Medical News Today

Tamiflu-Resistant Flu On The Rise

2009-03-02T20:00:00.000+02:00

The type A seasonal flu virus (a subtype of the H1N1 strain) appears to be developing increasing restistance to the most widely used flu drug in the US, Tamiflu (generic name oseltamivir). For the first time, type A viruses were starting to show increased resistance to Tamiflu in the 2007-2008 flu season, but this year the resistance is higher and more widespread.

These are the findings of a study that has been published early online in Journal of the American Medical Association, JAMA because of its public health importance said a press release from the publisher.

The study was the work of Dr Nila J. Dharan, of the Centers for Disease Control and Prevention (CDC), Atlanta, and colleagues who looked at trends and characteristics of patients infected with H1N1 type A Tamiflu-resistant and susceptible flu.

The viruses were tested as part of ongoing surveillance and were identified and submitted to the CDC between September 2007 and May 2008, and then a year later, between 28 September 2008 and 19 February 2009.

The researchers found that during the 2007-2008 flu season, the H1N1 type A flu strains accounted for about 19 per cent of circulating flu strains in the US. Of the 1,155 US H1N1 type A viruses tested during that season, 142 of them (12 per cent) showed resistance to Tamiflu (oseltamivir).

From that period (2007-2008) the researchers found data was available for 99 people infected with Tamiflu-resistant and 182 people infected with Tamiflu-susceptible flu. For the resistant cases the median (the midpoint of the range) age was 19, while 5 patients ended up in hospital and 4 died.

On analyzing the demographic, illness and symptom characteristics available on the infected people, the researchers found no significant differences between those infected with Tamiflu-resistant and those infected with Tamiflu-susceptible flu strains and neither did they find any links between use of Tamiflu and flu cases due to infection with H1N1 type A in the US.

The data on the current flu season, 2008-2009 is obviously not complete since the season is not yet finished, but an analysis on that which has been gathered so far shows that Tamiflu resistance in H1N1 type A strains continue at a high level. Up to 19 February 2009, Tamiflu resistance was found in 264 of 268 (98.5 per cent) of the H1N1 type A viruses tested by the CDC.

The authors wrote that:

"The emergence of oseltamivir resistance has highlighted the need for the development of new antiviral drugs and rapid diagnostic tests that determine viral subtype or resistance, as well as improved representativeness and timeliness of national influenza surveillance for antiviral resistance."

In December last year the CDC issued draft guidelines for the use of antiviral flu medications in line with what they found after analyzing the data coming in for the current season. They recommended that doctors and other health professionals:

"Consider the results of patient testing and local influenza surveillance data on circulating types and subtypes of influenza viruses in deciding whether oseltamivir [tamiflu] alone could be used. These guidelines provide options, including preferential use of [the anti-viral drug] zanamivir or a combination of oseltamivir and [the anti-viral drug] rimantadine, which might be more appropriate in treating patients who might have influenza caused by an oseltamivir-resistant virus."

In an accompanying editorial, Dr David M. Weinstock of the Dana-Farber Cancer Institute, Boston, and Dr Gianna Zuccotti of Brigham and Women's Hospital, Boston, who is also Contributing Editor, JAMA, Chicago, wrote:

"The understanding of influenza biology and epidemiology has advanced markedly; however, the global dissemination of oseltamivir [Tamiflu]- resistant influenza came as a great surprise."

There is no doubt that further new susprises will occur in the "perpetual struggle with influenza" they warn, since the one thing we all know for sure is that the organism will evolve and at a pace that we need to outstrip with faster diagnosis down to identifying speciments at the molecular level, with extensive surveillance among humans and animals, and, they add:

"More rapid and [flexible] systems for translating basic and epidemiological discoveries into clinically applicable interventions."

But for now, our best defence is the tried and tested foursome:

"Vaccination, social distancing, hand washing, and common sense," they wrote.

"Infections With Oseltamivir-Resistant Influenza A(H1N1) Virus in the United States."

Nila J. Dharan; Larisa V. Gubareva; John J. Meyer; Margaret Okomo-Adhiambo; Reginald C. McClinton; Steven A. Marshall; Kirsten St. George; Scott Epperson; Lynnette Brammer; Alexander I. Klimov; Joseph S. Bresee; Alicia M. Fry; for the Oseltamivir-Resistance Working Group.

JAMA. 2009;301(10).

doi:10.1001/jama.2009.294.

Early Release Article, posted March 2, 2009

Click here for Article.

Sources: JAMA Archives press release, journal article and editorial.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

Manic Episodes Linked To Desire For Fame, UK

2009-03-02T14:00:00.000+02:00

Episodes of mania are linked to a desire for fame. This is the finding of a study published online today, 2nd March 2009, in the British Journal of Clinical Psychology.

Dr Johnson from the University of California, Berkeley said: "Manic episodes are characterised by elevated mood as well as increased talkativeness, racing thoughts, decreased need for sleep and extreme distractibility. Mania has already been linked to a belief in the importance of achievement and so we wanted to discover whether it is also linked with higher expectations for the future."

The manic and depressive levels of 103 people including 27 people with diagnosed manic depression (also known as bipolar disorder), were assessed and compared with the results of questionnaires designed to assess their ambitious life goals, such as a desire for fame, material success or recognition. Participants rated the likelihood of various things happening to them, such as; 'You will appear regularly on TV', 'You will have 20 million dollars or more'.

"We found that the people who had experienced episodes of mania during their lives had the highest expectations of achieving popular success and financial success. This pattern suggests that people with manic or bipolar tendencies are drawn to focus on success, money and popular fame."

"These results suggest that mania, along with all of its costs, may also drive people to set higher goals. In some cases they achieve them, giving us a glimpse into the advantages that can accompany this highly painful disorder," concluded Dr Johnson.

To access the paper visit here.

British Psychological Society

Siemens Sets A New Standard For Breast Ultrasound

2009-02-28T14:00:00.000+02:00

New automated breast ultrasound system automatically acquires volumes and offers intelligent clinical applications. Siemens Healthcare recently introduced the Acuson S2000 Automated Breast Volume Scanner (ABVS), the first multi-use ultrasound breast system that automatically acquires volume images of the breast. Thanks to the user-independent, standardized image acquisition, the system is ideally suited for early detection and diagnosis of breast cancer with ultrasound - especially for women with dense breast tissue.

According to the New England Journal of Medicine1, dense breast tissue increases the risk of breast cancer for a woman up to five-fold. While mammography remains the method of choice in breast cancer screening, a study published by the RSNA (Radiological Society of North America) in 20022 showed that the detection rate for non-palpable, invasive breast cancer increased by 42 percent when mammography was followed by an ultrasound examination.

"I am convinced that automatic ultrasound volume imaging with the Acuson S2000 ABVS can make a significant contribution in diagnostic confidence for women with dense breast tissue or inconclusive mammography findings," said Klaus Hambüchen, CEO, Ultrasound at Siemens Healthcare. Examinations performed with the Acuson S2000 ABVS technique generally take less than 15 minutes. "Time well spent if you consider the extended diagnostic capabilities of ultrasound in dense breasts."

Coronal anatomical view

The system quickly and comfortably acquires and surveys full-field sonographic volume images that provide a more comprehensive overview of the breast. Included is the intuitive, anatomical coronal plane of the breast (from the nipple to the breast wall), which is not available with conventional ultrasound imaging. This view provides a more understandable representation of the global anatomy and architecture of the breast.

The system's automatic image acquisition significantly improves the workflow of a breast ultrasound examination. While hand held examinations usually take up to 30 minutes, with the Acuson S2000 ABVS, the exam can be performed in less than 15 minutes. Semi-automated reporting and comprehensive BI-RADS® ultrasound reporting capabilities further enhance the clinical workflow. This Breast Imaging Reporting and Data System (BI-RADS) is a classification of the American College of Radiology (ACR) for reporting mammography screenings.

To further optimize high-volume patient care, the system also supports innovative breast imaging applications, such as Fatty Tissue and eSie Touch elasticity imaging. All of these applications help increase diagnostic confidence, while at the same time reducing examination and waiting time for the patient. The new system is an all-round system for ultrasound breast care, from early detection, to diagnosis to aftercare.

The Siemens Healthcare Sector is one of the largest suppliers of healthcare technology in the world. The company is a medical solution provider with core competences and innovative strengths in diagnostic and therapeutic technologies as well as knowledge processing, including information technology and system integration. With its acquisitions in laboratory diagnostics, Siemens Healthcare is the first integrated healthcare company that combines imaging and lab diagnostics, therapy solutions and medical information technology and also supplements these with consultation and services. Siemens Healthcare offers solutions for the entire supply chain under one roof - from prevention and early detection to diagnosis and on to treatment and aftercare. In addition, Siemens Healthcare is the global market leader for innovative hearing instruments. The company employs some 49,000 employees worldwide and is present in more than 130 countries. During fiscal 2008 (ending on September 30), Siemens Healthcare achieved sales of 11.17 billion euros and incoming orders totaling 11.78 billion euros. The Sector profit from operations amounted to 1.23 billion euros.

For more information, go to: www.siemens.com/healthcare

1 N Engl J Med 356;3. Boyd N.F. et Al., Mammographic Density and the Risk and Detection of Breast Cancer 2 Radiology 2002;225:165-175. Kolb T.M. et Al., Comparison of the Performance of Screening

Mammography, Physical Examination, and Breast US and Evaluation of Factors that Influence Them: An Analysis of 27,825 Patient Evaluations

Yeast Gives Clues To Parkinson's

2009-02-27T20:00:00.000+02:00

Scientists from the US and Australia are using cells from yeast and mammals to learn about how environment and genes affect whether a person gets Parkinson's disease or not.

Many aspects of the way yeast cells work are the same in animal and human cells, and since it is only possible to get hold of cells diseased with Parkinson's after a person is dead, having a similar more easily accessible cell to work with helps scientists study the early development of the disease and scan and test the thousands of genes that might be involved.

One such example is the subject of a study published this week in Nature Genetics, where Antony Cooper from Sydney's Garvan Institute of Medical Research in Australia and colleagues have for the first time found a way to connect three pieces of the Parkinson's disease jigsaw: sensitivity to manganese, and the behaviour of two genes, alpha-synuclein and PARK9 (also known as ATP13A2).

Alpha-synuclein and PARK9 have already been separately associated with forms of Parkinson's, and manganese poisoning can cause Parkinson-like symptoms in miners and welders exposed to high levels of the metal.

Parkinson's disease is where neurons that produce the neurotransmitter dopamine degenerate, and scientists have also known for some time that this is associated with an overexpression of the protein alpha-synuclein which autopsies have found in abundance in affected regions of the brain.

A European team also previously found that PARK9, already known to be involved in a hereditary form of Parkinson's, was in much greater abundance in the brains of people who had died of sporadic (ie not inherited) forms of the disease compared to the same parts of the brain in people who did not have the disease.

Cooper suspects that PARK9 was actually protecting the neurons and may explain why many of them surrounded by PARK9 survived.

What Cooper and colleagues found was that PARK9 appears also to diminish the toxic effects of alpha-synuclein, and it may also act as a manganese pump that is potentially capable of removing excess amounts of the metal from cells.

Cooper and colleagues were able to study the effect of PARK9 in yeast because it contains an equivalent gene.

An important and puzzling question in Parkinson's research is whether there is a single or cluster of genetic factors that cause the degeneration of neurons that produce dopamine.

As Cooper explained:

"We would love to be able to link all the genes that we know have something to do with Parkinson's disease."

"If you discover there's a central pathway involved, it provides much better potential for finding a successful treatment," he added, explaining that so far they have linked PARK9, alpha-synuclein and manganese, and this is no coincidence.

"They're likely to be affecting a pathway and we suspect it's a central pathway. To confirm that would be very exciting indeed," said Cooper.

Cooper has been working for some years, with co-authors Dr Susan Lindquist, from the Whitehead Institute for Biomedical Research and Dr Aaron Gitler, from the University of Pennsylvania School of Medicine, to find how alpha-synuclein might cause cell damage.

They teamed up with associate professor Guy Caldwell, of the University of Alabama, and associate professor Jean-Christophe Rochet from the University of Purdue in Indiana, to check their results using other models of Parkinson's disease.

The more models the findings fit into, the more you are likely to believe them, said Cooper.

"Alpha-Synuclein is part of a diverse and highly conserved interaction network that includes PARK9 and manganese toxicity."

Aaron D Gitler, Alessandra Chesi, Melissa L Geddie, Katherine E Strathearn, Shusei Hamamichi, Kathryn J Hill, Kim A Caldwell, Guy A Caldwell, Antony A Cooper, Jean-Christophe Rochet and Susan Lindquist.

Nature Genetics 41, 308 - 315, Published online: 1 February 2009.

doi:10.1038/ng.300

Click here for Abstract.

Sources: Journal abstract, Research Australia.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

More Cash For Contraception, UK

2009-02-27T14:00:00.000+02:00

£20.5m package to promote contraception Call for action to areas with high teenage pregnancy rates

An extra £20.5 million will help young people get better access to contraception and support for teenagers and raise the awareness of the risks of unprotected sex, Public Health Minister Dawn Primarolo and Young People's Minister Beverley Hughes announced today.

The cash supports the teenage pregnancy strategy that is focused on encouraging young people to delay early sex and to practice safe sex as and when they do become sexually active.

The new package of support and investment to promote the use of contraception includes:

- £7 million for a new 'contraceptive choices' media campaign to raise awareness of the different options - including Long Acting Reversible Contraceptives (LARCs) - available to young people, to prevent teenage conceptions;

- £10 million for local health services to ensure contraception is available in the right places at the right time;

- £1 million to support further education colleges develop and expand on-site contraception and sexual health services to help address the fact that 80 per cent of under-18 conceptions are among 16-17 year olds.

- A further £2.5m will help develop a Healthy College programme and help all services meet the Department of Health's 'You're Welcome' standards for young people friendly services.

Figures released by the Office of National Statistics today show that the increase in teenage pregnancy rates in the first three quarters of 2007 is due to a rise in unplanned conceptions ending in abortion, and not an increase in teenage mothers giving birth. However, the under 18 conception rate for the final quarter of 2007 is 2per cent lower than the same quarter in 2006 - suggesting that the drive to reduce teenage conceptions is continuing in the right direction.

Where there have been rises, and given these have resulted in abortions not births, this suggests that young people are not accessing effective contraception and may be engaging in more risky behaviour - pointing to the need for better advice and information about sex and relationships both from their parents and in schools.

Young people say they would prefer advice from parents and that is why the Government has invested in support for parents to help them talk more openly to their children. The Government has already announced its intention to make Sex and Relationships Education compulsory as part of Personal Social Health Education, and all schools will be provided with new SRE guidance this September.

Evidence shows that where the Government's teenage pregnancy strategy is implemented rigorously, significant reductions in teenage pregnancy rates have been achieved, such as in Oldham where rates have dropped by 29 per cent. The Government wants this success replicated across the country and is today calling on all local areas to redouble their efforts to drive a robust approach to reducing teenage pregnancy rates.

Despite the rise in national figures in the last year the long-term trend is still downward and overall there has been a 10.7 per cent reduction in under-18 conceptions and a 23.3 per cent decline in teenage births since the start of the Government's strategy in 1998. In 2006 the rates dropped to their lowest level in 20 years. Tackling teenage pregnancy requires sustained action by local authorities, the NHS parents, schools, and young people themselves.

Children and Young People's Minister, Beverley Hughes said: "Today's teenage pregnancy statistics are disappointing, although the reduction in the last quarter of 2007 over 2006 gives me cautious optimism that the drive to reduce teenage pregnancy conceptions is still on track. There is no doubt that rates have come down where local areas have implemented the strategy properly, even in deprived areas.

"The evidence suggests that more teenagers may have been engaging in risky behaviour and not using contraception, resulting in an increase in conceptions leading to abortion. Our strategy is to encourage teenagers to delay early sexual activity, but to use contraception when they do become sexually active.

"We have already announced our intention to make sex and relationship education (SRE) compulsory and we will be providing new SRE guidance to schools this September. This is in addition to more support for parents to help them talk more openly to their children about sex and relationships. And for the minority of families where parents are failing in their responsibilities we will continue our programmes of intensive family support which we know works in getting parents to do better by their children.

"Reducing teenage pregnancy requires everyone to play their part - parents, health, local authorities and schools. Where progress has slowed, efforts must be redoubled and we will be focusing our challenge on those areas with high and increasing rates."

Health Minister Dawn Primarolo said:

"Young people need good advice and easy access to contraception when they become sexually active. To help, we are improving access to contraception by providing an extra £20.5 million funding this year.

"We are supporting the NHS to offer women of all ages the full range of contraceptive choices, including long acting, reversible, methods such as implants and injections which are virtually 100 per cent effective. And we're giving local health services more money to come up with innovative ways of making sure young women use their contraceptives properly, such as text message reminders." Further Education Minister Sion Simon said:

"The Further Education sector has an important contribution to make in tackling sexual health issues. Colleges are ideally placed to offer support and advice to young people, and this extra investment will allow them to develop and expand on-site contraception and sexual health services. "Providing health advice services on-site avoids FE students having to take time off from their studies, helps them to deal quickly with health concerns that might be impacting negatively on their learning and can help avoid them dropping out of learning altogether."

The Government has issued clear guidance on effective strategies, which all areas must follow with a concerted and consistent approach. Ministers will be meeting with senior officials from Local Authorities and Primary Care Trusts in areas with high rates as well as receiving six monthly reports on the actions they are taking to strengthen their strategies. The Government has also taken action since 2007 to strengthen delivery of the strategy, which is not reflected in the statistics out today.

For the minority of families needing additional support, we have a range of parenting programmes designed to identify problems early and provide intensive help. These include the Family Nurse Partnerships for young mothers and Family Intervention Projects being expanded to all areas this year. From April this year, all areas will have at least two parenting experts to work with families and children experiencing serious problems.

In their guidance on Long Acting Reversible Contraceptives (LARC), NICE estimated that if 7 per cent of women switched from the pill to LARC methods (doubling current usage to 15 per cent) the NHS could save around £100 million each year through reducing unplanned pregnancies by 73,000.

Notes

1. England's under-18 conception rate is 41.7 per 1000 and has fallen by 10.7 per cent since 1998. The under-16 rate is 8.3 per 1000 and has fallen by 6.4 per cent over the same period.

2. Statistics published today by the Office of National Statistics show that in 2007 the under-18 conception rate rose by 2.6 per cent, accounted for by an increase in those having abortions. Despite the rise in national figures in 2007 the long-term trend is still downward.

3. The NHS offers women of all ages the full range of contraceptive choices, including long acting, reversible, methods such as implants and injections which are virtually 100 per cent effective. 4. In 2001 the Government published the National Strategy for Sexual Health and HIV which aims to prevent the spread of STIs and HIVe, improve care and treatment and reduce unintended pregnancies. See here.

5. The Teenage Pregnancy Strategy is based on the best international evidence. All areas have been provided with clear guidance on the key factors for effective local strategies. It is the responsibility of senior leaders in each Local Authority and Primary Care Trusts to implement this in their area.

6. The success of the Teenage Pregnancy strategy relies on all local areas applying it effectively. Where they do, rates come down - for example Calderdale has reduced its rate by 30 per cent and Oldham has reduced its rate by 29 per cent.

South West: Gloucestershire: -25.1 per cent

South East: Milton Keynes: -23.6 per cent

London: Newham: -24.9 per cent

East: Southend: -26.1 per cent

East Mids: Nottinghamshire: -24.0 per cent

West Mids: Telford & Wrekin: -23.9 per cent

Yorks & Humber: Calderdale: -29.9 per cent

North West: Oldham: -29.4 per cent

North East: Darlington: -13.7 per cent

7. A recent study from the US attributed 86 per cent of the decline in teenage pregnancy rates to improved contraception use.

8. Reducing the under-18 conception rate by 50 per cent by 2010 is one of the five National Indicators against which progress on PSA 14 "young people on the path to success" is measured, as part of a broader strategy to improve sexual health (joint DH/DCSF target). See http://www.condomessentialwear.co.uk and http://www.RUThinking.co.uk

9. Sexual health is identified as a priority area in the 2008/9 and 2009/10 NHS Operating Framework. The High Quality Care for All: NHS Next Stage Review Final Report has identified sexual health as one of six priority areas for PCTs to commission comprehensive wellbeing and prevention services to meet the needs of their local population. See here.

10. Under the Abortion Act 1967 women in Great Britain have access to safe, legal abortions. We are working hard to ensure that women have access to abortion services as soon as possible as evidence shows the risk of complications increases the later the gestation. Data for 2007 shows that progress is being made to increase early access: 68per cent of NHS funded abortions took place at under ten weeks, compared with 51per cent in 2001. In a bid to prevent repeat abortions, practitioners are now required to discuss future contraceptive options at the point of abortion.

- The 10 key factors of successful teenage pregnancy strategies

- 1. Advice and information for parents on talking to their children openly about relationships and sexual health.

- 2. A high priority given to sex and relationships (SRE) within PSHE in schools, with support from the local authority to develop comprehensive programmes of sex and relationships education (SRE) in all schools.

- 3. The availability of a well publicised young people-centred contraceptive and sexual health advice service, with targeted outreach work.

- 4. Strong senior champions in the LA and PCT who are accountable for delivery of the local strategy - with active engagement of Health, Education, Social Services, Targeted Youth Support and IYSS - and the voluntary sector.

- 5. Clear messages to young people on resisting peer pressure to have early sex and using contraception when they do become sexually active.

- 6. A strong focus on targeted interventions with young people at greatest risk of teenage pregnancy, in particular with Looked After Children and care leavers.

- 7. The availability (and consistent take-up) of SRE training for professionals in partner organisations (such as Connexions Personal Advisers, TYS Lead Professionals, Youth Workers and Social Workers) working with the most vulnerable young people.

- 8. Good use of local data to ensure strategies are targeted in high rate neighbourhoods and on young people most at risk of early pregnancy.

- 9. Support for vulnerable young people to raise self-esteem and tackle low aspirations.

- 10. A well resourced Youth Service, providing things to do and places to go for young people, with a clear focus on addressing key social issues affecting young people, such as sexual health and substance misuse.

Department of health, UK

FDA Says India's Largest Pharma Company Faked Test Results In Drug Applications

2009-02-26T20:00:00.000+02:00

The US Food and Drug Administration announced on Wednesday, 25th February, that a plant belonging to India's largest pharmaceutical company, Ranbaxy Laboratories, falsified data and test results in approved and pending applications of generic drugs for the US market.

The FDA said it was halting review of drug applications from Ranbaxy's Paonta Sahib Plant in India due to evidence of falsified data and was invoking powers under the Application Integrity Policy (AIP). This plant, and two others at Dewas and Batamandi, have been under an FDA Import Alert since September last year in respect of 30 different generic drugs, said the announcement.

The drugs affected by this move fall into three categories:

Drugs approved by the FDA for the US market that are made at the Paonta Sahib plant.

Drugs made at the plant that are not yet marketed in the US and are pending FDA approval.

Some drugs made in the US that relied on results provided by the plant.

While the FDA continues to investigate the matter, they assured they have no evidence that the drugs don't meet their quality specifications or of any health risks linked to products from the company that are currently sold in the US.

The agency's advice to patients currently taking drugs made by Ranbaxy is not to disrupt their therapy as this could be risky to their health; anyone worried about their medication should talk to their doctor.

The AIP covers applications that rely on information coming only from the Paonta Sahib factory, said the FDA, who raise the policy only when they are significantly concerned about the integrity of data provided with a drug application.

Under the policy, Ranbaxy is required to put in place a Corrective Action Operating Plan (CAOP) and show that the data from the plant is accurate and reliable. This includes for example allowing a third party to audit applications linked to data from the plant.

Director of the FDA's Center for Drug Evaluation and Research (CDER), Dr Janet Woodcock, told the press that:

"Companies must provide truthful and accurate information in their marketing applications."

Director of CDER's Office of Compliance, Deborah Autor said they applied the AIP because:

"The FDA's investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications."

She said that the "action reflects the FDA's continued vigilance and its steadfast commitment to safeguarding the public's health".

Click here for further information on FDA website.

Sources: FDA.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

The Latest DRX9000™ Study Data Published In Peer-Reviewed Journal!

2009-02-26T14:00:00.000+02:00

A study titled, "Prospective Evaluation of the Efficacy of Spinal Decompression via the DRX9000™ for Chronic Low Back Pain" was published in the December issue of The Journal of Medicine. The study authored by Dr. John Leslie, Mayo Clinic, et al, was designed to evaluate the effectiveness and safety of the DRX9000™ in the treatment of chronic lower back pain. Patients enrolled in the study had suffered an overall average of 266 weeks of low back pain. At the conclusion of the study, 16 of the 18 patients reported improvement in low back pain, greater than 50%. The authors state, "Patients also reported having better daily activity function as measured by the Oswestry Disability Index." Reprints are available through Axiom Worldwide. To view this article please visit here.

About Axiom Worldwide

Axiom Worldwide manufactures and distributes its flagship products, the DRX9000 True Non-surgical Spinal Decompression System™, DRX9000C™, and DRX9500™ in medical markets around the globe. Axiom also manufactures a digital electroceutical device, the EPS8000™, for use in relieving pain and for use in muscular rehabilitation. Axiom prides itself on providing safe, non-surgical alternatives that patients should consider prior to undergoing surgery. For additional information please visit: http://www.AxiomWorldwide.com. To schedule an interview please contact: Amber Pacetti, Marketing at: telephone: 001-813-249-6444 or email: apacetti@axiomworldwide.com.

Axiom Worldwide

Women With Oestrogen Receptor Positive Early Breast Cancer Should Receive Aromatase Inhibitors Upfront According To New NICE Clinical Guidelines

2009-02-25T14:00:00.000+02:00

AstraZeneca welcomes the National Institute for Health and Clinical Excellence (NICE) Early Breast Cancer (EBC) clinical guideline (1) that recommends upfront use of aromatase inhibitors (AIs), such as anastrozole (Arimidex),Anastrozole (Arimdex)(2) in women who are not deemed to be low risk, which will help to ensure that postmenopausal women with oestrogen (ER) positive EBC receive the most appropriate treatment available. Published today, the NICE Breast Cancer (early and locally advanced): Diagnosis and Treatment clinical guideline (1) elevates AIs over the previous gold standard treatment, tamoxifen, for newly diagnosed breast cancer sufferers who are not deemed to be low risk.

Astra Zeneca welcomes this recommendation as it will encourage more consistency in treatment practices across the country for early breast cancer - meaning that the 23,000 postmenopausal women diagnosed with breast cancer in the UK each year(3) are more likely to be treated with AIs immediately after surgery to help reduce the risk of early recurrence.

Professor Michael Baum, Professor Emeritus of Surgery and Visiting Professor of Medical Humanities, University College London said: "It is great news that NICE has acknowledged the wealth of data that supports the initiation of AIs immediately after surgery. All women with early breast cancer are at the greatest risk of recurrence in the first 2-3 years after surgery, regardless of the factors affecting the course of the disease. This guideline will help ensure women receive the most appropriate hormonal treatments available - ultimately helping to prevent their cancer returning."

AstraZeneca acknowledges the recommendation to offer a baseline bone scan to assess bone mineral density to all women starting an AI. (1) In the Arimidex, Tamoxifen Alone or in Combination (ATAC) trial women who had normal bone mineral density when entering the trial did not become osteoporotic after 5 years of treatment with anastrozole.(4) Data from the ATAC 100 trial showed the increased yearly fracture rate noted during treatment did not continue into the post-treatment follow-up period, where the fracture rate on anastrozole at 9 years was very similar to that with tamoxifen.(5)

AstraZeneca also acknowledges the NICE recommendation to offer an AI, such as anastrozole, instead of tamoxifen to postmenopausal women with ER positive EBC, who are not low risk and who have been treated with tamoxifen for 2-3 years. (1) However AstraZeneca would like to emphasize that there is no evidence that a planned sequencing strategy is superior to a 5 year AI strategy for newly diagnosed women with early breast cancer.

Advanced Breast Cancer

Today, NICE also published a clinical guideline for the diagnosis and treatment of advanced breast cancer (ABC) which highlights the place of endocrine therapies in this setting, including AIs and fulvestrant (Faslodex). Fulvestrant (Faslodex) (6).However, AstraZenca is disappointed that there is no mention of fulvestrant in the final recommendations, despite it being proven to be at least as effective as anastrozole in the treatment of postmenopausal women with advanced hormone receptor positive breast cancer, whose disease has relapsed on or after adjuvant antioestrogen therapy or progressed on therapy with an antioestrogen.(7 -9),

Professor Baum commented "Women should be fully informed of the advantages and disadvantages of medical and surgical treatment, understanding the overall benefits of treatment and the impact treatment has on quality of life. In the unfortunate instance that a women's breast cancer has progressed, it is important that everything possible is done to improve the patient's quality of life. Use of fulvestrant increases the options available to clinicians, delaying the need to start chemotherapy following failure of prior endocrine therapy."

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: http://www.astrazeneca.com

References

1. NICE (February 2009) Early and locally advanced breast cancer: diagnosis and treatment.

2. Anastrozole (Arimdex) SmPC. http://www.medicines.org.uk/

3. Technology Assessment Report commissioned by the HTA. Programme on behalf of The National Institute for Clinical Excellence. 'Hormonal therapies for early breast cancer: systematic review and economic evaluation'.

4. Coleman R. Effect of anastrozole on bone mineral density and bone fractures: results from the 'Arimidex'' (anastrozole), tamoxifen, alone or in combination (ATAC) trial. European Journal of Cancer Supplements 2004;2(3):140, Abs 289.

5. The ATAC Trialists' Group. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer; 100- month analysis of the ATAC trial. The Lancet Oncology , 2008; 9 (1) 45-53.

6. Fulvestrant (Faslodex) SmPC. http://www.medicines.org.uk/

7 Robertson JF, Osborne CK, Howell Aet al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women. Cancer 2003; 98 (2): 229-238. 8 Howell, A. et al. Fulvestrant, Formerly ICI 182,780, Is as Effective as Anastrozole in Postmenopausal Women With Advanced Breast Cancer Progressing After 9 Prior Endocrine Treatment. Journal of Clinical Oncology, 2002; 20 (16):3396-3403. 9 Osborne C.K et al. Double blind, randomised trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on with prior endocrine therapy: Results from a North American Trial. Journal of Clinical Oncology, 2002; 20 (16):3386-3395. AstraZeneca

Stroke And The 'Sight' Effects National Conference 2009 Tuesday 24 March At RNIB, Birmingham

2009-02-24T14:00:00.000+02:00

Every 5 minutes someone in the UK suffers a stroke. But did you know that up to 70 per cent of these people sustain some kind of related visual loss?

Stroke and the 'Sight' Effects National Conference 2009, brought to you by RNIB in partnership with The Stroke Association, offers you the opportunity to gain a greater understanding of the eye problems associated with stroke, explore the ophthalmologist's role in stroke care and understand the psychological impact of visual impairment on stroke sufferers.

Speakers include:

Mr Mohamad Jabir, Consultant Ophthalmologist, Rotherham General Hospital
Dr Fiona Rowe, Senior Lecturer in Orthoptics, University of Liverpool
Professor Glyn Humphreys, Professor of Cognitive Psychology, University of Birmingham.

Cost: £130 or £70 for voluntary organisations/students

Further details are available from http://www.rnib.org.uk/strokeconference09

Places are limited and will be allocated on a first-come, first-served basis.

Please ensure you book by 13 March. For further details, please contact Chris Smith on telephone 0121 665 4243.

Don't forget to use the Events section of the VISION 2020 UK website for more events and also, don't forget to let me (Laura Beaumont) know of any events that you are aware of, but aren't listed!

Featured event: 24 March 2009 - National Conference: Stroke and the "Sight" Effects

About the event

Did you know that up to 70 per cent of people who have had a stroke sustain some kind of visual loss or difficulty, as a result? This one-day national conference - in association with The Stroke Association - considers the visual effects of stroke, how stroke affects people, their rehabilitation and daily living. With high-profile speakers outlining the psychological impact of the 'sight' effects, the latest insights from health professional management and care, and up-to-date information about stroke and sight epidemiology, this conference will bring together senior social services contacts, NHS and PCT specialist staff, social work practitioners and all those involved in the support of people with sight loss, stroke survivors and older people.

Speakers include:

Elaine Roberts, Director of Operations: North of England, The Stroke Association
Stevie Johnson, Training and Practice Development Officer: Healthcare, RNIB
Sue Wayne, Stroke Services Training and Development Manager, The Stroke Association
Mr Mohamad Jabir, Consultant Ophthalmologist, Rotherham General Hospital
Dr Fiona Rowe, Senior Lecturer in Orthoptics, University of Liverpool
Kathryn Jarvis, Occupational Therapist, University of Liverpool
Professor Glyn Humphreys, Professor of Cognitive Psychology, University of Birmingham.

Learning outcomes

The conference offers an opportunity to deepen your knowledge of stroke and the 'sight' effects, as well as to network with colleagues and peers and to share ideas and solutions. Delegates will:

Develop a greater understanding of the range of eye problems associated with stroke
Explore the role of the Ophthalmologist in stroke care
Understand the psychological impact of visual impairment on someone who has suffered a stroke, their family and friends.

Who should attend?

The conference is a must-attend event for any of the following:

managers of services for older people
social workers and practitioners supporting people with stroke
social workers and practitioners supporting people with sight loss
NHS and PCT specialist nursing staff supporting older people, people with sight loss or stroke survivors
occupational therapists and rehabilitation officers for the visually impaired
assistant rehabilitation officers
all those from voluntary organisations supporting people with sight loss, stroke survivors and older people.

Programme

10.00 Registration/tea/coffee

10.30 Welcome and housekeeping, Chair - Elaine Roberts, Director of Operations: North of England, The Stroke Association

10.45 RNIB, Stevie Johnson, Training and Practice Development Officer: Healthcare, RNIB

11.00 The Stroke Association, Sue Wayne, Stroke Services Training and Development Manager, The Stroke Association

11.15 An Ophthalmologist's Viewpoint, Mr Mohamad Jabir, Consultant Ophthalmologist, Rotherham General Hospital

12.00 Prevalence of Visual Sequelae in Stroke Survivors, Dr Fiona Rowe, Senior Lecturer in Orthoptics, University of Liverpool

12.45 Q&A panel

13.00 Lunch

13.45 Real life stories from those affected by stroke and sight loss, Speaker to be confirmed

14.30 Vision and perception, Kathryn Jarvis, Occupational Therapist, University of Liverpool

15.00 Tea break

15.15 Psychological Effects - Fractionating Vision, Professor Glyn Humphreys, Professor of Cognitive Psychology, University of Birmingham

15.45 Q&A panel

16.00 Summary of day and evaluation, Chair

16.30 Close

Fees: £130 per delegate. £70 concessionary fee for students and voluntary organisations.

Organisaed by: RNIB in association with The Stroke Association

Venue: RNIB

58-72 John Bright Street

Birmingham

B1 1BN

http://www.rnib.org.uk/strokeconference09 RNIB

Alabama Receives Grant To Combat Obesity

2009-02-23T14:00:00.000+02:00

The Alabama Department of Public Health is one of eight state health departments selected to receive grants to support the development of physical activity and nutrition programs in partnership with selected communities. Because of the BITE (Balancing InTake and Expenditure) grant, the department will provide $15,000 directly to community groups.

Alabama has developed a competitive process to select at least five local communities to receive grants by April 2009. Successful community applicants will demonstrate that partnerships are in place to effectively plan and implement physical activity and nutrition projects to reduce community risks for obesity.

Community groups interested in this funding opportunity and who would like to obtain a request for funding application should contact Miriam Gaines, Nutrition and Physical Activity director, at (334) 206-5226 or by e-mail at mgaines@adph.state.al.us by March 16, 2009.

Community applicants will be expected to convene and coordinate a coalition of organizations that are vested in improving physical activity opportunities and improving nutritional status of their residents. These groups and their members will become part of a research project that will test various methods of project management. The planning and implementation of community projects will take place during the 13-month period from July 1, 2009, to July 31, 2010. The local project coordinator or chair will become a member of the state's Obesity Task Force. The community groups receiving awards will be encouraged to embrace combating obesity as a continuous priority.

Eligible applicants for BITE grants were the 15 states with the highest overweight and obesity rates in the U.S. The state grants were awarded based on the strength of the state's history and current ability to build and sustain partnerships with state and community-level organizations with capacity to build community-based health initiatives in obesity prevention.

Other states selected were Delaware, Kentucky, Mississippi, North Dakota, Oklahoma, South Carolina and West Virginia. Each of these states had some of the highest obesity prevalence rates in the nation in 2007, according to the Centers for Disease Control and Prevention; from 27.4 percent in Delaware to 32 percent in Mississippi. The National Association of Chronic Disease Directors, an Atlanta-based, national association of state health agency chronic disease prevention professionals, is pleased to award these funds as part of a collaborative research grant from Klein Buendel, Inc., a Golden, Colo., health education media research firm and the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) to assist communities in implementing programs targeting improvements in physical activity and healthy nutrition.

Alabama Department of Public Health

European Commisssion Grants Ferring Pharmaceuticals Approval Of FIRMAGON(R) (Degarelix) For Treatment Of Prostate Cancer

2009-02-20T14:00:00.000+02:00

Ferring Pharmaceuticals announced that it has received marketing authorisation from the European Commission, for FIRMAGON(R) (degarelix), a new GnRH receptor antagonist indicated for patients with advanced, hormone-dependent prostate cancer.

In Phase III studies degarelix produced a significant reduction in levels of testosterone (i,ii) within three days in more than 96% of study patients.(ii) Testosterone plays a major role in the growth and spread of prostate cancer cells.

The data show that degarelix provided an extremely fast effect on testosterone levels, close to the immediate effect achieved with surgery (orchidectomy).(ii,iii)

"We are delighted with the approval of FIRMAGON(R) (degarelix), which demonstrated in clinical trials both an immediate onset of action and a profound long-term suppression of testosterone and PSA" commented Dr. Pascal Danglas, Executive Vice President Clinical & Product Development at Ferring Pharmaceuticals. "We will work with local authorities to ensure the launch of FIRMAGON to patients across European Union countries as soon as possible."

The European Commission approval for FIRMAGON(R) (degarelix) follows approval from the FDA in the US in December 2008.

About Prostate Cancer

Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 218,890 new cases were estimated for 2007, with a mortality rate of 27,050. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan.

About degarelix

Degarelix is a GnRH receptor antagonist indicated for advanced prostate cancer. Ferring plans to communicate a range of information about the treatment at the European Academy of Urology (EAU) congress in Stockholm in March.

About Ferring

Ferring is a Swiss-headquartered, research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of urology, endocrinology, gastroenterology, gynaecology, and fertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 45 countries. To learn more about Ferring or our products please visit http://www.ferring.com

(i) Van Poppel H, De La Rosette JJ, Persson B.E, Oleson TK, Degarelix Study Group; Long-term evaluation of degarelix, a gonadotrophin-releasing hormone (GnRH) receptor blocker, investigated in a multicentre randomised study in prostate cancer (CAP) patients. Abstract (23.) Euro Urol Suppl 2007;6(2):28

(ii) Boccon-Gibod L, Klotz L, Schröder FH, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK; Degarelix compared to leuprolide depot 7.5 mg in a 12-month randomised, open-label, parallel-group phase III study in prostate cancer patients. Abstract 537 presented at the 23rd EAU Congress, Milan, Italy, 2008.

(iii) Nielsen S, Connolly M, Persson B, Variation between countries in the perceived use of antiandrogens to prevent flare symptoms: results of a comprehensive survey. Abstract 539 presented at the 23rd EAU Congress, Milan, Italy, 2008

Ferring Pharmaceuticals

Malaria Parasite Survival May Rely On Targeting Key Amino Acid

2009-02-19T20:00:00.000+02:00

New research from the US suggests that targeting and destroying a particular amino acid in the human body could be an important survival tactic for the deadly malaria parasite Plasmodium falciparum.

The study is the work of scientists at Princeton University in New Jersey and Drexel University College of Medicine in Philadelphia and is published in the 19 February issue of Cell Host & Microbe. The lead investigator was Manuel Llinás, assistant professor in the department of molecular biology and the Lewis-Sigler Institute for Integrative Genomics, both at Princeton.

Pathogens that invade the cells of their hosts have evolved biochemical mechanisms to help them make best use of their environment in order to survive and multiply. One such pathogen, the malaria parasite Plasmodium falciparum uses the host's metabolites, the chemicals derived from digested nutrients that are found inside cells that help the host make and use energy and do other things like repair and make new cells.

There are hundreds of metabolites in the human body, these include amino acids, sugars, nucleotides and vitamins. A new scientific field called metabolomics specializes in the study of the "metabolic network" of organisms: there can be as many as 500 core metabolites in such a network. Metabolomic scientists measure levels of core metabolites and produce a "metabolomic profile" of an organism, in essence a chemical signature of the genetic expression of an organism at the cellular level.

First author Kellen Olszewski, a graduate student at Princeton University, said:

"The more we know about the parasite's metabolic network, the more intelligent we can be about targeting therapies that will cure malaria."

For this study, the researchers used mass spectrometry to trace the changes in chemical signature in human red blood cells infected with the parasite over the parasite's 48-hour intraerythrocytic development cycle (a single "generation" of parasite replication).

Mass spectrometry detects the presence of chemicals in a mix because each one has its own unique wavelength at which it absorbs or emits electromagnetic radiation.

This metabolomic analysis showed that levels of several metabolites went up and down in phase with the parasite's development cycle. It showed that one in particular, the amino acid arginine, had dipped dramatically by the end of one 48-hour cycle.

The parasite was targetting it in preference to other available amino acids and converting it to ornithine.

To find how it was doing this, the researchers used a rodent model of malaria based on Plasmodium berghei and switched off the parasite's arginase gene. The parasites survived but did not convert the arginine to ornithine, suggesting it wasn't using it in order to grow but for some other purpose that helps it survive.

The researchers concluded that:

"Our results suggest that systemic arginine depletion by the parasite may be a factor in human malarial hypoargininemia associated with cerebral malaria pathogenesis."

They suggested that by depleting arginine, the parasite was triggering a more critical and deadly phase of the infection. Perhaps the parasite was getting rid of arginine to weaken the host immune system: arginine is an important fuel for the human immune system which also coverts it to nitric oxide, a chemical that is toxic to pathogens.

Perhaps the next generation of anti-malarial drugs will use detailed knowledge of the parasite's weaknesses, such as that revealed by its metabolic network, said Llinás.

The World Health Organization estimates that 350 to 500 million people are infected with malaria every year by mosquitos that carry one of the four human malaria parasites, P. falciparum, P. vivax, P. malariae or P. ovale. P. falciparum is by far the deadliest and kills more than than 1 million people a year, mainly young children and pregnant women.

"Host-Parasite Interactions Revealed by Plasmodium falciparum Metabolomics."

Kellen L. Olszewski, Joanne M. Morrisey, Daniel Wilinski, James M. Burns, Akhil B. Vaidya, Joshua D. Rabinowitz, andManuel Llinás.

Cell Host & Microbe, Volume 5, Issue 2, 191-199, 19 February 2009

doi:10.1016/j.chom.2009.01.004

Click here for Article.

Sources: Journal abstract, Princeton University press release.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

Misdiagnosis Of Some Young Adult Stroke Patients In ER

2009-02-19T14:00:00.000+02:00

Young adults with stroke symptoms are sometimes misdiagnosed in emergency rooms - making them miss effective early treatment - according to research presented at the American Stroke Association's International Stroke Conference 2009.

In the Misdiagnosis of Acute Stroke in the Young During Initial Presentation in the Emergency Room study, researchers reviewed data on 57 patients, ages 16 to 50 years old, enrolled since 2001 in the Young Stroke Registry at the Comprehensive Stroke Center at Wayne State University in Detroit, Mich.

Four males and four females (14 percent), average age 34, were misdiagnosed as having vertigo, migraine, alcohol intoxication or other conditions. They were discharged from the hospital and later discovered to have suffered a stroke. Those misdiagnosed included:

an 18-year-old man who reported numbness on his left side but was diagnosed with alcohol intoxication;
a 37-year-old woman who arrived with difficulty speaking and was diagnosed with a seizure;
a 48-year-old woman with sudden blurred vision, an off-balance walk, lack of muscle coordination, difficulty speaking and weakness in her left hand, who was told she had an inner ear disorder.

"Accurate diagnosis of stroke on initial presentation in young adults can reduce the number of patients who have continued paralysis and continued speech problems," said Seemant Chaturvedi, M.D., senior author of the study and a professor of neurology and director of the stroke program at Wayne State.

"We have seen several young patients who presented to emergency rooms with stroke-like symptoms within three to six hours of symptom onset, and these patients did not get proper treatment due to misdiagnosis. The first hours are really critical."

Intravenous delivery of the clot-busting drug tissue plasminogen activator (tPA) is the only U.S. government-approved treatment for acute stroke. It must be delivered within three hours of symptom onset to reduce permanent disability caused by stroke. Chaturvedi said experimental interventional stroke treatment such as intra-arterial clot busters and mechanical clot retrieval may be an option for some patients three to eight hours after symptoms.

"Part of the problem is that the emergency room staff may not be thinking stroke when the patient is under 45 years old," Chaturvedi said. "Physicians must realize that a stroke is the sudden onset of these symptoms."

Patients arriving with "seemingly trivial symptoms like vertigo and nausea" should be assessed meticulously, he said.

"Some people believe that younger people may respond better to stroke treatments, so that makes it doubly important to recognize when a stroke is happening. After 48 to 72 hours, there are no major interventions available to improve stroke outcome."

No matter the age, people must also get to the hospital quickly if these stroke symptoms occur:

sudden numbness or weakness of the face, arm or leg, especially on one side of the body;
sudden confusion, trouble speaking or understanding;
sudden trouble seeing in one or both eyes;
sudden trouble walking, dizziness, loss of balance or coordination; and/or
sudden, severe headache with no known cause.

Stroke is the third leading cause of death and one of the top causes of disability in the United States. "Early intervention is the most critical component of effective stroke care," said Abraham Kuruvilla, M.D., the study's lead author and a stroke fellow in the neurology department at Wayne State University. "Early intervention will reduce the burden of disability of the young patients afflicted with stroke disability and the associated high cost of medical care in this population."

The other co-author is Kumar Rajamani, M.D. Individual author disclosures are on the abstract.

The American Heart Association/American Stroke Association advocates for stroke telemedicine programs that provide effective stroke treatment to underserved areas and the elimination of disparities in stroke awareness and care. For more information, please visit http://www.strokeassociation.org/yourethecure.

Statements and conclusions of study authors that are presented at American Heart Association/American Stroke Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at http://www.americanheart.org/corporatefunding.

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Article adapted by Medical News Today from original press release.

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NR09-1015 (ISC09/Chaturvedi)

Source: Bridgette McNeill

American Heart Association

Drug To Treat Opioid Addiction Identified By Stanford Scientists

2009-02-18T14:00:00.000+02:00

Scientists at Stanford University School of Medicine have discovered that a commonly available non-addictive drug can prevent symptoms of withdrawal from opioids with little likelihood of serious side effects. The drug, ondansetron, which is already approved to treat nausea and vomiting, appears to avoid some of the problems that accompany existing treatments for addiction to these powerful painkillers, the scientists said.

Opioids encompass a diverse array of prescription and illegal drugs, including codeine, morphine and heroin. In 2007, about 12.5 million Americans aged 12 and older used prescription pain medications for non-medical purposes, according to the National Survey on Drug Use and Health, administered by the federal government's Substance Abuse and Mental Health Services Administration.

"Opioid abuse is rising at a faster rate than any other type of illicit drug use, yet only about a quarter of those dependent on opioids seek treatment," said Larry F. Chu, MD, assistant professor of anesthesia at the School of Medicine and lead author of the study that will be published online Feb. 17 in the Journal of Pharmacogenetics and Genomics. "One barrier to treatment is that when you abruptly stop taking the drugs, there is a constellation of symptoms associated with withdrawal." Chu described opioid withdrawal as a "bad flu," characterized by agitation, insomnia, diarrhea, nausea and vomiting.

Current methods of treatment are not completely effective, according to Chu. One drug used for withdrawal, clonidine, requires close medical supervision as it can cause severe side effects, while two others, methadone and buprenorphine, don't provide a satisfactory solution because they act through the same mechanism as the abused drugs. "It's like replacing one drug with another," said co-investigator Gary Peltz, MD, PhD, professor of anesthesia.

"What we need is a magic bullet," said Chu. "Something that treats the symptoms of withdrawal, does not lead to addiction and can be taken at home."

The researchers' investigation led them to the drug ondansetron, after they determined that it would block certain receptors involved in withdrawal symptoms.

The scientists were able to make this connection thanks to their having a good animal model for opioid dependence. Mice given morphine for several days develop the mouse equivalent of addiction. Researchers then stop providing morphine to trigger withdrawal symptoms. Strikingly, these mice, when placed into a plastic cylinder, will start to jump into the air. One can measure how dependent these mice are by counting how many times they jump. Like humans, dependent mice also become very sensitive to pain when they stop receiving morphine.

But the responses vary among the laboratory animals. There are "different flavors of mice," explained Peltz. "Some strains of mice are more likely to become dependent on opioids." By comparing the withdrawal symptoms and genomes of these different strains, it's possible to figure out which genes play a major role in addiction.

To accomplish this feat, Peltz and his colleagues used a powerful computational "haplotype-based" genetic mapping method that he had recently developed, which can sample a large portion of the genome within just a few hours. This method pinpoints genes responsible for the variation in withdrawal symptoms across these strains of mice.

The analysis revealed an unambiguous result: One particular gene determined the severity of withdrawal. That gene codes for the 5-HT3 receptor, a protein that responds to the brain-signaling chemical serotonin.

To confirm these results, the researchers injected the dependent mice with ondansetron, a drug that specifically blocks 5-HT3 receptors. The drug significantly reduced the jumping behavior of mice as well as pain sensitivity - two signs of addiction.

The scientists were able to jump from "from mouse to man" by sheer luck: It turns out that ondansetron is already on the market for the treatment of pain and nausea. As a result, they were able to immediately use this drug, approved by the Food and Drug Administration, in eight healthy, non-opioid-dependent humans. In one session, they received only a single large dose of morphine, and in another session that was separated by at least week, they took ondansetron in combination with morphine. They were then given questionnaires to assess their withdrawal symptoms.

Similar to mice, humans treated with ondansetron before or while receiving morphine showed a significant reduction in withdrawal signs compared with when they received morphine but not ondansetron. "A major accomplishment of this study was to take lab findings and translate them to humans," said principal investigator J. David Clark, MD, PhD, professor of anesthesia at Stanford University School of Medicine and the Palo Alto Veterans Affairs Health Care System.

Chu plans on conducting a clinical study to confirm the effectiveness of another ondansetron-like drug in treating opioid withdrawal symptoms in a larger group of healthy humans. And the research team will continue to test the effectiveness of ondansetron in treating opioid addiction.

The scientists warned that ondansetron will not by itself resolve the problems that arise with continued use of these painkillers. Addiction is a long-term, complex process, involving both physical and psychological factors that lead to compulsive drug use. "This is not a cure for addiction," said Clark. "It's naïve to think that any one receptor is a panacea for treatment. Treating the withdrawal component is only one way of alleviating the suffering. With luck and determination, we can identify additional targets and put together a comprehensive treatment program."

Collaborators on this study included De-Yong Liang, PhD, the study's co-lead author, previously a research associate in the Department of Anesthesia and currently a research associate at the Palo Alto Institute for Research and Education; Xiangqi Li, MD, a life science research assistant in the department; Nicole D'Arcy, a medical student: Peyman Sahbaie, MD, a research associate at the institute; and Guochun Liao, PhD, of the pharmaceutical company Hoffman-La Roche. This work was supported by grants to Clark from the National Institutes of Health and the National Institute on Drug Abuse, and grants to Chu from the NIH and the National Institute of General Medical Sciences.

The researchers are working with the Stanford University Office of Technology Licensing to seek a patent for the use of ondansetron and related medicines in the treatment of drug addiction.

----------------------------

Article adapted by Medical News Today from original press release.

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Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu.

Source: Rosanne Spector

Stanford University Medical Center

Haemophiliac Died With But Not From Variant CJD

2009-02-17T20:00:00.000+02:00

The UK's Health Protection Agency said earlier today, 17 February, that a post mortem on a patient with haemophilia had found evidence in his spleen of abnormal prion protein that causes variant CJD (vCJD) but it did not kill him: he died with rather than from the disease which is commonly called mad cow disease.

The post-mortem is part of an ongoing study by the UK Haemophilia Centre Doctors Organisation and the National CJD Surveillance Unit that started in 2001.

The patient was a man in his seventies and had died of a condition unrelated to vCJD. He had not shown any symptoms of vCJD before he died, and had shown no other neurological problems either. The first sign of vCJD was from the post mortem.

The HPA, who are working with the UK Haemophilia Centre Doctors Organisation, said this will not change the way that haemophilia patients are cared for or treated, and are doing all they can to inform patients with bleeding disorders about this situation and that further investigations are also taking place.

Haemophilia patients already know from their doctors about the possibility that they may have been exposed to vCJD through use of clotting factors derived from plasma of infected donors.

All patients treated with plasma sourced and pooled in the UK between 1980 and 2001 were told in 2004 that they were classed as at risk of vCJD for public health reasons: in other words there was a risk they were infected and their blood could pass this onto others. At that time the risk was a theoretically calculated one, quite small, but not real until this latest finding.

The chances of a person infected with the vCJD abnormal prion protein developing symptoms of the disease are unknown, and probably depend on how susceptible they are; it may be the case that some infected people never develop symptoms.

The HPA said the latest finding does not change the public health vCJD "at risk" status of patients with bleeding disorders, even though this is the first time that abnormal vCJD prion protein has been found in a haemophilia patient, or anyone treated with plasma products. The risk status does not change because measures have already been in place for some years that are based on a theoretical risk which has now become real but not changed in size.

As professor Mike Catchpole, Director of the Health Protection Agency's Centre for Infections, explained:

"This new finding may indicate that what was until now a theoretical risk may be an actual risk to certain individuals who have received blood plasma products, although the risk could still be quite low."

"We recognise that this finding will be of concern for persons with haemophilia who will be awaiting the completion of the ongoing investigations and their interpretation," he added.

The HPA said the main priority now was to make sure patients were informed about this finding and can talk to a doctor at their haemophilia centre as soon as possible.

"This finding does not change our understanding of the risk from vCJD for other people in any specific way. But it does reinforce the importance of the precautionary measures that have been taken over the years," said Catchpole.

"UK plasma has not been used for the manufacture of clotting factors since 1999 and synthetic clotting factors are provided for all patients for whom they are suitable," he said.

The authorities don't know how the patient got vCJD; there are more investigations to do yet.

What they do know is that he was treated with several batches of clotting factors derived from UK donors before 1999, when the vCJD blood safety measures were brought in. This included one batch of Factor VIII (the blood clotting factor that is faulty in people with haemophilia) made using plasma from a donor that developed symptoms of vCJD six months after donating blood in 1996.

Click here for more information about vCJD (from the HPA).

Sources: HPA news release.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

Compound Can Distinguish Between Benign, Localized And Metastatic Prostate Cancer

2009-02-17T14:00:00.000+02:00

Researchers have determined that a molecule produced by the body's metabolism could be used to differentiate between benign prostate tissue vs. localized and metastatic prostate cancer. They also found that this molecule, known as sarcosine, may be associated with prostate cancer invasiveness and aggressiveness. The findings were reported by researchers at the Michigan Center for Translational Pathology, Ann Arbor, and were supported by the National Cancer Institute's (NCI) Early Detection Research Network (EDRN). The research appears in the Feb. 12, 2009 issue of Nature. NCI is part of the National Institutes of Health.

"Current biomarkers for detection or progression of prostate cancer are not as precise as we would like. Therefore, a more accurate indicator of cancer is of great interest," said Sudhir Srivastava, Ph.D., chief of NCI's Cancer Biomarkers Research Group. "Sarcosine and some other select metabolites may be excellent indicators of cancer progression."

Multiple, complex molecular events characterize cancer development and progression. Determining which molecular networks dictate whether cancer will be confined to the prostate or spread to other parts of the body could lead to the identification of critical biomarkers associated with prostate cancer invasion and aggressiveness.

Although many genes and proteins related to cancer have been extensively characterized by genomic and proteomic studies, little is known about metabolomic changes that mark a tumor's progression. Metabolomics, upon which this current finding is based, is the study of the unique chemical fingerprints that cellular processes leave behind, which can help scientists understand the makeup of a cell. One of the challenges that scientists currently face is integrating genomic, proteomic, and metabolomic information to give a more complete picture of living organisms and the diseases that afflict them.

Using a long-established laboratory technique called mass spectrometry, which sorts chemical compounds by their molecular weight, the researchers profiled more than 1126 metabolites from 262 clinical samples related to prostate cancer (42 tissue samples, 110 urine samples and 110 samples of blood plasma). These metabolomic profiles enabled researchers to distinguish between benign prostate tissue, clinically localized prostate cancer, and metastatic disease. Sixty metabolites were identified in localized and/or metastatic prostate tumors that were not present in benign prostate tissue. Ultimately, six metabolites, including sarcosine, were found to be significantly elevated during progression from benign tissue to localized cancer to metastatic disease. Sarcosine was also detected in the urine of men with prostate cancer. Because this metabolite showed progressive elevation from benign tissue to localized prostate cancer to metastatic disease, it was selected for further study.

To investigate the role of sarcosine in prostate cancer progression, the researchers performed analyses of laboratory-grown cells. They found that sarcosine levels were higher in invasive prostate cancer cells than in benign prostate cells. Moreover, the addition of sarcosine to benign prostate cells caused them to become invasive. By manipulating levels of the enzymes that regulate sarcosine metabolism, the researchers found they were able to control the invasiveness of benign and malignant prostate cells.

"Components of the sarcosine pathway could serve as novel avenues for therapeutic intervention," said Arul M. Chinnaiyan, M.D., Ph.D., Michigan Center for Translational Pathology at the University of Michigan, Ann Arbor. "Our next step will be to confirm these findings in a greater number of specimens and to have our results validated by other laboratories."

Sreekumar A, Poisson LM, Rajendiran TM, Khan AP, Cao Q, Yu J, Laxman B, Mehra R, Lonigro RJ, Yong L, Nyati MK, Ahsan A, Kalyana-Sundaram S, Han B, Cao X, Byun J, Omenn GS, Ghosh D, Pennathur S, Alexander DC, Berger A, Shuster JR, Wei JT, Varambally S, Beecher C, and Chinnaiyan AM. Metabolomic profiles delineate potential role for sarcosine in prostate cancer progression. Nature. February 12, 2009.

For more information on Dr. Chinnaiyan's research, please go here.

For more information on NCI's EDRN, please go to: http://edrn.nci.nih.gov.

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Beta-Blocker Erases Bad Memories

2009-02-16T20:00:00.000+02:00

A generic beta-blocker normally used to control blood pressure could one day be used to treat anxiety and phobia by erasing bad memories, according to a new Dutch study.

The research was the work of Dr Merel Kindt, a professor in the Faculty of Social and Behavioural Sciences - Clinical Psychology at the University of Amsterdam and other colleagues from the university and was published in the advanced online issue of Nature Neuroscience on 15 February.

Animal studies have shown that memories involving fear can change when recalled, a process that psychologists term reconsolidation.

In this study Kindt and colleagues found that giving human subjects propranolol pills before getting them to recall fear memories erased the behavioural expression of the fear 24 hours later and prevented the return of the fear.

Propranolol is a widely available generic beta-adrenergic receptor antagonist (beta-blocker) that is normally used in the treatment of high blood pressure.

For the study, the researchers recruited 60 healthy male and female volunteers. According to a report in BBC news, on day 1 they got them to learn to associate spiders with fear by giving them mild electric shocks to their wrists while they looked at pictures of spiders.

On day 2 the participants were randomly assigned to either a treatment group or a placebo group. The treatment group was given propranolol and the placebo group was given a dummy drug before they were all shown the spider pictures again.

In each case, the participant's startle response (how much they blink when a sudden noise occurs) was measured, this is a standard way of measuring how fearful a person is at a certain point in time.

The results showed that the startle response was significantly lower in the treatment group compared to the placebo group.

On day 3, by which time the drug would no longer be in their bodies, the participants were retested. The results were largely similar: the treatment group showed lower startle responses compared to the placebo group.

The researchers concluded that disrupting the reconsolidation of fear memory could be a route to new treatments for patients with emotional disorders.

Kindt told Reuters news agency in a telephone interview that:

"We could show that the fear response went away, which suggests the memory was weakened."

BBC news reported that Kindt said the drug had dampened the emotional intensity of the fear memories and that animal studies had shown that beta blockers can interfere with how the brain makes sense of fear memories.

She did however caution that it was too early to say if such a procedure would work for complex conditions like post traumatic stress.

The current therapy for helping people cope with bad memories, for instance in post traumatic stress disorder, is to teach them to build new associations and extinguish the bad memory link. The problem with such approaches, Kindt told Reuters, is that people relapse and the memories don't become extinguished.

The BBC said some British experts were sceptical and questioned the ethics of treating the mind by using drugs to alter memory.

Paul Farmer, chief executive of mental health charity Mind, told BBC news that he was worried about the "fundamentally pharmacological" approach for the treatment of phobias and anxiety.

And medical ethics expert, Dr Daniel Sokol said we need to reflect on the effects of approaches like erasing memories may have on people. What if they also affect the "good memories" and we end up with cases of "accelerated Alzheimer's"?

"Beyond extinction: erasing human fear responses and preventing the return of fear."

Merel Kindt, Marieke Soeter and Bram Vervliet.

Nature Neuroscience Published online: 15 February 2009.

doi:10.1038/nn.2271

Click here for Abstract.

Sources: Journal abstract, Reuters, BBC News.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

Delays In Activity Based Neural Networks

2009-02-16T14:00:00.000+02:00

In this paper we study the effect of two distinct discrete delays on the dynamics of a Wilson-Cowan neural network. This activity based model describes the dynamics of synaptically interacting excitatory and inhibitory neuronal populations. We discuss the interpretation of the delays in the language of neurobiology and show how they can contribute to the generation of network rhythms.

First we focus on the use of linear stability theory to show how to destabilise a fixed point, leading to the onset of oscillatory behaviour. Next we show for the choice of a Heaviside nonlinearity for the firing rate that such emergent oscillations can be either synchronous or anti-synchronous depending on whether inhibition or excitation dominates the network architecture.

To probe the behaviour of smooth (sigmoidal) nonlinear firing rates we use a mixture of numerical bifurcation analysis and direct simulations, and uncover parameter windows that support chaotic behaviour.

Finally we comment on the role of delays in the generation of bursting oscillations, and discuss natural extensions of the work in this paper.

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