Journal SLEEP: Methylphenidate can have sleep benefits in adults with ADHD

Public release date: 1-Mar-2008
Contact: Jim Arcurijarcuri@aasmnet.org 708-492-0930
American Academy of Sleep Medicine

Journal SLEEP: Methylphenidate can have sleep benefits in adults with ADHD
WESTCHESTER, Ill. – Treatment with methylphenidate (MPH) appears to have beneficial effects on sleep parameters in adults with ADHD, including increased sleep efficiency and a feeling of improved restorative value of sleep, according to a study published in the March 1 issue of the journal SLEEP.
The study, authored by Esther Sobanski, MD, of the Central Institute of Mental Health in Mannheim, Germany, focused on 34 non-medicated patients with ADHD, of whom 24 were without current psychiatric disorders, and 34 control subjects without current psychiatric disorders or psychotropic medication. Compared to the control group, all subjects in the ADHD sample displayed reduced sleep efficiency, with longer sleep onset latency and more nocturnal awakenings. They had altered sleep architecture, with a higher percentage of stage 1 and reduced percentage of REM sleep. Patients also showed a trend toward the reduced total REM density and elevated percentage of wakefulness after sleep onset.
According to Dr. Sobanski, this study showed that objective and subjective sleep problems in adults with ADHD are identical with sleep problems in children with ADHD, including longer sleep latencies, more nocturnal activity, reduced sleep efficiency, more nocturnal awakenings and slightly decreased REM activity during sleep, although the clinical significance of the last findings remains to be clarified.
Dr. Sobanski added that the effects of MPH on sleep in adults with ADHD have never been shown before, and that this study demonstrated that it has beneficial effects on several sleep parameters in addition to the positive effects on daytime functioning.
“Under treatment with MPH, patients reported improved evening mood, less psychosomatic symptoms while falling asleep, reduced sleep latency, and fewer nocturnal awakenings during the night spent in our sleep laboratory,” said Dr. Sobanski. “For the two weeks at home preceding their polysomnographic investigation, patients reported significantly better restorative value of sleep and a trend for less nocturnal awakenings compared to baseline.”
MPH is a prescription stimulant commonly used to treat ADHD. It is also one of the primary drugs used to treat the daytime drowsiness symptoms of narcolepsy and chronic fatigue syndrome.
A medication can provide much needed relief for someone with a severe sleep problem. This can promote good health and an overall sense of well being. But there is also a level of risk involved with the use of any medication. Many people will have some side effects.
Keep in mind that the same drug can affect people in different ways. A medication that helps someone else may not work for you. Your doctor can determine if a medication is the best treatment for your sleep problem. Never take a medication without the approval of your doctor.
It is recommended that adults get between seven and eight hours of nightly sleep.
The American Academy of Sleep Medicine (AASM) offers the following tips on how to get a good night’s sleep:
· Follow a consistent bedtime routine.
· Establish a relaxing setting at bedtime.
· Get a full night’s sleep every night.
· Avoid foods or drinks that contain caffeine, as well as any medicine that has a stimulant, prior to bedtime.
· Do not bring your worries to bed with you.
· Do not go to bed hungry, but don’t eat a big meal before bedtime either.
· Avoid any rigorous exercise within six hours of your bedtime.
· Make your bedroom quiet, dark and a little bit cool.
· Get up at the same time every morning.
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Those who suspect that they might be suffering from a sleep disorder are encouraged to consult with their primary care physician or a sleep specialist.
SLEEP is the official journal of the Associated Professional Sleep Societies, LLC, a joint venture of the AASM and the Sleep Research Society.
SleepEducation.com, a patient education Web site created by the AASM, provides information about various sleep disorders, the forms of treatment available, recent news on the topic of sleep, sleep studies that have been conducted and a listing of sleep facilities.
For a copy of this article, entitled, “Sleep in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Before and During Treatment with Methylphenidate: A Controlled Polysomnographic Study”, or to arrange an interview with an AASM spokesperson regarding this study, please contact Jim Arcuri, public relations coordinator, at (708)492-0930, ext. 9317, or jarcuri@aasmnet.org.

ABILIFY approved for acute treatment of bipolar I disorder in patients 10 to 17 years old

Public release date: 29-Feb-2008
Contact: Debra Kaufmanndebra.kaufmann@otsuka.com 240-683-3568
Otsuka America Pharmaceutical, Inc.

ABILIFY approved for acute treatment of bipolar I disorder in patients 10 to 17 years old
Otsuka-sponsored study evaluated use of ABILIFY for the acute treatment of manic and mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age
TOKYO, JAPAN & PRINCETON, NEW JERSEY, FEBRUARY 29 -- Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY® (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old). ABILIFY has been approved for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.
“Pediatric bipolar illness is a serious condition,” said Christoph Correll, M.D., Medical Director, Recognition and Prevention Program, The Zucker Hillside Hospital and Assistant Professor of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Glen Oaks, New York. “The availability of an additional treatment option that can help guide decisions in managing Bipolar I Disorder in children and adolescents is welcome news.”
The approval is based on results from a four-week, multicenter, randomized, double-blind, placebo-controlled study in pediatric patients (10 to 17 years old) with Bipolar I Disorder that demonstrated efficacy with ABILIFY compared to placebo on the primary efficacy endpoint, mean change from baseline to Week 4 on the Young-Mania Rating Scale (Y-MRS) Total Score.
“We are pleased that the FDA has approved ABILIFY to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder,” said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. “The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population.”
“We are committed to developing innovative new medicines to their fullest potential,” said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. “Expanding the clinical use of an important therapy such as ABILIFY gives pediatric patients with Bipolar I Disorder and their caregivers a new treatment option in their fight against this serious disease.”
Clinical Trial Design and Findings
These findings are from a four-week, multicenter, randomized, double-blind, placebo-controlled study, which evaluated the efficacy and safety of ABILIFY in 296 pediatric patients (10 to 17 years old) with a DSM-IV diagnosis of Bipolar I Disorder, manic or mixed episodes, with or without psychotic features. Diagnosis was made by a trained child and adolescent psychiatrist and confirmed by a separate diagnostic interview. This study was conducted on an outpatient basis with the possibility of inpatient hospitalization, as needed. This clinical trial was sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) with enrollment at 54 U.S. centers.
After a screening period of up to four weeks, pediatric patients (10 to 17 years old) who scored greater than or equal to 20 on the Y-MRS* were randomly assigned to receive one of two fixed doses of ABILIFY [10 mg/day (n=98) or 30 mg/day (n=99)] or placebo (n=99). ABILIFY was initiated at a starting dose of 2 mg/day and titrated to the target dose of 10 mg/day or 30 mg/day.
The primary efficacy endpoint was the mean change in the Y-MRS Total Score from baseline to Week 4. Safety evaluations included incidence of adverse reactions, discontinuation due to adverse reactions, laboratory measures and body weight.
For the primary endpoint, both doses of ABILIFY demonstrated statistically significant improvement in symptoms when compared to placebo (p-value less than 0.0001) as measured by the mean change from baseline to endpoint (Week 4) on the Y-MRS Total Score. The efficacy of ABILIFY for the maintenance treatment of Bipolar I Disorder in the pediatric population has not been evaluated.
Approximately 80% of patients completed the four-week study (ABILIFY 10 mg: 86%; ABILIFY 30 mg: 78%; placebo: 77%). There was a low rate of discontinuation due to adverse reactions at Week 4 (ABILIFY: 7%; placebo: 2%).
During the study, the most commonly observed adverse reactions (greater than or equal to 5% in combined ABILIFY groups and at least twice the rate of placebo) associated with ABILIFY were: somnolence (ABILIFY: 23%; placebo: 3%), extrapyramidal disorder (ABILIFY: 20%; placebo: 3%), fatigue (ABILIFY: 11%; placebo: 4%), nausea (ABILIFY: 11%; placebo: 4%), akathisia (ABILIFY: 10%; placebo: 2%), blurred vision (ABILIFY: 8%; placebo: 0%), salivary hypersecretion (ABILIFY: 6%; placebo: 0%) and dizziness (ABILIFY: 5%; placebo: 1%). Four common adverse reactions had a possible dose-response relationship at Week 4: extrapyramidal disorder (ABILIFY 10 mg: 12.2%; ABILIFY 30 mg: 27.3%; placebo: 3.1%), somnolence (ABILIFY 10 mg: 19.4%; ABILIFY 30 mg: 26.3%; placebo: 3.1%), akathisia (ABILIFY 10 mg: 8.2%; ABILIFY 30 mg: 11.1%; placebo: 2.1%) and salivary hypersecretion (ABILIFY 10 mg: 3.1%; ABILIFY 30 mg: 8.1%; placebo: 0%). Children and adolescents might be more sensitive than adults in developing antipsychotic-related adverse events.(1)
In the study, weight gain greater than or equal to 7% change from baseline was seen in 3.2%, 9.4% and 3.3% for the ABILIFY 10 mg, ABILIFY 30 mg and placebo groups, respectively. The mean change from baseline to Week 4 in body weight was 0.6 kilograms (kg) for ABILIFY 10 mg, 0.9 kg for ABILIFY 30 mg and 0.5 kg for placebo.
In this study, ABILIFY demonstrated no clinically important differences on prolactin and the following metabolic parameters: triglyceride, HDL-C, LDL-C and total cholesterol. All treatment groups showed a reduction in mean serum prolactin levels at last visit relative to baseline.
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About ABILIFY® (aripiprazole)
The first and only available dopamine partial agonist, ABILIFY is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and pediatric patients (10 to 17 years old). ABILIFY® (aripiprazole) Injection is indicated for the treatment of adults with agitation associated with Bipolar I Disorder, manic or mixed.
Initially approved in November 2002, over 14.9 million prescriptions have been written for ABILIFY in the U.S.(2) through December 2007.
ABILIFY is available by prescription only. ABILIFY Tablets should be taken once daily with or without food and are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. ABILIFY® DISCMELT(TM) (aripiprazole) Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. In addition, ABILIFY is available in a 1 mg/mL nonrefrigerated Oral Solution and as a single-dose, ready-to-use solution for intramuscular injection 7.5 mg/mL. In adult patients, the recommended ABILIFY® (aripiprazole) Oral target dose is 15 mg/day to 30 mg/day in Bipolar I Disorder. In pediatric patients (10 to 17 years old) with Bipolar I Disorder, the recommended ABILIFY Oral target dose is 10 mg/day (with a starting dose of 2 mg/day which was titrated to 5 mg/day after 2 days and to the target dose of 10 mg/day after 2 additional days). In adult patients with agitation associated with bipolar mania, the ABILIFY Injection initial dose is 9.75 mg/1.3 mL. If ongoing ABILIFY therapy is clinically indicated, oral ABILIFY in a range of 10 mg/day to 30 mg/day should replace ABILIFY Injection as soon as possible. The safety of doses of ABILIFY Oral or ABILIFY Injection above 30 mg/day has not been evaluated in clinical trials.
IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY
INDICATIONS:
· ABILIFY is indicated for acute and maintenance treatment of adults with manic or mixed episodes associated with Bipolar I Disorder with or without psychotic features
· ABILIFY is indicated for acute treatment of pediatric patients (10 to 17 years old) with manic or mixed episodes associated with Bipolar I Disorder with or without psychotic features
· ABILIFY Injection is indicated for the treatment of adults with agitation associated with Bipolar I Disorder, manic or mixed.
IMPORTANT SAFETY INFORMATION:
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). ABILIFY is not approved for the treatment of patients with dementia-related psychosis (see Boxed WARNING).
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or another antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increased risk of suicidality in adults beyond age 24. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised for the need for close observation and communication with the prescriber. ABILIFY is not approved for use in pediatric patients with depression (See Boxed WARNING).
Contraindications: Known hypersensitivity reaction to ABILIFY. Reactions have ranged from pruritus/urticaria to anaphylaxis.
Cerebrovascular adverse reactions (eg, stroke, transient ischemic attack), including fatalities, have been reported at an increased incidence in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY
Neuroleptic malignant syndrome (NMS)–As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with ABILIFY. NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation is recommended
Tardive dyskinesia (TD)–The risk of developing TD and the potential for it to become irreversible may increase as the duration of treatment and the total cumulative dose increase. Prescribing should be consistent with the need to minimize TD. If signs and symptoms appear, discontinuation should be considered since TD may remit, partially or completely
Hyperglycemia and diabetes mellitus–Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including ABILIFY. Patients with diabetes should be monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. There have been few reports of hyperglycemia with ABILIFY
ABILIFY may be associated with orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.
As with other antipsychotic drugs, ABILIFY should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.
Like other antipsychotics, ABILIFY may have the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are certain ABILIFY does not affect them adversely.
Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.
Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY; use caution in patients at risk for aspiration pneumonia.
The possibility of a suicide attempt is inherent in psychotic illnesses, bipolar disorder, and major depressive disorder, and close supervision of high-risk patients should accompany drug therapy.
Physicians should advise patients to avoid alcohol while taking ABILIFY.
Strong CYP3A4 or CYP2D6 inhibitors increase ABILIFY drug concentrations when used concomitantly.
CYP3A4 inducers decrease ABILIFY drug concentrations when used concomitantly.
Commonly observed adverse reactions (greater than or equal to 5% incidence and at least twice the rate of placebo for ABILIFY vs placebo, respectively):
· Adult patients with bipolar mania: constipation (13% vs 6%), akathisia (15% vs 3%), sedation (8% vs 3%), tremor (7% vs 3%), restlessness (6% vs 3%), and extrapyramidal disorder (5% vs 2%)
· Pediatric patients (10 to 17 years) with Bipolar I Disorder: somnolence (23% vs 3%), extrapyramidal disorder (20% vs 3%), fatigue (11% vs 4%), nausea (11% vs 4%), akathisia (10% vs 2%), blurred vision (8% vs 0%), salivary hypersecretion (6% vs 0%), and dizziness (5% vs 1%)
· Adult patients with agitation associated with bipolar mania: nausea (9% vs 3%)
Please see FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, for ABILIFY.
About Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in the development and commercialization of ABILIFY in the United States and major European countries.
ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka - people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment. The Otsuka Pharmaceutical Group comprises
99 companies and employs approximately 31,000 people in 18 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned U.S. $7.2 billion in annual revenues in fiscal 2006.
Bristol-Myers Squibb is a global biopharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
For more information and FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, visit: www.abilify.com
Visit Otsuka Pharmaceutical Co., Ltd. at: www.otsuka-global.com
Visit Bristol-Myers Squibb at: www.bms.com
* The Y-MRS is a standard measure that is an 11-item rating scale used by healthcare providers to assess the scope and severity of manic symptoms.(1) Y-MRS Total Scores range from 0 (no manic symptoms) to 60 (severe mania).(2) *(1) Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity, and sensitivity. Br J Psychiatry. 1978; 133:429-435. *(2) Rush AJ, et al. Handbook of Psychiatric Measures. Washington, DC: American Psychiatric Association;2000.
References
(1) Kumra S, Oberstar JV, Sikich L, Findling RL, McClellan JM, Vinogradov S, Schulz SC. Efficacy and Tolerability of Second-Generation Antipsychotics in Children and Adolescents With Schizophrenia. Schizophrenia Bulletin. Published online October 8, 2007. (2) IMS Auditrac NGPS: ABILIFY total monthly retail prescriptions: Data accessed December 2007.
February 2008 0308N-0662
Additional Contacts
Hideki Shirai Otsuka Pharmaceutical Co., Ltd siraih@otsuka.jp
Sonia Choi/Communications Bristol-Myers Squibb Company Office: +1-609-252-5132 sonia.choi@bms.com
John Elicker/Investor Relations Bristol-Myers Squibb Company Office: +1-212-546-3775 john.elicker@bms.com

Workshop Wednesday March 5th - Davis Correction Method for DYSLEXIA,L/D & ADD/ADHD

Davis Dyslexia Association - Israel"THE CENTER FOR SELF-CHANGE"
INVITES YOU TO A FREE LECTURE
Presenting The Davis Correction Method for DYSLEXIA,L/D & ADD/ADHD PRACTICAL TOOLS FOR FUNCTIONING WITH ADD/ADHD DYSLEXIA AND LEARNING CHALLENGES in English & Hebrew.

LET ME SHOW YOU HOW YOUR CHILD /ADULT CAN SUCCEED!(DYSLEXIA AD/HD or ADD) L/D & and other related conditions can change even themost lovable child into an "impossible" child in the home and school environment; And our program GURANTEES NO Medication!Come and See HOW ...................................WHO SHOULD ATTEND: Educators, Special Ed Teachers, Guidance Counselors, Parents of children with these symptoms, Adults with these symptomsTOPICS TO BE DISCUSSED:How we can achieve Focusing & Listening Skills

1) How your child can achieve his/her true potential within the Yeshiva Environment.
2) The reduction of symptoms in ADD, ADHD and L/D. 3) Improvement in reading, math and learning abilities. 4) Gaining a higher threshold for confusion. 5) Improvement in self- confidence and self-esteem

Wednesday March 5th, 2008 @ 7:30 PM
Where: 596 Derby Avenue/Woodmere For more information and to Confirm attendance: Call 516-343-8331
For additional information visit her website at: www.dyslexia.org.il

ADVOCACY AND THE LAW What You NEED to Know! Workshop March 4th , 7pm-9pm

This presentation will be extremely informative, it is appropriate for Parents, Educators, Administrators, Attorneys and anyone with an interest in Special Education!Regina Brandow Esq., of Berger & Brandow, LLPwww.bergerandbrandow.com
…Will help us to understand Special Education Law and Regulations and…What we need to know to be sure our students are getting an appropriate educational program.Where: Long Island Parent Center887 Kellum Street, Lindenhurst(631) 603-3300 (Workshop is FREE of charge, please call to reserve your space)When: Tuesday, March 4th , 7pm-9pmLong Island Parent Technical Assistance Centeris funded through NYSED/VESID and hosted by the Just Kids Early Childhood Learning CenterLIPTAC provides training and support to families and professionals regarding the provision of appropriate services to children with special needs

Government Concede Vaccine-Autism Connection in Federal Court

Julie Cauich> Government Concede Vaccine-Autism Connection in Federal Court> The US Government has finally conceded that at least some cases of > autism can be caused by the mercury in vaccines. Despite what the > media says, some vaccines STILL contain mercury at toxic levels > ( for example, the FLU vaccine). This article is written by David > Kirby, who wrote the book "Evidence of Harm" about the politics > behind mercury and vaccines. There is a link at the bottom to the > courts full conclusion.>> I also highly recommend the reading of the book,> The Virus and the Vaccine: The True Story of a Cancer-Causing Monkey > Virus, Contaminated Polio Vaccine, and the Millions of Americans > Exposed (Hardcover)> by Debbie Bookchin (Author), Jim Schumacher (Author)> Be sure you have a strong stomach before reading.>> Laura - Mom to William, diagnosed with ADHD, Asperger's, asthma, > allergies, chronic gastrointestinal issues, chronic sinusitis, > chronic immune dysfunction, specific learning disabilities, visual > disabilities(newly diagnosed) and more! Waiting on test results for > mercury and other heavy metal poisoning.>>> After years of insisting there is no evidence to link vaccines with > the onset of autism spectrum disorder (ASD), the US government has > quietly conceded a vaccine-autism case in the Court of Federal Claims.> The unprecedented concession was filed on November 9, and sealed to > protect the plaintiff's identify. It was obtained through > individuals unrelated to the case.>> The claim, one of 4,900 autism cases currently pending in Federal > "Vaccine Court," was conceded by US Assistant Attorney General Peter > Keisler and other Justice Department officials, on behalf of the > Department of Health and Human Services, the "defendant" in all > Vaccine Court cases.> The child's claim against the government -- that mercury-containing > vaccines were the cause of her autism -- was supposed to be one of > three "test cases" for the thimerosal-autism theory currently under > consideration by a three-member panel of Special Masters, the > presiding justices in Federal Claims Court.> Keisler wrote that medical personnel at the HHS Division of Vaccine > Injury Compensation (DVIC) had reviewed the case and "concluded that > compensation is appropriate."> The doctors conceded that the child was healthy and developing > normally until her 18-month well-baby visit, when she received > vaccinations against nine different diseases all at once (two > contained thimerosal).> Days later, the girl began spiraling downward into a cascade of > illnesses and setbacks that, within months, presented as symptoms of > autism, including: No response to verbal direction; loss of language > skills; no eye contact; loss of "relatedness;" insomnia; incessant > screaming; arching; and "watching the florescent lights repeatedly > during examination."> Seven months after vaccination, the patient was diagnosed by Dr. > Andrew Zimmerman, a leading neurologist at the Kennedy Krieger > Children's Hospital Neurology Clinic, with "regressive > encephalopathy (brain disease) with features consistent with > autistic spectrum disorder, following normal development." The girl > also met the Diagnostic and Statistical Manual for Mental Disorders > (DSM-IV) official criteria for autism.> In its written concession, the government said the child had a pre- > existing mitochondrial disorder that was "aggravated" by her shots, > and which ultimately resulted in an ASD diagnosis.> "The vaccinations received on July 19, 2000, significantly > aggravated an underlying mitochondrial disorder," the concession > says, "which predisposed her to deficits in cellular energy > metabolism, and manifested as a regressive encephalopathy with > features of ASD."> This statement is good news for the girl and her family, who will > now be compensated for the lifetime of care she will require. But > its implications for the larger vaccine-autism debate, and for > public health policy in general, are not as certain.> In fact, the government's concession seems to raise more questions > than it answers.> 1) Is there a connection between vaccines, mitochondrial disorders > and a diagnosis of autism, at least in some cases?> Mitochondria, you may recall from biology class, are the little > powerhouses within cells that convert food into electrical energy, > partly through a complex process called "oxidative phosphorylation." > If this process is impaired, mitochondrial disorder will ensue.> The child in this case had several markers for Mt disease, which was > confirmed by muscle biopsy. Mt disease is often marked by lethargy, > poor muscle tone, poor food digestion and bowel problems, something > found in many children diagnosed with autism.> But mitochondrial disorders are rare in the general population, > affecting some 2-per-10,000 people (or just 0.2%). So with 4,900 > cases filed in Vaccine Court, this case should be the one and only, > extremely rare instance of Mt disease in all the autism proceedings.> But it is not.> Mitochondrial disorders are now thought to be the most common > disease associated with ASD. Some journal articles and other > analyses have estimated that 10% to 20% of all autism cases may > involve mitochondrial disorders, which would make them one thousand > times more common among people with ASD than the general population.> Another article, published in the Journal of Child Neurology and co- > authored by Dr. Zimmerman, showed that 38% of Kennedy Krieger > Institute autism patients studied had one marker for impaired > oxidative phosphorylation, and 47% had a second marker.> The authors -- who reported on a case-study of the same autism claim > conceded in Vaccine Court -- noted that "children who have > (mitochondrial-related) dysfunctional cellular energy metabolism > might be more prone to undergo autistic regression between 18 and 30 > months of age if they also have infections or immunizations at the > same time."> An interesting aspect of Mt disease in autism is that, with ASD, the > mitochondrial disease seems to be milder than in "classic" cases of > Mt disorder. In fact, classic Mt disease is almost always inherited, > either passed down by the mother through mitochondrial DNA, or by > both parents through nuclear DNA.> In autism-related Mt disease, however, the disorder is not typically > found in other family members, and instead appears to be largely of > the sporadic variety, which may now account for 75% of all > mitochondrial disorders.> Meanwhile, an informal survey of seven families of children with > cases currently pending in Vaccine Court revealed that all seven > showed markers for mitochondrial dysfunction, dating back to their > earliest medical tests. The facts in all seven claims mirror the > case just conceded by the government: Normal development followed by > vaccination, immediate illness, and rapid decline culminating in an > autism diagnosis.> 2) With 4,900 cases pending, and more coming, will the government > concede those with underlying Mt disease -- and if it not, will the > Court award compensation?> The Court will soon begin processing the 4900 cases pending before > it. What if 10% to 20% of them can demonstrate the same Mt disease > and same set of facts as those in the conceded case? Would the > government be obliged to concede 500, or even 1,000 cases? What > impact would that have on public opinion? And is there enough money > currently in the vaccine injury fund to cover so many settlements?> When asked for a comment last week about the court settlement, a > spokesman for HHS furnished the following written statement:>> "DVIC has reviewed the scientific information concerning the > allegation that vaccines cause autism and has found no credible > evidence to support the claim. Accordingly, in every case under the > Vaccine Act, DVIC has maintained the position that vaccines do not > cause autism, and has never concluded in any case that autism was > caused by vaccination.">> 3) If the government is claiming that vaccines did not "cause" > autism, but instead aggravated a condition to "manifest" as autism, > isn't that a very fine distinction?> For most affected families, such linguistic gymnastics is not so > important. And even if a vaccine injury "manifested" as autism in > only one case, isn't that still a significant development worthy of > informing the public?> On the other hand, perhaps what the government is claiming is that > vaccination resulted in the symptoms of autism, but not in an > actual, factually correct diagnosis of autism itself.> 4) If the government is claiming that this child does NOT have > autism, then how many other children might also have something else > that merely "mimics" autism?> Is it possible that 10%-20% of the cases that we now label as > "autism," are not autism at all, but rather some previously > undefined "look-alike" syndrome that merely presents as "features" > of autism?> This question gets to the heart of what autism actually is. The > disorder is defined solely as a collection of features, nothing > more. If you have the features (and the diagnosis), you have the > disorder. The underlying biology is the great unknown.> But let's say the government does determine that these kids don't > have actual "autism" (something I speculated on HuffPost a year > ago). Then shouldn't the Feds go back and test all people with ASD > for impaired oxidative phosphorylation, perhaps reclassifying many > of them?> If so, will we then see "autism" cases drop by tens, if not hundreds > of thousands of people? Will there be a corresponding ascension of a > newly described disorder, perhaps something like "Vaccine Aggravated > Mitochondrial Disease with Features of ASD?"> And if this child was technically "misdiagnosed" with DSM-IV autism > by Dr Zimmerman, how does he feel about HHS doctors issuing a second > opinion re-diagnosis of his patient, whom they presumably had > neither met nor examined? (Zimmerman declined an interview).> And along those lines, aren't Bush administration officials somewhat > wary of making long-distance, retroactive diagnoses from Washington, > given that the Terry Schiavo incident has not yet faded from > national memory?> 5) Was this child's Mt disease caused by a genetic mutation, as the > government implies, and wouldn't that have manifested as "ASD > features" anyway?> In the concession, the government notes that the patient had a > "single nucleotide change" in the mitochondrial DNA gene T2387C, > implying that this was the underlying cause of her manifested > "features" of autism.> While it's true that some inherited forms of Mt disease can manifest > as developmental delays, (and even ASD in the form of Rhett > Syndrome) these forms are linked to identified genetic mutations, of > which T2387C is not involved. In fact little, if anything, is known > about the function of this particular gene.> What's more, there is no evidence that this girl, prior to > vaccination, suffered from any kind of "disorder" at all- genetic, > mitochondrial or otherwise. Some forms of Mt disease are so mild > that the person is unaware of being affected. This perfectly > developing girl may have had Mt disorder at the time of vaccination, > but nobody detected, or even suspected it.> And, there is no evidence to suggest that this girl would have > regressed into symptoms consistent with a DSM-IV autism diagnosis > without her vaccinations. If there was such evidence, then why on > earth would these extremely well-funded government attorneys > compensate this alleged injury in Vaccine Court? Why wouldn't they > move to dismiss, or at least fight the case at trial?> 6) What are the implications for research?> The concession raises at least two critical research questions: What > are the causes of Mt dysfunction; and how could vaccines aggravate > that dysfunction to the point of "autistic features?"> While some Mt disorders are clearly inherited, the "sporadic" form > is thought to account for 75% of all cases, according to the United > Mitochondrial Disease Foundation. So what causes sporadic Mt > disease? "Medicines or other toxins," says the Cleveland Clinic, a > leading authority on the subject.> Use of the AIDS drug AZT, for example, can cause Mt disorders by > deleting large segments of mitochondrial DNA. If that is the case, > might other exposures to drugs or toxins (i.e., thimerosal, mercury > in fish, air pollution, pesticides, live viruses) also cause > sporadic Mt disease in certain subsets of children, through similar > genotoxic mechanisms?> Among the prime cellular targets of mercury are mitochondria, and > thimerosal-induced cell death has been associated with the > depolarization of mitochondrial membrane, according to the > International Journal of Molecular Medicine among several others. > (Coincidently, the first case of Mt disease was diagnosed in 1959, > just 15 years after the first autism case was named, and two decades > after thimerosal's introduction as a vaccine preservative.)> Regardless of its cause, shouldn't HHS sponsor research into Mt > disease and the biological mechanisms by which vaccines could > aggravate the disorder? We still do not know what it was, exactly, > about this girl's vaccines that aggravated her condition. Was it the > thimerosal? The three live viruses? The two attenuated viruses? > Other ingredients like aluminum? A combination of the above?> And of course, if vaccine injuries can aggravate Mt disease to the > point of manifesting as autism features, then what other underlying > disorders or conditions (genetic, autoimmune, allergic, etc.) might > also be aggravated to the same extent?> 7) What are the implications for medicine and public health?> Should the government develop and approve new treatments for > "aggravated mitochondrial disease with ASD features?" Interestingly, > many of the treatments currently deployed in Mt disease (i.e., > coenzyme Q10, vitamin B-12, lipoic acid, biotin, dietary changes, > etc.) are part of the alternative treatment regimen that many > parents use on their children with ASD.> And, if a significant minority of autism cases can be linked to Mt > disease and vaccines, shouldn't these products one day carry an FDA > Black Box warning label, and shouldn't children with Mt disorders be > exempt from mandatory immunization?> 8) What are the implications for the vaccine-autism debate?> It's too early to tell. But this concession could conceivably make > it more difficult for some officials to continue insisting there is > "absolutely no link" between vaccines and autism.> It also puts the Federal Government's Vaccine Court defense strategy > somewhat into jeopardy. DOJ lawyers and witnesses have argued that > autism is genetic, with no evidence to support an environmental > component. And, they insist, it's simply impossible to construct a > chain of events linking immunizations to the disorder.> Government officials may need to rethink their legal strategy, as > well as their public relations campaigns, given their own slightly > contradictory concession in this case.> 9) What is the bottom line here?> The public, (including world leaders) will demand to know what is > going on inside the US Federal health establishment. Yes, as of now, > n=1, a solitary vaccine-autism concession. But what if n=10% or 20%? > Who will pay to clean up that mess?> The significance of this concession will unfortunately be fought > over in the usual, vitriolic way -- and I fully expect to be slammed > for even raising these questions. Despite that, the language of this > concession cannot be changed, or swept away.> Its key words are "aggravated" and "manifested." Without the > aggravation of the vaccines, it is uncertain that the manifestation > would have occurred at all.> When a kid with peanut allergy eats a peanut and dies, we don't say > "his underlying metabolic condition was significantly aggravated to > the extent of manifesting as an anaphylactic shock with features of > death."> No, we say the peanut killed the poor boy. Remove the peanut from > the equation, and he would still be with us today.> Many people look forward to hearing more from HHS officials about > why they are settling this claim. But whatever their explanation, > they cannot change the fundamental facts of this extraordinary case:> The United State government is compensating at least one child for > vaccine injuries that resulted in a diagnosis of autism.> And that is big news, no matter how you want to say it.> NOTE: Full text of the government's statement is posted here.> David Kirby is the author of "Evidence of Harm - Mercury in Vaccines > and the Autism Epidemic, A Medical Controversy" (St. Martins Press > 2005> Laura Cox is offline Add to Laura Cox's Reputation Report Post IP > Edit/Delete Message

AUTISM: THE MUSICAL - HBO Documentary Films®

Unlocking the inner world of autism Follow the emotional journey of five autistic children who star in their own stage show in the moving HBO Documentary Films presentation of Autism: The Musical, premiering Tuesday, March 25 at 8 pm.

AUTISM SPEAKS UNVEILS 100 DAY KIT, A UNIQUE RESOURCE FOR PARENTS OF CHILDREN NEWLY DIAGNOSED WITH AUTISM

AUTISM SPEAKS UNVEILS 100 DAY KIT, A UNIQUE RESOURCEFOR PARENTS OF CHILDREN NEWLY DIAGNOSED WITH AUTISMProviding Families with Connections to Resources and Support Services in Their CommunitiesNEW YORK, NY (February 29, 2008) -- Autism Speaks, the nation's largestautism advocacy organization, today announced the launch of its 100 DayKit, a personalized resource to assist families in getting through thecritical time following an autism diagnosis. In addition to receivingthe contents of the kit, which includes information about services andservice providers in a family's community, those who register will alsobe connected with a regional Autism Speaks Autism Response Team memberwho can provide further insight and guidance. A personalized version of the 100 Day Kit is available by visitinghttp://www.autismspeaks.org/community/family_services/100_day_kit.php<http://www.autismspeaks.org/community/family_services/100_day_kit.php>, where parents of a newly diagnosed child will be asked to fill out ashort survey. In response, an Autism Response Team coordinator willcontact the family to get additional information so that the 100 Day Kitcan be tailored to include resources specific to their child's age andlocation. The family will receive a binder with pertinent information,as well as contact information for an Autism Response Team coordinatorin their region who has been trained specifically to answer questionsthey may have. The turn-around time for a new kit will be approximately one week fromthe date of the initial request. Members of the Autism Response Teamwill follow up with families four months after they receive the 100 DayKit to see how they are doing, answer any questions they may have, andsolicit their feedback. Families may also download the text of the kitwithout registering - and without personalization - and use AutismSpeaks' Family Services Resource Guide to access local resourceinformation. The 100 Day Kit includes basic information about autism and dealing withthe news of a diagnosis. The personalized kit lists local serviceproviders, support groups, recreational activities, sources of legalinformation, conferences, local autism and disability organizations andinformation about the local chapter of Autism Speaks. It providesinsight into getting services for a newly diagnosed child and explainsvarious available treatment options. A week-by-week action plan helpswalk a family through the steps it needs to take to ensure that it is onthe right track. The kit also includes a glossary of terms associatedwith autism, as well as a safety plan and a list of recommended booksand informational web sites."When a child is diagnosed with autism, his or her parents are oftenleft feeling overwhelmed and confused about what to do next and where toturn for help," said Peter Bell, Autism Speaks Executive Vice Presidentfor Programs and Services. "This kit will be a valuable tool for thesefamilies and will help make the first few weeks and months afterdiagnosis a little less daunting.""Parents need to know that they are not alone," said Lisa Goring, AutismSpeaks Director of Family Services. "The 100 Day Kit and the AutismResponse Team will help families get informed, get organized and getconnected to important resources and support services in theircommunity."The 100 Day Kit was created by the Autism Speaks Family Services staffin conjunction with a professional advisory committee comprised oftwelve autism professionals, a parent advisory committee that includedparents from across the country, and members of the Autism Speaks FamilyServices Committee.About AutismAutism is a complex brain disorder that inhibits a person's ability tocommunicate and develop social relationships, and is often accompaniedby extreme behavioral challenges. Autism spectrum disorders arediagnosed in one in 150 children in the United States, affecting fourtimes as many boys as girls. The diagnosis of autism has increasedtenfold in the last decade. The Centers for Disease Control andPrevention have called autism a national public health crisis whosecause and cure remain unknown.About Autism Speaks Autism Speaks is dedicated to increasing awareness of autism spectrumdisorders, to funding research into the causes, prevention andtreatments for autism, and to advocating for the needs of individualswith autism and their families. It was founded in February 2005 bySuzanne and Bob Wright, the grandparents of a child with autism. BobWright is Vice Chairman, General Electric, and served as chairman andchief executive officer of NBC Universal for more than twenty years. Tolearn more about Autism Speaks, please visit www.autismspeaks.org<http://www.autismspeaks.org/> .