"Gamechanging" cancer drug rejected for use on NHS

A gamechanging immunotherapy drug that can extend the life of patients with advanced head and neck cancer has been turned down for use in the NHS because of its high cost.

Nivolumab is one of a new class of drug that stimulates the patient’s own immune system to fight the cancer. Immunotherapy drugs have had some spectacular successes in some patients with some cancers. But although nivolumab can give people with advanced head and neck cancers an extra three months of life – when survival expectancy at present is around six months – the National Institute for Health and Care Excellence (Nice) has rejected it.

“The committee heard that treatment options for patients in this area are limited, and it’s important to patients that treatment extends their life and improves the quality of life. But the additional costs of nivolumab were considered to be very high in relation to its benefit to be recommended for routine NHS use at present,” said Prof Carole Longson, director of the health technology evaluation centre at Nice.

Nice will not approve drugs that cost more than its threshold of £20,000 to £30,000 per year of quality life, except for an end-of-life treatment – as this drug is – in which case the threshold rises to £50,000. But Nice believes nivolumab would cost between £66,000 to £75,000 per year of quality life.

The Institute of Cancer Research (ICR), which led the UK arm of the final phase of trials before licensing, regretted the decision. “It is disappointing and frustrating that today’s decision means doctors will not be able to offer this gamechanging immunotherapy to patients with advanced head and neck cancer,” said Prof Kevin Harrington, consultant clinical oncologist at the Royal Marsden. “Once it has relapsed or spread, the disease is extremely difficult to treat and options, including surgery and radiotherapy, are very limited.

“Nivolumab is an expensive drug but it is also the only treatment shown in a phase-III trial to improve survival for this group of patients – and it did so without worsening patients’ quality of life, and with fewer side-effects than other options. It’s crucial that talks on the drug’s availability continue and ultimately that this decision is reversed, otherwise patients face missing out on a genuinely effective treatment simply because of cost.”

The ICR’s chief executive, Prof Paul Workman, said the price of cancer drugs was too high. “This decision denies patients a genuine breakthrough treatment that makes a real difference for people with relapsed or metastatic head and neck cancer. It is another example, and a particularly stark one, of an innovative cancer therapy not being made available on the NHS because of cost. I’d urge Nice and the manufacturer to work together to reach an agreement on price so that this decision can be overturned as soon as possible.

“We need pharmaceutical companies to bring down the cost of drug development through smaller, more targeted trials, and to do much more to pass on the savings to patients. Nice for its part must take much greater account of innovation in its appraisal processes to give exciting treatments like nivolumab a better chance of reaching patients.”

"Gamechanging" cancer drug rejected for use on NHS

Dragon"s Den rejected me but my invention saves lives across the NHS

Nurses work on the frontline and are in an ideal position to innovate

“Since I appeared on Dragons’ Den last year, the business has surged and there is more support,” says Neomi Bennett.

Bennett is the inventor of Neo-slip, a pouch-like contraption that makes it easier for patients to wear their anti-embolism stockings, known to reduce the risk of deep vein thrombosis (DVT) clots. Although it was rejected on Dragons’ Den, Bennett considers being able to highlight the problem of DVT with millions of viewers as her biggest achievement.

Bennett came up with the idea in 2011 while working as a student nurse at Kingston University. She says: “In my final year, I was asked to look at problems faced by patients and find a solution [as part of risk assessment essay]. I noticed many people, especially the elderly, were finding it difficult to apply anti-embolism stockings because they are tight and often uncomfortable. Some would eventually give up and stop using them.

“Twenty-five thousand people die every year in the UK from preventable deep vein thrombosis, so I knew we needed a product that encourages people to use those stockings and this is how Neo-slip came about.”

With help from UnLtd, which supports social entrepreneurs in the UK, and a government loan, she set up her own enterprise in 2012 and has not looked back. Neo-slip is currently supplied to 34 hospitals and various independent pharmacies across the UK. The product has also won Royal College of Nursing and Smarta 100 innovation awards.

A single mother of three, who left school at the age of 16, Bennett says her entrepreneurial journey hasn’t been easy. “In addition to studying nursing, I had to learn how to run a business – its structure, processes and logistics – as I didn’t have any business background. There were also financial challenges as [is the case] with start-ups.”

She says the health service is better at signposting than at practical support.

My children inspired me to invent a tool to prevent dehydration in older patients

Naomi Campbell first thought of a drinking aid while watching her children use a toy to sip their drink. A community nurse at the time, she wondered if something similar could be used to prevent dehydration inolder people. “It may sound corny but it really was a light bulb moment,” she says.

With the help of a £15,000 grant by NHS Innovations South West, she designed a device called a micro straw that allows patients to drink their fluids independently, reducing their dependence on nursing staff.

The next problem was monitoring their intake, so Campbell came up with another creation: a cup with a scale on the side to make it easier for staff and carers to check the amount of fluid consumed. The micro straw was granted a UK patent in 2013, while the simple measures cup was trialled in Falmouth hospital and is now used in all Cornish community hospitals.

Campbell is now working on a complete education package, combining her innovations with practical risk assessment and monitoring tools, to raise awareness among carers and healthcare organisations.

“Dehydration is long-term problem … elderly patients need to be supported, encouraged and helped to drink. Sometimes older people avoid drinking water because they are concerned about going to the bathroom or too hesitant to ask for help,” she says.

“There is a need to improve basic hydration care in the NHS and wider health and social care system. There are many issues around elderly care hydration that nursing hasn’t addressed – poor chart-keeping, monitoring of drink consumed and identification of patients who are at risk.”

Nurses understand problems and have solutions but we’re not good at putting ourselves forward

Bernadette Porter, creator of NeuroResponse, a nurse-led telehealth service for MS patients, says there needs to be a culture change in the NHS. “To encourage more nurses to innovate, we have to give them permission to fail,” she says.

With a career spanning more than 25 years, Porter understands the health service and its complexities. In 2003 she was the first nurse in the NHS to be appointed a multiple sclerosis nurse consultantand was was awarded an MBE in 2013.

The idea of NeuroResponse came to her at a social entrepreneurship course. “We were challenged to think about care from a user’s perspective … and we use technology in all spheres of life such as banking and shopping, so why not use it to bring expert care nearer to patient’s home?”

She was selected as one of the 17 innovators for the NHS Innovation Accelerators (NIA) programme last year to scale up the project across England. It is already being expanded to other parts of London and Essex.

Porter says it was a good experience to network with other NIA innovators: “All of them had a ‘can do’ attitude, which is what we need in the NHS.”

She adds that there should be more community forums for innovators where they can share their ideas, support each other and learn more about entrepreneurship, information technology and co-designing services. “Nurses work with patients directly, understand their problems and have a good idea about the solutions. However, we are not good at putting ourselves forward. We need to be more confident.”

Shrestha Trivedi is a freelance journalist

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Dragon"s Den rejected me but my invention saves lives across the NHS

If my team’s research on ME is rejected, the patients will suffer | Peter White

Chronic fatigue syndrome – sometimes called ME (myalgic encephalomyelitis) – is a sad tale for everyone involved. It is a debilitating illness that affects about 250,000 children and adults in the UK alone, wrecking lives as people are unable to hold down a job and are sometimes left bed-bound for years on end.

Unfortunately these patients have not been treated well – their illness is often dismissed or belittled, leading to much anger, misinformation and argument. There are claims of foul play, with issues over freedom of information and sharing of trial data; this week it was claimed that sexism is part of the reason those with ME struggle to get the proper treatment. My colleagues, Professors Trudie Chalder and Michael Sharpe, and I have spent our careers trying to improve care for patients with CFS/ME. At the heart of this story is the Pace trial we have been conducting since 2005.

For many years Nice (the National Institute for Health and Care Excellence, which oversees healthcare evidence) recommended just two treatments – graded exercise therapy (GET) and cognitive behavioural therapy (CBT) – because it had the best evidence that these therapies worked. However, many patients were not using them, following instead a self-guided treatment called “pacing”: listening to the messages from their bodies and pacing themselves – trying not to do too much, wary of pushing themselves to a point where they might make the illness worse. The idea of doing exercise therapy was scary for some patients, worried that over-exertion would exacerbate their ill-health. The idea that CBT, a talking treatment, might help, raised fears that the illness was regarded as “merely psychological”, or even “all in the mind”.

With so much uncertainty and fear among patients, we wanted to find out which of these treatments worked best and whether they were safe. So we ran a large trial with 640 patients that would seek to replicate earlier studies, but on a much bigger scale. All those who took part were given specialist care and randomly allocated to also receive either pacing therapy, CBT, GET, or nothing extra. We had involvement from CFS/ME community, and the research was overseen by independent committees looking at data, safety and how the trial was run.

The results of our study, published in The Lancet in 2011, were clear – those patients given CBT or GET experienced significantly greater improvements in both symptoms and ability to do things, compared with either pacing therapy or specialist medical care alone. Not only were CBT and GET more effective: crucially, they were just as safe as the other treatments when done correctly.

In short, CBT and GET are safe, can definitely help some people and are more effective than other treatments

Our results confirmed the earlier smaller trials, and strengthened the evidence upon which the recommendations of Nice were based. Added to this, a recent Cochrane review (a summary of all the evidence, and considered the gold standard in medical research) also concluded that exercise is a safe and effective treatment. In short, CBT and GET are safe, can definitely help some people and are more effective than other treatments: but, as with all treatments in medicine, they cannot help everyone.

From here on this should have become a happier story. However, some of the ensuing newspaper headlines – such as “Got ME? Just get out and exercise, say scientists” – gave the misleading impression that patients just needed to pull themselves together, or even that they were making it all up. In our clinics we had seen far too much suffering to ever think this illness could be dismissed in this way.

Our research, and that of our colleagues in this field, has attracted its fair share of criticism. Some campaigners have even called for the research to be stopped, the findings retracted, and CBT and GET abandoned completely as they cause harm. One recent focus of criticism has been whether CBT and GET can actually bring about recovery or remission from the illness, not just reduce the symptoms. And by recovery we mean recovery from a patient’s present episode of illness – which is not necessarily the same as being cured, as someone might fall ill again.

To address this we did another test on the data, and found that 22% of people could be considered as recovered with either CBT or GET. Though not a large proportion it was about three times more than the recovery rates achieved by the other two treatments. Other studies showed similar proportions recovering after CBT.

In the latest step in this saga, a blog that hasn’t gone through the rigours of scientific peer-review, or being published in a journal claims that CBT and GET are not as effective as we reported. The authors got their figures by tweaks such as increasing the pass-grade for what counted as recovery, and excluding patients who had reported themselves as “much better”.

Whichever way the data is viewed, patients get better results from CBT and GET – both confirmed as safe – than they do from pacing or medical care alone.

This whole affair is perhaps saddest for the patients themselves, whose suffering has been neglected for far too long. However, there is hope. First, the important message for patients is that it is possible to get treatment that will help them improve and for some to recover. Second, we agree with campaigners that we need more research into the causes and treatments of CFS/ME. However, if their campaign puts people off trying CBT and GET, it will be the patients themselves who will suffer the most.

If my team’s research on ME is rejected, the patients will suffer | Peter White

AstraZeneca"s contact to velocity approval of cancer drug rejected by US panel

AstraZeneca, Britain’s second-largest drugmaker fought off a £69bn takeover approach from US rival Pfizer final month. Photograph: Phil Noble/Reuters

AstraZeneca has suffered a setback right after a panel of US overall health authorities rejected its request for accelerated approval of a new ovarian cancer drug.

The shock determination by the US FDA’s Oncologic Medication Advisory Committee comes at a delicate time, with Britain’s second-biggest drugsmaker working difficult to supply on its drug pipeline right after fighting off a £69bn takeover method from bigger US rival Pfizer last month. Any setbacks on new medicines could stir discontent amid AstraZeneca shareholders, some of whom needed the board to engage further with Pfizer.

The FDA panel asked the AstraZeneca to submit more clinical information on olaparib, a upkeep treatment for relapsed ovarian cancer which is in mid-stage clinical trials.

The information is due at the end of 2015, but AstraZeneca had hoped to get the green light for the remedy from the FDA in October. Chief medical officer Briggs Morrison said the organization was disappointed by the determination.

Even though the setback must have minor affect on AstraZeneca’s future revenues and profits, investors and analysts are viewing closely for any slip-up in its R&ampD efforts.

New medicines are important to its ambitious forecast of a 75% leap in revenues from $ 26bn to more than $ 45bn by 2023, a key plank of the defence technique outlined by chief executive Pascal Soriot. At the heart of it are new cancer immunotherapy remedies, for which the business acquired largely good feedback at a big US oncology conference at the commence of the month.

Bernstein analyst Tim Anderson explained: “The rejection comes at a essential time simply because failed R&ampD efforts might make AstraZeneca shareholders more inclined to push AstraZeneca into Pfizer’s arms. Is the olaparib ruling a main setback for AstraZeneca that will materially adjust how traders consider about AstraZeneca? No, but every single bit of slippage at the firm probably does tilt the balance somewhat more in favour of a future Pfizer-AstraZeneca tie-up.”

He reckons the odds are less than 50% that either AstraZeneca asks Pfizer back to the negotiating table in under two months, or the New York drugsmaker returns with a greater supply in November, but “obviously the predicament is fluid”. AstraZeneca is reportedly thinking about promoting off the rights to future revenues from present medicines or partnering on assets to make itself significantly less appealing to Pfizer.

Meanwhile, analysts at Jefferies earlier this month put an 80% probability on AstraZeneca inviting Pfizer back right after a mandatory cooling-off period ends in late August.

AstraZeneca"s contact to velocity approval of cancer drug rejected by US panel

Steve Jobs Rejected The Initial Health care App In 1977

There’s been a good deal of speculation that long term Apple Apple merchandise will consist of wellness-associated apps and biometric sensors. Here’s the story of what might have been the initial Apple health care app, except for the truth that in 1977 Steve Jobs had absolutely no interest in going in that route.

George Diamond is now retired right after a lengthy and extremely distinguished career as a cardiologist at Cedars-Sinai Health-related Center in Los Angeles. But in 1977 he was just commencing his job at Cedars, where he was functioning on cutting-edge devices and statistical techniques to enhance the diagnosis of heart disease (a major issue that even nowadays is far from becoming solved).

Diamond’s operate concerned one particular of the 1st attempts to use Bayes’ theorem– a sophisticated and complex instrument for analyzing probability– and it involved a lot of computation. In 1977 there weren’t a lot of selections. Here’s his (lightly edited) story:

“I purchased 1 of the really initial programmable hand calculators– the TI 59. It had magnetic cards that stored 1k of memory, and I was capable to compose a plan that utilised Bayes’ theorem to determine the probability of ailment based on the test outcomes. It worked wonderfully, except that  I instantly exhausted the 1k of memory due to the fact there was so a lot information.

“Just about that time the Apple II was introduced. There was a personal computer keep in Santa Monica– one of the extremely first laptop stores,  called ‘The Laptop Retailer.’ So I went there to see an Apple II in action. I fell in adore with it right away and purchased it with my personal income. (And by the way, you know what it value? 48 k of memory and two floppy disk drives and a 9″ monochrome check: I shelled out $ 2700.)

“With the Apple II I wrote a fairly sophisticated plan that analyzed a number of diagnostic tests using Bayes’ theorem for the diagnosis of coronary illness. Now I considered it was really fantastic and should be marketed, but it required to be expanded with people who actually knew some thing far more about programming than I did. So I picked up the phone and referred to as Apple in Cupertino. I informed the secretary that I desired to communicate with someone about a health care application for the Apple II computer. The secretary linked me directly to Steve Jobs. (Of program I did not know who he was. I didn’t even understand the title as currently being one of the individuals who had actually invented the issue.)

“He listened to me for a couple of minutes on the phone. I said I’d love to come up and speak with him about my notion. He explained certain, any time, just choose a date. and so I did, and I got on a flight to Cupertino. When I got to his workplace he looked exactly like he constantly looked in the future– he was sporting jeans, a black t-shirt, and sandals. His desk was definitely cluttered with all varieties of things on it, which includes, of course, an Apple II.

“I described to him what I had been doing, and how impressed I was with his gadget. Other men and women imagined it was a toy but I noticed anything significant in it and imagined that sooner or later a pc like this should be on the desk of every medical doctor in the globe. I informed him that I imagined my system could be a implies towards that finish, and I would adore to get his thoughts about it, and if he would he be ready to do anything to assist us advance that thought.

“He stated he was extremely impressed with what I had accomplished, and that he agreed about the potential for the long term, but ‘frankly I’m not interested in operating with you on this.’ I asked why. He explained: ‘You have to realize. This is some thing that nobody in the planet nevertheless understands. I cannot be distracted. I’m trying to make the very best hammer I can make, the ideal hammer in the world. You can use my hammer to tear one thing down, or you can use it to construct anything up. I genuinely really do not care what you do with my hammer. I just want to make the very best feasible hammer. And what you are undertaking is a superb bit of development, but to me it is a distraction.’

“So that was pretty much the finish of our conversation. There was no exactly where else to go after that so I thanked him extremely much for his time and flew back to LA.”

Steve Jobs Rejected The Initial Health care App In 1977