Maxine Vaccine examines the lessons of a preventable death for doctors and the healthcare industry, and asks whether the true barriers to integrated care are cultural rather than economic.

This week, many UK newspapers carried the story of Alina Sarag: a 15-year-old Birmingham girl who died of tuberculosis after being told by two doctors that her problems were purely ‘emotional’. The correct diagnosis was only made post mortem.

The patient suffered from breathing difficulties, severe weight loss and frequent vomiting. Her GP allegedly refused to refer her for a blood test, suggested she needed to see a psychiatrist, and asked her if she was missing a boyfriend.

Later, a doctor at Birmingham Children’s Hospital diagnosed her problem as “a psychological issue”. She died after a respiratory arrest, and a pathologist said she had “one of the most severe cases” of TB in his experience.

This terrible chain of events was a failure of the medical profession to approach a critical problem empirically, rather than applying the ‘patient psychology’ of a TV doctor.

Alina Sarag’s GP allegedly said: “We don’t need these tests, we are not going to get them done either.” Because he had already put the patient into a box: she was the type of patient he knew all about.

As the squeeze on NHS funding intensifies, it’s that kind of doctor – cynical, hasty, preferring cleverness to evidence – who will flourish. The new CCGs will be assessed in terms of their business performance. That means competing with other health organisations, not working with them.

Expert clinical opinion has pointed to a need for integrated care – for primary and secondary care providers to work more closely together, ensuring that each patient is supported by a combination of diagnostic and therapeutic services, so their treatment is evidence-based and meets their real needs.

Within that context, the pharmaceutical industry has the opportunity to work across the spectrum of care providers to bring the right medicines to the right patients, at the right time, at the right dosage. The outcome is both definable and achievable: optimal medication. That’s what patients deserve.

Whether CCGs and Foundation Trusts, as businesses, will be incentivised to achieve that, or whether putting patients into convenient boxes and making categorical diagnoses will prove a better fit with the new business culture of the NHS remains to be seen.

But when you put a person into a box, you may be nailing down the lid.

Maxine’s views are not necessarily those of Pharmaceutical Field.

The NHS Commissioning Board will work closely with NICE to improve levels of healthcare, commissioning chair Professor Malcolm Grant has said.

Speaking at NICE’s Annual Conference, Professor Grant said the Board plans to “embrace NICE with great warmth” and work closely with other arms-length bodies to meet Government targets.

“We need to work with NICE to help improve innovation in the NHS,” he told delegates.

NICE’s quality standards play a fundamental part in supporting the Government’s vision for clinical commissioning and delivering the best possible outcomes.

There has so far been 17 quality standard published by the Institute. The standards will inform payment mechanisms and incentive schemes as part of the Commissioning Outcomes Framework.

Professor Grant also outlined the “huge structural change” involved in creating the NHS Commissioning board and discussed the “profound cultural change for all those involved”.

“This is the first time that political power is being taken away,” he said.

“The future is in our hands not the hands of politicians. The Secretary of State will annually produce a mandate for the Board to commission care.

“The Commissioning Board will authorise clinical commission groups from the 1 April next year. Any conditions of authorisation will be minimal and transitional.”

Diabetes care in England is in a “state of crisis” with fewer than half of patients receiving adequate care, a new report has said.

According to Diabetes UK’s State of the Nation 2012 report, failure to provide diagnostic services is leading to an epidemic of preventable complications.

Despite the range and quality of diabetes medications available, their impact is blunted by inadequate prescription and dosage control.

The existing National Service Framework for diabetes is far from being realised, according to the report, and 40% of patients (including 85% of children and young adults) are not well-controlled.

Under 50% of people with diabetes are receiving the tests recommended by NICE – and as a result, receiving the correct types and levels of medication.

Diabetes care costs 10% of the NHS budget, and 80% of that is spent on treating complications that correct medication could prevent.

The report calls for an urgent strategy of early diagnosis and risk assessment to match treatment to patient needs, combined with better patient education.

Barbara Young, Chief Executive of Diabetes UK, said: “The wide variation in standards of care shows the need for a national plan to be put in place. By taking the longer-term approach of investing in making sure people get the basic checks and services, we could save money by reducing the number of complications.”

Workers at Merck Serono’s doomed headquarters in Geneva are planning strike action if Merck does not extend the timeframe for consultation with union leaders over job cuts.

Employees have already staged ‘coffee and croissant’ protests and have now threatened industrial action at the planned closure of the plant.

Merck estimates that up to 500 jobs will be lost and 750 transferred. However, trade union Unia claims that up to 1,500 positions will be affected in total.

A spokesperson for the Swiss employee group said the terms and condition provided by Merck under its transfer plans are “really unattractive and mean lower quality of life if accepted”.

Merck revealed its efficiency plans back in April as part of measures aimed to make net savings in the Serono division of €300m by 2014. It estimates the restructuring costs will be approximately €600m.

Karl-Ludwig Kley, Chairman of Merck’s Executive Board, said the company faces “unprecedented market shifts and increasing competition in key areas” and is “fortunate” it can address these issues from a “position of relative strength”.

He warned that if Merck does not take action it faces “tackling these issues from a much weaker position”.

Mr Kley added that the efficiency programme is not solely reserved for Merck Serono and will “affect all businesses in all regions” but remains convinced the plans “will lay the foundation” for Merck to build on new opportunities.

Menarini has signed a $75 million licensing agreement with Furiex Pharmaceuticals to the commercial rights of the premature ejaculation (PE) drug Priligy.

Under the terms of the agreement, Menarini will gain the rights to the drug in Europe, the majority of Asia, Africa, Latin America and the Middle East.

Dr June Almenoff, President and Chief Medical Officer of Furiex, is confident the company’s “experience and skills” and Menarini’s global presence will expand the commercialisation and development of Priligy.

Furiex will receive an initial $15m after the transaction is completed plus $20m in regulatory and launch milestones. It will also receive up to $40m in sales-based milestones plus other tiered royalties.

It will also retain full development and commercialisation rights in the US, Japan and Canada.

Priligy is the first oral treatment approved for ‘on-demand’ treatment of PE. It has gained approval in 43 countries and was recently backed by the European Commission for use in 20 EU states.

“Priligy is an innovative drug and the only product that has received regulatory approval specifically for the treatment of premature ejaculation,” said Menarini board member Alberto Giovanni Aleotti. “Premature Ejaculation is an underdiagnosed medical condition with only 9% of sufferers seeking medical advice due to the social stigma associated with the condition.”

PE is the most common male sexual dysfunction with around 30% of adult men across the globe experiencing it at some point during their lives.

CCG funding will be based more strongly on population age, with a reduced focus on economic deprivation, Health Secretary Andrew Lansley has said.

This will shift more funding to localities such as Eastbourne that have a high population of relatively wealthy elderly people.

The decision reflects the fact that economic deprivation is more a concern of “public health”, now the responsibility of local government, Lansley said.

Speaking at a conference for CCG leaders, Lansley explained that the NHS Commissioning Board and the Advisory Committee on Resource Allocation would shift funding towards “elderly populations who are not in substantial deprivation”.

The current weighted capitation formula that determines allocation of funding to PCTS is based primarily on population age, but also takes into account population health status and socioeconomic characteristics.

Lansley commented: “The way in which the formula for distribution of resources to PCTs has worked in the past, there was a significant element that was based around deprivation” – which was “more relevant to very particular aspects of certain kinds of health need and in particular public health requirements”.

The division of primary care funding from April 2013 between local authorities (responsible for public health) and CCGs (responsible for commissioning services) meant the former was no longer the concern of CCGs, he said.

The FDA has said that MS drug Gilenya (fingolimod) should not be used in patients with a recent history of stroke or heart disease.

The requested label change adds to changes requested by the EMA and the FDA in April to reduce the risk of cardiovascular and neurovascular events.

The FDA also concluded that a number of sudden deaths in patients with severe MS taking Gilenya could not be conclusively linked to the drug.

Gilenya was recommended by NICE in late April as a “valuable new therapy” for severe relapsing-remitting MS.

The new FDA safety review reinforced the earlier recommendation that doctors monitor the heart rate of patients taking Gilenya for the first time.

However, it said that the death of a 59-year-old patient in November after a first dose of Gilenya could have been caused by the patient’s advanced brainstem MS lesions and not by the drug.

In other cases of sudden death in patients taking Gilenya, it said, the drug’s “contribution to the death was unclear”.

However, the FDA definitely recommended not using Gilenya in patients who have suffered a stroke or heart disease within the previous six months, or who are taking certain medications for cardiac arrhythmia.

Gilenya was approved in the US in 2010 and in the EU in 2011, and remains the only oral MS drug on the market.

Profits after tax nearly halved (-48.7%) at Merck despite sales at Merck Serono and Merck Millipore divisions witnessing growth.

Total group revenues increased by 3.2% to €2.6 billion as overall sales improved by 3.5% to €2.5 billion.

However, profits fell to €177m in the first three months of the year compared with €344m in the same period a year ago.

Karl-Ludwig Kley, Chairman of the Executive Board at Merck, admitted the company had delivered only “a reasonable operating performance” in the first quarter of 2012.

Merck revealed at the end of last month it planned drastic cutbacks in its Serono division cutting 500 jobs and transferring another 750 as part of plans to close its Geneva headquarters.

But despite the planned cuts, the division’s Q1 sales grew by 5.4% as global demand for Rebif generated income of €430m and demand for Erbitux earned €214m.

Its Merck Millipore division also saw sales increase by 7.3% to €653, driven by solid results from its Lab Solutions and Process Solutions business units.

Merck now predicts modest increase in profits for the full year for its Serono division before the planned efficiency savings and an increase in profits in line with sales at Merck Millipore.