New NICE (National Institute for Clinical Excellence) Work UK

New treatments for prostate cancer, drugs misuse, osteoporosis and heart failure are being referred to the National Institute for Clinical Excellence (NICE), Lord Warner announced today.


NICE is also being asked to develop clinical guidance on the care and management of osteoarthritis and Attention Deficit Hyperactivity Disorder in children and young adults.


Lord Warner said:


"This is an extremely important programme of work that we are sending to NICE and it includes clinical areas that we have not asked the Institute to consider before, specifically the two technology appraisals and clinical guideline on the treatment of drug misuse. This is a matter of growing clinical concern in the UK and it is only right that we ask NICE to provide guidance in this area, as this will have benefits, not just to the NHS, but to the wider society as a whole.


"The rest of the 10th wave focuses on other key issues, treatments for cancer and heart failure for example, which will assist the NHS in continuing to provide clinical and cost effective care to its patients, irrespective of where they live."


The NHS is now required to make drugs available throughout England where NICE advises that they are clinically and cost effective.


Notes to editor


1. Drawing on top experts in each field and consulting widely with patient groups, NICE has produced guidance on 124 pharmaceuticals, 20 procedures, 17 diagnostics, 1 Health Promotion and 106 devices. The majority of NICE appraisals have suggested partial or full use of technologies.


2. For further information, please contact NICE press office: 0207 067 5900


3.NICE also develops clinical guidelines, broader guidance on best care for all aspects of the treatment of specific conditions. Over the next few years NICE will be developing guidelines covering many of the conditions responsible for the greatest burden of ill-health, disability and premature death in the UK. To date NICE has issued 13 guidelines on clinical areas such schizophrenia, chronic heart failure, eating disorders, multiple sclerosis and fertility.


Technology Appraisals


Atrasentan for hormone refractory prostate cancer


Prostate cancer is the most common male cancer, with about 18,000 new cases and 9,300 deaths each year (England & Wales). Advanced (metastatic) disease usually responds at least initially to hormone treatment, but the prognosis for hormone refractory disease is poor. Atrasenten (ABT-627, Abbott) is an oral drug in a new pharmaceutical class (endothelin A receptor antagonists) which inhibits the process leading to the production of cancerous cells in prostate and other cancers.















Cetuximab for head and neck cancer


There are 4,000 new case of head and neck cancer per year. This group of tumours includes cancer of the mouth, tongue, salivary glands, sinuses and pharynx. The 1-year survival rate for head and neck cancer is an estimated 70%, with 5-year survival between 44-52%. Cetuximab is a new treatment in the same drug class as Iressa (lung cancer, proposed for 8th wave).


Pemetrexed disodium in the treatment of mesotheliomia


There were about 1,600 cases of mesothelioma in England and Wales in 1999, and approximately 1,600 deaths in 2001. The incidence is currently rising and will continue to do so over the next few years, expecting to peak around 2010 with around 3000 new cases per year. Pemetrexed disodium is a multi-targeted antifolate (MTA) in clinical trials for a variety of cancers.


Oxaliplatin, irinotecan and capecitabine as adjuvant therapy in colorectal cancer:


Colorectal cancer is a common disease with about 31,000 new cases reported in England and Wales in 1999, and just over 14,000 deaths in 2001. At least 8,060 patients with Dukes' stage C cancer may be eligible to benefit from adjuvant therapy for early stage disease. Oxaliplatin, irinotecan and capecitabine are already licensed for use in advanced and metastatic colorectal cancer and have all been reviewed by NICE for that indication. They are now in clinical trials for use as adjuvant therapy in early colorectal cancer.


Docetaxel for hormone-refractory prostate cancer


There were over 22,400 cases of prostate cancer registered in 1999 and 8,900 deaths due to prostate cancer in England and Wales during 2001. Men with hormone-refractory prostate cancer (HRPC) currently have a poor prognosis and require palliative care and periodic hospitalisation for pain management. Docetaxel (Taxotere) is an anti-neoplastic agent already licensed for breast cancer and non-small cell lung cancer in the UK and is in ongoing trials for head and neck, gastric and ovarian cancer.


Carmustine implants (Gliadel Wafers) for newly diagnosed high grade glioma


Primary malignant brain tumours make up about 1.5% of all cancers in adults in England and Wales, but over 7% of years of life lost from cancer before the age of 70.


There are many different types of brain cancer presumed to arise from different cell types. Gliomas make up the majority of primary brain tumours (50-60%). Carmustine implants (Gliadel Wafers) are biodegradable polyanhydride polymer (polfeprosan 20) implants that deliver carmustine directly into the excision cavity of a surgically removed tumour.


Biventricular pacing (cardiac resynchronisation) for heart failure


Heart failure - failure of the heart to pump an adequate flow of blood - is a major cause of CHD morbidity and mortality, with 106,000 hospital admissions in England in 2000-01. Biventricular (BiV) pacing, or cardiac resynchronisation, aims to restore synchronous cardiac contraction. Biventricular pacing entails pacing the right atrium and right ventricle (as in conventional dual chamber permanent pacing) and additionally the left ventricle. Combined biventricular pacemakers and implantable cardiac defibrillator (ICD) devices may be used in patients who have ventricular dyssynchrony and who are also at risk of ventricular arrhythmia's that could lead to sudden cardiac arrest.


Methadone & Bupenorphine as opiate substitutes


It is estimated that there are between 230,00 and 280,000 problem drug users and approximately 145,000 in treatment in any year with a Government target of ensuring 200,000 are in effective treatment in 2008. The majority of those requiring treatment are opiate dependent (usually illicit heroin). The number of illicit opiate users is largely stable. Many opiate dependent users regularly use cocaine. Methadone and buprenorphine are the most commonly used Opiate substitution therapies and allow the addict to replace street heroin with a longer-acting, less euphoriant and safer drug whilst avoiding the withdrawal syndrome. Once stabilised many patients remain on maintenance treatment (with consequent improvements in illicit drug use, physical health, well-being, social stabilisation and very substantially reduced criminality and costs to society). Buprenorphine is substantially more expensive than oral methadone and it takes longer to supervise its consumption.


Naltrexone as a treatment for relapse prevention


It is estimated that there are between 230,00 and 280,000 problem drug users and approximately 145,000 in treatment in any year with a Government target of ensuring 200,000 are in effective treatment in 2008. The majority of those requiring treatment are opiate dependent (usually illicit heroin). The number of illicit opiate users is largely stable. Many opiate dependent users regularly use cocaine. Oral naltrexone is a long-acting opiate antagonist that effectively blocks the effects of all opiates so that a patient taking naltrexone will feel no benefit from taking illicit heroin for some days after the last dose was taken. There is very varied use of this as a treatment and lack of clarity for whom it may be most appropriate. It is also recommended that a relative supervises its use to aid compliance.


Pegaptanib for age-related macular degeneration


Age-related macular degeneration (AMD) is one of the leading causes of irreversible visual loss in people over the age of 50 years in the western world. "Wet" AMD accounts for 10% of all cases (110,000 patients in England) but about 90% of the blindness associated with AMD. Wet AMD is caused by a proliferation of blood vessels beneath the retina ("choroidal neovascularisation" or CNV). These new blood vessels are very fragile, leak blood and fluid, and lead to retinal scarring and permanent loss of vision in affected areas. The affected areas often include the fovea with the consequent loss of sharp, central vision. Pegaptanib is new drug currently in clinical development for the treatment of wet AMD. It is administered as an injection into the eye every 6 weeks.


Natalizumab for multiple sclerosis


Multiple sclerosis (MS) is a debilitating disease of the central nervous system that usually begins between the ages of 20 and 40 and is the most frequent cause of neurological disability in young adults. Around 63,000 people have MS in England and Wales. Natalizumab is a monoclonal antibody under development for the treatment of relapsing-remitting and secondary progressive MS. It has a different mode of action from interferon beta and could potentially be used in combination with it.



Adalimumab for rheumatoid arthritis



RA affects between 0.5% and 1% of the population. It is characterised by inflammation of the joints, which causes swelling and stiffness and can lead to joint destruction. A wide range of anti TNF products are available for the treatment of RA. Adalimumab is a fully human anti-TNF- monoclonal antibody. Adalimumab is administered either subcutaneously or intravenously once a fortnight. It was launched in the USA in January 2003 for reducing the signs and symptoms of disease and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis who have had insufficient response to one or more disease modifying anti-rheumatic drugs.



Lerdelimumab (CAT-152) for prevention of scarring after glaucoma filtration surgery



Glaucoma, one of the commonest causes of blindness in the developed world, is usually associated with a high build-up of pressure in the front of the eye. This can be treated by drug therapy or by surgery to drain away the excess fluid. Surgery can however lead to scarring in and around the eye. Lerdelimumab is a new drug currently in phase III trials for the prevention of scarring following glaucoma filtration surgery. It was awarded European Orphan Drug status in May 2001. Lerdelimumab could potentially be given to all patients to improve their outcome instead of antiproliferative drugs such as mitomycin or 5-fluoracil.



Strontum ranelate for osteoporosis



Osteoporosis is a progressive deterioration of bone mass increasing the risk of fractures. It affects 1 in 3 women and 1 in 12 men over 50 (3.8 million patients E&W) and causes 40,000 fractures each year. Strontium ranelate is an oral drug in a new class which stimulates bone formation and reduces bone resorption.



Inhaled insulin



There are about 1.3 million patients in England and Wales with diagnosed diabetes, of whom around 15% have Type 1 diabetes and 85% Type 2 diabetes. All those with Type 1 diabetes, and around 30% of patients with Type 2 diabetes - those whose blood glucose levels can no longer be controlled by diet, exercise or oral treatments alone - require insulin treatment. In all, about 500-550,000 people in England are currently being treated with insulin.



Corticosteroids For Asthma



Asthma is a very common condition in both children and adults, with an overall prevalence of about 8-10% (4-5m people in England and Wales). Although for many patients it is well controlled, it can be severely disabling or life-threatening in severe cases. Treatment with inhaled corticosteroids is the mainstay of current treatment strategies; in 2001 some 12 million prescriptions were dispensed at a cost of over ??300m. There is a wide variation in the price of available corticosteroids, but it is not clear that the more expensive drugs are more effective than the cheaper in the majority of patients.



CLINICAL GUIDELINES



Attention Deficit Hyperactivity Disorder (ADHD) in children, young people and adults



Attention Deficit Hyperactivity disorder is defined by the 'core' symptoms of inattention, hyperactivity and impulsivity that are more frequent or severe than is typically observed in individuals at a comparable level of development. Approximately 10-20% of children with ADHD will not benefit from stimulant medication, even in expert hands, due to lack of effect or adverse effects. ADHD frequently occurs co-morbidly with other conditions such as oppositional defiant disorder, learning disabilities, conduct disorder, Tourettes syndrome, depression, autism spectrum disorders, anxiety disorders, and bipolar disorders.



Care and management of osteoarthritis



Osteoarthritis (OA) is a degenerative joint disease characterised by the breakdown of the joint's cartilage causing pain and loss of movement. OA is the most common form of arthritis affecting primarily middle aged and older people. Pain and joint stiffness are the primary complaints - in the most severe cases people find it difficult to move and use the joint. The clinical guideline will consider the best available evidence for the cost-effectiveness of interventions to reduce pain, improve mobility, improve psychological well being, social participation, and the extension of healthy active life.



Drug treatment



It is estimated that there are between 230,00 and 280,000 problem drug users and approximately 145,000 in treatment in any year with a Government target of ensuring 200,000 are in effective treatment in 2008. The majority of those requiring treatment are opiate dependent (usually illicit heroin). The number of illicit opiate users is largely stable. Many opiate dependent users regularly use cocaine. The guideline will cover what the evidence tells us about the effectiveness and cost-effectiveness of methadone and buprenorphine and the appropriate patient groups for each treatment. The guideline should also make clear the key components of the effectiveness of the treatments (such as dose, supervision, being given within a wider package of care/psychosocial interventions).



Management of faecal incontinence



It is estimated that incontinence (both urinary and faecal) accounts for 2% of the total annual healthcare budget of the UK. The annual NHS bill for treating and managing incontinent persons is estimated at ??500 million. Annual costs relating to the elderly include ??22 million for drugs, ??58 million for appliances, and ??27 million for containment products. Optimal management of the conditions will reduce the considerable morbidity associated with this condition, the negative impact on psychological health and lifestyle, and improve quality of life.



Contact Press Officer


Phone Alison Langley

(UK) 020 7210 5649

Press Release from the UK Dept of Health


View drug information on Gliadel Wafer; Iressa; Naltrexone Hydrochloride Tablets.

Nature Study: Discovery Of Key Pathway Interaction May Lead To Therapies That Aid Brain Growth And Repair In Children And Adults

Researchers at the Center for Neuroscience Research at Children's National Medical Center have discovered that the two major types of signaling pathways activated during brain cell development - the epidermal growth factor receptor pathway and the Notch pathway - operate together to determine how many and which types of brain cells are created during growth and repair in developing and adult brains. This knowledge may help scientists design new ways to induce the brain to repair itself when these signals are interrupted, and indicate a need for further research to determine whether disruptions of these pathways in early brain development could lead to common neurodevelopmental disorders such as epilepsy, cerebral palsy, autism, Down syndrome, ADHD, and intellectual disabilities.



"By understanding how these cellular signaling pathways operate in the brain, we may be able to develop genetic or molecular approaches that target those signals to facilitate or induce regeneration of the brain from neural stem cells," said Vittorio Gallo, PhD, director of the Center for Neuroscience Research at Children's National. "These signaling pathways, normally activated during brain development, work in concert through the cellular microenvironment and through interactions with existing brain cells to determine how many of each type of brain cell are required for proper brain function."



These findings will be published in the September issue of Nature.



Dr. Gallo and the research team used an approach in a laboratory setting that modified genes involved in the two signaling pathways. This approach induced gain or loss of function, allowing researchers to change the properties of neural stem cells as they developed - including altering the size of the pool of neural stem cells in the brain, the number of viable neural stem cells, and types of brain cells these stem cells ultimately become.



Neural stem cells can develop into all major cell types of the brain. The discovery of the interaction between the two types of cellular signaling pathways is a critical step toward understanding, and potentially impacting, the molecular networks that regulate the cellular microenvironments, or niches, in which these neural stem cells operate.



"Children's National provides an ideal setting for pursuing this research, because we are able to use a multidisciplinary approach to our studies," Dr. Gallo said. "Investigators and clinical fellows work together in the labs to tackle important questions that have great clinical importance for children with neurodevelopmental disabilities, and tap resources and expertise at other institutions as well. This environment allows us to translate our findings into the design of specific therapeutic approaches, working together with neuroscientists, child neurologists, neurosurgeons, and neuro-oncologists."



The research was conducted by Dr. Gallo and Adan Aguirre, PhD, of the Center for Neuroscience Research at Children's National Medical Center, and Maria E. Rubio, MD, PhD, of the Department of Otolaryngology at the University of Pittsburgh Medical School.



Source:

Jennifer Stinebiser

Children's National Medical Center

Physicians Pay Attention To ADHD On College Campuses

Can't study. Can't focus. Can't remember what I was supposed to do next. I've got to do this. No, I've got to do that. What was I doing?


In college, students with attention deficit/hyperactive disorder face an array of challenges-long days and nights of classes, studying and activities, all of which require increasing amounts of concentration.


Dr. Mark Thomas stands ready to help, both at The University of Alabama's Student Health Services and through his research into treating AD/HD on campuses across the country. That treatment includes prescribing drugs that allow students to focus over long periods of time and training in better study habits.


"Medications are, far and away, the most effective treatment for ADHD," says Thomas, a physician in the Student Health Center/University Medical Center, part of UA's College of Community Health Sciences. "They're not the total treatment, but they're the component of treatment that makes the most difference. We do try to advocate to students with AD/HD that the medication is just one part of the overall treatment approach."


A Disruptive Force


Attention Deficit/Hyperactive Disorder has a few categories; some children, for example, are unable to focus but don't exhibit hyperactive symptoms. They are diagnosed with "AD/HD, inattentive type." Those who exhibit both attention problems and hyperactivity are diagnosed with "AD/HD, combined type."


Children with ADHD, according to the Centers for Disease Control and Prevention, "have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be) and in some cases, are overly active." Everybody has periods of distraction or forgetfulness, but for a diagnosis of ADHD, the symptoms need to disrupt the child's life at school and at home.


"The characteristics of inattentiveness would include not only daydreaming, being easily distracted, procrastination, lack of organization, losing things, misplacing things, forgetting appointments, just an overall sense that the world is passing you by, and you're not able to keep up with it," Thomas says. "Patients end up feeling quite overwhelmed."


The Centers for Disease Control and Prevention notes that, as of 2006, 4.5 million children between the ages of 5 and 17 had been diagnosed with ADHD. In 2003, Alabama led the nation with 11 percent of its children diagnosed with ADHD, according to a center report. When these children reach college, they'll need to continue treatment. In addition, some students are being diagnosed with ADHD for the first time in college.


Guidelines Needed For College-Aged


So, Thomas and his fellow physicians are responding with research to develop guidelines on treating ADHD on campus. The New York Times recognized his expertise in an April 2009 article on ADHD, and he co-presented a paper in May 2009 at the American College Health Association meeting in San Francisco. At the meeting, he was asked to co-chair an effort to write guidelines for treating ADHD on American college campuses.















"What grew out of that particular meeting was a consensus that we need to establish some guidelines for treatment of AD/HD across campuses," Thomas says. "There are guidelines in place for the pediatric population - children roughly between 6 to 12 - that the American Academy of Pediatrics has come up with. There are also guidelines that psychiatric associations have prescribed for grownups. What are really lacking are guidelines for adolescents and young adults, college age in particular."


Thomas surveyed 124 campus health centers from across the country about how staff members diagnose and treat ADHD. His preliminary findings suggest that about a third of these health centers do not offer prescription treatment for ADHD.


"While students on these campuses could presumably go off campus to receive this service, not having it readily available on-campus may provide a significant barrier to receiving care," Thomas says.


Inconsistencies Among Campuses


Campuses also vary widely when it comes to diagnosing ADHD among students.


"Only about half of them handle making a new diagnosis of ADHD," Thomas says. "Who they have handling their prescriptions and making the diagnoses varies widely. The most common providers they have are family-medicine physicians or psychiatrists. As far as making the diagnosis, there's a larger number that use mental health professionals, which also would include psychologists as well as psychiatrists."


Preliminary research also suggests that more than half of the students treated for ADHD in colleges were diagnosed on campus. Students who do not show the hyperactive component of ADHD in their childhood sometimes slip through the diagnosis net because they develop coping mechanisms in elementary or high school. Those coping mechanisms often break down in college.


"Eventually they get to the point where they're no longer able to function adequately either due to the increasing complexity of the school work or because they are now without the aid of parents or teachers looking over their shoulders. That's when they present and become diagnosed."


Students come to Thomas seeking advice usually because a friend or professor notices the symptoms before they do.


Part of the guidelines Thomas is helping develop involves diagnosis. Physicians need to be careful about distinguishing between ADHD and normal problems with concentration. Also, he's looking at who should make the diagnosis and whether the student has other problems that either mimic ADHD or make it worse.


"We don't want to establish the bar for making the diagnosis so high that it presents a significant barrier to care," Thomas says. "At the same time, we don't want to set it so low that it's easy for someone to come off the street and get a prescription they don't really need.


"As part of that diagnostic process, we do want to address the possibility of learning disorders, either co-existing with ADHD or mimicking ADHD. We also look out for other psychiatric diagnoses that mimic ADHD or coexist with ADHD. Why that's important is, with psychiatric diagnoses, we don't want to be treating the wrong thing.


"Sometimes the right medication for ADHD would be the wrong medication for other conditions and make the other conditions worse. On the other hand, if there are some unrecognized psychiatric diagnoses or learning disabilities, then we're losing the opportunity to being able to fully help the patient or the student."


Prescription medicine remains at the forefront of treating ADHD, Thomas says, including dextroamphetamines and methylphenidates. Innovations have refined and improved the way these drugs work on the brains of people with ADHD.


"The stimulant medication helps their brain to get tasks completed without getting distracted and going in other directions. It also helps to filter out extraneous stimuli coming in to their brain," Thomas says. "They're better able to sort out what's important for them to keep in their conscious brain and what bits of information can go into their subconscious."


Podcasts To Offer Peer-To-Peer Support


In the "old school" of treating ADHD, physicians perceived that the medication could be harmful, so they prescribed drugs only during school days. Now physicians recognize that the medication is relative very safe and that ADHD affects all aspects of a student's life, including hanging out with friends or studying late into the night. Having untreated ADHD also negatively affects driving safety in young adults. So, medication is needed over an extended period. As a result, physicians are using medicine that's delivered in pills or patches that spread the delivery of the drug over time.


Beyond drugs, Thomas is working to include in the guidelines other avenues of support for students with ADHD. He is working with students from the University Computer-Based Honors program to develop podcasts produced by students with ADHD to offer peer-to-peer support for the condition. He and other University staff members have formed the ADHD Consortium, a group of faculty and staff members interested in students with ADHD. The group is working to coordinate services for these students.


"We try to get them to go to the Office of Disability Services for academic accommodations," Thomas says. "Another leg of their treatment is academic training help, such as training in study skills and time management skills. There are a number of places we can send them to for that, for example the Center for Teaching and Learning at UA. We also are very interested in developing more programs for helping in that area, because that's an area in which students don't have a lot of awareness of what's available."


Source
University of Alabama

CONCERTA® Now Available For Patients With ADHD Ages 6 To 65 In USA

ADHD is the most common emotional, cognitive and behavioral disorder treated in children1, and according to the National Institute of Mental Health (NIMH), between 30 percent and 70 percent of children with ADHD continue to exhibit symptoms in the adult years 2. ADHD is thought to affect about eight million, or one in 20, adults in the United States3, and research on the life span of the condition notes the disorder impairs academic, social and occupational functioning1, and is associated with academic underachievement, conduct problems, underemployment, motor vehicle safety and difficulties with personal relationships1.



Today, there's a new treatment option for the millions of adults in the United States with ADHD: Johnson & Johnson Pharmaceutical Research & Development L.L.C. (J&JPRD) announced the U.S. Food and Drug Administration (FDA) approved J&JPRD's Supplemental New Drug Application (sNDA) for CONCERTA® treatment of ADHD in adults ages 18-65. The doses approved for adults range from 18 to 72 mg daily.



Today's approval expands the CONCERTA® indication from children and adolescents into adults with ADHD, and offers these patients a patented once-daily formulation. Using its unique OROS® delivery system, the CONCERTA® formulation delivers an initial dose of medication when the tablet is ingested. Medication is then delivered into the bloodstream at a controlled rate throughout the day.



The CONCERTA® brand, which was the first 12-hour extended-release methylphenidate (MPH) treatment for ADHD, is the market leader for MPH treatment of children and adolescents with ADHD. CONCERTA® is marketed in the United States by McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.



"What we've seen in the growing body of knowledge on adult ADHD suggests a challenging burden of impairment in everyday functioning," said Janet Vergis, President of McNeil Pediatrics™. "Recognizing this need - and as the market leader in extended-release MPH for children and adolescents - we see today's approval as a treatment option milestone for adults with ADHD and their healthcare professionals. We are proud to offer patients ages 6 to 65 with ADHD our CONCERTA® product knowledge based on more than seven years of clinical experience."



Researchers examining ADHD across the lifespan have noted the condition is often chronic, with prominent symptoms and impairment spanning into adulthood, and is often associated with co-occurring anxiety, mood and disruptive disorders as well as substance abuse3. According to the NIMH, ADHD is thought to be a biological condition, usually inherited, and tends to run in some families more than others. Often when a child is diagnosed with the disorder, a parent will recognize that he or she had many of the same symptoms, and for the first time, will begin to understand some of the traits that have troubled them for years4. All aspects of an individual's life must be considered in the diagnosis and treatment of ADHD3.
















Today's FDA approval was based on clinical trial data in adults ages 18 to 65. In these studies, use of CONCERTA® was shown to significantly improve ADHD symptoms such as attention, impulsivity and hyperactivity compared to placebo, and the medication was shown to be generally well tolerated.



About CONCERTA®


CONCERTA® is approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.



IMPORTANT SAFETY INFORMATION


Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.



CONCERTA® should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA®; significant anxiety, tension, or agitation; glaucoma; tics, Tourette's syndrome, or family history of Tourette's syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under six years of age should not take CONCERTA®.



Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure. Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking CONCERTA®.



Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA® does not adversely affect your ability to engage in such activities.



The most common adverse reaction (> 5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia. Visit concerta/concerta/pages/full.jsp for full prescribing information.



About McNeil Pediatrics


McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to meeting the needs of pediatric medicine through the development of therapies specifically formulated for children. McNeil Pediatrics markets CONCERTA® for the treatment of children, adolescents and adults with ADHD in the United States. McNeil Pediatrics continues to explore other new therapies to meet the needs of children and the pediatric community. Visit mcneilpediatrics for more information.



About J&JPRD


Johnson & Johnson Pharmaceutical Research & Development L.L.C. (J&JPRD) is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide. jnjpharmarnd



References



1. Wilens, T.E., Dodson, W. A Clinical Perspective of Attention-Deficit Hyperactivity Disorder into Adulthood. Journal of Clinical Psychology 65:10. October 2004.

2. National Institute of Mental Health. "ADHD in Adults." Available at nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml. Accessed June 19, 2008.

3. Wilens, T.E., Biederman J., Spencer T.J. Attention Deficit/Hyperactivity Disorder Across the Lifespan. Annual Review of Medicine, Vol. 53. 2002.

4. National Institute of Mental Health. "Genetics." Available at nimh.nih.gov/health/publications/adhd/attention-deficit-hyperactivity-disorder-in-adults.shtml. Accessed June 19, 2008.


View drug information on Concerta.

Three Effective Treatments For Childhood Anxiety Disorders Identified By Study

Treatment that combines a certain type of psychotherapy with an antidepressant medication is most likely to help children with anxiety disorders, but each of the treatments alone is also effective, according to a new study funded by the National Institutes of Health's National Institute of Mental Health (NIMH). The study was published online Oct. 30, in the New England Journal of Medicine.



"Anxiety disorders are among the most common mental disorders affecting children and adolescents. Untreated anxiety can undermine a child's success in school, jeopardize his or her relationships with family, and inhibit social functioning," said NIMH Director Thomas R. Insel, M.D. "This study provides strong evidence and reassurance to parents that a well-designed, two-pronged treatment approach is the gold standard, while a single line of treatment is still effective."



The Child/Adolescent Anxiety Multimodal Study (CAMS) randomly assigned 488 children ages 7 years to 17 years to one of four treatment options for a 12-week period:
Cognitive behavioral therapy (CBT), a specific type of therapy that, for this study, taught children about anxiety and helped them face and master their fears by guiding them through structured tasks;


The antidepressant sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI);


CBT combined with sertraline;


pill placebo (sugar pill).

The children, recruited from six regionally dispersed sites throughout the United States, all had moderate to severe separation anxiety disorder, generalized anxiety disorder or social phobia. Many also had coexisting disorders, including other anxiety disorders, attention deficit hyperactivity disorder, and behavior problems.



John Walkup, M.D., of Johns Hopkins Medical Institutions, and colleagues found that among those in combination treatment, 81 percent improved. Sixty percent in the CBT-only group improved, and 55 percent in the sertraline-only group improved. Among those on placebo, 24 percent improved. A second phase of the study will monitor the children for an additional six months.



"CAMS clearly showed that combination treatment is the most effective for these children. But sertraline alone or CBT alone showed a good response rate as well. This suggests that clinicians and families have three good options to consider for young people with anxiety disorders, depending on treatment availability and costs," said Walkup.



Results also showed that the treatments were safe. Children taking sertraline alone showed no more side effects than the children taking the placebo and few children discontinued the trial due to side effects. In addition, no child attempted suicide, a rare side effect sometimes associated with antidepressant medications in children.
















CAMS findings echo previous studies in which sertraline and other SSRIs were found to be effective in treating childhood anxiety disorder. The study's results also add more evidence that high-quality CBT, with or without medication, can effectively treat anxiety disorders in children, according to the researchers.



"Further analyses of the CAMS data may help us predict who is most likely to respond to which treatment, and develop more personalized treatment approaches for children with anxiety disorders," concluded Philip C. Kendall, Ph.D., of Temple University, a senior investigator of the study. "But in the meantime, we can be assured that we already have good treatments at our disposal."







The six CAMS sites were Duke University; New York State Psychiatric Institute/Columbia University Medical Center; Johns Hopkins University; Temple University/University of Pennsylvania; University of California, Los Angeles; and the Western Psychiatric Institute and Clinic/University of Pittsburgh Medical Center.



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/.



Reference: Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill J, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive-behavioral therapy, sertraline and their combination for children and adolescents with anxiety disorders: acute phase efficacy and safety. New England Journal of Medicine. Online ahead of print 30 Oct 2008: 359(17).



Source: Colleen Labbe


NIH/National Institute of Mental Health
What is Anxiety?
For more information on what anxiety is and what to do about it, please see:
What is Anxiety? What Causes Anxiety? What To Do About It.


View drug information on Zoloft.

Recent Trends In Children's Stimulant Prescriptions For ADHD, USA

The percentage of U.S. children taking stimulants for attention deficit hyperactivity disorder (ADHD) remained at a constant level between 1997 and 2002. These data were collected by the federal government and are summarized in an article in the April 2006 issue of The American Journal of Psychiatry (AJP), the official journal of the American Psychiatric Association (APA).


The article by Samuel H. Zuvekas, Ph.D., Agency for Healthcare Research and Quality, Benedetto Vitiello, M.D., National Institute of Mental Health and Grayson S. Norquist, M.D., M.S.P.H., University of Mississippi Medical Center, "Recent Trends in Stimulant Medication Use Among U.S. Children," comes from the Medical Expenditure Panel Survey. This is a nationally representative survey and included more than 7,000 children in each of the five years. Prescription drug use was determined by the families' responses and pharmacy surveys. The stimulants included were methylphenidate (Ritalin), dexmethylphenidate (Focalin), pemoline (Cylert), amphetamine (Adderall) and dextroamphetamine (Dexedrine, Dextrostat).


"This study provides evidence that the use of stimulants in children is not increasing indiscriminately in the U.S. population. The side effects of stimulant drugs mandate good medical judgment to balance therapeutic effect with risk," stated Robert Freedman, M.D., AJP editor-in-chief. "The fear that serious, but rare, side effects will become common does not appear to be supported by current epidemiological evidence."


In 1997, 2.0 million U.S. children (2.7 percent) were treated with stimulant drugs. In 2002, 2.2 million children were treated (2.9 percent). Rates were highest among children ages 6-12 years old. The rates were also higher for boys, whites, and children with functional impairment than for other children. However, the rates for these subgroups also did not change from 1997 to 2002.


Stimulants are the most commonly prescribed treatments for children with ADHD. They are effective for 70-80 percent of patients. Paradoxically, stimulants diminish motor overactivity and impulsive behaviors in children with ADHD and allow them to sustain attention.


An accompanying editorial by Andr?s Martin, M.D., M.P.H., Yale Child Study Center, comments on how doctors and families should regard the current controversies about stimulant use in children: "The past decade clearly has shown potential problems associated with psychotropic use, but it has also provided research that demonstrates the tremendous burden of developmental psychopathology and the availability of effective interventions."
(Am J Psychiatry. 2006; 163: 574-585).




About the American Journal of Psychiatry


The American Journal of Psychiatry, the official journal of the American Psychiatric Association, publishes a monthly issue with scientific articles submitted by psychiatrists and other scientists worldwide. The peer review and editing process is conducted independently of any other American Psychiatric Association components. Therefore, statements in this press release or the articles in the Journal are not official policy statements of the American Psychiatric Association. The Journal's editorial policies conform to the Uniform Requirements of the International Committee of Medical Journal Editors, of which it is a member. For further information about the Journal visit ajp.psychiatryonline.



About the American Psychiatric Association


The American Psychiatric Association is a national medical specialty society whose more than 36,000 physician members specialize in diagnosis, treatment, prevention and research of mental illnesses including substance use disorders. Visit the APA at psych and healthyminds.


View drug information on Adderall XR; Cylert; Focalin.

Reduced Frontal-Lobe Activity And Impulsivity May Be Linked To Alcoholism Risk

Increased impulsivity, or a lack of impulse control, is a key characteristic of many psychiatric disorders, including alcohol dependence. Recent studies suggest that increased impulsivity is involved in a predisposition to developing these disorders. A new study of brain processes provides support for this theory.



Results are published in the January issue of Alcoholism: Clinical & Experimental Research.



"Altered impulsivity is a prominent manifestation in many disinhibitory psychiatric disorders, such as alcohol- or substance-related disorders, conduct disorder, attention-deficit hyperactive disorder (ADHD), antisocial personality disorder (ASP), bipolar disorder, impulse control disorders, and so on," said Bernice Porjesz, professor and director of the Henri Begleiter Neurodynamics Laboratory at SUNY Downstate Medical Center. "Individuals suffering with these disorders may frequently and unpredictably act without planning in advance or without regard to the negative consequences of their behaviors, which in turn can result in serious aftermath. In severe cases, it may lead to danger to the patient or to others."



Porjesz added that the majority of psychiatric diseases are "complex diseases," meaning that their development is influenced by an underlying biological susceptibility of genetic factors, environmental factors, and interactions among multiple genes and the environment.



"Disinhibitory disorders share many similar clinical presentations as well as similar neurobiological abnormalities such as brain waves," said Porjesz. "This suggests that this group of disorders may have some underlying genetic vulnerabilities in common that contribute to the disorders. One recent study of genetic and environmental contributions to internalizing and externalizing disorders determined that the single most important factor underlying externalizing disorders is a genetic liability involving impulse control."



For this study, researchers recruited 57 alcohol-dependent individuals and 58 healthy adult "controls" from the New York City area. All participants were assessed with a standard visual oddball task, where the subject presses a button only to rarely occurring target stimuli (the letter "X") embedded in a series of frequent non-target stimuli. Meanwhile, brain waves or event-related potentials (ERPs) were recorded with a non-invasive technique using 61 scalp electrodes to measure P3 amplitudes. (P3 amplitudes reflect level of neural inhibition in the central nervous system - the larger the P3, the more the inhibition.) Levels of impulsivity were also measured through a standardized self-report scale, the Barratt Impulsiveness Scale. Self-reported measures of impulsivity were also gathered through questionnaires. Furthermore, source localization of brain sources contributing to P3s was computed through a recently developed method of low-resolution electromagnetic tomography called LORETA.
















Results showed that the alcohol-dependent subjects, as well as those individuals with high impulsivity, had significantly lower P3 amplitudes and reduced frontal-lobe activity while processing the visual target signals.



"This is the first study to demonstrate that reduced brain activity in the frontal lobe during processing of target visual stimuli is highly related to impulsivity, regardless of a clinical diagnosis such as alcoholism," said Porjesz. "Genetically influenced underlying factors, such as neural disinhibition and impulsivity, involve frontal-lobe function and influence a wide range of clinical outcomes. Thus, the low P3 amplitude and reduced frontal activation that we found reflect risk for the development of many externalizing disorders, not just specifically alcohol dependence."



Porjesz noted that impulsivity as a behavioral process is essential for normal and socially relevant functioning. "However," she added, "an increased level of impulsiveness may indicate that an individual is more vulnerable than others to behaviors such as excessive drinking, abuse of illicit drugs, and perhaps the development of other disinhibitory disorders. Awareness of this increased vulnerability can aid in better prevention strategies, and early identification of individuals manifesting high impulsivity may prevent more serious clinical outcomes."



Porjesz and her colleagues plan to continue with their research, and will next examine the relationship between impulsivity and ERPs in the offspring of alcoholics. As part of a large nine-center collaborative study known as COGA (Collaborative Study on the Genetics of Alcoholism), they are also trying to identify genes associated with impulsivity, and the underlying predisposition involved in disinhibitory disorders, by following young offspring of alcoholics with "risk genes" as they go though the age of risk and respond to their environmental factors.







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, "Reduced Frontal Lobe Activity in Subjects with High Impulsivity and Alcoholism," were: Madhavi Rangaswamy, Chella Kamarajan, Yongqiang Tang, Kevin A. Jones, David B. Chorlian, Arthur T. Stimus, and Henri Begleiter of the Neurodynamics Laboratory in the Department of Psychiatry at SUNY Downstate Medical Center in Brooklyn. The study was funded by the National Institute on Alcohol Abuse and Alcoholism.



Contact:
Bernice Porjesz, Ph.D.

Andrew C. H. Chen, M.D., Ph.D.

SUNY Downstate Medical Center



Alcoholism: Clinical & Experimental Research

VYVANSE Demonstrated Significant Improvement In ADHD Symptoms In Adults

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, presented the results of a phase III pivotal study in which VYVANSE demonstrated significant improvements in Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults and met all safety and efficacy endpoints.


"Adults with ADHD often find it challenging to focus and organize during the day. The disorder may impact many aspects of their lives from career to family and personal commitments," said Lenard A. Adler, M.D., lead researcher in this study and director of the Adult ADHD program at the NYU Langone Medical Center, associate professor of psychiatry, neurology and child and adolescent psychiatry at the New York University School of Medicine, as well as author of Scattered Minds: Help and Hope for Adults with ADHD (G. P. Putnam's Sons 2006). "This study demonstrated that VYVANSE significantly improved ADHD symptoms in adults, including inattention, such as the ability to focus, organize and complete tasks, which are essential during an adult day, as well as hyperactivity, such as restlessness, and impulsivity."


This double-blind, placebo-controlled, four-week, forced-dose study in 414 adults aged 18 to 55 years showed that treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) provided a significant reduction in ADHD Rating Scale (ADHD-RS-IV) scores within one week that were observed throughout the full treatment period. At endpoint, VYVANSE demonstrated a significant improvement in ADHD symptoms, based on a 43 percent reduction in ADHD-RS scores. This is the largest placebo-controlled stimulant trial of ADHD in adults conducted to date.


Additional Study Findings



Investigators also measured the efficacy of VYVANSE with the Clinical Global Impressions-Improvement (CGI-I) scale and found that the percentage of subjects taking VYVANSE rated "much improved" or "very much improved" was approximately 60 percent across all doses and was significantly greater than placebo.


The most commonly reported adverse events in this study were generally mild to moderate in severity and included decreased appetite, insomnia and dry mouth.


On April 23, 2008, Shire received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE for the treatment of ADHD in adults aged 18 to 55 years. The FDA approved VYVANSE for the treatment of ADHD in children aged 6 to 12 years on February 23, 2007.


Additional information about VYVANSE and Full Prescribing Information are available at vyvanse.















The study was supported by funding from Shire.


Note



ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment. The scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®, a publication of the American Psychiatric Association.


The CGI-I scale is a standard assessment used to rate the severity of a patient's illness and improvement over time.


About ADHD



ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders. ADHD is a neurobiological 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 level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.


Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.


About VYVANSE


Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.


Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.


Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.


Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.


Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.


Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.


Shire PlC


Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.


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 including, but not limited to the successful development of JUVISTA® (Human TGF-3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE™ (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on Shire's 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 date of INTUNIV™ (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2007.


shire


View drug information on Intuniv; Vyvanse.

OROS(R) Methylphenidate In Adults With ADHD: New Insights

Although once considered to be a
disorder only seen in children, Attention Deficit Hyperactivity Disorder
(ADHD) is now known to be a condition associated with a wide range of
functional impairments throughout the lifespan(1). In the US, the overall
prevalence of ADHD in adults is estimated to range between 3.4% and
4.4%(2), and between 30 and 70% of children with ADHD continue to exhibit
symptoms into adult years(3).


Today at the 161st Annual Meeting of the American Psychiatric
Association (APA) there were new insights provided into treatment of adult
ADHD with OROS(R) methylphenidate (MPH) HCl Extended-release Tablets. The
findings included efficacy and safety sub-analyses from a randomized,
double-blind, placebo-controlled, dose-titration trial completed in 2007
and final results from a long-term, open-label safety trial.



"What we're learning more and more is that adult ADHD, while considered
the same medical condition as pediatric ADHD, often has a strikingly
different patient impact due to what can be a lifetime of functional
impairment related to individualized symptoms," noted Lenard Adler, M.D.,
Director of the Adult ADHD Program at the NYU Langone Medical Center and
Associate Professor of Psychiatry, Neurology and Child and Adolescent
Psychiatry at the NYU School of Medicine. Dr. Adler* participated as an
investigator in the long-term, open-label trial and was the lead
investigator of the placebo-controlled dose-titration trial presented in
October 2007. In that study, 226 patients with ADHD ages 18-65 were
randomized to receive placebo or OROS(R) MPH (36 to 108 mg/day) for seven
weeks; results showed significant improvements with OROS(R) MPH in symptom
management compared to placebo.



Efficacy Findings from Short-Term, Dose-Titration Trial



In sub-analysis findings from that study presented today, OROS(R) MPH
demonstrated efficacy in the study population. Specifically, OROS(R) MPH
demonstrated significant efficacy in adults with ADHD across the dose range
studied (36 to 108 mg/day) and consistency in symptom evaluation between
clinicians (using the Adult ADHD Investigator Symptom Rating Scale [AISRS])
and patients (using the Conners' Adult ADHD Rating Scale-Self Report, Short
Version [CAARS-S:S]).



"What's important about these data is that patients and clinicians in
this study showed clear agreement on how each viewed the severity of the
condition being treated, as well as the patient response to the medication
being tested," notes Joseph M. Palumbo, M.D., Franchise Medical Leader in
Psychiatry, Johnson & Johnson Pharmaceutical Research & Development, LLC
(J&JPRD). "What we saw in patients' responses to treatment across the dose
range studied suggest that adults with ADHD may benefit from more
personalized treatment options."



Safety and Cardiovascular Data
















Other findings presented today showed OROS(R) MPH to be well tolerated,
with no unexpected cardiovascular effects associated with OROS(R) MPH in
the study populations of the short-term dose-titration trial as well as the
long-term, open-label trial. Consistent with Food and Drug Administration
class labeling for all stimulant ADHD medication, which states that
patients with serious cardiovascular illness should generally not be
treated with stimulants, patients with a history of serious cardiovascular
illness were excluded from both the short-term dose-titration study and the
long-term open-label trial. Throughout both trials, heart rate and blood
pressure were monitored during the titration period and the dose was
reduced if certain cut-off heart rate or blood pressure values were
reached. The long-term, open-label trial included an ECG every three
months.



Final results from the open-label trial conducted for up to one year
showed that in the study population of 550 patients, mean increases in
blood pressure (BP) and heart rate (HR) observed with OROS(R) MPH were
consistent with those seen in other data from the methylphenidate class.
Mean systolic and diastolic blood pressure increased by 2.6 mmHg and
1.9mmHg, respectively and mean heart rate increased by 4.1 beats per minute
(bpm).



Overall, cardiovascular-related adverse events occurred in 23.3% of
patients and mainly consisted of BP and HR increases. There was no evidence
of a treatment effect in any ECG assessment aside from an increase in HR.
No deaths, heart attacks or strokes were reported and no unexpected safety
findings were noted.



The safety profile of OROS(R) MPH in the long-term, open-label study's
dose range of 36 mg to 108 mg per day, was consistent with that seen in
shorter-term trials in adults. Adverse events with an incidence greater
than 10% included decreased appetite, headache, insomnia, dry mouth,
anxiety, upper respiratory tract infection, nausea, increased heart rate
and irritability.



Additionally, a cardiovascular sub-analysis from the short-term
dose-titration study of OROS(R) MPH versus placebo showed no clinically
significant mean changes from baseline in blood pressure, heart rate or ECG
parameters. The cardiovascular effects noted in this sub-analysis were
consistent with those previously documented in other data from the MPH
class.



Data from this sub-analysis showed similar mean changes from baseline
in systolic and diastolic BP for OROS(R) MPH and placebo groups. Systolic
mean change from baseline was -1.2 mmHg for OROS(R) MPH vs. -0.5 mmHg for
placebo; diastolic mean change from baseline was +1.1 mmHg for OROS(R) MPH
vs. +0.4 mmHg for placebo. Mean change in pulse from baseline was greater
for the OROS(R) MPH group, with +3.6 beats per minute (bpm) vs. -1.6 bpm in
placebo. Increased BP was the only cardiovascular adverse event reported in
greater than 10% of OROS(R) MPH patients (10% for OROS(R) MPH vs. 5.2% for
placebo). BP or HR increase led to down titration in 4.5% (5/110) of
OROS(R) MPH patients and 0.9% (1/116) of placebo patients.



The studies were presented and sponsored by J&JPRD, which filed for
U.S. approval of OROS(R) MPH for the treatment of adult ADHD last year.



The following New Research Posters on OROS(R) MPH will be presented at APA:



NR6-019: Cardiovascular Safety Data From a Long-Term, Open-Label Study of
OROS(R) MPH in Adults with ADHD



NR6-017: A Long-Term Safety Study of OROS(R) Methlyphenidate in Adults
with ADHD



NR6-034: Cardiovascular Effects of OROS(R) MPH in a Dose-Titration Study
of Adults with ADHD



NR6-014: Treatment Response with OROS(R) MPH in a Dose-Titration Study of
Adults with ADHD



NR6-010: Clinician-Rated and Patient-Rated Symptom Improvement in a
Double-Blind, Placebo-Controlled, Dose-Titration Study of OROS(R) MPH in
Adults with ADHD



NR6-005: Efficacy of OROS(R) MPH in a Double-Blind, Placebo-Controlled,
Dose-Titration Study of Adults with ADHD: Secondary Endpoints



Dr. Adler has been a consultant, served on advisory boards and
received research grants from J&JPRD and McNeil Pediatrics(TM), Division of
Ortho- McNeil-Janssen Pharmaceuticals, Inc.



About ADHD



Attention Deficit Hyperactivity Disorder (ADHD) is a common and
treatable neuropsychiatric condition, which includes inattention,
hyperactivity and impulsivity. According to the National Institutes of
Mental Health (NIMH), ADHD is one of the most common mental disorders in
childhood. It affects an estimated four million children and adolescents in
the United States.



Important Safety Information


OROS(R) MPH should not be taken by patients with: significant anxiety,
tension or agitation; allergies to methylphenidate or other ingredients in
OROS(R) MPH; glaucoma; Tourette's syndrome, tics or family history of
Tourette's syndrome. Abuse of methylphenidate may lead to dependence. Tell
your health care professional if your child has had problems with alcohol
or drugs, has had depression, abnormal thoughts or visions, bipolar
disorder, seizures, high blood pressure or has had any heart problems or
defects. If your child develops abnormal thinking or hallucinations,
abnormal, extreme moods and/or excessive activity, or if aggressive
behavior or hostility develops or worsens while taking OROS(R) MPH, consult
your health care professional. The most common adverse events reported in
children receiving up to 54 mg were headache, upper respiratory tract
infection and abdominal pain. The most common adverse events reported by
adolescents receiving up to 72 mg were headache, accidental injury and
insomnia.



Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD)
is part of Johnson & Johnson, the world's most broadly based producer of
healthcare products. J&JPRD is headquartered in Raritan, NJ, and has
facilities throughout Asia, Europe and the United States. J&JPRD is
leveraging drug discovery and drug development in a variety of therapeutic
areas to address unmet medical needs worldwide.



McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., is committed to meeting the needs of pediatric
medicine through the development of therapies specifically formulated for
children. McNeil Pediatrics(TM) markets OROS(R) methylphenidate HCL for
treatment of children and adolescents with ADHD in the US. McNeil
Pediatrics(TM) is continuing to explore other new therapies to meet the
special needs of children and the pediatric community. Visit
mcneilpediatrics for more information.



OROS(R) is a registered trademark of ALZA Corporation.


References



1: Kessler RC et al, Journal of American Occupational Environmental
Medicine 2005



2: Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of
adult ADHD in the United States: Results from the National Comorbidity
Study replication. Am J Psychiatry 2006;163:716-23.insert reference



3: NIMH website, Silver LB. Attention-deficit hyperactivity disorder in
adult life. Child and Adolescent Psychiatry Clinics of North America,
2000:9:3: 411-523


McNeil Pediatrics(TM)

ortho-mcneil

ADHD's Role In Smoking Examined By Columbia Study

Are you easily forgetful, distracted, impulsive or fidgety? Do you find that smoking helps you alleviate these symptoms?



Columbia University Medical Center researchers are investigating whether these most common symptoms of attention deficit hyperactivity disorders (ADHD) could be causing people to smoke. If that is the case, will treatment for ADHD combined with the standard treatment to help people quit smoking -- the patch with counseling -- increase the quit rates for smokers trying to quit?



Lirio S. Covey, Ph.D., director of the Smoking Cessation Program at Columbia University Medical Center, is trying to find out.



Covey and her colleagues are recruiting smokers who have been diagnosed with ADHD or who may have symptoms of ADHD but have not yet been diagnosed, to be part of a study that will help them quit smoking. Approximately 7-8 million adults in the U.S. have ADHD. Smoking is twice as common in this population as in the general population.



Research has shown that most smoking in the U.S. occurs among people who have psychiatric conditions, such as alcohol or drug abuse, major depression, anxiety and ADHD. One line of research has shown that smokers with these conditions "self-medicate" their symptoms with nicotine, the primary addictive substance in tobacco.



Participants in the study will receive the nicotine patch, behavioral counseling, and a drug approved by the Food and Drug Administration for the treatment of ADHD called methylphenidate (brand name CONCERT?®). Because methylphenidate and nicotine act on the brain in a similar way, the premise is that treatment with methylphenidate when trying to quit smoking may reduce symptoms of ADHD while also reducing tobacco withdrawal symptoms. These benefits together may lead to increased success in quitting.



"Nicotine seems to quell the symptoms for ADHD, but unfortunately the other ingredients in cigarettes and the act of taking in nicotine through the lungs makes it very bad for you," says Dr. Covey. Our hope is that we can affect some of the same receptors and transmitters activated by nicotine with this ADHD treatment so that smokers are relieved from their ADHD symptoms and are less likely to light up."



The Smoking Cessation Program at Columbia University Medical Center is seeking participants aged 18- to 55-years-old to enroll in this study. The study, being run out of the New York State Psychiatric Institute located on the CUMC campus on the upper west side of Manhattan, is one of six sites funded by the National Institute on Drug Abuse (NIDA) to carry out this study in the U.S.



Participation is conditional upon completion of screening procedures including assessments to determine the presence of ADHD and the smoker's level of cigarette use. Qualified participants will be randomized to receive either methylphenidate or an identical-looking placebo or sugar pill. All participants will receive the nicotine patch and 11 weeks of behavioral counseling. Reimbursement for time and travel will be offered to research participants.







Relevant Stats:



* Cigarette smoking is the number one health problem in the U.S.


* About a quarter of New Yorkers still light up daily.
* An estimated 450,000 Americans lose their lives as a result of smoking related disease.



Columbia University Medical Center provides international leadership in pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, nurses, dentists, and public health professionals at the College of Physicians & Surgeons, the College of Dental Medicine, the School of Nursing, the Mailman School of Public Health, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. cumc.columbia/


Contact: Susan Craig


Columbia University Medical Center

Boston Researchers Present Study Showing Working Memory Training In School Can Help Students With Attention Deficits

Dr. Enrico Mezzacappa, assistant professor of psychiatry at Harvard University, has presented findings from a pilot project studying the effectiveness of using Cogmed Working Memory Training in the classroom to improve attention in children with ADHD. The research was conducted in the Boston school system and builds on previous findings from Sweden's Karolinska Institute that revealed a breakthrough in the way attention problems are understood and treated.


Mezzacappa studied nine grade school students who had been diagnosed with ADHD as they completed the Cogmed Working Memory Training program. Each student was screened positively for ADHD based on teacher ratings and was not receiving any form of treatment for ADHD. The students used video-game software developed by Cogmed to perform verbal and spatial working memory tasks five days a week, for five weeks.


"Our pilot study indicated that the training of working memory in school settings may be a feasible, safe, and effective way to help children with ADHD that warrants further investigation," Mezzacappa concluded in the study. "It offers the possibility of stimulating cognitive skills that are critical to mental health, to cognitive development and academic achievement. It may also be readily disseminated through schools so as to reach many children who might not otherwise receive treatment."


"We are thrilled that researchers like Dr. Mezzacappa continue to put the Cogmed program to the test," said Jonas Jendi, Cogmed's chief executive officer. "Across several recent studies, the conclusion is clear: Cogmed Working Memory Training translates to measurable improvements in behavior and in the key areas for academic success for students with attention problems. Working memory is critical for learning, and it can be improved by training, properly designed and administrated."


Dr. Mezzacappa presented the results during the American Academy of Child and Adolescent Psychiatry annual meeting in Boston, on October 24th. Dr. John C. Buckner, psychologist and also of Harvard Medical School and the Children's Hospital in Boston, is co-investigator in the study.



About Cogmed


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Improved Childcare Prevents Increase In Number Of Problem Pupils

More money, improved teacher training and a change to the indicator scheme. According to researcher Hans Grietens that is the only way to prevent an increase in the number of pupils with serious behavioural problems. On behalf of NWO, Hans Grietens, professor at the Faculty of Psychology and Educational Studies at the Katholieke Universiteit Leuven, investigated with his colleagues whether the number of problem pupils in the Netherlands and Flanders is increasing, and if so, which measures are necessary to prevent a further increase.



Grietens' research report makes four recommendations, based on working conferences with Dutch and Flemish experts from academia, education and educational policy. First of all more attention and funds are necessary for prevention within ordinary education. That means extra training for teachers and school management teams and greater involvement of schools in initiatives to support the upbringing of children. Other examples are the presence of satisfactory protocols at schools and small-scale projects for underprivileged young people or pupils with a developmental disorder.



Further the assessment of whether a child has special educational needs should not only include a diagnosis but also an explanatory analysis of general and specific factors related to the problem concerned. Only then, in their view, is it possible to make a correct choice with respect to the supervision of a child in a specific situation. They fear that otherwise the diagnosis will be reduced to ticking off boxes; a decision to allocate care or not.



Additionally more investments are needed in scientific research into practical experiences of dealing with behavioural problems in an ordinary educational setting. Also the funding within the policy needs to be adjusted so that organisations with a regional function are made jointly responsible for a fair distribution of the resources.



ADHD

Has the number of children and young people with serious behavioural problems, such as aggression, autism and depression increased? Although such an increase is often assumed, the evidence is not clear cut. Grietens and his colleagues made a comparative analysis of a number of European and American studies about problem pupils published during the past twenty years. This revealed that despite differences in geography, age range and the problems studied there was no clear indication of a substantial rise in the number of problem pupils at a population level. However, trend analysis of specific problems provides a different picture. For example, between 1990 and 1998 the number ADHD diagnoses among 5 to 18-year olds rose considerably, even allowing for the role that the increasing familiarity with ADHD played in this. Child delinquency also increased throughout the world. The number of incidents reported to the Dutch and Flemish youth welfare offices equally increased.



Grietens' research was carried out on behalf of the Policy-Oriented Primary Education Research (BOPO) programme committee of NWO.






For further information please contact:



* Prof. Hans Grietens (Katholieke Universiteit Leuven)

* Publication data: Toename leerlingen met gedragsproblemen. Een Nederlands-Vlaamse vergelijking
[Increasing number of pupils with behavioural problems. A Dutch-Flemish Comparison].



Contact: Kim van den Wijngaard


Netherlands Organization for Scientific Research

Asbestos And Lead Uncovered During Home Energy Retrofits Threaten Children's Health

Home energy retrofits tackle climate change and when done right they should make homes healthier, while aiding families struggling with utility bills.



Without adequate training and precaution, however, renovators, energy retrofitters and do-it-yourselfers who disturb lead-based paint, asbestos insulation and other toxic materials in older buildings put the health of all - especially children - living there at risk of serious health impacts.



Lead exposure can potentially lead to lowered intelligence and worse; asbestos exposure can potentially lead to debilitating long term illness, and certain materials used in renovation can increase other health risks, experts warn in a new report by the Canadian Environmental Law Association (CELA).



CELA and fellow members of the Canadian Partnership for Children's Health and Environment (CPCHE) have launched a multi-year project to promote healthier home energy retrofits. They strongly encourage retrofits to reduce greenhouse gas emissions and home energy costs but urge government co-operation to ensure such work is done without damaging the vulnerable health of children.



"Many families in Canada struggle with high energy costs and retrofits help ease the financial burden while aiding the fight against climate change," says CELA Executive Director Theresa McClenaghan. "Retrofits, done right, will also make these families' homes healthier and prevent health problems known to result from mould or inadequate heating and ventilation. Unless care is taken to avoid the release of toxic chemicals and ensure proper ventilation, however, such renovations can create serious health risks, especially for children."



Adds Erica Phipps, CPCHE Partnership Director: "The goal here is a 'win-win' situation: homes that are more energy and cost efficient and healthier for children and their families."



The report, "Healthy Retrofits: The Case for Better Integration of Children's Environmental Health Protection into Energy Efficiency Programs," offers a suite of recommendations for improvement in several areas, including the coverage and design of government energy efficiency incentive programs and policies, the training of energy auditors, the education of contractors and public awareness of the issues.



Among the biggest concerns is lead, which can pose a risk inside any home built prior to 1978. Until 1977, lead was often added to interior paint to make it more brilliant, durable and moisture-resistant. It can be present at exceptionally high levels in paints used before the 1960s. It was also added at high levels to outdoor paint until 1992.



Homes first built in the 1930s and earlier may have accumulated over 200 kilograms of lead, which poses little threat if undisturbed. However, replacing old windows or drilling into walls to blow in insulation, for example, can contaminate the house with lead dust, which is especially dangerous for babies and young children, who tend to crawl on the floor and put their hands and other objects in their mouths.
















Surprisingly, according to a survey of Canadian auditors and renovators and contractors done for the report, while 93% talk about some environmental health issues with their clients, just one in six (16%) raise lead as a concern.



And, even though the Canadian federal government's public information urges homeowners to be careful, potential exposure to lead from paint is not covered in federal training of energy auditors, who are unlikely to point it out. Only 7.1% of energy professionals surveyed report screening or testing for lead.



The US Environmental Protection Agency, on the other hand, requires contractors to be lead-safe certified if they are doing renovation, repair or painting in pre-1978 homes, child care facilities and schools. The US and France are among very few countries known by medical experts to have created mandatory precautions or other legal requirements related to old lead paint.



"There is no safe level of lead exposure," stresses Simon Fraser University professor Bruce Lanphear, MD, a world-leading expert on children's environmental health who served as a report advisor. "Exposure to lead at a young age can permanently alter the pre-frontal cortex of a child's brain."



The report cites studies documenting lead levels of just 1 to 10 micrograms per deciliter of blood causing IQ scores 6 points lower than children with lead-free blood. Average Canadian children have levels of 1 to 3 micrograms of lead per deciliter (??g/dL) of blood, meaning there is no safety margin for any additional exposures.



Long-term effects may include slow development, learning disabilities, hearing loss and reduced height. And there is a correlation between children with Attention Deficit Hyperactivity Disorder (ADHD) and presence of lead in their bodies, even at levels officially considered safe, he adds.



Children with moderate to high lead exposure may suffer neurological and behavioural changes, including a far greater likelihood of committing crimes as adults, according to recent US studies by Dr. Lanphear and others.



A 2009 US study by the Economic Policy Institute in Washington, D.C., found that every dollar invested in controlling the hazard of lead paint returned between $17 and $221 in health benefits. These benefits included higher IQs, lifetime earnings and tax revenue, reduced spending on special education and reduced criminal activity. Total savings from the US investments were estimated at $181 to 269 billion.



Other major health concerns include asbestos, a known carcinogen for which, like lead, there is no safe exposure level. Asbestos was widely used in Canadian homes and buildings from the 1930s until the mid-1980s.



It is difficult to estimate how many buildings in Canada contain asbestos. However, it is known that asbestos-containing insulation was used in as many as 300,000 to 400,000 Canadian homes as loose fill in attics until 1990 when it was removed from the market.



Canada Mortgage and Housing Corporation (CMHC) describes many ways in which asbestos can become a risk - disturbing loose-fill insulation, removing roof shingles or siding, tampering with roofing felt, ripping away asbestos insulation from a hot water tank, sanding or scraping asbestos floor tiles, breaking apart acoustical ceiling tiles, and sanding plaster or coatings such as roofing compounds, sealants, paint, putty caulking or drywall containing asbestos.



Disturbing asbestos-containing materials can release microscopic fibres into the air.



While there are regulations governing asbestos removal, private homes or residential buildings with four units or less are exempt. If homeowners suspect asbestos is present and may be disturbed during renovations, they are advised to consult an expert in asbestos abatement and removal.



Buildings constructed or renovated in Canada between 1950 and 1978 may also have Polychlorinated biphenyls (PCBs)-contaminated caulk around windows and door frames, between masonry columns and in other masonry building materials. PCBs were added to caulk to increase its flexibility. PCBs cause cancer in animals,and their use in caulking was discontinued in 1978. Dust created during renovations can be contaminated with PCBs from this older caulking.



Choosing healthy building materials



The report notes that sealing and tightening a building to improve energy efficiency can reduce air exchange, resulting in more concentrated levels of indoor pollutants and potential health troubles.



And new building materials such as such as caulking, sealants, glues and insulation that contain volatile organic compounds can off-gas or release toxic chemicals such as benzene, toluene and formaldehyde.



Recent studies have shown that the risk of asthma and respiratory diseases increases in infants or children exposed to formaldehyde or particleboard with formaldehyde-based glues, phthalates or plastic materials and paint fumes.



Polystyrene insulation material also carries potential health risks. It is manufactured by combining two carcinogens, ethylene and benzene, to produce ethylbenzene, which then forms styrene. Polystyrene often contains the flame retardant, hexabromocyclododecane (HBCD), a long-lasting compound associated with decreased fertility and effects on the thyroid gland.



Says CELA researcher Kathleen Cooper: "Retrofits can greatly benefit the environment and the estimated 1 million lower-income Canadian families who spend more than 10% of family income on energy costs. Often, however, those families live in older buildings where lead, asbestos and other hazards may be present, putting a premium on doing retrofits safely."



She notes that about half of Canada's current housing stock was built before 1980, and that, according to Statistics Canada, about 75% of the lowest income group in Canada live in these buildings. The Ontario government is embarking on a large province-wide program to retrofit low-income housing, she adds.



"There is very little awareness in Canada of these issues," says Ms. Cooper. "We need measures in place to ensure that renovations and retrofits are done in a way that minimizes potential health problems. Implementing our recommendations would help ensure that retrofits also create indoor environmental health benefits."



Source:

Terry Collins

Canadian Environmental Law Association

Best Practice Guidelines On Identifying And Treating ADHD

The American Academy of Child and Adolescent Psychiatry (AACAP) is proud to announce its new Practice Parameter and Pocketcard on attention-deficit hyperactivity disorder (ADHD). The Practice Parameter represents best practices in evaluating and treating ADHD and the pocketcard is the document's portable summary. Both the Parameter and Pocketcard were designed to teach health care professionals about the disorder.


AACAP's Practice Parameter shows that ADHD is a medical illness on par with diabetes or asthma. Like these conditions, ADHD can be successfully managed, but not cured. Left untreated, children with ADHD often experience failure at school, problems at home, substance abuse, and depression.

AACAP's Practice Parameter presents the effects, including the long-term data, of treating ADHD with and without medication. Although medications must be balanced against rare adverse reactions, the safety of ADHD medicinal treatment is equal to other pediatric conditions.


In addition to updating mental health professionals, the Practice Parameter and Pocketcard will teach health care professionals who do not specialize in mental health about ADHD. As there is a shortage of child and adolescent psychiatrists, most youth with ADHD who receive treatment obtain it from their pediatricans or general practictioners.


The AACAP is a medical association committed to supporting its members' research on ADHD. Families interested in learning about the disorder should view the video, ADHD, A Guide for Families, and read the AACAP Facts for Families, The Child Who Can't Pay Attention.


Representing over 7,500 child and adolescent psychiatrists nationwide, the American Academy of Child and Adolescent Psychiatry (AACAP) is the leading authority on children's mental health.


Mission of the AACAP


Promote mentally healthy children, adolescents and families through research, training, advocacy, prevention, comprehensive diagnosis and treatment, peer support and collaboration.


aacap

ADHD Brains Develop More Slowly, But Generally Catch Up Later

Children with Attention Deficit Hyperactivity Disorder (ADHD) have slower developing brains, when compared to children without ADHD, however, in most cases they still follow a normal pattern of development, according to an article in Proceedings of the National Academy of Sciences (PNAS).


The scientists found that the outer mantle of the brain - the cortex - develops with an average delay of three years among ADHD children. They studied 450 children, 225 had ADHD, while the other 225 did not. The cortex plays an important role in our planning and attention, the researchers explain.


The scientists, from the National Institute of Mental Health (NIMH), say their study may eventually lead to novel treatments for ADHD.


The researchers wanted to find out when the brain reaches peak thickness - a sign that it has matured. Half of the children with ADHD reached peak thickness when they were, on average 10.5 years old, compared to 7.5 years among children without ADHD.


However, even though many ADHD children's brains were developing three years behind the other children, their brains still followed a normal pattern of development.


Lead researchers, Dr. Philip Shaw, said "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."


The next step, the authors explain, will be to try to find out why this delay occurs, and look at ways of speeding it up.


Some experts say the idea of "catching up" is somewhat misleading. While an ADHD person is catching up, those without ADHD continue to develop further.


"Brain Matures a Few Years Late in ADHD, But Follows Normal Pattern"

National Institute of Mental Health

Click here to see article online


What is ADHD?


ADHD (Attention Deficit Hyperactivity Disorder) is one of the most common neurobehavioral disorders of childhood and can persist through adolescence and into adulthood. Currently the causes are unknown.


A person with ADHD has a chronic level of inattention, impulsive hyperactivity, or both such that daily functioning is compromised.


The symptoms of the disorder must be present at levels that are higher than expected for a person's developmental stage and must interfere with the person's ability to function in different settings (e.g., in school and at home).


A person with ADHD may struggle in important areas of life, such as peer and family relationships, and school or work performance.


The American Psychiatric Association's Diagnostic and Statistical Manual-IV, Text Revision (DSM-IV-TR) estimates that 3%-7% of children suffer from ADHD. Some studies have estimated higher rates in community samples. ADHD is diagnosed approximately three times more often in boys than in girls.















Three types of ADHD have been established according to which symptoms are strongest in the individual. These types are described below:


1. PREDOMINANTLY INATTENTIVE TYPE: It is hard for the individual to organize or finish a task, to pay attention to details, or to follow instructions or conversations. The person is easily distracted or forgets details of daily routines.


2. PREDOMINANTLY HYPERACTIVE-IMPULSIVE TYPE: The person fidgets and talks a lot. It is hard to sit still for long (e.g., for a meal or while doing homework). Smaller children may run, jump or climb constantly. The individual feels restless and has trouble with impulsivity. Someone who is impulsive may interrupt others a lot, grab things from people, or speak at inappropriate times. It is hard for the person to wait their turn or listen to directions. A person with impulsiveness may have more accidents and injuries than others.


3. COMBINED TYPE: Symptoms of the above two types are equally predominant in the person.


As many as half of those with ADHD also have other mental disorders. These comorbidities of ADHD (other disorders that occur along with ADHD) can make it harder to diagnose and treat ADHD. They may also present further challenges to the individual with ADHD.


Used by mental health professionals, the DSM-IV-TR provides criteria for diagnosing ADHD. This diagnostic standard helps ensure that people are appropriately diagnosed and treated for ADHD. Using the same standard across communities will help determine the public health impact of ADHD.


Treating ADHD can be done through medical or behavioral therapies, or a combination of the two.


Criteria for the three primary subtypes are:


AD/HD - INATTENTIVE TYPE

-- Fails to give close attention to details or makes careless mistakes.

-- Has difficulty sustaining attention.

-- Does not appear to listen.

-- Struggles to follow through on instructions.

-- Has difficulty with organization.

-- Avoids or dislikes tasks requiring sustained mental effort.

-- Loses things.

-- Is easily distracted.

-- Is forgetful in daily activities.


AD/HD - HYPERACTIVE TYPE

-- Fidgets with hands or feet or squirms in chair.

-- Has difficulty remaining seated.

-- Runs about or climbs excessively.

-- Difficulty engaging in activities quietly.

-- Acts as if driven by a motor.

-- Talks excessively.

-- Blurts out answers before questions have been completed.

-- Difficulty waiting or taking turns.

-- Interrupts or intrudes upon others.


AD/HD - COMBINED TYPE

-- Individual meets both sets of inattention and hyperactive/impulsive criteria.


Written by - Christian Nordqvist