Guest contributor, Louise Campbell, an undergraduate with the University of Southampton, examines the impact of the National Institute of Clinical Excellence and how judges remain reluctant to be seen as driving healthcare policy

Ageing population and lower healthcare costs leave regulatory authorities with a big headache. NICE faces up to the challenges of 21st Century healthcare

Ever since the NHS was created in the UK it has lurched from financial crisis to financial crisis and this year is no exception. Out of 137 NHS Foundation Trusts in the UK that submitted plans to the independent regulator, Monitor, this year, 11 listed themselves within the two highest financial risk ratings and a further ten say they will experience a high level of financial risk.   Consequently, the NHS ‘postcode lottery’ – where a patient’s location will have a bearing on the treatment they can receive – and its apparent inability to treat patients with the most effective and expensive drugs and treatments can only be expected to increase.

Before medical devices drugs are prescribed or given on the NHS they are scrutinised and recommended by the National Institute for Health and Clinical Excellence (NICE) which evaluates them for cost effectiveness. NICE has been blamed for the start of explicit, national “rationing” on the NHS, but it has also been faced the challenge of lowering the possibility of a ‘postcode lottery’ over the years through issuing uniform practice guidance, that, though not compulsory, drive the policies that Primary Care Trusts (PCT) should be following. This was  highlighted in a successful legal challenge in 2000 against North West Lancashire Health Authority, in which three transsexuals successfully challenged a decision to refuse funding for gender reassignment surgery. In this case, it was shown 34 out of 41 other authorities made some provision for funding such surgery and that a policy which effectively amounted to a ‘blanket ban’ in one locality would therefore recognise that treatment would depend upon where the patient lived.

Essentially, NICE is a non-governmental agency with a key role of evaluating the clinical effectiveness of treatments versus the associated cost burden.  The guidelines are passed onto the NHS with advice as to whether the technology is for routine or restricted use on the NHS. The NHS is constrained by a crippling budget, yet demand is always rising for its services, creating a climate for difficult and often unpopular decisions.

Ultimately, it will be the individual PCT that decides whether certain technology is used in treatment based on NICE’s recommendations. If a PCT refuses to treat a person with certain drugs or surgery, to challenge the decision involves a lengthy expensive, judicial review process. Case law also suggests that Judges are reluctant to get involved in the allocation of NHS resources as shown in a challenge against Cambridge Health Authority by a young girl and her father that attracted much media attention. In this case, potentially lifesaving treatment was refused to a ten year-old girl due to the success rate/cost ratio.

In another recent case, a 22st man lost his legal challenge against North Staffordshire PCT over its refusal to pay for gastric band surgery. Social factors do not have to be considered by PCTs in making their decision. Failure to consider such factors was ruled not to be in contravention of his human right to respect for private and family life under Article 8 of the European Convention of Human Rights. Some align the decision to an inherent prejudice against the obese. However, despite an envisaged long term saving by the claimant as the operation may cure his diabetes and related illness, the money is not always available in the short term. NICE recommendations suggest that people may be eligible for the surgery if they are morbidly obese which, for the purpose of the guidelines, means if they have a body mass index (BMI) of 40 or more or they have a BMI of between 35 and 40 and other significant disease (for example, diabetes, high blood pressure) that may be improved if they lose weight. Many PCTs chose to have the BMI threshold at above 50 as a way of controlling the cost-burden.

However, this is not to say that judges will not get involved should the situation demand as it was in case of a breast cancer sufferer who challenged her health authority and the Secretary of State for Health on their decision not to give her the drug Herceptin when they were giving it to others. The claimant proved the PCT’s decision process was “irrational” as the policy could not be rationally explained. The PCT would provide the drug in ‘exceptional circumstances’ but could not discern a threshold for what these circumstances were.

Over the past 18 months, two life-saving drugs have also been denied on the NHS after cost recommendations by NICE. In January 2010, lifesaving drugs Dasatinib and Nilotinib, which are supplied in Scotland and parts of Europe, were refused to cancer patients in England. Both drugs cost around £30,000 per year but could increase life expectancy by decades. At this time, NICE claimed the decision was based on a lack of robust evidence that the drugs are effective or more effective than those available, despite hearing evidence from clinical experts that the drugs are effective.

NICE also recently proposed not to recommend the drug Lucentis to treat the eye condition diabetic macular oedema (DMO) on the NHS, a decision which Diabetes UK and three other charities are challenging and campaigning against on the basis of a call for a proper consultation allowing stakeholders to submit their comments. The charities are also urging Novartis, the drug manufacturer, the Department of Health and NICE to reconsider the option of a Patient Access Scheme so that a maximum number of patients can benefit from this sight saving treatment.  The Lucentis injections have the potential to save the sight of thousands. Whilst the treatment is expensive, the Institute is accused of failing to consider the long-term effects of their decision. If people lose their sight, much of their independence is gone and costs for the NHS will ultimately rise despite a short-term saving.

Some think it ludicrous that potential life-saving treatment and treatment that enables a person to continue to live independently is denied when the NHS will offer cosmetic procedures such as Breast Enlargement surgery and Rhinoplasty. It’s a debate that is likely to increase in frequency over the next decade as the NHS grapples with an ageing population and a reduction in healthcare expenditure.

The weekend’s nearly here and we finish off with an article from Orthopaedic Business News by Espicom’s medical news editor Sophie Bracken.

CellSonic Medical, an India and UK-based developer and manufacturer of machines and consumables for wound healing, orthopaedic, urology and skin care in the medical, veterinary and cosmetic markets, is looking for worldwide distributors for its products, which span the areas of lithotripsy, urology, surgery, laparoscopy and dermatology, and also include cosmetic creams and gels. All of CellSonic’s products possess CE mark approval.

The CellSonic medical device is a lithotripter with variable power for use in hospitals and clinics to treat bones, wounds and sports injuries. The device produces a shockwave that is focused by the parabola in the head. According to CellSonic, the company has miniaturised the lithotripter, making it “safe, reliable, easy to use and reduced to price to reach a worldwide market for wound healing”. Calcified shoulder is the most commonly treated condition with shockwaves. Tennis and golfer’s elbow are also commonly treated with the technique. A power boost can be provided for machines that require a bone-healing facility.

According to CellSonic, its system can cost half that of electro-magnetic machines and claims to be cheapest in the medical, veterinary and cosmetic markets. The distributor will exclusively offer CellSonic’s full range and undertake all sales functions.

Have a great weekend, thanks for reading, Paul.

US regulatory bodies respond to rapid rise of modern wireless technology and apps for medical devices

Latest news from Medical Industry Week

The proliferation of broadband and wireless-enabled medical devices has prompted the FDA and US Federal Communications Commission (FCC) to issue a joint plan aimed at bringing clarity to the issue.

Although these devices represent the opportunity to enhance health and reduce the costs of healthcare, they aren’t without a few risks too. The devices, which include wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems, are increasingly playing a major role in treatments.

The US government agencies have come to the conclusion that clear guidelines are needed to make sure these devices are operated in a safe, reliable and secure manner. The FDA, in particular, is of the opinion that the industry, healthcare providers, patients, and other interested stakeholders in the medical environment should have clear regulatory pathways, processes and standards to bring the technology to market.

Although specific details are thin on the ground at the moment, the aim still pretty noble enough. “All Americans should be afforded the opportunity to benefit from medical technology advances with improved broadband and wireless technology” – the communiqué boldly claims.  At the end of the day though, by clarifying each agency’s scope of authority with respect to these devices, the hope is that interested parties will get a clearer picture of the regulatory process, streamline the application process, and make sure that innovation doesn’t get stifled through bureaucracy.
The move comes as the FDA grapples with even more complex issue of software applications (apps), the likes of which are increasingly been used in mobile medical technology, such as mobile phones, tablet computers and PDAs.

In general, the FDA’s position is that if a mobile app is intended for use in performing a medical device function it is a medical device, regardless of the platform on which it is run. This can range from mobile apps used on mobile phones to analyse glucose meter readings.

In consultation with the US public, the agency is looking to establish formal guidance that define a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. The offending apps could be used as an accessory to medical device already regulated by the FDA transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.

There’s an obvious need for some kind of monitoring in this area. Nowadays an app can be used by a healthcare professional to make a specific diagnosis by viewing a medical image on a mobile phone or tablet, whilst some apps can turn a smartphone into an ECG machine and be used to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack. Understandably, the FDA is of the opinion that these particular mobile apps pose the same or similar potential risk to the public health as currently regulated devices if they fail to function as intended.

The FDA has set a deadline for 19th October 2011 for interest parties – including manufacturers and app developers, to submit comments relating to the agency’s draft policy document, with a view to formulating clear guidance on the matter once and for all.  One thing is for sure, it’s a good idea to revise the present guidelines – the FDA’s last significant attempt to address the topic was made in 1989!

Thanks to Lawrence Miller for yet another great article, Lawrence is the Espicom’s editor for Medical Industry Week, and medical newsletter teamleader. For more articles like this, or to start your subscription please click on the link to Medical Industry Week

Welcome back to The Medical Technology Blog, todays article is taken from Espicom’s business publication Diagnostics Focus, please read on…

Johns Hopkins University (JHU) scientists have developed a gene-based test to distinguish harmless from precancerous pancreatic cysts, and which could eventually help some patients avoid needless surgery to remove the harmless variety. The investigators estimate that fluid-filled cysts are identified in more than a million patients each year, most of whom have undergone CT or MRI scans to evaluate non-specific symptoms, such as abdominal pain and swelling.

Dr Bert Vogelstein, co-director of the Ludwig Center at JHU and a Howard Hughes Medical Institute investigator, and his colleagues analysed precancerous cysts from 19 patients and searched for mutations in 169 cancer-causing genes. They found mutations in the KRAS gene, known for its prevalence in pancreatic cancers, and the GNAS gene, which had not previously been associated with pancreatic cancer. In both KRAS and GNAS, the mutations occur at a single coding spot in the DNA, the equivalent of a typo in a word within an entire encyclopaedia. KRAS and GNAS genes produce signalling proteins, relaying signals from the cell surface to areas within the cell.

The researchers then tested a total of 132 precancerous pancreatic cysts for mutations in KRAS and GNAS. The latter were found in more than half of the samples (87 of them), and KRAS mutations occurred in 107 samples. Nearly all (127) had mutations in GNAS, KRAS or both. The mutations occurred in large and small, high- and low-grade cysts, and in all major types of the most common precancerous pancreatic cysts. There were no major differences in age, gender or smoking history for people with GNAS or KRAS mutations in their cysts’ cells. Finally, the investigators tested tissue from pancreatic cancers that had developed in eight people with GNAS-mutated cysts. Seven of the eight had GNAS mutations in their cancer, as well as cells in the cysts.

GNAS and KRAS mutations were not found in benign cysts, although KRAS mutations did appear occasionally in a rare type of cyst with a relatively low potential to become cancerous. These rare, mostly benign cysts are less challenging to diagnose because of their location within the pancreas and type of patient, according to the investigators. Genetic analysis of the kind reported in the new study offers a new way to sort the potential of these cysts to cause malignant trouble.

The investigators caution that cyst fluid removal, an invasive procedure, also has its drawbacks and can cause bleeding, infection and inflammation in a very small percentage of patients. Further studies on a larger number of patients are expected to be done before the gene-based test can be widely offered. However, Vogelstein says that the technology for developing a gene-based test in this case is relatively straightforward because “the mutation occurs at one spot in both of the genes.”

Major funding for the study was provided by the Lustgarten Foundation, a private foundation that provides to funding pancreatic cancer research. Other funding was provided by the Virginia and D K Ludwig Fund for Cancer Research, the Sol Goldman Center for Pancreatic Cancer Research, the Joseph L Rabinowitz Fund, the Michael Rolfe Foundation, the Indiana Genomics Initiative of Indiana University, which is supported in part by Lilly Endowment., the J.C. Monastra Foundation, Swim Across America and the National Institutes of Health. JHU has filed a patent application on inventions described in the study.

Thanks to Lawrence Miller for this post, if you woul like more information like this, or to start your subscription please click on the link  Diagnostics Focus Newsletter

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• Why is pancreatic cancer so painful? (zocdoc.com)
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Results of a survey conducted at europacolon’s European CRC Patient Conference show that patients believe tests using blood samples would encourage more people to participate in regular screening for colorectal cancer.

The survey was jointly conducted by Epigenomics and europacolon, a European non-profit organisation dedicated to colorectal cancer. Of the participants in the survey, more than 50 per cent had previously heard of the possibility of colorectal cancer blood testing and more than 70 per cent thought that using a blood test would encourage more people to participate in regular screening for the condition. Some of the most often mentioned reasons that survey participants gave for preferring blood tests were ease-of-use and simplicity, not having to handle stool samples as necessary for conventional non-invasive testing, and overall fit with other routine blood tests.

In June, Quest Diagnostics, one of Epigenomics’ partners in the US, in collaboration with the non-profit organisation Colon Cancer Alliance, reported the results of a US national telephone survey of more than 1,300 men and women 50 years of age and older. In this survey, 31 per cent of the participants reported that they had never been screened for CRC. Of the respondents between 60 to 70 years of age that had previously participated in screening, 33 per cent stated that they had only been screened once in the past. These results highlight widespread lack of adherence to national guidelines in the US, which recommend regular screening by colonoscopy in combination with other tests for colorectal cancer for all men and women aged 50 and older. When asked about the option of a blood test, 78 per cent of the participants said that they were likely to take a blood test for colorectal cancer screening and 75 per cent said they were more likely to get screened more frequently if a blood test was offered to them.

According to Dr Jürgen Beck, Senior VP Medical Affairs of Epigenomics, the lack of widespread acceptance and regular use of conventional methods for the early detection of colorectal cancer, such as colonoscopy and stool tests, severely limits the potential of screening to reduce mortality from this common cancer. The two surveys in Europe and the US show the potential of blood-based screening as an approach to increase compliance. Epigenomics expects these findings to be substantiated further through studies into patient preferences and screening adherence that are ongoing at clinical centres in the US and Europe.

Epigenomics has developed an in vitro diagnostic blood test for the early detection of colorectal cancer, known as the Septin9 test. Alongside its partner, Abbott, the companies already market their respective first-generation CE-marked Septin9 tests in Europe, the Middle East, Asia/Pacific and further markets. Epigenomics is in the process of developing a second-generation Septin9 assay as a colorectal cancer screening test for the US and European markets. The company expects to submit this enhanced Septin9 colorectal cancer screening test, branded Epi proColon 2.0, to the FDA for regulatory review before the end of the year. Under licences from Epigenomics, Septin9 testing is currently offered in the US by Quest Diagnostics (ColoVantage) and ARUP Laboratories (Methylated Septin9 Test) as laboratory-developed tests aiding in the detection of colorectal cancer.

This article was provided by Sophie Sanderson, editor of Espicom’s newsletter Diagnostics Focus.

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Last post on the Medical Technology blog before i shoot off on my hols, so no posts till i get back. Today’s article comes from Drug Delivery Insight, please read on…

Leading RNA interference (RNAi) company Silence Therapeutics has been busy lately. The UK-based firm tapped investors for nearly £6 million in funds last month, and has wasted no time in putting it to use. The company believes the funds, which were raised by both new and existing shareholders, will place it on a much improved financial footing.

The first slice of the funding was allocated to plan the closure of Silence’s US operations, which are located in Redwood City, CA. The US closure is expected to take place in the third quarter of this year, but the company’s German operations will remain open. As a result of the closure of the US base, Silence’s CEO, Phil Haworth, will step down once a replacement is found.

The second chunk of funding will be put towards Silence’s ongoing R&D efforts. The first portion will be used to complete the company’s ongoing Phase I trial of Atu027 for the treatment of advanced solid cancer, and is earmarked for completion during the second half of this year. Also, a Phase Ib trial of Atu027 in particular tumour types will be started in mid-2012. IND applications for Atu027 in solid will also be paid for by the funding in the second half of next year, and preclinical development will be stepped up for Silence’s Atu111 programme. The latter provides systematic delivery to the lung for treatment of pulmonary diseases.

Representing Silence’s most advanced drug candidate, Atu027 is a liposomal siRNA formulation targeting PKN3 for the treatment of advanced solid cancer that incorporats the company’s very own AtuPlex delivery technology. The company says it has proven its value by inhibiting the growth of blood vessels, thereby inhibiting blood supply to the tumour. Half-time results from the Phase I solid tumour trial of Atu027 are “encouraging”, as the drug has so far shown to be safe and well-tolerated. Silence hopes to finish the Phase I trial in the second half of this year, and release data before year-end.  The release of updated data from the trial was made at the recently-convened ASCO meeting in Chicago, IL.

Atu111, for the treatment of acute lung injury, is Silence’s most advanced candidate outside of the oncology field. It combines the company’s DACC drug-delivery system with AtuRNAi. The product’s target is being kept under wraps by Silence at the moment, but preclinical models using the DACC delivery system have shown sustained knockdown of up to three weeks in the lung endothelium.

As far as collaborative partners go, Silence is getting ready to start a Phase IIb trial for PF-‘655 in the second half of 2011, which is licensed to Quark Pharmaceuticals and Pfizer for the treatment of diabetic macular oedema.  Silence hopes Quark and Pfizer will report data from the trial later this year. Quark is also developing QPI-1002 for the treatment of delayed graft function and acute kidney injury in partnership with Novartis. In September 2010, quark kicked off a Phase II trial of QPI-1002 for the treatment of delayed graft function and plans to begin a second Phase II trial of the product in acute kidney injury during the course of this year.

Thanks to Sophie Bracken for this article, Sophie is editor of Drug Delivery Insight at Espicom Business Intelligence.

Today’s article in the Medical Technology Blog is provided by Sophie Sanderson editor of Diagnostics Focus, please read on…

A team of researchers from the UK look to have come up with a ‘cheap and reliable’ diagnostic test for a rare form of cancer – hereditary leiomyomatosis and renal cell cancer (HLRCC) – which involves screening tumour samples for a particular molecular fingerprint unique to this cancer.

HLRCC is a disorder that causes the development of benign, but often painful tumours in the skin and, in females, in the uterus. Between one in six and one in ten people affected by the disorder will go on to develop an aggressive form of kidney cancer called papillary renal cell cancer. The disorder is caused by mutations, which may be inherited, in a gene responsible for the production of an enzyme known as fumarate hydratase (FH). This leads to an accumulation within cells of fumarate, which promotes the development of cancer cells. Normally, every cell has two copies of each gene: one inherited from the mother and one inherited from the father. HLRCC is said to follow an autosomal dominant inheritance pattern, in which a mutation happens in only one copy of the gene – meaning that a parent with a gene mutation may pass along a copy of their normal gene or a copy of the gene with the mutation.

Led by researchers at the Henry Wellcome Building for Molecular Physiology, University of Oxford, an international team of scientists claim to have identified a particular protein modification that is induced by FH deficiency (and hence an over-abundance of fumarate). This alteration is unique to this type of tumour and can be used as a biomarker – a biological ‘fingerprint’ to identify tumours caused by this mechanism.

For the first time, scientists are now in a position to screen for tumours caused by this rare, but often very serious condition using a test that is simple, cheap and reliable. The test for this protein modification offers great potential as it can be carried out in under two hours and will identify tumours with FH mutations. This approach is also said to be more cost-effective than genetic testing of all possible cases using DNA sequencing. When screening cases of papillary renal cell cancer using this new test, the researchers identified undiagnosed cases of HLRCC for genetic testing.

In the future, by applying this test in all cases of papillary renal cell cancer to identify people with FH mutations, families could receive advice on their own relative risks of developing the disorder and associated kidney cancer. Dr Lesley Walker, Director of cancer information at Cancer Research UK, reinforces the importance of this notion, stating that “…being able to identify other family members who are at risk so they can be monitored more closely is crucial to improving survival rates from this rare aggressive form of kidney cancer.” Tests like this could also help identify other patients with the same mutation, paving the way for the development of targeted treatments for specific groups of patients that could revolutionalise cancer treatment in the future.

Related articles

• New Interactive Dashboard for Medical Market Analysis! (medical-technologyblog.com)

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> > > Medistat Interactive < < <

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Combining Espicom’s world class data with a state-of-the-art analysis tool, Medistat Interactive takes medical market evaluation to a new level.

Dashboard driven and rich in graphics, you can now easily mobilise key data, immediately compare and contrast key health indicators, infrastructure and market data for multiple markets at the click of a button. Track changes to historical/forecast data, export the data to other programs or create pdfs of charts and tables for inclusion in plans and presentations.

Whether it’s fast access through one of the many pre-defined tabs or the easy-to-use custom report builder, you have complete control over the data, making it work quickly for you.

For over 30 years, Espicom has been the leader in analysing medical device and equipment markets worldwide. Its reputation as a provider of reliable and thorough information is well founded and its services are used by leading healthcare companies in more than 50 markets.

Key benefits & features of Medistat Interactive

Compare Key Indicators
How does per capita health spend compare in BRIC countries? What is the forecast market growth in orthopaedics in Poland, Czech Republic and Hungary? With Medistat Interactive you can easily compare any statistics for any number of countries.

Strategic Insights
Medistat Interactive provides the strategic intelligence to support key investment, business planning and marketing decisions.

Market Snapshots
Easily review all statistics and forecasts for a particular market.

Benchmarking
Assess your company’s performance against actual market figures or monitor regional/national sales offices and the work of specialist sales agents.

Medical Sector Analysis
With actual figures and reliable forecasts, use Medistat Interactive to view market data on specific medical technology areas in the context of other health indicators.

Book a demonstration today
Contact

• Email: victoria_mcveigh@espicom.com

• Telephone: +44 (0)1243 756027 to speak to a representative

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Todays article in the Medical Technology Blog is provided by Sophie Sanderson who is the editor of Diagnostics Focus, please read on…

A move to tackle the rates of lung cancer detection and survival by researchers in Germany seems to have led to an interesting new test that could potentially help save the lives of smokers in the future. The blood test, which is the result of work carried out by colleagues from the University of Cologne and University of Bonn, would make it easier to detect a lung tumour and improve the chances of survival.

The aim of the research was to develop a subsequent test that was not only able to differentiate lung cancer patients from healthy subjects, but also from persons with chronic lung diseases. The blood of over 200 smokers was studied, half of whom had lung cancer. Examining the research subjects’ blood using biochips for certain nucleic acids led to the finding of typical patters. Interestingly, over 480 molecules were recognised whose concentration in the blood changes when a person develops lung cancer. These nucleic acid molecules can be seen in the blood cells either in increased or decreased quantities and form in the body when certain genes are transcribed. In patients with lung cancer, a typical pattern emerges that can be detected with a measuring programme.

The stakes are huge and the development of a test for lung cancer offers huge potential. Lung cancer is already the second most common cancer in the UK, and in many cases the cause can often be linked back to smoking. Although people who have never smoked can also get lung cancer, nine out of ten cases are related to smoking. There are four different stages to lung cancer, going from stage I where the cancer is small and only in one area of the lung, to stage IV where the cancer has spread to another part of the body. Dr Joachim Schultze comments that “The prognosis for patients in stage III and IV is still very poor even today; even with the most modern therapies, the point of death can only be postponed.” When considering stage I lung cancer, it can be treated surgically and in most cases it can be cured, however, a tumour is detected in only about 15 per cent of all such cases.

It is anticipated that if a boost to the detection rates could be achieved with the use of a screening blood test, it could lead to an increase in survival rates. In the future, there is the potential for a lung cancer screening test to become part of routine practice. Whether this can be achieved remains to be seen, but for researchers the positive results will serve as an encouraging development.

Check out more articles like this by signing up to Espicom’s fortnightly publication Diagnostics Focus, thanks for reading.

Paul