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June 06, 2008

MMR Vaccine and Thimerosal-Containing Vaccines Are Not Associated With Autism

Based on a thorough review of clinical and epidemiological studies, neither the mercury-based vaccine preservative thimerosal nor the measles-mumps-rubella (MMR) vaccine are associated with autism, says a new report from the Institute of Medicine of the National Academies.

Furthermore, the hypotheses regarding how the MMR vaccine and thimerosal could trigger autism lack supporting evidence and are theoretical only. Further research to find the cause of autism should be directed toward other lines of inquiry that are supported by current knowledge and evidence and offer more promise for providing an answer, said the committee that wrote the report.

"The overwhelming evidence from several well-designed studies indicates that childhood vaccines are not associated with autism," said committee chair Marie McCormick, Sumner and Esther Feldberg Professor of Maternal and Child Health, Harvard School of Public Health, Boston. "We strongly support ongoing research to discover the cause or causes of this devastating disorder. Resources would be used most effectively if they were directed toward those avenues of inquiry that offer the greatest promise for answers. Without supporting evidence, the vaccine hypothesis does not hold such promise."

The report updates two earlier IOM reports, published in 2001, on possible links between autism and the MMR vaccine and thimerosal. At that time, the committee determined that the evidence did not show an association between the MMR vaccine and autism, but there was not enough evidence to determine whether thimerosal was associated with neurodevelopmental disorders such as autism.

Given that mercury is known to have a toxic effect on the nervous system and that prenatal exposures to another form of mercury have been shown to adversely affect early childhood development, the committee concluded in 2001 that it was possible to hypothesize that thimerosal might trigger neurodevelopmental problems.

The committee revisited these issues because several studies exploring the epidemiology and biological mechanisms of possible links between vaccines and autism have been undertaken during the past three years.

The committee based its latest conclusions and recommendations on a careful review of the literature it had assessed to develop its previous reports; subsequent studies; and other information provided by researchers, parents, and others. Epidemiological studies that looked at autism rates and exposures to vaccines carried the most weight in the committee's assessment of causality, but it considered other kinds of studies as well.

Five large epidemiological studies conducted in the United States, the United Kingdom, Denmark, and Sweden since 2001 consistently provided evidence that there is no association between thimerosal-containing vaccines and autism. Similarly, 14 large epidemiological studies consistently showed no association between the MMR vaccine and autism.

The committee also reviewed five studies that reported links between thimerosal and autism and two that indicated a connection between the MMR vaccine and the disorder. However, limitations in how these studies were conducted and how the data were analyzed led the committee to conclude that they did not provide evidence supporting an association between vaccines and autism.

The committee also reviewed evidence related to possible biological mechanisms by which immunizations might trigger autism. For example, it has been hypothesized that the measles virus in the MMR vaccine might lodge in the intestines and trigger the release of toxins that lead to autism. Another hypothesis suggests that the MMR vaccine might stimulate the release of immune factors that damage the central nervous system, resulting in autism. It also has been suggested that thimerosal may interfere with biochemical systems in the brain, leading to the disorder.

However, no evidence has yet been found that the immune system or its activation play a direct role in causing autism, the report notes. Autism also has never been documented as a consequence of exposure to high doses of mercury. While the committee agreed that the studies exploring these hypotheses raise interesting questions, they do not address the specifics of how autism could result. Therefore, evidence for any biological mechanism linking vaccines with autism can only be considered theoretical.

Autism is not a single condition, but rather a complex set of severe developmental disorders -- also referred to as autistic spectrum disorders -- characterized by sustained impairments in social interaction and communication abilities, as well as restricted or repetitive patterns of behaviors and interests. It is unclear how many cases of autism there are, but two reviews of published studies put the prevalence at one case for every 1,000 children. While some information suggests that autism rates may be rising, it is not clear whether the observed increase is real or due to factors such as heightened awareness of the disorder or the use of a broader diagnostic definition.

Thimerosal is an organic mercury compound that is still used as a preservative in some adult vaccines. It began to be removed from vaccines for children in 1999, and as of mid-2000, vaccines that are recommended for universal use in infants and young children are available in forms that have no or only trace amounts of thimerosal.

This study is the eighth and final in a series on vaccine safety sponsored by the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.

Pre-publication copies of Immunization Safety Review: Vaccines and Autism are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

[ This news release and report are available at http://national-academies.org ]

INSTITUTE OF MEDICINE
Board on Health Promotion and Disease Prevention

Immunization Safety Review Committee

Marie C. McCormick, M.D., Sc.D. (chair)
Sumner and Esther Feldberg Professor of Maternal and Child Health
Department of Society, Human Development and Health
Harvard School of Public Health
Boston

Ronald Bayer, Ph.D.
Professor
Department of Sociomedical Sciences
Joseph L. Mailman School of Public Health
Columbia University
New York City

Alfred Berg, M.D., M.P.H.
Professor and Chair
Department of Family Medicine
University of Washington School of Medicine
Seattle

Rosemary Casey, M.D.
Associate Professor of Pediatrics
Jefferson Medical College, and
Director
Lankenau Faculty Pediatrics
Wynnewood, Pa.

Betsy Foxman, Ph.D.
Professor
Department of Epidemiology
School of Public Health
University of Michigan
Ann Arbor

Constantine Gatsonis, Ph.D.
Professor of Medical Science and Applied Mathematics, and
Director, Center for Statistical Sciences
Brown University
Providence, R.I.

Steven Goodman, M.D., M.H.S., Ph.D.
Associate Professor
Department of Oncology
Division of Biostatistics
School of Medicine
Johns Hopkins University
Baltimore

Ellen Horak, M.S.N.
Education and Nurse Consultant
Public Management Center
University of Kansas
Topeka

Michael Kaback, M.D.
Professor of Pediatrics and Reproductive Medicine
University of California
San Diego

Gerald Medoff, M.D.
Professor
Department of Internal Medicine
Washington University School of Medicine
St. Louis

Rebecca Parkin, Ph.D.
Associate Professor of Environmental and Occupational Health, Epidemiology and Biostatistics, and Associate Dean for Research and Public Health Practice
School of Public Health and Health Services
George Washington University
Washington, D.C.

Bennett A. Shaywitz, M.D.
Professor of Pediatrics and Neurology
Yale University School of Medicine, and
Co-Director
Yale Center for the Study of Learning and Attention
New Haven, Conn.

Christopher Wilson, M.D.
Professor and Chair
Department of Immunology
University of Washington
Seattle

INSTITUTE STAFF

Kathleen Stratton, Ph.D.
Study Director
Date: May 18, 2004
Contacts: Christine Stencel, Media Relations Officer
Chris Dobbins, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail news@nas.edu
� Copyright IDSA 2003

Infectious Diseases Society of America

Publicado por Andrea Cane às 10:49 PM | Comentários (0)

European Oncology Nursing Society (EONS) Calls For Adopting New Guidelines Across Europe To Protect Nurses And Patients Involved In Cancer Treatment

March 28th 2008: The European Oncology Nursing Society (EONS) is calling for new guidelines to be adopted across Europe to help all nurses involved in cancer care manage extravasations, thereby improving treatment for cancer patients overall.

Extravasation is caused by the leaking of fluids used in chemotherapy from the blood vessels into surrounding tissue, which can lead to severe and permanent disability[i]. It is relatively uncommon, estimated to occur in 0.1% to 1.0% of all anthracycline treatments[ii], however it can be debilitating, disabling and requires immediate attention from those involved in administering intravenous chemotherapy. Over 100,000 doses of chemotherapy and a million intravenous (IV) infusions are given every day worldwide[iii].

'Currently the management of this potentially debilitating condition is very inconsistent across Europe,' said Yvonne Wengström, Chair of the EONS task force. 'Most nurses do not receive any specific training on how to manage the condition should it occur. For this reason, the new guidelines and their implementation are very important for safeguarding patients and nurses from these type of events occurring in the first place, as well as dealing with them appropriately when they do'.

The guidelines, which have been specifically developed for nurses, are officially launched today at the 6th EONS Spring Convention, 'New ways of working: innovation in cancer nursing practice'.

Based on existing literature, the guidelines support the use of Savene®, as a first-line, gold-standard treatment for anthracycline extravasation. Savene® is the only licensed antidote to counteract the condition and is changing the way the complication of anthracycline extravasation is managed[iv].

Along with the pain, discomfort and inconvenience caused to the patient as a result of extravasation, it is also associated with a number of other adverse factors, such as longer hospital stays, increased length of follow up care, need for physical therapy, and loss of earnings for the patient as well as psychological trauma[v].

Helen Roe, Consultant Cancer Nurse and Chair of the UK Oncology Nursing Society (UKONS) Chemotherapy Forum says that although extravasations are not a frequently seen side-effect associated with chemotherapy, they have the potential to cause long-term consequences: 'Nurses play a key role in the management of extravasation and these evidence-based guidelines support nursing practice through prevention, recognition and essentially the management of extravasations.'

The guidelines are available for download from the EONS website.

References

1. Langer SW, Jensen PB, Sehested M. Other uses of dexrazoxane: savene, the first proven antidote against anthracycline extravasation injuries. Cardiovasc Toxicol 2007; 7: 151-153.

2. Buter J. Savene (dexrazoxane): an effective nonsurgical treatment for anthracycline extravasation. Hospital Pharmacy Europe 2007; 33: 38-9.

3. European Oncology Nurses Society [accessed March 2008]

4. European Oncology Nurses Society [accessed March 2008]

5. European Oncology Nurses Society [accessed March 2008]

European Oncology Nursing Society

Publicado por Andrea Cane às 10:48 PM | Comentários (0)

Safety With Injectable Medicines Implementing The NPSA Alert, UK

Baxter Healthcare launched today an Educational Programme to support hospitals in the implementation of the recently released NPSA Safety Alert 20 - Promoting safer use of injectable medicines. The Baxter sponsored programme has been developed and organised by an NHS Working Group consisting of senior Pharmacists, Nurses and Clinicians.

The programme is aimed at Chief/Head 'Pharmacists, Clinical Nurse Specialists, Consultant Anaesthetists, Clinical Governance and Risk Managers and anyone who will be involved in implementation of the alert.

Two one day training events are scheduled; London on the 13th June and Harrogate on 25th June. There is a full agenda planned for the day, focusing very much on the practical implementation of the alert, and will include presentations, scenario planning workshops and an opportunity to share learnings and ideas. Attendees will receive a resource pack including all of the speaker's presentations and a How to Guide to facilitate reproduction of a similar event in their own health authority to other members of staff.

"As intravenous therapy becomes steadily more complex and use of potent, "high-tech" drugs more commonplace, the chance of mistakes in prescribing, preparation or administration also increases, with a consequent risk of harm to patients. The NPSA Safety Alert 20 highlights the key risk issues and makes detailed recommendations to the NHS about how to minimise them. This study day is designed to introduce the Alert to senior NHS clinical staff and to support local implementation of its recommendations." Tim Root, Specialist Pharmacist, Clinical Governance and Technical Services, London, Eastern & South East Specialist Pharmacy Services.

There is no charge for attendance but there are a limited number of spaces for each day, early registration is recommended. To find out more and register to attend contact patient_safety_uk@baxter.com

-- Baxter Healthcare's sponsorship of the event includes financial and logistical support to enable the Education Programme.

-- Baxter Healthcare Ltd. is the primary domestic operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

-- The content of the Educational Programme has been developed and organised by an NHS Working Group comprised of:

- Prof. Ray Fitzpatrick: Clinical Director Pharmacy, Royal Wolverhampton Hospitals NHS Trust
- Jill Kayley, Independent Nurse Consultant
- Prof. David Cousins: Head of Safe Medication Practices, NPSA
- Richard Hey, Director of Pharmacy, Manchester Royal Infirmary
- Victor Standing, Liverpool Royal infirmary
- Anne Black, QA Pharmacist, Freeman Hospital
- Dr. Dominic Bell, Consultant in Intensive Care/Anaesthesia, Leeds General Infirmary
- Gillian Cavell: Associate Director for Pharmacy, King's College Hospital NHS Trust
- Ian M. Beaumont, Director Quality Control North West-.Regional Quality
- Tim Root, Specialist Pharmacist, Clinical Governance and Technical Services, London, Eastern & South East Specialist Pharmacy Services

-- The NPSA safety alert 20, "Promoting Safer Use of Injectable Medicines" was released on 28 March 2007. The alert covers multi-professional safer practice standards with particular emphasis on prescribing, preparation and administration of injectable medicines in clinical areas. The alert must be fully implemented by 31 March 2008

-- NPSA Patient safety alert 20: Promoting safer use of injectable medicines

Research evidence indicates that the incidence of errors in prescribing, preparing and administering injectable medicines is higher than for other forms of medicine. In one study, at least one error occurred in 49 per cent of intravenous medicine doses prepared and administered on hospital wards; one per cent of errors were judged to be potentially severe; and 29 per cent potentially moderate errors.

Using data from the NRLS and other evidence, the NPSA has identified a number of latent system risks and is making recommendations that can make the use of injectable medicines safer. These recommendations are published in the form of an alert and are supported by a range of supporting materials to aid implementation and embed safer practice: 1

1. npsa.nhs.uk/display?contentId=5755 Web page accessed 28 March 07

Baxter Healthcare Ltd.
Wallingford Road, Compton
Newbury, Berkshire RG20 7QW
UK

Publicado por Andrea Cane às 10:47 PM | Comentários (0)

New nurse guidelines launched for COPD

Primary care nurses can take on a key role managing one of the UK's fastest growing killers1 - New guidelines on the role primary care nurses can play in COPD, based on the recommendations of leading UK experts on the condition, have been launched today. The guidelines should help practices manage their resources to hit COPD targets in the new GMS contract.

The new recommendations build on the NICE guidelines for COPD published earlier this year by highlighting the responsibilities that primary care nurses can take on, including management of patient reviews, spirometry and ensuring uptake of the flu jab. These guidelines have been developed in cooperation with GlaxoSmithKline.

COPD, which is one of the country's fastest growing killers,1 is a progressive condition involving inflammation in the lungs, which leads to breathlessness and exacerbations (chest infections). Exacerbations have a major impact on patients' quality of life and increase the risk of disease progression and mortality. However, growing evidence suggests that careful management of COPD can reduce the risk of exacerbations and therefore make a real difference for patients' lives.

"COPD exacerbations are not a trivial matter as patients are more likely to survive a heart attack than an acute exacerbation. COPD is also the major cause of winter bed pressures as it is the only common disease, which has a huge seasonal variation in hospitalisations and mortality," commented Dr Tony Crockett, GPIAG member and GP based in Shrivenham. "COPD care is at the same stage as asthma care 20 years ago; we need to move from reactive, nihilistic care where patients and clinicians have low expectations to a system of improved, realistic expectations with much of this care being nurse-led."

COPD is a day to day challenge for the primary care team, accounting for around 1.5 million primary care consultations each year (2-3 consultations annually for a typical patient).2,3 The estimated cost of COPD to the NHS is �817 million every year,3 with hospitalisation due to exacerbations causing the biggest financial and patient health burden.

"COPD kills 30,000 people every year and is the only major cause of death currently increasing in the UK," said Judith Smith, Respiratory Nurse Consultant, East Lincolnshire Primary Care Trust and one of the contributors to the guidelines. "Patients with severe COPD lead extremely restricted lives as they are often too breathless and too frightened to leave the house. Better management really makes a difference to people's lives and will be a fulfilling role for many primary care nurses. Many hospitalisations could be avoided if exacerbations were prevented or reduced in severity."

"Primary care nurses are playing an increasingly important role in the diagnosis and management of COPD", commented Dr David Bellamy, GPIAG member and Bournemouth-based GP. "Their more holistic approach to care is ideally suited to the recommendations in the NICE Guidelines by helping to optimise therapy and teach patients in self-management action plans."

To obtain a copy of the guidelines, please contact the GSK Customer Care Team on 0800 221 441.

For further information, please contact:

Katie Banks
Ketchum
020 7611 3619
katie.banks@ketchum.com

Gareth Field
Ketchum

020 7611 3668 gareth.field@ketchum.com

Notes to editors:

---- COPD stands for Chronic Obstructive Pulmonary Disease

---- COPD is the fourth biggest killer in Europe1

---- There are an estimated 2.5 million sufferers in the UK4, although only an estimated 900,000 are correctly diagnosed5

---- An estimated 100,000 hospital admissions were recorded for COPD in England in the year 2000, equating to around 1 million bed days3 ---- The new guidelines for primary care nurses have been developed in cooperation with GlaxoSmithKline and based on recommendations by COPD expert contributors:

-- Rachel Brooker, National Respiratory Training Centre

-- Chris Fehrenbach, Senior Respiratory Nurse, Portsmouth

-- David Lynes, Respiratory Educational Training Centre, Liverpool

-- Ruth Oliver-Williams, Assistant Director of Nursing, Heatherwood and Wexham Hospitals

-- June Roberts, Nurse Practitioner, Manchester

-- Jane Scullion, Respiratory Nurse Consultant, Leicester

-- Judith Smith, East Lincolnshire Primary Care Trust

-- Gail South, Respiratory Care Nurse Consultant, Chesterfield

-- Robert M Angus, Consultant Respiratory Physician, Liverpool

References:

1. Murray CJL, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet 1997; 349:1498-1504

2. Royal College of General Practitioners, Office of Population Censuses and Surveys, Department of Health. Morbidity statistics from general practice. Third National Study, 1991 - 1992. London: HMSO, 1995

3. National Respiratory Training Centre. Impact of Respiratory Conditions: a guide for Primary Care Organisations. Warwick: NRTC (2002)

4. Siafakos NM, Vermeire P, Pride NB et al. ERS-Consensus statement. Optimal assessment of and management of chronic obstructive pulmonary disease. Eur Respir Rev 1995; 8:1398-1420

5. NICE guidelines 2004

Publicado por Andrea Cane às 10:45 PM | Comentários (0)