tag:theconversation.com,2011:/id/topics/nice-4885/articlesNICE – The Conversation2024-02-22T17:26:30Ztag:theconversation.com,2011:article/2236882024-02-22T17:26:30Z2024-02-22T17:26:30ZHow to choose a trustworthy mental health app in a market bloated with options<figure><img src="https://images.theconversation.com/files/576000/original/file-20240215-28-7gauhc.jpg?ixlib=rb-1.1.0&rect=17%2C52%2C5766%2C3564&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/mental-health-application-concept-close-smartphone-1962853882">myboys.me/Shutterstock</a></span></figcaption></figure><p>I like to start my day with a bowl of cereal. It’s quick, light and, if I make the right choice, good for me. I also have the freedom to make a less healthy choice – but when I go to the supermarket and look over the array of options in front of me, I need only look at the back of the box to understand what I’ll be eating and, most importantly, whether the ingredients are nutritious.</p>
<p>Today’s <a href="https://www2.deloitte.com/xe/en/insights/industry/technology/technology-media-and-telecom-predictions/2022/mental-health-app-market.html">vast market in mental health apps</a> feels similar to choosing cereal. With the <a href="https://www.rcpsych.ac.uk/news-and-features/latest-news/detail/2022/10/10/hidden-waits-force-more-than-three-quarters-of-mental-health-patients-to-seek-help-from-emergency-services">waiting lists for NHS mental health services</a> being months long, apps appear to have the potential to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9533203/">ease pressure and are relatively cheap</a>. Their accessibility and light-touch approach suggests that people in need of support will be able to manage their own mental health.</p>
<p>But increasingly, we’re seeing <a href="https://www.wsj.com/articles/the-failed-promise-of-online-mental-health-treatment-11671390353">reports that</a>, for all their promise, <a href="https://www.psychologytoday.com/gb/blog/digital-well-being/202206/the-promise-and-perils-mental-health-apps">mental health apps might not be all</a> they’re made out to be. With questions being asked about <a href="https://www.theguardian.com/society/2024/feb/04/they-thought-they-were-doing-good-but-it-made-people-worse-why-mental-health-apps-are-under-scrutiny">the need for regulation</a>, is it possible that these apps are <a href="https://www.telegraph.co.uk/news/2024/01/15/online-therapy-dangerous-mental-health/">doing more harm than good</a>?</p>
<p>The frustrating answer is: we don’t yet have enough information to say one way or another.</p>
<h2>Unlikely to cause damage, but may not support wellbeing</h2>
<p>It’s unlikely that most apps are actively damaging people’s mental health, although some encourage behaviour that is unlikely to support wellbeing. </p>
<p>To get around the problem of responsibility, <a href="https://www.psychologytoday.com/gb/blog/artificial-intelligence-and-mental-health/202402/wellness-is-not-healthcare">many apps categorise themselves as wellness</a> rather than therapy. They cannot offer advice that needs to be regulated, but they can point to services that might offer more help. This approach also reduces their responsibility for monitoring problems such as someone <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6921471/">reporting they are going to self-harm</a>. </p>
<p>Apps are also different from face-to-face therapy as they are generally designed to be used in short, ten-minute bursts that are accessible as and when they’re needed. </p>
<p>There’s certainly a lot of choice. App stores are bloated with options offering different levels and types of support. Unfortunately, hardly any offer extensive evidence of their effectiveness – in terms of controlled trials and in-depth analysis rather than user reviews – and even if they did, the app store would not tell you that before you downloaded.</p>
<p>This leaves potential users in a situation where they don’t know what they’re getting, and it could be stopping them from accessing actual evidence-based care. </p>
<p><a href="https://www.rsph.org.uk/static/uploaded/b215d040-2753-410e-a39eb30ad3c8b708.pdf">Effective interventions</a> should always be based on evidence, but they also require the user to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8726056/">engage with them over a period of time</a>. While they are easy to download, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8074985/">apps are also easy to ignore</a>. There are <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929738/">numerous examples of trials</a> using app-based interventions in which participants download but never actually open the app, or which have a very steep drop-off in engagement after a few sessions.</p>
<p>It’s clear to me that these apps are more than a passing fad. When the National Institute for Care and Excellence (Nice) made the decision to <a href="https://www.nice.org.uk/news/article/eight-digitally-enabled-therapies-to-treat-depression-and-anxiety-in-adults-conditionally-recommended-by-nice">approve eight online interventions</a> in March 2023, I (cautiously) welcomed the idea. <a href="https://www.nhsconfed.org/publications/maximising-potential-digital-mental-health">Digital therapies have the potential</a> to offer additional support for people in need and provide a welcome bridge between sessions of therapy.</p>
<p>Importantly, these eight apps will be scientifically assessed for how and where apps can be effective in the real world, laying the foundations for the rest of the market to follow.</p>
<h2>Four principles for mental health apps</h2>
<p>More than anything, people need to know what they are getting, and we need to see greater transparency from providers. This is likely to increase their market share, so it really is in their interests. </p>
<p>In 2019, <a href="https://faculty.sites.uci.edu/schuellerlab/stephen-schueller-phd/">Stephen Schueller</a> and I <a href="https://pubmed.ncbi.nlm.nih.gov/31045497/">set out four principles</a> that all mental health apps should work towards, in order to provide the most transparent possible offering to their users. What personal information is collected, and how is it used? Were target users involved in the design of the app? How much should you use it, and is it safe? Are there measurable benefits to using the app?</p>
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<p>My view in 2019 was that formal regulation wasn’t necessarily needed. Anyone making false claims on an app can be reported to advertising standards authorities, and anyone providing actual therapy already operates within a regulated market – although it’s always worth reminding those seeking therapy to do their due diligence and find the therapist that is right for them. </p>
<p>My view about regulation hasn’t changed, but this isn’t to say that no changes are needed. While set up as libertarian havens, app stores such as Google Play and Apple’s App Store need to adopt some rules for the way that health apps are marketed. </p>
<p>By tightening up what’s considered a “health” app and setting out clear rules like those I’ve listed, mental health app consumers should have greater confidence that the app they’re downloading has the power to help them. Essentially, consumers need to be able to choose their mental health apps as easily as I can make a choice about my cereal.</p><img src="https://counter.theconversation.com/content/223688/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span><a href="mailto:til.wykes@kcl.ac.uk">til.wykes@kcl.ac.uk</a> has received government research grants to investigate the benefit of digital therapies</span></em></p>Have mental health apps lived up to their promise to offer tailored support in a challenging public health context? The answer is mixed.Til Wykes, Professor of Clinical Psychology and Rehabilitation at the Institute of Psychiatry, Psychology & Neuroscience, King's College LondonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1449712020-09-28T15:03:53Z2020-09-28T15:03:53ZWhy is race still in the British blood pressure guidelines?<figure><img src="https://images.theconversation.com/files/358420/original/file-20200916-24-7ojr3l.jpg?ixlib=rb-1.1.0&rect=0%2C18%2C6221%2C3246&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-vector/blood-pressure-measurement-384543322">Visual Generation/Shutterstock</a></span></figcaption></figure><p>I looked around the lecture theatre and scribbled down what the lecturer had said: <strong>ABCD</strong>. <strong>A</strong>CE inhibitors (angiotensin-converting enzyme inhibitors), <strong>B</strong>eta blockers, <strong>C</strong>alcium channel blockers and (thiazide) <strong>D</strong>iuretics. These were the four groups of drugs used to treat high blood pressure (hypertension) – except there were exceptions. </p>
<p>We didn’t use beta blockers anymore and ACE inhibitors don’t work for black people, specifically black African or Afro-Caribbean people. The lecturer explained to us that all black people were inherently less likely to respond to ACE inhibitors. This is what I learned at medical school, and this is what medical students still learn today. Now, as a practising GP, this is <a href="https://www.nice.org.uk/guidance/ng136">the guidance</a> we use every day (click to make them bigger).</p>
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<a href="https://images.theconversation.com/files/357526/original/file-20200910-22-lv17x2.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/357526/original/file-20200910-22-lv17x2.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/357526/original/file-20200910-22-lv17x2.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=425&fit=crop&dpr=1 600w, https://images.theconversation.com/files/357526/original/file-20200910-22-lv17x2.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=425&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/357526/original/file-20200910-22-lv17x2.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=425&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/357526/original/file-20200910-22-lv17x2.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=534&fit=crop&dpr=1 754w, https://images.theconversation.com/files/357526/original/file-20200910-22-lv17x2.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=534&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/357526/original/file-20200910-22-lv17x2.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=534&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<p>On the other hand, in <a href="https://www.heart.org/en/health-topics/high-blood-pressure/high-blood-pressure-toolkit-resources">the US blood pressure guidance</a>, there is no mention of race. Why the disparity? Do black people really react to blood pressure drugs differently from white people? Are black bodies different from white bodies? </p>
<p>Speculation on why black people have higher blood pressure than white people is often attributed to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1694537/">a genetic adaptation to slavery</a>: specifically, salt retention allowed black people to survive long trips on slave transportation ships across the Atlantic Ocean. The implication that there are <a href="https://www.ahajournals.org/doi/full/10.1161/HYPERTENSIONAHA.118.11064">inherent biological differences</a> between black people and members of other races has entered blood pressure medication guidance. Black people are labelled “low-renin responders” so are less likely to respond to ACE inhibitors. But there are several things wrong with this idea:</p>
<ol>
<li><p>The highest quality <a href="https://ssom.luc.edu/media/stritchschoolofmedicine/publichealthsciences/documents/kc2010.pdf">evidence</a> (a meta-analysis) found a small but statistically significant 4mmHg (millimetres of mercury) difference between the response to ACE inhibitors between black people and white people. If black people were all poor responders to this drug, you would expect the difference to be far bigger.</p></li>
<li><p>There is <a href="https://journals.sagepub.com/doi/10.1177/1060028018779082">conflicting evidence</a> on whether ACE inhibitors are beneficial or detrimental in terms of heart disease outcomes for black people. If they didn’t work that well, surely there would be no change or a clear detriment. </p></li>
<li><p>Even if black people are inherently different from white people, what medication should a person receive if they have a black parent and a white parent? What if they have a grandparent of African heritage? Using the “one-drop rule” – where any person with even one ancestor of black ancestry is considered black – could be problematic as very few people can trace their ancestry back a few generations. This means it is difficult to rule out any African or Caribbean heritage in anyone’s lineage. A commercial genetics test <a href="https://www.vox.com/science-and-health/2019/1/28/18194560/ancestry-dna-23-me-myheritage-science-explainer">probably won’t help you</a>.</p></li>
<li><p>Recent genetic research consistently shows that there are greater genetic differences between members of the <em>same</em> race compared with members of <em>different</em> races, looking <a href="https://www.genetics.org/content/176/1/351">generally</a> and <a href="https://www.cell.com/ajhg/fulltext/S0002-9297(14)00355-3">specifically</a> at African-Americans. </p></li>
<li><p>The social and economic circumstances and the environment in which a person lives has <a href="https://nyaspubs.onlinelibrary.wiley.com/doi/abs/10.1111/j.1749-6632.1999.tb08123.x">a greater effect</a> on health than biological or genetic factors. So could there be an alternative explanation for why black people have higher blood pressure compared with white people? Could <a href="https://journals.lww.com/jhypertension/Abstract/2015/02000/Socioeconomic_status_and_hypertension__a.4.aspx">poverty</a>, <a href="https://www.ahajournals.org/doi/10.1161/JAHA.119.012139">stress</a> or <a href="https://doi.apa.org/doiLanding?doi=10.1037%2Fa0033718">perceived racism</a> be reasonable explanations?</p></li>
</ol>
<h2>Decolonising medicine</h2>
<p>Medicine is not objective; scientific research is conducted by people who bring their own perspectives. These biases colour the way research is conducted, the way data is analysed and the way conclusions are drawn. Perhaps it’s time for an overhaul.</p>
<p>The reform of medical curricula is called “<a href="https://jme.bmj.com/content/medethics/46/4/265.full.pdf?casa_token=Y46tD5ZfqT4AAAAA:p0lNvoyEVeq6_FjcYk_xB8kRfynjdYgTEu6CNHWBsLxe14OgUkrSsTkJJVkLqHLsML1B1jtFoWY">decolonisation</a>” where the impact of history and colonisation is examined so medicine can better meet the needs of people who come from ethnic minorities. In a recent example, medical student <a href="https://twitter.com/malone_mk">Malone Mukwende</a> wrote a <a href="https://www.blackandbrownskin.co.uk/mindthegap">textbook</a> to help doctors recognise skin conditions on black and brown skin. This is significant since skin conditions in medicine are almost exclusively taught on white skin.</p>
<p>Where it comes to blood pressure research, a more holistic approach is needed to involve other sectors, such as genetics and social sciences. The <a href="https://www.nice.org.uk/guidance/ng136">UK blood pressure guidelines</a> need to be re-examined as does much of medicine. This re-examination will challenge assumptions and the objectivity of medical research. This may fill some members of the medical profession and the public with dread as this adds to further <a href="https://www.bmj.com/content/370/bmj.m3349">uncertainty</a> during a global pandemic. Perhaps this is the beginning of a change that will lead to a fairer health system for all.</p><img src="https://counter.theconversation.com/content/144971/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>I am an In-Practice Fellow supported by the Department of Health and Social Care and the National Institute for Health Research.
The views expressed in this publication are my own and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care.
I have not been paid any honoraria to promote Angela Saini's book "Superior: the rise of race science".</span></em></p>Decolonising medicine will create a fairer healthcare system for all.Dipesh Gopal, Honorary Research Fellow, General Practice, Queen Mary University of LondonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1439302020-08-06T16:25:52Z2020-08-06T16:25:52ZFewer opioid prescriptions in the UK look likely – and the consequences could be dire<figure><img src="https://images.theconversation.com/files/351535/original/file-20200806-14-l4ovgb.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4000%2C2664&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/prescription-bottle-backlit-oxycodone-tablets-generic-1478645945">Tomas Nevesely/Shutterstock</a></span></figcaption></figure><p>Painkillers such as morphine have transformed the way pain can be controlled – but there are drawbacks, not least the risk of <a href="https://europepmc.org/article/nbk/nbk470415">overdose</a> or becoming dependent. The havoc and misery caused by over-prescribing these drugs in <a href="https://theconversation.com/roots-of-opioid-epidemic-can-be-traced-back-to-two-key-changes-in-pain-management-50647">the US</a> has seen hundreds of thousands of people die prematurely. </p>
<p><a href="https://theconversation.com/what-is-chronic-pain-and-why-is-it-hard-to-treat-57943">Chronic pain</a> can be caused by a range of <a href="https://www.nhsinform.scot/illnesses-and-conditions/brain-nerves-and-spinal-cord/chronic-pain">conditions</a>, including diabetes, back problems and fibromyalgia. In England alone, 5.6 million people were given a <a href="https://www.gov.uk/government/publications/prescribed-medicines-review-report">prescription</a> for an opiate-based medicine in 2018. And at least 25% of these people are thought to have been using the drugs for three months or more. This three-month cut-off is significant as it is the point at which the risk of dependence on these drugs develops.</p>
<p>The growing number of patients prescribed these drugs and the duration of the prescription was revealed in a <a href="https://www.gov.uk/government/publications/prescribed-medicines-review-report">recent report</a> by Public Health England. This triggered a review by the National Institute for Health and Care Excellence (Nice) examining the effectiveness of this class of pain medicines. Nice has just <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10069/consultation/html-content-2">published its guidance</a> for treating chronic pain. </p>
<p>Contrary to what many believe, these drugs were found not to be effective at managing anything more than short-term pain – three months or less. Nice suggests alternatives, including exercise, talking therapy or acupuncture. This is a radical move by Nice and will surprise many patients and doctors. </p>
<p>Doctors know how challenging it can be to wean patients off opioids, especially when patients have been taking them for decades. Patients who for whatever reason have missed a dose of their pain medication will also know how uncomfortable it can make them feel. Withdrawal <a href="http://www.naabt.org/documents/cows_induction_flow_sheet.pdf">symptoms</a> can feel like extreme flu, shivering, raised temperature, aching, vomiting and irritability. </p>
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<img alt="Elderly man in bed with a fever." src="https://images.theconversation.com/files/351620/original/file-20200806-18-138u22x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/351620/original/file-20200806-18-138u22x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/351620/original/file-20200806-18-138u22x.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/351620/original/file-20200806-18-138u22x.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/351620/original/file-20200806-18-138u22x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/351620/original/file-20200806-18-138u22x.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/351620/original/file-20200806-18-138u22x.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=504&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Withdrawal can feel like an extreme case of influenza.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/coronavirus-warning-old-people-senior-man-1505023982">simona pilolla 2/Shutterstock</a></span>
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<p>Opioids are <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1360-0443.1994.tb03745.x">known</a> to cause physical and psychological dependence, so withdrawal can be a psychological as well as a physical challenge. It is not surprising then that patients will want to avoid experiencing this double discomfort. </p>
<p>Some doctors will view the managed withdrawal process as a job <a href="https://cks.nice.org.uk/opioid-dependence#!scenario:1">for a specialist</a>, even if just to start the process, which they can then supervise once established. For some, this will be a process that will take years as they are <a href="https://www.nejm.org/doi/full/10.1056/NEJMra1604339">gradually weaned</a> off their prescribed drug, sometimes just a few milligrams a month. Although a carefully managed professional withdrawal programme won’t be life threatening, it is not without risk.</p>
<p>Beyond the withdrawal symptoms already mentioned, which could be brought on if the reduction of opioids is too rapid, there are more severe risks to patients. Many will have <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2628209/">built up a tolerance</a> to these drugs which will fall as their managed reduction takes place. This makes any relapse during this time potentially fatal. The patient may return to the dose they started on and risk a fatal overdose. This phenomenon <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/j.1360-0443.2007.02081.x?casa_token=AhwFTMY6SlIAAAAA%3ADxVX-FOOyMuggedow4vZLXJbXEdKGPolZC2bn8lMHR_D301AMZAcIr6ZPRIrpzyCoY5g7BLbWAv-wR_F1Q">has been witnessed</a> in previously heroin-dependent prisoners when released from prison.</p>
<p>But, of course, it’s not just prisoners who are at risk. Some patients whose opioid prescriptions will be reduced will find ways to maintain their usual dose. Doctor <a href="https://journals.sagepub.com/doi/full/10.1177/1178221817696077">shopping</a> is one way patients shop around for extra medication over and above the medication prescribed by their primary doctor. This can be a difficult situation for doctors to recognise. Even if they drug-test their patients – and many won’t – most tests merely show the presence or absence of a substance, not the quantity consumed. </p>
<h2>Scarcity of specialists</h2>
<p>These risks add to the case for ensuring doctors and patients receive professional and experienced support during this process. Unfortunately, this will be extremely difficult to find as the one group of professionals that they would naturally turn to have been made <a href="https://www.rcpsych.ac.uk/news-and-features/latest-news/detail/2020/02/17/addiction-psychiatry-could-be-wiped-out-in-a-decade-without-urgent-government-funding">almost extinct</a>: addiction psychiatrists. </p>
<p>Since specialist addiction was effectively contracted out to the third sector in the UK, there have been <a href="https://www.bbc.co.uk/news/uk-england-44039996">significant cuts</a> to this area of healthcare. With addiction psychiatrists being the most expensive personnel involved, it isn’t surprising that this group has rapidly shrunk to ensure the survival of services.</p>
<p>It will take years for the number of these specialists to be restored and have the ability to meet the demand that this guidance will trigger. In the meantime, doctors and patients will be left to manage the process themselves. It will be a miracle if no one dies as a consequence.</p><img src="https://counter.theconversation.com/content/143930/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ian Hamilton does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A new Nice guidance suggests exercise, talk therapy and acupuncture to treat chronic pain. Where does this leave those dependent on painkillers?Ian Hamilton, Associate Professor, Addiction and Mental Health, University of YorkLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1280202019-12-02T11:09:17Z2019-12-02T11:09:17ZHow to protect the NHS in a post-Brexit trade deal with the US<figure><img src="https://images.theconversation.com/files/304289/original/file-20191128-178107-8522b0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/1555864100?src=0733de61-1f5c-4c51-991b-35c6a650abf0-1-4&size=huge_jpg">Sherry Yates Young/Shutterstock</a></span></figcaption></figure><p>A US-UK trade deal is being negotiated, and drug prices are a key issue. Several <a href="https://www.express.co.uk/news/uk/960953/Brexit-news-donald-trump-NHS-freeloading-UK-pay-more-drugs-post-brexit-prescription-prices">US officials are demanding that foreign countries pay higher prices</a> to US drug companies. The UK government is <a href="https://www.independent.co.uk/news/uk/politics/nhs-us-trade-deal-trump-boris-johnson-healthcare-drug-prices-liz-truss-a9175261.html">denying that drug prices will be included</a>. But the UK is the weaker partner in this trade deal and might have to decide between <a href="https://theconversation.com/will-drug-prices-rise-following-a-uk-us-trade-deal-126473">accepting higher drug prices</a> or risk not signing a new US trade deal at all.</p>
<p>US drug companies are seeking “full market access” to the UK and to have “competitive pricing”. In reality, this means that US companies would expect the NHS to treat all eligible patients with their new drugs, at prices set within free-market conditions. At the moment, NHS drug prices are controlled by the National Institute for Health and Care Excellence (Nice), which evaluates their value for money. Under new trading conditions of “competitive pricing”, a US-UK trade agreement could stop Nice from setting prices based on value. </p>
<p>NHS budgets are fixed and extra money spent on overly expensive drugs will take away funding for more NHS nurses and doctors in frontline services. Also, if the UK agreed to these conditions with the US and changed national laws, the NHS would have to accept the same conditions in new trade deals with other countries – as stipulated by World Trade Organisation rules. So the prices of drugs imported from other countries could rise as well.</p>
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<a href="https://theconversation.com/conservative-plan-for-the-nhs-but-does-it-add-up-127706">Conservative plan for the NHS – but does it add up?</a>
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<p>Twenty years ago, drug prices in the US and UK were similar, but in <a href="https://edition.cnn.com/2003/ALLPOLITICS/12/08/elec04.medicare/">2003 a law was passed in the US</a> (Medicare Part B legislation) that prevented the main US health authorities from negotiating prices. Since then, the prices of drugs have risen <a href="https://www.commonwealthfund.org/chart/2017/national-trends-capita-pharmaceutical-spending-1980-2015">far more in the US than the UK</a>. </p>
<p>Currently, the average spending on drugs in the US is 2.5 times higher than in the UK. If the UK had to pay US prices for all drugs (the worst case scenario), the additional cost would be <a href="https://fournews-assets-prod-s3-ew1-nmprod.s3.amazonaws.com/media/2019/11/US-UK-trade-deal-Channel-4.pdf">£27 billion a year</a>. That’s £519 million extra a week. </p>
<p>The US prices of the <a href="https://fournews-assets-prod-s3-ew1-nmprod.s3.amazonaws.com/media/2019/11/US-UK-trade-deal-Channel-4.pdf">top 20 drugs (by NHS spend)</a> are 4.4 times higher than the UK. Looking only at the top 20 drugs, the additional spending would be £11.7 billion a year (£215 million a week). There will be many other drugs outside this top 20 that would raise this burden even higher.</p>
<h2>Enforced trading conditions</h2>
<p>Other US trade deals include “investor state dispute settlements”, which allow US companies to take <a href="https://www.state.gov/nafta-investor-state-arbitrations/">legal action to enforce trading conditions</a>. If the UK signed this type of trade deal, US drug companies could then take the NHS to court to enforce higher drug prices. Even the threat of legal action could make the NHS hesitate before challenging high prices for a new drug. One US drug company – Eli Lilly – has already <a href="https://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/disp-diff/eli.aspx?lang=eng">taken the Canadian government to court</a> over drug patents.</p>
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Read more:
<a href="https://theconversation.com/will-drug-prices-rise-following-a-uk-us-trade-deal-126473">Will drug prices rise following a UK-US trade deal?</a>
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<p>The UK has the “voluntary price access scheme” or VPAS, which sets a limit on annual NHS drug spending. Companies in the VPAS have to refund any excess sales over this limit. But the NHS Confederation, a membership body for organisations that commission and provide NHS services, warns that US drug companies could take legal action against the NHS to cancel VPAS if a US-UK trade deal was signed because, again, the scheme would <a href="https://www.theguardian.com/politics/2019/nov/01/nhs-drugs-bill-could-soar-if-johnson-signs-trump-trade-deal-report">prevent “full market access” and “competitive pricing”</a>. </p>
<p>US drug companies have an added incentive to raise prices in the UK because the UK provides “<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4802694/">reference prices</a>” for 14 other countries. These 14 other countries will not pay more than the UK prices for their drugs. So if prices rise in the UK, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4802694/">drug companies stand to gain elsewhere</a> as well.</p>
<h2>Two solutions</h2>
<p>There are two solutions to this impending problem, which most political parties could agree to if they are truly committed to protecting the NHS. </p>
<p>First, pass a parliamentary bill that prevents trade deals with other countries from damaging NHS drug prices. This bill would enforce the exclusion of any conditions in new trade agreements that undermine the role of Nice, extend drug patents or allow other countries to take legal action against the NHS.</p>
<p>Second, request a written, legally binding, commitment from the US Board of Trade that negotiations on drug pricing will not include any reference to either “full market access”, “competitive pricing” or extending patents. The continued role of Nice controlling NHS drug prices needs to be guaranteed in this legal commitment from the US. </p>
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<img alt="" src="https://images.theconversation.com/files/300094/original/file-20191104-88372-xpdf2e.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/300094/original/file-20191104-88372-xpdf2e.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=140&fit=crop&dpr=1 600w, https://images.theconversation.com/files/300094/original/file-20191104-88372-xpdf2e.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=140&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/300094/original/file-20191104-88372-xpdf2e.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=140&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/300094/original/file-20191104-88372-xpdf2e.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=176&fit=crop&dpr=1 754w, https://images.theconversation.com/files/300094/original/file-20191104-88372-xpdf2e.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=176&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/300094/original/file-20191104-88372-xpdf2e.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=176&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<p><em><a href="https://theconversation.com/uk/newsletters/the-daily-newsletter-2?utm_source=TCUK&utm_medium=linkback&utm_campaign=TCUKGE2019&utm_content=GEBannerA">Click here to subscribe to our newsletter if you believe this election should be all about the facts.</a></em></p><img src="https://counter.theconversation.com/content/128020/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Hill receives funding from World Health Organisation, UNITAID and the Clinton Health Access Initiative, not connected with this project. </span></em></p>NHS drug budgets could rise by billions of pounds a year after a US-UK trade deal.Andrew Hill, Senior Visiting Research Fellow, Translational Medicine, University of LiverpoolLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1262272019-11-26T10:48:57Z2019-11-26T10:48:57ZSome patients with suspected cancer fail to attend referral appointments – we found out why<figure><img src="https://images.theconversation.com/files/302938/original/file-20191121-524-1krwo71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/digital-render-three-chairs-plant-pot-29094811?src=334082c3-9420-4e2f-8942-51d33c523874-1-75">Oliver Klimek/Shutterstock</a></span></figcaption></figure><p>If a patient has signs or symptoms of cancer, a GP would refer him or her to a specialist. You might think every patient suspected of having cancer would be sure not to miss this visit to an oncologist, but our latest research shows that <a href="https://www.sciencedirect.com/science/article/pii/S1877782119300992#bibl0005">more than 5%</a> of patients cancel or don’t turn up for these crucial appointments. An appointment could confirm cancer, but equally, it could rule it out. </p>
<p>We found that patients who didn’t attend these appointments (let’s call them non-attending patients) were less likely than attending patients to be diagnosed with cancer. (All cancers in the UK are registered, which is how we know about cancers in patients who attended the initial appointment and later in those who didn’t.) But non-attending patients who were eventually diagnosed with cancer were 12% more likely to die <a href="https://www.sciencedirect.com/science/article/pii/S1877782119300992">within a year of receiving a diagnosis</a>.</p>
<p>Non-attending patients tended to have more advanced disease when their cancer was confirmed, suggesting they had been slower to make the GP appointment that <a href="https://www.nature.com/articles/bjc201549">resulted in a referral to a specialist</a>. </p>
<h2>Better outcomes</h2>
<p>Cancer outcomes in the UK have improved greatly over recent decades. <a href="https://webarchive.nationalarchives.gov.uk/20160107053639/http:/www.ons.gov.uk/ons/rel/cancer-unit/cancer-trends-in-england-and-wales/smps-no--66/index.html">People with cancer</a> now live longer and have a greater chance of the disease being successfully treated. These <a href="https://www.nature.com/articles/bjc201549">improvements</a> are because treatments are better and cancers are being found and diagnosed sooner.</p>
<p>In the UK, <a href="https://www.sciencedirect.com/science/article/pii/S0959804913000889">quicker cancer diagnoses</a> have happened partly through shortening the time between patients’ first report of symptoms and the diagnosis being made. In 2000, the <a href="https://www.thh.nhs.uk/documents/_Departments/Cancer/NHSCancerPlan.pdf">NHS introduced a two-week-wait policy</a> which, as the name suggests, aimed to ensure that people who may have cancer are seen by a specialist within <a href="https://www.england.nhs.uk/wp-content/uploads/2015/03/delivering-cancer-wait-times.pdf">two weeks of a GP referral</a>.</p>
<p>The UK’s National Institute for Health and Care Excellence (NICE) <a href="https://www.nice.org.uk/guidance/ng12">recently changed</a> the two-week-wait policy, lowering the threshold at which a GP should refer a patient to a cancer specialist. For example, under the new guidelines, GPs should now refer patients aged over 40 with unexplained weight loss and abdominal pain, thereby increasing the referral of more patients with non-specific symptoms that could be cancer. </p>
<p>In England there are now <a href="https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2017/06/Cancer-Waiting-Times-Annual-Report-201617-1.pdf">1.9 million two-week-wait referrals</a> each year and <a href="https://fingertips.phe.org.uk/profile/cancerservices/data#page/0/gid/1938133085/pat/46/par/E39000030/ati/153/are/E38000010">48% of all cancers</a> in the UK are diagnosed through this route. Most other cancers are identified through emergency hospital admission or screening. </p>
<p>Lowering referral thresholds has identified more cancers - the planned outcome – but it has also reduced the chance that a referred patient will actually have cancer. The rate of cancer diagnosis <a href="https://fingertips.phe.org.uk/profile/cancerservices/data#page/0/gid/1938133085/pat/46/par/E39000030/ati/153/are/E38000010">is 9% among patients</a> referred under two week wait, which means that GP referrals are used to <em>rule out</em> cancer in most patients. </p>
<p>Lowering the cancer referral threshold creates two problems. First, more patients having a period of worry between GP referral and the hospital appointment. Second, for GPs, <a href="https://www.nature.com/articles/bjc201541">the difficult task of communicating</a> two pieces of potentially conflicting information to patients. One, that the referral is important, and two, that most referred patients will not have cancer.</p>
<p>Our research into patients who don’t attend their hospital appointment comprised a statistical study of more than <a href="https://www.sciencedirect.com/science/article/pii/S1877782119300992">100,000 patients who’d received an urgent referral for suspected cancer</a>, and an <a href="https://bjgp.org/content/early/2019/11/19/bjgp19X706625">interview study</a> with GPs and with patients who had cancelled or not attended their urgent referral appointment.</p>
<h2>Reasons for not attending</h2>
<p>Our statistical analysis showed that people who were least likely to attend their hospital appointment were men, the very young and the very old, patients with particular types of suspected cancer (especially gastro-intestinal cancer), people living far from the hospital, and people from poorer parts of the city.</p>
<p>The interviews revealed several reasons for not attending appointments. They included patients having several health problems or many other competing demands, patients finding it difficult to navigate the appointment system, <a href="https://journals.sagepub.com/doi/full/10.1177/0969141316645629">being afraid of the diagnosis</a>, and expecting diagnostic tests to be unpleasant or <a href="https://www.nature.com/articles/bjc2015176">embarrassing</a>. And, surprising as it may seem, some people didn’t see a possible cancer diagnosis as the most important thing in their lives.</p>
<p>All cancers, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2883152/">except for melanoma</a>, are more common in <a href="https://link.springer.com/article/10.1007/s10552-008-9256-0">lower-income groups in the UK</a>. People from <a href="https://www.nature.com/articles/6605752">higher income groups</a> also live longer after cancer is diagnosed. Poverty affects health behaviour in different ways, <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61690-6/fulltext">both directly</a> (for example, not having enough money to pay for a prescription) <a href="https://www.penguin.co.uk/books/188/188607/the-inner-level/9780141975399.html">and indirectly</a> (for example, valuing your life less than other people’s). Many practical, financial and health demands on lower-income patients <a href="https://bmjopen.bmj.com/content/5/4/e006965">can influence</a> how important they see the hospital appointment to be.</p>
<p><a href="https://www.sciencedirect.com/science/article/abs/pii/S0033350616000044">Health literacy</a> may also explain non-attendance. Health literacy is a person’s ability to find, understand and use health information and healthcare systems. It has become <a href="https://www.who.int/healthpromotion/conferences/9gchp/health-literacy/en/">highly influential</a> over the past 20 years. For example, health literacy is a <a href="https://www.bmj.com/content/344/bmj.e1602.full">predictor of life expectancy</a> in older people.</p>
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<span class="caption">Health literacy is key.</span>
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<p>Our research suggests it may play an important role in urgent referral appointments, with patients with lower levels of health literacy delaying seeing their GP about <a href="https://cebp.aacrjournals.org/content/19/9/2272.short">their symptoms</a>, or finding it difficult to use the hospital appointments system, or <a href="https://www.nature.com/articles/6605398">not understanding</a> the importance of the urgent referral hospital appointment.</p>
<p>Patients failing to attend urgent referral appointments have caused great concern among GPs and hospital staff, partly about the cost of wasted staff time, but also because of the health of these patients, who had symptoms when the GP referred them. </p>
<p>We need to find solutions to this important problem, such as GPs ensuring that patients understand the appointments system and the importance of attending, and reassuring patients about possible diagnostic tests. Contacting and re-booking non-attenders must also be a priority. </p>
<p>A greater challenge is to ensure that patients don’t delay reporting symptoms to their GP. Our research suggests that patients who delay may be at greater risk of not attending their hospital appointment, so GPs could stress the importance of attendance in those patients especially.</p>
<p><em>Correction. An earlier version of this article stated that “non-attending patients who were eventually diagnosed with cancer were 12% more likely to die from cancer within a year of receiving a diagnosis”. It should have read: “But non-attending patients who were eventually diagnosed with cancer were 12% more likely to die within a year of receiving a diagnosis.”</em></p><img src="https://counter.theconversation.com/content/126227/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The Two Week Wait study was funded by a grant from the charity Yorkshire Cancer Research. Peter Knapp also receives funding from the UK National Institute for Health Research; the Academy of Medical Sciences; and the Health Research Board of Ireland. </span></em></p>One in 20 patients referred to a cancer specialist by their GP don’t turn up.Peter Knapp, Reader in Health Sciences, University of YorkLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1246502019-11-11T11:20:18Z2019-11-11T11:20:18ZDrug experts on the new guidance for medicinal cannabis<figure><img src="https://images.theconversation.com/files/300332/original/file-20191105-88372-1pb45h0.jpg?ixlib=rb-1.1.0&rect=0%2C80%2C6679%2C4405&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/commercial-marijuana-grow-operation-631014320?src=d96470f8-68a9-489a-ba89-61ebc9b3e4ac-1-29">shutterstock/Canna Obscura</a></span></figcaption></figure><p>It’s now one year since the government announced they would <a href="https://theconversation.com/medical-cannabis-and-the-challenge-for-regulation-of-medicines-97771">allow</a> access to cannabis-based products for medicinal use, and guidelines advising doctors how to prescribe <a href="https://www.nice.org.uk/guidance/NG144">have now been published</a>.</p>
<p>Opening up access to medicinal cannabis was welcomed by many as a bold policy move, but this hasn’t been matched by the reality for those trying to obtain these products. Only <a href="https://theconversation.com/uk-law-on-medicinal-cannabis-changed-six-months-ago-what-have-we-learned-114846">a few</a> patients have been able to access medicinal cannabis on the NHS. Others have secured access through expensive private prescriptions – albeit still in small numbers. </p>
<p>Rescheduling cannabis-based products for medicinal use was a legal move which meant that doctors could prescribe, but not necessarily that they would prescribe. Indeed, doctors and their professional bodies have been cautious – waiting for The National Institute for Health and Care Excellence (<a href="https://www.nice.org.uk/about">NICE</a>) to publish its clinical guidance on the topic. As with other guidance, it serves as advice rather than instruction, but doctors working in the NHS very rarely contradict NICE recommendations. </p>
<h2>What the guidelines say</h2>
<p>In short, NICE has concluded that more research is needed before it can recommend the use of cannabis-based products for medicinal use. </p>
<p>To reach this conclusion, NICE examined thousands of studies and found that most evidence on cannabis-based products for medicinal use was poor – and much weaker than is often popularly discussed. So despite high profile stories of individual patients benefiting from cannabis, NICE hasn’t recommended that such treatments should be provided on the NHS. </p>
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<p>Not for the first time <a href="https://www.thetimes.co.uk/article/medical-cannabis-will-fuel-addiction-crisis-say-doctors-bf7xv8j6b">concerns</a> about the misuse of these products were also raised. Some doctors are worried about mental health effects – with fears that patients could become dependent on the cannabis products prescribed, or that prescribed cannabis products will be sold on the black market. But given the ease with which cannabis can be <a href="https://www.gov.uk/government/statistics/drug-misuse-findings-from-the-2018-to-2019-csew">obtained illicitly</a>, it would be illogical for anyone to opt for the onerous route of obtaining a legal prescription for cannabis. </p>
<p>Research from the US suggests there is only a <a href="https://www.ncbi.nlm.nih.gov/pubmed/29468763">weak relationship</a> between the introduction of medicinal cannabis products at state level and changes in adolescent use more generally. Illicit sales and distribution of prescribed cannabis in adults is usually a result of weak clinical and regulatory oversight and poor patient monitoring – something which would be of much less concern in the UK’s <a href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency">strongly regulated</a> medicines system.</p>
<p>In the guidelines, NICE also highlights the importance of professional education, as the current understanding of cannabis-based medicines in prescribers is low. The commercial sector is <a href="https://www.independent.co.uk/voices/cbd-cannabis-legalise-thc-weed-drugs-david-lammy-a9038626.html">very active in promoting</a> cannabis and is now beginning to provide professional education as well. But it’s important that education and training are developed and delivered by independent providers who are not influenced by commercial pressures – and that training is accredited and overseen by a certifying body so the potential benefits of cannabis are not overstated.</p>
<h2>What this means for patients and doctors</h2>
<p>The hope was that patients and doctors would now have a list of recommended cannabis products and dosing regimes, matched with the conditions they can treat – as seen <a href="https://www.tga.gov.au/medicinal-cannabis-guidance-documents">in some other</a> <a href="https://www.xn--4dbcyzi5a.com/medical-cannabis-official-israeli-clinical-guide/">countries</a>. But this has not materialised. In some ways though, it may have been an unrealistic outcome. Naturally, excitement and interest in cannabis led to raised patient expectations and demand. But when cannabis was promoted as a medicine it also became subject to the same system of checks and balances as other medicines, and the same questions of evidence and affordability. </p>
<p>So while the new guidelines describe how the process of accessing and prescribing such products should be managed, it’s unlikely many NHS patients or their doctors will be navigating this system – at least for the time being. This will no doubt disappoint many patients and some doctors. </p>
<p>NICE will review these guidelines as <a href="https://www.nihr.ac.uk/documents/cannabis-based-products-for-medicinal-use/11654">new evidence</a> <a href="https://www.theguardian.com/society/2019/nov/03/medical-cannabis-uk-clinical-trial-patients-nhs">emerges</a>. But it’s worth keeping in mind that the original decision to change the law on cannabis was led more by <a href="https://theconversation.com/uk-law-on-medicinal-cannabis-changed-six-months-ago-what-have-we-learned-114846">political than clinical considerations</a>. So it would be naive to think any change in the new guidance would be instigated purely by newly emerging evidence. Commercial and political interests will also play a part. </p>
<p>Some patients may receive cannabis medicines as part of these new clinical trials. But a lack of prescriptions may leave many other people with a difficult decision – should they <a href="https://www.theguardian.com/society/2019/oct/27/minister-told-mother-to-flout-cannabis-law-for-epileptic-son">break the law</a> in the pursuit of something they think will improve their health? Only time will tell whether the police and courts will begin to <a href="https://www.bmj.com/content/363/bmj.k4844">take into account</a> people’s claims they are buying and <a href="https://www.vice.com/en_uk/article/bj9zpd/growing-weed-penalty-uk-arrests">growing</a> cannabis to self-treat a medical condition.</p><img src="https://counter.theconversation.com/content/124650/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Harry Sumnall receives and has received funding from public grant awarding bodies for alcohol and other drugs research. He was an unpaid member of the Advisory Council on the Misuse of Drugs (ACMD) when the recommendation to reschedule cannabis was made and is currently an unpaid co-optee of the ACMD Working Group that is developing further recommendations on cannabis-based medicinal products and evaluating the impact of rescheduling. Please note that the contents and framing of this article are deliberately not based on any privileged information emerging from that work. Harry received travel expenses to contribute to a public health discussion panel at the 2018 Cannabis Europa conference in London. He has sat on previous NICE guideline development groups unrelated to medical cannabis. This article represents his personal views only.</span></em></p><p class="fine-print"><em><span>Ian Hamilton does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>NICE has concluded that more research is needed before it can recommend the use of cannabis based products for medicinal use.Ian Hamilton, Associate Professor, University of YorkHarry Sumnall, Professor in Substance Use, Liverpool John Moores UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1225672019-09-20T10:06:10Z2019-09-20T10:06:10ZAlcohol advice for pregnant women – a lost opportunity to communicate new guidelines<figure><img src="https://images.theconversation.com/files/292425/original/file-20190913-8687-1nomvi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/cropped-image-midwife-measuring-blood-pressure-638474116?src=wzkcZpuhqZ3gI4s5Op3B4Q-1-10">Shutterstock/Newman Studio</a></span></figcaption></figure><p>Pregnant women in the UK are now <a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/545937/UK_CMOs__report.pdf">officially advised</a> to consume no alcohol at all. These guidelines, from the Chief Medical Officer (CMO), were issued in January 2016, and replaced a previous recommendation that women should limit themselves to one or two units of alcohol, once or twice per week, and not get drunk. </p>
<p>But how widely were these more recent guidelines promoted, and how well did such an important message get passed on to mothers-to-be? In our <a href="http://www.ias.org.uk/uploads/pdf/IAS%20reports/rp37092019.pdf">recent study</a>, we examined awareness and implementation among midwives. And our findings show that more than three years after the guidelines were published, only 58% said they were of aware of them. </p>
<p>There was also variation in what midwives thought the content of the CMO guidelines were. Alongside abstinence, some 19% believed it to be the same limit of units as before – a limit set in <a href="https://www.nice.org.uk">National Institute for Health and Care Excellence</a> (NICE) guidelines.</p>
<p>Midwives told us that NICE guidelines are commonly used to inform their work. Since those were not updated to align with the government’s alcohol guidelines until December 2018, it is perhaps unsurprising that midwives gave mixed responses. </p>
<p>Nonetheless, we found that 97% of midwives said they advised all women to abstain from alcohol at the first antenatal appointment, which usually takes place during the first ten weeks of pregnancy. In subsequent appointments, however, only around two fifths of midwives always or usually advised women to abstain. </p>
<p>This might reflect what midwives told us in interviews about taking time to build a trusting relationship with women, and that bringing up the subject of alcohol later on was felt to be a good strategy.</p>
<p>Our survey also showed that after qualifying, midwives received little – if any – follow up training on alcohol. Nor is alcohol included in annual training updates, unlike smoking, which is. </p>
<p>This is an important gap, given the changes in guidelines over time. And it reflects what seems to be a missed opportunity to ensure that alcohol is prioritised within governmental maternal health policy. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-problem-of-drinking-in-pregnancy-and-what-to-do-about-it-106129">The problem of drinking in pregnancy – and what to do about it</a>
</strong>
</em>
</p>
<hr>
<h2>The pressure in maternity care</h2>
<p>In recent years, the public health role of midwives has become vastly more extensive. It covers a range of topics including antenatal screening, immunisation, mental health and risks like smoking, alcohol and drug use. </p>
<p>Yet we found that while midwives acknowledged that public health is an important part of their role, they often feel limited by time constraints during antenatal appointments for women with uncomplicated pregnancies.</p>
<p>With a <a href="https://www.rcm.org.uk/news-views/rcm-opinion/2019/england-short-of-almost-2-500-midwives-new-birth-figures-confirm/">national staff shortage of midwives</a> it’s hardly surprising that attending extra training sessions is a challenge in itself. </p>
<p>So, did the government succeeded with introducing their updated CMO guidelines in 2016? Our study suggests not, likely due to the NICE guidelines remaining unchanged for a substantial amount of time after the adjustment. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/293195/original/file-20190919-22433-yojaye.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/293195/original/file-20190919-22433-yojaye.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=316&fit=crop&dpr=1 600w, https://images.theconversation.com/files/293195/original/file-20190919-22433-yojaye.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=316&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/293195/original/file-20190919-22433-yojaye.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=316&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/293195/original/file-20190919-22433-yojaye.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=397&fit=crop&dpr=1 754w, https://images.theconversation.com/files/293195/original/file-20190919-22433-yojaye.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=397&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/293195/original/file-20190919-22433-yojaye.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=397&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Sticking to the soft stuff.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/close-pouring-purified-fresh-drink-water-658012429?src=u1CBEbNYSfJuR53ejxoklA-1-0">Shutterstock/Cozine</a></span>
</figcaption>
</figure>
<p>This does not mean that midwives did not advise abstinence as the guidelines recommended. But in order to ensure that a workforce that is under increasing pressure are aware of changes to guidelines, better communication is required. </p>
<p>The problem of lack of knowledge about drinking guidelines is not isolated to health professionals, of course. <a href="https://academic.oup.com/alcalc/article/53/4/453/4812631">A study of the general population</a> showed that while 71% were aware that general alcohol guidelines had been updated in 2016, only 8% knew what they were (a maximum of 14 units per week for both men and women spread over three days or more). </p>
<p>Updating drinking guidelines in line with the latest research is a good idea. It can help people change their behaviours and reduce harm. But those updates seem futile unless they are accompanied by investing in efforts to support health professionals in their efforts to share the latest information with the people under their care.</p><img src="https://counter.theconversation.com/content/122567/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lisa Schölin has received funding from the Institute for Alcohol Studies. Lisa Schölin currently works as a temporary policy analyst at Foundation for Alcohol Research and Education. </span></em></p><p class="fine-print"><em><span>Lesley Smith does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Front line professionals need more support and time.Lisa Schölin, Visiting Research Fellow, Liverpool John Moores UniversityLesley Smith, Professor of Women's Public Health, Institute of Clinical and Applied Health Research, University of HullLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/965622018-05-31T13:11:32Z2018-05-31T13:11:32ZUK spends generously to extend lives of people with terminal illnesses – against the public’s wishes<figure><img src="https://images.theconversation.com/files/219955/original/file-20180522-51095-20z8b8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/heart-pulse-monitor-flatline-raster-version-87801649?src=2fR2njpIEc8B5gFq7pitTw-1-60">Tripplex</a></span></figcaption></figure><p>When deciding which treatments publicly funded healthcare systems should provide, medicines that extend terminally ill patients’ lives are among the most hotly debated – particularly for advanced cancer. </p>
<p>The National Health Service (NHS) spent an <a href="https://www.england.nhs.uk/publication/next-steps-on-the-nhs-five-year-forward-view/">estimated</a> £17 billion on medicines in England in 2016-17, roughly 13% of its budget. This was up from £13 billion in 2010-11, with the medicine bill <a href="https://www.kingsfund.org.uk/publications/rising-cost-medicines-nhs">currently increasing</a> at over 5% a year as <a href="https://files.digital.nhs.uk/publication/n/1/hosp-pres-eng-201617-report.pdf">new drugs</a> get ever more <a href="http://www.cancerresearchuk.org/funding-for-researchers/research-features/2016-08-10-health-economics-the-cancer-drugs-cost-conundrum">expensive</a>. </p>
<p>Underlying this is a controversy many people probably aren’t aware of. The relevant authorities – the National Institute for Health and Care Excellence (<a href="https://www.nice.org.uk">NICE</a>) in England and Wales, and the Scottish Medicines Consortium (<a href="https://www.scottishmedicines.org.uk">SMC</a>) north of the border – take a more generous approach to approving end of life drugs than all other drugs. </p>
<p>Yet according to our research, most people are not in favour. This raises searching questions about why it happened and what to do in future. </p>
<h2>NICE numbers</h2>
<p>NICE was first set up in 1999 (and SMC in 2001) to determine the availability of different drugs and treatments nationally, thus ending postcode prescribing. </p>
<p>The two agencies decide which drugs to make available by looking at how many <a href="https://www.nice.org.uk/glossary?letter=q">quality-adjusted life years</a> or QALYs the average patient will gain from them. QALYs are calculated by multiplying how much a given treatment will lengthen a patient’s life by how much it will improve the quality. </p>
<p>You can then work out the “cost per QALY” by dividing the additional cost of the treatment by the number of QALYs gained. This is used to compare how much different treatments will improve patients’ health, per pound spent. For more explanation, watch this video:</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/wtmz0hhxrV4?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
</figure>
<p>When NICE and SMC were set up, they both introduced a <a href="https://www.nice.org.uk/process/pmg9/chapter/the-appraisal-of-the-evidence-and-structured-decision-making">threshold</a> of £20,000-£30,000 per QALY, above which medicines are unlikely to be recommended. This presented problems for new end of life drugs, with <a href="https://www.bmj.com/content/355/bmj.i5792">their</a> high prices and limited information about effectiveness. </p>
<p>The government was also under political pressure following <a href="https://www.telegraph.co.uk/finance/personalfinance/insurance/3378442/Victory-for-cancer-patients-as-NHS-ban-on-top-up-drugs-is-lifted.html">media reports</a> about cancer patients using life savings to buy drugs unavailable on the NHS. New Labour “cancer tsar” Mike Richards <a href="http://www.idsihealth.org/wp-content/uploads/2016/02/A-TERRIBLE-BEAUTY_resize.pdf">recommended</a> making an exception to the general threshold. NICE duly <a href="https://www.nice.org.uk/guidance/gid-tag387/documents/appraising-life-extending-end-of-life-treatments-paper2">introduced</a> supplementary guidance in 2009, which set an <a href="https://pharmaphorum.com/articles/end-of-life-treatments-what-will-nice-accept/">effective threshold</a> of £50,000 <a href="https://jamanetwork.com/journals/jama/article-abstract/2671713">per QALY</a> for medicines which extend life for at least three months. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/221014/original/file-20180530-120499-l13gli.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/221014/original/file-20180530-120499-l13gli.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/221014/original/file-20180530-120499-l13gli.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=429&fit=crop&dpr=1 600w, https://images.theconversation.com/files/221014/original/file-20180530-120499-l13gli.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=429&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/221014/original/file-20180530-120499-l13gli.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=429&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/221014/original/file-20180530-120499-l13gli.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=539&fit=crop&dpr=1 754w, https://images.theconversation.com/files/221014/original/file-20180530-120499-l13gli.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=539&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/221014/original/file-20180530-120499-l13gli.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=539&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Are all QALYs equal?</span>
<span class="attribution"><span class="source">www.joelcooper.co.uk</span></span>
</figcaption>
</figure>
<p>In 2011, the Cameron government launched a special Cancer Drugs Fund (CDF) for England to enable still more patients to access cancer drugs not (or not yet) approved by NICE. The CDF’s cost per QALY threshold <a href="https://www.ncbi.nlm.nih.gov/pubmed/27565274">was estimated</a> to be over £200,000 per QALY. The body was overhauled in 2016 because spending was getting out of hand, having spent a total of £1.3 billion on cancer drugs for 95,000 patients. </p>
<p>Nonetheless, QALYs gained through life extensions for terminally ill and cancer patients remain more highly valued than QALYs for everyone else – <a href="https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/process-and-methods-guide-addendum.pdf">at least 1.7 times more</a>. Senior figures at NICE and the CDF have justified this by <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2949905/pdf/bcp0070-0346.pdf">claiming that</a> the public places <a href="https://www.bmj.com/content/349/bmj.g5545">special value</a> on extending lives. But does this stack up? </p>
<h2>Public opinion</h2>
<p>Previous studies show <a href="https://www.sciencedirect.com/science/article/pii/S0277953618301035?via%3Dihub">mixed results</a> on public values in this context: eight out of 23 found that end of life health gains were valued more; 11 found the contrary, while another four were equivocal. This probably reflects differences in study design, but also suggests people are highly conflicted. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/219963/original/file-20180522-51105-7vwho1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/219963/original/file-20180522-51105-7vwho1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/219963/original/file-20180522-51105-7vwho1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=390&fit=crop&dpr=1 600w, https://images.theconversation.com/files/219963/original/file-20180522-51105-7vwho1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=390&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/219963/original/file-20180522-51105-7vwho1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=390&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/219963/original/file-20180522-51105-7vwho1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=490&fit=crop&dpr=1 754w, https://images.theconversation.com/files/219963/original/file-20180522-51105-7vwho1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=490&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/219963/original/file-20180522-51105-7vwho1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=490&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">What the public thinks.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-vector/illustration-group-demonstrators-protesting-perspective-color-739326304?src=0nBmitHjAP0pe-Pjg7-iBQ-1-1">rob zs</a></span>
</figcaption>
</figure>
<p>We sought to find out more. Where most studies focused on the choices respondents would make (for themselves or for society), we also looked at what people believed. We did this in three stages over a number of years. </p>
<p>First <a href="https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-015-0008-x">we sought</a> the views of 59 specialists, including academics, clinicians, people working in the pharmaceutical industry, patient families and health policy makers; plus a sample of 250 members of the public. </p>
<p>They each had to arrange 49 statement cards on a grid, placing those they most agreed and disagreed with at either end. Examples were, “Treatments should be directed towards people who have a greater chance of survival”; and “We should support an individual patient’s choice for treatments that give short life extensions”. </p>
<p>Three viewpoints <a href="https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-015-0008-x">emerged</a>:
</p><ul>
<a href="https://vimeo.com/productionattic/review/116354862/712ea88720"></a><li><a href="https://vimeo.com/productionattic/review/116354862/712ea88720"><strong>Viewpoint 1</strong></a>: Maximise health gain across the population to give best value for money overall, making no special case for end of life medicines. Many of the new cancer medicines therefore wouldn’t be provided;</li>
<a href="https://vimeo.com/productionattic/review/116354863/0a8a227bbd"></a><li><a href="https://vimeo.com/productionattic/review/116354863/0a8a227bbd"><strong>Viewpoint 2</strong></a>: Don’t deny treatments because of cost – prioritise patient rights and entitlements, not value for money. We should pay to extend lives, but all patient choice matters, not only terminally ill people; </li>
<a href="https://vimeo.com/productionattic/review/116354872/0c9ac890cf"></a><li><a href="https://vimeo.com/productionattic/review/116354872/0c9ac890cf"><strong>Viewpoint 3</strong></a>: Costs and benefits are key, as in viewpoint 1, but we should include non-health benefits like time to set your affairs in order. Sometimes even short life extensions are worth it, but it should be about quality of life and death, not extending life at all costs. </li>
</ul><p></p>
<p>We <a href="https://onlinelibrary.wiley.com/doi/full/10.1002/hec.3640">then designed</a> an online survey to test the prevalence of these views more widely. From nearly 5,000 respondents, 37% most agreed with viewpoint 1, 49% with viewpoint 2 and 9% with viewpoint 3 (the remaining 5% had mixed views). This mixed response echoes <a href="https://www.kingsfund.org.uk/publications/does-public-see-tax-rises-answer-nhs-funding-pressures">other population surveys</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/220647/original/file-20180528-80626-1g90g1z.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/220647/original/file-20180528-80626-1g90g1z.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/220647/original/file-20180528-80626-1g90g1z.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/220647/original/file-20180528-80626-1g90g1z.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/220647/original/file-20180528-80626-1g90g1z.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/220647/original/file-20180528-80626-1g90g1z.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/220647/original/file-20180528-80626-1g90g1z.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/220647/original/file-20180528-80626-1g90g1z.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">What the doctor ordered.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/white-medical-pills-on-colored-background-651760954?src=XFkX9G8vnGWzir94u3m-LA-2-7">evkaz</a></span>
</figcaption>
</figure>
<p><a href="https://www.sciencedirect.com/science/article/pii/S0277953617307499?via%3Dihub">Finally</a> we asked 1,496 respondents to choose between policy options a national body like NICE must make, and treatment choices to reflect trade-off decisions made by regional health boards with fixed budgets. </p>
<p>Just 4% supported the options closest to NICE policy, and only 6% prioritised the equivalent treatment. Far more supported policies (32%) and treatments that improved quality of life (43% for end of life and 51% for non-terminal conditions).</p>
<h2>What this means</h2>
<p>Clearly NICE is out of step with public opinion – even if it’s not simple to make policy recommendations to reflect the views we found. When people did back paying more for end of life medicines, it was not to extend lives but to improve quality. This might imply shifting resources from expensive cancer drugs towards palliative and social care services. </p>
<p>The findings also raise questions about why the disparity between public and policy exists: is it government by headlines? Is it because industry lobbyists are being listened to instead? At the same time, if pharmaceutical companies made new medicines cheaper, these would meet the general QALY thresholds and none of this would matter. That key issue doesn’t receive enough attention from politicians or the media. </p>
<p>This much is clear: there is a gap between what the public thinks and the official approach to end of life medicines. We should recognise this and reflect on where we go from here.</p><img src="https://counter.theconversation.com/content/96562/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rachel Baker received a grant from the Medical Research Council to cover research from 2011-14. </span></em></p><p class="fine-print"><em><span>Helen Mason received a grant from the Medical Research Council to cover research from 2011-14. </span></em></p><p class="fine-print"><em><span>Neil McHugh received a grant from the Medical Research Council to cover research from 2011-14. </span></em></p>New findings show what the public really thinks about how we prioritise treatments at the end of people’s lives.Rachel Baker, Professor of Health Economics, Director Yunus Centre for Social Business and Health, Glasgow Caledonian UniversityHelen Mason, Professor of Health Economics, Glasgow Caledonian UniversityNeil McHugh, Research Fellow, Health Economics, Glasgow Caledonian UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/870352018-03-26T15:16:45Z2018-03-26T15:16:45ZGene therapies are proving their worth, but with million dollar price tags, it’s not clear who should pay for them<figure><img src="https://images.theconversation.com/files/211924/original/file-20180326-148742-jq9r9l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/430593091?src=3GyINNbIEk51CeYt_6wggQ-1-7&size=medium_jpg">Festa/Shutterstock</a></span></figcaption></figure><p>If you were born with a rare form of blindness, there is now a treatment for you that may restore your eyesight. That’s because gene therapies became a clinical reality in 2017. Yet many people with rare diseases that could be treated in this way may never benefit from these therapies because they are too expensive for drug companies to develop, or too costly for the patient or health service to afford. Is witnessing a starry night worth an eye-watering <a href="https://www.statnews.com/2018/03/21/gene-therapy-luxturna-launch/?utm_source=STAT+Newsletters&utm_campaign=5d2675fbab-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-5d2675fbab-149899525">US$425,000</a> per eye?</p>
<p>There are fewer things more harrowing than news that your child suffers from a rare genetic disorder that will consign them to a disabled, progressively worsening or possibly very short life. For example, spinal muscular atrophy is a debilitating, muscle-wasting disease caused by death of neurons (nerve cells) in the spine. The neurons are meant to produce a protein that is necessary for their survival, but in these patients, the levels of this protein are low to nonexistent. And the lower the level of this protein, the more the patient suffers. </p>
<p>The most severely affected are unable to sit and may even die before their second birthday without mechanical support for their breathing. Yet, almost a year ago, the US Food and Drug Administration <a href="https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm534611.htm">approved</a> the sale of a new drug, nusinersen, for the treatment of this disease. Nusinersen tricks the spinal neurons into using another gene to produce the protein, allowing the patient to survive. </p>
<p>Many doctors have rightly called the drug <a href="http://www.sciencemag.org/news/2016/12/updated-fda-approves-drug-rescues-babies-fatal-neurodegenerative-disease">a miracle</a>. There are severely affected children who received nusinersen in clinical trials and are now at school, enjoying ball games in the playground. </p>
<p>Hope arrived for other rare diseases, too. <a href="https://www.nature.com/articles/nature24487">Genetically engineered skin stem cells</a> restored about 80% of the skin of a seven-year-old who had suffered from blisters and open wounds from birth due to a genetic disorder. Two drug companies received approval for groundbreaking gene therapies for <a href="https://labiotech.eu/yescarta-kymriah-car-t-therapy/">childhood leukemias</a>. Another gene therapy designed for so-called <a href="https://www.fiercepharma.com/pharma/gsk-picks-up-nice-recommendation-for-strimvelis-a-eu594-000-gene-therapy">bubble boy syndrome</a> also hit the market, followed recently by a fourth for an <a href="https://doi.org/10.1016/j.preteyeres.2017.10.004">inherited form of blindness</a>. </p>
<p>Besides fixing the genomes of embryos, <a href="https://www.theguardian.com/science/2017/nov/15/scientists-make-first-ever-attempt-at-gene-editing-inside-the-body">editing the genome of an adult</a> has now also been attempted to fix small but devastating genetic errors. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/211964/original/file-20180326-148717-m3i5as.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/211964/original/file-20180326-148717-m3i5as.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/211964/original/file-20180326-148717-m3i5as.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/211964/original/file-20180326-148717-m3i5as.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/211964/original/file-20180326-148717-m3i5as.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/211964/original/file-20180326-148717-m3i5as.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/211964/original/file-20180326-148717-m3i5as.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Children who received nusinersen in clinical trials for spinal muscular atrophy are leading normal lives.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/332743895?src=0pk2_pdBurTK2LnMwhOPuQ-1-1&size=medium_jpg">NadyaEugene/Shutterstock.com</a></span>
</figcaption>
</figure>
<h2>Lifetime costs</h2>
<p>The cost of these treatments, though, ranges from about US$500,000 to <a href="https://endpts.com/cascade-of-costs-could-push-new-gene-therapy-above-1-million-per-patient/">US$1.5m</a>. And over a lifetime, drugs like nusinersen can be even more expensive: US$750,000 in the first year followed by US$375,000 a year after that – for life.</p>
<p>As these prices suggest, it’s expensive to get a gene therapy drug to the market. It takes many years from drug design to approval. Even if the drug is approved by the regulators, costs might be so high, and patients so few, that it ultimately makes no commercial sense for drug companies to make and sell such drugs. </p>
<p>So far, four gene therapies have been pulled off the market, the last one being the US$1m gene therapy, Glybera, used to treat a rare inherited disorder called lipoprotein lipase deficiency. Approved in 2012 and apparently <a href="https://www.technologyreview.com/s/601165/the-worlds-most-expensive-medicine-is-a-bust/">sold to just one patient</a>, it was eventually dropped in 2016. </p>
<h2>Crowdfunding</h2>
<p>So, what does the future hold for gene therapy treatments and the patient’s purse? Since 2015, drugs companies have started adopting <a href="https://www.reuters.com/article/us-novartis-heart/novartis-to-test-new-pricing-model-with-heart-failure-drug-idUSKCN0PA1N720150630">pay-only-if-it-works</a> approaches. Previous false starts illustrated the need to find new ways for patients to access specialist drugs and for payers to afford this new form of medicine. This needs a very clear definition of what “it works” means, by when and, crucially, for how long. Often, in these desperate situations, emotion can get in the way of reason, making the value of a day of life very difficult to price.</p>
<p>Could a crowdfunded, open-source model work? One young girl, Mila Makovec, was diagnosed with a unique mutation causing Batten’s disease (a disorder of the nervous system). An American doctor, based in Boston, believes he has designed a nusinersen-like drug for Makovec that appears to be working when tested in the lab. The owners of the nusinersen technology have given the Boston doctor the freedom to use it for Makovec. <a href="https://www.today.com/parents/batten-disease-parents-strive-raise-money-research-t107945">Crowdfunded money</a> has helped manufacture the drug and test it in animals, and now Makovec is being dosed with this experimental drug. </p>
<p>This is the apex of personalising medicine: a unique drug, probably suitable only for a single patient, ever. However, in the six months that I’ve been following Makovec’s story, the costs have more than doubled. So far, this new drug has cost more than <a href="https://www.gofundme.com/savingmila">US$1.6m</a>. </p>
<h2>Approving an entire class of drugs</h2>
<p>These successes and challenges have forced researchers, pharmaceutical companies and organisations, such as the UK’s National Institute for Health and Care Excellence (NICE), to <a href="https://www.fiercepharma.com/financials/car-t-and-other-gene-therapies-need-new-payment-model-says-express-scripts">re-evaluate payment models</a> for personalised medical treatments. One group of experts even called for approving an entire class of drugs and <a href="http://online.liebertpub.com/doi/pdfplus/10.1089/nat.2017.0682">extrapolating</a> between trials, drugs and possibly even diseases, helping to bring the cost down.</p>
<p>There is merit in this proposal; it opens the doors of hope for the handfuls of patients, or even unique patients like Makovec, that would otherwise be impossible to treat and condemned to premature, painful death. History, however, teaches us that there is no such thing as a safe family of drugs. In 2006, a phase one clinical trial for an experimental drug called <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964774/">TGN1412</a> caused an adverse reaction in the participants, all six of whom ended up in intensive care, fighting for their lives. Although TGN1412 was not a gene therapy, the story serves as a sombre reminder of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964774/">things could go wrong</a> and how experiments in cells and animals do not always prepare us for what may happen in a human.</p><img src="https://counter.theconversation.com/content/87035/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sterghios Moschos is affiliated with the Oligonucleotide Therapeutics Society, the RNA Society, the American Society of Gene and Cell Therapy, the British Society of Cell and Gene Therapy, the Genetics Society, and The British Pharmacological Society. He is also a Fellow of the Royal Society of Chemistry and the Institute of Biomedical Sciences. </span></em></p>An increasing list of rare diseases can now be treated with gene therapy. But we need to figure out a way to make them affordable.Sterghios Moschos, Associate Professor in Cellular and Molecular Sciences, Northumbria University, NewcastleLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/736102017-05-04T09:54:31Z2017-05-04T09:54:31ZCommunity weight loss programmes should be more widely available - here’s why<figure><img src="https://images.theconversation.com/files/167490/original/file-20170502-17251-yfpw47.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/234997663?src=V7LR46JFYQA1-Cow-3hRLw-1-5&size=medium_jpg">Rosie Apples</a></span></figcaption></figure><p>Community weight loss programmes, such as Weight Watchers, are effective at helping people to lose weight, our <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30647-5/fulltext?elsca1=tlpr">latest research</a> shows. We found that a three-month programme helps people lose weight, but a one-year programme helps people lose more weight for longer and reduces their risk of developing type 2 diabetes. Wider availability of these programmes could help people avoid metabolic diseases, such as diabetes, and may even save the NHS money in the long run. </p>
<p>Obesity increases people’s risk of developing illnesses such as type 2 diabetes, heart disease and some cancers. In the UK, where almost <a href="http://content.digital.nhs.uk/catalogue/PUB20562/obes-phys-acti-diet-eng-2016-app.pdf">two-thirds</a> of adults are overweight or obese, some GPs are tackling this problem by referring their patients to community weight loss programmes. </p>
<p>The UK’s National Institute for Health and Care Excellence (NICE), the agency that decides which medicines and treatments are appropriate for the NHS to fund, <a href="https://www.nice.org.uk/guidance/ph53/chapter/1-Recommendations">recommends</a> that adults who are obese are referred to a structured weight loss programme for at least three months. The NICE guidance specifically highlights community weight loss programmes as both cost-effective and evidence-based interventions. However, research published in <a href="http://bmjopen.bmj.com/content/5/1/e006642">BMJ Open in 2015</a> revealed that over a seven-year period only 6% of obese adults received a referral to any form of weight management service, let alone an evidence-based programme. </p>
<p>Low referral rates can be partially explained by the reluctance of GPs to raise the issue of weight with their patients and a lack of confidence in the effectiveness of these programmes. But even when GPs are willing, there are limited services available to refer patients to. Coverage of weight management services across the UK is patchy and the quality of the services is variable. </p>
<h2>The longer the programme, the better</h2>
<p>In our study, <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30647-5/fulltext?elsca1=tlpr">published in The Lancet</a>, we compared the effectiveness and cost-effectiveness of three treatment options: referral to Weight Watchers for three months, referral to Weight Watchers for one year, and a brief intervention (one-off advice together with a self-help booklet). </p>
<p>We recruited 1,267 overweight or obese adults from 23 GP clinics across the UK and randomly allocated them to one of the three interventions. Over a two-year follow-up, those who were referred to Weight Watchers lost more weight than those who were in the self-help group. And those in the one-year programme lost more weight than those in the three-month programme. </p>
<p>A year after the intervention ended, those in the one-year programme had lost on average 6.8kg, compared with 4.8kg in the three-month group, and 3.3kg in the advice and self-help group. At two years, all groups had regained some of the weight, but those given a year-long programme were still lighter than the other groups. Those in the year-long programme had lost 4.5kg since the trial started, compared with 3kg in the three-month programme and 2.3kg in the brief intervention group. </p>
<p>Compared with participants in the other groups, those in the year-long programme also had significantly greater reductions in fasting blood glucose and glycosylated haemoglobin, which are important markers of the risk of developing diabetes. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/167497/original/file-20170502-17245-1mr43wu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/167497/original/file-20170502-17245-1mr43wu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=320&fit=crop&dpr=1 600w, https://images.theconversation.com/files/167497/original/file-20170502-17245-1mr43wu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=320&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/167497/original/file-20170502-17245-1mr43wu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=320&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/167497/original/file-20170502-17245-1mr43wu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=402&fit=crop&dpr=1 754w, https://images.theconversation.com/files/167497/original/file-20170502-17245-1mr43wu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=402&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/167497/original/file-20170502-17245-1mr43wu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=402&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Some GPs may find it difficult to raise the issue of weight with their patients.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/271845803?src=pQ5Y13-5qF9RH0uD1vFpIA-1-0&size=medium_jpg">Syda Productions/Shutterstock</a></span>
</figcaption>
</figure>
<h2>Modelling the long-term impact</h2>
<p>To understand the long-term cost-effectiveness of these programmes, we modelled their impact over 25 years. Modelling uses assumptions as well as hard data, which might cause scepticism, so in our modelling we tried to make conservative assumptions – such as assuming that all weight lost was regained after five years and that the full cost of the programme was incurred if people attended one session (when in practice this might not be the case). </p>
<p>With this model we found that, compared with the self-help group, the three-month programme achieved greater reductions in weight-related illnesses. Cost-savings on NHS treatment outweighed the cost of the programme – a net saving of about £2.68 per person referred. </p>
<p>The year-long programme achieved greater weight loss for longer, so led to even bigger reductions in illnesses. The extra costs of the year-long programme were not offset by savings on NHS treatment costs (the additional treatment cost was estimated at £49 per person), but it was still very cost-effective by <a href="https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness">NICE standards</a>. The benefits may even be underestimated because our model did not include potential savings in social care and indirect healthcare costs.</p>
<p>While modelled data does not provide the same level of evidence as the findings from the randomised controlled trial, it does add to <a href="https://www.nice.org.uk/guidance/ph53/evidence">previous evidence</a> that these programmes are a cost-effective treatment option. </p>
<p>So what barriers might prevent greater investment in them? Community weight loss programmes are commissioned by local authorities, but our data shows the benefit as being a reduction in NHS treatment costs (that is, a different department), and only in the long term. The focus on savings in NHS treatment costs may distract from the wider social and economic benefits of a reduction in obesity, which are not captured in current cost-effectiveness models. </p>
<p>With constrained budgets and short parliaments, local authorities may struggle to take the necessary long-term perspective and may focus on what they can afford now. While this is understandable, it may mean we miss a vital opportunity to provide effective treatment options to millions of people who need them.</p><img src="https://counter.theconversation.com/content/73610/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Amy Ahern has received research grants from the National Prevention Research Initiative, the National Institute of Health Research, and the BUPA foundation. She is also a trustee of the Association for the Study of Obesity. The trial described in this article was funded by the National Prevention Research Initiative. Weight Watchers International provided funds to the Medical Research Council to enable the collection and analysis of blood samples and provided the intervention to participants at no cost. The views in this article are her own. </span></em></p>It’s time we considered the long-term benefits of community weight loss programmes to both individuals and society.Amy Ahern, Senior Investigator Scientist, University of CambridgeLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/649312016-09-12T10:42:16Z2016-09-12T10:42:16ZWhy are vaccination rates in England falling?<figure><img src="https://images.theconversation.com/files/137089/original/image-20160908-25253-1bsc7an.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-432466561/stock-photo-vaccination-for-women-in-vaccine-roomselective-focusmedical-concept.html?src=MGpi8gJPZveksm6kA4A9DA-1-12">Komsan Loonprom/Shutterstock.com</a></span></figcaption></figure><p><a href="https://www.nice.org.uk/news/article/nice-to-tackle-falling-child-vaccination-rates">Millions of children</a> in England risk contracting potentially fatal diseases as vaccination rates continue to fall for the second year running. According to Gillian Leng, deputy chief executive of the UK’s National Institute for Health and Care Excellence, about 3m children and adolescents may have missed their mumps, measles and rubella (MMR) vaccine.</p>
<p>It is not possible to vaccinate every child in the country. At any given time, some children will be too young and a very small number will have allergies or other conditions that make vaccination unacceptably risky. However, if a sufficient proportion of the population are vaccinated, a disease cannot spread and everyone is protected. This is known as “<a href="https://theconversation.com/explainer-what-is-herd-immunity-52377">herd immunity</a>”. The World Health Organisation (WHO) considers that a 95% uptake is necessary to achieve this protection. </p>
<p>Low vaccination rates are a particularly English problem: Scotland, Wales and Northern Ireland all achieve the WHO target, although there are pockets, particularly in economically deprived urban areas, where they fall short. In England, the national rates are 2-3% below WHO recommended levels. In some urban areas, particularly those with high levels of deprivation and minority ethnic populations, rates fall towards 80%. This creates a high risk of outbreaks of serious childhood diseases.</p>
<h2>Reasons for the fall in uptake</h2>
<p>The decline in vaccination rates is often attributed to parental resistance provoked in the late 1990s by the <a href="https://theconversation.com/mondays-medical-myth-the-mmr-vaccine-causes-autism-3739">now-discredited claim</a> made by Andrew Wakefield of a link between the MMR vaccine and autism. However, the comparisons between the different nations within the UK suggest a more complex picture. </p>
<p>Before we blame parents, we should consider whether they have easy access to child health advice and vaccination services. If they are not aware of the benefits and cannot get to the places where vaccines are available, we should not be surprised if their children are not vaccinated. </p>
<p>Although the UK has a single framework of principles and funding for the NHS, each component nation chooses how to organise their delivery. Scotland, Wales and Northern Ireland have had less reorganisation than England so they have been able to focus on providing rather than reforming their services. </p>
<p>An improvement in <a href="https://www.gov.uk/government/statistics/cover-of-vaccination-evaluated-rapidly-cover-programme-2015-to-2016-quarterly-data">vaccination rates</a> in England coincided with the rebuilding of the health visiting service under the 2010-15 UK coalition government. Health visitors are specialist nurses who provide screening, counselling, advice and support to all families with children from birth to the age of five. <a href="http://www.unitetheunion.org/uploaded/documents/Health%20visiting%20in%20England%20May%20201611-26805.pdf">Health visitor numbers increased</a> by 49% and the average caseload for each health visitor fell from just over 400 to around 280 children. Staffing shortages remained in the urban areas where low vaccination rates are found. </p>
<p>However, much of this investment has since been negated by <a href="http://www.unitetheunion.org/uploaded/documents/Health%20visiting%20in%20England%20May%20201611-26805.pdf">local authority cuts</a> since they took over responsibility for the service in October 2015. The improvement in vaccination rates seems to have come <a href="https://www.nice.org.uk/news/article/nice-to-tackle-falling-child-vaccination-rates">to a halt or reversed slightly</a> in the last two years. This is a time when there have been increasing cutbacks in Sure Start children’s centres – their <a href="http://sticerd.lse.ac.uk/dps/case/spcc/RR04_SUMMARY.pdf">numbers and budgets</a> are down by about a quarter since 2010 – and problems in <a href="https://www.nice.org.uk/guidance/GID-QS10015/documents/briefing-paper">sustaining GP vaccination clinics</a> among the other pressures on primary care. </p>
<p>The lack of support for reaching out to parents contributes to the low uptake. Traveller groups, for example, have difficulty accessing healthcare. Some minorities have distinctive medical traditions. These beliefs are often dismissed as irrational or primitive by health professionals – a poor foundation for persuading parents of the benefits of change. Recent migrants may simply not understand how the health system works and what is available to them. </p>
<p>All these problems are familiar to health visitors, whose interpersonal skills can make an impact, provided that caseloads allow enough time to engage parents. </p>
<p>Overt resistance is much less common. There are a small number of “new age” parents, whose preferences for alternative medicine could probably be accommodated without compromising herd immunity. </p>
<p>Of more concern is the emerging group of affluent parents who are opting out because they believe they can micromanage all risks to their children. This group has not been studied in the UK, but <a href="http://sociology.nd.edu/students/kevin-estep/">recent work</a> in California found that where there is a critical mass of parents who think this way in a school catchment, refusal rates are high because the parents believe that the minimal risks from vaccination need not be accepted. They can insulate their children from the “others” who carry infectious disease. Their children do not share school classrooms, public transport or public leisure facilities with children from poorer backgrounds. Their children’s social contacts are carefully supervised so that they only mix with other children from a similar background whose parents think in the same way. They seem to be the forerunners of the “helicopter parents” who hover over their children at university and even into first employment. </p>
<p>We may need to relearn the lessons that drove public health reform in 19th-century Britain: infectious diseases are a potential threat to everyone. No one can buy protection on an individual basis.</p><img src="https://counter.theconversation.com/content/64931/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Robert Dingwall does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>We can’t keep blaming the MMR-autism scare – there are other forces at play.Robert Dingwall, Professor, Nottingham Trent UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/644052016-09-01T09:05:26Z2016-09-01T09:05:26ZMultiple sclerosis survivors swear by hyperbaric oxygen – but does it work?<figure><img src="https://images.theconversation.com/files/135530/original/image-20160825-6604-m3202w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-372222991/stock-photo-pocatello-idaho-usa-july-22-2010-hyperbaric-chambers-in-a-wound-care-centerto-sped-healing.html?src=QWomzBGTmTc12487VVZilg-1-3">B Brown/Shutterstock</a></span></figcaption></figure><p>There is no cure for multiple sclerosis (MS) yet. As a complex neurodegenerative disease of the brain, it is incredibly difficult to treat. Despite the development of new and sophisticated therapies to control the inflammation and physical symptoms of the disease, these treatments don’t work for everyone. This is because MS comes in many guises and one treatment does not fit all. Perhaps for this reason people with MS are turning to alternative means of controlling their condition. </p>
<p>Many of the 100,000 people with MS in the UK have taken charge of managing their treatment. With the assistance of 60 or more independent charitable MS therapy centres, people with the disease regularly enter a chamber and breathe oxygen under moderate pressure (<a href="https://www.hyperbaricoxygentherapy.org.uk">hyperbaric oxygen</a>). Some people have done so for <a href="http://www.jpands.org/vol10no4/maxfield.pdf">more than 20 years</a>. </p>
<p>The air we breathe contains 21% oxygen, but 100% oxygen is considered a drug and is prescribed in hospitals to aid people’s recovery. In the case of MS, people <a href="http://www.oxygenunderpressure.com/category/multiple-sclerosis/">self-prescribe the hyperbaric oxygen</a>, which is delivered to them by trained operators. But does breathing pure oxygen under pressure on a weekly basis do them any good? </p>
<p>The idea to use oxygen as a treatment for MS began over 45 years ago. In 1970, two Romanian doctors, Boschetty and Cernoch, treated patients with brain injuries with pressurised oxygen <a href="http://www.ncbi.nlm.nih.gov/pubmed/4314654">to help more oxygen enter their tissues</a> – oxygen helps protect nerve cells from damage and maintains the integrity of the <a href="http://www.brainfacts.org/brain-basics/neuroanatomy/articles/2014/blood-brain-barrier">blood-brain barrier</a>. In a study of MS patients, they found that symptoms in 15 out of 26 volunteers improved. This led to further interest in the use of hyperbaric oxygen to treat MS specifically. </p>
<p>Since Boschetty and Cernoch’s discovery, around 14 clinical trials have been conducted. The trials have been on relatively small numbers of people and have reported conflicting results, <a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1755-5949.2009.00129.x/full">ranging from great improvements to none at all</a>. This has led to a dilemma: should clinicians endorse the use of hyperbaric oxygen for MS or not? </p>
<h2>Not officially sanctioned</h2>
<p>The clinical regulatory bodies in the US and the UK, <a href="http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm364687.htm">the FDA</a> and <a href="https://www.nice.org.uk/donotdo/interventions-affecting-disease-progression-hyperbaric-oxygen-should-not-be-used-in-patients-with-multiple-sclerosis-because-research-evidence-does-not-show-beneficial-effects-on-the-course-of-the">NICE</a> respectively, do not feel the clinical trial evidence is strong enough to endorse the procedure, yet thousands of people in the UK and elsewhere continue to treat themselves with hyperbaric oxygen. Between 1982 and 2011, over 20,000 people with MS in the UK used hyperbaric oxygen <a href="http://www.hjernebarnet.dk/fileadmin/_temp_/Philip_James_-110405.pdf">over 2.5m times</a>. </p>
<p><a href="http://www.nhs.uk/conditions/Multiple-sclerosis/Pages/Introduction.aspx">Multiple sclerosis</a> is a chronic inflammatory disease of the brain. It is usually diagnosed between the ages of 20 and 40. Lesions in the brain develop as a result of inflammatory autoimmune cells crossing the blood-brain barrier and destroying the protective protein coat (myelin) that surrounds the axon of some nerve cells. Over time MS develops into a neurodegenerative disease, leading to problems with vision, bladder control and mobility. </p>
<p>The brain’s ability to repair some of this damage helps people with MS to feel better for a while before relapsing once more. Eventually the disease becomes chronic and the ability to repair the damage and undergo remission declines. Most conventional treatments focus on the early phases of the disease. Unfortunately, there are few treatments for the later stages of MS. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/135521/original/image-20160825-6625-11w4vb8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/135521/original/image-20160825-6625-11w4vb8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=444&fit=crop&dpr=1 600w, https://images.theconversation.com/files/135521/original/image-20160825-6625-11w4vb8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=444&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/135521/original/image-20160825-6625-11w4vb8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=444&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/135521/original/image-20160825-6625-11w4vb8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=558&fit=crop&dpr=1 754w, https://images.theconversation.com/files/135521/original/image-20160825-6625-11w4vb8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=558&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/135521/original/image-20160825-6625-11w4vb8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=558&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<p>Perhaps the inability of prescribed drugs that work for all people with MS, or indeed work for some but <a href="http://www.ncbi.nlm.nih.gov/pubmed/15596735">produce unpleasant side-effects</a>, has driven people to seek other treatments. Despite the scepticism of some doctors, many people with MS claim that hyperbaric oxygen therapy <a href="http://www.express.co.uk/life-style/health/452441/Oxygen-therapy-Fresh-air-relief-for-Multiple-Sclerosis-patients">has benefits</a>. The <a href="http://www.msntc.org.uk/downloads/Perrins_and_James_IJNN_vol_2_issue_1_2005.pdf">benefits</a> include improvements in mobility, bladder control, pain relief and gait. However, since the treatment is transient, regular exposure to pressurised oxygen is required to sustain any benefit. </p>
<p>The increase in oxygen to the brain may lead to a number of effects such as speeding repair to damaged tissue, or inhibiting the ability of immune cells to cross the blood-brain barrier and cause damage. These possibilities are <a href="https://www.dovepress.com/safety-and-efficacy-of-hyperbaric-oxygen-therapy-in-chronic-wound-mana-peer-reviewed-fulltext-article-CWCMR">being investigated</a>. </p>
<h2>Poorly designed trials</h2>
<p>So why are many clinicians sceptical of hyperbaric oxygen? The main reason is various MS disability-status scores are used to judge improvement. In the former clinical trials, hyperbaric oxygen was not used over a sustained periods of time (only a few weeks) and often people with irreversible damage were used, so no or <a href="http://www.nejm.org/doi/full/10.1056/NEJM198301273080402">very little improvement in scores was seen</a>. </p>
<p>So are poorly controlled clinical trials to blame for the conflict of opinion? Probably, yes. Until we understand more at the molecular level about how oxygen under pressure can make sustained changes to various biological processes in the brain, people with MS will continue to use the treatment and the majority of the medical community will remain unconvinced of its merits.</p><img src="https://counter.theconversation.com/content/64405/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Paul Eggleton does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>There is conflicting medical evidence.Paul Eggleton, Senior lecturer in Immunology, University of ExeterLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/604722016-06-15T09:37:18Z2016-06-15T09:37:18ZSurfing helps veterans cope with PTSD<figure><img src="https://images.theconversation.com/files/125543/original/image-20160607-15031-1j3ge8l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&searchterm=surfing&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=414110377">Christian Vinces/Shutterstock.com</a></span></figcaption></figure><p>Surfing often conjures up images of freewheeling hippies, but now military veterans are <a href="http://www.surfaction.co.uk/">turning to the waves</a> to help them deal with the traumatic legacy of war. They say it gives them a wonderful “freeing” feeling, and helps them manage the psychological turmoil of their everyday lives. <a href="https://nickcaddickacademic.files.wordpress.com/2015/01/surfing-and-veterans-well-being1.pdf">Our research</a> is among the first to document the positive influence surfing can have for veterans struggling with <a href="http://www.mind.org.uk/information-support/types-of-mental-health-problems/post-traumatic-stress-disorder-ptsd/#.V1lB0k32aUk">post-traumatic stress disorder</a> (PTSD). </p>
<p>PTSD is a debilitating psychological condition that some veterans experience in the aftermath of combat. The symptoms can include <a href="https://theconversation.com/the-possible-cause-of-flashbacks-discovered-59105">flashbacks</a>, vivid nightmares, traumatic memories, and a profound and enduring sense of sadness. There are other symptoms of PTSD too, including hyper-vigilance (such as scanning rooftops for concealed snipers) and hyper-arousal (the classic example of jumping when a car back-fires).</p>
<p>You could be forgiven for believing that all soldiers inevitably come home from war damaged by their experiences, and that a <a href="http://www.telegraph.co.uk/news/uknews/defence/7716014/Medical-journal-warns-of-tidal-wave-of-mental-trauma-among-servicemen.html">“tidal wave”</a> of PTSD cases are flooding out of the military. But <a href="http://www.kcl.ac.uk/kcmhr/publications/assetfiles/iraqafghan/Fear2010-consequencesofdeployment.pdf">research</a> from Kings College London suggests that the rate of combat veterans being diagnosed with PTSD is around 7%.</p>
<h2>Moving meditation</h2>
<p>So how could surfing help? In our research we asked British war veterans about their experiences. Their stories – collected over a series of in-depth interviews and observations – reveal the strong emotional benefits that surfing brings. According to the veterans, surfing is like having PTSD “pummelled out” of their system by the force of the waves. </p>
<p>The mental state veterans report when surfing has many parallels with what psychologists call <a href="https://www.ted.com/talks/mihaly_csikszentmihalyi_on_flow?language=en">“flow”</a>, where a person becomes fully and completely involved in an activity to the exclusion of everything else. Their minds are emptied of the traumatic memories that continually cycle through them. They become immersed in the activity, much like a moving form of <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Association+of+participation+in+a+mindfulness+program+with+measures+of+PTSD%2C+depression+and+quality+of+life+in+a+veteran+sample">mindfulness</a> or meditation.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/126292/original/image-20160613-29225-17khkga.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/126292/original/image-20160613-29225-17khkga.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/126292/original/image-20160613-29225-17khkga.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/126292/original/image-20160613-29225-17khkga.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/126292/original/image-20160613-29225-17khkga.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/126292/original/image-20160613-29225-17khkga.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/126292/original/image-20160613-29225-17khkga.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Surfing – not dissimilar to meditation.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/dl2_lim.mhtml?src=pPidKUUXliiUCr-S4_a4QA-3-29&clicksrc=download_btn_inline&id=394542460&size=medium_jpg&submit_jpg=">www.shutterstock.com</a></span>
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<p>When surfing, veterans are rooted in the present moment and experience it with a renewed sense of intensity and pleasure. There’s also a connection with nature that helps to bolster veterans’ sense of mental well-being. When surfing, veterans are immersed in the natural environment, which has mental health benefits according to a growing body of <a href="http://bit.ly/1RYjFrg">research</a>. As <a href="http://www.ncbi.nlm.nih.gov/pubmed/25005502">studies</a> conducted with veterans in California suggest, it also helps build resilience, and alleviates the troubling symptoms associated with PTSD and depression.</p>
<p>But surfing is not the only complementary therapy being proposed for veterans suffering from PTSD. A wide range of activities are now being tested. These are often provided by charities and include horse therapy, gardening therapy, fly-fishing, sailing, drama therapy and <a href="https://theconversation.com/yoga-helps-war-veterans-with-post-traumatic-stress-disorder-31662">yoga</a>.</p>
<p>The UK’s <a href="https://www.nice.org.uk/guidance/CG26/chapter/1-Guidance#the-treatment-of-ptsd">National Institute for Health and Care Excellence</a> recommends psychological therapies, including trauma-focused cognitive behavioural therapy and eye movement desensitisation and reprogramming. Antidepressants are also recommended for those who don’t want, or don’t respond to talking therapies. Although these treatments help some veterans, they don’t work for everyone. That’s why it’s important that different forms of treatment and support for veterans experiencing PTSD can be shown to be effective. </p>
<p>Indeed, at a time when military charities are coming under <a href="http://www.veteranstransition.co.uk/vtrreport.pdf">increasing pressure</a> to demonstrate the effectiveness of their proposed solutions to veterans’ mental health, identifying the impact that new approaches have, and the reasons behind such impact, is crucial.</p>
<p>One priority for research in this area now is to understand how <a href="https://theconversation.com/surfing-on-prescription-helps-kids-at-breaking-point-20798">innovative approaches like surfing</a> can work alongside clinical approaches to benefit the mental health of veterans struggling to adapt in the aftermath of trauma.</p><img src="https://counter.theconversation.com/content/60472/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nick Caddick does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Talking therapy for people with post-traumatic stress disorder is one suggestion. A new study finds that surfing may be beneficial too.Nick Caddick, Research Fellow at Veterans and Families Institute, Anglia Ruskin UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/595542016-05-24T09:10:52Z2016-05-24T09:10:52ZIs there really a benefit from getting an early dementia diagnosis?<figure><img src="https://images.theconversation.com/files/123412/original/image-20160520-10353-1pudmof.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=VvQqKHVlc_w0u_NTi-XDvA&searchterm=dementia&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=402621205">Monkey Business Images/Shutterstock.com</a></span></figcaption></figure><p>The Alzheimer’s Society wants people with symptoms such as memory loss and confusion to seek early medical help. The British charity is worried that people may be putting off getting a dementia diagnosis and not receiving the health care and support they need. As the Alzheimer’s Society’s recent <a href="https://www.alzheimers.org.uk/site/scripts/news_article.php?newsID=2606">blog post</a> put it: “A lack of diagnosis is denying many people with dementia the chance of getting the best possible treatment, information and support – evidence shows the earlier on you receive these, the better your chance of living well for longer.” But is early diagnosis always a good thing?</p>
<p>Early diagnosis has also been a key policy aim for government. We can see this in the <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/168220/dh_094051.pdf">National Dementia Strategy</a>, and David Cameron’s <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/414344/pm-dementia2020.pdf">Challenge on Dementia</a>. A few years ago, the NHS even trialled a <a href="http://www.theguardian.com/society/2014/oct/22/nhs-dementia-diagnoses-gps-patients-criticised">scheme</a> to pay GPs £55 for each dementia diagnosis made. This move was widely condemned by doctors’ groups and quietly dropped after six months. In any event, the push for earlier diagnosis continues. So what exactly are the benefits of earlier diagnosis? And who are the beneficiaries?</p>
<h2>What works?</h2>
<p>There are no known treatments to prevent or reverse dementia, although drugs called memantine and acetylcholinesterase inhibitors can help to <a href="https://www.nice.org.uk/guidance/cg42/chapter/1-Guidance#interventions-for-cognitive-symptoms-and-maintenance-of-function-for-people-with-dementia">relieve symptoms </a>. </p>
<p>In the course of my recent fieldwork, however, I met some people with memory loss who invested hope in these treatments beyond what was possible. They believed that getting onto anticholinesterase inhibitors as soon as possible could delay further decline. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/123656/original/image-20160523-11025-uxjp63.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/123656/original/image-20160523-11025-uxjp63.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=900&fit=crop&dpr=1 600w, https://images.theconversation.com/files/123656/original/image-20160523-11025-uxjp63.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=900&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/123656/original/image-20160523-11025-uxjp63.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=900&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/123656/original/image-20160523-11025-uxjp63.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1130&fit=crop&dpr=1 754w, https://images.theconversation.com/files/123656/original/image-20160523-11025-uxjp63.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1130&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/123656/original/image-20160523-11025-uxjp63.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1130&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Drugs can help with symptoms.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&searchterm=person%20taking%20pills&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=245553973">Photographee.eu/Shutterstock.com</a></span>
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<p>One of the most difficult experiences in my recent research was meeting a woman who felt she had been denied treatment by the doctors, and asked me and my colleague if we were able to prescribe them for her. We had to explain that we were not clinically qualified, and in any case, the drugs would not prevent the progression of dementia. But false hope can translate into big profits for drugs companies. </p>
<p>The anticholinesterase inhibitor market had an estimated value of US$4.2 billion globally in 2011, with this figure set to increase over coming years as people <a href="https://www.rootsanalysis.com/reports/view_document/alzheimers-drug-market-2012-2017/4.html">live longer</a>. One <a href="http://store.globaldata.com/market-reports/pharmaceuticals-and-healthcare/pharmapoint-alzheimers-disease-global-drug-forecast-and-market-analysis-to-2023-event-driven-update/highlights">recent market analysis</a> identified early diagnosis as “a challenge [that] will affect the growth of the market over the 2013-2023 forecast period”.</p>
<p>Thankfully, drug treatment is not the only option for people with dementia. Anyone with suspected dementia can access a memory clinic on the NHS to seek practical support for their needs. Memory clinics typically include a range of health professionals – including occupational therapists, psychologists, specialist nurses and psychiatrists. These multidisciplinary teams can help with emotional and occupational support. They can also offer advice on adapting homes – for instance, by providing memory aids, grab rails for bathing and toileting, and extra lighting. </p>
<p>The National Institute for Health and Care Excellence (NICE) also <a href="https://www.nice.org.uk/guidance/cg42/evidence/full-guideline-including-appendices-17-195023341">recommends</a> “group cognitive stimulation programmes”. Cognitive stimulation uses enjoyable activities to engage thinking and memory – for example, musical activities, reminiscence sessions, and games. A recent <a href="http://www.cochrane.org/CD005562/DEMENTIA_can-cognitive-stimulation-benefit-people-with-dementia">review</a> suggests this approach could help to maintain cognitive abilities, particularly memory and communication. </p>
<p>However, the current evidence relies on a number of small trials of often quite different activities, going back to 1979. Nevertheless, in the absence of effective drug treatments, cognitive stimulation is important for many people with dementia, and continues to attract research and practice interest. </p>
<p>Finally, we shouldn’t underestimate the psychological importance of receiving a diagnosis. Overall, the evidence shows a <a href="http://www.ncbi.nlm.nih.gov/pubmed/21281553">mixed picture</a>. On the one hand, people are glad to understand the cause of their symptoms, to be able to plan for the future, and access resources such as dementia support groups. However, people often worry about the stigma of dementia, and some want to avoid the emotional impact of the diagnosis.</p>
<h2>Is earlier better?</h2>
<p>Over the last couple of years, I’ve been involved in a project looking at people’s experiences of mild cognitive impairment. This syndrome is defined as a “<a href="http://archneur.jamanetwork.com/article.aspx?articleid=774828">boundary state</a>” between cognitive ageing (a normal process) and dementia. </p>
<p>If the Alzheimer’s Society’s suggestion that dementia is being under-diagnosed holds, then people with mild cognitive impairment are an anomaly. They have sought medical advice for possible dementia symptoms which are not severe enough for a diagnosis. Might it be that more people are already seeking help earlier, as the Alzheimer’s Society hopes? It seems plausible. </p>
<p>After the National Dementia Strategy was launched, there was a <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3902654/">12% increase</a> in dementia diagnosis rates in the UK between 2009 and 2011, and recent studies show a continued upward trend. </p>
<p>So, who benefits from early diagnosis? As suggested above, a number of commercial and charitable organisations stand to gain substantially. There are also some benefits that may accrue to people with dementia from an early diagnosis in terms of symptom control and cognitive stimulation. Though any potential gains are small, these can still be meaningful to the person. </p>
<p>The other side of this, however, is the risk of <a href="https://theconversation.com/preventing-over-diagnosis-how-to-stop-harming-the-healthy-8569">over-diagnosis</a> and increased public health anxiety associated with such “public awareness” campaigns. For example, our recent review of mild cognitive impairment research suggests people with this diagnosis live with significant uncertainty about the <a href="https://gerontologist.oxfordjournals.org/content/early/2015/08/26/geront.gnv067.full.pdf">cause of their problems</a>. </p>
<p>These patients often continue to worry about possible dementia, and the infrastructure for supporting them is patchy at best. The ethics of diagnosing people who may have no underlying illness has also been <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2682374/">questioned</a>. So yes, we should be helping people with dementia to get the support they need as soon as possible. But this shouldn’t come at the cost of over-diagnosing and over-medicating people.</p><img src="https://counter.theconversation.com/content/59554/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Tim Gomersall does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The Alzheimer’s Society is concerned that people with dementia aren’t getting diagnosed soon enough. But there are pros and cons to an early diagnosis.Tim Gomersall, Senior Lecturer in Psychology, University of HuddersfieldLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/591022016-05-12T13:00:38Z2016-05-12T13:00:38ZLocal takeaways create a double burden for obesity<figure><img src="https://images.theconversation.com/files/122120/original/image-20160511-18157-1ltnfqf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Poor neighbourhoods have more takeaway outlets.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=AMsT084965JL8j4WNoHf8Q&searchterm=fish%20and%20chip%20shop&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=256404478">pxl.store / Shutterstock.com</a></span></figcaption></figure><p>People in the UK are spending <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/485982/familyfood-2014report-17dec15.pdf">more than ever</a> on takeaway food and there’s good reason to believe that this is contributing to the nation’s obesity problem. Two-thirds of UK adults are either <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/295149/07-1662-obesity-modelling-trends.pdf">overweight or obese</a>.</p>
<p>But the amount of excess weight the nation is carrying isn’t equal. On average, people in socially disadvantaged groups – those less educated or on lower incomes – are more likely to be <a href="http://www.noo.org.uk/LA/impact/education">overweight</a>. This can be explained by the fact that the socially disadvantaged tend to have <a href="http://www.sciencedirect.com/science/article/pii/S019566631500255X">less time for cooking</a>, <a href="http://her.oxfordjournals.org/content/15/2/163.long">less knowledge about healthy eating</a> and <a href="http://nutritionreviews.oxfordjournals.org/content/67/suppl_1/S36.long">less money for healthy food</a>. Levels of takeaway food consumption are also greater <a href="http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=8468256&fileId=S136898001100139X">in disadvantaged groups</a>.</p>
<p>Disadvantage can also be environmental. We know that disadvantaged neighbourhoods tend to have <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/296248/Obesity_and_environment_March2014.pdf">greater numbers of takeaway outlets</a>. Although all UK neighbourhoods have become less healthy in the last two decades, disadvantaged neighbourhoods have <a href="http://www.sciencedirect.com/science/article/pii/S1353829215000325">become unhealthier fastest</a>. It would seem to make sense then that unequal neighbourhoods could be contributing to unequal waistlines. </p>
<h2>“But I never use my local takeaway”</h2>
<p>This, of course, assumes that neighbourhood food access influences what people eat and how much they weigh. A growing body of evidence suggests that it does. In an analysis, using data on nearly 6,000 people from the Fenland Study in Cambridgeshire, we showed that the greatest neighbourhood exposure to takeaway food was linked to consuming the equivalent of an additional serving of French fries per week and nearly <a href="http://www.bmj.com/content/348/bmj.g1464">doubling</a> one’s odds of obesity.</p>
<p>We might like to believe that we make entirely free choices about what, when and where to eat. And we often hear from people that they never use their local takeaway outlets. But given that we need to buy our food from somewhere, we’re all influenced to some degree by what’s on offer within our environment. For people living or working in areas full of takeaways but short on healthier options, unhealthy choices are likely to be the easiest or only option. Among our Cambridgeshire adults, as many as <a href="https://ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-10-85">47 takeaway outlets</a> were present within just a mile of one person’s home. And growth in the takeaway sector over two decades outpaced that of <a href="http://www.sciencedirect.com/science/article/pii/S1353829215000325">supermarkets</a>, convenience stores and restaurants, so our environment has become more imbalanced towards greater availability of takeaway food. </p>
<h2>Understanding levels of influence</h2>
<p>Our <a href="http://ajcn.nutrition.org/content/early/2016/05/11/ajcn.115.128132.full.pdf+html">new study</a> explores the interplay between social disadvantage and access to neighbourhood takeaway outlets. We used low educational attainment as a marker of social disadvantage – so it’s also an indication of lacking the social, economic, behavioural and psychological resources that might leave people more vulnerable to their environment. For example, less well off consumers are particularly <a href="http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=9994657&fileId=S1368980015000361">price sensitive</a>, and may be disproportionately affected by the lure of takeaways serving large portions at <a href="http://ajcn.nutrition.org/content/79/1/6.full">low prices</a>.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/122122/original/image-20160511-18123-1sklrbh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/122122/original/image-20160511-18123-1sklrbh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/122122/original/image-20160511-18123-1sklrbh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/122122/original/image-20160511-18123-1sklrbh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/122122/original/image-20160511-18123-1sklrbh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/122122/original/image-20160511-18123-1sklrbh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/122122/original/image-20160511-18123-1sklrbh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Cheap, calorific and ubiquitous.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=sPFijT3IldBsddQkL0XONw&searchterm=kebab%20uk&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=122823118">www.shutterstock.com</a></span>
</figcaption>
</figure>
<p>This picture of the effects of a disadvantageous unhealthy neighbourhood being compounded by social disadvantage came through clearly in our analysis. People with the greatest exposure to takeaway outlets consumed a third more unhealthy takeaway food per day if they were the least educated than if they were highest educated. These differences would add up over a year to an additional consumption of over 4kg of unhealthy food. By comparison, people with least exposure to takeaway outlets consumed only a fifth more takeaway food if they were least educated.</p>
<p>In the paper, we also compared the odds of being obese for those facing this double burden of individual and neighbourhood disadvantage. We found that those least educated and most exposed to takeaways were three times more likely to be obese than the most educated and least exposed. </p>
<p>So while neighbourhood takeaway food access is important in shaping everyone’s diet and weight, the effects seem to be greater for those with less education. This means that where takeaways are most abundant, inequalities in diet and obesity are likely to be amplified. </p>
<h2>What’s the takeaway message?</h2>
<p>The good news is that this situation can be addressed. Fixing the food environment alone isn’t going to cure the obesity crisis, but healthier food choices can be better supported by modifying and shaping the geography of food access across our neighbourhoods. </p>
<p>Our results suggest that if we reduce takeaway access in particular, this will not only benefit all social groups, but will also minimise differences in consumption between social groups. Changing neighbourhoods may seem like a radical step, and there may be challenges, but such efforts are currently underway and are endorsed by <a href="https://www.nice.org.uk/advice/lgb9/chapter/Introduction#nice-recommendations">NICE</a>, <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/296248/Obesity_and_environment_March2014.pdf">Public Health England</a>, the <a href="https://www.london.gov.uk/sites/default/files/takeawaystoolkit.pdf">Greater London Authority</a> and the <a href="http://www.aomrc.org.uk/doc_view/9673-measuring-up">Academy of Medical Royal Colleges</a>. </p>
<p>Traditional individually-focused efforts, such as improving nutrition knowledge and cooking skills, may also be important but their success will be limited if we continue to live in neighbourhoods that make unhealthy choices the easy and cheap option. The effects of takeaway food outlet access on diet and weight and the implications of this access for social inequalities are now being realised by researchers and public health bodies and constitute a potentially important point of intervention for improving the health of all of us.</p><img src="https://counter.theconversation.com/content/59102/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Thomas Burgoine receives or has received funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust under the auspices of the UK Clinical Research Collaboration.</span></em></p><p class="fine-print"><em><span>Pablo Monsivais receives funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust under the auspices of the UK Clinical Research Collaboration</span></em></p>It’s not easy to make good food choices when there’s a takeaway on every corner.Thomas Burgoine, Career Development Fellow (Post-doctoral Research Associate), University of CambridgePablo Monsivais, Senior University Lecturer, University of CambridgeLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/569492016-04-06T10:59:11Z2016-04-06T10:59:11ZThe high cost of publicly funded cancer drugs<figure><img src="https://images.theconversation.com/files/116637/original/image-20160329-13709-30gfrw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">yari2000/Shutterstock</span></span></figcaption></figure><p>Patients with prostate cancer in England and Wales <a href="http://www.bbc.co.uk/news/health-35861202">will now have</a> early access to <a href="http://prostatecanceruk.org/prostate-information/treatments/abiraterone">abiraterone</a>, a drug which can delay the need for chemotherapy. The drug previously cost £3,000 a month, and was not considered “<a href="https://www.nice.org.uk/nice-appraisal-of-earlier-treatment-with-abiraterone-for-prostate-cancer">cost-effective</a>” for the NHS until cancers were more advanced – even though patients in Scotland <a href="http://www.dailymail.co.uk/health/article-3278615/Prostate-cancer-sufferers-denied-wonder-pill-s-widely-available-Scots.html">had access</a> to it.</p>
<p>The U-turn comes after a lower price was agreed with the manufacturer Janssen – making abiraterone affordable for widespread use. Janssen is also said to have submitted <a href="https://www.nice.org.uk/news/press-and-media/nice-recommends-abiraterone-for-prostate-cancer">fresh data</a> about the drug’s effectiveness to the National Institute for Health and Care Excellence (NICE), <a href="http://www.cancerresearchuk.org/about-cancer/cancers-in-general/cancer-questions/what-is-nice-and-how-does-it-work">which decides which drugs and treatments are available</a> on the NHS in England and Wales.</p>
<p>This change in price now means that abiraterone can be given to prostate cancer patients who have mild symptoms but evidence of the disease spreading. The drug will also be used in patients who have not previously responded to hormone therapy and have not undergone radiotherapy. </p>
<p>While this new widespread use of the drug is great news for cancer patients, why has it taken so long to get things to this point? It does not seem entirely clear what this <a href="https://www.nice.org.uk/guidance/GID-TAG434/documents/final-appraisal-determination-document">new data</a> is, or why the current, <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1209096">published data</a> was considered to be insufficient. And it’s not the first time decisions on life-saving drugs have come into question.</p>
<h2>Dying for treatment</h2>
<p>There are a wide and generally effective range of treatment options for prostate cancer available. The main one is hormone therapy, which is aimed at blocking androgen (testosterone) production. </p>
<p>The rationale for this treatment is that most prostate tumours, especially in the earlier stages of the disease, require <a href="http://prostatecanceruk.org/prostate-information/treatments/hormone-therapy">androgens</a> for their continued growth and survival, in much the same way that some breast cancers are dependent on oestrogen. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/ygoQ_kWf5ZQ?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Prostate Cancer kills one man every hour in the UK.</span></figcaption>
</figure>
<p>The original treatment for depriving prostate tumours of androgen was the removal of the testicles, giving rise to the delightful term “<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2935714/">castration resistant prostate cancer</a>”. </p>
<p>Abiraterone delays the need for chemotherapy by helping to overcome the problem of “castration resistant tumours” – where the cancer cells become more and more sensitive to androgen in response to its reduced levels after hormone therapy.</p>
<p>Castration was subsequently replaced with drug-based therapy, with abiraterone developed in the early 1990s by scientists at <a href="http://www.icr.ac.uk/news-features/latest-features/abiraterone-a-story-of-scientific-innovation-and-commercial-partnership">Cancer Research UK’s</a> Centre for Cancer Therapeutics – using money donated by cancer survivors, the families of cancer patients, and numerous other individuals and organisations.</p>
<p>And yet the final product has until recently been prohibitively expensive, to the point where thousands of men may have missed out on its potential benefits, and it has <a href="http://www.dailymail.co.uk/health/article-2627653/Prostate-cancer-pill-extend-life-years-delay-need-chemotherapy-set-ban-not-cost-effective.html">severely strained NHS budgets</a>.</p>
<h2>Drug of choice</h2>
<p>Abiraterone has long been considered to be one of the most effective treatments for prostate cancer as it almost completely blocks testosterone production. This has been supported by a number of large <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1209096">clinical trials</a>, including one that recruited 1,088 men and revealed that abiraterone increased the average time taken for prostate cancer to spread from eight months to 16.5 months.</p>
<p>Despite this, NICE refused to approve the use of abiraterone for prostate cancer on the grounds that its cost was not justified by its proven clinical benefits. </p>
<p>While NICE have now reversed this decision, it still doesn’t take away from the fact that for so long, so many men have been unable to access an effective treatment for prostate cancer, which could have helped to delay the spread of the disease.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/116640/original/image-20160329-13718-1b6yaom.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/116640/original/image-20160329-13718-1b6yaom.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/116640/original/image-20160329-13718-1b6yaom.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/116640/original/image-20160329-13718-1b6yaom.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/116640/original/image-20160329-13718-1b6yaom.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/116640/original/image-20160329-13718-1b6yaom.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/116640/original/image-20160329-13718-1b6yaom.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">One in seven men will be diagnosed with prostate cancer during their lifetime.</span>
<span class="attribution"><span class="source">Image Point Fr/Shutterstock</span></span>
</figcaption>
</figure>
<p>Of course, hormone therapy is not without side effects – it can (and usually does) lead to varying degrees of feminisation, alongside erection problems, hot flushes and breast tenderness. However, these side effects are generally far less severe than those associated with therapies used when tumours fail to respond to hormone treatment. </p>
<p>This type of treatment includes conventional chemotherapy with <a href="http://www.evidence.nhs.uk/formulary/bnf/current/8-malignant-disease-and-immunosuppression/81-cytotoxic-drugs/side-effects-of-cytotoxic-drugs">cytotoxic drugs</a> that are generally designed to selectively kill rapidly dividing cells. </p>
<p>Many normal adult cells also need to divide quickly though – for example those involved in replacing the lining of the gut or in generating new blood cells – meaning this type of chemotherapy can have a broad and significant range of unpleasant side effects including hair loss, mouth ulcers, nausea and vomiting as well as increased chance of infection from the drop in white blood cells.</p>
<p>When you consider the debilitating side effects associated with chemotherapy, and the fact that prostate cancer is the most common male-specific cancer with around <a href="http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer#heading-Zero">35,000 new cases</a> and about <a href="http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer#heading-Zero">10,000 deaths</a> every year in the UK, the fact that drug therapy is withheld in treatment is very concerning.</p>
<p>But abiraterone is not the first anti-cancer drug to prove prohibitively expensive. Consider the small sum of <a href="http://www.bbc.co.uk/news/health-34831197">£90,000</a> required for a course of the breast cancer drug Kadcyla. Or the <a href="http://www.theguardian.com/business/2015/sep/23/uk-cancer-patients-being-denied-drugs-due-to-inflated-prices-say-experts">£24,000</a> cost per patient per year for another breast cancer drug, lapatinib. </p>
<p>Then there is also growing disquiet about the regional differences in the cost of drugs with lapatinib costing considerably less in a number of <a href="http://www.theguardian.com/business/2015/sep/23/uk-cancer-patients-being-denied-drugs-due-to-inflated-prices-say-experts">other countries</a>. </p>
<p>Questions need to be asked around drug costs and accessibility across the whole of the UK. Because although abiraterone isn’t the first high-cost cancer drug, sadly it won’t be the last.</p><img src="https://counter.theconversation.com/content/56949/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Richard Morgan does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The cost of cancer drugs is killing patients and it needs to stopRichard Morgan, Professor of Molecular Oncology, University of BradfordLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/543692016-02-18T12:08:49Z2016-02-18T12:08:49ZAre treatment guidelines on schizophrenia and bipolar disorder just plain wrong?<figure><img src="https://images.theconversation.com/files/111553/original/image-20160215-22566-1mx7eye.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Show me the evidence.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&searchterm=psychotherapy&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=247411348">www.shutterstock.com</a></span></figcaption></figure><p>The National Institute for Health and Care Excellence (NICE) has become a byword for unbiased, evidence-based healthcare advice. Its recommendations strongly influence which treatments are made available on the NHS. We wouldn’t expect NICE to make recommendations that are unsupported by evidence or, worse, contain contradictory evidence. However, two recent NICE publications recommend psychological therapies for bipolar disorder and schizophrenia despite a lack of robust evidence for their effectiveness. </p>
<h2>Bipolar disorder</h2>
<p>The NICE guideline for <a href="https://www.nice.org.uk/guidance/cg185">bipolar disorder</a> recommends psychological therapy for adults who are seeing their GP for treatment. And for those being treated in hospital, NICE puts psychotherapy on a par with drugs, such as antidepressants and lithium. We recently published a paper in <a href="http://bit.ly/1QQOeBW">Lancet Psychiatry</a> reassessing the evidence used by NICE in the guideline.</p>
<p>NICE recommendations are mainly based on evidence from studies known as meta-analyses. A meta-analysis is where data from several studies are combined and analysed in order to arrive at more reliable estimates of treatment effects. </p>
<p>The first thing that struck us about the NICE guideline was the sheer number of meta-analyses performed. There were over 170 – but they used just 55 trials, meaning that most analyses contained very few trials and many of the analyses were looking at the same trials. The largest meta-analysis looked at just six trials, but even more worryingly, over half of all meta-analyses in the NICE guideline looked at a single trial. This form of “data mining” contradicts the purpose of meta-analysis. And such an approach inevitably reduces the probability of obtaining reliable findings and increases the possibility of false discoveries.</p>
<p>NICE recommends a number of therapies for the treatment of bipolar disorder, including cognitive behavioural therapy (CBT). Six of their meta-analyses tested whether CBT reduces the symptoms of depression in bipolar disorder – but the results were mixed. One analysis reported a significant reduction of depressive symptoms at the end of therapy. But another showed that improvements disappeared after therapy ended. Two other studies found that CBT is less successful at reducing depression than an “active control”, such as supportive counselling, which has no known therapeutic effect.</p>
<p>NICE assessed the quality of the psychological therapy trials used in these metanalyses and almost all (96%) were rated “low” or “very low” quality. The remaining 4% were rated “moderate”. We might think then that NICE would have been cautious when interpreting the findings, especially since low-quality studies often <a href="http://www.mentalhealth.freeuk.com/moher.htm#results">inflate the reported effects</a>. Unfortunately, this wasn’t the case. Indeed, where high-quality evidence was not available, the guide says that the committee adopted “an informal consensus process”. In other words, NICE shifted from evidence to opinion.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/111933/original/image-20160218-1233-4uqjc0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/111933/original/image-20160218-1233-4uqjc0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/111933/original/image-20160218-1233-4uqjc0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/111933/original/image-20160218-1233-4uqjc0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/111933/original/image-20160218-1233-4uqjc0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/111933/original/image-20160218-1233-4uqjc0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/111933/original/image-20160218-1233-4uqjc0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">A lot of the evidence was of low quality.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=bYISbmYA-uJ-LyMVbqaQbg&searchterm=documents&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=296999168">www.shutterstock.com</a></span>
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</figure>
<h2>Schizophrenia</h2>
<p>Turning to schizophrenia, NICE has repeatedly made strong claims for the effectiveness of CBT. In their <a href="https://www.nice.org.uk/guidance/cg178">2009 guideline</a>, the agency recommended that doctors: “Offer CBT to all people with psychosis or schizophrenia”. Similar data mining is apparent in this guideline, with 110 meta-analyses conducted on a mere 31 trials. Around half of the meta-analyses contain only one or two studies. There were very few positive findings and NICE didn’t pay much attention to the quality of the studies included in the guideline. </p>
<p>In what seems to be a major oversight, NICE decided not to update the 2014 guideline with the latest evidence. Although NICE declares that it is “<a href="https://www.nice.org.uk/media/default/about/what-we-do/our-programmes/developing-nice-guidelines-the-manual.pdf">committed to keeping guidelines current”</a>, with updates undertaken every four years at least, the 2014 NICE meta-analyses contain no trials published after 2008. </p>
<h2>A different view</h2>
<p>In 2014, we published our own <a href="http://bjp.rcpsych.org/content/204/1/20.long">meta-analysis</a> of all the available evidence and came to more cautious conclusions about the effectiveness of CBT at reducing the symptoms of schizophrenia. Similarly, a Cochrane Review, published in 2012, found “<a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008712.pub2/abstract?systemMessage=Wiley+Online+Library+will+be+unavailable+on+Saturday+27th+February+from+09%3A00-14%3A00+GMT+%2F+04%3A00-09%3A00+EST+%2F+17%3A00-22%3A00+SGT+for+essential+maintenance.++Apologies+for+the+inconvenience.">no clear and convincing advantage for cognitive behavioural therapy</a>”. </p>
<p>These shortcomings have begun to raise concerns. A recent editorial in the <a href="http://bjp.rcpsych.org/content/206/5/357">British Journal of Psychiatry</a> by Professor Mark Taylor, former chair of Scotland’s equivalent of the NICE group, said that the NICE guideline on schizophrenia “promotes some psychosocial interventions, especially CBT, beyond the evidence”. </p>
<p>Is NICE achieving its stated aims of unbiased and evidence-based recommendations? Or are poor-quality, unconvincing and outdated evidence being employed in the political urgency to promote psychological therapies? Some argue that psychological therapies are what people want and that they are cost effective, but both claims rely on first showing that they are effective.</p><img src="https://counter.theconversation.com/content/54369/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>NICE recommends psychotherapy for treating schizophrenia and bipolar disorder,
despite a lack of high quality evidence to show that they’re effective.Keith Laws, Professor, University of HertfordshireSameer Jauhar, King's College LondonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/505642015-11-17T10:44:02Z2015-11-17T10:44:02ZIs HRT safe to use for the menopause? What the science says<figure><img src="https://images.theconversation.com/files/101599/original/image-20151111-9366-16d1qe9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Mixed messages about HRT</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=m3emppnoZdow8KaDL9SZNA&searchterm=menopause&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=279343904">www.shutterstock.com</a></span></figcaption></figure><p>The National Institute for Health and Care Excellence launched its first <a href="https://www.nice.org.uk/guidance/ng23">guidelines</a> on how to treat the menopause. But don’t expect this to be the final word on the subject. There is an ongoing debate about the pros and cons of hormone replacement therapy (HRT), and not all of it is based on sound evidence. So now might be a good time to take a look at what the science tells us.</p>
<h2>Is HRT safe?</h2>
<p>HRT can’t be described as safe or unsafe. Its <a href="http://www.ncbi.nlm.nih.gov/pubmed/26335958">effects vary</a> depending on the types of hormone used, the form in which it is given (pills, or patches and gels), and the timing of first use (around menopause, or later). The safety of HRT can also depend on other things, such as <a href="http://www.ncbi.nlm.nih.gov/pubmed/21278356">body mass index</a>. Factor in a woman’s family and personal medical history, and her individual experience of menopausal symptoms, and it is clear that one size cannot fit all. Whether or not the benefits of this treatment outweigh the risks will continue to be a personal decision.</p>
<p>Most <a href="https://www.nice.org.uk/guidance/ng23">doctors and scientists agree</a> that HRT, and specifically the oestrogen in HRT, is good for menopausal symptoms. None of the alternatives – diet, exercise, SSRIs (antidepressants) or other prescription drugs, herbal remedies such as red clover and black cohosh, nor “bioidentical” or “natural” hormones - have been shown to be <a href="http://www.ncbi.nlm.nih.gov/pubmed/16670414">as effective</a> as HRT at controlling symptoms such as hot flushes. Many women find that HRT transforms their lives. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/101608/original/image-20151111-9400-18uhh1p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/101608/original/image-20151111-9400-18uhh1p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/101608/original/image-20151111-9400-18uhh1p.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/101608/original/image-20151111-9400-18uhh1p.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/101608/original/image-20151111-9400-18uhh1p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/101608/original/image-20151111-9400-18uhh1p.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/101608/original/image-20151111-9400-18uhh1p.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Hot flushes.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&search_tracking_id=m3emppnoZdow8KaDL9SZNA&searchterm=menopause&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=181675298">www.shutterstock.com</a></span>
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<p>But HRT has benefits beyond treating the symptoms of the menopause. For example, it’s good for bone health. It’s been shown to reduce <a href="http://www.ncbi.nlm.nih.gov/pubmed/15138243">risk of fractures</a> in postmenopausal women. This is important, as osteoporosis and bone fractures become more common as women age, and can be very debilitating. </p>
<p>HRT use has also been consistently associated with a small reduction in the <a href="http://www.ncbi.nlm.nih.gov/pubmed/21671473">risk of bowel cancer</a>.</p>
<h2>Long-running studies</h2>
<p>A lot of what we know about the effects of HRT comes from large studies set up in the early 1990s, a time when HRT was widely prescribed in the US and the UK, not only to relieve menopause symptoms and to prevent osteoporosis, but also to prevent heart disease (as suggested by some, but not all, <a href="http://www.ncbi.nlm.nih.gov/pubmed/9251544">studies</a> at the time). However, evidence for a beneficial effect of HRT on heart disease risk has not been confirmed. </p>
<p>The Women’s Health Initiative (<a href="https://www.nhlbi.nih.gov/whi/background.htm">WHI</a>) trials in the US were designed to study cardiovascular risk and the UK Million Women Study (<a href="http://www.millionwomenstudy.org/introduction/">MWS</a>) investigated the risk of breast cancer in women using different types of HRT. Over the last 15 years, these studies, and others, have found little or no evidence that HRT reduces the risk of heart disease. In fact, they have found evidence for an increased risk of <a href="http://www.ncbi.nlm.nih.gov/pubmed/12117397">blood clots and stroke</a>. They also found an increased risk of <a href="http://www.ncbi.nlm.nih.gov/pubmed/12927427">breast</a> and <a href="http://www.ncbi.nlm.nih.gov/pubmed/17512855">ovarian</a> cancer in women using HRT. Most of the effects of HRT - positive and negative - are seen while women are taking HRT, and disappear once they stop.</p>
<p>Prescribing guidelines have for some years agreed that HRT should not be used to prevent long-term disease, but should be used in the short-term to relieve menopausal symptoms. The NICE guidelines reiterate this advice.</p>
<h2>A nuanced picture</h2>
<p>The publication of the WHI results on heart disease and the MWS results on breast cancer in 2002 and 2003 led to a marked and rapid fall in HRT prescribing throughout the world. And shortly afterwards, <a href="http://www.ncbi.nlm.nih.gov/pubmed/19219631">breast cancer rates</a> also fell. It is estimated that tens of thousands of cases of breast cancer have been <a href="http://www.ncbi.nlm.nih.gov/pubmed/26335958">avoided worldwide</a> in the past decade because of the fall in use of HRT. </p>
<p>Breast cancer is a good example of the complexity of HRT risk. The risk is greater for oestrogen-progestagen (combined) HRT than for oestrogen-only HRT (we don’t know why). Also, the risk appears to be greater when HRT is started around the time of menopause <a href="http://www.ncbi.nlm.nih.gov/pubmed/21278356">rather than later</a>. The risk also depends on body mass index – the increased risk of breast cancer from HRT is greater for thinner than for fatter women. This is thought to be because fat tissue is an important source of oestrogen hormones produced by the body after the menopause, and these are known to affect breast cancer risk. Fatter women produce more oestrogen, and have a higher background risk of breast cancer than thinner women; adding the extra hormones of HRT seems to make more difference in thinner women, who have lower levels of naturally-made oestrogens. The Million Women Study found that HRT-associated risks for breast cancer ranged from over <a href="http://www.ncbi.nlm.nih.gov/pubmed/21278356">twofold increased risk to no added risk</a>, depending on type of HRT, timing of use and body mass index.</p>
<p>Other conditions such as heart disease, stroke, fractures and ovarian cancer also have differing patterns of association with different forms of HRT, so the picture is much more complex than it at first appeared. On the other hand, understanding the effects of these other factors on risk can explain some apparent differences in the results from different HRT studies. Overall, a clearer picture - albeit not a simple one- is emerging from the large amount of evidence we now have on HRT’s effects.</p>
<h2>Exaggerated fears?</h2>
<p>Some feel the pendulum has swung too far against HRT, and that women have been denied effective treatment for menopausal symptoms because of “exaggerated” fears over risks.</p>
<p>Speaking to women for studies we’ve <a href="http://www.millionwomenstudy.org">conducted</a>, there is anecdotal evidence that this has happened. Some doctors, for example, have been reluctant to continue prescribing HRT beyond the five years described as “short term” in prescribing guidelines, even when a woman continues to have severe menopausal symptoms and - knowing the potential risks - wishes to keep taking HRT. Many other women, however, have probably avoided inappropriate treatment with HRT, and an increased risk of breast cancer and other conditions, as a result of the new evidence accumulated over the past 15 years. </p>
<p>There’s a lot we still don’t know about HRT. For example, what effect does it have on other important conditions such as <a href="http://www.ncbi.nlm.nih.gov/pubmed/15213206">dementia</a>? The search goes on for forms of hormone treatment which have more of the benefits and fewer of the risks compared with the current therapies. And we need to carry on looking at alternatives to HRT, such as the bisphosphonates (bone strengthening drugs) and examining how the risks and benefits of these treatments compare with those of HRT.</p>
<p>Media outlets often struggle to get beyond “HRT good” or “HRT bad” headlines, but a polarised and oversimplified debate conceals the considerable advances we have made in our knowledge about HRT. It would be good if scientific differences of opinion were seen as part of the advancement of knowledge, rather than a reason to distrust science.</p><img src="https://counter.theconversation.com/content/50564/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jane Green receives funding from Cancer Research UK and the Medical Research Council.
</span></em></p>There are pros and cons to HRT. Whether or not to use it comes down to personal choice.Jane Green, Professor of epidemiology, University of OxfordLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/440722015-07-26T20:12:12Z2015-07-26T20:12:12ZIf we don’t talk about value, cancer drugs will become terminal for health systems<figure><img src="https://images.theconversation.com/files/89712/original/image-20150726-8474-72m20i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A group of oncologists have called on cancer patients to challenge the high prices charged by pharmaceutical companies for new cancer drugs.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/ep_jhu/3308079338/in/photolist-63jLJE-6sSezB-4cXa6D-9bH4ur-8VPze4-4nVDsE-8Pomnt-7V1PRy-4CZCmU-jR9gc-oH4rdU-pCYRsM-35k1qw-95qvZs-sCTxH-5ybjn2-5VQHuA-9sw3y4-9Xcshz-e8UEr-dAjLrS-kxHJW-bqRwgf-cqiNS1-6m4PWH-6ZHdXN-9d5WGV-dEWvJE-4M7pV-ncFSjE-78ePNM-2JagVw-7kihrz-jK2whx-9XtRCC-oK4qob-bq31mE-dg7YLC-e59Fxe-2zyGn9-6nrmLQ-bDvpYV-ardcyt-bkbW8T-vdvJCW-5S73oK-wnYnx-3vuBP9-vdUfav-dErKR5">ep_jhu/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span></figcaption></figure><p><a href="http://www.mayoclinicproceedings.org/article/S0025-6196(15)00430-9/abstract">More than 100 prominent oncologists</a> from across the United States have called on <a href="http://www.nytimes.com/2015/07/23/business/drug-companies-pushed-from-far-and-wide-to-explain-high-prices.html?_r=1">cancer patients to challenge the high prices</a> charged by pharmaceutical companies for new cancer drugs. They claim drug companies, insurance companies, some patient advocacy groups and many hospitals and physicians are <a href="http://newsnetwork.mayoclinic.org/discussion/leading-experts-prescribe-how-to-make-cancer-drugs-more-affordable/">too financially conflicted to be driving the debate</a>. </p>
<p>Their call is motivated by the astronomical prices charged for some new cancer drugs. And Australia is in the same boat. Earlier this year, for instance, the Pharmaceutical Benefits Scheme (PBS) <a href="http://www.smh.com.au/national/health/ron-walkers-150000-cancer-drug-keytruda-approved-for-melanoma-patients-20150420-1more8.html">started subsidising pembrolizumab (Keytruda)</a> for the treatment of patients with advanced melanoma. The drug is expected to cost A$150,000 per patient for each year of treatment, which is <a href="http://www.abs.gov.au/ausstats/abs@.nsf/mf/6302.0">almost twice</a> the national average annual income.</p>
<p>Unlike in the United States, where patients’ insurance covers the costs, the Australian taxpayer subsidises <a href="http://www.pbs.gov.au/pbs/home">drugs listed on the PBS</a>. In cases where new drugs are not subsidised, they’re paid for directly by patients, or by state-funded hospitals (often after approval by drug committees). They can also be provided free or subsidised by pharmaceutical companies for “compassionate use”. </p>
<h2>Blurred by emotion</h2>
<p>Decisions to subsidise drugs and improve their accessibility should be based on an assessment of their value. In Australia, for instance, the <a href="http://www.pbs.gov.au/info/industry/listing/participants/pbac">Pharmaceutical Benefits Advisory Committee</a> examines new drugs for effectiveness, safety and value for money compared to other treatments before recommending PBS listing – or not. </p>
<p>But the imperative to “save lives” or “beat cancer” — particularly where there’s vigorous public, professional and industry advocacy — can be so profound that it overwhelms the requirement that medicines should be efficacious and cost-effective. This tension between emotional and economic considerations frequently challenges and compromises public decision-making about the value of drugs. </p>
<p>Consider the case of eribulin (Halaven), a drug for treating advanced breast cancer. The UK <a href="https://www.nice.org.uk/about">National Institute for Health and Clinical Excellence</a> (NICE is the rough equivalent of PBAC although it has a broader role) considered the drug but rejected it as too expensive. </p>
<p><a href="http://www.economist.com/news/britain/21640343-well-meaning-gesture-causing-more-and-more-trouble-benign-or-malignant">Eribulin was subsequently covered</a> by the <a href="http://www.cancerresearchuk.org/about-cancer/cancers-in-general/cancer-questions/cancer-drugs-fund">UK Cancer Drugs Fund</a>, a pool of public money allocated to pay for drugs not approved via the usual route. The price accepted by the fund was among the highest in Europe for the drug; the price rejected by NICE had been the lowest. </p>
<p>Clearly, when standards of cost-effectiveness are reduced in the name of “improved access”, prices can rise arbitrarily. In most markets, supply and demand, competition and consumer choice curtail such arbitrary fluctuations in price. </p>
<p>But the market for innovative cancer drugs doesn’t follow this pattern because prices can increase dramatically even in “growing” markets, without clear reasons. In 2013, for example, a group of <a href="http://www.bloodjournal.org/content/121/22/4439">experts in chronic myeloid leukemia described</a> how the price of imatinib (Gleevec) increased three-fold over a decade. This happened even though all research and development costs were accounted for in the original price, and the number of people using the drug was dramatically increasing. Heightened demand alone cannot explain such an increase.</p>
<h2>What makes cancer drugs different</h2>
<p>Cancer drug markets clearly behave quite differently to what we might expect. There are three key reasons for this. </p>
<p>First, governments are creating a “price deregulation eco-system” for cancer drugs by establishing special funds that challenge accepted standards of value, and by curtailing the ability of payers to negotiate prices. The UK government has the Cancer Drugs Fund discussed above, while US legislation limits the ability of <a href="https://www.medicare.gov/">Medicare</a> – the US government’s health insurance program for people who are 65 and older and certain others –
<a href="http://ww_w.nejm.org/doi/full/10.1056/NEJMhpr0807774">to negotiate drug prices</a>. Laws in the latter country effectively force the health insurer to pay for cancer drugs used for a “medically accepted indication”, and prevent it from considering related cancer drugs as interchangeable. </p>
<p>In other words, US Medicare cannot make the call about whether the drug is worth its asking price, or negotiate prices based on cheaper available alternatives. The fact that the US pays the most for many drugs — including many cancer drugs — should therefore be no surprise. And if other countries are paying high prices for drugs, it makes it easier to justify these high prices elsewhere.</p>
<p>Second, there’s a lack of significant competition for many new cancer drugs. In an attempt to understand why South Korea paid so much less for drugs used to treat chronic myeloid leukemia — in some instances less than 20% of the US price — the <a href="http://www.bloodjournal.org/content/121/22/4439">same group of experts mentioned previously</a> noted the country had its own locally discovered drug for treating this disease. The price of competing products appeared to be based on this local drug’s price.</p>
<p>The lack of competition in the cancer drugs market is exacerbated by the rise of new “<a href="https://www.cornerstone.com/GetAttachment/4274a2ec-56b5-403f-af6d-022aae98b97a/Emerging-Competition-Issues-in-Biologics.pdf">biological agents</a>”, which are more difficult to replicate than small-molecule drugs, and <a href="http://healthaffairs.org/blog/2013/12/04/why-are-cancer-drugs-commonly-the-target-of-schemes-to-extend-patent-exclusivity/">by industry practices</a> aimed at extending the patent lives of existing products, thwarting generic competition.</p>
<p>Finally, markets in health care, including for high-cost cancer drugs, are powerfully influenced by existential and moral considerations — specifically fear of death and disability, and desire for greater quantity and quality of life. Cancer patients, their families and the oncologists who care for them are often willing to try drugs in the hope they will work, regardless of the price or prospect of benefit, which is frequently quite limited in the case of new, expensive cancer therapies. And as long as there are people willing to pay high prices or, as is usually the case, to demand subsidised access to cancer drugs, there’s no reason for the industry to reduce its prices.</p>
<p>Hope, fear and desperation, along with the unique characteristics of the cancer drug market, create a “perfect storm” that continues to drive up prices for cancer drugs. Unless we regain sight of the need to use regulatory incentives to reward only genuine innovation and ensure that we receive sufficient value for the money we spend on new medicines, this upward trend for cancer drug prices is set to continue. </p>
<p>The call by the <a href="http://www.reuters.com/article/2015/07/23/cancer-costs-protest-idUSL1N1022Y420150723">US oncologists</a> for patients to demand reductions in the price of the new drugs may be too much of an ask as these people have more to lose in this debate. It may also be too narrowly focused as it’s not just cancer patients but all of us who should demand the drugs we need at a price that our publicly funded health systems can afford.</p>
<p><strong>CORRECTION:</strong> <em>This article has been amended to reflect the fact that the PBS lists subsidised drugs, not the Therapeutic Goods Administration it said originally.</em></p><img src="https://counter.theconversation.com/content/44072/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Narcyz Ghinea receives funding from the National Health and Medical Research Council.</span></em></p><p class="fine-print"><em><span>Ian Kerridge receives funding from NHMRC for research into high cost drugs and for the study of conflicts of interest in medicine and science.</span></em></p><p class="fine-print"><em><span>Wendy Lipworth receives funding from the National Health and Medical Research Council. She is affiliated with the DIA..</span></em></p>Hope, fear, and desperation, along with the unique characteristics of the cancer drug market, create a “perfect storm” that continues to drive up prices for cancer drugs.Narcyz Ghinea, Research Associate, Centre for Values, Ethics and the Law in Medicine, University of SydneyIan Kerridge, Associate Professor in Bioethics & Director, Centre for Values and Ethics and the Law in Medicine, University of SydneyWendy Lipworth, Senior Research Fellow, Bioethics, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/257292014-04-23T11:56:49Z2014-04-23T11:56:49ZNHS watchdog changes could endanger new cancer drugs<figure><img src="https://images.theconversation.com/files/46851/original/5bhddb8w-1398180469.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Cancer drugs like trastuzumab may not have been approved under the proposed rules.</span> <span class="attribution"><a class="source" href="http://pl.wikipedia.org/wiki/Plik:HerceptinFab.jpg">RedAndr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>The National Institute for Health and Care Excellence (NICE) has published <a href="http://www.nice.org.uk/media/FE2/2B/VBA_TA_Methods_Guide_for_CONSULTATION_upload.pdf">new draft proposals</a> laying out major changes to the way it assesses whether new medicines offer value for money for the NHS. These evaluations are difficult – requiring as they do an assessment of the value of life – but are <a href="http://www.thelancet.com/commissions/delivering-affordable-cancer-care-in-high-income-countries">necessary in all healthcare systems</a> that face spiralling costs worldwide. The new proposals, however, could prevent or delay new and effective drugs from reaching patients with cancer.</p>
<p>The draft proposals show that NICE, the body that decides which drugs are available on the NHS in England and Wales, plans to change the parameters its appraisal committees use</p>
<h2>End-of-life criteria</h2>
<p>Under the current system, NICE gives extra weight in its evaluation of cost-effectiveness if drugs have shown a particular benefit in patients at the end of their lives. The calculations it uses are complex but essentially, if a drug has been shown to add three months of life expectancy to patients who have an incurable illness then the NHS may pay a price significantly higher than it would otherwise pay to roll it out.</p>
<p>The importance of end-of-life criteria is very clear: since 2009, when they were introduced, 12 cancer drugs have been approved on this basis. It is likely that many of these drugs would have been rejected in the absence of end-of-life criteria. The new system proposes to remove the criteria, instead incorporating end-of-life benefit into a broader, less defined measure of what would qualify for a higher price bracket. This risks fewer drug approvals in future.</p>
<p>In addition to removing end-of-life criteria from the drug appraisal system, NICE has also suggested it will remove specific consideration of how innovative a new treatment is. I worry that both of these changes will result in cancer drugs being rejected when under the current system they would have been approved. This could deny cancer patients access to life-extending drugs and dramatically reduce the likelihood of achieving the cancer cures of the future.</p>
<p>At The Institute of Cancer Research in London, we have direct experience of the value of the current drug approval process. For example, a groundbreaking new prostate cancer drug called abiraterone that we discovered has helped thousands of sufferers. Initially approved for patients with late-stage prostate cancer resistant to existing drugs, abiraterone has since gone on to <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1209096">benefit patients in earlier stages of the disease</a>. Yet abiraterone would probably not be approved under the proposed changes.</p>
<h2>Stifling innovation risk</h2>
<p>By omitting specific consideration of innovation, the new guidelines will discourage the more creative, high-risk drug discovery research. Previously, NICE’s cost-benefit analysis allowed innovation to be rewarded by paying more for innovative drugs, although the definition of innovation was quite loose. In the new proposals, the chance to formalise the importance of developing novel treatment types has been overlooked. The consequences could be very damaging.</p>
<p>Innovative cancer drugs are those with new mechanisms of action – particularly precision medicines that act on new molecular targets derived from basic cancer biology research and the latest genomics studies, and also those that exploit cutting edge immunological research. Innovative drugs are tremendously important because they offer the possibility of major breakthroughs that cannot be achieved with those that simply mimic or marginally <a href="http://www.ncbi.nlm.nih.gov/pubmed/22235862">enhance the effects of existing drugs</a>.</p>
<p>In recent years, our understanding of cancer has increased dramatically and we’ve learnt that cancer medicine <a href="http://www.ncbi.nlm.nih.gov/pubmed/23361103">works best when it is personalised</a> to individuals. One of the best examples of developing this kind of personalised, precision medicine is trastuzumab. This has helped extend the lives of breast cancer patients with high tumour levels of the HER2 marker, a protein which drives the growth of their cancer. HER2 is also important in a proportion of stomach cancers and NICE approved trastuzumab use in these patients on the NHS under the old end-of-life criteria. Again, this might not have happened under the new draft proposals. </p>
<h2>Tackling drug resistance</h2>
<p>Innovation is also essential if we are to overcome the massive problem of drug resistance – the most important challenge facing cancer drug discovery and development today. We now know that resistance arises because cancers are extraordinarily variable and versatile in evolving mechanisms to get around the effects of both molecular targeted and conventional drugs.</p>
<p>An example of an innovative approach to tackle resistance is the discovery and development of <a href="http://www.ncbi.nlm.nih.gov/pubmed/22215907">Hsp90 inhibitors</a> – a totally new type of drug that we, and only a few other research centres worldwide, have pioneered. These inhibitors have the exciting ability to target several different cancer molecular weaknesses at once, and so can overcome or even prevent drug resistance.</p>
<p>It took costly, high-risk research to develop Hsp90 inhibitors and they have progressed from being a poorly appreciated drug target to one of the most actively pursued in the drug industry today. Leading Hsp90 inhibitors have shown very encouraging results in trials of patients with HER2-positive breast cancers that have become resistant to trastuzumab and patients with non-small cell lung cancer who have become resistant to the widely used molecular targeted drugs erlotinib and crizotinib.</p>
<p>It would be very disappointing if this sort of innovation is not rewarded when it comes to deciding if the NHS will pay so that patients can benefit.</p>
<p>Another crucial benefit arising from both the end-of-life criteria and the current guidance that promotes innovation is that drugs originally approved for “end-of-life” use very often turn out, later on, to benefit patients with earlier stage cancer – as noted above with abiraterone. Also, the current system provides an initial route into the NHS for innovative drugs, which can then subsequently be shown to be effective in the harder-to-treat cancers, especially by combining them with other drugs. New drug combinations could hold the key to tackling drug resistance for many cancers and encouraging innovation is critical for this.</p>
<h2>Crucial time</h2>
<p>The proposed NICE changes could mean a backward step at a crucial point in the history of cancer drug discovery and development, research and development costs of which are of course very high. Clinical trials are the most expensive part and failure in these is still depressingly common. But the high costs and failure rates are mostly a result of the old one-size-fits-all approach where potential drugs are not targeted to the specific molecular characteristics of individual patients. </p>
<p>The costs of developing personalised drugs will eventually fall because clinical trials supporting drug approval will be smarter, smaller and shorter. Instead of relying on a small number of one-size-fits-all blockbusters, companies will have a larger portfolio of lower volume, personalised precision drugs that are targeted to smaller patient populations. The transition to personalised drugs with reduced prices will take time, but this must happen.</p>
<p>Nonetheless, it’s a hugely exciting time, both in basic cancer research and in creative drug discovery and development. We must not let overly restrictive regulation deprive patients of access to innovative and life-prolonging drugs that are being developed now and in the future.</p><img src="https://counter.theconversation.com/content/25729/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Paul Workman works at The Institute of Cancer Research (ICR), London which is involved in cancer drug discovery and development research and operates a Rewards to Discoverers scheme. ICR receives income from sales of abiraterone (Janssen) that are reinvested in research. ICR has licensed intellectual property on HSP90 inhibitors to Vernalis and Novartis and may benefit from future income for research. Paul Workman has previously been a consultant for Novartis and Chroma Therapeutics and is a consultant for Astex Pharmaceuticals and Nextech Ventures. He holds shares in Chroma Therapeutics. He has received grant funding from Cancer Research UK, The Wellcome Trust, Medical Research Council, Vernalis, Janssen, Astex Pharmaceuticals, Chroma Therapeutics and the Kidani Trust.</span></em></p>The National Institute for Health and Care Excellence (NICE) has published new draft proposals laying out major changes to the way it assesses whether new medicines offer value for money for the NHS. These…Paul Workman, Head of the Division of Cancer Therapeutics, Institute of Cancer Research, LondonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/248672014-03-31T05:16:01Z2014-03-31T05:16:01ZWhy do politicians stand back from the school gates only to turn up in the classroom?<p>Demonstrating her considerable skills as a teacher, in <a href="http://www.birmingham.ac.uk/schools/education/events/priestley-lecture-2014.aspx">a recent lecture</a> at the University of Birmingham, Estelle Morris posed a question that reminded her audience of the start of a children’s book. “Where are the politicians now?” she asked.</p>
<p>“They’re in the classroom!” she answered, before asking “How did they get there?” and “Should they be there in the first place?”. </p>
<p>Reflecting on her own time in government as well as current policies, the former Labour education minister concluded that it had all gone too far. Politicians would do well to step out of the classroom. Instead, they should set up a body for education that would do the same job that the National Institute for Health and Care Excellence (NICE) does for health: providing a judgement on proposals for changing education at arms-length from government and on the basis of the best available evidence.</p>
<h2>Was 1979 a watershed?</h2>
<p>Identifying 1979 as a pivotal year in politicians’ relationship with schooling, Morris contrasted political manifestos before and after this date. Before Margaret Thatcher’s election, politicians were preoccupied with who should go to school together: are comprehensive schools good or bad?; should private schools be abolished? </p>
<p>She suggested that around 1979, politicians of all parties realised that changing the organisation of schooling was not the answer. The real difference was made in the classroom. </p>
<p>So after 1979, that’s where the politicians thought they should be. They re-designed the curriculum, they decided which books children should read and which bits of history they should learn, they decided how often children should be tested, they decided how teachers should organise their lessons and which was the best way to teach children to read. </p>
<p>But was 1979 really a watershed for politicians’ belief in their ability to improve the schools by reorganising them? Since that time we have had city technology colleges, grant-maintained schools, foundation schools, specialist schools, <a href="https://theconversation.com/topics/academies">academies</a> and free schools. Secretaries of state have taken on more power to close schools they don’t want and to choose which new schools open. </p>
<p>On the day of Morris’s speech, the government announced “an ambitious <a href="https://www.gov.uk/government/news/step-change-in-ambition-will-mean-higher-standards-for-all">new accountability system</a> (that) will raise standards across the board”, including introducing <a href="https://theconversation.com/why-testing-four-year-olds-as-they-start-school-is-a-bad-idea-24929">new tests for four-year-olds</a>. </p>
<p>These changes have been prefaced by politicians arguing that schools need freedom to do what they know is best. Many headteachers speak of relishing their freedom to run schools for the benefit of the children they teach. </p>
<p>So why have politicians promised to stand back from the school gates only to turn up later in the classroom? Why is it necessary for politicians to make such frequent adjustments to headteachers’ freedom of action? </p>
<p>The frequency and detail of politicians’ interventions in education goes well beyond what used to be called “fine-tuning” in economic policy.</p>
<h2>Pulled under the department’s control</h2>
<p>By 1979, economic orthodoxy had dismissed the idea that governments knew enough or could act fast enough to manage the economy in <a href="http://www.economist.com/economics-a-to-z/f#node-21529569.">any kind of fine-grained manner</a>. In 1998, the task of managing the country’s money was devolved to the Bank of England so that the professionals in the money markets could have confidence that the interests of the economy would not play second fiddle to the interests of politicians.</p>
<p>The reverse has happened in education. Between 2011 and 2012 the government <a href="http://webarchive.nationalarchives.gov.uk/20130401151655/http://www.education.gov.uk/aboutdfe/armslengthbodies">closed its “arms-length” agencies</a> and drew all of their work into the department for education under the more direct control of the secretary of state. Do politicians really know so much more about education than they do about the economy? </p>
<p>The proposal by Morris for an education version of NICE has its attractions. If “arms-length” works for the Bank of England, (though <a href="http://www.theguardian.com/society/2014/mar/27/jeremy-hunt-control-freak-manipulating-nhs">arguably not so cleanly for the NHS</a>), why not for education? Surely an independent assessment of evidence on best practice for schools has to be welcomed? </p>
<p>But there are some problems. First, <a href="https://theconversation.com/we-still-dont-know-what-works-in-education-24382">is there enough evidence</a> to review? For example, the NHS currently spends over £1 billion a year on research through the National Institute for Health Research (NIHR). Between 2010 and 2012, government <a href="http://www.ft.com/cms/s/0/5b9ce27c-82aa-11e3-9d7e-00144feab7de.html?siteedition=intl#axzz2xG2m3Axz">spending on educational research</a> at the Department for Education was cut by 59% in real terms from £32m to £13m. The cumulative effect of this kind of difference is that not only a much smaller volume of research on education but a much smaller and less secure knowledge base. </p>
<p>In addition, what is the incentive for politicians to get out of the classroom now they’re in? There is enormous scope for changes to teaching and testing which sound plausible enough to the electorate. It is easier to talk with voters about requiring children to learn a modern foreign language than it is to explain what you are doing about quantitative easing and fiscal cliffs. </p>
<p>It is no accident that becoming secretary of state for education puts you on a ladder rather than a snake. Finding politicians in the classroom looks odd from the perspectives of “rolling back the state” or “public sector reform”. But it would take a politician with a new sense of direction to allow NICE and NIHR equivalents to take centre stage in education.</p><img src="https://counter.theconversation.com/content/24867/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Peter Davies receives funding from the Nuffield Foundation and the European Union.</span></em></p>Demonstrating her considerable skills as a teacher, in a recent lecture at the University of Birmingham, Estelle Morris posed a question that reminded her audience of the start of a children’s book. “Where…Peter Davies, Professor of Education Policy Research and Director of Research, School of Education, University of BirminghamLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/124862013-02-27T03:30:37Z2013-02-27T03:30:37ZNew proposals to increase donation rates may go too far<figure><img src="https://images.theconversation.com/files/20695/original/xjsy5css-1361931766.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The proposals are aimed at increasing the gift of organ donation.</span> <span class="attribution"><span class="source">asenat29/Flickr</span></span></figcaption></figure><p>The continuing shortfall of organs available for transplantation has recently prompted a radical rethink of current end-of-life practices in the United Kingdom. The <a href="http://bma.org.uk/">British Medical Association</a> (BMA) has suggested a possible change in practice for potential donors dying from catastrophic brain injury that leaves them short of brain dead. </p>
<p>Current standard practice is not to admit such patients to intensive care units to provide life-saving measures when they have stopped breathing. Such measures are considered not to be in their best interests since they would only prolong the dying process.</p>
<h2>Proposals for change</h2>
<p>But it’s possible to take steps prior to the patient’s death to stop her organs from deteriorating so that, once she has died, her organs are suitable for transplantation. Among other things, this involves inserting breathing tubes to provide ventilation to the patient once she has stopped breathing to ensure her organs continue receiving oxygen.</p>
<p>The changes mooted by the BMA involve admitting people with catastrophic brain injury into intensive care and doing just that. But it would only happen in cases where there has been an expressed wish on the part of the patient to donate her organs.</p>
<p>There’s an even more radical proposal being made by the UK National Institute for Health and Clinical Excellence (NICE). They have published a guideline recommending the possible commencement of some of these pre-mortem measures even when the patient’s wishes are not yet known. People with catastrophic brain injury would be admitted into intensive care and ventilated (if needed), until their wishes are discovered.</p>
<p>The purpose of this more radical proposal is to prevent the opportunity to donate being lost if the patient stops breathing before doctors have had time to consult the patient’s family and find out what her wishes were.</p>
<h2>Are these proposals lawful?</h2>
<p>There are laws governing when organs can be retrieved from a brain-stem dead patient, whom the law regards as being dead, but they don’t apply to these patients because they’re still alive. In the United Kingdom, the law that deals with decision-making in these cases is found in the <a href="http://www.justice.gov.uk/protecting-the-vulnerable/mental-capacity-act">Mental Capacity Act</a>. This Act permits treatment that’s in a patient’s “best interests”. </p>
<p>A range of factors must be considered to judge whether a treatment is in a patient’s best interests, including the wishes and values of the patient to the extent that these are “reasonably ascertainable”.</p>
<p>Can non-therapeutic treatment of this kind – treatment that’s not for the benefit of the patient but for the benefit of others – be in a patient’s best interests? Perhaps. If there’s evidence that the patient wanted to donate, either because she has made comments to that effect, or because it’s reasonable to deduce this from her values, then it may be possible to conclude that pre-mortem measures to facilitate donation after death are in the patient’s best interests. </p>
<p>Best interests under the Mental Capacity Act includes “altruistic wishes” so a patient’s desire to benefit others through donation is a relevant consideration. To that extent, the proposals mooted by the BMA might, if they were put into effect, be in the best interests of those patients who have expressed a desire to donate.</p>
<p>But what about the NICE guideline, which contemplates ventilation before the views and wishes of patients are known? <a href="http://eprints.qut.edu.au/57250/2/57250.pdf">We have argued</a> that this may not be lawful. If we don’t know what a patient wanted, it’s not possible to argue as a matter of course that it will always be in her best interests to receive ventilation until we find out those views. But this is what the guideline appears to be suggesting.</p>
<p>Some might argue that it is in a patient’s best interests for us to discover what her wishes are because otherwise she might lose the opportunity to donate. This might hold if we subsequently discover the patient did want to donate, but it would clearly not work if we discovered that she didn’t. Indeed, what if the patient had expressly avowed that she never wanted to be put on life-sustaining measures at all? How would we know, in advance, which patient would be which?</p>
<p>The requirement to consider the wishes and values of the patient doesn’t itself sanction providing ventilation until we’ve had the chance to ascertain her wishes; the legislation only requires wishes and values to be considered if they’re “reasonably ascertainable”.</p>
<p>The law in Australia is similar. All eight states and territories have guardianship legislation that determines when an adult patient who lacks decision-making capacity can receive medical treatment. There’s variation across jurisdictions but most involve consideration of the “best interests” test (often alongside other criteria). So the consideration of similar guidelines in Australia would also give rise to these legal concerns.</p>
<h2>Tackling organ donation directly</h2>
<p>The proposals in the NICE guideline amount to presuming that it’s always in the best interests of a patient to be put on life-sustaining measures if she’s a potential organ donor. But doing so stretches the best interests test beyond breaking point. </p>
<p>If the primary goal is to increase the supply of organs available for donation, which is laudable, then that should be tackled squarely. We should be clear that such proposals are really about the societal need to increase donation rates, and that they’re thought to be an ethically appropriate way to do this. </p>
<p>If we take that step, we would be in the position to make legislative changes to authorise the measures, and avoid misshaping the general principles of an area of law designed to safeguard the rights of vulnerable people, namely patients who lack decision-making capacity.</p><img src="https://counter.theconversation.com/content/12486/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The continuing shortfall of organs available for transplantation has recently prompted a radical rethink of current end-of-life practices in the United Kingdom. The British Medical Association (BMA) has…Andrew McGee, Lecturer, Faculty of Law, Queensland University of TechnologyBen White, Professor of Law and Director, Health Law Research Centre, Queensland University of TechnologyLicensed as Creative Commons – attribution, no derivatives.