life sciences industry, BioPharm America is intended as a forum where biotech and pharma executives from around the world can meet, and identify and enter strategic relationships. BioPharm America 2010 is the third annual international partnering conference.
Safe Harbor Statement
This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of CM-AT, its potential advantages, its potential for use in treating autism, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning CM-AT. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of CM-AT, our ability to finance our development of CM-AT, regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.
Source: Curemark, LLC
пятница, 3 июня 2011 г.
Antipsychotic Prescribing For Children Has Risen Sharply
A research team set out to investigate the epidemiologic features of antibiotic prescribing to patients under the age of 18 by GPs (general practitioners, primary care doctors) in Great Britain. They gathered data from the UK General Practice Research Database, involving 384 participating general practices, to identify how many child/adolescent patients were prescribed at least one antipsychotic drug between the beginning of 1992 to the end of 2005. They calculated age-specific prevalences and incidences of antipsychotic prescribing.
You can read about this in the journal Pediatrics.
The researchers found that:
-- In 1992 there were 0.39 users per 1,000 patient-years
-- In 2005 there were 0.77 users per 1,000 patient-years
-- Prescribing prevalence for 7-12 year-old patients nearly tripped between start 1992 to end 2005, from 0.23 users per 1,000 patient-years to 0.61 users per 1,000 patient-years.
-- Atypical antipsychotic prescribing rose 60-fold during the same period, from 0.01 users per 1,000 patient-years to 0.61 users per 1,000 patient-years.
-- Typical antipsychotic prescribing fell from 0.44 users per 1,000 patient-years in year 2,000 to 0.18 users per 1,000 patient-years in 2005.
Although incidences for typical and atypical antipsychotics showed trends similar to those of the respective prevalences "the overall incidence (number of new starters) for all antipsychotics was relatively stable between 1992 and 2005, which suggests that patients remain on treatment longer. " the researchers wrote.
The researchers concluded that the overall prevalence of antipsychotics nearly doubled during 1992-2005. The increase in the USA during the same period was much greater. Despite lack of conclusive evidence that atypical antipsychotic drugs are superior to older conventional antipsychotics the prescribing of them has increased. The scientists say more research is needed to find out how efficacious and safe these drugs are for children and adolescents.
According to some US newspapers today (Associated Press) children in the United States are prescribed antipsychotic drugs at approximately six times the rate of UK children. Many report that both US and UK kids are probably being over-prescribed.
Most commonly used medications are for treating ADHD (attention deficit hyperactive disorder) and Autism.
Possible reasons for higher US rates, compared to the UK:
1. Prescription drug advertising to non-health care professionals is not allowed in the UK, while it is in the USA. Perhaps US consumers are more aware of available prescription drugs and influence their doctors' prescribing behavior.
2. The UK has a universal health care system which encourages doctors to keep prescription rates low.
3. UK doctors tend to be more conservative than their American counterparts about prescribing psychiatric drugs (quote from Associated Press, Wayne Ray, Vanderbilt University researcher).
"Epidemiologic Features of Antipsychotic Prescribing to Children and Adolescents in Primary Care in the United Kingdom.
Fariz Rani, BPharm, Macey L. Murray, BSc, Patrick J. Byrne, FRCPsych and Ian C. K. Wong, PhD
PEDIATRICS Vol. 121 No. 5 May 2008, pp. 1002-1009 (doi:10.1542/peds.2007-2008)
Click here to view Abstract online
Sources - Pediatrics, AP, BBC and American Academy of Pediatrics.
Written by - Christian Nordqvist
You can read about this in the journal Pediatrics.
The researchers found that:
-- In 1992 there were 0.39 users per 1,000 patient-years
-- In 2005 there were 0.77 users per 1,000 patient-years
-- Prescribing prevalence for 7-12 year-old patients nearly tripped between start 1992 to end 2005, from 0.23 users per 1,000 patient-years to 0.61 users per 1,000 patient-years.
-- Atypical antipsychotic prescribing rose 60-fold during the same period, from 0.01 users per 1,000 patient-years to 0.61 users per 1,000 patient-years.
-- Typical antipsychotic prescribing fell from 0.44 users per 1,000 patient-years in year 2,000 to 0.18 users per 1,000 patient-years in 2005.
Although incidences for typical and atypical antipsychotics showed trends similar to those of the respective prevalences "the overall incidence (number of new starters) for all antipsychotics was relatively stable between 1992 and 2005, which suggests that patients remain on treatment longer. " the researchers wrote.
The researchers concluded that the overall prevalence of antipsychotics nearly doubled during 1992-2005. The increase in the USA during the same period was much greater. Despite lack of conclusive evidence that atypical antipsychotic drugs are superior to older conventional antipsychotics the prescribing of them has increased. The scientists say more research is needed to find out how efficacious and safe these drugs are for children and adolescents.
According to some US newspapers today (Associated Press) children in the United States are prescribed antipsychotic drugs at approximately six times the rate of UK children. Many report that both US and UK kids are probably being over-prescribed.
Most commonly used medications are for treating ADHD (attention deficit hyperactive disorder) and Autism.
Possible reasons for higher US rates, compared to the UK:
1. Prescription drug advertising to non-health care professionals is not allowed in the UK, while it is in the USA. Perhaps US consumers are more aware of available prescription drugs and influence their doctors' prescribing behavior.
2. The UK has a universal health care system which encourages doctors to keep prescription rates low.
3. UK doctors tend to be more conservative than their American counterparts about prescribing psychiatric drugs (quote from Associated Press, Wayne Ray, Vanderbilt University researcher).
"Epidemiologic Features of Antipsychotic Prescribing to Children and Adolescents in Primary Care in the United Kingdom.
Fariz Rani, BPharm, Macey L. Murray, BSc, Patrick J. Byrne, FRCPsych and Ian C. K. Wong, PhD
PEDIATRICS Vol. 121 No. 5 May 2008, pp. 1002-1009 (doi:10.1542/peds.2007-2008)
Click here to view Abstract online
Sources - Pediatrics, AP, BBC and American Academy of Pediatrics.
Written by - Christian Nordqvist
четверг, 2 июня 2011 г.
Children With Attention Deficit Hyperactivity Disorder At Risk For Alcohol Problems
Parental alcoholism and family stress can also facilitate the development of alcohol problems
* Prior research has shown that children with ADHD can develop alcohol problems later in life.
* Two studies confirm this association, indicating that drinking problems begin around age 15.
* Parental alcoholism and family stress appear to add to the risk of children with ADHD developing alcohol problems themselves.
Researchers believe that children with attention deficit hyperactivity disorder (ADHD) are at risk for alcohol- as well as other substance-related problems as they grow older. Yet the research is not always consistent. Two new studies help to confirm that ADHD is a risk factor for alcohol problems; adding that parental alcoholism and stressful experiences in the family play an important role in this risk.
Results are published in the April issue of Alcoholism: Clinical & Experimental Research.
"Children with ADHD are believed to be at risk for alcoholism because of their impulsivity and distractibility, as well as other problems that often accompany ADHD such as school failure and behavior problems," explained Brooke Molina, associate professor of psychiatry and psychology at the University of Pittsburgh, and corresponding author for both studies.
In the first study, on "Age specificity," Molina and her colleagues interviewed participants in the larger Pittsburgh ADHD Longitudinal Study. Children diagnosed with ADHD (n=364) were interviewed either as adolescents (11 to 17 years of age) or as young adults (18 to 28 years of age). Demographically and age-matched individuals without ADHD were also recruited as adolescents (n=120) or as adults (n=120) to serve as a comparison. Alcohol use was determined through questionnaires and interviews.
"We found that the children with ADHD were more likely than the comparison group to drink heavily and to have enough problems related to their drinking that they were diagnosed with alcohol abuse or dependence," said Molina. "This means that their drinking caused problems such as fights with their parents or friends, a drop in their grades at school, or difficulty with controlling the amount of alcohol that they drank."
Drinking problems began around age 15, said Molina. "The 15-to-17-year olds with childhood ADHD reported being drunk an average of 14 times in the previous year, versus only 1.8 times for 15-to-17-year olds in the study who did not have childhood ADHD. Whereas 14 percent of the 15-to-17-year olds with childhood ADHD were diagnosed with alcohol abuse or dependence, none of the 15-to-17-year olds without childhood ADHD were."
"It appears that one of the reasons for the past inconsistencies in research is that the ADHD-alcohol relationship does not become solid until at least mid-adolescence," observed Stephen Hinshaw, professor and chair of the department of psychology at UC Berkeley. "Later on, it may be that only a subset of kids with ADHD - namely, those with more aggressive or antisocial behavior patterns - are at risk by young adulthood."
Molina says her findings support this theory. "For example, 42 percent of those children with ADHD who also had serious, persistent behavior problems [later] had alcohol abuse or dependence by the age of 18 to 25." Molina also says, however, that researchers know little about the risk for alcoholism for children with ADHD beyond this age range. "Most young adults drink less after they settle into jobs and family life," she said. "We will be following the young adults in the Pittsburgh study to see if this happens or not."
In the second study, on "Life stress," Molina and her colleagues interviewed 142 adolescents (133 males, 9 females) who had been diagnosed with childhood ADHD, as well as 100 demographically matched adolescents without childhood ADHD. All participants were asked about their drinking behavior and negative life events; in addition, parents reported their drinking histories.
"One of the reasons that children with ADHD might be at risk for alcohol problems is that alcoholism and ADHD tend to run together in families," said Molina. "We found that parental alcoholism predicted heavy problem drinking among the teenagers, that the association was partly explained by higher rates of stress in these families, and these connections were stronger when the adolescent had ADHD in childhood. So, the bottom line is that when the child has ADHD and the parent has suffered from alcoholism, either currently or in the past, the child will have an increased risk for alcohol problems himself or herself."
"In other words," added Hinshaw, "when a youngster has ADHD, he or she is more likely to either provoke higher rates of drinking in parents, exacerbating overall stress levels; or be more confused and upset by parental drinking, then reverting to this pattern himself or herself."
However, noted Molina, "we need to put these findings in perspective; it is important to recognize that not all children with ADHD will have problems with alcohol."
Alcoholism: Clinical & Experimental Research (ACER) is the official journal of the Research Society on Alcoholism and the International Society for Biomedical Research on Alcoholism. Co-authors of the ACER paper called "ADHD Risk for Heavy Drinking and Alcohol Use Disorder is Age-Specific" were: William E. Pelham, Jr. and Elizabeth M. Gnagy of the Departments of Psychology & Pediatrics at the State University of New York at Buffalo; Amanda L. Thompson of the Department of Psychology at the University of Pittsburgh; and Michael P. Marshal of the Department of Psychiatry at the University of Pittsburgh School of Medicine. Co-authors of the ACER paper called "ADHD Moderates the Life Stress Pathway to Alcohol Problems in Children of Alcoholics" were: Michael P. Marshal of the Department of Psychiatry at the University of Pittsburgh; William.E. Pelham, Jr. of the Departments of Psychology & Pediatrics at the State University of New York at Buffalo; and JeeWon Cheong of the Department of Psychology at the University of Pittsburgh. The studies were funded by the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, the National Institute on Mental Health, and the National Institute of Environmental Health Sciences.
Contact: Jocelyn Uhl Duffy
University of Pittsburgh
Stephen Hinshaw, Ph.D.
University of California Berkeley
Alcoholism: Clinical & Experimental Research
* Prior research has shown that children with ADHD can develop alcohol problems later in life.
* Two studies confirm this association, indicating that drinking problems begin around age 15.
* Parental alcoholism and family stress appear to add to the risk of children with ADHD developing alcohol problems themselves.
Researchers believe that children with attention deficit hyperactivity disorder (ADHD) are at risk for alcohol- as well as other substance-related problems as they grow older. Yet the research is not always consistent. Two new studies help to confirm that ADHD is a risk factor for alcohol problems; adding that parental alcoholism and stressful experiences in the family play an important role in this risk.
Results are published in the April issue of Alcoholism: Clinical & Experimental Research.
"Children with ADHD are believed to be at risk for alcoholism because of their impulsivity and distractibility, as well as other problems that often accompany ADHD such as school failure and behavior problems," explained Brooke Molina, associate professor of psychiatry and psychology at the University of Pittsburgh, and corresponding author for both studies.
In the first study, on "Age specificity," Molina and her colleagues interviewed participants in the larger Pittsburgh ADHD Longitudinal Study. Children diagnosed with ADHD (n=364) were interviewed either as adolescents (11 to 17 years of age) or as young adults (18 to 28 years of age). Demographically and age-matched individuals without ADHD were also recruited as adolescents (n=120) or as adults (n=120) to serve as a comparison. Alcohol use was determined through questionnaires and interviews.
"We found that the children with ADHD were more likely than the comparison group to drink heavily and to have enough problems related to their drinking that they were diagnosed with alcohol abuse or dependence," said Molina. "This means that their drinking caused problems such as fights with their parents or friends, a drop in their grades at school, or difficulty with controlling the amount of alcohol that they drank."
Drinking problems began around age 15, said Molina. "The 15-to-17-year olds with childhood ADHD reported being drunk an average of 14 times in the previous year, versus only 1.8 times for 15-to-17-year olds in the study who did not have childhood ADHD. Whereas 14 percent of the 15-to-17-year olds with childhood ADHD were diagnosed with alcohol abuse or dependence, none of the 15-to-17-year olds without childhood ADHD were."
"It appears that one of the reasons for the past inconsistencies in research is that the ADHD-alcohol relationship does not become solid until at least mid-adolescence," observed Stephen Hinshaw, professor and chair of the department of psychology at UC Berkeley. "Later on, it may be that only a subset of kids with ADHD - namely, those with more aggressive or antisocial behavior patterns - are at risk by young adulthood."
Molina says her findings support this theory. "For example, 42 percent of those children with ADHD who also had serious, persistent behavior problems [later] had alcohol abuse or dependence by the age of 18 to 25." Molina also says, however, that researchers know little about the risk for alcoholism for children with ADHD beyond this age range. "Most young adults drink less after they settle into jobs and family life," she said. "We will be following the young adults in the Pittsburgh study to see if this happens or not."
In the second study, on "Life stress," Molina and her colleagues interviewed 142 adolescents (133 males, 9 females) who had been diagnosed with childhood ADHD, as well as 100 demographically matched adolescents without childhood ADHD. All participants were asked about their drinking behavior and negative life events; in addition, parents reported their drinking histories.
"One of the reasons that children with ADHD might be at risk for alcohol problems is that alcoholism and ADHD tend to run together in families," said Molina. "We found that parental alcoholism predicted heavy problem drinking among the teenagers, that the association was partly explained by higher rates of stress in these families, and these connections were stronger when the adolescent had ADHD in childhood. So, the bottom line is that when the child has ADHD and the parent has suffered from alcoholism, either currently or in the past, the child will have an increased risk for alcohol problems himself or herself."
"In other words," added Hinshaw, "when a youngster has ADHD, he or she is more likely to either provoke higher rates of drinking in parents, exacerbating overall stress levels; or be more confused and upset by parental drinking, then reverting to this pattern himself or herself."
However, noted Molina, "we need to put these findings in perspective; it is important to recognize that not all children with ADHD will have problems with alcohol."
Alcoholism: Clinical & Experimental Research (ACER) is the official journal of the Research Society on Alcoholism and the International Society for Biomedical Research on Alcoholism. Co-authors of the ACER paper called "ADHD Risk for Heavy Drinking and Alcohol Use Disorder is Age-Specific" were: William E. Pelham, Jr. and Elizabeth M. Gnagy of the Departments of Psychology & Pediatrics at the State University of New York at Buffalo; Amanda L. Thompson of the Department of Psychology at the University of Pittsburgh; and Michael P. Marshal of the Department of Psychiatry at the University of Pittsburgh School of Medicine. Co-authors of the ACER paper called "ADHD Moderates the Life Stress Pathway to Alcohol Problems in Children of Alcoholics" were: Michael P. Marshal of the Department of Psychiatry at the University of Pittsburgh; William.E. Pelham, Jr. of the Departments of Psychology & Pediatrics at the State University of New York at Buffalo; and JeeWon Cheong of the Department of Psychology at the University of Pittsburgh. The studies were funded by the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, the National Institute on Mental Health, and the National Institute of Environmental Health Sciences.
Contact: Jocelyn Uhl Duffy
University of Pittsburgh
Stephen Hinshaw, Ph.D.
University of California Berkeley
Alcoholism: Clinical & Experimental Research
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