FDA lifts ban on Pfizer Lilly pain study

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Pfizer and Eli Lilly will resume Phase III clinical trials of tanezumab following the FDA lifting a ban on trials of this class in pain medicines.

As a result, Pfizer will receive a $200 million payment from Lilly under the terms of a collaboration agreement between the two companies to jointly develop and sell the drug.

The companies had been conducting late-stage trials of tanezumab in 11,000 patients with chronic pain. But in 2012 the US regulator placed a hold on these studies after nervous system side effects emerged during studies of similar drugs – monoclonal antibodies that block a protein called nerve growth factor (NGF) – conducted by other companies. Trials of tanezumab and other NGF receptor blockers for terminal cancer pain were allowed to continue.

The FDA has now lifted the hold on studies of tanezumab for chronic pain “after a review of a robust body of non-clinical data characterising the sympathetic nervous system response to tanezumab”, the regulator says.

In 2010 Pfizer had suspended late-stage trials of tanezumab, despite showing initially promising results as a treatment for knee and lower back pain in people with osteoarthritis after reports that patients’ osteoarthritis had worsened – although the FDA later recommended that the osteoarthritis trials could continue if patients taking other non-steroidal anti-inflammatory drugs were excluded.

“We are pleased with the FDA’s decision as chronic pain remains an area of significant unmet medical need and we believe tanezumab has potential to offer a new, non-narcotic option,” says Steve Romano, senior vice president and head of global medicines development at Pfizer’s global innovative pharmaceuticals business.

And David Ricks, Lilly senior vice president and president of Lilly bio-medicines adds: “We’re confident that tanezumab, if approved, can be an innovative treatment with the potential to help millions suffering from painful conditions.”

It is estimated that nearly one in five adults suffer from chronic pain. Should tanezumab be approved, it could reach sales of $100 million in 2020, according to financial services company Cowen and Co. This could rise if the drug is approved for other pain conditions including terminal cancer pain and diabetic neuropathy.

By Lilian Anekwe, Pharmafile online

Baxter’s haemophilia drug performs

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Baxter International has reported positive Phase III [BW1] clinical trial results for its investigational haemophilia drug BAX 817.

The recombinant factor VIIa (rFVIIa) treatment for people with haemophilia A or B who develop inhibitors – a molecule that binds to an enzyme and decreases its activity – was tested for its safety and efficacy in male patients ages 12 to 65.

The study met its primary endpoint with an overall success rate of 92%, 98% and 85% in each dosing group respectively. Furthermore, almost 90% of patients in the trial achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.

“The development of inhibitors remains one of the most significant challenges in treating haemophilia, as it may place patients at increased risk for life-threatening complications resulting from difficult-to-treat bleeding episodes,” comments John Orloff, who is the vice president and global head of R&D at Baxter’s BioScience division.

He adds: “These positive results reflect our commitment to addressing the complex treatment of haemophilia patients with inhibitors, and reinforce our legacy of advancing haemophilia care worldwide.”

Haemophilia A is a rare condition which affects one in 10,000 males, according to The Haemophilia Society. B on the other hand affects around one in every 50,000, and only 20% of people with haemophilia have type B. There are approximately 6,000 people living with the condition in the UK.

Both types have the same symptoms but they are caused by problems with different clotting factors. Both are inherited conditions that affect the blood’s ability to clot – typically meaning someone with haemophilia will bleed for longer than usual.

US-based Baxter recently announced its plans to split into two independent firms. Later this year its BioScience division will branch out with a focus on addressing unmet medical needs in niche areas of oncology.

Moreover, Baxter’s medical products business will remain as it is, but with more of an effort on developing new healthcare solutions in hospital and home based therapies.

Full data from the BAX 817 trial, including additional efficacy and safety outcomes, will be presented at a medical meeting later in 2015.

By Tom Robinson, Pharmafile online

Drug development contracts: can lessons be learned from healthcare delivery?

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There is a very good question to ask at the beginning of every project: “What does success look like?” If it’s not possible to define the required outcome, we should not be doing the project.

The outcome will be necessarily at the end of the project, so the next question is: “What do I need before I can work on the final outcome?” and so on to the beginning of the project, defining deliverables as we go.

I’ve planned clinical trials using a whiteboard and lots of sticky notes bearing the names of deliverables in just this manner, linking them all into a logical network by starting at the end and working forwards.

Traditionally however, contracts awarded to contract research organisations (CROs) are structured on a unitised basis, rather than as a network of deliverables.

For those not well versed in contracting, this means that projects are built up from libraries of activities, each of which has a unit cost attached, and sometimes a standard duration.

CROs with long histories have good experience of how much each activity costs. Bids can thus be generated quickly, and at the bid defence stage much of the horse trading comprises slotting activities in and out of the model.

The business development specialists in CROs will complain at my simplistic description, but I am reflecting my own experience of consulting for sponsors who have asked me to support them when commissioning major studies.

That experience has told me that unitised contracts can create a number of advantages for the CRO and not many for the sponsor; let’s have a look at some of these.

An expensive business

A global CRO confided to me not very long ago that change orders were more profitable than the baseline contract. It’s not too difficult to see why. Once the study is under way the sponsor is heavily committed, because changing the contractor is going to be highly disruptive and expensive.

So there is an incentive for the CRO to inflate the cost of any change. But also, plugging in extra activities is a cheap thing to do for CROs, because most of the negotiation was done at the bid stage.

To put it simply (again), if for example the project is running late it will require more periodic site monitoring visits. The cost per visit was negotiated and agreed at the outset so the sponsor has no option but to accept the agreed unit cost.

It is often not fully appreciated just how expensive this process can be for a sponsor. In my contract management support role, for multiple sponsors, much of my time was taken up with checking claims by CROs for additional costs.

To return to the site visit example, this meant that someone had to check that the visits being claimed had actually happened. But a site visit wasn’t a single activity; as well as the visit itself, there was writing the report, getting it reviewed, and signing it off.

So before approving the cost, all these items had to be verified by someone, and that someone has to be paid to do it. I have known sponsors to be quite sanguine about the expectation that costs will escalate.

Indeed, at the bid stage both parties expect this, but it’s really an elephant in the room. Yes, the contract wording does cater for project change, but without estimates of how much extra cost and lateness are likely.

I suspect this is because sponsors don’t like to face the possibility that anything can go wrong, but deep down they know it usually does. In my example of the unit cost of a periodic site visit, I missed out an important element – that of expenses.

Years ago sponsors became paranoid at the possibility that CROs were ripping them off by inflating expenses (as some of them probably were). So the practice of separating them as ‘pass-through’ costs became the norm.

You can see how this entails more cost for the sponsor, because all the expenses have to be checked against the pass-through element on the invoice.

The sponsor has to employ someone to do that. But the CRO is not going to handle expenses for free either, so there is usually an activity in the budget called ‘administration’ or more commonly ‘project management’, typically 15% of the whole. We end up with double-checking of expenses at double the cost.

Cost per outcome

All this stems from a focus on work done rather than on results achieved. But a sponsor surely isn’t interested in the effort expended by the CRO; only the results have any business benefit.

Indeed, one of the big current themes in the projects fraternity is benefits management. If you can’t define the benefit of any activity, don’t do it.

We could take that a stage further – if we are OK with the expected benefit, do we really care about the split between effort and pass-through expense? Well I don’t. I am, though, critically interested in the package cost for the item of benefit in the plan. In other words, the benchmark is cost per outcome.

This argument of course doesn’t only apply to drug development; it applies to any industry, and not just to R&D either. To my mind, a sponsor who insists on micro-managing a contractor by tracking every task and every expense is making their life unnecessarily difficult.

Yet sponsors have paid me to set up systems to do just that. They had to do this because by the time I came on board they were well down the road of a unitised contract with no chance of going back.

There can be no doubt that healthcare delivery is also an industry, albeit a largely public sector one in the UK. Social media are currently seething with the widely-held belief that the Conservative party intends to privatise the National Health Service.

I don’t propose to get into a political argument here, but I do want to look at how contracts work in the NHS, to see if there is anything for us to learn in pharma.

In reality, outsourcing in the NHS is not new. It has always been obliged to buy in certain services. But the Health and Social Care Act 2012 places the onus on commissioners to invite tenders from any qualified provider.

As I say, nothing new in this, other than the pressure to do it, and the NHS ‘internal market’ goes back decades. Hence there should be reasonably long experience of negotiating contracts.

The said Act is quite heavily reliant on outcomes, although rather vague as to how they will be achieved. Evidence-based clinical practice is not mentioned anywhere. We should expect that the outcomes for both the pharmaceutical R&D contract and the healthcare delivery contract are closely aligned.

Both sectors are striving to be patient-centred. For a clinical trial, the desired outcome is to verify a patient benefit from the medicine. For healthcare delivery, the patient outcome may be assessed via quality of life instruments, although of course more specific measures are also used.

Making care integration work

I have identified some progress towards a more modern type of contract in the NHS, as reported by the King’s Fund. Their Commissioning and Contracting for Integrated Care report highlights “holding providers to account for outcomes” as one of three main ambitions for contract managers.

To make care integration work, the author Rachel Addicott also identifies outcomes as comprising one of the three underlying principles of organisational integration, along with service integration and alignment of currencies, to streamline payments between providers.

There is some evidence that this is not just an academic exercise from a health-related think tank. The Oxfordshire Clinical Commissioning Group has issued a work programme on outcomes-based commissioning that apparently has attracted attention from several other CCGs.

It initially aims at care for mental health and for older people, both identified as having especially heavy demands on services. A wide range of advantages is expected to accrue, but I am particularly taken with the prediction that things will be simpler to implement.

A focus on the outcome will – it is said – mitigate against the high degree of fragmentation that prevails at present. With clinical trials becoming immensely complex, this struck a chord. I’m not suggesting that the more modern contract format will make trial protocols simpler, but it could signal a move away from the need to model every protocol item in the contract.

I also like the idea that the Oxfordshire CCG model releases providers to design services “to suit the needs of patients, under a single contract, with fewer process targets”. We have seen cases of suboptimal clinical trials resulting from unimaginative protocols, such as the notorious TG1412 disaster, and much of the time these have been dictated by sponsors.

Why not cut the brief to the CRO right down to the outcomes required, and ask for their ideas? This approach is very close to the project definition process that I taught to trainees for many years. The problem was that most of them had no scope to do that, and just had to conduct protocols that had already been set in stone.

So what type of contract is the norm among CROs these days? Ronald Openshaw, chief executive of Simbec-Orion, doesn’t see any significant trend towards an outcomes basis. He gives the example of a single study in a relatively uncommon condition, where the sponsor company was certain that it could be carried out with five investigator sites.

Simbec-Orion, with their experience in that therapeutic area, knew that 15 sites would be needed. The gap could not be bridged.

I suggested that both parties were not going to agree on the number of sites, but could agree on the outcome, so that should have been the basis of the negotiation. Openshaw feels it would be ‘wonderful’ if a client were to come to him with just a desired outcome, but nobody ever does.

He points out that a purely outcomes-based contract would not work as a business proposition as all CROs need cash flow – nobody can wait until the end before getting paid. I think this is a given, and contracts would ideally be structured with a mix of outcomes and interim deliverables as milestones.

Where there’s a will there’s a way

There is a way though in which a CRO can buy into the results of a trial, by accepting equity in lieu of some fees.

Sponsors seem to be constrained by the fear of delegating too much responsibility, and indeed they are legally responsible under medicines legislation. A profit-sharing deal should allay some of that fear, and of course is not new in the pharmaceutical industry. But I think it only really affects the financial clauses of the contract.

Sponsors and CROs of course have different objectives. TranScrip Partners supports many pharma companies in the management of R&D projects (among other activities), and senior partner Dr Mark Watling alludes to the CROs’ love affair with the item-of-service contract.

Perhaps they rely on sponsors’ carelessness or naiveté when signing off a contract – anything they have missed immediately triggers a change order, at higher cost. Because both parties are so risk-averse, Watling doesn’t see the unitised contract disappearing.

Maybe it can be improved by building in rigorous timelines, but whatever its structure it depends critically on the quality of project management within both client and contractor (a recurring theme of mine!). Not that CROs are always comfortable with the escalating complexity of contracts these days, made much worse by the increasing influential involvement of legal departments.

Nevertheless, I have not detected a clear refusal by CROs to consider outcomes as contract targets, contrary to my expectation. Any reluctance seems to stem more from sponsors, who are fearful of relying on the experience of CROs who have an appropriate specialism.

It does appear that there are some learnings available from what is going on in the NHS, although healthcare delivery is not the same as R&D. Making things simpler is usually good, and outcomes can help towards that.

The hurdles to be jumped seem to be rather more mental than methodological ones.

With R&D costs continuing to sound alarm bells around the world, it behoves pharmaceutical companies to be creative and explore innovation not just in the drugs themselves, but in the way they are developed.

Les Rose is a freelance clinical science consultant and medical writer

Pharmafile online

NICE recommends hep C and bowel treatments

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Three drugs to treat chronic bowel condition ulcerative colitis and one for hepatitis C will be funded by the NHS following final guidance recommendations by NICE.

The UK health watchdog says Merck’s Remicade (infliximab), AbbVie’s Humira (adalimumab) and Merck’s Simponi (golimumab) should be recommended as an option for treating moderate to severe ulcerative colitis.

Professor Carole Longson who is NICE’s health technology evaluation centre director, says: “This recommendation will benefit tens of thousands of people who live with this debilitating condition. We are very pleased that we can recommend all three drugs to treat ulcerative colitis. Those with the condition will have more options available to them and a greater chance of controlling their symptoms, so they can have a much better quality of life.”

An estimated 146,000 people in the UK live with ulcerative colitis in which the large intestine becomes inflamed. Symptoms vary, but may include bloody diarrhoea, abdominal pain, weight loss, fatigue and an urgent need to go to the toilet.

Sporadic in nature, the condition disappears for months or even years at a time, but it is thought that half of people with ulcerative colitis will relapse at least once a year – and whilst it can develop at any age the peak age appears to be between 15 and 25-years-old.

On these approvals, Chris Probert who is a Professor of gastroenterology at the University of Liverpool and vice-chair of the clinical advisers committee for Crohn’s and Colitis UK, says: “This is great news for our patients with ulcerative colitis. It is the first new class of drugs to be approved by NICE for ulcerative colitis and is a valuable tool in our armamentarium in the fight against ulcerative colitis.”

Remicade, Humira and Simponi are all licensed to treat moderate to severely active ulcerGilead’sative colitis in adults who have had an inadequate response to conventional therapy, or are unable to take such treatments. Remicade is also licensed to treat children and adolescents aged 6-17 years.

This drug has also been in the news of late for its biosimilar version Remsima, which was just launched by Napp in the UK for the treatment of a range of illnesses including Crohn’s disease ­– which followed Hospira’s biosimilar monoclonal antibody launch just prior.

Meanwhile NICE has been extra busy of late, as along with its final guidance this week approving Sovaldi for hepatitis C, it has also given the final nod to Johnson & Johnson’s fellow hep C offering Olysio (simeprevir).

Olysio has UK marketing authorisation for use along with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C, but this latest guidance recommends its use in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.

Olysio was in fact one of the stars in J&J’s full-year sales results, and the drug has seen the introduction of a novel ‘pay if you clear’ pricing agreement with the NHS, whereby NHS England will only pay for Olysio if patients are effectively cured of the virus after 12 weeks of treatment, with Janssen (J&J’s pharma wing) refunding the cost for those who aren’t.

By Brett Wells – Pharmafile online

FDA approves Eisai thyroid drug, fast-tracks Novartis heart pill

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The FDA has approved Eisai’s thyroid cancer drug Lenvima and also granted Novartis heart pill LCZ696 a priority review.

Lenvima (lenvatinib) has been approved in the US to treat the most common type of thyroid cancer – differentiated thyroid cancer (DTC) – and is for patients whose disease has progressed despite receiving radioactive iodine therapy.

DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.

“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” says Richard Pazdur, who is the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”

Lenvima was evaluated under the FDA’s priority review programme, and the drug also received orphan product designation because it is intended to treat a rare disease.

The firm is now trialling the drug for other tumour types, and Lenvima is undergoing regulatory review worldwide and the EU (where it was also granted accelerated assessment).

Speedy FDA review for Novartis 

Meanwhile there’s good news for Novartis too as the FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF).

For LCZ696 this means a welcome reduction in the total review time from 12 to 8 months, meaning the FDA could make a decision on approval as early as in August this year.

David Epstein who is the division head at Novartis Pharmaceuticals, says: “The FDA’s decision reflects the significant need to extend and improve life for HFrEF patients and Novartis is working to ensure LCZ696 can become available in the US as soon as possible.”

In the EU the Committee for Medicinal Products for Human Use (CHMP) has also granted accelerated assessment for the heart pill.

Nearly six million people that live with heart failure in the US alone. The twice a day medicine is said to work by reducing the strain on failing hearts, and acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).

By Brett Wells, Pharmafile online

Apple hails health benefits of new watch

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Users of the upcoming Apple Watch will be prompted to be more active because ‘sitting is the new cancer’ according to Apple boss Tim Cook.

The California-based company’s chief executive told delegates at a recent Goldman Sachs Technology and Internet Conference that the device will “tap you on the wrist to remind you to get up and move”.

He explained that the gadget’s latest trick is to give you a small vibration encouraging the user to be more energetic and keep fit.

The long-awaited ‘smartwatch’ – set for release in April – will be able to calculate all kinds of data including heart rate, calories burned whilst also counting steps. Additionally it will send and receive messages, play music and make calls.

Cook explained that: “One of the biggest surprises for Apple Watch will be the breadth of what it can do.” Acknowledging that there are competitors already out there he said: “None have changed the way people live their lives.”

Apple has been pioneering its launch into healthcare for some time now, it was boosted late last year after new figures released by the Department of Health found that NHS England has spent over £1.2 million on its products since 2012.

Furthermore, a pilot programme for Apple’s mobile health platform HealthKit was rolled out across a number of US hospitals this month to help doctors monitor patients with chronic conditions.

The tech company also announced plans in early 2014 to manufacture a new health-monitoring device that will be built into a pair of headphones. The gadget will be able to track user activity during exercise and record various biometric data.

No better than smartphones?

New wearable technology benefits aside, recent work by the University of Pennsylvania investigated just how accurate the tools really are. One study got 14 participants to trial six wearables and six smartphones laden with gadgets to see how they compared.

Results found that the activity tracking systems of wearables are no better than that of smartphones. Nike’s Fuelband device was found to be the most inaccurate tracker followed by the Jawbone’s UP24, and Flex by Flitbit.

Any firms making exaggerated health claims of its wearable devices face scrutiny following new FDA guidelines on how the gadgets for medical purposes could be regulated. The rules will define what separates a healthcare device from a consumer offering.

The potential for this type of technology in the industry will only be realised if Apple and others engage effectively with consumers and healthcare authorities, and pharma will no doubt be following the developments closely.

By Tom Robinson – Pharmafile online

BREAKING NEWS: Pfizer to buy injectible drugmaker Hospira for around $17 billion

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(Ref: First Word, Pfizer, CNBC, The Wall Street Journal, MarketWatch, StreetInsider, Yahoo!News, ABC News)

Pfizer entered a definitive merger agreement to acquire Hospira for $90 per share in cash, or a total enterprise value of approximately $17 billion, the companies reported Thursday.

“The proposed acquisition of Hospira demonstrates our commitment to prudently deploy capital to create shareholder value,” commented Pfizer CEO Ian Read.

The executive added that “Hospira’s business aligns well with our new commercial structure and is an excellent strategic fit for our Global Established Pharmaceutical business, which will benefit from a significantly enhanced product portfolio in growing markets.” Pfizer noted that the deal will add Hospira’s generic sterile injectables product line, including acute care and oncology injectables, as well as its biosimilars portfolio.

The companies indicated that both boards of directors have unanimously approved the transaction, which is expected to close in the second half. Pfizer noted that the purchase is expected to be immediately accretive upon closing and will deliver $800 million in annual cost savings by 2018.

By: Matthew Dennis, First Word Pharma, online

GSK blames respiratory woes as sales drop

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GlaxoSmithKline’s respiratory business has been flagged as the key factor in the firm’s fourth quarter financial misfortunes, as its total sales drop by 8% since the same period last year.

US losses relating to lung drug Advair and heart pill Lovaza have hit the British company hard, leaving adjusted net cash from its operations down 20%, raking in £5.9 billion for the year. Adding to that, profits have also seen a decline of £2.5 billion over prior year.

Speaking via a webcast on GSK’s website, chief executive Sir Andrew Witty declares: “Last year our environment was dynamic to say the least.” Before adding: “Having said that I am very pleased with the position we now have in terms of our contractual cover going forward into 2015 and 2016.”

Citing strong evidence of emerging market volume and with ‘demand that is growing’ however, Sir Andrew says this will present much opportunity for GSK as it expands its footprint there. “For 2015 we want to rebuild our sales growth momentum, after the challenges of last year we have some opportunities to do that. Especially from our recently-launched product portfolio.”

Tellingly he notes the pharma giant will “continue to focus on our costs and restructuring programmes, where we’ve already taken substantial costs out of the business”.

Last year was a tough one for GSK, which was saw the firm continue to get hit by both declining sales of blockbuster Advair, and a record fine over allegations of corruption in its business in China.

Sir Andrew confirmed on the back of these latest results that his target is now to return its respiratory business to growth next year, pinning hopes on newer products like its Anoro Ellipta inhaler and Breo to gain headway in the market, which have got off to a slow start.

Ketan Patel, an analyst at Ecclesiastical Investment Management, says of GSK’s future: “The key in 2015 will be the ability of management to deliver on the cost-cutting programme, the pipeline and stabilising the revenues in respiratory, all of which should not be underestimated.”

GSK’s other big news of course is its major pact with Swiss rivals Novartis, that is to see the manufacturers combine their consumer health units under GSK’s majority (63.5%) control, while also in effect swapping some of their major assets.

Patel says that the strategic options available to GSK post any deal with Novartis, include potential asset disposals, especially the HIV joint venture with Pfizer, which will naturally give the firm financial flexibility going forward.

That potential looks to be taking shape sooner rather than later now as Sir Andrew has just told Reuters his company would take the next two to three months to analyse the pros and cons of an initial public offering (IPO) regarding its HIV meds unit ViiV, along with deciding how much of it to sell.

Apparantly GSK will then decide around mid-year whether to go ahead with the float.

Patel adds: “If the board decide to cut the dividend in 2016 it would be a watershed moment, as no large cap pharmaceutical company has cut its dividend, excluding M&A deals, since the turn of the century.

Keen to highlight a company in the midst of a transformation, Sir Andrew says: “The Novartis transaction itself, once approved, will have a very substantial impact on the company. It changes the shape of the business. It is an important part of rebalancing the group’s future.”

By Brett Wells – Pharmafile online

Is asthma being overdiagnosed?

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A potentially alarming figure that emerged in the UK news last week was that “1 million” UK adults may have been wrongly diagnosed with asthma – a claim reported in various forms by BBC News, The Guardian, The Daily Telegraph, the Daily Mirror and the Mail Online. 

The headlines followed the publication of new draft guideline (PDF, 670kb) from the National Institute for Health and Care Excellence (NICE) on the diagnosis and management of asthma. Most of the media articles were true to the facts and explained that the guideline was aiming to improve asthma care by improving the accuracy of diagnosis.

So, where did the figure of 1 million come from? All the UK press rallied round a statement in the draft guideline that said: “studies of adults diagnosed with asthma suggest that up to 30% do not have clear evidence of asthma”. What followed was clearly a “back of the envelope” calculation extrapolating this to the number of people receiving treatment for asthma in the UK, which is around 4.1 million. This gave the magic figure of 1.23 million potentially misdiagnosed people.

Unfortunately, the 30% figure in the draft guideline is not referenced, so we can’t find out how accurate it is. We also don’t know whether it applies to specific asthma subgroups, such as those of a specific age, or the severity of a person’s symptoms. This makes it difficult to assess whether this calculation is accurate, or even reasonable.

The charity Asthma UK responded in a blog post, saying: “While we welcome the NICE guideline in the hope that it will help people with asthma to receive more personalised care, we are concerned that today’s headlines may make people think twice about taking their asthma medicines”.

“Although it is true that some people may receive treatment for asthma when they currently don’t have symptoms, this does not necessarily mean that they don’t have asthma. So it is vital that everyone diagnosed with asthma keeps taking their medication as prescribed and attends their annual asthma review”.

You should never stop taking any prescribed medication without first consulting with your GP or the doctor in charge of your care. This includes asthma medication.

 What is the basis for these current reports?

NICE recently released a draft guideline to improve asthma diagnosis and monitoring.

The draft guideline – NICE’s first on asthma – is now open for consultation until March 11 2015, so people and institutions can comment on its initial recommendations. The feedback and comments will be collated and incorporated into revised recommendations. Once agreed, these will form official NICE guidelines, which are expected to guide standard healthcare practice across the UK.

The draft guideline covers the diagnosis and monitoring of asthma in adults, children and young people. It draws on the best evidence available to determine the most clinical and cost-effective way to diagnose people with asthma and determine the most effective monitoring strategy to ensure optimum asthma control.

 What does it say?

The draft guideline outlines that there is currently no gold standard test available to diagnose asthma. At the moment, it is mainly based on a thorough history of symptoms taken by an experienced clinician.

However, the guideline stresses that to achieve a more accurate diagnosis, clinical tests should be used alongside symptom assessment. The process the healthcare professional should follow in the initial assessment, and the tests to use, are presented in simple flow charts.

This involves using a combination of tests, depending on the age of the person being assessed. Most commonly this will involve a test called spirometry, to test lung function. This will sometimes be repeated after a person has been given inhaled treatment to dilate the airways – known as a bronchodilator reversibility test. Other tests that may be used include measuring fractional exhaled nitric oxide, as a sign of airway inflammation, and looking at whether the airways are over-responsive to inhaled substances, such as histamine or methacholine.

The guidance also says that around one in 10 adults with asthma develop the condition because they are exposed to certain substances, such as chemicals or dust, in their workplace. Therefore, the draft guideline now recommends that healthcare professionals ask employed people how their symptoms are affected by work, to check if they may have occupational asthma.

 How does the guideline affect you?

If you have asthma, do not change your medication without first consulting a doctor. This could be dangerous, as untreated asthma can be fatal.

If you have concerns that you have been misdiagnosed or are taking medicines unnecessarily, the first thing to do is speak with your health professional.

At present, these guidelines are in a draft form, so may be revised based on feedback and comment over the next few months. In the meantime, there aren’t likely to be changes in the way asthma is diagnosed routinely across the NHS. However, if the changes proposed in this draft make it into the final version, this may lead to a change in practice – most likely, more standardisation around the diagnosis and monitoring of asthma.

The main implications of such a change would be that the accuracy of diagnosing new asthma cases should improve or standardise for people in the UK. The implications for people already diagnosed with asthma are less clear. It could potentially mean that cases where there was uncertainty around the diagnosis would be re-reviewed with further diagnostic tests. This could potentially lead them to be declared asthma-free, or to a change in their medications, as appropriate.

This is a good reminder to take full advantage of your asthma review, which is an appointment with your doctor or asthma nurse to talk about your asthma and discuss how you can better control your symptoms. This is something that everyone with asthma should do at least once a year or more if you have severe asthma symptoms.

NICE says it wants to hear your views. Information on how to comment on the draft guideline can be found here.

Analysis by Bazian. Edited by NHS ChoicesFollow Behind the Headlines on TwitterJoin the Healthy Evidence forum.

GSK-Novartis mega-deal signed-off by EC

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The European Commission has approved a GSK-Novartis M&A deal, in which GSK will purchase Novartis’ vaccines unit and Novartis will buy GSK’s oncology business.

Both firms announced the overhaul of their businesses in April. The multi-billion dollar contract will involve GSK acquiring Novartis’ global human vaccines business (except the influenza vaccines business) for $7.1 billion, and Novartis taking over GSK’s oncology business for up to $16 billion.

In a third part of the deal, GSK and Novartis will combine their global consumer health business in a new entity, over which GSK will have sole control.

Under the EU Merger Regulation the EC has a legal duty to assess mergers and acquisitions involving companies with a turnover above certain thresholds, and make sure that any arrangements would not significantly impede effective competition in Europe.

The EC had concerns that the GSK-Novartis deal would affect competition in the production of vaccines and promising oncology treatments. The Commission raised the potentially detrimental effect on competition for some vaccines.

To address this GSK agreed to sell its meningitis vaccines, Nimenrix and Mencevax, on a global basis. These are marketed outside of the US and generated annual global sales of £36m in 2013. In another condition set by the EC, GSK will also divest two Novartis diphtheria and tetanus vaccines in Italy and Germany.

The oncology tranche of the deal would also have affected competition, the Commission found, by reducing the number of companies developing and marketing two investigational skin cancer treatments, B-Raf and MEK inhibitors, from three to two.

The EC report notes that these treatments “are expected to become the standard of care for the treatment of skin cancer… [and] to reach peak sales of several hundreds of millions of euros in the next few years in the EEA”.

The Commission feared that Novartis’ purchase of GSK’s oncology portfolio, which includes B-Raf and MEK inhibitors would “lead to a duopoly between the merged entity and Roche”. It was also likely to result in Novartis abandoning its clinical trials of these treatments in ovarian, colorectal and lung cancer, which would have a ‘significant impact on innovation’.

As a condition of the deal Novartis agreed to return its rights over MEK162 to its owner and licensor Array BioPharma, and to divest LGX818 to Array. “This will ensure the worldwide development of LGX818 and MEK162 as well as the commercialisation of these inhibitors in the EEA”, the Committee report says.

The EC also signed-off another major pharma pact after concluding that Mylan’s purchase of Abbott’s generics business would not adversely affect European competition. The complex deal will mean Abbott will have a 21% share in ‘New Mylan’, which will become the parent company of Mylan and continue to operate from its base in Pittsburgh, Pennsylvania.

The Commission’s investigation found that for the majority of Abbott’s generic products no competition concerns arose. However, for five generic products in Germany, the UK and Ireland, France and Italy there are a lack of substitutable products and competitors present and low likelihood of competition.

To address these concerns, Mylan will divest its businesses and marketing authorisations in these countries. Both the GSK-Novartis and the Abbott-Mylan deals are conditional upon the companies complying with these commitments.

By Lilian Anekwe – Pharmafile online