DH pledges to improve child health outcomes

by JoelLane 21. February 2013 13:52

Sick child wiping his nose The Department of Health has published a ‘pledge’ to improve health outcomes for children and young people through co-ordinated activity across the NHS.

Stated aims include a reduction in the child mortality rate, improved care for children with long-term conditions, and better mental health care for the young.

A new Children and Young People’s Health Outcomes Board, led by the Chief Medical Officer, will focus on improving outcomes across paediatric care.

The DH is responding to a report from the Children and Young People’s Health Outcomes Forum, warning that child mortality rates in England are among the worst in Europe and that 26% of children’s deaths are linked to failures in direct care.

The Forum calls for attention to obesity, maintenance of long-term conditions, earlier diagnosis of mental health disorders, and better attention to the health needs of looked-after children.

GPs will be offered specialised training or support in paediatric health, and provided with new colour-coded health maps showing trends in conditions such as asthma and diabetes.

The CCGs will be asked to review their provision of services for children and investigate poor outcomes.

The DH also said it would investigate proposals by the Royal College of General Practitioners to extend GP training for a fourth year to include child health and mental health.

Health Minister Dan Poulter said: “It is a shocking fact that child mortality in Britain is the worst when compared to other similar European countries. There is unacceptable variation across the country in the quality of care for children – for example in the treatment of long-term conditions.

“Our pledge demonstrates how all parts of the system will play their part and work together to improve children’s health.”

Hilary Cass, President of the Royal College of Paediatrics and Child Health, commented: “It’s crucial that this momentum is maintained and that outcomes are regularly measured to drive improvements.

“We will be directly involved in a number of areas, which include enhancing the use of medicines in children and working with GPs to ensure paediatrics is part of their training.”

Signatories to the pledge include the DH, Healthwatch, the NHS Commissioning Board, NICE, MHRA and Public Health England.

A key principle of the pledge is that improving children’s health outcomes will not only reduce child mortality but lay the foundations for healthier adult lives.

Antibiotic cupboard is bare, says Chief Medical Officer

by JoelLane 24. January 2013 14:08

Prof. Dame Sally Davies, CMO web The ‘empty’ antibiotic pipeline threatens a future of mass death from antibiotic-resistant infections, the UK Chief Medical Officer has said.

Professor Dame Sally Davies told a Parliamentary committee that the pharmaceutical industry has no solutions to the growing problem of antibiotic resistance.

Overuse of antibiotics, especially in the developing world, and the combined impact of sex tourism and medical tourism were globalising the most serious health threats, the committee heard.

Antibiotic resistance has been recognised as a problem in Europe for decades, with the power of the standard antibiotics to fight disease steadily waning.

However, the massive current use of antibiotics in countries such as India, where private drug supply is deregulated, has caused a proliferation of drug-resistant infections that are spreading through the developed world.

Professor Davies warned: “The apocalyptic scenario is that when I need a new hip in 20 years I’ll die from a routine infection because we’ve run out of antibiotics.”

Antibiotic-resistant strains of tuberculosis and gonorrhoea are spreading globally, she said. Meanwhile, the pharmaceutical industry is failing to develop new antibiotics because there is no urgent need for them – but when there is, it may be too late to prevent a lethal pandemic.

GSK’s CEO, Andrew Witty, made the same point last year and warned that “the market has failed” to address the danger. He called for global collaboration between health systems and industry.

“There is a broken market model for making new antibiotics, so it's an empty pipeline, so as they become resistant, these bugs... there will not be new antibiotics to come,” said Professor Davies.

Liver disease is a public health priority

by JoelLane 21. November 2012 15:06

Prof. Dame Sally Davies, CMO web Urgent action by public health authorities is needed to address the rising prevalence of liver disease in England, the Chief Medical Officer has said.

Professor Dame Sally Davies noted that in the last decade, the incidence of liver disease has grown here by 20% while falling by a similar amount in Europe.

The CMO’s first annual report also highlighted the need for better access to healthcare and better public health surveillance as priorities.

The report is intended to guide and inform the public health strategies of local government and the new Health and Wellbeing Boards.

Drawing on international data, Davies commented that liver disease “is the only major cause of mortality and morbidity which is on the increase in England whilst decreasing among our European neighbours.”

The main causes are heavy drinking, obesity and undiagnosed hepatitis infection, but late diagnosis contributes to poor outcomes – so the report calls for a combined preventative and early intervention approach.

Variations in access to healthcare were also highlighted, with diabetes monitoring a particular area of concern – only 50% of people diagnosed with diabetes receive all nine NICE-recommended annual tests.

Public health surveillance was a third priority emphasised by Davies, who called for better information on significant but non-fatal diseases such as musculoskeletal and skin disorders, cognitive and sensory impairment, and incontinence.

In addition, she warned, cutting costs on public health surveillance could leave populations exposed: “The history of public health suggests that it is not enough to prepare for the health problems we already know about.”

Strikingly, Davies praised the contributions of the cancer registries and the Health Protection Agency – both due to be abolished in 2013.

All UK children to be offered flu vaccine

by JoelLane 25. July 2012 17:19

happy child Annual influenza vaccinations will be offered to all children aged two to 17 in the UK from 2014.

A nasal spray of the Fluenz vaccine will be used rather than an injectable form, except with children in high-risk groups.

The vaccination programme – the first of its kind in the world – is predicted to save 2,000 lives per year given only moderate uptake (30%).

As well as saving many children’s lives it could protect non-vaccinated people, especially elderly family members, through the ‘herd immunity’ effect.

The Joint Committee on Vaccination and Immunisation (JCVI) said the vaccine would be offered to nine million children in the UK, more than doubling the number of vaccinations available.

According to the Chief Medical Officer for England, Professor Dame Sally Davies, if only 30% of these children receive the vaccine there will be 11,000 fewer hospital admissions and 2,000 fewer deaths.

The vaccination will be optional and will depend primarily on GP surgeries, as there are too few school nurses to deliver the programme.

AstraZeneca’s Fluenz is a live attenuated vaccine sold in the US as FluMist. The UK contract could be worth £100m a year to the company.

Vaccinating children could also protect vulnerable family members, including babies and the elderly – an effect known as ‘herd immunity’.

Guidance hopes to raise hepatitis awareness

by IainBate 14. June 2012 16:35

Pharma NICE UpdateNICE aims to tackle the ignorance and barriers to effective testing of those at an increased risk of infection of hepatitis B or C in new draft guidance.

Services, organisations and practitioners should promote testing by measures such as raising awareness to the general public and identifying those most at risk, the guidance advises.

Professor Mike Kelly, NICE Director of Public Health, said a “general ignorance” has contributed to a lack of services and poor uptake of testing due to the “stigma surrounding hepatitis B and C”.

According to the Chief Medical Officer, around 180,000 people in the UK are now chronically infected with the hepatitis B virus – with a further 216,000 people chronically infected with the hepatitis C virus.

Hepatitis B and C are blood-borne viruses that predominately infect the liver and can lead to chronic liver damage, cirrhosis and liver cancer.

The draft guidance also recommends testing through contact tracing, testing in prisons and in drug services and commissioning viral hepatitis testing and treatment services.

Professor Kelly added that NICE hopes to raise “general awareness” on myths surrounding the virus within the guidance. “This is aimed at addressing any misconceptions about the risk of hepatitis B and C that can act as barriers to testing, including the belief that treatments are not effective and that treatment is not needed until the illness is advanced,” he said.

“It is also aimed at demystifying the risks of transmission among families, friends and colleagues of people diagnosed with chronic hepatitis B or C, and in doing so reducing much of the stigma attached to the diseases.”

Final guidance is now expected towards the end of the year.

New CMO at Amgen

by IainBate 16. February 2012 12:06

Pharma Industry News Dr Michael Severino has been appointed Senior Vice-President for Global Development and Corporate Chief Medical Officer at Amgen.

The 46-year-old will replace Dr Sean Harper after his move to Executive Vice President of Research and Development.

Dr Harper says his replacement brings “broad experience and immense expertise” to the role.

The former Vice President of Global Development joined the biotech company in 2004 as Senior Director of Inflammation Early Development. He then held the role of Head of Amgen’s Proof-of-Concept group within Medical Sciences before assuming the leadership of the Inflammation Therapeutic Area in Global Clinical Development in 2006. A year later he took on the Global Development role.

Previously to joining Amgen, Dr Severino held positions of increasing responsibility at Merck Research Laboratories.

“Since joining Amgen in 2004, Mike has demonstrated leadership across Amgen’s Global Development organisation and has made significant contributions to the overall advancement of Amgen’s pipeline,” said Dr Sean Harper.

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EC approves DuoCort's adrenal insufficiency therapy

by Emma 8. November 2011 16:50

 

The European Commission (EC) has authorised DuoCort Pharma’s Plenadren (hydrocortisone) to be marketed in the EU for the treatment of adrenal insufficiency.

The dual release hormone replacement therapy is the first pharmaceutical innovation in over 50 years for adults suffering from adrenal insufficiency, or cortisol deficiency.

Professor Gudmundur Johannsson, Chief Medical Officer at DuoCort Pharma, said: “Plenadren offers a welcome new treatment option to help patients suffering from adrenal insufficiency. It can improve therapy for many of the almost 200,000 patients in Europe who suffer from this disease and who need lifelong cortisol replacement therapy for their survival.”

The once-daily tablet is designed to imitate the normal physiological cortisol profile, with an outer layer that releases hydrocortisone immediately into the bloodstream and an inner core releasing the rest of the medicine gradually throughout the day.

Although glucocorticoid replacement therapy for adrenal insufficiency has been available for decades, complications have been linked to the medication, including premature death, impaired quality of life, increased risk of cardiovascular diseases, and decreased bone mineral density.

Adrenal insufficiency (cortisol deficiency) is a rare, life-threatening disease that affects patients in their active years. Patients require lifelong replacement therapy with hydrocortisone, the synthetic form of cortisol, replacing or substituting the hormones that the patient's adrenal glands are not producing.

DuoCort Pharma provides drug development with a focus on improving glucocorticoid therapy. The company is currently being absorbed by ViroPharma, who acquired the pharmaceutical company for an upfront payment of $33 million dollars in October.

First app for heart disease education

by emma 27. October 2011 16:11

Cardioteach

Boston Scientific has launched the first iPad app to help healthcare professionals educate patients and carers about cardiovascular diseases and their treatment.

CardioTeach, available free of charge, provides an overview of normal heart function and the therapy options for atrial and ventricular arrhythmias, coronary artery disease, heart failure, heart rhythm disorders and peripheral vascular disease.

The app’s accessible content and graphics (see picture) help the clinician to explain specific conditions and procedures used to treat them, helping patients and their families to make informed choices.

Healthcare providers can also use CardioTeach to mark up anatomical illustrations with cardiac devices, add notes to a page or attach graphics to an e-mail for the patient or carer.

The patient can receive personalised cardiovascular education anywhere, helping them to make decisions and understand compliance and adherence requirements.

“Most medical device apps are designed to educate physicians on a specific product or therapy, said Leslie Saxon, Chief of Cardiovascular Medicine at the University of Southern California. “CardioTeach is unique because it lets clinicians better educate patients about their overall heart and vascular health and available treatment options.”

He added that CardioTeach gives patients “something they can reference after they leave my office and when thinking about or explaining what went on during the office visit,” as well as helping patients and their families “educate themselves prior to and between visits.”

Kenneth Stein, Boston Scientific’s Chief Medical Officer for Cardiac Rhythm Management, commented: “A recent study shows that one in five physicians use a tablet computer in their practice. Creating an app that enables healthcare professionals to use this technology to enhance communication with patients and caregivers is a logical extension of our efforts to empower patients with information about Boston Scientific’s therapies.”

Based in Massachusetts, USA, Boston Scientific is a global supplier of interventional medical devices.

Lilly withdraws septic shock drug

by emma 26. October 2011 11:27

Pf Product News

Eli Lilly has withdrawn Xigris (drotrecogin alfa) from all markets due to it showing no gain in 28-day survival of septic shock patients in the PROWESS-SHOCK study.

New results showed that the drug failed to meet its primary endpoint and question the overall benefit-risk balance of Xigris for patients with severe sepsis.

Timothy Garnett, Senior Vice President and Chief Medical Officer of Lilly, said that the results were unexpected to the company. “A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past 10 years.”

Xigris was approved in the US by the FDA in November 2001, and in the EU in 2002 under exceptional circumstances for septic shock patients with multiple organ failure, in addition to best standard care.

As a condition for continued market authorisation in Europe, Eli Lilly established the placebo-controlled PROWESS-SHOCK study in March 2008, to assess the benefit-risk profile of the product.

Aside from failing its primary aim, the study also failed its secondary endpoint of reducing mortality in patients with severe protein C deficiency. The small difference in the 28-day mortality of the overall population (26.4% in the Xigris arm versus 24.2% in the placebo arm) was not statistically significant.

Xigris is administered as a continuous intravenous infusion, in one dose for a total duration of 96 hours.

The CHMP will assess the issue during its plenary meeting in November 2011.

FDA approves ALK gene diagnostic for lung cancer

by emma 12. October 2011 15:45

MB product news

The FDA has approved Abbott Molecular’s Vysis ALK Break Apart FISH Probe companion diagnostic for lung cancer patients.

The test detects all ALK gene rearrangements and is the only FDA-approved diagnostic assay to predict response using Pfizer’s targeted therapy Xalkori for patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Dr Mark Brecher, Chief Medical Officer of LabCorp, said that the personalised medication “will play an even larger role in cancer care, assisting physicians in administering the treatments best suited to the disease.”

The Probe Kit for Xalkori uses Fluorescence In-Situ Hybridisation (FISH) to detect a specific rearrangement in the ALK gene.

Approximately 3-5% of NSCLC tumours are characterised by genetic rearrangements in the ALK gene. When this gene is altered by combining ALK with other gene sequences, the pathway becomes constitutively active causing mutation. Xalkori inhibits the mutant ALK protein, and halts the growth of cancer cells.

LabCorp’s Centre for Molecular Biology and Pathology (CMBP) supported clinical studies of the new diagnostic and collaborated with Abbott Molecular in the analytical validation of the product.

According to LabCorp, approximately 6,500-11,000 people will develop advanced ALK-positive NSCLC in the US in 2011.

The Vysis ALK Break Apart FISH Probe test is available for patient testing through LabCorp, which is one of the largest medical diagnostic companies in the US.

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