Two major diagnostic imaging specialists showcased paediatric imaging applications of their computed tomography (CT) scanners at the International Paediatric Radiology 2011 conference in London.

Toshiba presented the Aquilion ONE CT system with dose reduction capability and new paediatric software. Siemens presented the Somatom Definition Flash with new applications for dose reduction.

The new applications reflect the growing priority of limiting radiation exposure in children, given the potential for harmful effects on growing tissues and cumulative toxic effects in later life, and also of reducing sedation.

Toshiba’s Aquilion ONE features Adaptive Iterative Dose Reduction (AIDR) software, which reduces ‘noise’ to increase image quality at a lower radiation dose. In addition, the scanner can capture a structure up to 16cm wide (such as the heart or brain) in one rotation, potentially eliminating the need for sedation.

The Aquilion ONE now features the dedicated paediatric software SUREExposure, which allows the clinician to set ‘child-sized’ examinations by entering the patient’s age or weight. A separate Paediatric Kit includes a number of child-friendly accessories and features, including:

• an audio-visual instructional tool to help children maintain breath holds

• child-sized table straps and cushion

• a small replica of the scanner to help the child understand the process.

“Toshiba understands the sensitivities underlying pediatric CT exams and has developed a full line of dose-reduction technologies customizable to a child's specifications,” said Joseph Cooper, Director, CT Business Unit. “Limiting radiation and sedation are crucial to these patients to ensure the safest possible exam that gives physicians accurate data to develop a treatment plan.”

 
Aquilion ONE

The Somatom Definition Flash from Siemens Healthcare offers CT scans without sedation or breath holds, and with new applications for dose reduction. The need for sedation to prevent motion artefacts has made CT scanning of very young children more difficult, expensive and hazardous.

The Definition Flash, which uses two X-ray tubes and detectors, is the world’s fastest scanner. It has been used to scan infants in less than 1 second, at an X-ray dose of less than 1mSv. Using conventional CT technology, the procedure would take several seconds and require a dose 8–20 times higher.

The system has three new dose reduction applications:

• The Care kV function recommends the correct tube voltage for the patient’s anatomy and adapts all other parameters to optimise the image. This allows the dose to be reduced by up to 60%.

• The Care Child function reduces the voltage from its usual range of 80–140kV to only 70kV.

• The Safire (Sinogram Affirmed Iterative Reconstruction) function reduces the time required to reconstruct slice images, allowing a further 60% reduction in the radiation dose for children.

 
Somatom Definition Flash

Chiesi, Eli Lilly and Bayer Healthcare have all been named in advertisements for breaches of the ABPI Code of Practice, while Bayer Schering Pharma has been publicly reprimanded.

The first three companies have each been found guilty of bringing discredit upon, and reducing confidence in, the pharma industry – Clause 2 of the Code.

Chiesi was found guilty of providing a clinical support service that was assisting GPs to switch to a Chiesi medicine, while Eli Lilly provided “inappropriate hospitality” to two healthcare professionals.

Bayer Healthcare has been ‘named and shamed’ for making misleading claims about its contraceptive Yasmin and underplaying its side effects.

Bayer Schering Pharma’s public reprimand was the result of a prescribing policy document for Levitra that did not include the prescribing information (a breach of Clause 4.1) and for circulating the document more widely than was acknowledged to the PMCPA.

The advertisements appeared in The Nursing Standard, the BMJ and The Pharmaceutical Journal.

The first draft guidance from the new NICE Diagnostics Assessment Programme does not recommend a new whole-body X-ray system.

The provisional recommendations do not support routine use of the EOS Low Dose 2D/3D X-ray imaging system from EOS Imaging in the NHS, but recommends its use in research settings to develop evidence regarding its clinical benefits.

The EOS system uses a low radiation dose to take 2D X-ray images and 3D reconstructions of bones. By scanning a line at a time rather than the entire image, it allows upright, weight-bearing whole-body images to be taken.

This could assist the treatment of orthopaedic patients by showing the relationship between the spine, hip, pelvis and knees, as well as cutting patient turnaround times. Current imaging systems cannot show the whole spine or lower limbs in a weight-bearing position in a single image.

Professor Adrian Newland, Chair of the Diagnostics Advisory Committee, said: “This technology may have a number of potentially significant benefits for patients, and there is evidence to suggest that the system does confer some benefits in terms of reducing radiation dose. Also, simultaneous 2-view imaging may permit improved patient throughput.

“However, in order for the EOS system to be cost-effective, benefits relating to its use… need to be translated into health benefits for patients. Unfortunately there is no available evidence relating to these benefits. In particular, no data was found that compared the EOS system’s diagnostic accuracy to conventional radiological examinations.

“This, together with the high cost of the system relative to conventional methods of imaging, has led the Committee to provisionally conclude that routine use of the EOS system would not be an effective use of NHS resources.

Professor Newland also noted that NICE’s diagnostics guidance aims to indicate where a technology has “plausible potential of providing substantial benefits,” and to suggest research that could provide clear evidence of such benefits. On this basis, he said, NICE recommends further research to establish whether the EOS device offers better health outcomes.

Final guidance will be published in October 2011.

 
                EOS X-ray

UNICEF has revealed a decision to publish the prices it pays to vaccine manufacturers in an attempt to lower the cost of vaccines needed in the developing world.

UNICEF spent US$757 million on vaccines in 2010, but has never before revealed the prices charged by each producer.

Many companies have given the green light for their prices from the last 10 years to be openly published as part of a voluntary price reporting system. From now on, all company prices will be routinely published.

“This is a real step forward—until now it was difficult for countries to find out what companies were charging for specific vaccines,” said Daniel Berman, Deputy Director of the Campaign for Access to Essential Medicines at Médecins Sans Frontières (MSF). “Full price transparency facilitates competition and will allow buyers to make the best choices for immunisation programmes.”

MSF has also urged The GAVI Alliance (The Global Alliance for Vaccines and Immunisation) to stimulate competition and to create incentives for emerging country producers to speed up the development of low-cost, adapted versions of vaccines.

“Developing countries would benefit from vaccines that are easier to store and transport, do not need refrigeration and that are easier to administer – orally or through patches, for example rather than with needles. GAVI should flex its purchasing muscles to encourage manufacturers down this path,” Mr Berman added.

A new mobile app for the Android and iPhone enables users to interact with the NHS Direct service, checking their symptoms and gaining health advice.

The free app from Mobikats was commissioned by Transform Innovation, digital strategy advisers to NHS Direct, and is expected to reduce pressure on GP surgeries and A&E departments.

All 37 of NHS Direct’s online symptom checkers are featured in the app, including those for colds and flu, sore throats and hay fever. The user answers a set of automatic questions and then the app provides self-care advice, generates a call-back from an NHS Direct Nurse Advisor or suggests a course of action.

The NHS Direct app has clear graphics and a user-friendly interface, and can store care guides for up to 30 days.

The iPhone version was released five days after the Android version, which was

downloaded 1,774 times in between.

Philippe Homsy, a Mobikats director, commented: “The importance of keeping the design of the app simple yet with all the functionality needed by NHS Direct was a key challenge for Mobikats. Users were likely to be stressed when they used it, so we needed to ensure they could access the right information in the shortest time.”

Roger Donald, Associate Director of Multichannel for NHS Direct, said: “The NHS Direct app has been developed in response to the popularity of this new mobile channel and to the specific needs of the growing number of patients who prefer to access health advice online. Patients can access rapid and convenient health advice through the app with the reassurance that the information is from a trusted source.”

Mobikats develops smartphone apps and advises companies on mobile strategies.

Analysing the performance of sales representatives has never been more important to pharma. David Round, Cegedim Relationship Management, explains the importance of Customer Relationship Management (CRM) and business intelligence in tracking and improving KAM activity.

In the good old days, performance measurement was about coverage and frequency, sales volume and value, and various other activity-based measures. The customer base rarely changed and pharmaceutical companies had a consistent approach to tracking representative’s performance. Those days are long gone. Yet despite the widespread adoption of Key Account Management and the challenges of meeting the needs of a now constantly changing customer base, some companies are still reliant on more traditional measures.

Over the past decade, the pharmaceutical industry has endured/embraced numerous changes, not least the shift towards the Key Account Management (KAM) model. Yet despite the declining relevance of ‘coverage and frequency’ in today’s highly complex sales environment, there is still no consensus across the industry as to how best to measure and manage performance.

The traditional model was straightforward and adopted by pretty much every company, irrespective of therapeutic area. It was a relatively simple process to determine the right message and assess the required frequency of visits to influence prescribing. But it was not always satisfactory – not least given the inability to directly match activity information to a specific end sale.

The good news is that now the industry can measure absolute performance against definite success factors, such as whether or not the product is on formulary, providing a far more tangible link to KAM activity. The challenge is trying to find meaningful performance measures to support a sales process that could last for 18-months and is specific to the requirements of the local health economy.

Local empowerment

The KAM model is indisputably harder to measure. It is complex, multi-layered and involves numerous individuals within the team. Pharmaceutical companies need to put in place a way of supporting KAMs within the local health economy, co-ordinating the many individuals and tasks required to deliver the key account plan and understanding how best to drive the process through a number of key milestones towards defined end goals, such as progression through the stages of local drug approval process.

For companies that can leverage strong CRM and business intelligence technology, there is an opportunity to attain unprecedented granularity of performance information. In this multi-discipline environment, the CRM system is fast becoming the key repository for KAM information, from the key account plan and the SWOT analysis, through to tactical plans, including the required engagement with specific individuals within the local health economy. It is the source of information for defining the internal resources required to undertake these tactical requirements and, critically, provides the central platform to track the progress of the key account plan towards specific milestones.

Today’s business intelligence technology allows pharmaceutical companies to build on that CRM system to track performance at several levels. From the task/action level for each individual user, through to the performance against the business objectives set for each account, and up to the overall account ranking, which demonstrates performance towards the end goal.

Using dashboards at each level provides the KAM with an immediate insight into the status of tactical actions that need to be carried out to achieve the overall account and strategic objectives, and how the performance of these actions is affecting or could affect the longer term performance and account status. Furthermore, by using traditional red, amber and green to highlight the action status, a well designed dashboard can make it far easier to prioritise activity and minimise the chance of action slippage which could damage the entire team’s performance. For example, has the medical scientific liaison engaged the local Key Opinion Leaders or stakeholders; or the KAM attended formulary meetings?

Determining performance measures

This visibility of activity, and the ability to track performance in real-time is key in enabling the pharmaceutical company to ensure the key account plan is progressing. With a 360 degree view, companies have a fantastic platform to achieve excellent performance management. The challenge for pharmaceutical companies today is to determine the relevant metrics.

And this, to date, has been a stumbling block for many companies: simply measuring performance against the rest of the industry is no longer relevant. In this brave new world, every pharmaceutical company has a different value proposition and supporting strategies that reflects specific therapeutic areas and the individual local health economy.

The performance measures must reflect that value proposition. However, since value propositions vary between therapeutic areas and within different local health economies, companies that opt to impose one set of performance metrics across the board risk fundamentally constraining the KAMs. Metrics must be set within the context of each specific account plan, and then rolled up to measure performance within the overall market strategy.

With this local empowerment, pharmaceutical companies can then truly enable KAM through full local budget management. KAMs can include budget information within the CRM system, from the cost of promotion meetings to grants and sponsorships, providing a single, central resource that can deliver key insight into the effectiveness of budget management within the overall context of performance against business goals.

Adding sales data provides pharmaceutical companies with the ability to assess performance from a P&L perspective within a local health economy.

New measurements

After decades as the primary way of measuring performance – both internally and against the competition – it is no surprise that activity measures are still in place. This is an easy crutch to lean on. But if organisations really want to create highly efficient, functional KAM structures, the measures need to change and support KAMs in day to day, as well as long-term, account management.

The market has fundamentally changed; these traditional measures will not be replaced with another standardised industry measurement of KAM performance. The key question is: just what will success look like under this KAM strategy to your organisation? Pharmaceutical companies must determine those measures of success that reflect the corporate strategy – and put in place methods of tracking movements towards that success.

Deploying the right technology is critical. True KAM tracking and performance management cannot be achieved without excellent CRM and business intelligence tools – the processes are simply too complex and involve too many different people. But ultimately, it will be the ability to monitor the soft and hard measures that reflect local/account level objectives that will be key in this evolution from the familiar industry standard approach to performance management to one that is highly tailored, highly specific and flexible enough to reflect the demands of a constantly shifting customer base.

David Round is General Manager of Cegedim Relationship Management.

Merck KGaA has created a committee of renowned experts to advise it on bioethical matters.

The Merck Bioethics Advisory Panel will provide recommendations on how to take bioethical aspects into consideration when discovering and developing new products and processes.

Three American, two German and one Swiss professor will sit on the panel and support Merck in addressing related topics, such as integrity, sustainability and legal compliance.

Biotechnological and biomedical research is an important factor for Merck. Last year, its Merck Serono division generated 61% of its sales with its top five selling biopharmaceuticals.

The panel of experts includes: Professor Dena S. Davis, Professor Jeanne Loring, Professor Jeremy Sugarman, Professor Jochen Taupitz, Professor Nikolaus Knoepffler and Professor Christoph Rehmann-Sutter.

A specific batch of the Japanese encephalitis vaccine Ixiaro has been recalled throughout the EU.

The CHMP was informed by Intercell AG that batch JEV09L37 may be less potent than expected and may not provide a full protective immune response in patients.

The Committee now recommends that individuals who have received up to two doses of the affected batch be revaccinated if they are travelling to an affected country in the future.

Twenty thousand syringes of batch JEV09L37 have been distributed in the UK and Spain together, with a further 3,000 in Italy and 3,000 in France.

Ixiaro is a highly purified vaccine and limited information from clinical trials does not indicate any specific safety concerns for those receiving more than two does in a short period of time.

As an additional precaution, the CHMP also agreed that further potency testing of other batches should now be conducted by Intercell AG, in particular those which are in the middle and end of their ‘shelf lives’.

The Health and Social Care Bill should be changed in major respects to reduce its emphasis on competition between providers, or else be withdrawn, the British Medical Association (BMA) has said.

In its formal response to the NHS Future Forum, the body leading the Government’s ‘listening exercise’, the BMA warns that its members are seriously concerned about the effects of enforcing competition.

Instead, the BMA sets out recommendations for the development of more integrated services based on “a more mature form of commissioning”, improving quality and efficiency through greater collaboration between NHS providers.

The BMA comments that its members are deeply concerned that the proposed changes to the structure of the NHS are already being rapidly implemented.

Over 80% of 1,000 BMA members surveyed in May said they were broadly opposed to the Health Bill. Key concerns included the powers given to Monitor to enforce competition and the powers given to the Health Secretary to control consortia via the new National Commissioning Board.

The BMA submission calls for a commissioning system whereby clinical networks of specialists and primary care professionals work together alongside GP consortia, with specialists involved in the design of patient pathways.

The recommendations it has made to the NHS Future Forum include:

• The primary role of Monitor should be amended to protecting and promoting high-quality, comprehensive, integrated services, not promoting competition.

• GP consortia should have an explicit duty to fully involve all relevant clinical staff in commissioning.

• The NHS Commissioning Board should be required to consult with consortia before using its powers to impose changes that affect them.

• The Secretary of State’s duty to secure the provision of comprehensive healthcare services for the people of England should be reinstated, and his or her powers over the NHS Commissioning Board should be subject to explicit safeguards.

Dr Hamish Meldrum, Chairman of Council at the BMA, said: “The message from doctors is clear and simple – the Bill must be changed significantly, if not withdrawn altogether, if the NHS is to continue to improve. We are right in the thick of the challenges the NHS faces, and while change is necessary, this major upheaval is not.

“We know that the NHS has to become more efficient, that chronic illness is growing, and that we need a step change in improvements in public health. Increasing and enforcing competition is not the answer. Instead, we are putting forward recommendations that aim to maximise the potential for positive change in the proposals, by genuinely giving more say to patients and to clinicians at the front line.”

Healthcare corporation Covidien has launched an online resource to promote ethical working between healthcare professionals (HCPs) and suppliers of medical devices and pharmaceuticals.

Conscientious Collaboration is designed to help educate HCPs about as the laws and codes of conduct that govern supplier-clinician relationships, as well as Covidien’s own policies for commercial engagement.

This initiative comes at a time of unprecedented public scrutiny into the ethical compliance of medical device companies.

Covidien was the first large medical device company to stop direct sponsorship of HCP travel to third-party conferences and congresses worldwide (in 2010). Other measures adopted by the company to ensure its compliance include:

• Delegating decision-making authority for educational and research grant requests to a cross-functional team led by the Company’s Medical Affairs department.

• Creating Investigator-Sponsored Research Grant Committees to evaluate research grant proposals, separate from the company’s commercial operations.

• Moving its funding for minimally-invasive surgical fellowships to neutral organisations such as the Foundation for Surgical Fellowships.

“Given the advancement of technology in healthcare today, the provider-industry relationship has never been more relevant or important, nor more scrutinized or challenged,” said Michael Tarnoff, Covidien’s Global Chief Medical Officer. “Conscientious Collaboration is Covidien’s platform through which we can discuss our proactive approach to ensuring ethical interactions with our HCP partners.”