Maxine Vaccine considers the motives of politicians, clinicians and the pharmaceutical industry and concludes that no matter what direction you approach it from, health is never a simple issue.

My last blog, ‘Life in the balance’, provoked some interesting feedback. I had argued that the current government’s application of free-market principles to the NHS would encourage those doctors who saw what they do primarily as a business rather than as a service. An industry expert commented that a series of health policies over the past two decades, from GP fundholding to QOF indicators, have promoted the same mentality.

This of course is true. Not only are New Labour’s fingerprints all over the current phase of NHS reforms, but the medical profession has never been unified in its perspective on the relationship between health and financial priorities. Different doctors have different attitudes – or have various attitudes in different proportions. Where important decisions are concerned, most of us have mixed motives.

However, it’s rather in the nature of blogs, Twitter feeds, press releases and Parliamentary statements that we pretend otherwise. “Only one thing matters to me” is the opening clause (explicit or implicit) of almost any public statement. “I’m torn” would be bad business, bad politics and bad bedside manner... but it would, almost every time, be the truth.

So let’s be clear that when doctors say “We are motivated only by clinical priorities” it is not necessarily the pure truth. They are motivated to succeed at a professional and business level, and that may extend to practice finances. When the BMA decided to oppose the Heath and Social Care Bill it was not only on clinical grounds, but because the business proposition did not appeal despite its lucrative potential. Maslow’s ‘hierarchy of needs’ is a relevant concept here: the fear of losing control may override the desire to increase your income.

And when politicians say “Our priority is only to improve services” that is not necessarily the pure truth either. Most comment on the NHS reforms has focused on whether the Government is right to believe the new system will deliver better patient outcomes. But is that the only issue? Politicians are not doctors, and – as recent events have proved – they don’t even want to listen to doctors. It’s not cynical to see NHS reform in terms of wider political priorities for society and the economy: that is precisely how politicians see it.

There’s no doubt that Andrew Lansley would like to see patient outcomes improve. But his sense of what can achieve that does not come from expert medical opinion: it comes from the political ideology that assumed privatisation would make the rail service cheaper, safer and more reliable. At least as important, from his viewpoint as health secretary, is the priority of breaking down the national and public sector employment basis of health workers, so that local employers can set their own terms and conditions.

As for the pharma industry – well, it depends on who you talk to. Your CEO will tell you (and the media) that everything your company does is driven by a passionate commitment to making a difference for patients. The public largely believe that everything your company does is driven by the need to make a difference for shareholders. The truth is that even a humble field representative is motivated by a complex blend of factors: short-term targets, longer-term business growth, customer relationships, clinical success, public reputation and the need to laugh once in a while.

Like mixing a drink, medical sales is all about finding the right balance – and not losing your own.

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

Roche’s Zelboraf (vemurafenib) can extend the lives of patients with advanced melanoma by more than a year, data from a phase III trial has shown.

Patients given Zelboraf showed a median overall survival of 13.2 months, compared to 9.6 months with chemotherapy.

An abstract of the trial report stated that the increased survival meant a 38% reduction in the risk of death from melanoma.

A previous controlled trial, which formed the basis for the drug’s FDA approval in 2011, was halted early so that patients in the chemotherapy arm could be given Zelboraf for their clinical benefit.

Zelboraf has been hailed as a leading example of ‘personalised’ medicine as it targets the BRAF gene mutation, carried by about half of all melanoma patients.

Jennifer Low, Group Medical Director in Product Development for Genentech, Roche’s US subsidiary, commented: “The life expectancy for these patients isn’t very long, so they have an opportunity to have therapy that on average improves survival by a really significant amount.”

Roche is also testing Zelboraf as a treatment for other types of cancer, alone or in combination with other drugs.

A generic formulation of Pfizer’s blockbuster Lipitor (atorvastatin) has been launched in the UK on the first day of its patent expiry.

Indian pharmaceutical company Ind-Swift, in collaboration with its marketing partner Wockhardt UK, wasted no time in releasing the drug to gain market share.

Sirjiwan Singh, Wockhardt UK Managing Director, said the generic’s prompt launch was down to the partnership between the two companies.

“With increase in demand for cost effective drug for cardiovascular diseases, this generic launch is an excellent example of collaboration efforts of the two companies in leveraging on mutual strengths and competencies,” he said.

Lipitor, used for the treatment of high cholesterol and the prevention of heart attack, is the best selling drug in pharmaceutical history.

Pfizer recently admitted defeat in its fight against generic competition against the drug when it decided to cease marketing the product in the US. However, it is still expected to promote Lipitor in emerging markets, where increased demand may still generate billion dollar sales.

The arthritis therapeutics market is expected to experience significant growth in the coming years, a new report predicts.

Research found that arthritis therapeutics are becoming a “gigantic attraction” for pharmaceutical companies as the condition continues to be one of the most common causes of disabilities.

Rising incidence rates of osteoarthritis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are expected to see revenues reach $35.8 billion by 2018.

Several major pharmaceutical and biotechnology companies have already shown an interest in obtaining market share and have made investments in the potentially lucrative industry.

Pfizer, Amgen, Merck, Roche and Novartis, the report found, have increased R&D efforts in the field with several promising therapies in late-stage development.

The current pipeline includes many small molecule drugs and biologic therapies, as well as novel oral Disease-Modifying Anti-rheumatic Drugs (DMARDs).

Biologics, the report predicts, will feature heavily as the market expands and drive growth during the coming years.

Existing market leaders are also expected to benefit from the predicted demand.

Amgen’s patent on blockbuster drug Enbrel was recently extended until 2028 by the FDA following a number of court proceedings. Other well-established brands have also had their protection protected.

However, the patents for Rituxan (rituximab), Remicade (infliximab), Celebrex (celecoxib) and Humira (adalimumab) will see a number of generic alternatives enter the market.

Despite cheaper therapeutic products being made available, the report estimates the market will grow at a compound annual growth rate (CAGR) of 7.2% for the next six years.

A new service to coordinate 24-hour palliative care in Bedfordshire has been commended for improving patients’ experience during the difficult phase of end of life care.

The Bedfordshire Partnership for Excellence in Palliative Support (PEPS) Coordination Centre is an innovative venture between NHS Bedfordshire, local health and care services and the national charity Sue Ryder.

It is the first point of contact for patients, families, carers and healthcare professionals who require 24-hour advice and support for palliative care.

The service is being piloted across the country and has also attracted national interest. The Centre will host a visit from DH leaders working on an end of life care strategy later this month.

Launched in December last year, more than 360 local people have already registered to use the service.

Sarah Martin-Merchant, Care Centre Manager at Sue Ryder-St John’s Hospice, said that the majority of people like to remain at home during their palliative care.

“The PEPS Service brings organisations together to deliver this care, including that needed out-of-hours, which is in line with patients’ preferences and choices,” she said. 

“By working as a partnership, PEPS aims to minimise the need for hospital admission by providing more end of life care at home and to improve continuity of care for patients, their families and carers.”

The European Alliance for Access to Safe Medicines (EAASM) has called for the regulation of off-label drug use in Europe to be improved.

The patient safety group’s comments were triggered by the current debate over the unlicensed use of Avastin to treat wet AMD.

There should be a system of written patient consent for off-label medication, the EAASM said, as well as mandatory reporting of adverse events.

Following the publication of two studies into the use of Avastin as a cheaper alternative to the licensed medication (Lucentis), the AMD Society said: “The overall question of the safety of Avastin is, unfortunately, not answered to everyone’s satisfaction. The use of Avastin will remain a matter of judgement for clinicians.”

EAASM Chair Jim Thomson commented: “This is not an issue solely for the discretion of physicians. We are talking about an elderly population and these patients should be fully informed and give written consent.”

The CATT and IVAN studies have suggested an increased risk of adverse events from the use of Avastin rather than Lucentis.

This risk is exacerbated by the cost-saving strategy of dividing a single Avastin dose between many patients – a direct result of its formulation not being geared to the off-label use.

“Patients remain not only at risk but uninformed about those risks,” argued Jim Thomson, warning that the wet AMD debate was “just the tip of a barely visible patient safety iceberg” arising from pressure to reduce medical costs.

Bristol-Myers Squibb’s anti-platelet therapy Plavix (clopidogrel) has become the latest blockbuster to lose patent protection in the US.

A mainstay of heart disease treatment since 1997, Plavix faces immediate generic competition from Cardinal Health.

BMS, who markets Plavix in partnership with Sanofi, has said it will cease promoting the drug immediately following patent expiry.

Used together with aspirin, Plavix is the standard blood-thinning therapy for people who have suffered a heart attack.

The product earned BMS $7.1bn in 2011, a third of the company’s revenue.

BMS has decided not to follow the example of Pfizer, who promoted Lipitor extensively for six months after its US patent expiry, because the usual six-month exclusivity to one generic supplier will not apply.

The reason is that the first authorised supplier of generic clopidogrel, Apotex, forfeited its exclusivity period due to unlicensed sales in 2006.

As a result, seven companies have already received tentative approval to sell generic clopidogrel in the US. Cardinal Health plans a next-day launch. A spokesman for Sun Pharmaceutical Industries said the company would lose no time: “I would not be surprised if there was a stopwatch involved.”

BMS’s 2011 annual report predicted “a rapid, precipitous and material decline in Plavix net sales” following expiry of its US patent.

The company has developed a new blood-thinning drug, Eliquis, in partnership with Pfizer. Its FDA approval for stroke prevention is expected in June.

Patients are being denied access to treatments on the NHS for life-threatening conditions due to NICE’s prolonged appraisal system, according to a new report.

Research found the health regulator takes an average of a year to complete a Single Technology Appraisal (STAs) but up to a decade on a Multiple Technology Appraisal (MTA).

Sir Andrew Dillon, NICE Chief Executive, said the report was “misleading and unhelpful” using data from before NICE was established to generate its conclusions.

The report, by the Office for Health Economics, examined all drugs approved by NICE since 2000. It found that the average delay for treatments in 2010 assessed under MTAs was 10.2 years.

In 2005, the average delay for multiple drugs assessed was 8.7 years.

A spokesperson for NICE insisted the Institute does not “recognise most of the conclusions reached”.

“NICE has never taken 9 years to make a recommendation to the NHS on the use of a new drug,” said Sir Andrew Dillon.

He said the “gap” between a new drug being licensed and NICE guidance being published is “around five months”.

Sir Andrew added that the report included “drugs that were licensed for use, in some cases, more than 5 years before NICE was established”.

“Making sure that we provide advice on the best use of all important new drugs quickly remains our priority and we have the resources and the commitment to do it,” he said.

The health regulator aims to complete STAs within six months but claims there are “elements to the appraisal process that we cannot control” which may extend this timeframe.