Almost 15 Million Alzheimer’s And Dementia Caregivers In USA Today

There are nearly 15 million people caring for individuals with Alzheimer’s disease and dementia in the USA, the Alzheimer’s Association has revealed today. The number of caregivers is 37% higher than estimates published last year, according the 2011 Alzheimer’s Disease Facts and Figures.

The authors of the report found that American caregivers gave 17 billion hours of unpaid care, estimated at $202.6 billion. A state with a population of 15 million would be the 5th largest in the USA.

Most individuals over the age of 65 years survive for about four to eight years after they are diagnosed with Alzheimer’s disease, sometimes 20 years. Because of the debilitating effects of the disease and its long duration, family members and friends who care for patients are placed under increasingly intense demands

The longer a caregiver has to look after somebody with Alzheimer’s, the greater their own health issues become, representing a further financial burden of almost $8 billion in raised healthcare costs.

Harry Johns, president and CEO of the Alzheimer’s Association, said:

“Alzheimer’s disease doesn’t just affect those with it. It invades families and the lives of everyone around them. It is stressful and heartbreaking to see someone you love trapped in a present where their past is fading and their future too frightening to contemplate. Nearly 15 million dedicated and committed family members and friends are living with this every day.”

5.4 million Americans are thought to be living with Alzheimer’s disease. Alzheimer’s is not a part of normal aging, even though age is its greatest risk factor, the Alzheimer’s Association writes.

Alzheimer’s is the sixth-leading cause of death in America. It is “the only cause of death among the top 10 in the United States that cannot be prevented, cured or even slowed.”

Deaths from Alzheimer’s disease have gone up 66% during the period 2000-2008, compared to minus 3% for major diseases of the heart, minus 29% for HIV/AIDS, minus 20% for stroke, minus 8% for prostate cancer, and minus 3% for breast cancer.

Total payments for health care and long-term services for patients with Alzheimer’s will rise by $11 billion this year compared to last year to $183 billion, the Alzheimer’s Association estimates. Most of this increase will be made up by Medicare and Medicaid costs.

Over the next four decades Medicare costs related to Alzheimer’s and dementias will rise by almost 600% and Medicaid costs by 400% the Alzheimer’s Association believes.

Robert Egge, Vice President for Public Policy for the Alzheimer’s Association, said:

“The projected rise in Alzheimer’s incidence will become an enormous balloon payment for the nation a payment that will exceed 1 trillion dollars by 2050. It is clear our government must make a smart commitment in order make these costs unnecessary.”

Early detection and intervention of Alzheimer’s disease has significant benefits for both patients and caregivers. Early interventions and improved treatments are currently our greatest hopes in dealing with or halting brain damage.

Beth Kallmyer, senior director of constituent services, said:

“For people affected by irreversible cognitive decline or dementia, a formal and documented diagnosis helps the individual and their family explain and expect behaviors, and opens doors to vital care and support services. A diagnosis can help reduce the anxiety and emotional burden experienced by opening access to valuable support services.”

If patients are diagnosed early they are more likely to have a prompt evaluation and treatment of reversible or treatable causes of cognitive impairment. Families which are affected by the disease also have more time to ponder over available medical and non-medical services, as well as taking part in clinical trials.

“2011 Alzheimer’s Disease Facts and Figures” (PDF)

Source: Alzheimer’s Association

Medistem Reports Rheumatoid Arthritis Patient Success Using Adult Stem Cell Protocol

Medistem Inc. (PINKSHEETS: MEDS). Medistem Inc. together with the Stem Cell Institute reported publication in the peer reviewed journal Cellular Immunology its paper titled “Autologous stromal vascular fraction cells: A tool for facilitating tolerance in rheumatic disease,” which describes the first use of a patient’s own fat stem cells for treatment of rheumatoid arthritis.

In collaboration with the company Vet-Stem Inc, the University of Western Ontario, and The University of California San Diego, Medistem scientists detailed the scientific rationale for use of patient’s own fat derived stem cells for “reprogramming” the immune system of patients with autoimmune diseases such as rheumatoid arthritis. A case report of a 67-year-old American woman who recovered from rheumatoid arthritis after intravenous treatment with adult stem cells is provided.

“We have been treating companion animals for osteoarthritis and rheumatoid arthritis for over five years, achieving and publishing excellent efficacy data,” said Robert Harman, CEO of Vet-Stem. “Medistem’s identification of potential mechanisms of action, as well as translation of this technology into the clinic, supports the importance of our findings.”

Medistem previously identified and filed intellectual property covering the co-purification of high concentrations of T regulatory cells using protocols that enrich for adipose derived stem cells, a finding that was later confirmed and published by Diane Mathis’s group from Harvard University (Feuerer et al. Nat Med. 2009 Aug;15(8):930-9). T regulatory cells are used by the body to control autoimmunity, which is explained in this video by Thomas Ichim, the CEO of Medistem.

“We are very excited that Medistem’s protocol for isolation of a patient’s own fat derived stem cells and T regulatory cells, which produced promising results in multiple sclerosis, appears to be useful in rheumatoid arthritis, another autoimmune disease,” said Neil Riordan, Chairman of Medistem.

In a 2009 paper Medistem together with Vet-Stem and University of California San Diego reported substantial clinical improvement in a small group of multiple sclerosis patients treated using a similar protocol. The paper is available here.

Medistem Inc.

Alzheimer’s Society Memory Campaign Boosts Dementia Diagnosis

Newly released research from Alzheimer’s Society shows that 1 in 7 GPs have noticed more people asking about memory problems since the launch of its Worried About Your Memory? campaign. Up to two thirds of people with dementia never receive a diagnosis. Campaign materials, distributed in GP surgeries across the country, sought to address this. Findings from a new survey show that up to half of the respondents who requested the Worried About Your Memory? materials went on to receive a diagnosis.

Dementia affects as many as half a million in England alone. The recently published National Dementia Strategy for England highlighted the need to raise awareness, improve diagnosis and provide dementia training. This new research from Alzheimer’s Society confirms the importance of these priorities to GPs. Ninety two per cent agreed that it is important to diagnose dementia early but nearly a quarter said they did not feel they’d had sufficient basic and post-qualification training to help diagnose and manage dementia. Over half also wanted further information on local support services for people with dementia and 30% wanted advice on when to refer for treatment.

Neil Hunt, Chief Executive of Alzheimer’s Society, says,
‘Dementia is not a natural part of ageing it is caused by diseases of the brain and robs people of their lives. The Worried About Your Memory? campaign has made some inroads into improved awareness and diagnosis. However, this must be followed through in the implementation of the National Dementia Strategy for England. We need to see ongoing improvements in diagnosis and widespread training of healthcare professionals so that people are directed towards the support they need.’

Care Services Minister Phil Hope says,
‘The success of the Worried About Your Memory? campaign is a step forward in making sure people are better informed about dementia. It is also helping to tackle the stigma associated with the disease, so more people feel they can come forward for earlier diagnosis. But there’s lots more to do. I want to see more national and local information made available and our work on the National Dementia Strategy will help make that happen.’

Dr Barbara Woodhatch, a GP from Islington, says,
‘Awareness raising campaigns like Worried About Your Memory? can really help make a difference to diagnosis rates, as this research shows. However, the data also highlights how important it is to back this up with structured dementia training for GPs to help them refer people and provide them with information about local services.’

- 1 in 3 people over the age of 65 will die with dementia.

- Alzheimer’s Society research shows dementia costs the UK ??17 billion. This figure is predicted to treble in the next 30 years.

- 570,000 people have a form of dementia in England, more than half have Alzheimer’s disease. In less than 20 years nearly a million people will be living with dementia. This will soar to 1.7 million people in UK by 2051.

- Dementia is not a natural part of ageing; it is caused by diseases of the brain and robs people of their lives.

- Alzheimer’s Society champions the rights of people living with dementia and those who care for them. Alzheimer’s Society works in England, Wales and Northern Ireland.

- Alzheimer’s Society needs to raise money to care for people today and to find a cure for tomorrow. You can donate now by calling 0845 306 0898 or visiting alzheimers

- Alzheimer’s Society provides a National Dementia Helpline, the number is 0845 300 0336

About memory problems

Although memory problems are common and factors such as age, tiredness, stress, depression and some physical illnesses can affect it, Alzheimer’s Society is encouraging people to seek advice and help if the following occur:

- It’s a struggle to remember recent events, although it’s easy to recall things that happened in the past
- It’s hard to follow conversations or programmes on TV
- Regularly forgetting the names of friends or everyday objects
- Inability to recall things heard, seen or read
- Difficulty in making decisions
- Repeat themselves in conversation or lose the thread of what they are saying
- Have problems thinking and reasoning
- Feel anxious and depressed or angry about their forgetfulness
- Find that other people start to comment on their forgetfulness

About the Worried About Your Memory? Campaign

- The Worried About Your Memory? campaign was rolled out across England, Wales and Northern Ireland in May 2008 (following a previous pilot).

- 42,550 GPs received a dementia CD Rom and 10,752 GP surgeries received 50 leaflets, a poster and a dispenser. Further leaflets have been sent each quarter.

- To date 12,000 people have requested further information, 50,000 booklets have been downloaded from the website and 1,800 enquiries have been made to Alzheimer’s Society Dementia Helpline.

- The Worried About Your Memory? campaign has also been rolled-out through pharmacies in England, Wales and Northern Ireland from January to June 2009

- Alzheimer’s Society conducted research in January 2009 to evaluate the success of the Worried About Your Memory? campaign. Surveys were sent to GP surgeries that received the Worried About Your Memory? materials and members of the public who have requested the Worried About Your Memory? booklet. 1,817 GPs and 524 members of the public responded to the survey.

- The Worried About Your Memory? campaign is supported by funding from the Department of Health in England

- The Worried About Your Memory? campaign is supported by funding from Eisai Limited, Novartis Limited, Pfizer Limited and Shire Pharmaceuticals Limited in Wales and Northern Ireland.

Alzheimer’s Society
Devon House
58 St Katherine’s Way
London, . E1W 1JX
United Kingdom

Cimzia(R) Filed With EMEA For Treatment Of Rheumatoid Arthritis, Europe

UCB announced that a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of Cimzia® (certolizumab pegol) as a subcutaneous treatment for adults with moderate to severe active rheumatoid arthritis (RA) and has been accepted for review. Subject to approval, Cimzia® will be the first and only PEGylated, Fc-Free anti-TNF (Tumour Necrosis Factor alpha) biologic therapy available in Europe for the treatment of RA.

“Along with a fast onset of action, Cimzia® has been shown to rapidly reduce the rate of progression of joint damage and to improve measurements of patients’ physical function,” said Olav Hellebo, President of Inflammation Operations for UCB. “With millions of people suffering from rheumatoid arthritis across the globe, Cimzia®, when approved, will provide a new and effective treatment option for this debilitating condition.”

The MAA filing is based on UCB’s clinical programme with data from more than 2,300 patients involved in several multi-centre placebo-controlled Phase III trials totaling over 4,000 patient-years of experience. Cimzia® has been studied at two or four week dosing intervals, and administered together with methotrexate (MTX) or as monotherapy.

In the RAPID trials, Cimzia® together with MTX demonstrated a rapid and significant reduction in the signs and symptoms of active RA as early as Week 1 and inhibited progression of structural damage, with results maintained through to week 52 (p

Speech, Language And Hearing The Focus Of Canadian Association of Speech-Language Pathologists and Audiologists Conference

Scenic southwestern Ontario will host the 34th annual conference of the Canadian Association of Speech-Language Pathologists and Audiologists (CASLPA), April 29 – May 2. Professionals from across Canada will gather in the Forest City, London, Ontario, in pursuit of leading edge professional knowledge. Invited speakers will present on a wide range of topics including dysphagia, autism, stuttering, evidence based practice, dementia, swallowing, cochlear implants, cerumen management, audiologic rehabilitation, auditory neuropathy and more. In addition, for the first time ever, one full day of special programming will be offered for supportive personnel.

The conference kicks off with opening ceremonies on Wednesday, April 29. Thursday, April 30 will feature the CASLPA annual general meeting and the annual CASLPA awards ceremony and dinner, which recognizes both members and non-members for their significant contributions to the professions of speech-language pathology and audiology, will be held on Friday, May 1. CASLPA is also honouring 89 long-term members who have belonged to the association for more than 25 years. These individuals, along with a group of 541 other 25+ year members, together represent 15,750 years of service to the professions and the communities and patients they serve. Check out our website to see who from your community is on the list: caslpa/english/professions/25year_award.asp.

The CASLPA conference also kicks off Speech and Hearing Awareness Month which is celebrated throughout North America during the month of May. Millions of Canadians have a speech, language, or hearing disorder. Speech-language pathologists and audiologists are professionals who evaluate and treat people with speech, language, or hearing difficulties and May month generates awareness that encourages early detection and prevention of related disorders.

Numerous partners have helped make this conference possible, including the generous support of Exceptionalities Inc, Barbershop Singers Harmonize for Speech, Canadian Language & Literacy Research Network (CLLRNet), University of Western Ontario, Logital Inc., AON Risk Services, Starkey Labs, Lifestyles Hearing Corporation and Alberta Health Services.

The Canadian Association of Speech-Language Pathologist and Audiologists is the national voice of 5,000 professionals. A not-for-profit association, CASLPA supports the professional needs of its members, champions the interests of those who require speech, language, and hearing services and promotes awareness of how speech-language pathologists and audiologists contribute to the well being of Canadians living with communication disorders. Visit us at caslpa/english/events/conference.asp

Canadian Association of Speech-Language Pathologist and Audiologists

The Journal Chest, September 2007

Placebo Use in Clinical Trials May Cause Problems in Patients With Pulmonary Hypertension

A new study shows that patients with pulmonary hypertension who receive a placebo during a clinical trial may experience clinical deterioration. Researchers from Dwight David Eisenhower Army Medical Center in Georgia conducted a meta-analysis of 13 randomized, placebo-controlled clinical trials that included a total of 1,999 patients with pulmonary hypertension. Of the patients, 1,131 were treated with a study drug, while 868 were treated with placebo. The analysis showed that placebo-treated patients were 1.81 times more likely to suffer a clinical worsening, including a decline in pulmonary hemodynamic parameters and a decrease in 6-minute walk distance. Placebo treatment was not associated with a difference in mortality. Researchers suggest future studies involving patients with pulmonary hypertension should focus on evaluating existing medications against one another and comparing novel therapies with those currently accepted. This study appears in the September issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

Asthma Medication May Lower Risk of Cardiovascular Disease

The use of some asthma medications may lower the risk of cardiovascular disease in patients with asthma, shows a new study from the University of Southern California. Researchers measured cardiovascular disease (CVD) inflammatory biomarkers and lipid levels in 161 patients receiving theophylline, 164 patients receiving montelukast, and 164 patients receiving a placebo. Serum levels of C-reactive protein (CRP), interleukin-6, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density cholesterol were measured at 1 month and 6 months after treatment. Patients with moderate to severe asthma receiving montelukast had significantly lower serum CRP and lipid levels compared to placebo at both time points. Lipid levels also were significantly lower in the theophylline group compared with placebo in patients using inhaled corticosteroids. Researchers conclude that these asthma medications may have some beneficial value in patients with asthma in respect to CVD risk. This study appears in the September issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

CPAP Use for Sleep Apnea May Lower Patient’s Cardiovascular Risk

Continuous positive airway pressure (CPAP), when used on a consistent basis for managing sleep apnea, may reduce a patient’s risk for cardiovascular disease. Researchers from Greece measured serum cardiovascular risk factors at baseline and at 6 months after CPAP usage in 53 nonsmoking patients, newly diagnosed with sleep apnea. Patients were classified based on CPAP compliance: good compliance (n=20), poor compliance (n=19), and refusal of CPAP (n=14). Patients with good CPAP compliance showed significant decreases in most cardiovascular risk factors. Patients with poor compliance showed a decrease in one cardiovascular risk area, while the patients who refused CPAP experienced no significant changes. Researchers conclude that good CPAP compliance may have a beneficial effect on overall cardiovascular risk. This study appears in the September issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

Source: Jennifer Stawarz

American College of Chest Physicians

American Thoracic Society Journal news_new tips for September 2004 (second issue)


In its first official statement since 1986 on the topic, the American Thoracic Society (ATS) has published a document entitled “Diagnosis and Initial Management of Nonmalignant Diseases Related to Asbestos.”

The revised statement, updated and reviewed by an 11-person committee of experts, appears in the second issue for September 2004 of the ATS peer-reviewed American Journal of Respiratory and Critical Care Medicine.

According to the authors, the new statement is designed to provide guidance to clinicians in the diagnosis of nonmalignant asbestos-related disease.

The nonmalignant medical conditions covered, which are associated with breathing the mineral dust, include: asbestosis, a chronic, progressive lung disease often marked by scarring (fibrosis) of the lung tissue; pleural plaques and more diffuse forms of pleural thickening; benign or nonmalignant pleural effusions (the abnormal collection of fluid in the pleural space); and airway obstruction. (The pleura is the delicate membrane covering the lungs and the inner walls of the chest.)

In the late 19th century, industry recognized that commercial asbestos had high tensile strength, flexibility, resistance to chemical and thermal degradation, and high electrical resistance. Because of these qualities, asbestos was widely used in the past for insulation, brake linings, flooring, cement, paint, textiles, and various other products.

However, after documentation of its hazards in the 1970s and 1980s, use of asbestos fell rapidly, and the industrial mineral was ultimately banned in many western countries. When asbestos-related illness is suspected by a physician, the document advises the doctor to take a comprehensive occupational and environmental history, with emphasis on exposure 15 years or more prior to the current office visit.

The report estimates that asbestos is still a hazard for 1.3 million workers in the construction industry in the United States and for workers involved in the maintenance of buildings and equipment. Although the majority of products containing asbestos are older versions, new products that may contain the industrial mineral include brake pads, roofing materials, vinyl tiles, and imported cement pipe and sheeting.

According to the experts, a chest X-ray is an extremely useful tool to aid in the diagnosis of asbestos-related pleural disease (fluid in the pleural spaces). In addition, the report notes: “The specificity of the diagnosis of asbestosis increases with the number of consistent findings on chest film, the number of clinical features present (symptoms, signs, and pulmonary function changes), and the significance and strength of the history of exposure.” However, according to the document, once exposure to asbestos has occurred, no prophylactic medication or treatment is currently available to prevent the development or the progression of asbestosis or other asbestos-related diseases. Treatment is often designed to ease symptoms.


In a study of patients with severe asthma who had eosinophils in their sputum despite extensive anti-asthma medication, investigators showed that a high dose of extra intra-muscular corticosteroids resulted in almost complete disappearance of eosinophilic cells, led to decreased use of “rescue” medications by treated patients, and helped to improve the individual’s lung function tests. (Eosinophils are a type of white blood cell that constitutes from 1 to 3 percent of total white cell count and functions in allergic or inflammatory responses.)

The researchers studied 22 non-smoking outpatients with severe asthma in order to prove that patients with extensive eosinophilia, despite significant anti-inflammatory treatment, were sensitive to high dose injected corticosteroids. Of the 22 patients in the study, 11 received injected steroids and 11 were given placebo over a 3-week period. All patients had sputum eosinophilia above the upper limit of normal. However, after treatment with injected corticosteroids, sputum eosinophils returned to normal levels (from zero to 2 percent) in the 11 treated patients.

The researchers believe that levels of symptoms and lung function can, and should be, improved by intensifying treatment and/or administering corticosteroids via the systemic route. They point out that injecting these drugs might help reach regions of the airways that are not accessible to inhaled corticosteroids. The 22 nonsmoking patients who had severe bronchial asthma were between the ages of 21 and 73; 15 of the group were women. The research appears in the second issue for September 2004 of the ATS peer-reviewed American Journal of Respiratory and Critical Care Medicine.

For the complete text of these articles, please see the American Thoracic Society Online Web Site at http//atsjournals.

Contact: Cathy Carlomagno
American Thoracic Society

ACTEMRA(TM) (tocilizumab) Third Phase III Study Results Show Significant Improvement In Symptoms Of Patients With Rheumatoid Arthritis

Roche today announced that
results from the ACTEMRA(TM) RADIATE (RheumAtoiD ArthritIs Study in
Anti-TNF FailurEs) trial successfully met its primary endpoint in patients
with moderate to severe rheumatoid arthritis (RA) who failed to respond to
anti-tumor necrosis factor treatments (anti-TNFs).

The trial – the third multinational Phase III study of ACTEMRA outside
of Japan – showed that a greater proportion of patients treated with
ACTEMRA plus methotrexate (4 mg/kg or 8 mg/kg) achieved a significant
reduction in the signs and symptoms of RA as evaluated by ACR20 following
24 weeks of treatment, compared to those who were treated with placebo plus

ACTEMRA was generally well tolerated; the most common adverse events
reported more frequently in the ACTEMRA arms of the RADIATE trial were
nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract

“The study results reconfirm the findings from the previous
multinational trials that interleukin-6 receptor inhibition is a novel
mechanism for reducing inflammation caused by RA,” said Lars Birgerson,
M.D., Ph.D., Global Head Medical Affairs, Roche. “The data demonstrate that
ACTEMRA can potentially offer an effective approach in reducing the signs
and symptoms of RA, particularly when therapies such as anti-TNFs prove

Data from this trial will be submitted for presentation at upcoming
national scientific meetings. In addition, other Phase III trials exploring
ACTEMRA in RA are ongoing with another study scheduled to report in 2007.

About the RADIATE Study

The RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) study is
a three-arm, randomized, double-blind, placebo-controlled study designed to
evaluate the safety and efficacy of ACTEMRA plus methotrexate (4 mg/kg or 8
mg/kg) compared to placebo plus methotrexate in RA patients who had an
inadequate response to anti-TNFs alone. Patients received either ACTEMRA
intravenously (4 mg/kg or 8 mg/kg) every four weeks plus methotrexate
weekly or placebo infusions every four weeks plus methotrexate weekly.

Data from the study were analyzed to determine patients’ response to
treatment by using three standard assessments: ACR score (1), developed by
the American College of Rheumatology (ACR), DAS28 (2), a measurement of RA
disease activity, and EULAR response criteria (3), a measurement of
treatment response. The study included 498 patients at 128 trial sites in
13 countries, including the United States.

The RADIATE trial is one of five Phase III clinical studies designed to
investigate ACTEMRA as a potential new treatment for RA. Roche and Chugai
have initiated the collaborative clinical development program that has
enrolled a total of more than 4,000 patients in 41 countries including the
United States and several European countries.

About ACTEMRA (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting
monoclonal antibody and represents a novel mechanism of action to treat RA.
Studies suggest that reducing the activity of IL-6, one of several key
cytokines involved in the inflammatory process, may reduce inflammation of
the joints. The global ACTEMRA Phase III clinical development program is
designed to evaluate this clinical finding. The compound is not currently
approved in the United States.

The most common adverse events reported in ACTEMRA global clinical
studies are upper respiratory tract infections, headache, nasopharyngitis
and hypertension. As with other biological disease modifying anti-rheumatic
drugs (DMARDs), serious infections have been reported in some patients
treated with ACTEMRA.

About Rheumatoid Arthritis

Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in the joints. This
inflammation causes a loss of joint shape and function, resulting in pain,
stiffness and swelling, ultimately leading to irreversible joint
destruction and disability. Characteristics of RA include redness,
swelling, pain, and movement limitation around joints of the hands, feet,
elbows, knees and neck that leads to loss of function. In addition, the
systemic symptoms of RA include fatigue, decreased hemoglobin and
osteoporosis and may contribute to shortening life expectancy by affecting
major organ systems. After 10 years, less than 50% of patients can continue
to work or function normally on a daily basis. RA affects more than 21
million people worldwide with approximately 2.1 million people affected in
the United States.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world’s leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people’s
health and quality of life. An employer of choice, in 2006, Roche was named
one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to
Sell For (Selling Power), and one of AARP’s Top Companies for Older
Workers, and in 2005, Roche was named one of Fortune magazine’s Best
Companies to Work For in America. For additional information about the U.S.
pharmaceuticals business, visit our websites: rocheusa or


(1) ACR20, ACR50 and ACR70 represent the percentage of reduction (20%, 50%
or 70%) in certain RA symptoms and measures the number of tender
and swollen joints, pain, patient’s and physician’s global assessments
and certain laboratory markers. An ACR70 response is considered
exceptional and represents a significant improvement in a patient’s

(2) The Disease Activity Score (DAS)28 is a combined index that measures
disease activity in patients with RA. It combines information from 28
tender and swollen joints (range 0-28), erythrocyte sedimentation rate,
and a general health assessment on a visual analog scale. The level of
disease activity is interpreted as low (DAS28 less than or equal to
3.2), moderate (3.2 < DAS28 less than or equal to 5.1) or high (DAS28
>5.1). DAS28

Study To Boost Quality Of Life And Improve Outcomes For Children Born With Half A Heart

A trial on shunts used to direct blood flow to the lungs, led by researchers at the University of Michigan’s C.S. Mott Children’s Hospital, will lead to better outcomes for kids worldwide born with hypoplastic left heart syndrome, the most common severe heart birth defect.

Under the leadership of the University of Michigan, the first multi-institutional randomized prospective trial ever conducted in congenital heart surgery was just completed by the Pediatric Heart Network with funding from the National Heart, Lung, Blood Institute.

Kids with the hypoplastic left heart syndrome have hearts that don’t develop properly in the womb. Because the left side of the heart fails to develop, they are often referred to as being born with half a heart.

This groundbreaking study is published in the May 27, 2010 issue of the New England Journal of Medicine. Richard G. Ohye, M.D., Division Head of the Pediatric Cardiovascular Surgery at the University of Michigan’s C.S. Mott Children’s Hospital, is the study chair and lead author.

“Congenital heart disease is much more common than people realize,” says Ohye. “Heart abnormalities are the most common birth defect, and it occurs in almost one out of every 100 live births.”

Twenty years ago, doctors were unable to save these children with hypoplastic left heart syndrome. Today, because of efforts by the University of Michigan Congenital Heart Center and other centers like it around the world, most of these infants can be saved through a series of three operations that can be compared to re-plumbing their heart.

Research into this congenital defect has been rare because most centers do not see enough patients with any one diagnosis to be able to effectively study it. Hypoplastic left heart syndrome occurs in about 1,000 kids every year in the United States and it accounts for roughly about 8 percent of all different congenital heart defects.

“We can’t really rebuild the heart so we have to make do with what there is — the one pumping chamber,” Ohye says. “So we re-plumb the heart so that the kids can get by with just the single ventricle or pumping chamber.”

The treatment of hypoplastic left heart syndrome requires three operations and the first one is done around the time of birth, the second one at about four to six months of age and the last one at 18 to 24 months of age.

The University of Michigan has had a pioneering role in the treatment of hypoplastic left heart syndrome.

Prior to the early 1980s, there was no operation for it at all, so all the kids unfortunately died as newborns. Since that time, survivals have dramatically improved. Initially, they were quite low. During the 1990s, hospital survivals for the first operation were only about 40 percent. Now, at experienced centers, they’re up above 90 percent.

In the first stage operation for hypoplastic left heart syndrome, there are two different versions. Researchers were interested in finding out which had a better survival rate.

One version gets blood directly from the heart through a tube, or shunt, to the artery to the lungs. The other allows the blood first to exit the heart through the reconstructed aorta and then bring the shunt from that reconstructed aorta over to the artery to the lungs.

“What we found was that the shunt that went directly from the heart to the artery to the lungs did better over the course of the first year,” Ohye says. “We also found that they had tended to have a few more complications though, and so I think the jury’s still out over the long run which is going to be better.”

“We’re going to continue to follow these kids,” says Ohye. “We’re almost up to a four-year follow-up at this point and then we’ll continue to follow them and plan on looking at them again when they’re about 8 or 10 years old.”

This research also is significant because it is the very first randomized prospective trial ever done in congenital heart surgery. The study enrolled 555 kids and will provide a tremendous opportunity to observe them all the way into adulthood and follow them and see how they do.

“It is important to test anything we do to manage our patients in a rigorous scientific way, and it’s the first time that we’ve ever gotten together, many centers – 15 in this case – and agreed that this was really important to do,” Ohye adds. “We showed that we can do it and that we believe that it’s important to do for our kids.”

“Not only did the study answer an important question about how we care for them at birth, but it’s going to continue to help us understand how we take care of them throughout their lives,” says Ohye.

Additional authors paragraph: Richard G. Ohye, M.D., Lynn A. Sleeper, Sc.D., Lynn Mahony, M.D., Jane W. Newburger, M.D., M.P.H., Gail D. Pearson, M.D., Sc.D.,
Minmin Lu, M.S., Caren S. Goldberg, M.D., Sarah Tabbutt, M.D., Ph.D., Peter C. Frommelt, M.D., Nancy S. Ghanayem, M.D., Peter C. Laussen, M.B., B.S., John F. Rhodes, M.D., Alan B. Lewis, M.D., Seema Mital, M.D., Chitra Ravishankar, M.D., Ismee A. Williams, M.D., Carolyn Dunbar-Masterson, B.S.N., R.N., Andrew M. Atz, M.D., Steven Colan, M.D., L. LuAnn Minich, M.D., Christian Pizarro, M.D., Kirk R. Kanter, M.D., James Jaggers, M.D., Jeffrey P. Jacobs, M.D., Catherine Dent Krawczeski, M.D., Nancy Pike, R.N., Ph.D., Brian W. McCrindle, M.D., M.P.H., Lisa Virzi, R.N., M.S., M.B.A., and J. William Gaynor, M.D., for the Pediatric Heart Network Investigators

Funding source: Funded by the Pediatric Heart Network

Journal reference: N Engl J Med 2010;362:1980-92.

University of Michigan Health System

Global South Countries Increasing Health, Development Cooperation

Some of the world’s “emerging economies” — such as Brazil, China, India, Malaysia, South Africa and Thailand — recently have increased their trade with and development assistance to other developing nations, the Inter Press Service reports. The United Nations in a report released last month provided examples of the increasing cooperation between developing countries, including HIV/AIDS treatment assistance and aid to Africa. According to the report, Brazil has provided locally manufactured antiretroviral drugs to about 11 other developing countries, such as Bolivia, Burkina Faso, Cape Verde, Colombia, East Timor, El Salvador, Guinea-Bissau, Mozambique, Nicaragua, Paraguay, and Sao Tome and Principe. In addition, the study said that Brazil coordinates an international HIV/AIDS technical cooperation network that includes Argentina, China, Cuba, Nigeria, Russia, Thailand and Ukraine. The network aims to facilitate the transfer of technologies for the production of antiretrovirals.

The report also found that India has allocated about $200 million for the New Partnership for Africa’s Development and provided West African countries with about $500 million in aid. In addition, China has pledged to double aid to Africa by 2009 to about $1 billion, as well as to establish a China-Africa development fund of about $5 billion aimed at encouraging Chinese companies to invest in the continent.

“Clearly, today there is growing economic complementarity and capacity for developing countries to advance their development through mutual cooperation,” Munir Akram, the outgoing chair of the Group of 77 developing nations, said at a meeting last week. He added that many “developing countries are investing their surpluses in other developing countries, and many are engaged in extensive development cooperation” (Deen, Inter Press Service, 1/15).

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