Guidance is no barrier to engaging on Twitter - Five simple, compliant tactics for European pharma marketers to consider

1. Listen

Listening is the starting point when thinking about engagement opportunities on Twitter. Using the many listening platforms available (they vary from free and small monthly fees to enterprise licences), one can quickly set up profiles around the topics which are important to you. For example, if you are interested in listening to what your customers are saying about your disease state or brand, you’ll create a stream of data to sort through to help build a picture of what topics are important to them, from an unbranded and branded standpoint.

And your customers are definitely talking about your disease area and brand, whether you are listening to them or not. From rare diseases to common ailments, there is a good chance that your customers are talking. One note: I would recommend knowing your adverse event reporting procedure (or make sure your digital agency is trained on your policy) to ensure you are following your established protocol for reporting appropriate content.

2. Identify and engage community leaders

Once you start listening, you’ll begin to see trends in who is speaking, sharing and engaging the most. Active users are most likely the ‘leaders’ of the community, regularly posting to, and engaging with, the same customers you spend your marketing budgets to build relationships with.

This presents a great opportunity to start a dialogue with these important community influencers. If you can, you should go to the same conferences they are attending and listen to what they have to say. Their presentations and points of view are critical to the path of better understanding what your communities are looking for. Invite them to have a coffee at the local café and continue to listen. You may not like what they have to say all the time, but it’s important to build a long term relationship, which will ultimately benefit the community by helping to fill in gaps with the support and content you are supplying on behalf of your company.

3. ‘Hashtag customer service’

Once you have established a listening programme on Twitter, a natural next step is to work on increasing the reach of the services you already provide. Let’s say you have a service on your disease education website where members of the public can post a question that is not product related and receive a response via email.

What if you extended this service to Twitter via a hashtag? All a Twitter user has to do is place the hashtag in their message (example: #askPHARMA) and your Twitter listening platform will pick up on the hashtag request and notify the appropriate team member (maybe even your medical information call centre), giving your team the immediate opportunity to send a response, providing the same level of customer service that most customers expect outside pharma.

4. Sponsored tweet

There is a simple approach to getting your message out to your audiences without being directly involved in the Twitter community. Pharma companies have started to use sponsored tweets. This is the ability to use an established Twitter account to deliver a message to an audience. For example, a pharma company could pay any Twitter influencer to tweet a message about a particular healthcare-related topic to its followers.

By sponsoring the Tweet, pharma companies expand the reach of that message beyond their community of followers and reach an even larger audience of prospects and customers. This also can help link the company to a respected individual or corporation. In fact, CVS just sponsored the hashtag #onegoodreason to promote its new no-tobacco policy to as wide an audience as possible. Without choosing to sponsor the hashtag, #onegoodreason would only be visible to its current Twitter followers.

5. Build an FDA-approved Tweet

As you build your community and determine content to engage your audience, it’s important to be mindful of the new FDA regulations, which were designed to promote health literacy and accuracy. This can be challenging with a 140-character limit, but if you follow these steps, you will be tweeting FDA approved messages in no time.

1. Include the benefit information


2. Communicate at a minimum the most serious risk, along with a direct hyperlink to a more complete discussion of risk information


3. Include the full FDA-approved product name.

Below is an example that follows these steps and was provided by the FDA:

NoFocus (rememberine HCl) for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk [134/140]

Consider starting with basic steps to develop a social approach to Twitter – small steps can help you move forward in your social engagement journey.

Three steps for building an FDA-approved tweet

Include the benefit information
Communicate at a minimum the most serious risk, along with direct hyperlink to a more complete discussion of risk information
Include the full FDA-approved product name

 

 

This post is provided by Cadient for information purposes only and is not intended and should not be construed as regulatory or legal advice.

Source PMLive http://www.pmlive.com/blogs/smart_thinking/archive/2014/october/guidance_is_no_barrier_to_engaging_on_twitter

Guidance is no barrier to engaging on Twitter - Five simple, compliant tactics for European pharma marketers to consider

Cancer survival rates 'continue to improve'

Prostate cancer survival rates are expected to improve for patients diagnosed in 2013

Most people diagnosed with cancer in England in recent years are surviving for longer, according to the latest statistics.

Eighty per cent of those with breast, prostate and skin cancer are living for five years after diagnosis. The figure is 90% for testicular cancer.

Recently diagnosed prostate cancer patients will see a large improvement in their hopes of survival.

The figures are published by the Office for National Statistics.

The ONS report estimated the chances of people surviving for one year and for five years after being diagnosed with cancer in England.

The report looked at survival rates for 24 different common cancers diagnosed between 2008 and 2013.

It found survival improving for the majority of cancers, with survival generally higher in women.

Survival boost

For people with cancers diagnosed in 2013, the greatest improvement in survival chances will be in men with prostate cancer – from 83.6% to 87.6%.

High survival rates for prostate cancer and breast cancer are thought to be due to the increasing number of men and women getting their cancer diagnosed and treated at an early stage.

Other lesser-known cancers also showed promising improvements in the chances of survival.

For women with myeloma, or cancer of the white blood cells, there was a rise in five-year survival from 41.6% for those diagnosed in 2007-2011 to 46.2% for diagnosis between 2008 and 2012.

There were also large increases in survival chances for men with myeloma and men with leukaemia.

While some cancers have a good prognosis, others “remain extremely poor”, the ONS report says.

Five-year survival estimates for cancers of the brain, lung, liver, pancreas and stomach are all below 19% for men and 22% for women.

Pancreatic cancer for both men and women has a survival rate of just 5.4% – the lowest in both sexes.

‘Greater awareness’

Nick Ormiston-Smith, head of statistical information at Cancer Research UK, said more people were surviving cancer then ever before “thanks to better treatments, earlier diagnosis and greater awareness”.

“But the story’s not so positive for all types of cancer,” he said.

“Lung, pancreatic, oesophageal cancer and brain tumours still have relatively low survival rates, partly because they tend to be diagnosed at a later stage when they’re much harder to treat.”

He added: “We’re working to beat all cancers sooner, increasing our research into cancers with lower survival rates and boosting our investment to help diagnose cancer earlier – accelerating progress to save more lives.”

Source BBC News/Health http://www.bbc.co.uk/news/health-29832237

Cancer survival rates 'continue to improve'

Google is developing cancer and heart attack detector

Google hopes to develop a wristband that would carry out non-invasive blood tests

Google is aiming to diagnose cancers, impending heart attacks or strokes and other diseases, at a much earlier stage than is currently possible.

The company is working on technology that combines disease-detecting nanoparticles, which would enter a patient’s bloodstream via a swallowed pill, with a wrist-worn sensor.

The idea is to identify slight changes in the person’s biochemistry that could act as an early warning system.

The work is still at an early stage.

Early diagnosis is the key to treating disease. Many cancers, such as pancreatic, are detected only after they have become untreatable and fatal.

There are marked differences between cancerous and healthy tissues.

Google’s ambition is to constantly monitor the blood for the unique traces of cancer, allowing diagnosis long before any physical symptoms appear.

The project is being conducted by the search company’s research unit, Google X, which is dedicated to investigating potentially revolutionary innovations.

Mr Conrad, seen on the left, joined Google X as head of Life Sciences in 2013

It marks the firm’s latest shift into the medical sector following its work on glucose-measuring contact lenses for patients with diabetes and the acquisition of a start-up that developed a spoon to counteract the tremors caused by Parkinson’s disease.

Google has also bought stakes in Calico, an anti-ageing research company, and 23andMe, which offers personal genetic-testing kits.

Nanoparticles

The diagnostic project is being led by Dr Andrew Conrad, a molecular biologist who previously developed a cheap HIV test that has become widely used.

“What we are trying to do is change medicine from reactive and transactional to proactive and preventative,” he told the BBC.

Doctor-patient relationships are pretty privileged and would not involve Google in any way”

Dr Andrew Conrad Google X

“Nanoparticles… give you the ability to explore the body at a molecular and cellular level.”

Google is designing a suite of nanoparticles which are intended to match markers for different conditions.

They could be tailored to stick to a cancerous cell or a fragment of cancerous DNA.

Or they could find evidence of fatty plaques about to break free from the lining of blood vessels. These can cause a heart attack or stroke if they stop the flow of blood.

Another set would constantly monitor chemicals in the blood.

High levels of potassium are linked to kidney disease. Google believes it will be possible to construct porous nanoparticles that alter colour as potassium passes through.

“Then [you can] recall those nanoparticles to a single location – because they are magnetic – and that location is the superficial vasculature of the wrist, [where] you can ask them what they saw,” said Dr Conrad.

Unattached nanoparticles would move differently in a magnetic field from those clumped around a cancer cell.

In theory, software could then provide a diagnosis by studying their movements.

As part of the project, the researchers have also explored ways of using magnetism to concentrate the nanoparticles temporarily in a single area.

The tech company’s ambition is ultimately to create a wristband that would take readings of the nanoparticles via light and radio waves one or more times a day.

Prof Paul Workman, chief executive of the Institute of Cancer Research in London, told the BBC News website: “In principle this is great. Any newcomers with new ideas are welcome in the field.

“There is an urgent need for this. If we can detect cancer or other diseases earlier, then we can intervene with either lifestyle changes or treatment.

“How much of this proposal is dream versus reality is impossible to tell because it is a fascinating concept that now needs to be converted to practice.”

His team at the institute is investigating cancer cells and cancer DNA in the blood as new methods of diagnosis and planning treatment.

He did warn Google that a diagnosis could increase anxiety and lead to unnecessary treatment, so there needed to be “very careful and rigorous analysis” before this type of blood monitoring could be used widely.

The scheme is being made public because Google is now seeking to establish partnerships.

But Dr Conrad sought to play down the idea that his firm wanted to run a search tool for the human body, alongside the one it already offers for the internet.

“We are the inventors of the technology but we have no intentions of commercialising it or monetising it in that way,” he said.

“We will license it out and the partners will take it forward to doctors and patients.

“These are not consumer devices. They are prescriptive medical devices, and you know that doctor-patient relationships are pretty privileged and would not involve Google in any way.”

Analysis: James Gallagher, health editor

From searching the internet to searching your blood, Google certainly has high ambitions. But is it feasible?

The basic principles are sound and mirror the work already taking place around the world.

Many research groups are looking at bits of cancer floating in the blood as a better way of diagnosing the disease and also to assess which tumours are more aggressive.

But Google will have to address concerns around “false positives”, when healthy people are told they are ill.

These have plagued the PSA test for prostate cancer, as PSA levels can soar even when cancer is absent.

There is also the issue of “over-diagnosis”. Who needs treating even if a condition is discovered?

There is continuing controversy around breast cancer screening: for every life saved, three women have invasive treatment for a cancer that would never have proved fatal.

Screening the body for disease is littered with dangers, and if it is not done carefully, it could make hypochondriacs out of all of us.

Big risk?

The nanoparticle project is the latest so-called “moonshot” to originate from Google X.

Other schemes include the firm’s driverless car effort and Project Loon, an attempt to provide internet access to remote areas via a network of high-altitude weather balloons.

While such ideas have the potential to make money, there is also a high risk of failure, and Google X acknowledges that several of its ideas have been ditched before being made public.

One analyst commented that its parent was in a rare position to make such investments.

“Under normal circumstances this is the kind of thing that would worry investors because such projects are too long-term and the miss rate is too high,” said Cyrus Mewawalla, from CM Research.

“But because Google’s core search business is currently so strong, shareholders are not worried at the moment and are allowing the firm to take a gamble.”

Analysis: Leo Kelion, technology desk editor

Google’s diagnostic project may never come to fruition, but its significance lies in the fact it represents part of a wider push by the firm into health tech.

Bearing in mind this is already a crowded sector, it begs the question: why?

The search firm denies that it wants to run its own diagnosis service, with all the privacy headaches that would entail, but the patents it creates along the way could prove lucrative.

No doubt the fact that co-founder and Google X chief Sergey Brin has been told that a gene mutation has increased his likelihood of contracting Parkinson’s has also focused efforts.

And the company clearly believes its expertise in “big data” analysis and its freedom to focus on giant leaps forward, rather than incremental steps, plays to its advantages.

It’s worth remembering that another much hyped health idea, Google Flu Trends – which aimed to predict the spread of the virus based on internet searches – has been dubbed a failure by some after researchers said it had overestimated the number of cases in 100 out of 108 weeks.

And US health watchdogs banned Google-backed 23andme from selling its genetic screening kits last year.

On the other hand, Google’s “smart lens” for diabetics shows promise, with Swiss firm Novartis stepping up to license the technology in July.

And the forthcoming Android Fit platform, designed to harness data from other apps and wearables, has a good chance of success given the huge number of people using the operating system.

Source BBC News/Health http://www.bbc.co.uk/news/technology-29802581

By Leo Kelion & James Gallagher Technology and health desk editors

Google is developing cancer and heart attack detector

EFPIA promotes pharma's contribution to Europe

Launches Pharmafigures website to detail industry investment

EFPIA has launched a new online initiative to promote pharma’s contribution to Europe.

The European trade body’s new pharmafigures.eu website details industry investment in R&D, levels of employment it brings and its contribution to the trade balance in 32 European countries.

The resource, which went online in the weeks before the line-up of Jean-Claude Juncker’s new European Commission was confirmed, also gives a regional breakdown of some of the figures for Germany, France, Spain and Italy.

Source PMLive http://www.pmlive.com/blogs/digital_intelligence/archive/2014/october/efpia_promotes_pharmas_contribution_to_europe

EFPIA promotes pharma's contribution to Europe

EC: medicines to remain part of health directorate

Juncker U-turns on decision to move pharma oversight to enterprise and industry

New president of the European Commission (EC) Jean-Claude Juncker has backtracked on a much-criticised decision to move control of pharmaceuticals and medical devices to the enterprise and industry directorate.

Instead medicines will remain under control of the Directorate General for Health and Consumers, whose Commissioner is now Vytenis Andriukaitis after the recent reshuffle of EC ministers.

“Responsibility for medicines and pharmaceutical products will stay with the Directorate-General for Health because I agree with you that medicines are not goods like any other,” said Juncker in a speech before the European Parliament to announce his presidency.

“The relevant policy will be developed jointly by Vytenis Andriukaitis and by Elżbieta Bieńkowska [Directorate-General for the Internal Market and Industry], who showed her incredible talents in her hearing.”

The announcement was welcomed by several healthcare organisations who had strongly criticised the original decision to move the control of medicines to the industry directorate as a retrograde step that would damage the EC’s ability to handle major health crises and to keep patients at the heart of policy decisions.

Twenty-six major healthcare bodies in Europe, including the European Public Health Alliance and the UK’s Royal College of Nurses, issued a joint press release welcoming the U-turn.

“With this new perspective, Mr Juncker has demonstrated that medicines are not an ordinary internal market good and that pharmaceutical policy is crucial to the sustainability of health systems; not solely an instrument for promoting economic growth,” said the partners.

“Dr Vytenis Andriukaitis will now have the tools to fulfil his mandate to harmonise pharmaceutical governance within the EU and facilitate emergency preparedness; the very reasons that in 2009 led the European Commission to move responsibility for medicines and medical devices into the hands of the health Commissioner.”

Health Action International (HAI) Europe – a network working to improve access to essential medicines – also hailed the decision, although there were still concerns about the possibility of an expanded role for the Directorate-General Enterprise and Industry in the development of medicines policy.

HAI Europe said it “calls upon the new EU health commissioner, Vytenis Andriukaitis, to use all available means to ensure that public health is not compromised by private sector interests”.

Source PMLive http://www.pmlive.com/pharma_news/ec_medicines_to_remain_part_of_health_directorate_609283

EC: medicines to remain part of health directorate

Facebook: mobile is not a technology, it's a consumer behaviour

Social network gives pharma marketers attending ThinkDigital some tips

Mobile is not a technology, it’s a consumer behavior – that was one of the messages from Facebook to the pharma marketers present at the recent ThinkDigital event.

The social network told the audience at the Digitas Health Lifebrands event in London last month to look at the wider trends that technological advances were enabling.

“You shouldn’t be talking about mobile, you should be talking about mobility,” explained Nick Pestell, agency partner, global marketing solutions at Facebook.

“The best example of this is that if you were to spend £100 on Facebook, then £73 of that would end up on a mobile device – that’s not just Facebook pushing it out to mobile devices, it’s because that is where the consumers are.”

It is also a trend, Pestell told ThinkDigital, that applies to all demographics. “We’re starting to see the [number of] people who exclusively access Facebook on a mobile device continue to rise.

“It’s now about 40%, up from 35% a year ago, and in certain demographics it is as high as 85%. The data that is being generated from all of this activity – especially on the smartphone level – has increased exponentially.”

June Dawson, managing director of Digitas Health LifeBrands, said: “Customers are driving much of the demand for mHealth technologies and applications. Mobile apps are helping to improve overall consumer engagement in health care by simplifying the access and the flow of information; lowering costs through better decision-making, fewer in-person visits, and greater adherence to treatment plans; and improving satisfaction with the service experience.

“Facebook gave us an Insight into health care consumers’ behaviours and attitudes at ThinkDigital14 – this is critical information in an environment where health care is moving rapidly towards patient-centered care where individuals ARE active participants in managing in their own health care.”

A growing number of pharmaceutical companies use Facebook, which has built a global user base of 1.2 billion people in its first ten years, and the social network’s Pestell offered a few tips on how to do so more effectively.

• Think ‘stories’ not ‘facts’: consumers, in healthcare as elsewhere, engage emotionally through stories rather than dry facts


• Develop ‘atomised’ content: Facebook’s users generally don’t visit every day, so you need a strategy that enables them to dip in and out of your posts – so that whenever they visit they can still know what’s going on


• Stories need themes: Create ‘ownable’, repeatable things that users can engage with, Pestell advised. Acknowledging it was not a healthcare example, he highlighted McDonald’s rich, engaging, real-time video-led Facebook campaign that was developed for this year’s football World Cup in Brazil


• Audience pockets and targeting: Make data – either your own or that provided by companies like Acxiom and Datalogics – work for you by unearthing either a new audience or an existing customer base.

Pestell concluded by revealing that the single biggest question asked of Facebook is ‘what is good creative on Facebook?’.

“The easiest answer that,” he said, “ is that good creative is just good creative – it shouldn’t be adapted for Facebook – and it definitely does not need to be a cat or a dog or something cute.”

Source PMLive http://www.pmlive.com/blogs/digital_intelligence/archive/2014/october/facebook_mobile_is_not_a_technology,_its_a_consumer_behaviour

Facebook: mobile is not a technology, it's a consumer behaviour

NHS needs extra cash and overhaul, say health bosses

By Nick Triggle Health correspondent, BBC News

The plan wants more done to reduce obesity, smoking and drinking rates

Drastic changes to services and extra money is needed if the NHS in England is not to suffer, health bosses say.

A five-year plan for the NHS – unveiled by six national bodies – once again highlighted an annual £30bn shortfall would open up in the next Parliament.

It said changes, such as GP practices offering hospital services, would help to plug a large chunk of the gap.

But health chiefs said the NHS would still need above inflation rises of 1.5% over the coming years.

That works out at an extra £8bn a year above inflation by 2020.

The current budget stands at £100bn a year, but all the political parties have already started talking about what they would do in the next Parliament.

Health Secretary Jeremy Hunt said difficult decisions needed to be taken, but added the Conservatives were committed to “protecting and increasing” funding in real terms.

“A strong NHS needs a strong economy, then it is possible to increase spending this report calls for.”

 

£100bn

NHS England budget for 2014-15

£30bn

Shortfall predicted by 2020

• That could fund 100 hospitals


• New ways of working could save £22bn


• But NHS still needs an extra £8bn

Source: NHS England

Thinkstock

Labour’s shadow health secretary Andy Burnham said some of the proposals were ideas Labour had already suggested.

“We’ve have found an extra £2.5bn for the NHS, we’ve said that the NHS will be our priority in the next Parliament, and alongside that, we’re saying that the time has come to bring social care into the NHS.”

The Liberal Democrats have said they will make sure the budget rises in line with inflation.

The plan – called the NHS Forward View – also said the future of the health service depended on it becoming more efficient.

To achieve this, it called for a rethink about the way services were delivered.

It put forward a range of models – although stressed it was up to each local area to decide which ones to adopt.

These include:

• Large GP practices to employ hospital doctors to provide extra services, including diagnostics, chemotherapy and hospital outpatient appointments


• In areas where GP services are under strain, hospitals could be encouraged to open their own surgeries


• Smaller hospitals to work as part of larger chain, sharing back-office and management services


• Larger hospitals to open franchises at smaller sites, as Moorfields Eye Hospital has done in London


• Hospitals to provide care direct to care homes to prevent emergency admissions


• Volunteers could be encouraged to get more involved, by offering council-tax discounts

Many of these measures are designed to curb the rise in hospital admissions and impact of the ageing population – the source of most pressure in the health service.

Case study: Working with care homes

Nurses and doctors from Airedale Hospital in West Yorkshire have set up video link-ups with local care homes.

It allows consultations to take place with residents on everything from cuts and bumps to diabetes management.

Emergency admissions from these homes have reduced by 35% and A&E attendances by 53%.

But the report – produced by NHS England, Public Health England, the regulator Monitor, the NHS Trust Development Authority, Care Quality Commission and Health Education England – also said more needed to be done to reduce obesity, smoking and drinking rates.

It suggested employers should be encouraged to incentivise their staff to become healthier by taking steps such as offering them shopping vouchers for healthy behaviour.

Meanwhile, councils could play their part by using their powers in areas such as planning and licensing to limit the opening of junk food outlets and the sale of cheap high-strength alcohol.

Simon Stevens, chief executive of NHS England, the lead body for Forward View, said the NHS was at a “crossroads”.

NHS England chief executive Simon Stevens: NHS “must fundamentally change”

“It is perfectly possible to improve and sustain the NHS over the next five years in a way that the public and patients want. But the NHS needs to change substantially.”

He said if the health service did not improve, the “consequences for patients will be severe” in terms of what could be done to ensure patients received the best care in areas such as cancer and heart disease.

But he added there was no reason why a tax-funded NHS would not continue if the plans outlined were followed.

‘Close the gap’

Health minister Norman Lamb welcomed the report, saying it was “really imaginative thinking”.

“I think this combined case of more investment but also change… is absolutely the right message.”

The Liberal Democrat minister said his party wanted to “reopen” spending plans for 2015/16, saying “the NHS needs more money next year”. He said it would be “our top priority” for the Autumn Statement.

Case study: The GP super-practice

Whitstable Medical Practice, in Kent, is one of the new super-practices that are being developed. It offers the traditional GP services alongside a host of services more associated with hospitals.

It operates out of three sites and employs nearly 150 staff, providing care for 34,000 people.

It runs maternity services, a minor injury unit with X-ray facilities and dedicated diabetes, heart disease and asthma clinics as well as diagnostics and minor surgery.

Nigel Edwards, the chief executive of the Nuffield Trust think tank, said: “This report makes crystal clear that the NHS cannot continue with ‘business as usual’ if it is to meet the needs of a diverse and ageing population.”

Royal College of Nursing general secretary Peter Carter called the report “rigorous and realistic”.

Source BBC News/Health http://www.bbc.co.uk/news/health-29726934

NHS needs extra cash and overhaul, say health bosses

NICE conflicts of interest: Call for MPs to investigate

By Adam Brimelow Health Correspondent, BBC News

A group of leading doctors and researchers has called on MPs to investigate potential conflicts of interest at the watchdog NICE.

In a letter to the Health Select Committee, they have expressed concern about financial ties to drug companies among experts working for NICE.

The concerns follow controversy over the recent NICE guideline on statin drugs.

NICE has defended its procedures on conflicts of interests.

The letter reflects continuing disquiet among some doctors and researchers over the recent decision by NICE to extend the availability of cholesterol-lowering drugs to millions of people at low risk of developing heart disease.

A majority on the NICE panel that recommended this had ties to pharmaceutical companies.

Their interests were declared but the letter argues that is not enough to ensure impartiality.

‘Licensed’ to advise?

“Transparency is important but accuracy and objectivity should be the gold standard expected of an independent panel,” it says.

The letter argues disclosure of a conflict of interest may even make matters worse because experts may feel “licensed” to emphasise their advice still further.

NICE rules stipulate that members of advisory committees should not have had a personal financial interest in a related company in the last 12 months.

One of the letter signatories, the former Conservative shadow health minister Lord Ian McColl, said this was dubious.

“They could have had millions paid before the 12 months. It really needs to be tightened up.”

Another signatory, a London cardiologist Dr Aseem Malhotra, urged NICE to act.

“I have always had tremendous respect for NICE but their conflicts-of-interest policy clearly needs to be strengthened so that the medical profession and patients can feel fully confident that decisions are made completely independent of personal or industry interests.”

Not “fit for purpose”

The letter is clear that there is no suggestion of any impropriety, but it says the governance arrangements for conflicts of interest at NICE are “not fit for purpose”.

It proposes the establishment of “more independent panels” to minimise the possibility of conflicts of interest, and calls on the Health Select Committee to consider looking into the issue “as a matter of urgency”. They will discuss the matter later today.

In June, a letter supported by many of the same signatories argued that plans to extend the use of statins should be scrapped. It said NICE had used data which “grossly underestimated” the side-effects.

NICE says its response to that letter dealt with concerns raised over conflicts of interests, and it has nothing to add. That statement from NICE defended its procedures.

“Where conflicting interest exists, the individual concerned is either not appointed in the first place or asked to withdraw temporarily, or to leave the group altogether, depending on the nature of the conflict.”

Source BBC News/Health http://www.bbc.co.uk/news/health-29705499

NICE conflicts of interest: Call for MPs to investigate

Care Quality Commission annual report: responses from the social care sector

Caroline Abrahams: ‘Providing care for older people must not be about completing tasks in whatever is the quickest or cheapest way.’ Photograph: Owen Franken/CORBIS

There are “significant differences in the quality of adult social care that people receive in England”, the Care Quality Commission (CQC) has found.

The State of Care report for 2013/14, which also considers healthcare, found that: “This variation in the quality and safety of care in England is too wide and unacceptable. The public is being failed by the numerous hospitals, care homes and GP practices that are unable to meet the standards that their peers achieve and exceed.”

The report includes the case study of an East Anglia care home specialising in dementia, where residents were left lying in wet beds and staff did not respond to calls for help.

The report notes that people in nursing homes received worse care than those in residential care homes. It states: “These differences have not changed over the last three years and are a continuing concern.”

Smaller care homes did better than larger providers, with 92% of small homes complying with the quality standards for safeguarding and safety, compared with 86% of medium homes and 80% of large homes. Small care homes are those with between one and 10 beds; medium have between 11 and 50 beds, and large have more than 50. Smaller homes were more likely to meet all of the quality standards set by the CQC.

We’ve put together a compilation of responses from across the sector. To contribute to the debate, comment below or tweet us @GdnSocialCare – we’ll put the best responses above the line.

Caroline Abrahams, charity director at Age UK: “We welcome the fact that the report shows that care in some areas has improved and that the CQC is committed to improving services. However, let’s not mince words about what some of the findings show – leaving someone in soiled beds or clothing for a long time or failing to ensure that an older person is able to eat or drink is neglect and should be treated as such.

Providing care for older people must not be about completing tasks in whatever is the quickest or cheapest way. Decent care is about looking after a fellow human being in the way that we would like to be cared for when we are older.”

Janet Morrison, chief executive of Independent Age: “The CQC report rightly highlights the wide variance in the quality of care homes, often even within a single geographical area. While it is right to call on people to become more active ‘consumers’, in reality – as the CQC itself acknowledges – most decisions about care are made at a time of crisis and with little opportunity to test the market for the best possible care. The CQC must maintain a focus on driving out the very worst examples of care – the abuse and neglect we see on our TV sets and in our newspapers – so that people can be sure that all care is safe and protects dignity.”

Jane Harris, campaigns director at Leonard Cheshire: “The Care Quality Commission is right to highlight how much care varies around the country. People should expect basic standards of care wherever they live and no-one should suffer the indignity of 15-minute care visits. Every day, thousands of disabled and older people are being forced to choose between having a cup of tea and going to the toilet. Some good councils have taken the right step and reviewed the number of 15-minute visits they buy. But councils across the country need to follow their lead so we can have a care system that is fair to all.”

Sharon Allen, CEO of Skills for Care and National Skills Academy: “We welcome this report that rightly shines a spotlight on services that are not delivering quality care and support, but also acknowledges the key role played by highly motivated, well-trained frontline workers.

CQC is urging health and care systems to respond to the needs of people who access care and support services and there is no doubt that a skilled and knowledgeable workforce with leaders at every level is central to that agenda.”

Dr Katherine Rake, chief executive of Healthwatch England: “The variability in care across the country is simply unacceptable. We wholeheartedly support the CQC’s challenge to sub-standard parts of the system to improve and ensure everyone has access to high quality, safe and dignified support. We welcome CQC’s commitment to empower the public through its new ratings system, and we look forward to working with them to arm patients with the information they need to make decisions about their care and force failing providers to buck their ideas up.”

Local Government Association spokesman: “Councils work closely with local care providers to try to continuously improve services for people who rely on care and their carers.

“We know that more still needs to be done. We want all people who need care and support to have access to the best quality, safe services whether they are in a care home or a hospital so they can return home sooner and live safely in the community for longer. To do this, councils and health partners need to work with providers to ensure that well supported and trained staff are working to put people at the centre of decisions about their needs and support.

“In the period of the current parliament, local government funding has been cut by 40% and councils will have to have made £20bn of savings. As a result, councils have had to reduce adult social care budgets by more than £3.5bn since 2010. So far, services have been protected as much as possible, but this is becoming an increasing challenge for councils in the face of growing cuts.”

We’ve put together a compilation of responses from across the sector. To contribute to the debate, comment below or tweet us @GdnSocialCare – we’ll put the best responses above the line.

Caroline Abrahams, charity director at Age UK: “We welcome the fact that the report shows that care in some areas has improved and that the CQC is committed to improving services. However, let’s not mince words about what some of the findings show – leaving someone in soiled beds or clothing for a long time or failing to ensure that an older person is able to eat or drink is neglect and should be treated as such.

Providing care for older people must not be about completing tasks in whatever is the quickest or cheapest way. Decent care is about looking after a fellow human being in the way that we would like to be cared for when we are older.”

Janet Morrison, chief executive of Independent Age: “The CQC report rightly highlights the wide variance in the quality of care homes, often even within a single geographical area. While it is right to call on people to become more active ‘consumers’, in reality – as the CQC itself acknowledges – most decisions about care are made at a time of crisis and with little opportunity to test the market for the best possible care. The CQC must maintain a focus on driving out the very worst examples of care – the abuse and neglect we see on our TV sets and in our newspapers – so that people can be sure that all care is safe and protects dignity.”

Jane Harris, campaigns director at Leonard Cheshire: “The Care Quality Commission is right to highlight how much care varies around the country. People should expect basic standards of care wherever they live and no-one should suffer the indignity of 15-minute care visits. Every day, thousands of disabled and older people are being forced to choose between having a cup of tea and going to the toilet. Some good councils have taken the right step and reviewed the number of 15-minute visits they buy. But councils across the country need to follow their lead so we can have a care system that is fair to all.”

Sharon Allen, CEO of Skills for Care and National Skills Academy: “We welcome this report that rightly shines a spotlight on services that are not delivering quality care and support, but also acknowledges the key role played by highly motivated, well-trained frontline workers.

CQC is urging health and care systems to respond to the needs of people who access care and support services and there is no doubt that a skilled and knowledgeable workforce with leaders at every level is central to that agenda.”

Dr Katherine Rake, chief executive of Healthwatch England: “The variability in care across the country is simply unacceptable. We wholeheartedly support the CQC’s challenge to sub-standard parts of the system to improve and ensure everyone has access to high quality, safe and dignified support. We welcome CQC’s commitment to empower the public through its new ratings system, and we look forward to working with them to arm patients with the information they need to make decisions about their care and force failing providers to buck their ideas up.”

Local Government Association spokesman: “Councils work closely with local care providers to try to continuously improve services for people who rely on care and their carers.

“We know that more still needs to be done. We want all people who need care and support to have access to the best quality, safe services whether they are in a care home or a hospital so they can return home sooner and live safely in the community for longer. To do this, councils and health partners need to work with providers to ensure that well supported and trained staff are working to put people at the centre of decisions about their needs and support.

“In the period of the current parliament, local government funding has been cut by 40% and councils will have to have made £20bn of savings. As a result, councils have had to reduce adult social care budgets by more than £3.5bn since 2010. So far, services have been protected as much as possible, but this is becoming an increasing challenge for councils in the face of growing cuts.”

Source Guardian http://www.theguardian.com/social-care-network/2014/oct/17/care-quality-commission-annual-report-responses-social-care

Care Quality Commission annual report: responses from the social care sector

EMA expands adverse event reporting website

Opens it up to all nationally-authorised medicines

The EMA has expanded the remit of its adverse event reporting website – allowing patients, the public and healthcare professionals to report suspected side effects on any nationally-authorised medicine.

The move allows any problems with an additional 1,700 active substances to be reported on www.adrreports.eu, which was first launched in 2012 and previously accepted suspected side effects associated with centrally authorised medicines.

In addition to filing reports on suspected problems with medicines, the site also lets the public obtain information on suspected adverse drug reactions – ie, those that have been reported but may not be related to, or caused by, the medicine.

The EMA said in a statement: “Spontaneous reports of suspected side effects provide regulatory authorities with important information which is used to monitor the safety of a medicine.”

The reports are sent electronically to the EMA”s EudraVigilance database of suspected side effects and each report on the public website provides aggregated data that can be viewed by a patient’s age and sex, the type of suspected side effect and its outcome.

Wide-reaching changes to the EMA’s approach to pharmacovigilance in 2012 significantly increased the number of side effects that patients reported directly to either national regulatory authorities or pharma companies within the European Economic Area.

EudraVigilance received 35,600 patients reports in the 2013, compared to 21,600 in 2011 – the year before the pharmacovigilance changes came into effect.

Source PMLive http://www.pmlive.com/blogs/digital_intelligence/archive/2014/october/ema_expands_adverse_event_reporting_website

EMA expands adverse event reporting website

Trafalgar and Parliament squares smoking ban call

Smoking could be banned in Trafalgar Square as well as public parks

Smoking could be banned in Trafalgar and Parliament squares as well as the city’s parks if a report by London’s Health Commission is implemented.

Other measures put forward include Oyster card discounts for commuters who walk part of the way to work.

There should also be a ban on junk food shops near schools, it says.

Smokers’ group Forest labelled the call for a smoking ban “outrageous”. Boris Johnson said a ban could be considered if “it would actually save lives”.

The report, called “Better Health for London“, has been put together by former health minister and cancer surgeon Lord Ara Darzi.

The next thing you know we’ll be banned from smoking in our own gardens”

 Simon Clark Forest

In it he claims half of all adults in London are obese or overweight and the city now has more obese and overweight people than New York, Sydney, Sao Paolo, Madrid, Toronto and Paris.

‘Beacon of health’

About 1.2 million Londoners smoke, and the commission claims 67 school children take up the habit every day.

The smoke free plan would see the mayor use his by-law powers over Trafalgar Square and Parliament Square and his influence over the Royal Parks, the board of which he appoints.

Local councils could pass similar by-laws for their parks and open spaces.

The implementation of the scheme has an estimated cost of £6.5m over five years.

London Mayor Boris Johnson asked Lord Darzi to come up with a plan to make Londoners healthier

The report’s recommendations also include:

• Traffic light labelling on menus at restaurant chains with more than 15 outlets


• Planning guidance to prevent new junk food outlets opening within 400m (1,300ft) of schools


• A minimum 50p per unit price for alcohol in boroughs affected by problem drinking


• An acceleration of measures to reduce air pollution in the capital.

Lord Darzi told the BBC he would like parks to be a “beacon of health”.

“London should lead the way for Britain, and the mayor should lead the way for London by acting to make our public spaces smoke free,” he said.

Speaking on BBC Radio 4′s Today programme, Lord Darzi said: “We want to make sure kids are out there exercising rather than looking at adults smoking in the corner.”

At the scene

Domica Perfect called the possible ban a “load of rubbish”

by Megan Bramall

In Trafalgar Square there are mixed feelings about a ban.

Robin Mason, 68, from Oxford, says it’s a “waste of money”.

“The government should not be spending £6.5m on a ban that would be so hard to enforce,” he says.

His opinion is echoed by 21-year-old smoker Domica Perfect who thinks the ban is “a load of rubbish”.

“I don’t think it really matters because we’re outside in the open so it’s not like people are forced to breathe in your smoke,” she says.

French student Matthieu Osmond, visiting London on holiday, says: “Personally I don’t like smoking or the smell but outside I don’t have a problem with it.”

But retired teacher Kathleen Barnsley, from Wakefield, says: “It would be an absolutely brilliant idea.

“The problem that occurred when they banned smoking inside is that it brought everyone outside so children now see lots of people smoking and it sets an awful example.”

Boris Johnson, the Mayor of London, said: ” If we were to consider a ban on smoking in parks, we would need pretty clear evidence that this would have direct health benefits – in other words, that it would actually save lives.”

The Chief Medical Officer for England, Professor Sally Davies said: “I welcome any measures to reduce both active smoking and its role modelling in front of children.”

‘Walk away’

Simon Clark, director of Forest, said: “A ban on smoking in parks and squares would be outrageous.

“There’s no health risk to anyone other than the smoker. If you don’t like the smell, walk away.

“Tobacco is a legal product. If the Chief Medical Officer doesn’t like people smoking in front of children she should lobby the government to introduce designated smoking rooms in pubs and clubs so adults can smoke inside in comfort.

“The next thing you know we’ll be banned from smoking in our own gardens in case a whiff of smoke travels over the fence.”

In 2011, New York introduced a ban on smoking in Central Park and all of the city’s parks and beaches.

Source BBC News/Health http://www.bbc.co.uk/news/uk-england-london-29623851

Trafalgar and Parliament squares smoking ban call

IBM: Watson can make the world a better place

ThinkDigital event hears how the supercomputer could improve people’ lives

One of IBM’s Watson-based cognitive computing products (PRNewsFoto/IBM)

In an era when ‘data is the new oil’ IBM says its supercomputer Watson is poised to make a huge difference to the way healthcare is delivered.

IBM Watson, which famously beat human contestants on the US game show Jeopardy two years ago, can process huge amounts of information in a similar way to how people think.

Amer Fasihi, associate partner at IBM, told ThinkDigital 14 recently: “It’s the beginning of a huge change in the way healthcare is accessed, developed and paid for, simply because of the speed at which all of the information and insights will be available at everyone’s fingertips.

Watson can locate an answer to a question – rather than just a fact that needs to be found – and then assign a confidence level to its findings. So for fever, Fasihi noted, it can know the difference between the “Saturday Night” or the “West Nile” and “Dengue” varieties.

“Watson’s learnings are very powerful in healthcare – it changes everything and the companies that don’t change are not going to survive,” Fasihi told the audience at DigitasHealth Lifebrands‘ annual London event.

The company is exploring a number of different healthcare applications for Watson, including partnering with health insurer WellPoint and the Memorial Sloan-Kettering Cancer Center to combine medical data with clinical practice information.

“IBM’s underlying drive over its 100 year history has been ‘to make the world a better place’. It’s a grand claim, but that’s what it aims to do. We believe that Watson is a technology that can make the world a better place and it’s application in healthcare is certainly something that will improve the lives of many people.”

He added: “I’ve got no doubt that in a couple of years Watson will be available on a mobile or miniature device.”

Outlining what this kind of advance will bring to the sector, Digitas Health Lifebrands’s managing director June Dawson told PMLiVE technology is drive “an unprecedented era of human progress”.

“Its impact on pharma is a game changer,” Dawson added. “The reality of this evolution has seen digital healthcare communication change, beyond recognition the amount of medical information available is doubling every five years and much of this data is unstructured.

“Physicians simply don’t have time to read every journal that can help them keep up to date with the latest advances in medicine and the growing complexity of medical decision making which means the future lies with technology like Watson.”

IBM’s Amer Fashi discusses Watson (view video on YouTube)

Pharma change

But negotiating these changes could prove challenging for the industry. Pharma’s typical model is pretty linear, Fasihi said, “but things are changing and it’s becoming very, very complicated and it’s very confusing for organisations that are now faced with a rapid evolution, where the patient is now in the middle”.

He points to the recalibration that has taken place in healthcare, moving the patient from the end of the care process to being at its centre, creating a much more complex and interconnected process.

For pharma this presents a number of difficulties. “Managing complexity is really difficult when all you’ve been doing until now is operating to a linear model – you need much more insight and capability,” Fasihi said.

“There’s a big drive in pharma to try and address the complexity of this system and trying to engage better [but] it feels like pharma has been left behind and companies are missing out on a lot of insight.”

He highlighted three factors that will drive pharma’s future success:

• Quantifying outcomes


• The suitability to a patient of a medicine or service


• The level of patient engagement.

He said: “The industry has been talking for a long, long time about personalised medicine. There are a lot of therapies out there that require more diagnostics, and that’s one element of personalisation, but there’s another whole element that brings in engagement.

“What we’re seeing is that the more personalisation and engagement that takes place, the better the outcomes that are generally seen.”

Source PMLive http://www.pmlive.com/pharma_news/ibm_watson_can_make_the_world_a_better_place_605919

IBM: Watson can make the world a better place

NICE publishes its first medicines optimisation guidance

Draft guidelines encourage patient-centred care and improved NHS communications

The National Institute for Health and Care Excellence (NICE) has published new guidance on how NHS patients in England and Wales can achieve the full benefits of their medicines.NICE, which provides healthcare guidance for the NHS, said the draft guidelines on medicines optimisation are intended to make sure patients “get the most appropriate medicines when they are needed” in a safe manner.

The guidance encourages shared decision-making between patients and professionals in health and social care. It is a response to the UK’s ageing population and growing number of people with long-term conditions who take medicines on a regular basis, according to NICE.

Around 15 million people in England now have a long-term condition, such as heart failure and diabetes, yet 30% to 50% of medicines prescribed for long-term conditions are thought not to be taken as intended.

This lack of optimisation includes taking an incorrect dosage of medicine or taking medicines at inconsistent times, and can be down to a variety of reasons, including problems in paying for medicines, problems in acquiring medicines in rural areas and a poor understanding of treatment.

Safety concerns are particular relevant for the growing number of patients with more than one long-term condition who take a variety of medications. According to the BMJ, around 5% to 8% of all hospital admissions are due to preventable problems with medicines such as adverse effects or their interaction with other medicines or conditions.

A key part of the NICE guidance is to improve communications across care settings. According to the Royal Pharmaceutical Society, between 30% and 70% of patients have an error or unintentional change to their medicines when moving from one care setting to another.

To combat this NICE has published a list of the key information that should be known about a patient moving from one setting to another. This includes known allergies and reactions to medicines or their ingredients, and the type of reaction experienced; what medicines the person is currently taking and why; and changes to medicines, including medicines started or stopped, or dosage changes, and reasons for the change.

The draft guidance also makes recommendations about what systems HCPs can use to identify, report and learn from medicines-related patient safety incidents that are both effective and cost-effective.

The guidance adds to existing efforts to improve medicines optimisation within England’s NHS, including the launch of a dashboard to bring together health data in a one place.

Health minister Lord Howe last month made a call for community pharmacists to drive optimisation by improving their relationship with patients, while Pfizer – working with several pharmacy associations – has produced a medicines optimisation scratch card that allows patients to guide discussions with pharmacists based on their priorities.

Source PMLive http://www.pmlive.com/pharma_news/nice_guidance_to_improve_use_of_medicines_605915

NICE publishes its first medicines optimisation guidance

UK biotech leaders partner on science lobbying

The BIA, Bionow, BioPartner and One Nucleus will work together on influencing government policy

Four of the UK’s leading life science groups have formed a partnership to promote bioscience and make policy recommendations to the government.

Under the banner of United Life Sciences the BioIndustry Association (BIA), Bionow, BioPartner and One Nucleus (ON) will work together on issues that it says “directly benefit members and the wider UK sector”. Together these organisations comprise more than 1000 life science and healthcare members.

Steve Bates, CEO of the BIA, said: “Through this collaboration, all four organisations are fully committed to providing a united front and critically, one voice, to the government via the lobbying and advocacy work that the BIA undertakes for the sector.”

The members of United Life Sciences – all of whom have been informally working together for two years – have also contributed to the Life Sciences Manifesto 2015-20.

This manifesto, which was launched at the BIA’s UK Bioscience Forum in London this week, highlights key issues for the sector and makes policy recommendations to the government.

Core issues covered in the manifesto include retaining focus of strategically important technologies, such as regenerative medicine and synthetic biology and ensuring a supportive tax and finance environment through continuing policies such as the Biomedical Catalyst and R&D tax credits.

The manifesto also demands support for flexible routes to licensing, evaluation uptake and reimbursement of medicines and treatments to facilitate fast patient access.

United Life Sciences plans to hold a series of UK roadshows to enable early stage companies to access capital, understand the evolving policy landscape and grow their business. It also plans to promote and provide discounts for members on each other’s events and work together to provide a combined approach at large international events.

Source PMLive http://www.pmlive.com/pharma_news/uk_biotech_leaders_partner_on_science_lobbying_604691

UK biotech leaders partner on science lobbying

Half of England’s adults say NHS spends too little on drugs

Medicines account for 10p of every £1 spent by NHS, says ABPI

A new survey sponsored by the Association of the British Pharmaceutical Industry (ABPI) has revealed that 52% of English adults believe that not enough of the NHS budget is being spent on medicine.

The ComRes poll of more than 1,700 adults found that 60% of people aged 55 and above believe that the current spend on medicines of 10p in every £1 spent by the NHS was not enough, compared with 40% of adults aged 18 to 24.

Opinion appeared to be divided across the sexes, with 57% of women and 47% of men believing not enough is spent on medicines compared to NHS spending on hospitals, staff and equipment.

The results were published as the political party conference season continues, with major parties citing the NHS as a priority for the next Parliament.

The ABPI survey found that 90% of participants believe that the Government should do more to ensure that people across the UK can access the latest medicines when they have a serious or life threatening diseases.

A third (32%) of those polled say that a political promise to spend more on new medicines would more than likely sway their vote.

Commenting on the publication of the survey, ABPI chief executive Stephen Whitehead said: “With the public united in the belief that access to the latest medicines would be a top priority if they had a serious illness and the overwhelming importance of equality of access to medicines, especially for the sickest of patients, it goes to show how passionately the public cares about medicines and access to them.

“It is a testament to the strength of feeling that a third of adults in England would be more likely to vote for a party that promised to invest more in this vital area and supports the industry’s calls for government to increase access to medicines.”

At their party conferences, the Labour Party and the Liberal Democrats have offered NHS funding increases of more than £1bn, while the Conservatives have said that they will protect the NHS budget in real terms until 2020.

Source PMLive http://www.pmlive.com/pharma_news/half_of_englands_adults_believe_nhs_spends_too_little_on_medicines_604650

Half of England’s adults say NHS spends too little on drugs

AZ launches breast cancer photo-sharing campaign

Social media campaign will see a selection of the pictures displayed in New York

AstraZeneca has launched a photo-sharing campaign on Twitter, Instagram and other social media sites to raise awareness of metastatic breast cancer (MBC).

The campaign encourages women with MBC to take photos of themselves that highlight their journey with the disease and post them on the sites along with #MBCStrength.

The campaign was launched last month and pictures had been uploaded to Twitter by October 1 may be used for a display in New York’s Times Square on October 13 – Metastatic Breast Cancer Awareness Day, though only with the user’s permission.

Gregory Keenan, vice president of medical affairs and US head medical officer at AstraZeneca, said: “Patients are at the heart of everything we do at AstraZeneca, and this campaign reinforces our commitment to the strong, inspiring women who live with metastatic breast cancer every day.

“Our goal is to further connect these women during their journeys and provide access to tailored educational tools.”

The campaign fits with AZ’s MyMBCStory.com site, which houses tools and information for women with MBC.

Source PMLive http://www.pmlive.com/blogs/digital_intelligence/archive/2014/october/az_launches_breast_cancer_photo-sharingcampaign

AZ launches breast cancer photo-sharing campaign

Facebook 'considering' new online health communities and apps

Social network is reportedly exploring healthcare options

Long a destination for health discussions, Facebook is now reportedly considering setting up its own therapy area-based patient support communities.

The social network is also investigating the possibility of creating its own range of ‘preventative care’ applications, according to a report by Reuters.

Sources told the news agency that Facebook has held a number of meetings with medical industry experts and entrepreneurs over the last couple of months and is setting up a research and development unit to test new health apps.

But the plans, which could see it challenge established online patient communities like PatientsLikeMe and HealthUnlocked and mark a major new entrant to the crowded health app space, are “still in the idea-gathering stage”, Reuters said.

Meanwhile, Facebook has picked a wide range of consumer executives – some with healthcare interests – to sit on its new EMEA (Europe, Middle East, Africa) Client Council.

Alongside Reckitt Benckiser’s executive VP for Europe and North America Rob Degroot and Sophie Blum – CEO at Procter & Gamble Israel, will be representatives of companies such as Nestlé, Unilever, Red Bull, BMW, Samsung  and Disney.

Facebook said the Council would help it better serve its advertisers in the region and act as a forum for the sharing of ideas about the future of marketing.

Source PMLive http://www.pmlive.com/blogs/digital_intelligence/archive/2014/october/facebook_considering_new_online_health_communities_and_apps

Facebook 'considering' new online health communities and apps

EMA draws fire on new clinical reports policy

Has recently come under pressure from transparency groups

The European Medicines Agency (EMA) published its new policy on publishing clinical trial results this week amid a flurry of pressure from transparency advocates.

The agency said its new policy would apply to all centralised marketing authorisation applications submitted as of January 1, adding that clinical study reports (CSRs) will be released as soon as a decision on the filing is made.

The first phase of the initiative will only make CSRs available, with access to anonymised, patient-level data coming after a consultation period to “address the various legal and technical issues linked with the access to patient data.”

The EMA also suggested the policy will serve as a “complementary tool” ahead of the implementation of EU transparency rules for clinical trials that are not scheduled to come into effect before May 2016.

It will apply to new medicines from the start of next year and be expanded to line extensions for existing product from July 1 2015, said the agency.

EMA executive director Guido Rasi said the new policy “sets a new standard for transparency in public health and pharmaceutical research and development” but transparency groups – which mounted a Twitter campaign to try to influence yesterday’s vote – said two out of three major concerns remain unaddressed.

The AllTrials campaign welcomed the decision to scrap restrictions on accessing CSRs by researchers – an earlier policy draft had suggested these would only be available on screen and not able to be saved or printed – but said other parts of the policy remain a concern for researchers.

A particular sticking point is that the responsibility for redacting information in reports is in the hands of trial sponsors, which means they “get to suggest which information submitted to the EMA should be kept hidden,” it said. Deciding what is commercially confidential information – and so can be redacted – remains a grey area.

Meanwhile, trial sponsors can take direct legal action against researchers if they believe the Terms of Use clauses in contracts are breached, making individual scientists “vulnerable to protracted legal battles with large companies which will introduce a new and unpredictable risk of high legal costs into routine academic work,” said AllTrials.

“It is still the case that trial sponsors might be able to cut out any information they don’t want others to see,” commented Tracey Brown, managing director of Sense About Science, a charity that tries to encourage an evidence-based approach to scientific and technological developments.

“Companies and other bodies that have embraced an open approach to their trials have made it clear that the need for redaction is very limited,” she added.

Meanwhile, Ben Goldacre, author of Bad Pharma, also raised concerns about the redactions process, noting that EMA reached an agreement this year with AbbVie to “censor information on protocol changes from the public release of a CSR”.

“Protocol changes in a trial are precisely the kind of information that researchers need to make an informed decision about whether that trial was a ‘fair test’ of the treatment,” he said.

“It is hard to see how it is justifiable to hide protocol changes, in a trial from eight years ago, on over-riding grounds of commercial confidentiality.”

The EMA insists that there will only be “limited instances” in which redactions will be proposed on commercial grounds and the decision on redactions will lie with the agency.

The new policy will also increase trust in its regulatory work by permitting the public “to better understand the agency’s decision-making processes, whilst allowing researchers to re-assess data sets will help “avoid duplication of clinical trials, foster innovation and encourage development of new medicines.”

EU consumer organisation the BEUC said the policy should further boost trials transparency if it is implemented by regulatory authorities in EU member states, but it warned that the guidelines “are not set in stone and might face further undermining.”

In particular, it suggested that legal challenges such as those mounted by AbbVie and InterMune could happen again, while ongoing discussions on commercial confidentiality in the context of the Transatlantic Trade Investment Partnership (TTIP) could also lead to a reversal.

The planned transfer of pharma policy from the European Commission’s health affairs directorate to industry also “augurs badly”, it said.

Source PMLive http://www.pmlive.com/pharma_news/ema_draws_fire_on_new_clinical_reports_policy_603534

EMA draws fire on new clinical reports policy

Biosimilars could make EU big cost savings after slow start

Report says biological copies could cut health spending in region by $11bn

The emergence of biosimilars could cut EU health spending by $11bn to $33bn by 2020, claims a new Thomson Reuters report.

While the analysis reveals that the availability of biosimilars has not had a massive impact on some of the reference biologic brands so far – with most maintaining market share while biosimilars have taken business from alternative therapies – but has placed downward pressure on pricing.

In the case of Amgen’s once-daily white blood cell stimulator Neupogen (filgrastim), however, the drug has now been overtaken by its biosimilar rivals – led by Sandoz’ Zarzio – and the EU market for these products is expected to decline from more than $6bn to around $4.6bn by 2019.

The report also notes that a number of factors are holding back the development of the global market for biosimilars, not least the lack of products reaching the market in the US, which it attributes to later patent expiries for first-wave biologics in Europe.

“Sandoz filed the first Biologic License Application (BLA) for a biosimilar with the FDA in July 2014,” it notes. That application was for Zarxio, a biosimilar of Neupogen that lost US patent protection in 2013, five years after Europe.

Similarly, Celltrion has already secured approval of a biosimilar referencing Janssen Biotech’s Remicade (infliximab) in the EU but is having to challenge patents on the drug which does not expire until 2018 in the US.

The report says “by 2018, $31bn-worth of biologic sales are expected to come from off-patent drugs in the US and $43bn from off-patent biologics in the rest of the world”. By the end of the decade, patents will have expired for originator biologics accounting for about $100bn in global sales, it adds, citing figures from biosimilar developer Sandoz.

The reality is that biosimilar sales will lag behind the market size, however, in part because the discounts for biosimilars compared to their branded counterparts are less than for small-molecule generics – typically 20-30% – which reduces the incentive for wholesale adoption in the market.

Thomson Reuters predicts however that the slow market uptake of biosimilars in the EU may not also hold true for the US.

“Unlike most of the EU, the US will allow interchangeability, which is expected to speed adoption and lead to lower prices,” it notes. The World Health Organization’s recently proposed voluntary, global naming scheme could also level the playing field for biosimilars and their reference biologics, says the report.

Biosimilars are expected to account for approximately one quarter of the $100bn market by the end of the decade.

There are currently 700 follow-on biologics therapies moving through pipelines and 245 biopharma companies and institutes developing or already marketing these products in markets throughout the world.

Jon Brett-Harris, managing director of Thomson Reuters Life Sciences, said: “Rather than forgo the benefits of biologics, governments and payers are counting on biosimilars to dramatically change drug development and patient costs by reducing the price tag of important biologics and increasing access to life-saving drugs.”

“For this to happen, biosimilars must deliver the power of the reference drugs at a price developing countries can afford and gain the confidence of the marketplace,” he added.

Source PMLive http://www.pmlive.com/pharma_news/biosimilars_could_make_eu_big_cost_savings_after_slow_start_603230

Biosimilars could make EU big cost savings after slow start

The benefits of Big Data

Using real-world patient outcomes data

Big Data is big business. As technology advances and more information about healthcare is recorded and stored, the opportunities for turning information into insight to improve outcomes have never been greater.It is no surprise that it is those most able to collect and, crucially, interpret this data who are pushing the boundaries of what is possible in market access. In the new health economies, biopharma needs to work much harder to meet the demands of stakeholders for robust evidence of exactly how a product will lead to better patient outcomes in the real world. Compelling data lies at the very heart of this challenge.

Turning a buzzword into real value

There is one major barrier that currently stops biopharma realizing the full potential of Big Data: at the moment, there is no consensus on exactly what it is, nor how to effectively use it. It is a buzzword that is high up on every company’s agenda, but as an industry, we are perhaps two years away from understanding exactly how it can deliver improved commercial and clinical outcomes.

There is an unprecedented wealth of information out there, be it national, such as hospital episode statistics (HES) and prescribing figures, or local, including patient-reported outcomes (PROMS), patient reported experience measures (PREMS), quality of life, patient level clinical notes and local hospital systems. When Big Data is discussed in the context of the NHS, the assumption often is that ‘big’ means ‘national’, implying that insight comes solely from HES and other large and structured historical data sets.

I believe the real value comes when you are able to unpick this huge volume of data and hone in on what is most relevant to local clinicians, in a unique local health economy, for a specific patient population. This would not be too much of a challenge if Big Data described perfectly comprehensive, accessible and clean data with no gaps and contradictions. If that was the case, drilling down to pull out the local context would be a relatively simple task.

However, Big Data is just the beginning of a complex process of segmenting, analyzing and interpreting. HES data can provide an overview, presenting the ‘what and when’ in healthcare, but what we really want to know is ‘why’. The latter is far harder to pinpoint, but certainly worth searching for.

Where are we now?

There is no doubt that market access already achieves a lot from data. Outcomes audits utilise in-the-field nurses and analysts to gather national and local information, giving biopharma a highly detailed understanding of the entire care pathway. It can reveal gaps in that pathway, where adherence is unsustained, where extra patient support is needed, and where clinicians need clearer communication about a product’s benefits.

Similarly, simulation modeling uses multiple sources of data to create a virtual, near-live local pathway. Stakeholders can then see how this pathway’s performance and outputs compare against national and international pathways, and test scenarios to see what impact modifications would have on budgets, adherence and outcomes.

This modeling can be hugely important for biopharma, as it allows them to demonstrate to payers and providers the potential value of their product within a wider therapy pathway and within this specific local health economy. These stakeholders want to see the impact on outcomes in their very specific geography, and modeling fuelled by this data can help them make effective decisions to change  local care pathways (perhaps supported by the biopharma company through a joint working programme), or to develop the intelligence and insight to make cases-for-change with local commissioners.

The logical follow-on from pathway analysis and simulation modeling is service redesign. If running these simulations has revealed where new approaches would improve outcomes, then biopharma can present a powerful case for change to the local providers in this specific geography. Because the proposed service redesign is informed by localised, real-world data, and considers a product’s impact on the therapy pathway as a whole, stakeholders can be confident that there is strong evidence to back-up these proposed modifications. Biopharma can then combine an enhanced understanding of current and possible future care pathways with consultancy and change implementation expertise services to help implement any recommendations, and support the delivery of new services in a local health economy.

Finally, patient outcome studies and patient services is another market access area that relies on big data, because pragmatic analysis of real-time patient outcomes data can deliver an extremely valuable snapshot of the use of treatment in a specific local health economy. Combining patient-reported and clinical outcomes with patterns of resource allocation can assist in developing a clearer understanding of current medicine use, associated clinical practices and potential impact of a therapy across the local health economy. This insight can inform the development of patient-focused services ranging from local review clinics and remote patient support, to adherence support services and the deployment of managed clinical workflow tools.

What does the future look like?

What do payers and providers want to see from Big Data? Where are the gaps, and how can the information be better manipulated and localized? Should we be expanding our frame of reference, moving from PROMS and PREMS, and delving more into quality of life? There is clearly huge potential in social media too. Do we need a shift in focus towards non-health specific lifestyle data sets so we can understand not just the clinical impact of a drug on a patient, but how that patient’s exercise levels and diet, for example, are affecting outcomes?

Patients are just as likely to blog or tweet about their health as tell their GP directly, so social media could be seen as a major source of real-world experiential information.

It is exactly these sorts of questions that I want to tackle in an upcoming webinar with Dr Junaid Bajwa, GP and board member for Greenwich CCG. Big Data is a big opportunity for every market access stakeholder, so now is the time to open up a discussion and take an active role in shaping the future.

Source PMLive http://www.pmlive.com/blogs/smart_thinking/archive/2014/september/the_benefits_of_big_data

The benefits of Big Data