The ‘open data’ campaign led by the Cochrane Collaboration and the BMJ has called for a boycott of clinical trials whose publication is not guaranteed.

The campaigners have launched a public petition to discourage researchers, academic institutions, funding bodies and patients from supporting drug trials whose results may be ‘confidential’.

Other supporters of the petition include the charity Sense About Science; the James Lind Alliance, an alliance of patients and clinicians focused on medical research; the Centre for Evidence-Based Medicine in Australia; and journalist Ben Goldacre (pictured), author of Bad Pharma.

The ‘Tamiflugate’ controversy over the ongoing non-publication of clinical trial results relating to Roche’s influenza drug has fuelled the campaign. The BMJ has campaigned for the medical profession to put pressure on Roche to reveal the missing data since November 2012.

Ben Goldacre’s book claimed that pharmaceutical companies systematically distort the landscape of clinical evidence by withholding the results of less favourable drug trials.

MPs including Conservative MP Sarah Wollaston have called for a public enquiry into the £500m spent by the Government in stockpiling Tamiflu during the ‘swine flu’ crisis.

Tracey Brown, Director of Sense About Science, commented: “There have been years of foot dragging and non-compliance with requirements. We expect regulatory bodies to evaluate the best available evidence, not half of it.”

Launching the petition, the BMJ argued that patients should not participate in ‘confidential’ trials: “Participants in clinical trials assume that they are contributing to the advancement of medical knowledge; non-publication of study results negates this reasonable assumption and betrays those who have volunteered.”

The Care Quality Commission (CQC) was formed in 2009 to replace three separate inspection bodies: the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission. Since October 2010 all providers of healthcare and social care, whether in the public or private sector, have had to register with the CQC – which now regulates more than 21,000 providers.

This massive registration task was divided into phases: the Commission registered NHS secondary care providers, then re-registered adult social care and independent healthcare providers, then registered primary dental care and independent ambulance providers. Its next challenge is to register all GP practices. Most importantly, it will need to continue monitoring the quality and safety of all these providers’ services.

The CQC’s declared purpose is to eliminate poor quality care, defend patients’ rights and ensure that care is centred on people’s needs. Initially it adopted a ‘risk-based’ strategy of using evidence of potential danger to determine the frequency of inspections. In 2011/12 it shifted to annual inspection of all care providers. Next year, however, it will revert to a ‘riskbased’ approach – as well as participating in local Quality Surveillance Groups, alongside CCGs and local Healthwatch.

These changes follow a year in which the CQC has faced criticism of its leadership and its overall performance. The Mid Staffordshire Foundation Trust enquiry led to criticism (for different reasons) of its Chief Executive, Cynthia Bower, and its Chair, Dame Jo Williams. The recent scandal of sustained patient abuse at Winterbourne View Care Home led the CQC to be accused of failing to conduct regular inspections and respond to ‘whistleblowers’.

In March a Commons Public Accounts Committee concluded that the CQC had “a long way to go” before it could be considered an effective regulator. The recent resignations of Bower and Williams have reduced the shadow over the leadership. The new CQC Chief Executive, David Behan, has a background in social care rather than healthcare. But can the problems of regulating provider quality in the new health and social care system be solved by such changes, or are they systemic issues beyond the scope of the CQC?

In safe hands
The CQC’s annual report for 2010/11 noted that by April 2010 it had licensed all 378 NHS provider trusts, and had required 22 trusts to take specific actions to improve their services. By October 2010 it had re-registered 12,000 adult social care and independent health providers, and had required almost 1,000 care homes to put in place qualified managers. By July 2011 it had registered 18,000 dental care and independent ambulance providers. The inclusion of primary medical services will add 8,000 providers to the list.

Each provider is accountable for each separate ‘regulated activity’ it provides, and must show that the service meets acceptable standards of quality and safety. CQC standards cover these areas:

• Informing patients and involving them in decisions about their care.
• Personalised care, treatment and support.
• Safeguarding and safety of the care environment.
• Suitably qualified and capable management and staff .
• Risk management and incident reporting.

A further responsibility of the CQC is to respond to complaints about services – and in particular, to provide a safe and responsive port of call for ‘whistleblowers’: care provider staff who report failings in quality or safety.

Winter in social care
Financial pressure was a feature of the CQC’s role from the outset. Its initial budget was 30% less than the combined budget of the three organisations it had replaced. The Labour Government set a ‘light-touch’ agenda for inspection: unless there was evidence of risk, providers would be left uninspected for
up to two years.

The coalition Government’s review of arm’s length bodies in July 2010 reinforced the CQC’s role as regulator for health and social care. However, it was not exempt from the general requirement that the NHS ‘do more with less’. Its annual budget for 2010/11 was set at £16.4m – £10m less than it had told the DH it needed to cope with the combined task of registering and inspection.

As a result, the number of inspections carried out by the CQC fell by 70%. Concern over its performance came to a head in the Winterbourne View scandal, where action to stop the mistreatment of learning-disabled patients in a care home run by private firm Castlebeck had been unacceptably slow. The regulator had failed to act on information from a ‘whistleblower’, and only a BBC Panorama report had brought the abuses to public attention.

In the aftermath of the scandal, a Health Select Committee report accused the CQC of devoting too much of its resources to registration, a sign of “distorted priorities”. However, Kings Fund Director of Policy Anna Dixon observed: “It is no good preaching the virtues of light touch regulation, and then blaming the regulator for not taking a more interventionist approach when problems emerge.”

The later Commons Public Accounts Committee report highlighted several CQC failings: lack of inspections,
failure to fill key vacancies in its inspection team, and the decision to scrap a helpline for whistleblowers. The committee said the CQC risked becoming a mere “postbox” for complaints.

Jo Williams described the Winterbourne View case as a “watershed moment” for the CQC, triggering its abandonment of the ‘light touch’ approach. The regulator asked for – and got – a £10m increase in its budget for 2012/13 to increase its number of inspectors by 15%, enabling it to adopt a policy of inspecting each provider at least once a year.

Crisis of leadership
The issues affecting the CQC leadership reflect some of the conflicts of interest that can arise for care regulators. The Mid Staffordshire inquiry – the greatest hospital safety scandal in the NHS’s history – concerned events that took place before the formation of the CQC. However, Cynthia Bower was head of the West Midlands SHA at that time, and the inquiry was critical of her role.

The Healthcare Commission (HCC) had warned the SHA about the unusually high mortality rate at Stafford General Hospital. According to the Guardian, Bower responded by commissioning a known critic of the HCC at Birmingham University to write a report on the HCC’s methodology. When the CQC was formed, Bower disbanded the HCC’s inspection team.

The Mid Staffs inquiry led to severe damage within the CQC. Senior operations analyst Rona Bryce claimed the testimony of CQC Board members was “aspirational”. Board member Kay Sheldon contacted the enquiry to voice concerns she said she had raised internally without result. Dame Jo Williams then asked the Health Secretary to dismiss Sheldon, but he declined. Williams also commissioned a third-party investigation of Sheldon’s mental health.

The way forward
David Behan, who took over as CQC Chief Executive in July 2012, had been Director General of Social Care at the DH since 2006. His appointment suggests a shift towards greater focus on social care regulation. The DH has set three core goals for the CQC going forward: to become more strategic in its approach and define quality more clearly in terms of outcomes; to make its Board stronger and more accountable; and to make the regulatory process more systematic and proportionate to risk.

The reversion to a risk-based approach is clearly driven by the cost-cutting agenda. However, Behan promises a “more ambitious” use of performance data to highlight success as well as failure, helping to drive widespread improvements in care. He also plans a “differentiated regulation” of health, mental health and social care providers.

In addition, from April 2013 the CQC will work alongside CCGs and local Healthwatch to develop a network of local and regional Quality Surveillance Groups. According to the NHS Commissioning Board, this system will “act as a virtual team” across health and social care, and will “need to manage itself ” without governance. It will use a ‘risk summit’ model to deal with problems, but who takes primary responsibility will depend on the circumstances.

These changes show the CQC becoming more devolved, but also more able to assist the integration of health and social care. However, as providers become more diverse while funding both for inspection and for care becomes steadily tighter, the future is unlikely to be problem-free for the regulator. The CQC will need to continue walking a tightrope between a ‘light touch’ agenda and urgent reactions to healthcare disasters – its success will depend primarily on getting better at it.

A new personal health budget pilot scheme has been launched across the country by the Department of Health.

More than 60 programmes are currently underway with the aim to give patients control and choice over their care to ensure individual needs are met.

Norman Lamb, Care and Support Minister, said giving people with complex health needs the control of funds creates a “flexibility to try innovative new approaches to achieve better health outcomes.”

The scheme, which will be evaluated this autumn, has been allocated £1.5 million by the Government to support the first stage of a potential roll-out.

The pilot programmes are intended to clarify how money may benefit patients who require tailored health care, what the funds could be used for and how best the DH should implement the schemes.

Tailored plans are initially developed by patients in partnership with their clinicians and are then agreed with their local Primary Care Trust. The amount of money allocated is then decided according to the individual’s needs.

Examples of how personal budgets are being used during the pilot phase include the organisation of flexible nursing care at home and arranging for assistance at convenient times from a healthcare professional instead of waiting for a weekly visit from the district nurse.

“We want to ensure more care is tailored around people’s individual needs and preferences,” said Norman Lamb. “We want to be on the front foot as the results become known – that is why we’ve identified £1.5m to support the NHS in the first stage of the roll out as it starts to implement personal health budgets.”

The DH described the budget for personal health as “not new money” but an allocated sum that is “spent on meeting a person’s health and wellbeing needs.”

NHS rationing is affecting the relationship between doctors and their patients, a new survey has found.

The survey by Pulse Magazine revealed that three quarters of GPs believe the doctor-patient relationship has been tainted by cut backs to certain treatments.

Dr Clare Gerada, Royal College of General Practitioners, said the problems of the Health and Social Care Act have resulted in patients holding GPs responsible.

Typical treatments which have been affected by a rationing include GP referrals for bariatric, hip and knee and cataract surgery.

Out of the 237 doctors questioned, nine out of 10 reported pressure to ration treatments or services over the past twelve months. Two-thirds of respondents admitted local rationing was adversely affecting standards of patient care.

More than 40% of doctors said they had changed the therapy of patients to less effective options due to rationing guidelines in the past twelve months. A third also raised issues with getting patients to guideline-directed targets.

GPs also exposed other forms of rationing with 89% finding patients had been referred back to them after missed hospital appointments and 31% claimed hospitals were overemphasising the risks of surgery in an attempt to off put individuals.

A spokesperson for the Department of Health said they would be writing to the NHS to remind them that rationing on the grounds of cost was wrong.

Patients have been tasked with helping Leicester, Leicestershire and Rutland (LLR) PCT Cluster save £5.6 million worth of wasted medicines each year.

An eight-week campaign has been launched to target individuals in an attempt to reduce the misuse of repeat prescriptions and to return any unwanted medicines to local pharmacies.

Dr Paul Danaher said the issues can only be solved by “patients and the health community working together”.

Posters and leaflets have been put on display in GP surgeries and in pharmacies to raise awareness of the campaign.

Individuals are urged to think before ordering repeat prescriptions; talk to healthcare professionals for advice on medicines; and bring unwanted medicines to pharmacists for safe disposal.

“Unused prescriptions cost the NHS in LLR an estimated £5.6 million each year and this is money that could be used to pay for other important health services locally,” said Dr Danaher.

“We want to encourage patients only to order repeat prescriptions if they are needed and not to stockpile medicines at home. We are also encouraging patients to have a medicines review with their GP or pharmacist to make sure they get the most out of the drugs which are prescribed for them.”

The PCT Cluster estimates that across the LLR region the misuse of medicines is the equivalent of 219 more nurses, 5,600 more treatment courses for Alzheimer’s disease, more than 1,500 hip replacements or 5,833 cataract operations.

Biopharmaceutical company Genzyme, part of Sanofi, has appointed William ‘Bill’ Sibold as Head of Multiple Sclerosis and Rogério Vivaldi as Head of Rare Diseases.

These two businesses make up Genzyme’s core focus following its integration with Sanofi.

David Meeker, Genzyme’s President and CEO, commented: “These appointments are a critical step in launching the new Genzyme. Bill and Rogério are dynamic leaders with the experience, energy, vision and commitment to patients needed to move us forward.”

Bill Sibold has worked in the biopharmaceutical industry for two decades, primarily in commercial roles – including responsibility for the MS drugs Avonex and Tysabri. In eight years at Biogen Idec he rose to become Senior Vice President of US Commercial. He joins Genzyme from Avanir Pharmaceuticals, where he was the Chief Commercial Officer.

“Our goal is to build a world-leading multiple sclerosis franchise,” said Meeker. “Bill’s substantial commercial experience and his deep knowledge of the MS field will be critical to the launch of Lemtrada and Aubagio, two investigational therapies with the potential to transform the lives of people living with MS.”

Rogério Vivaldi joined Genzyme in 1997; his roles have included President of the company’s Renal and Endocrinology Business and President of Genzyme Latin America. As a doctor, he became a recognised expert on the rare Gaucher disease and its treatment.

“Rogério’s experience as a physician treating Gaucher patients in Brazil and his subsequent work in building our rare disease business in Latin America will provide both continuity and an energising new beginning for our global rare disease business,” noted Meeker.

Based in Massachusetts, US, Genzyme specialises in biopharmaceutical therapies for rare and debilitating diseases. As part of Sanofi, it benefits from the commercial reach of a leading global pharmaceutical company.

Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

In Part III of his diary, Omar Ali discusses the significance of process mapping and the wide reaching influence of health technology assessments and regulatory bodies.

1.10pm: GP CONSORTIA/CCG – RESPIRATORY ASTHMA PROCESS MAPPING & FORMULARY

I’m trying to step into the main meeting room but one of the CCG/GPs pulls me aside. It’s a mixture of a low-key signal and a discreet ‘thumbing’ to pull away from the group. He wants a quiet word and it’s clear that there are some key issues, agendas and directions that are on the table for this asthma meeting.

The process mapping event takes some four hours – evaluating everything and anything that ‘leads to an asthma admission’, followed by everything and anything that occurs after the admission and leads to discharge – which is then followed by QIPP ‘bottlenecks’, where re-admissions and inefficiencies occur.

It’s always a challenge having so many viewpoints – nurses, physicians, pharmacists, budget holders, and of course patients and carers who often change the whole paradigm when we hear about their experience, expectations and concerns around ‘choice’.

Thoughts for pharma

Respiratory is big. Whether on prescribing budgets, healthcare priorities, implementation of national guidance or QIPP streamlines. Companies haven’t yet got their act together on process mapping of care pathways, but it’s the only way to invest in prescribing up-front drugs for potential ‘return to the QIPP baseline’ over the next three to five years. Needless to say, whilst the NHS talks QIPP, pharma is getting used to it and patients are still puzzled by it.

Asthma

With so much behind National Guidance/BTS, QoF and commissioning cycles, some companies are indeed getting into the mix with Clinical Commissioning Groups and supporting process mapping. That support is vital, as not only does it bring pharma in as key stakeholders, but more importantly there is a level playing field here in the same room bringing the cause back on track.

So often in the NHS we have silo budgets chasing after silo savings. Process mapping brings us out of our silos into the bigger picture and into the ‘process map’. Seeing it happen is a wonderful thing.

COPD

Given we make such a fuss around the cost of drugs, in truth we know two things: the most expensive drug is the one that is not being taken, and the tariff for an admission for COPD at £3,400 is more expensive than the annual price of the most expensive inhaler!

So where’s the issue? It goes like this. Pharmaceutical companies come to us quoting the costs of admissions in COPD then tell us how amazing it would be to reduce these hospitalisations.

They then tell us how amazing their COPD product is and tell us that we would be crazy to not buy their inhaler, which is a fraction of the cost of COPD burden/admissions. The GPs, nurses and patients love it and want it and state they ‘need it’. Medicines Management then look like the bad guys for not funding the said branded inhaler.

4.15pm: DRIVING BACK TO NHS BASE CAMP – CHECKING VOICEMAILS

One of the big five companies has asked me to come and present to their European heads-of-country on ‘payer issues’ in the UK and the influence of HTAs.

It’s a bit short notice and I gather the VP for Europe, Middle-East and Asia will be there. Times are tough and I see this as an example of how the EU can join forces on some of the key payer issues beginning to filter through.

I have one question back to these pharma companies. What is your data on reducing these expensive hospitalisations in COPD? Because in truth, with the data, I buy the story.

In most cases pharma will then spin another story around how compliance is great, or a patient support programme is excellent. But given all the spin that has come on how much COPD costs me in hospitalisations, it’s a shame many of the companies don’t have the evidence to help me.

They have marketing but not the evidence. Show me the money. And the formulary will be yours.

Thoughts for pharma

There is no doubt that the UK is ‘different’, but I don’t imagine global HQ for any of the pharmaceutical companies readily accepting that – especially when the targets are high and sales may not be so. It sometimes takes global agencies to hear about payer issues ‘from the horse’s mouth’.

This was the quote stated to me regarding this piece of work/event. From my work abroad – at NICE I informally interact with a number of contacts in other countries who belong to their residing equivalents – I can’t stress enough the importance of NICE, the SMC and similar bodies.

The last SMC decision on pain management was quoted verbatim within two weeks by three different countries within the EU. I’m also aware from my US/value-based pricing work that when NICE rules on a drug the impact on the US healthcare system is far reaching.

Insurance companies download the information – they can’t believe NICE do all this work transparently and then leave it freely available for anyone to download – and the US agencies then use this information on deciding what percentage they will ask patients to pay.

So, if NICE say no and SMC say no, somewhere a butterfly flaps its wings and then a patient in the US, who has paid extra funds into a private insurance policy, will be told that this particular brand is not covered and that the patient will have to make an additional payment if they want the drug.

To be continued...

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk.

Inconsistent NHS leadership questioned

The NHS has suffered due to inconsistent leadership over a prolonged period, peers in the House of Lords have been told.

Baroness Cumberlege, a Conservative peer, told the House the number of different health secretaries in recent times has led to a lack of trust and confusion by the health service.

Speaking during the committee stage of the Health Bill, Baroness Cumberlege compared the Sir Alex Ferguson’s 25-year reign at Manchester United and asked “what difference it might make to the NHS” had it had a leader for a similar tenure.

Since 1997, there have been seven different health secretaries – six of which under the previous Labour government.

“One of the real problems that we have, and it exists even if it is the same party in power for a length of time, we lack a consistency of leadership, because the Secretaries of State are here one minute and gone the next,” said Baroness Cumberlege.

“I think that contributes to an NHS that gets confused, that gets fed up and is mistrustful of its masters.”

Bristol-Myers Squibb (BMS) has entered into a broad framework agreement with Dako on the development of pharmacodiagnostic tests.

The agreement, which builds on a collaboration begun in 2008, aims to develop diagnostics to identify patients more likely to benefit from treatment with BMS investigational drug candidates.

Pharmacodiagnostics (or companion diagnostics) are an important feature of the growing personalised medicine approach, which can improve outcomes and reduce healthcare costs by identifying individuals who are more likely to benefit from specific therapies.

Dako, a global leader in tissue-based diagnostics, has a history of developing clinical diagnostics in collaboration with pharmaceutical companies that are used in conjunction with drugs.

“It is a great pleasure for me to announce Dako’s new collaboration with Bristol-Myers Squibb,” said Lars Holmkvist, CEO of Dako. “This alliance heralds the intentions of both companies to work closely together to develop new diagnostic tests linked to drugs for the higher purpose of identifying the patients most likely to respond to treatment.”

“It is part of Dako’s long-term strategy to collaborate with pharma companies on the development of companion diagnostic tests.”

Based in Denmark, Dako produces reagents, instruments and software used by hospitals and clinics in more than 80 countries worldwide in the diagnosis of cancer and the planning of its treatment.