'More statins, less deaths', says NICE

by Admin 12. February 2014 11:20

A quarter of all adults should take statins to reduce the risk of heart attacks, says NICE.

According to new draft guidelines issued by National Institute for Health and Care Excellence (NICE) for the NHS England, one in four adults should be placed on cholesterol-lowering statin drugs to reduce the risk of heart attacks and stroke.  

Under current guidelines, doctors offer statins to those with a 20% chance of developing cardiovascular disease over 10 years, but new NICE guidelines suggest that people with a risk as low as 10% should be offered the drug. The new guidelines will placed the onus on doctors to “make a judgement” and advise patients on whether or not they should be taking statins.

NICE says the lives of millions more people could be saved if the scope for offering this treatment were to be widened. Cardiovascular disease is still the leading cause of death in the UK, responsible for one in three mortalities. In 2010, around 80,000 deaths were caused by cardiovascular disease and 49,000 by stroke.

If the draft guidelines are approved, the current NHS spend of £450m per year on statins will increase dramatically, although the cost of the drugs has reduced significantly over the years.

The proposed changes have been backed by various heart disease charities and doctors, with Professor Peter Weissberg of the British Heart Foundation speaking in support of a guideline update that would allow more people to benefit from taking statins.

However, some critics have warned of side effects and the need for patients to adopt healthy lifestyle changes rather than resorting to statins. Speaking on BBC Breakfast News, Deputy Chair of the British Medical Association Dr Kailash Chand warned that statins “should be used judiciously, where they are needed.” 

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Drugs | News

EU rules deny children cancer drugs

by Admin 12. February 2014 10:48

UK cancer experts have called for a change in EU ruling to encourage more drugs testing on children as too many potential treatments are unexplored.

The Institute of Cancer Research (ICR) has called for a change in European guidelines in regards to testing cancer treatments on children, suggesting that too many potential treatments are going untested due to the current waiver scheme.

According to estimations, of the 28 new cancer drugs approved in the EU for adults since 2007, 26 had potential for treating children and yet 14 of these were exempt from child testing under EU rules.

The European Commission (EC), responsible for setting the guidelines for drug testing and market approval, currently grants child trial exemption to pharma companies based on the fact that the treatment only targets a cancer that appears in adults.

The ICR is calling for a change in EC rulings, suggesting that many modern cancer treatments target genetic tumours that could be common to other types of cancer and potentially treat both adults and children.

 Professor Alan Ashworth, chief executive of the ICR, said: “it’s essential that ground breaking cancer treatments are tested not only in adults but also in children, whenever the mechanism of action of the drug suggests they could be effective.”

The EC ruling makes it too easy to companies to seek exemptions, explained Professor Ashworth, despite companies being offered longer market exclusivity if they test their treatments on children.

“The current system is failing to provide children with access to new treatments that could add years to their lives,” said Professor Ashworth.

A spokesman for the National Institute of Health and Care Excellence said they supported any incentives for potential treatments to be tested on children. The EC has confirmed it will review the guidelines and consider whether a change is necessary. 

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General | News

'Inappropriate' financial penalties scrapped for new fund

by Admin 11. February 2014 13:07

The Department of Health will not be financially penalising commissioners failing to meet their targets when spending the Better Care fund.

As the Department of Health (DH) continues to flesh out plans for the forthcoming Better Care fund, ministers confirmed that previously planned financial penalties are to be scrapped for being “inappropriate” to the fund’s aims.

The Better Care fund, a £3.8bn cash pot available for local health commissioner and councillors to spend on integrated health and social care in 2015-16, was announced last year. While previously published guidance suggested the fund would include financial penalties for those failing to meet objectives, the idea has recently been axed for being ‘inappropriate’.

Care and support minister Norman Lamb confirmed “we’ve decided it would be inappropriate to withdraw funds for areas that fail to hit targets”, with the health body instead offering “support” to “help improve their performance” when local authorities fail to meet targets.

While it was previously envisaged that £1bn of the cash fund – almost a quarter – would be tied to performance and paid out in two phases, all parties will now receive the £1bn regardless of objectives being met, although the two-phase delivery method will continue.

Local government minister Brandon Lewis explained that the move was avoidance of “a system that has unintended consequences”.

“If we were to penalise somebody in the very early stages, actually all you’re doing is penalising the users because you’re taking money away from an area that needs money spent on adult social care,” he added.   

Steve Kell, co-chair of the NHS Clinical Commissioners leadership group, said the removal of financial penalties made “absolute sense.”

“The whole point is to get a better system – to penalise when places are under financial pressure is not good management in the long run,” he said.

The Better Care fund for 2015-16 is at £3.8bn, with portions of the cash delivered to commissioners and councillors via local health and wellbeing boards to fund integrated health and social care services in local areas. 

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News | NHS

Biotec unveils new CEO

by Admin 11. February 2014 10:17

Dr Fiona Withey is to be the new chief executive officer at Biotec Services International, moving into the top job after six years with the company.

Biotec Services International has announced the appointment of Dr Fiona Withey as chief executive officer, a promotion from the position of operations manager that Dr Withey has held since 2012.

With a PhD in Biochemical engineering and 12 years of experience in the pharmaceutical outsourcing sector, Dr Withey was a stellar recruit for Biotec when the company hired her in 2007. She entered the business development team initially, before being appointed to the board of directors as business development manager in 2008.   

In her new role, Dr Withey will be responsible for guiding Biotec into a new stage of development, expanding its US operations and further strengthening the company’s worldwide presence as a provider of temperature controlled pharmaceutical services.

Dr Withey takes the position from Keren Winmill, who will become non-executive director and advisory board chair. Her predecessor had high praise for the new CEO: “Fiona has a trusted reputation across the pharmaceutical industry. She will ensure the company continues to bring a combination of client focus, operational discipline and strong leadership to the team,” said Ms Winmill.

Speaking on her own appointment, Dr Withey said she was “delighted” and “very keen..to develop the services for our existing customers and to grow more and more partnerships worldwide”. 


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News | Personnel

We need more money, say GPs

by Admin 10. February 2014 13:13

The Royal College of GPs has called for increased budgets for GPs as underfunding ‘compromises patient care’.

The Royal College of General Practitioners (RCGP) has called for more money to be spent on GPs as funding hits a record low despite demand for doctor consultations continuing to rise.

Dr Maureen Baker, chair of the RCGP, has warned that “a chronic lack of investment in general practice is compromising patient care across the whole of the NHS” as figures suggest that GP funding comprises just 8.5% of the overall health budget. I

While the RCGP acknowledged the financial strain on the health service and the “difficult challenge” that health commissioners face in “ensuring proper investment in a range of services whilst balancing and extremely tight budget”, the shift in investment towards frontline care is seen as key to manage the current pressures on the health service.

“In the context of an ageing population with patients increasingly living with multiple long-term conditions, we believe there is a strong case for investing in the generalist skills that GPs and their team provides” said Dr Baker.

According to the RCGP’s figures, funding for GPs accounts for 8.5% of the NHS budget, a slip from 10.95% eight years ago despite the fact that 90% of patient contact is made at the GP surgery.

The College is calling for a rise to 11% by 2017 to cope with the increased demand placed on GPs – figures suggest that there will be 40 million more consultations in 2014 than in 2008 – and have warned that four-fifths of GPs are concerned that sustaining elderly care will be difficult due to budget cuts.

In response to the RCGP’s impassioned plea for CCGs to “help us reverse the decline in general practice”, the Department of Health has stressed that it recognises the ‘vital job’ of the GPs and has already made provisions to ease issue.

“GPs do a vital job, which is why we increased their overall budget last year,” said a spokesperson, drawing attention to the changes to GP contracts to “free them up...to devote more time to patients” and suggesting the changes would “go hand in hand with a £3.8bn fund to merge health and social care.”


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News | NHS

AbbVie steps into Asia

by Admin 10. February 2014 11:01

AbbVie plans to build its first manufacturing site in Asia, with a Singapore production facility due to open its doors in 2019.   

AbbVie recently announced plans to spend nearly £200m on a new production facility in Singapore – the company’s first manufacturing site in Asia.

The build in Singapore will increase the company’s capacity for producing the emerging compounds developed by their oncology and immunology division, with the Asian facility to be used to manufacture small molecules and biologics active drug substances.

Dr Azita Saleki-Gerhardt, senior vice-president of operations at AbbVie, said: “Our presence in Singapore will help assure geographic balance and continuity of product supply, as well as increased capacity to deliver on our growing biologics and small molecule product pipeline.”

It will also allow AbbVie to increase its influence in Asia, better supplying customers in the region and ensuring the company is well-placed to maximise on the emerging markets of the region.

While AbbVie already has a presence in Singapore, the new production base will boost the number of employees by 250 and ensure the company establishes a firm geographical foothold in the region.

The facility is set to be fully operational by 2019. 

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General | News

Friend or foe?

by Admin 7. February 2014 12:03

The debate over the risks and benefits of the NHS’ medical record database scheme continues.

As the NHS prepares to establish its controversial care.data database, pooling patients’ medical records into a central database, former health minister Lord Darzi has entered the debate, speaking out in support of the “data revolution”.

“Better data is key to improving the quality of care,” said Lord Darzi in his HSJ article. He also claimed that the data analysis made possible with a centralised record database could help tackle the financial problems of the health service and offer “keys to the NHS’ survival”.

The interview, which health secretary Jeremy Hunt later described as “brilliant” on Twitter, also sought to answer the widespread concerns over patient confidentiality within the new database.

“All healthcare innovations carry risks,” said Lord Darzi, “but they must be balanced against the benefits. In this case the risks...are very low and the benefits potentially huge.”

Lord Darzi’s assertions did not prevent ministers continuing to criticise the care.data scheme, with former shadow home secretary David Davis claiming the database would offer a “backdoor” for the police to access patient medical records. He also suggested that, despite promised anonymity, records serve as a person’s “fingerprint” and could easily be traced back to their owners:

“Let me be clear,” he said “people can be identified from this data.”

Phil Booth of medConfidential, a medical privacy campaign group, said the “lack of independent transparency and oversight” was “worrying”, while Brian Jarman of healthcare information provider Dr Foster said there was “simply too much data and the risks that something leaks are too great”.

The Department of Health responded to these concerns, reassuring the public that there were “strong legal safeguards in place” and that any “release of identifiable data without consent would only be in a very limited number of exceptional circumstances”.  

Unless patients explicitly opt out of the scheme, all medical records will be transferred to the care.data database from May 2014, which is to be managed by the Health and Social Care Information Centre.  

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News | NHS

Pfizer and Siemens are diagnostic duo

by Admin 7. February 2014 11:02

Pfizer has sought the expertise of electronics leader Siemens to develop diagnostic tools to enhance the pharma company’s clinical studies.

Siemens Healthcare Diagnostics’ expertise has been sought by Pfizer in a bid to improve the diagnostic tests used in clinical studies, with the electronics company set to develop in vitro diagnostic tests for use in clinical trials.

Pfizer is hoping the diagnostic tools will improve patient selection, treatment, monitoring and dosing during trials. There is also potential for the tools, if proven successful, to be commercialised and marketed alongside the related treatments.   

Siemens and Pfizer already have a working relationship after the former entered into a partnership with ViiV Healthcare – Pfizer’s joint-venture with GlaxoSmithKline – in February 2012. As part of that agreement, Siemens has been developing diagnostic tools for use in trials of the HIV treatment Celsentri.

Siemens has been welcoming many partnerships with influential pharma companies in recent years, as the industry places higher emphasis on tailoring medicines to patients’ individual needs and conditions, with diagnostic tools foreseen as the means for success.

Other agreements for Siemens include selling two imaging agents for diagnosing early-stage Alzheimer’s to Lilly and a deal with Tocagen on developing tools to assist in brain cancer gene therapy trials.  


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General | News

Patients may be charged for cancer treatment

by Admin 6. February 2014 12:26

Experts have warned that NHS budget issues could translate into patient cancer treatment charges.

In a paper recently published in the Journal of Cancer Policy, two cancer experts have suggested that NHS cancer care standards can only be maintained if “new approaches to paying for cancer” are found, one of which is “user charges”.

The report, written by NHS hospital cancer specialist Dr Ajay Aggarwal and Richard Sullivan, director of the Institute of Cancer Policy at King’s College London, documented the duo’s investigation into healthcare sustainability. The report concluded that cancer care standards were unsustainable without changes in funding, with experts suggesting that patient charges could “provide the key”.

“User charges could provide the key to long-term sustainability of high-quality cancer care in the UK,” said the report, as the authors suggested the projected rise in cancer cases and “stagnating NHS budgets” would combine to make cancer care standards unsustainable in the future.

The report suggested that some cancer treatments that receive approval in the US and the EU fail to secure NICE support as they are not deemed cost-effective in the wake of rising cancer drug costs. Findings also suggested the health service had a shortage of radiotherapy machines, with an estimated 147 additional machines needed by 2016 – at a cost of £205.8m.

The authors warned that if solutions weren’t found – user charges being the suggested option – then patients could see a “rationing of high-value treatments” or face a drop in standards of cancer care available on the NHS.   

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News | NHS

Biogen’s MS drug welcomed into the EU

by Admin 6. February 2014 10:51

The European Commission (EC) has granted approval for Biogen Idec’s proven MS treatment Tecfidera to enter the EU market.

Oral treatment Tecfidera, one of Biogen Idec’s big earners, recently earned EC approval as a first-line oral treatment for patients with relapsing-remitting multiple sclerosis, the most common form of the disease.  

As Biogen’s fourth treatment for MS, Tecfidera earned its EU approval following positive global clinical trials, with the treatment serving to significantly reduce important measures of the disease and slow the progression of the illness.

Dr George Scangos,   chief executive officer of Biogen Idec, said the treatment had already proven its “significant impact on transforming the standard of care for multiple sclerosis” and the company was “excited to quickly bring its benefits to patients in the EU as well.”

The European approval comes eleven months after the treatment was approved in the US, where Tecfidera became America’s number one prescribed drug of its kind within six months. Tecfidera is one of three Biogen drugs credited with earning the company a 26% year-on-year revenue increase in 2013.

Biogen Idec expects to start introducing the treatment into various EU countries in the coming weeks.   


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Drugs | News


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