Research Study To Establish Criteria For Early Diagnosis Of Alzheimer’s Disease In Down Syndrome, Leading To Earlier Treatment

The Institute for Basic Research in Developmental Disabilities (IBR), a vital branch of the New York State Office for People with Developmental Disabilities (OPWDD) will play a key role in addressing crucial gaps in knowledge about Alzheimer’s disease in adults with Down syndrome through new research funded by an $8.5 million grant from the National Institutes of Health (NIH).

The grant, a continuation of an existing project, was awarded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development: Intellectual and Developmental Disabilities Branch, and will support part of IBR’s Research Program on Aging; funding will be provided through May 31, 2015. This work will be done in close collaboration with scientists at the Kennedy Krieger Institute and the Johns Hopkins University, Baltimore, and Columbia University Medical Center, Manhattan. The directors of specific projects include Warren Zigman, PhD, Edmund Jenkins, PhD, and Sharon Krinsky-McHale, PhD, at IBR; Wayne Silverman, PhD, at the Kennedy Krieger Institute; and Nicole Schupf, PhD, DrPH, Benjamin Tycko, MD, PhD, and Joseph Lee, DrPH, at Columbia University.

“Since this program began in 1987, it has developed into one of the largest research efforts of its kind in the world,” said IBR Director W. Ted Brown, MD, PhD. “The findings may have direct implications for promoting more successful treatment and outcomes for adults with Down syndrome as they age.”

“Early signs of Alzheimer’s disease can be difficult to distinguish from the normal aging process in any older adult. For adults with Down syndrome, who are particularly vulnerable to Alzheimer’s disease, it is even more so,” said Brown. “Because effective intervention needs to begin as early in the disease process as possible, prior to the onset of the irreversible impacts on the brain that are characteristic of this devastating disease, early diagnosis is of critical importance.”

This program’s earlier studies showed that risk for dementia among adults with Down syndrome was lower than expected in their 30s and early 40s, but increased substantially thereafter, much as Alzheimer’s disease risk increases in the overall population from the late 60s onward. Earlier findings also revealed that some health-related factors influence whether a specific individual with Down syndrome will be at higher or lower risk. They also showed that risk of Alzheimer’s disease for adults with intellectual disability who do not have Down syndrome seems to be similar to what it is in the general population.

The work will now undertake a variety of projects to extend the understanding of the onset and progression of Alzheimer’s disease within the older population with Down syndrome to its earliest stage of clinical impact.

These projects will:

- Conduct studies to determine if risk for Alzheimer’s disease within the elderly population with Down syndrome might be associated with insulin resistance;

- Develop empirically validated methods for identifying the presence of mild cognitive impairment (state of mind impairment that is intermediate between declines associated with lifespan brain aging and the deficits that occur in conjunction with dementia) in adults with Down syndrome, differentiating this condition from cognitive changes associated with developmentally appropriate aging;

- Determine the role of basic biological mechanisms that underlie Alzheimer’s disease, including altered patterns of DNA methylation (a chemical modification in DNA) and other observed characteristics within this population, including aging-selected processes; and

- Ascertain the contribution of genetic variants that may influence cognitive function, risk for Alzheimer’s disease and age at onset of Alzheimer’s disease in adults with DS.

“This study will help us find out why dementia does not develop or is postponed in some individuals with Down syndrome, despite their higher risk for developing Alzheimer’s disease,” said Brown. “It also will establish how we can identify dementia in its earliest stages, possibly leading to earlier treatments.”

“Through this new study, IBR, together with two other renowned research organizations, will help OPWDD better support successful and improve care for adults with Down syndrome as they age and, perhaps, other individuals with developmental disabilities who are at risk for dementia,” said OPWDD Acting Commissioner Max E. Chmura.

About Down syndrome

Down syndrome is the most common and readily identifiable chromosomal conditions associated with intellectual disabilities. Down syndrome is a genetic disorder that occurs in approximately one in 800 live births. It is caused most often by an abnormality during cell division in gamete formation called nondysjunction. As a result, the fertilized egg will contain three copies of chromosome 21. The extra chromosome interferes with normal growth and development. Therefore, it is important for parents, health care professionals, and teachers to have a clear and accurate understanding of each child’s medical concerns and level of developmental functioning. In most cases, the diagnosis of Down syndrome is made according to results from a chromosome test administered shortly after birth. Although parents of any age may have a child with Down syndrome, the incidence is higher for women of advanced age (greater than 35 years).

Source:

OPWDD

IBR

Bystander CPR Can Improve Survival Of Children Who Have Cardiac Arrests Outside Of A Hospital, Children’s Hospital Researchers Say

Bystanders who perform cardiopulmonary resuscitation (CPR) on a child with cardiac arrest increase the child’s likelihood of survival, according to the largest pediatric study to date. The outcomes are similar for both chest compression alone (hands-only) CPR and CPR with chest compression and rescue breathing.

CPR was more effective when rescue breathing was combined with chest compressions for children with cardiac arrest from non-cardiac causes, such as trauma, near-drowning or respiratory problems. Nevertheless, say the authors, because most children suffering cardiac arrest outside a hospital receive no bystander CPR, even compression-only CPR is preferable to no CPR.

The study, Bystander-initiated Conventional and Chest Compression-only Cardiopulmonary Resuscitation for Pediatric Out-of-hospital Cardiac Arrests, was published online today by the medical journal, The Lancet. Lead authors are Tetsuhisa Kitamura, M.D., Taku Iwami, M.D., and Takashi Kawamura, M.D., of Kyoto University Health Service. Two prominent U.S. pediatric CPR researchers from The Children’s Hospital of Philadelphia, Robert Berg M.D. and Vinay Nadkarni M.D. collaborated to study, analyze and interpret data and co-author the final report.

This is the largest study of children to identify the important beneficial impact of bystander CPR on pediatric cardiac arrest survival outcomes. Importantly, the relative value of rescue breathing during bystander-initiated CPR depends on the cause of the arrest, whether from an underlying heart condition, or a non-cardiac cause such as sudden trauma, near drowning or respiratory illness.

“This study is the first large study to specifically confirm that CPR with rescue breathing is the best approach for a cardiac arrest from respiratory problems in children,” said Robert A. Berg, M.D., chief of Critical Care Medicine at the Children’s Hospital of Philadelphia. “Our study is also sufficiently large to identify the important beneficial effect of any bystander CPR on survival outcomes after pediatric cardiac arrest.”

The American Heart Association recommends bystanders who are not trained or willing to provide rescue breathing with CPR to provide “hands-only” chest compressions for adults who have cardiac arrests outside of a hospital. However, previous studies have not had a large enough sample size or enough children included to evaluate this strategy for children.

These researchers enrolled 5,170 children ages 1 through 17 who had had an out-of-hospital cardiac arrest in Japan. They compared whether or not the children had been given CPR, and if so, whether CPR was compression-only or CPR with rescue breathing.

Children receiving any CPR were three times more likely to have better survival outcomes (4.5 percent of those patients receiving CPR had a favorable outcome compared with 1.9 percent who received no CPR). In children whose cardiac arrests had a non-cardiac cause, conventional CPR with rescue breathing was more likely to improve survival than compression-only CPR. (7.2 percent compared with 1.6 percent). For children whose arrests were cardiac in cause, both types of CPR had the same effect.

“CPR with rescue breathing should continue to be taught as the gold standard for those who care for children and who have a duty to respond,” said Vinay Nadkarni, M.D., another co-author of the study and medical director of the Center for Simulation, Advanced Education and Innovation at Children’s Hospital. “Most importantly, if you witness a child suddenly collapse, such as an athlete on the field, and suspect cardiac arrest, perform at least chest compressions until medical help and a defibrillator arrives.”

The study authors encourage a two-pronged CPR training strategy: hands-only CPR training for everyone, to increase CPR by bystanders, and conventional CPR (chest-compression plus rescue breathing) training for individuals who are most likely to witness children who have cardiac arrests with non-cardiac causes, such as medical professionals, lifeguards, school teachers, families with children, and families with swimming pools.

Other authors include Ken Nagao M.D., of Surugadai Nihon University Hospital, Tokyo; Hideharu Tanaka, M.D. of Kokushikan University, Tokyo; and Atsushi Hiraide M.D., of Kyoto University Graduate School of Medicine, Kyoto.

About The Children’s Hospital of Philadelphia: The Children’s Hospital of Philadelphia was founded in 1855 as the nation’s first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children’s Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 441-bed hospital recognition as a leading advocate for children and adolescents.

Source: The Children’s Hospital of Philadelphia

Asthma Diagnosis Using Electronic Nose

An “electronic nose” may one day be used to diagnose asthma, say researchers who presented a preliminary study of the device at the American Thoracic Society 2007 International Conference.

The device contains chemical vapor sensors that react to the presence of volatile organic compounds, or VOCs, in a person’s exhaled breath. “A person’s breath contains a mixture of thousands of VOCs that may be used as markers of lung disease,” says researcher Silvano Dragonieri, M.D., of Leiden University Medical Center in the Netherlands.

The electronic nose is a newer version of a sensor that has been used in the food, wine and perfume industries. It is also being used as an aid against terrorism, to sniff out explosives or toxic chemicals in the air.

An electronic nose responds to a given odor by generating a pattern, or “smell print,” which is analyzed and compared with stored patterns. An electronic nose has been developed that can diagnose respiratory infections such as pneumonia by comparing smell prints from the breath of a sick patient with those of patients with standardized readings. It is also being studied as a diagnostic tool for lung cancer.

In the new study, the researchers compared the “smell prints” of 20 people with diagnosed asthma (half with severe asthma and half with mild disease) and 20 people without asthma to see if the electronic nose could classify them as asthmatic or non-asthmatic. The subjects breathed into a face mask attached to a bag connected to the electronic nose.

The nose was able to detect which smell prints came from people with asthma, but was less accurate in classifying how severe a person’s asthma was. “The asthmatic patients in this study already had been diagnosed with asthma,” Dr. Dragonieri says. “The next step is to see whether the nose can diagnose new patients with asthma. It’s still a futuristic device – one day different electronic noses may be built to detect specific diseases.”

“An Electronic Nose in the Classification of Asthma” (Session B96; Abstract # 2470)

Contact: Suzy Martin

American Thoracic Society

UNICEF Congo: Law For Indigenous Populations Welcome Milestone

UNICEF hailed a groundbreaking new law that gives Congolese children belonging to indigenous populations – until now the most vulnerable amongst the vulnerable – a legal basis to access health, education and protection.

“This law is unique in the region and sets an example for all other countries having indigenous populations similar to the ones in Congo,” said Marianne Flach, UNICEF Country Representative, in Congo. “This is a great step forward for the children of the Congo, and represents a milestone in Congolese history.”

The Senate adopted the law protecting and promoting the rights of indigenous populations after the National Assembly ratified it and as a response to the recommendations made by the International Committee on the Rights of the Child and as way to consolidate of Congo’s engagement in the Convention on the Rights of the Child which the nation ratified in 1993.

“This law is the beginning of a long road to ensure that discrimination and exploitation of our indigenous brothers and sisters finally ends,” said Mr Aim?©-Emmanuel Yoka the Minister of Justice and Human Rights. “It is also the opportunity for them to gain equitable access to basic social services so they can attain a dignified way of living, always respecting their cultures and traditions.”

Addressing the needs of the most vulnerable and the most isolated population is a cornerstone of UNICEF’s strategy to accelerate toward the achievement of the Millennium Development Goals.

In the Congo, one of the poorest countries in the world, indigenous populations are precariously balanced on the bottom rung of the society, the poorest of the poor.

A vast majority of them live under the poverty line, 50 per cent of the children have no birth certificate, one out five children dies before reaching the age of five (in the rest of the population, one in eight children die before five); 40 per cent of children suffer chronic malnourishment and where 75 per cent of young people lack any schooling.

The law is the result of a wide group of partners, including the Government, the Parliament, civil society organizations, in particular the Congolese Observatory of Human Rights (OCDH), the National Network of Indigenous Populations of Congo (RENAPAC) as well as the UN Centre for Human Rights and Democracy in Central Africa, the UN system, the European Union and donor governments.

The next step is the enactment of the law by the President. “This is the beginning of a long road leading to diffusion and application of the law by the authorities” said Mrs Flach, “This is the only way to ensure this law becomes a reality for the most vulnerable in the Congo”.

Source:

UNICEF

Social Support Improves Mental Health After A Traumatic Health Care Intervention

Support from hospital staff and family is an important factor in preventing post-traumatic stress disorder after a major intensive-care intervention. A study published 15 October 2006 in the open access journal Critical Care reveals that patients who were successfully treated for severe acute respiratory distress syndrome (ARDS) are less likely to report symptoms of post-traumatic stress disorder (PTSD) if they feel that they were supported during and after the intervention in the Intensive Care Unit.

Maria Deja and colleagues from the Charite Hospital in Berlin, Germany, studied 65 survivors of ARDS on average 4.7 years after the patients had been discharged from the Intensive Care Unit (ICU) in their hospital. PTSD, health- related quality of life, symptoms of psychopathology and perception of social support were assessed in these people using standard questionnaires. The authors compared the questionnaire scores of ARDS survivors with the scores of healthy individuals who hadn’t suffered from ARDS.

Deja et al.’s results show that ARDS survivors’ health-related quality of life was significantly reduced. Eighteen ARDS survivors were identified as being at increased risk for PTSD, and this was not related to the severity or to the cause of their ARDS. But these people did report having experienced more anxiety while at the ICU, and also showed a tendency to remember experiences of pain more often than ARDS survivors who were not at risk of PTSD. In addition, psychological problems were significantly more intense in ARDS survivors who were at risk of PTSD. These patients showed a reduced mental dimension of quality of life compared to ARDS survivors who were not at risk of PTSD and compared to healthy individuals. For survivors who were at risk of PTSD, the perception of the support they had received was significantly lower than that of the other group of ARDS survivors. Overall, better-perceived social support was associated with a reduction in PTSD symptoms.

The authors also find that ARDS survivors who were at risk of PSTD were more likely to claim benefits or be unable to work.

Deja et al. conclude: “The main result of our study was that social support and its probable mental health benefits may favourably affect the long-term outcome, including the employment status, of ICU patients who recover from ARDS.”

Article: Social support during intensive care unit stay might reduce the risk for the development of posttraumatic stress disorder and consequently improve health related quality of life in survivors of acute respiratory distress syndrome Maria Deja, Claudia Denke, Steffen Weber-Carstens, Juergen Schroeder, Christian E Pille, Frank Hokema, Konrad J Falke and Udo Kaisers Critical Care 2006, in press

Contact: Juliette Savin

BioMed Central

National Autism Association Teams Up With 12 Organizations To End Abusive Restraint And Seclusion In Schools

The National Autism Association (NAA) along with 12 other organizations launched a campaign this week to spur letter writing and raise awareness about dangerous restraint and seclusion practices in schools. The initiative comes on the heels of the May 19th GAO Report that revealed no federal laws regulating restraint and seclusion in schools, no laws in 19 states, and “widely divergent” laws in remaining states.

It also investigated cases where two children died from “mechanical compression to the chest” and being “smothered to death,” one died from restraint following a seizure, another died from hanging himself in a seclusion room. Other cases included a four-year-old girl who was tied to a chair and abused, five children who were duct-taped to their desks, and a ten-year-old boy who was put in a seclusion room “75 times over a 6-month period for hours at a time for offenses such as whistling, slouching and hand-waving.”

The report only adds to stories around the country of disabled children being handcuffed, locked in closets and bathrooms, and restrained with chemicals and lemon spray. “These are essentially torture tactics that are outlawed for terrorists, but children with autism and other disabilities have no federal regulations in place protecting them,” says Wendy Fournier of NAA. “We’re not speaking of all teachers – but we do need to protect children from the ones who are putting them in danger.”

This week, the group launched an ad campaign with headlines that called handcuffs “the new circle time, and “when our disabled children can’t figure out how to sit still, more schools are showing them the ropes.” They’re asking lawmakers to ban dangerous restraint and seclusion and enforce proper training, ample reporting, and better monitoring.

Source: National Autism Association

NICE Recommendation On Alzheimer’s Medicines – ABPI Statement

The Association of the British Pharmaceutical Industry (ABPI) today welcomed the revised position on Alzheimer’s medicines expressed by NICE while expressing disappointment that their value for people with mild Alzheimer’s has still not been recognised.

And the ABPI also stressed that it was important that NICE’s recommendation actually resulted in people receiving the medicines and not still being subject to the vagaries of local funding.

“There is no point in NICE making recommendations that are then ignored on the ground,” said Dr Richard Barker, Director General of the ABPI. “We want people to benefit from these medicines yet, sadly, it is often the case that local health authorities put budgetary considerations over people’s wellbeing by not allowing them to be prescribed.”

Although the current Alzheimer’s treatments are licensed for use in mild to moderate Alzheimer’s – as is the case throughout Europe and around the world – the NICE recommendation is for use with those who have moderate Alzheimer’s only.

“While the decision to allow patients with moderate Alzheimer’s treatment with these medicines is naturally welcome, it is disappointing that their potential value in those with the mild form of the condition has not been recognised,” Dr Barker said. “Doing everything possible to prevent or at least slow down the development of this distressing condition should be a top priority for the health service.”

ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY

Columbia University Medical Center Joins Study To Find Earliest Changes In The Brain That May Lead To Alzheimer’s Disease

Volunteers in New York, NY are being sought for a clinical study examining the subtle changes that may take place in the brains of older people many years before overt symptoms of Alzheimer’s disease (AD) appear. Researchers at Columbia University Medical Center are specifically looking for people with the very earliest complaints of memory problems that affect their daily activities. The study will follow participants over time, using imaging techniques specifically developed to advance research into changes taking place in the structure and function of the living brain, as well as biomarker measures found in blood and cerebrospinal fluid.

More than 5.3 million people across the U.S. are suffering from AD, and every 70 seconds, another person develops this devastating disease. In New York alone, approximately 320,000 people aged 65 and older are currently living with AD, making finding a cure a pressing need in our local communities.

The National Institute on Aging (NIA), part of the National Institutes of Health, and the NIH Office of the Director are funding the $24 million, two-year Alzheimer’s Disease Neuroimaging Initiative Grand Opportunity (ADNI-GO) study. Researchers seek to recruit local volunteers between the ages of 55 and 90 who may be transitioning from normal cognitive aging to an early stage of amnestic mild cognitive impairment (aMCI), a condition that may progress to Alzheimer’s disease, but are otherwise healthy. In addition to Columbia University Medical Center, there are 49 other sites across the United States participating in the study.

“ADNI-GO is part of an ongoing effort to establish imaging and fluid biomarker measures of Alzheimer’s disease from the onset of mild symptoms to the advanced stages of the disease process,” said NIA Director Richard J. Hodes, M.D. “By advancing understanding of the full spectrum of the disease, we’ll be better able to identify who is at risk, track progression of the disorder, and devise measurements to test the effectiveness of potential prevention or treatment strategies.”

The grant expands the efforts of the Alzheimer’s Disease Neuroimaging Initiative (ADNI), a research partnership supported primarily by the NIA with private-sector support through the Foundation for the National Institutes of Health. ADNI began in 2004 to establish neuroimaging and biomarker measures to track the changes taking place in the brains of 800 older people either free of symptoms or diagnosed with late-stage MCI and early Alzheimer’s disease. ADNI is led by the Northern California Institute for Research and Education, a nonprofit foundation affiliated with the San Francisco VA Medical Center. Michael Weiner, M.D., is the principal investigator.

The new ADNI-GO effort enables researchers to continue studying nearly 500 of the original ADNI volunteers, including those in New York, NY, while expanding the study to include the new participants with early amnestic MCI. Newly enrolled participants and some original study volunteers will undergo a lumbar puncture to collect cerebrospinal fluids.

“We cannot end this terrible disease unless we know more about it,” said Yaakov Stern, Ph.D., principal investigator at Columbia and professor of clinical neuropsychology in the Departments of Neurology, Psychiatry, and Psychology at the Taub Institute for the Research on Alzheimer’s Disease and the Aging Brain at Columbia University Medical Center. “This is where amazing volunteers, their friends and their families can make the difference in our success.”

About ADNI

In addition to NIA, the original ADNI study involved other federal partners: the National Institute of Biomedical Imaging and Bioengineering, also part of NIH, and the U.S. Food and Drug Administration, another agency of the U.S. Department of Health and Human Services. To learn more about ADNI advances and the private-public partnership supporting the research, go here.

The NIA leads the federal government effort conducting and supporting research on the biomedical, social and behavioral issues of older people. For more information on aging-related research and the NIA, go here. The NIA provides information on age-related cognitive change and neurodegenerative disease specifically at its Alzheimer’s Disease Education and Referral (ADEAR) Center site.

Foundation for the National Institutes of Health (FNIH) was established by the United States Congress to support the mission of the National Institutes of Health-improving health through scientific discovery. The foundation identifies and develops opportunities for innovative public-private partnerships involving industry, academia, and the philanthropic community. A non-profit, 501(c)(3) corporation, the foundation raises private-sector funds for a broad portfolio of unique programs that complement and enhance NIH priorities and activities.

The 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.

Source:

Columbia University Medical Center

Foundation for the National Institutes of Health

FDA Expands ENBREL Psoriatic Arthritis Indication

Amgen Inc and Wyeth Pharmaceuticals, a division of Wyeth, today announced that the US Food and Drug Administration (FDA)
approved an expanded indication for Enbrel(R) (etanercept) to improve physical function in patients with psoriatic arthritis.
ENBREL is the first and only treatment to receive this expanded indication. In addition, the FDA approved an update to the
ENBREL label to include new radiographic data demonstrating that ENBREL continued to inhibit the progression of joint
destruction for two years among most psoriatic arthritis patients who received ongoing therapy.

ENBREL received its approval to treat signs and symptoms of psoriatic arthritis in 2002. With this expanded approval, ENBREL
is now indicated for reducing signs and symptoms, inhibiting the progression of joint destruction of active arthritis
associated with psoriatic arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL is also
approved to treat moderate-to-severe rheumatoid arthritis and juvenile rheumatoid arthritis, ankylosing spondylitis and
moderate-to-severe plaque psoriasis.

“This approval for improving physical function and the addition of the two-year radiographic data builds on the
well-established efficacy and safety profile of ENBREL in psoriatic arthritis. No other treatment has been FDA-approved to
provide efficacy for psoriatic arthritis patients using these multiple clinical measures,” said Will Dere, M.D., chief
medical officer and senior vice president of global development, Amgen. “ENBREL is unique because it has received 10 FDA
approvals in five distinct diseases and has been used by more than 280,000 patients worldwide across indications. ENBREL also
has 12 years of collective clinical experience.”

The expanded approval of ENBREL was based on significant improvements in physical function as assessed by the disability
index of the Health Assessment Questionnaire (HAQ), a test used to evaluate a patient’s ability to perform daily activities
such as dressing, walking and grooming, and the Medical Outcomes Study Short-Form Health Survey (SF-36), a measurement tool
that also assesses the physical impact of a disease.

Almost 40 percent of psoriatic arthritis patients taking ENBREL in this study achieved a HAQ score of zero, indicating no
functional disability at 24 weeks. In addition, the SF-36 found that many patients treated with ENBREL experienced a greater
improvement from baseline, compared to placebo, in their ability to participate in physical activities such as walking,
carrying groceries, or climbing a flight of stairs.

Psoriatic arthritis is a chronic, often destructive disease characterized by both joint inflammation and erosion, and is
associated with psoriatic skin lesions. The progressive joint pain and swelling, which is often coupled with painful, scaly,
red skin lesions, can disrupt a person’s ability to perform activities of daily life that most people take for granted such
as getting dressed, eating or walking. Approximately one million people suffer from psoriatic arthritis in the United States.

“We are pleased that ENBREL has shown the ability to inhibit the progression of joint destruction for a continuous two years
in most psoriatic arthritis patients in this study, which is vital in helping to ease the debilitating effects of this
disease,” said Gary L. Stiles, M.D., executive vice president and chief medical officer of Wyeth Pharmaceuticals. “Similar to
rheumatoid arthritis, ENBREL is the only treatment approved to provide long-term inhibition of joint destruction for most
patients.”

ABOUT ENBREL

ENBREL is the only soluble tumor necrosis factor (TNF) receptor approved to reduce signs and symptoms, induce major clinical
response, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely
active rheumatoid arthritis (RA). ENBREL can be used alone or in combination with methotrexate.

ENBREL is the only treatment indicated to reduce the signs and symptoms, inhibit the progression of structural damage of
active arthritis, and improve physical function in patients with psoriatic arthritis. It is approved to reduce the signs and
symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients four years of
age or older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). It is also
the first biologic approved to reduce the signs and symptoms in patients with active ankylosing spondylitis (AS). ENBREL is
indicated for the treatment of adult patients (18 years or older) with chronic moderate-to-severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.

ENBREL has been used by more than 280,000 patients worldwide across indications.

ENBREL acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in
both normal immune function and the cascade of reactions involved in the inflammatory process of RA, JRA, psoriasis,
psoriatic arthritis, and AS. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in
significant reduction in inflammatory activity.

What important information do I need to know about taking ENBREL?

ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body’s
immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis,
psoriatic arthritis, and psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of TNF in the body to
normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to
fight infections.

All medicines have side effects, including ENBREL. Possible side effects of ENBREL include:

— Serious infections

— Many occurred in people prone to infection, such as those
with advanced or poorly controlled diabetes

— Some serious infections have been fatal

— Rare cases of tuberculosis have occurred

— What not to do

— Do not start ENBREL if you have an infection or are
allergic to ENBREL or its components

— What to do

— Tell your doctor if you are prone to infection

— Stop ENBREL if a serious infection occurs

— Contact your doctor if you have questions about ENBREL or
develop an infection

— Tell your doctor if you have ever been treated for heart
failure

— Serious nervous system disorders such as multiple sclerosis,
seizures, or inflammation of the nerves of the eyes

— Tell your doctor if you have ever had any of these
disorders or if you develop them after starting ENBREL

— Rare reports of serious blood disorders (some fatal)

— Contact your doctor immediately if you develop symptoms
such as persistent fever, bruising, bleeding, or paleness

— In medical studies of all TNF blockers, including ENBREL, a
higher rate of lymphoma (a type of cancer) was seen compared
to the general population. The risk of lymphoma may be up to
several fold higher in rheumatoid arthritis and psoriasis
patients

— The role of TNF blockers, including ENBREL, in the
development of lymphoma is unknown

— ENBREL can cause injection site reactions.

Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North
America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL. Additional information about ENBREL,
including full Prescribing Information, can be found on the website sponsored by the companies at ENBREL or by
calling toll free 888-4ENBREL (888-436-2735).

Amgen is a global biotechnology company that discovers, develops, manufactures, and markets important human therapeutics
based on advances in cellular and molecular biology.

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, cardiovascular disease,
central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one
of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and nonprescription medicines
that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth
Consumer Healthcare, and Fort Dodge Animal Health.

This news release contains forward-looking statements that involve significant risks and uncertainties, including those
discussed below and others that can be found in Amgen’s Form 10-K for the year ended December 31, 2004, and in Amgen’s
periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does
not undertake any obligation to update any forward-looking statements contained in this document as a result of new
information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new indications for existing products cannot be guaranteed and
movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate
or development of a new indication for an existing product will be successful and become a commercial product. Further,
preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes even adequately, modeled by computer or cell culture systems or animal models.
The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing
has in the past varied, and Amgen expects similar variability in the future. Amgen develops product candidates internally and
through licensing collaborations, partnerships, and joint ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at
the time of entering into such relationship. Also, Amgen or others could identify side effects or manufacturing problems with
Amgen’s products after they are on the market.

In addition, sales of Amgen’s products are affected by the availability of reimbursement and the reimbursement policies
imposed by third-party payors, including governments, private insurance plans, and managed care providers, and may be
affected by domestic and international trends toward managed care and health care cost containment as well as possible U.S.
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the development, usage, and pricing of our products. In addition, Amgen competes with other companies with respect to some of
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products, product candidates, or new indications for existing products, may face competition when and as they are approved
and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior
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Only the FDA can determine whether the products are safe and effective for these uses. Health care professionals should refer
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View drug information on Enbrel.

Autism And History Of Wandering: New Diagnostic Code

With increasing frequency, parents of children with autism spectrum disorder (ASD) report the terrible consequences that can occur when their children wander or unexpectedly run away. One mother described the recent death of her child who had wandered away from her home, despite efforts to lock doors and windows. Recognizing the seriousness and urgency of this problem, Autism Speaks, the world’s largest autism science and advocacy organization, vigorously supports the proposed ICM-9-CM diagnostic code and asks the autism community to sign the petition found here. In addition, Autism Speaks has joined the Interagency Autism Coordinating Committee in the call for action for Health and Human Services (HHS) Secretary Kathleen Sebelius to study the causes of wandering and elopement behavior, and to develop ways of preventing its occurrence.

“Many people with ASD are unaware of the dangers associated with traffic or other unsafe conditions. When a child with autism unexpectedly wanders from the home, parents greatest concern is that their child might be harmed or die as a consequence,” explained Autism Speaks Chief Science Officer Geraldine Dawson, Ph.D. “We need to understand how to prevent wandering and how to quickly and effectively respond when a child is lost after wandering from the home or school. These measures could save children’s lives.”

There is little to no formal data collection on autism-specific wandering/elopement. So it is unknown how frequently it occurs, in what environments it occurs, how many deaths or injuries can be attributed to wandering/elopement incidents, why the incidents may have taken place, or what strategies may be most effective to prevent wandering- or elopement-related injuries and fatalities.

In addition to supporting this coding for ASD wandering, Autism Speaks calls on the Department of HHS to:
Collect data on ASD-related wandering/elopement behavior
Explore and research the potential need for and utility of an alert system similar to the AMBER alert or Silver alert, but tailored to the specific needs and characteristics of children under the age of 18 with autism who wander/elope, to help families and communities rapidly locate children with autism who have wandered/eloped
Develop and test programs to prevent wandering/elopement incidents
Work with the Department of Education to research and develop best practice models related to parental notification of any wandering or fleeing incidents in schools

“The issue of wandering/elopement is critical to many families and must be addressed in a manner that protects health and safety for individuals who wander,” concluded Dr. Dawson. “We need to better understand the scale of the problem of wandering and develop ways of preventing it. At the same time, we need to respect the essential freedom for independence in daily life for people in the autism community. This balance between protecting people with ASD while respecting their rights is achievable.”

The Interactive Autism Network will be launching the first ever major survey on wandering in the coming weeks. All survey participants must enroll here.

About Autism

Autism is a complex neurobiological disorder that inhibits a person’s ability to communicate and develop social relationships, and is often accompanied by behavioral challenges. Autism spectrum disorders are diagnosed in one in 110 children in the United States, affecting four times as many boys as girls. The prevalence of autism increased 57 percent from 2002 to 2006. The Centers for Disease Control and Prevention have called autism a national public health crisis whose cause and cure remain unknown.

Source:
Jane E. Rubinstein
Autism Speaks