tag:theconversation.com,2011:/us/topics/bmj-journal-11131/articlesBMJ journal – The Conversation2017-08-23T05:39:44Ztag:theconversation.com,2011:article/827532017-08-23T05:39:44Z2017-08-23T05:39:44ZBeer, bongs and baby boomers: the unlikely tale of drug and alcohol use in the over 50s<figure><img src="https://images.theconversation.com/files/183066/original/file-20170822-13660-1p7ity1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Baby boomers who drink and take drugs risk a range of physical and mental problems that younger substance users don't necessarily face.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/496022509?src=J4JwkXDIzM9va_WIHJgxBQ-2-62&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>If you ask someone what a typical heavy drinker or drug user looks like, they’re probably more likely to evoke images of Gen Ys with tattoos and piercings than greying baby boomers. </p>
<p>But recent Australian data, outlined in our <a href="http://www.bmj.com/content/358/bmj.j3885">British Medical Journal editorial today</a>, shows rates of alcohol and drug use are actually decreasing among younger age groups, while increasing dramatically in people over the age of 50.</p>
<p>Not only is there a rise in the proportion of older people who regularly drink at risky levels, there are also more older people using cannabis.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/maybe-moderate-drinking-isnt-so-good-for-you-after-all-72266">Maybe moderate drinking isn't so good for you after all</a>
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</em>
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<p>So, it’s not surprising Australia’s <a href="https://www.hcasa.asn.au/documents/555-national-drug-strategy-2017-2026/file">recently released National Drug Strategy 2017-2026</a> identifies older people as a priority group for attention.</p>
<p>The data has implications not only for the health of the over 50s, but also for health professionals that diagnose and manage substance use or misuse, and the complications that can arise from it.</p>
<p>Evidence shows we can no longer view drug and alcohol issues purely as a young person’s concern.</p>
<h2>Why is alcohol and drug use rising in older Australians?</h2>
<p>Low birth rates and extended life expectancy have resulted in large increases in the <a href="https://aifs.gov.au/facts-and-figures/ageing-australia">proportion of older Australians</a> and higher absolute numbers of older people who drink and use drugs.</p>
<p>For example, the <a href="http://www.aihw.gov.au/alcohol-and-other-drugs/data-sources/ndshs-2016/data/">one in four 50-59 year-olds</a> drinking at risky levels (five or more standard drinks in a single session) corresponds to <a href="http://www.abs.gov.au/AUSSTATS/abs@.nsf/DetailsPage/3101.0Sep%202016?OpenDocument">about 755,394</a> people.</p>
<p>Baby boomers (born between 1946 and 1964) have <a href="http://www.bmj.com/content/343/bmj.d6761">higher rates</a> of alcohol and drug use than earlier cohorts of older Australians and many continue this use into their older years.</p>
<p><a href="http://nceta.flinders.edu.au/files/3514/1679/0404/EN557.pdf">Improvements in health care and treatments for substance use</a> mean more people survive into old age, drinking and taking drugs for longer.</p>
<p>Older Australians today also have more disposable income than in previous generations, making access to alcohol and drugs <a href="http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0021-25712012000300004">more affordable</a>.</p>
<h2>What does the evidence say?</h2>
<p>Our research, using data from the <a href="http://www.aihw.gov.au/alcohol-and-other-drugs/data-sources/about-ndshs/">National Drug Strategy Household Survey</a>, shows high-risk drinking (11 or more standard drinks on a single occasion) in the over 50s increased significantly between 2004 and 2013. People living in regional or remote areas or who smoke tobacco were more likely to drink this way.</p>
<p>The <a href="http://www.aihw.gov.au/alcohol-and-other-drugs/data-sources/ndshs-2016/data/">newly released 2016 data</a> indicates this upward trend is continuing even more strongly.</p>
<p><a href="http://www.aihw.gov.au/alcohol-and-other-drugs/data-sources/ndshs-2016/data/">In 2016</a>, 11.9% of 50-59 year olds drank at high-risk levels at least yearly (up from 9.1% in 2013). A total of 5.8% did so at least monthly (up from 4.1%).</p>
<p>Cannabis use among the over 50s <a href="http://onlinelibrary.wiley.com/doi/10.1111/ajag.12357/abstract">more than doubled</a> between 2004 and 2013, from 1.5% to 3.6%. Unmarried men who smoked, drank alcohol, and used other drugs were particularly likely to use cannabis.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/remind-me-again-how-does-cannabis-affect-the-brain-40641">Remind me again, how does cannabis affect the brain?</a>
</strong>
</em>
</p>
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<p>There is little reliable data on other illicit drug use in older people. But our data shows older people are using more pharmaceuticals, like <a href="http://onlinelibrary.wiley.com/doi/10.1002/pds.1899/abstract">sedatives</a> and <a href="https://www.mja.com.au/journal/2011/195/5/prescription-opioid-analgesics-and-related-harms-australia">opioids</a>, than before.</p>
<p>And <a href="http://www.aihw.gov.au/alcohol-and-other-drugs/data-sources/ndshs-2016/data/">in 2016</a>, 4.1% of 50-59 year olds and 4.5% of people 60 and over used pharmaceutical drugs for non-medical purposes.</p>
<p>Older people often use pharmaceuticals to treat pain (both physical and emotional) or sleep problems. This can also result in balance problems, falls/injuries, reduced ability to function, and even death.</p>
<p>You can find out more about the prevalence of substance use among older Australians in the <a href="http://nadk.flinders.edu.au/">National Alcohol and Drug Knowledgebase</a>.</p>
<h2>Why is all this concerning?</h2>
<p>Growing use of alcohol, cannabis, and prescription drug misuse among older Australians is concerning for a number of reasons.</p>
<p>Older people are more sensitive to the toxic effects of substances such as alcohol. This is because ageing <a href="http://nceta.flinders.edu.au/files/4114/2249/7473/RCP_2011.pdf">reduces the body’s capacity</a> to metabolise, distribute, and excrete alcohol and drugs.</p>
<p>Older people are also more likely to have <a href="http://nceta.flinders.edu.au/files/3514/1679/0404/EN557.pdf">existing physical or psychological conditions</a>, or to take medicines that may <a href="http://nceta.flinders.edu.au/files/4114/2249/7473/RCP_2011.pdf">interact</a> with alcohol and drugs.</p>
<p>So older people who use alcohol and/or drugs may be more <a href="http://nceta.flinders.edu.au/files/4114/2249/7473/RCP_2011.pdf">likely to have</a>: falls and other injuries, diabetes and cardiovascular disease, mental health problems (including suicide), obesity, liver disease, <a href="https://pdfs.semanticscholar.org/b8ed/eefa7da25bb2656bc0335cc6768d62b9f039.pdf">early-onset dementia and other brain injury</a>, sleep disorders, and blood borne diseases.</p>
<h2>Not all older people have problems with drugs and alcohol</h2>
<p>Not all older people who use alcohol and/or drugs have problems. Older people, like other age groups, use alcohol or drugs in many different ways and for many different reasons, as we show with this “<a href="http://nceta.flinders.edu.au/files/7014/1679/1083/EN559.pdf">typology of older users</a>”:</p>
<ul>
<li><p><strong>maintainers</strong> continue with their previously unproblematic use as they get older. But age-related changes (like those already outlined) result in increased harms later in life</p></li>
<li><p><strong>survivors</strong> begin using alcohol/drugs early in life. They have a long history of substance use problems that persist into older age and this often results in other physical and/or mental health problems</p></li>
<li><p><strong>reactors</strong> begin using alcohol/drugs in their 50s or 60s, often due to <a href="http://au.wiley.com/WileyCDA/WileyTitle/productCd-1118993772.html">stressful events</a>, like grief, retirement, marital breakdown, social isolation (<a href="http://press.psprings.co.uk/bmj/august/substancemisuse.pdf">particularly older women</a>), or due to pain.</p></li>
</ul>
<h2>Do treatments work for older people?</h2>
<p>The good news is, research shows substance use treatment is <a href="http://nceta.flinders.edu.au/files/9814/2250/4969/Hunter_2010.pdf">just as effective</a> for older people as it is for younger age groups. </p>
<p>Treatment programs adapted specifically for older people have <a href="http://www.sciencedirect.com/science/article/pii/S1878764915001394">even better outcomes</a>.</p>
<p>This is important, as the number of older people who require treatment for alcohol or drug problems is increasing substantially, <a href="http://press.psprings.co.uk/bmj/august/substancemisuse.pdf">both in Australia</a> <a href="http://www.tandfonline.com/doi/abs/10.1080/13607863.2013.793653?tab=permissions&scroll=top">and</a> <a href="https://academic.oup.com/ije/article/43/2/304/675582/Substance-use-disorders-and-psychiatric">overseas</a>.</p>
<h2>Not everyone gets treatment</h2>
<p>Unfortunately, there are <a href="http://nceta.flinders.edu.au/files/1314/1679/1662/EN561.pdf">barriers</a> that can <a href="http://alcoholresearchuk.org/downloads/finalReports/FinalReport_0085">make it harder</a> for older Australians to access treatment or support.</p>
<p>Health-care practitioners and family members may:</p>
<ul>
<li><p>be reluctant to ask older people “embarrassing” questions about substance use</p></li>
<li><p>not know alcohol/drug use is common in older people, or how to address it</p></li>
<li><p>incorrectly attribute symptoms of problem substance use to “just getting older”</p></li>
<li><p>incorrectly believe older people are too old to change.</p></li>
</ul>
<p>Older people may also be reluctant to seek help because of embarrassment, logistical problems (like a lack of transport), inappropriate treatment services for older people, or they do not know where to turn for help.</p>
<p>To combat these problems, we developed a <a href="https://www.peninsulahealth.org.au/wp-content/uploads/AODPenHealth_150915.pdf">free guide</a> to preventing and reducing alcohol and drug related harm among older people for health and welfare professionals.</p>
<h2>What needs to change</h2>
<p>Health-care services and the aged care sector need to work better together to prevent problem substance use among older people. They also need to provide age-appropriate treatment and harm minimisation services to people who need them. </p>
<p>Clinicians also need to better identify and treat alcohol, cannabis, and prescription drug misuse in their older patients.</p>
<p>Finally, we need more research into the best approaches for helping older people with substance use problems.</p>
<hr>
<p><em>If you would like to talk to a professional about your own or someone else’s alcohol or drug use, contact the free Alcohol and Drug Information Service in your <a href="http://www.drugs.health.gov.au/internet/drugs/publishing.nsf/content/CA12F53389330BD1CA2577EC007DEAFB/$File/ADIS.pdf">state or territory</a>.</em></p><img src="https://counter.theconversation.com/content/82753/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The National Centre for Education and Training on Addiction receives funding from the Commonwealth Department of Health.</span></em></p>More Australians over 50 are drinking and taking drugs than ever before. Here’s why that can be a problem.Ann Roche, Professor and Director of the National Centre for Education and Training on Addiction, Flinders UniversityVictoria Kostadinov, Research officer, National Centre for Education and Training on Addiction, Flinders UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/823192017-08-16T22:50:18Z2017-08-16T22:50:18ZFive commonly over-diagnosed conditions and what we can do about them<figure><img src="https://images.theconversation.com/files/182175/original/file-20170816-22170-1op0ocd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some conditions should be classified as normal in some people and don't need treatment. </span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>Today five influential Australian health-care organisations – representing professionals, the public and policy makers – have <a href="http://wiserhealthcare.org.au/national-action-plan/">released a statement</a> outlining that some medical conditions are being diagnosed too often, and calling for action to tackle over-diagnosis and the over-treatment it produces. </p>
<p>Over-diagnosis occurs when someone is diagnosed with a disease that wouldn’t harm them, or when treatment does more harm than good. It happens because healthy people are often tested or screened to find the early signs of disease, and because diagnostic technology can see ever-smaller abnormalities. </p>
<p>The problem is that early detection of disease is a double-edged sword. While it can be life-saving, for some people the “abnormalities” that are diagnosed and treated would never have caused harm if left alone. </p>
<p>Researchers are <a href="http://wiserhealthcare.org.au">currently investigating</a> the size of this problem, and how many people are over-diagnosed. But <a href="https://theconversation.com/au/topics/overdiagnosis-3771?page=2">existing evidence</a> from Australia and elsewhere suggests it’s a problem across a lot of conditions. </p>
<h2>Thyroid cancer</h2>
<p>Researchers documented in <a href="http://www.nejm.org/doi/full/10.1056/NEJMp1604412">The New England Journal of Medicine last year</a> that Australia, like other nations including the United States, has experienced a recent tripling of the numbers of people diagnosed with thyroid cancer - many of them with very small tumours. </p>
<p>The problem is, as the researchers explain, many of those small tumours are in fact benign, and many of the people being diagnosed, and then treated with potentially risky operations and drugs, are over-diagnosed. </p>
<p>The <a href="http://www.nejm.org/doi/full/10.1056/NEJMp1604412">NEJM piece</a> estimated over 500,000 people may have been over-diagnosed in the past two decades, across 12 countries, including 10,000 people in Australia.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/182176/original/file-20170816-4761-h6mu9b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/182176/original/file-20170816-4761-h6mu9b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/182176/original/file-20170816-4761-h6mu9b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/182176/original/file-20170816-4761-h6mu9b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/182176/original/file-20170816-4761-h6mu9b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/182176/original/file-20170816-4761-h6mu9b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/182176/original/file-20170816-4761-h6mu9b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/182176/original/file-20170816-4761-h6mu9b.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>
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<span class="caption">Some thyroid cancers which are operated on don’t need to be, as they’re benign.</span>
<span class="attribution"><span class="source">from www.shutterstock.com</span></span>
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</figure>
<h2>ADHD</h2>
<p>There are <a href="https://theconversation.com/moving-the-diagnostic-goalposts-medicalising-adhd-8675">on-going debates</a> about whether too many children are being diagnosed with and medicated for attention deficit hyperactivity disorder. </p>
<p><a href="http://www.cmaj.ca/content/184/7/755.abstract">A study</a> of almost one million Canadian children found those born in December were much more likely than those born in January to receive an ADHD diagnosis and medication, which could mean immaturity is being pathologised. Researchers concluded: </p>
<blockquote>
<p>These findings raise concerns about the potential harms of over-diagnosis and over-prescribing.</p>
</blockquote>
<h2>Prostate cancer</h2>
<p>Concerns about over-diagnosing prostate cancer date back at least 30 years. Many men will <a href="https://theconversation.com/latest-research-shows-surgery-for-early-stage-prostate-cancer-doesnt-save-lives-81089">die with prostate cancer, rather than of it</a>. Despite evidence of unnecessary diagnoses and over-treatment, the push to test healthy men, with no symptoms, for prostate cancer continues. </p>
<p>While it’s hard to know exactly how many Australian men are over-diagnosed with prostate cancer, <a href="https://www.uspreventiveservicestaskforce.org/Page/Document/draft-evidence-review/prostate-cancer-screening1">recently reported estimates</a> from the US suggest between 20-50% of prostate cancers diagnosed via screening (during the period of screening) may be over-diagnosed – in other words they would not have caused harm if left undetected. </p>
<hr>
<p><em><strong>Read more: <a href="https://theconversation.com/most-people-want-to-know-risk-of-overdiagnosis-but-arent-told-41889">Most people want to know risk of overdiagnosis, but aren’t told</a></strong></em></p>
<p><strong><em><a href="https://theconversation.com/costly-and-harmful-we-need-to-tame-the-tsunami-of-too-much-medicine-48239">Costly and harmful: we need to tame the tsunami of too much medicine</a></em></strong></p>
<p><strong><em><a href="https://theconversation.com/resisting-expanding-disease-empires-why-we-shouldnt-label-healthy-people-as-sick-56924">Resisting expanding disease empires: why we shouldn’t label healthy people as sick</a></em></strong></p>
<hr>
<h2>Polycystic ovary syndrome</h2>
<p>Polycystic ovary syndrome is an example of a condition where changes in the definition have greatly expanded the number of people potentially labelled. In a <a href="http://www.bmj.com/content/358/bmj.j3694">piece published today</a> in the British medical journal, the BMJ, Tessa Copp and colleagues from the University of Sydney show how the proportion of women of reproductive age who could potentially be labelled has jumped dramatically from around 5% using the 1990 definition, to up to 21% when using the 2003 definition. </p>
<p>As the authors suggest, there are concerns many healthy women may be labelled unnecessarily, causing anxiety about their fertility or long-term health. The authors therefore recommended a cautious approach to diagnosing the condition. </p>
<h2>Breast cancer</h2>
<p>Reflecting uncertainty around exactly how to measure over-diagnosis, there are sometimes wide variations in estimates of the size of the problem. A <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61611-0/abstract">major independent review</a> of the global evidence suggested 19% of the breast cancers diagnosed during active mammography screening may be over-diagnosed. This means they would not have caused harm to the women because they may be benign. </p>
<p><a href="https://www.ncbi.nlm.nih.gov/pubmed/19894130">Previous estimates in Australia</a> suggest the rate could be around 30%.</p>
<h2>What can we do about over-diagnosis?</h2>
<p>Together with colleagues Thanya Pathirana and Justin Clark, we’ve today published a <a href="http://www.bmj.com/content/358/bmj.j3879">comprehensive analysis</a> in the BMJ of possible drivers of over-diagnosis and potential solutions. Causes range from cultural beliefs that “more is better” in medicine, to financial incentives driving unnecessary tests and treatments.</p>
<p>The good news is doctors’ groups across the globe – including in Norway, Britain, Canada and now Australia – are now publicly acknowledging the problem of overdiagnosis.</p>
<p>As our <a href="http://www.bmj.com/content/358/bmj.j3879">BMJ analysis</a> highlights, there are many potential solutions. There’s an urgent need for public information and awareness campaigns. New educational curricula for health professionals are a priority. And screening programs need to be reformed to make sure we’re only targeting those at high risk.</p><img src="https://counter.theconversation.com/content/82319/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Ray Moynihan receives grant funding from the Australian National Health and Medical Research Council, is co-chair of the scientific steering committee for the international Preventing Overdiagnosis conference, and was chair of the planning committee which organized the National Summit on Overdiagnosis in Australia.</span></em></p>Australian health-care organisations are urging action on treatments of people who don’t need them.Ray Moynihan, Senior Research Fellow, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/790362017-06-13T20:21:51Z2017-06-13T20:21:51ZResearch Check: can even moderate drinking cause brain damage?<figure><img src="https://images.theconversation.com/files/173522/original/file-20170613-10220-6kbdn3.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C3234%2C1525&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Heavy alcohol consumption over ten years or more can cause significant brain function problems. But what about casual drinking? </span> <span class="attribution"><a class="source" href="https://unsplash.com/search/beer?photo=aS7puomg6Oc">Robert Mathews/Unsplash</a></span></figcaption></figure><p>Research <a href="https://www.theguardian.com/society/2017/jun/06/even-moderate-drinking-can-damage-the-brain-claim-researchers">reported last week</a> found “even moderate drinking” could “damage the brain”. Considering 78% of Australians over 14 years old <a href="http://www.aihw.gov.au/alcohol-and-other-drugs/data-sources/ndshs-2016/key-findings/">drink alcohol</a>, this is understandably concerning information.</p>
<p>News reports were reasonably accurate in their interpretation of the study. With measured headlines using words such as “may damage the brain” and “linked with”, these reported that the observational study found an association between moderate drinking and brain damage, not a causation.</p>
<p><a href="http://www.afr.com/lifestyle/health/mens-health/the-silent-damage-from-drinking-moderately-down-the-decades-20170605-gwl2ge">The Financial Review</a> ran the headline:</p>
<blockquote>
<p>The silent damage from drinking moderately down the decades</p>
</blockquote>
<p>and <a href="http://www.cbsnews.com/news/even-moderate-drinking-could-harm-the-brain/">CBS News said</a>:</p>
<blockquote>
<p>Even moderate drinking could harm the brain.</p>
</blockquote>
<p>Others, such as the <a href="http://www.deccanchronicle.com/lifestyle/health-and-wellbeing/070617/moderate-drinking-leads-to-changes-in-brain-structure.html">Deccan Chronicle</a>, were more hyperbolic, hinting at causation:</p>
<blockquote>
<p>Moderate drinking leads to severe brain damage.</p>
</blockquote>
<p>We know about 17% of <a href="http://www.aihw.gov.au/alcohol-and-other-drugs/data-sources/ndshs-2016/key-findings/">Australians drink at levels</a> considered to put them at risk of long-term harm such as diabetes, liver disease and cognitive problems.</p>
<p>And it’s well established heavy drinking over ten years or more can cause significant cognitive difficulties. These include disorders such as <a href="http://www.alz.org/dementia/wernicke-korsakoff-syndrome-symptoms.asp">Korsakoff’s Syndrome</a> and <a href="https://en.wikipedia.org/wiki/Wernicke%27s_encephalopathy">Wernicke’s Encephalopathy</a>, where memory and other essential thinking functions, as well as motor co-ordination, are severely and permanently damaged.</p>
<p>But what about those of us who have two to three drinks a night? </p>
<p>First, this is an observational study that followed people over time, showing an association between their alcohol intake and certain cognitive functions. Observational studies cannot prove that one (alcohol) caused the other (impaired brain function).</p>
<p>And while alcohol can potentially affect multiple parts of the brain, the researchers found significant impact in only one part of the brain. And that did not appear to correlate with poorer brain functioning overall.</p>
<hr>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/173524/original/file-20170613-15666-18fbxvb.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/173524/original/file-20170613-15666-18fbxvb.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=893&fit=crop&dpr=1 600w, https://images.theconversation.com/files/173524/original/file-20170613-15666-18fbxvb.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=893&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/173524/original/file-20170613-15666-18fbxvb.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=893&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/173524/original/file-20170613-15666-18fbxvb.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1122&fit=crop&dpr=1 754w, https://images.theconversation.com/files/173524/original/file-20170613-15666-18fbxvb.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1122&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/173524/original/file-20170613-15666-18fbxvb.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1122&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption"></span>
<span class="attribution"><span class="source">The Conversation</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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<h2>How was the study conducted?</h2>
<p>Researchers from the University of Oxford and University College London conducted the study, which was published in the well-regarded journal <a href="http://www.bmj.com/content/357/bmj.j2353">The BMJ</a>. It followed 550 men and women for 30 years who were not alcohol-dependent. </p>
<p>Participants were categorised into four groups based on how much alcohol they drank per week. The “abstinent” group drank less than one standard drink a week, and the “light” between one and seven drinks. “Moderate” drinkers had between seven and 14 drinks a week for women, and between seven and 21 drinks for men. Men who had 21 or more drinks per week, and women who drank 14 or more, were classified as “unsafe” drinkers.</p>
<p>The participants had brain scans once (at the 30-year point) and neuropsychological testing five times over the 30 years.</p>
<iframe src="https://datawrapper.dwcdn.net/I51xI/1/" scrolling="no" frameborder="0" allowtransparency="true" allowfullscreen="allowfullscreen" webkitallowfullscreen="webkitallowfullscreen" mozallowfullscreen="mozallowfullscreen" oallowfullscreen="oallowfullscreen" msallowfullscreen="msallowfullscreen" width="100%" height="415"></iframe>
<h2>What did it find?</h2>
<p>The main difference between the drinking groups was a smaller <a href="http://psycheducation.org/brain-tours/memory-learning-and-emotion-the-hippocampus/">hippocampus</a> – the area of the brain important for learning, memory and spatial awareness – in people who drank more.</p>
<p>Compared to “abstainers”, people who drank an average 30 or more drinks a week over the 30 years were more likely to have a smaller hippocampus. But even those drinking between 14 and 21 drinks a week had, on average, a smaller hippocampus.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/173525/original/file-20170613-603-122a2ez.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/173525/original/file-20170613-603-122a2ez.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=525&fit=crop&dpr=1 600w, https://images.theconversation.com/files/173525/original/file-20170613-603-122a2ez.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=525&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/173525/original/file-20170613-603-122a2ez.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=525&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/173525/original/file-20170613-603-122a2ez.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=660&fit=crop&dpr=1 754w, https://images.theconversation.com/files/173525/original/file-20170613-603-122a2ez.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=660&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/173525/original/file-20170613-603-122a2ez.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=660&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption"></span>
<span class="attribution"><span class="source">The Conversation</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<h2>How should we interpret the results?</h2>
<p>There are a few reasons to be cautious about these results. The study looked at brain function (how well the brain works, measured by <a href="https://www.mentalhelp.net/articles/neuropsychological-tests/">neuropsychological tests</a>) over time. But researchers measured brain structure (the physical make-up of the brain) with a <a href="https://medlineplus.gov/ency/article/007341.htm">brain scan</a> only at the end of the study. </p>
<p>Although the hippocampus was smaller in the heavier drinking groups, alcohol consumption did not seem to affect the function of the brain. There was no alcohol-related decline in measures of memory and <a href="https://en.wikipedia.org/wiki/Executive_functions">executive functions</a> (such as planning, problem solving and impulse control). These are usually the cognitive domains most sensitive to effects of alcohol and most likely to show the negative impact of hippocampal shrinkage. </p>
<p>Not having scanned the brains of participants at the beginning of the study means researchers did not know the original size of their hippocampi. They visually assessed the size of brains from the scans and compared them to expected brain size, using an established scale for that purpose. Around 65% of people who drank 14 to 21 drinks a week showed a smaller hippocampus, but even 35% of the abstainers had “hippocampal atrophy”.</p>
<p>The study used many measures of brain functioning (visual and verbal memory, executive function and working memory), but it found alcohol-related decline in only one function – <a href="http://www.open.edu/openlearn/body-mind/psychology/verbal-fluency">verbal fluency</a> (the ease with which we can retrieve words). And none of the groups were particularly impaired overall compared to people in the general population of the same age and education level.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/173535/original/file-20170613-32456-1nlvmdu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/173535/original/file-20170613-32456-1nlvmdu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/173535/original/file-20170613-32456-1nlvmdu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/173535/original/file-20170613-32456-1nlvmdu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/173535/original/file-20170613-32456-1nlvmdu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/173535/original/file-20170613-32456-1nlvmdu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/173535/original/file-20170613-32456-1nlvmdu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/173535/original/file-20170613-32456-1nlvmdu.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>
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<span class="caption">Researchers scanned participants’ brains only once, at the end of the study.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
</figcaption>
</figure>
<h2>What else should we take into account?</h2>
<p>In a study with a moderate number of people like this, it can be harder to assess brain differences because it is difficult to properly take into account other important factors such as age, gender, mental health problems and other drug use.</p>
<p>It seems logical that something like alcohol, which has a strong short-term impact on the brain, might have longer-term effects, and this study adds to the growing evidence that alcohol can impact brain structure. But we are still some way off knowing how much moderate alcohol consumption affects the brain and whether that translates to a functional impairment.</p>
<p>Alcohol is implicated in a number of physical and mental health problems and should be used occasionally and within recommended limits. Studies that have reported <a href="http://www.abc.net.au/news/2016-03-22/studies-linking-alcohol-to-health-benefits-flawed-researchers/7264040">health benefits of moderate drinking</a> in the past have now been shown to be methodologically flawed.</p>
<p>The Australian National Health and Medical Research Council <a href="https://www.nhmrc.gov.au/health-topics/alcohol-guidelines">guidelines on alcohol consumption</a> recommend that adults (both men and women) should drink a maximum of two standard drinks a day to maintain long-term health and no more than four drinks on one occasion to prevent short-term harm. <strong>– Nicole Lee and Rob Hester</strong></p>
<hr>
<h2>Peer Review</h2>
<p>I agree with the observations made in this Research Check. There are several other factors to consider when interpreting this study.</p>
<p>Firstly, the researchers found a decline in verbal fluency, as well as atrophy of the hippocampus in participants. But (as Figure 7 in the study shows) there is no pathway between hippocampal volume and verbal fluency decline. Verbal fluency is <a href="https://www.cambridge.org/core/journals/journal-of-the-international-neuropsychological-society/article/role-of-frontal-versus-temporal-cortex-in-verbal-fluency-as-revealed-by-voxelbased-lesion-symptom-mapping/86562C8AF93BFCC9626A481CC90ECBCE">usually associated</a> with an area of the brain called the frontal lobe, while the <a href="http://science.sciencemag.org/content/253/5026/1380.long">hippocampus is associated with memory</a>. </p>
<p>Apart from differences in verbal fluency, the researchers found no other differences between groups on tests associated with the hippocampus, such as those for learning and memory. In the absence of changes to other executive and memory tests, it is uncertain what the clinical and functional significance of a reduction in verbal fluency means. </p>
<p>Further, it’s unknown how the participants spaced out their alcohol intake. There is <a href="http://www.magonlinelibrary.com/doi/abs/10.12968/bjon.2015.24.7.401?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed&">new evidence</a> showing moderate drinking in a “binge” fashion could be dangerous to cognitive ability. The researchers did not distinguish between those who drank two standard drinks per day throughout the week and those who saved their 14 drinks for a single session on the weekend. This could also be mediating their results.</p>
<p>There is also <a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1530-0277.2001.tb02174.x/abstract;jsessionid=141D8935B51895E920C433E8AF4F65C4.f03t02">evidence that abstinence</a> from alcohol can <a href="http://psycnet.apa.org/journals/neu/14/2/178/">improve brain structure</a> and cognitive performance, even <a href="https://academic.oup.com/brain/article-lookup/doi/10.1093/brain/awl303">after a few months</a>. So don’t be too alarmed when reading these results. – <strong>Travis Wearne</strong></p>
<hr>
<p><em>This article has been amended to say that the NHMRC guidelines recommend adults drink no more than four drinks on one occasion.</em></p><img src="https://counter.theconversation.com/content/79036/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicole Lee works as a paid consultant in the public, private and not for profit health sector to support treatment and policy implementation. She has previously been awarded grants by the state and federal government, NHMRC and other public funding bodies for alcohol and other drug research.</span></em></p><p class="fine-print"><em><span>Rob Hester receives funding from the Australian Research Council and National Health and Medical Research Council. </span></em></p><p class="fine-print"><em><span>Travis Wearne 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>New research shows an association between moderate drinking and long-term brain impairment. But there are a few reasons to be cautious about these findings.Nicole Lee, Professor at the National Drug Research Institute, Curtin UniversityRob Hester, Professor, Melbourne School of Psychological Sciences, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/578262016-04-15T13:09:16Z2016-04-15T13:09:16ZThe government cited my research in its campaign against porn and anal sex – here’s why I disagree<figure><img src="https://images.theconversation.com/files/118892/original/image-20160415-11179-10d1rep.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.flickr.com/photos/calistan/4413169375/in/photolist-8SeiC2-8ShFKo-D3wv51-5ArzRR-D5QDXH-CVh3rY-6GZxHq-7J3A95-7HYDva-j1tHZX-7J3AfS-FhNdFG-frAonm-5RXrsC-71G36o-71JsaV-6q48mj-8Sgz7W-71FzEJ-D5QE2v-71JrPT-71BLv4-71BBi2-2Z82Qr-9CVZww-71G4iA-71C19F-71BKRr-8S2eDL-71BwfT-71C3bT-8NPG4f-71FBJN-6q497q-3k3xQw-63vM3V-58AQLv-71FYt9-71BSXn-71FZzQ-aPb1b8-6pZ1wM-71BUJH-6q48X9-58AQNM-71FGCo-7HYDRx-72gmr7-aD6odJ-71BoaT">Calistan</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>Are we facing an epidemic of harmful anal sex, brought on only because of the availability of online porn? This is what you’d think from reading a <a href="https://www.gov.uk/government/consultations/child-safety-online-age-verification-for-pornography">recent policy note</a> from the Department of Culture, Media and Sport in support of the government’s aim to require all pornographic websites to use age verification by default.</p>
<p>But this suggestion rests on two debatable assumptions: first, that pornography has driven the rise in heterosexual couples trying anal sex, and second, that this is harmful, something to be discouraged or, in the government’s words: “unwanted”. Considering that it’s one of my research papers that the government cites in support of its claims, I feel I need to question these assumptions.</p>
<p>On the first assumption, there is no clear link between access to pornography and anal sex among young people – something pointed out in my <a href="http://bmjopen.bmj.com/content/4/8/e004996.full">paper published in the BMJ Open journal</a> in 2014. However, whether or not this is the case the second assumption misses – or blurs – the essential distinction between consensual and coercive sexual practices. My co-author Ruth Lewis and I argued that the harms we identified – as cited in the DCMS note – stem not from anal sex per se but from elements of coercion that seem to be an integral part of many young people’s experiences and expectations of anal sex between men and women. In fact this is not limited to anal sex, but a feature of <a href="http://www.tandfonline.com/doi/full/10.1080/00224499.2015.1117564">other sexual practices</a> too.</p>
<p>What <a href="https://theconversation.com/all-too-often-anal-sex-isnt-about-young-womens-desires-30489">we found in our research</a> was that young, straight men may derive some kudos among their friends from having anal sex with women, and that some of the young men in our study seemed to place a low value on their partner’s wishes. Participants talked about men “persuading” and using coercive methods to have anal sex with women as if this were normal. The fundamental problems behind coercion – of women’s desires being ignored, the men pushing/women resisting model of heterosex, and sex acts as goals for men – all long pre-date the era of easy access to online porn, as does sexual coercion itself. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/118894/original/image-20160415-11167-n815ak.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/118894/original/image-20160415-11167-n815ak.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=414&fit=crop&dpr=1 600w, https://images.theconversation.com/files/118894/original/image-20160415-11167-n815ak.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=414&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/118894/original/image-20160415-11167-n815ak.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=414&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/118894/original/image-20160415-11167-n815ak.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=520&fit=crop&dpr=1 754w, https://images.theconversation.com/files/118894/original/image-20160415-11167-n815ak.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=520&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/118894/original/image-20160415-11167-n815ak.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=520&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Consent is the thing.</span>
<span class="attribution"><span class="source">EQRoy/shutterstock.com</span></span>
</figcaption>
</figure>
<p>Of course, pornography may contain depictions of harmful practices, such as coercive or non-consensual sex. But this also appears in films, books and other media that aren’t classed as pornography – films such as Irreversible or Baise Moi, to name just two. But the fundamental causes of sexual coercion and rape go far deeper than simply copying what is on screen. It seems overly optimistic to suggest that reducing access to pornography will reduce the problem of sexual coercion or “unwanted sex”, when the socio-cultural attitudes that support sexual coercion remain unchallenged.</p>
<p>Good education on sex and sexuality can help challenge some of the harmful gender dynamics that promote the problematic sexual activities we identified in our study. Better education and more frank and open discussion would also help young people take a more critical view of pornographic imagery. The government’s policy document rightly talks about tackling the potential harms that can come from anal sex, but instead of asking why couples are increasingly trying anal sex – framed as if this is a threat to society – the government should be asking why they engage in sexual acts they do not want or do not enjoy. Addressing this is a question that goes far beyond restricting children’s access to porn.</p>
<p>A good starting point would be to ensure all young people have access to comprehensive sexuality education that challenges coercive practices, helps improve communication skills, and emphasises mutuality – the process where partners ask about and take account of each other’s desires. Instead, the government has taken steps to ensure that <a href="http://www.bbc.co.uk/news/education-35549295">sexuality education will not be a compulsory part</a> of the curriculum.</p><img src="https://counter.theconversation.com/content/57826/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Cicely Marston received funding for the study referred to in this article from the UK Economic and Social Research Council. The views in this article are the author's and not those of the research councils.</span></em></p>Its attitude to porn and anal sex suggests the government would benefit from some sex ed classes too.Cicely Marston, Senior Lecturer in Social Science, London School of Hygiene & Tropical MedicineLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/382872015-09-29T20:08:36Z2015-09-29T20:08:36ZControversies in medicine: the rise and fall of the challenge to Tamiflu<figure><img src="https://images.theconversation.com/files/96412/original/image-20150928-21366-d740kn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">As part of pandemic preparation, in the early 2000s many countries amassed large stockpiles of the influenza neuraminidase inhibitor Tamiflu.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/hisgett/3641376785/">Tony Hisgett/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>One of the biggest recent controversies in medicine involves the effectiveness – or otherwise – of the antiviral drug Tamiflu. Governments around the world have stockpiled the drug for use in severe influenza pandemics, but many have raised doubts about its effectiveness.</p>
<p>Influenza causes annual “seasonal” epidemics in temperate countries and circulates year-round in the tropics. Pandemics occur when there’s a relatively new flu virus containing components of bird or swine flu viruses, against which the human population has little protection. </p>
<p>Global pandemic preparedness efforts were spurred in the early 2000s by the emergence of SARS, and highly pathogenic H5N1 influenza in birds, which was associated with rare but often fatal infection in humans. The problem is that the severity of pandemics can vary markedly; from the Spanish flu of 1918-19, which is estimated to have killed 20-50 million people worldwide, to the much milder 2009 swine flu, which <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001558">resulted in between</a> 150,000 and 250,000 deaths (a similar number to the annual mortality of seasonal epidemics). </p>
<h2>Reviewing evidence</h2>
<p>Governments tend to prepare for the worst because there’s no way of knowing the impact a flu pandemic will have on the population. And, as pandemics are rare, the evidence base for public health responses has to be largely taken from studies of seasonal influenza.</p>
<p>As part of pandemic preparation, in the early 2000s many countries amassed large stockpiles of the influenza neuraminidase inhibitor Tamiflu. A 2000 clinical trial had <a href="http://jama.jamanetwork.com/article.aspx?articleid=192425">indicated modest benefits</a> from this drug, but its ability to <a href="http://jama.jamanetwork.com/article.aspx?articleid=193547">reduce disease severity and limit onward spread</a> had potential for much greater benefits in reducing death and disease at the population level.</p>
<p>In 2006 the <a href="http://www.cochrane.org/about-us">Cochrane Neuraminidase Inhibitors Review Team</a> published a review on behalf of the Cochrane Collaboration, an independent network of researchers who review evidence for medical interventions to help improve health-care decision-making. <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001265.pub2/abstract;jsessionid=DAAC348A24E621BF48DEDF728C522519.f01t02">Its overall conclusion</a> was that the drug shouldn’t be used for treating seasonal flu, but was suitable for use as part of a suite of public health measures in pandemics.</p>
<p>But in the aftermath of the – fortunately – mild 2009 pandemic, the social and economic costs of the global public health response to this event were widely questioned. In particular, given the large amounts of money spent on Tamiflu, claims of <a href="http://www.bbc.com/news/10235558">conflict of interest</a> and <a href="http://ahrcanum.com/2009/07/01/tamiflu-linked-to-origins-of-ah1n1-swine-flu-pandemic/">conspiracy theories</a>, some <a href="http://www.dailymail.co.uk/news/article-1176743/Donald-Rumsfelds-controversial-links-drug-company-Tamiflu.html">more credible than others</a>, abounded. </p>
<p>Then, in the process of updating their 2006 Cochrane review, and in response to <a href="http://www.bmj.com/content/339/bmj.b5106.long">questions raised</a> through the Cochrane review’s feedback mechanism regarding prevention of complications and drug safety, the reviewing team requested access to Roche Tamiflu trials data in 2009. They were refused. In the years that followed, Roche came under particular scrutiny with claims that <a href="http://www.bmj.com/content/345/bmj.e7303">critical clinical trial information</a> had been withheld from publication. </p>
<p>In 2012, the <a href="http://www.bmj.com/tamiflu">BMJ launched a website</a> devoted to a public campaign, lobbying the company to release full clinical reports on all relevant studies conducted in support of the drug’s licence. The campaign was successful when, in 2013, Roche provided all the requested documentation. </p>
<h2>The question mark</h2>
<p>For the first time, full clinical study reports, which include tables of all study outcomes rather than those selected for publication, were made available. In addition, submissions to and correspondence with drug regulatory authorities were included. These reports, often many hundreds of pages long, formed the basis of a new meta-analysis conducted by the <a href="http://bmjopen.bmj.com/content/4/9/e005253.full">Cochrane Neuraminidase Inhibitors Review Team</a>. </p>
<p>With the new information to hand, the authors concluded the <a href="http://bmjopen.bmj.com/content/4/9/e005253.full">risk of bias</a> in several published studies was higher than had been previously assessed. This was due to missing or incomplete information, or deficiencies in study design. </p>
<p>Roche provided data on 83 studies, and regulatory authorities provided information on more than 200 trials. But only 46 studies (20 of Tamiflu and 26 of Relenza) were included in <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008965.pub4/abstract;jsessionid=76F622C5B03F0FF262E8B76396219022.f03t01">the final analysis</a> as eligible and unbiased. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/96413/original/image-20150928-21366-19hmcgm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/96413/original/image-20150928-21366-19hmcgm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=420&fit=crop&dpr=1 600w, https://images.theconversation.com/files/96413/original/image-20150928-21366-19hmcgm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=420&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/96413/original/image-20150928-21366-19hmcgm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=420&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/96413/original/image-20150928-21366-19hmcgm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=528&fit=crop&dpr=1 754w, https://images.theconversation.com/files/96413/original/image-20150928-21366-19hmcgm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=528&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/96413/original/image-20150928-21366-19hmcgm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=528&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A 2014 review found giving the drug to family members of an infected person prevented infections in about 15% of people.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/k790i/3852576091/">Anil Jadhav/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>Still, the <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008965.pub4/abstract;jsessionid=76F622C5B03F0FF262E8B76396219022.f03t01">findings of this 2014 review</a> were remarkably similar to the group’s previous reports. The review showed Tamiflu hastened flu recovery by about 17 hours in adults and 29 hours in kids. Anticipated side effects of nausea and vomiting were reported in less than 5% of treated people. And giving the drug to family members of an infected person prevented infections in about 15%.</p>
<p>The meta-analysis also looked at the risk of hospitalisations and secondary infections following flu. It concluded that antivirals were ineffective for reducing these adverse outcomes. But because the trials under consideration were mostly in generally healthy people with seasonal influenza infections, the <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008965.pub4/abstract;jsessionid=76F622C5B03F0FF262E8B76396219022.f03t01">number of hospitalisations</a> was very small, affecting only 71 of 4,400 study participants. And while the main review finding was of a 1% absolute reduction in self-reported pneumonia, this figure represented a 56% relative risk reduction in the Tamiflu-treated group.</p>
<p><a href="http://community.cochrane.org/features/tamiflu-relenza-how-effective-are-they?">Based on this evidence</a>, BMJ and Cochrane Collaboration questioned the usefulness of neuraminidase inhibitors in pandemics and called for governments to review their guidance for the drug’s use.</p>
<h2>A different view</h2>
<p>Meanwhile, another independent group, the <a href="http://www.mugas.net">Multiparty Group for Advice on Science</a>, brought together four leading academics in the field of influenza to review and oversee re-analysis of Tamiflu trials data. To support this work, they obtained an unrestricted grant from Roche. Their aim was to resolve uncertainties regarding appropriate public health use of this drug. </p>
<p>The group negotiated with Roche to gain access to not just summary reports of treatment group outcomes (as previously analysed), but individually listed patient data from nine adult Tamiflu trials involving 4,328 participants. These provided much greater statistical power to assess differences. The trials, selected on the basis they assessed the currently recommended treatment dose, would have been included among those provided to the Cochrane reviewers.</p>
<p>This <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2962449-1/abstract">new analysis found</a>, similarly to the Cochrane review, that the drugs hastened recovery from influenza infection by about a day, with the side effects of nausea and vomiting in a minority of patients. It said that in people with confirmed flu, Tamiflu <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2962449-1/abstract">reduced the risk of secondary respiratory infections</a> requiring antibiotics by 44%. Hospitalisations in the Tamiflu group were down by 63%. </p>
<p>These findings were more in keeping with observational studies of “real world” Tamiflu use among patients hospitalised with a clinical or laboratory diagnosis of influenza during the 2009 pandemic. While this broader clinical definition of flu is less specific than in a randomised trial, it does represent the basis on which doctors make treatment decisions in everyday practice. </p>
<h2>Other research</h2>
<p>A <a href="http://www.ncbi.nlm.nih.gov/pubmed/23204175">meta-analysis of published data from 90 such studies</a> published in 2012 demonstrated a 60% reduction in the odds of intensive care unit admission and death among hospitalised influenza patients who received prompt antiviral therapy. This study was also funded by an unrestricted grant from Roche. </p>
<p>And <a href="http://www.thelancet.com/journals/lanres/article/PIIS2213-2600%2814%2970041-4/abstract">a follow-up 2014 analysis</a> of individual patient data from nearly 30,000 participants who took part in studies identified through the 2012 meta-analysis found a 50% reduction in the odds of death among those treated within 48 hours of symptom onset, compared with no treatment. It was also funded by Roche.</p>
<p>Given that randomised controlled trials are logistically and ethically challenging to conduct in pandemic events, it’s <a href="http://www.nature.com/news/analysis-of-trial-data-revives-flu-drug-row-1.16820">unlikely there will ever be a consensus</a> on Tamiflu’s effectiveness for use in pandemics. But observational studies conducted during the 2009 pandemic seem to reinforce the initial clinical trials evidence base on which Tamiflu was recommended for stockpiling against pandemic threats. </p>
<p>Indeed, <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2960074-5/abstract">the drug’s benefits</a> appear to be greatest in severe influenza seasons and pandemics.</p><img src="https://counter.theconversation.com/content/38287/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jodie McVernon is a member of the Australian Technical Advisory Group on Immunisation and has provided advice to the Australian Government Office of Health Protection on pandemic planning, including on antiviral stockpiling and distribution; she is also a Director of the Influenza Specialist Group. </span></em></p>One of the biggest recent controversies in medicine involves the effectiveness of the antiviral drug Tamiflu. Governments have stockpiled the drug but many have raised doubts about its usefulness.Jodie McVernon, Associate Professor, Population Health, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/474712015-09-17T00:06:25Z2015-09-17T00:06:25ZAntidepressant trial’s upended results show need for sharing all data<figure><img src="https://images.theconversation.com/files/95095/original/image-20150916-6275-1k24jtj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Our re-analysis
found significant increases in harms with both the antidpressants used in Study 329, compared to the placebo. </span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/destinysagent/1778953537/">Steve Smith/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span></figcaption></figure><p>In 2001, <a href="http://www.dcscience.net/keller-2001-paroxetine.pdf">a “landmark” study published</a> in the prestigious <a href="http://www.jaacap.com/article/S0890-8567%2809%2960309-9/abstract">Journal of the American Academy of Child and Adolescent Psychiatry</a> purported to show the safety and effectiveness of using a common antidepressant to treat adolescents. But soon after its publication, both researchers and journalists raised questions about the research. And in an <a href="http://www.bmj.com/cgi/doi/10.1136/bmj.h4320">article we published today</a> in the BMJ, we’ve shown that the original published findings were biased and misleading. </p>
<p>Known as Study 329, the randomised controlled trial compared paroxetine (Paxil, Seroxat, Aropax, among other brand names) with a placebo and an older antidepressant (imipramine) for treatment of adolescent depression. It was funded by SmithKline Beecham – now GlaxoSmithKline (GSK) – the manufacturer of paroxetine. </p>
<p>The research has been repeatedly criticised, and there have been numerous <a href="http://study329.org/request-to-retract-study-329/">calls for it to be retracted</a>. Our study, <a href="http://www.bmj.com/cgi/doi/10.1136/bmj.h4320">Restoring Study 329</a> was conducted under an initiative called <a href="http://www.bmj.com/content/346/bmj.f2865">restoring invisible and abandoned trials</a> (RIAT), which encourages abandoned or misreported studies to be published or formally corrected to ensure doctors and patients have complete and accurate information to make treatment decisions.</p>
<h2>Fundamental problems</h2>
<p>To re-analyse the evidence of effectiveness and safety of paroxetine, we used <a href="http://study329.org/the-data/">documents posted online by GSK</a>, including the <a href="http://www.gsk.com/media/389566/depression_329_full.pdf">clinical study report</a>, which was submitted to the US Food and Drug Administration (FDA) to gain approval for paroxetine to be prescribed to adolescents. We also had access to other <a href="http://www.healthyskepticism.org/global/news/int/hsin2010-01">publicly available documents</a> and individual participant data, as well as other documents provided by GSK. </p>
<p>The <a href="http://www.gsk.com/media/389566/depression_329_full.pdf">clinical study report</a> had significant problems; although it reported more adverse events than <a href="http://www.dcscience.net/keller-2001-paroxetine.pdf">the original article</a>, it omitted many problems our re-analysis found in the case report forms for individual patients.</p>
<p>We found that paroxetine was no more effective than a placebo, which is the opposite of the claim in <a href="http://www.dcscience.net/keller-2001-paroxetine.pdf">the original paper</a>. We also found significant increases in harms with both paroxetine and imipramine. Compared with the placebo group, the paroxetine group had more than twice as many severe adverse events, and four times as many psychiatric adverse events, including suicidal behaviours and self-harm. And the imipramine group had significantly more heart problems.</p>
<p>Our re-analysis has implications beyond Study 329; it has repercussions for all of evidence-based medicine. </p>
<p>First, we identified <a href="http://study329.org/potential-barriers-to-accurate-reporting-of-harms/">ten strategies</a> used by researchers in this clinical trial to minimise apparent harms. This included inconsistent classification of adverse events and ignoring their severity. Several of these strategies <a href="http://www.biomedcentral.com/1472-6904/1/3">can be readily identified</a> in reports of other trials. They influence the apparent safety of drugs, and can be used to present particular drugs in a favourable or unfavourable light. Many of these strategies may also be used to bias reporting of non-drug treatments.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/95094/original/image-20150916-6287-h586q9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/95094/original/image-20150916-6287-h586q9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=473&fit=crop&dpr=1 600w, https://images.theconversation.com/files/95094/original/image-20150916-6287-h586q9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=473&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/95094/original/image-20150916-6287-h586q9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=473&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/95094/original/image-20150916-6287-h586q9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=594&fit=crop&dpr=1 754w, https://images.theconversation.com/files/95094/original/image-20150916-6287-h586q9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=594&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/95094/original/image-20150916-6287-h586q9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=594&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Study 329 compared paroxetine with a placebo and an older antidepressant (imipramine) for treatment of adolescent depression.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/pyxopotamus/2457789657/">me and the sysop/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>Second and more importantly, our findings show influential peer-reviewed research published in leading medical journals can be seriously misleading. And that it’s not possible to adequately scrutinise trial outcomes, particularly in relation to harms, simply on the basis of what’s written in the body of clinical study reports, which can contain important errors. </p>
<p>We know that selective reporting is <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa065779">common in psychiatric literature</a>. And there are clearly no grounds to believe that such misrepresentation is restricted to psychiatric studies. </p>
<h2>Lessons for all</h2>
<p>It’s clear to us now that access to full individual patient level data, backed up by case report forms and the pre-specified protocols, are required to judge the validity of published reports of clinical trials. Only that degree of detail allows independent researchers to check how harms are recorded and reported. And whether researchers involved in clinical trials have accurately reported outcomes. </p>
<p>Our re-analysis was demanding because we were breaking new ground. And it was extremely time consuming because the data made available to us by GSK was <a href="http://www.bmj.com/content/349/bmj.g4353">in a form</a> that made our work highly inefficient. But we have now established a methodology for this kind of work. And it’s clear that if data are provided in a user-friendly format, it’ll be possible for researchers to carry out similar re-analyses reasonably inexpensively. </p>
<p>If other trials are found to contain similar errors – whether intentional or inadvertent – it might be time to change the requirements for submissions to drug regulators (such as Australia’s <a href="https://www.tga.gov.au/">Therapeutic Goods Administration</a>, the US <a href="http://www.fda.gov/">FDA</a>, and the <a href="http://www.ema.europa.eu">European Medicines Agency</a>), who are responsible for evaluating the safety and efficacy of prescribed drugs. </p>
<p>Indeed, if other re-analysis reach the sort of conclusions we did, it should become clear to editors of medical journals that trial results should not be published unless all the data are available for independent scrutiny both before and after publication. Peer reviewers also need to become far more critical of manuscripts they review.</p>
<p>Undoubtedly, there would be resistance to such changes. But scrutiny is warranted for drugs that are likely to be prescribed to millions of patients with potentially adverse outcomes and limited benefits.</p><img src="https://counter.theconversation.com/content/47471/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jon Jureidini was a founding member of Healthy Skepticism, and has provided expert analysis and opinion for plaintiffs about Study 329 and Forest’s paediatric citalopram randomised controlled trials.</span></em></p><p class="fine-print"><em><span>Melissa Raven was a founding member of Healthy Skepticism. </span></em></p>As part of an intiative to re-examine misrepresented or abandoned studies, we re-analysed an antidepressant trial. Here’s what we found.Jon Jureidini, Research Leader, Critical and Ethical Mental Health research group, Robinson Research Institute, University of AdelaideMelissa Raven, Postdoctoral research fellow, University of AdelaideLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/459442015-08-13T01:29:56Z2015-08-13T01:29:56ZDon’t panic, the internet won’t rot children’s brains<figure><img src="https://images.theconversation.com/files/91526/original/image-20150812-18088-10nsn1c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Dire predictions on the future of children’s brains are shocking, not least because of how flimsy the evidence is to support these views.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/kwarz/13974382668/">zeitfaenger.at/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>You know the deal: a social phenomenon rises from obscurity to international familiarity within the blink of an eye. Pitchforks are sharpened, torches lit, and higher thought goes out the window. <a href="http://othersociologist.tumblr.com/post/14900114577/elvis-presley">Elvis Presley’s hips</a>, the skin revealed by a bikini, <a href="https://www.questia.com/library/journal/1G1-238178966/much-ado-about-harry-harry-potter-and-the-creation">Harry Potter’s sorcery</a> – you would think by now we’d have learnt to occasionally sit back and thoughtfully stroke our collective chin before writing the eulogy for humankind.</p>
<p>You’d be wrong: an editorial published in the BMJ today <a href="http://press.psprings.co.uk/bmj/august/technology.pdf">highlights one more example</a> of our societal knickers getting into almighty knot. </p>
<p>The editorial focuses on Professor Susan Greenfield, British scientist and high-profile commentator, who has been publicising the idea that internet use and video games have harmful effects on children’s brain and behavioural development. </p>
<p>Her views are so strident that her recent book, <a href="http://www.amazon.co.uk/Mind-Change-digital-technologies-leaving/dp/1846044308">Mind Change: how digital technologies are leaving their mark on our brains</a>, draws deliberate parallels with climate change, arguing the two issues are of equal importance to our collective future. Greenfield’s dire predictions on the future of children’s brains are shocking, not least because of how flimsy the evidence is to support these views.</p>
<h2>The (lack of) evidence</h2>
<p><a href="http://www.theguardian.com/commentisfree/video/2011/aug/15/susan-greenfield-video">One claim</a> is that social networking media can negatively affect children’s sense of personal identity, and also how they develop empathy within friendships. Even more controversially, <a href="http://www.theguardian.com/society/2011/aug/06/research-autism-internet-susan-greenfield">Greenfield has drawn a link</a> between social media use and the development of autism.</p>
<p>However, a <a href="http://www.ncbi.nlm.nih.gov/pubmed/23645343">large amount of research</a> in this area has found that adolescents’ use of social networking sites often enhances the quality of existing friendships. It has also been found that most adolescents actually <a href="http://pps.sagepub.com/content/7/3/203.short">portray their identity quite accurately</a> on Facebook.</p>
<p>What’s the big deal, you may ask, isn’t this just harmless theorising? I strongly disagree. The purported link between social media and autism, which is <a href="http://deevybee.blogspot.com.au/2011/08/open-letter-to-baroness-susan.html">without evidence and scientifically implausible</a>, is insulting at best, and breathtakingly stigmatising at worst.</p>
<p><a href="http://www.news.com.au/technology/online/the-dark-side-of-social-media-baroness-susan-greenfield-says-social-media-is-rewiring-our-brains/story-fnjwnhzf-1227123736728">Another Greenfield claim</a> is that intense use of video games may lead kids to become aggressive and have shorter attention spans. Again, this view needs far more nuance than is being presented. <a href="http://www.ncbi.nlm.nih.gov/pubmed/23519430">One recent review</a>, for instance, found playing action video games may actually provide a small improvement in cognitive abilities.</p>
<p>The evidence linking violent video games and aggression in kids is not clear-cut. Some studies have found the playing of violent video games can lead to small, short-term increases in aggressive thoughts and behaviours. But <a href="https://theconversation.com/do-video-games-corrupt-childhood-9479">questions have been raised</a> about the quality of this evidence.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/91529/original/image-20150812-18101-ezk9d.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/91529/original/image-20150812-18101-ezk9d.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=398&fit=crop&dpr=1 600w, https://images.theconversation.com/files/91529/original/image-20150812-18101-ezk9d.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=398&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/91529/original/image-20150812-18101-ezk9d.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=398&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/91529/original/image-20150812-18101-ezk9d.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=500&fit=crop&dpr=1 754w, https://images.theconversation.com/files/91529/original/image-20150812-18101-ezk9d.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=500&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/91529/original/image-20150812-18101-ezk9d.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=500&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The sacrifice of physical activity for more screen time is a real concern that’s in grave danger of being overshadowed by a hyperbolic discussion about how technology damages kids’ brains.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/58648496@N02/5380522396/">Lighttruth/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span>
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</figure>
<p>These particular studies also don’t consider the social benefits that can come with gaming. Playing video games isn’t the socially isolating experience that it once was, and the <a href="https://www.apa.org/pubs/journals/releases/amp-a0034857.pdf">friendships and social learning</a> of multiplayer gaming can also be very important.</p>
<p>This, of course, is not to downplay other concerns that may accompany the increased use of social media and video games among children. <a href="http://telethonkids.org.au/news-events/news-feed/2015/july/video-top-10-tips-for-cyber-safety/">Cyber-safety</a> and the <a href="http://www.biomedcentral.com/content/pdf/1479-5868-8-98.pdf">sacrifice of physical activity</a> that accompanies more screen time are legitimate, evidence-based concerns with which parents need to engage. </p>
<p>But these important issues are in grave danger of being over-shadowed by a hyperbolic and evidence-light discussion that frames technology as damaging kids’ brains. There is little evidence for this view.</p>
<h2>Scientists and their responsibility</h2>
<p>Perhaps the biggest issue this kerfuffle raises in my mind concerns the responsibilities of scientists. </p>
<p>There’s no admission ceremony to become a scientist, no Hippocratic-like oath, no hand placed on a holy book while pledging to uphold this or that. There’s no need for any of this, because without following the fundamentals of science, you are, quite simply, not a scientist.</p>
<p>At the very core of science is the judgement of theories in light of available evidence. Scientists are humans. We have our own beliefs and prejudices, and at times it is near-on impossible to divorce ourselves from these. </p>
<p>That’s why the only kingmaker in science is evidence: objective, irrefutable observations. For every scientific theory proven through observations, there are dozens that lie shattered on the floor. And that’s how it should be. </p>
<p>Scientists can and should play a role in public discourse, particularly with issues of such importance as the impact of technology on children. At the very least, a scientist’s voice should – hopefully – add a dispassionate dimension to a very passionate debate.</p>
<p>There is currently little evidence that internet use and video games create “mind change” in kids. The only thing needed to change this position is evidence to the contrary.</p><img src="https://counter.theconversation.com/content/45944/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Whitehouse receives funding from the National Health and Medical Research Council and the Autism Cooperative Research Centre. </span></em></p>Baseless claims about the damage done to kids’ development create needless panic. And they distract from legitimate, evidence-based concerns with which parents need to engage.Andrew Whitehouse, Winthrop Professor, Telethon Kids Institute, The University of Western AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/300962014-08-04T20:42:34Z2014-08-04T20:42:34ZStatins saga shows some of the perils of modern medicine<figure><img src="https://images.theconversation.com/files/55654/original/9dh7kgd2-1407134098.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Whether the harms of statins outweigh their benefits depends on how you balance them up.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/ajc1/4700292186/in/photolist-8ame7s-eboVW9-ebihzB-amPgso-cEhggd-eboWZh-eboYds-eboWtu-ebiiET-ebigQ2-dnRxHt-ebiiUz-amLpwF-cBP6dU-ebikfT-amPen7-eboVe3-cEhfQb-amPh8q-amLrC2-dnRxqH-cGt8Ko-cBUzN1-cEhhkj-cBUz7E-eboYEh-7wvscM-7s61HH-77Vo2E-jUr5QZ-jKAV41-77Vo3b-a3UoA7-rqhJ9-6WR6NM-tFy9s-8SRnr5-8SRnDm-7wLnfg-8SRoob-8SNgZn-8SRn2Y-8SRnfq-8SRo8U-8SNi6M-6guvVW-amPePf-amPfNf-ebim9F-ebikGn">AJ Cann/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span></figcaption></figure><p>A panel convened by medical journal BMJ to investigate whether it was right to correct rather than retract two pieces featuring a mistake about side effects from statins has <a href="http://press.psprings.co.uk/bmj/august/statinpanelreport.pdf">endorsed the journal’s decision</a>. The ten-month controversy highlights some recurring issues with how medicine works. </p>
<p>Statins are a class of cholesterol-lowering drugs that have been attracting controversy recently as questions are raised about their effectiveness.</p>
<p>In October 2013, BMJ published a study and an opinion piece that both erred when quoting <a href="http://annals.org/article.aspx?articleid=1671715&resultClick=3">another study</a>. The journal published corrections on both pieces when the issue was raised by Oxford University Professor Rory Collins. And convened a panel to review its decision when Collins called for their retraction. </p>
<h2>Overstated side effects</h2>
<p>The first of the BMJ pieces was an analysis by a group led by Harvard University Medical School’s Professor John Abramson <a href="http://www.bmj.com/content/347/bmj.f6123">arguing against widening the criteria</a> for prescribing statins.</p>
<p>Currently, <a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2012-07/review-of-statin-therapies">one in eight of all the people</a> living in England, Wales, Northern Ireland and Australia are taking statins to reduce their cholesterol. Recent UK guidelines <a href="http://www.nice.org.uk/guidance/CG181">recommended widening these criteria</a>, potentially increasing the number of <a href="https://www.nice.org.uk/News/Article/wider-use-of-statins-could-cut-deaths-from-heart-disease">people taking them to one in five</a>. </p>
<p>Abramson’s paper argued that in the new group of patients who would be recommended statins, 140 would need to take the drug for five years to prevent one serious cardiovascular event. But, it said, 25 of the 140 (18%) would suffer “side effects ranging from minor and reversible to serious and irreversible”. </p>
<p>The other paper was <a href="http://www.bmj.com/content/347/bmj.f6340">an opinion piece</a> by UK cardiologist Aseem Malhotra that raised questions about the benefit of prescribing the drugs to healthy people at low risk of heart disease. Malhotra claimed that 20% of patients taking statins have unacceptable side effects. </p>
<p>Collins, who is head of the Oxford University Clinical Trial Service Unit and of the international Cholesterol Treatment Trialists’ Collaboration, asked for the papers’ retraction on the basis that these rates of side effects were overstated and incorrect.</p>
<p>The BMJ’s internal review panel found the risk of side effects published in both of the original papers was based on a misinterpretation of a result in an observational study, but that the journal had done the right thing in correcting rather than retracting the papers.</p>
<p>That’s all good and well, but how did this controversy arise anyway? Statins are, after all, one of the most well-studied classes of drugs in history; approximately <a href="http://www.ncbi.nlm.nih.gov/pubmed/24067403?access_num=24067403&link_type=MED&dopt=Abstract">200 million people worldwide</a> take them. </p>
<h2>Murky areas</h2>
<p>So how can it be that there are still such heated arguments about who should be taking them and about their risks and benefits? </p>
<p>As it happens, the controversy highlights some of the problems doctors face when weighing up the benefits and harms for any therapy. The only unusual matter here is that the arguments are being played out in the media rather than the pages of academic journals. </p>
<p>For most treatments, as we widen the criteria for who should get treated, the benefits get smaller. And it becomes more difficult to accurately balance harms and benefits.</p>
<p>While it’s generally accepted that treatment decisions should be guided by clinical trials, such trials can underestimate the side effects of drugs. Participants in randomised controlled clinical trials are generally younger, for instance, and healthier than typical patients. </p>
<p>And trial design can cause a systematic underestimate of side effects. Consider the fact that many trials have a run-in period of several weeks before the main trial starts. If participants dropped out during this time, that is, they stopped taking the drug because they didn’t want to take it any more or because they had side effects, then they would not proceed to the main trial. So people who are likely to have side effects are often excluded from trial results.</p>
<p>What’s more, trials may not measure all side effects. (To ameliorate this, <a href="https://www.statineffects.com/info/adverse_effects.htm">several studies have been set up</a> to try and clarify the side effects of statins, independent of research conducted by the pharmaceutical industry. And sometimes the side effects measured in trials are <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001526">not fully reported in academic papers</a>.</p>
<p><a href="http://www.alltrials.net/">An international campaign</a> is calling for the data from all trials to be made publicly available so doctors and patients can make better informed decisions about treatments.</p>
<h2>What do you think?</h2>
<p>Whether the harms of statins outweigh the benefits depends on how you balance those benefits – avoiding heart attacks and strokes – and the risks – possible side effects, and having to take a tablet every day. </p>
<p><a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=fontana+disutility+circulation">A recent study</a> showed that many people value the potential increase in life expectancy from taking statins less than the “disutility” of taking tablets. While another showed <a href="http://www.ncbi.nlm.nih.gov/pubmed/24473061">exercise works as about as well as statins</a> for preventing cardiovascular disease (as well as having positive knock-on effects on overall health).</p>
<p>Doctors don’t want to alarm people but they also don’t want to appear uncertain in front of them, so they often don’t discuss these issues with their patients. </p>
<p>But the days when doctors – or even worse, expert committees with vested interests – make decisions for patients should be over, particularly when the “patient” is not sick and the drug being taken is to prevent something that may not happen. </p>
<p>For those interested in taking charge of their health a little, here’s a <a href="http://bestsciencemedicine.com/chd/calc2.html">beta version of the type of calculator</a> that might help make decisions about risks and benefits, developed by Dr McCormack at University of British Columbia. </p>
<p>And next time you’re visiting a doctor, ask questions about treatment decisions. You have the right to know.</p><img src="https://counter.theconversation.com/content/30096/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jenny Doust receives funding from the National Health and Medical Research Council. She was previously a member of the Pharmaceutical Benefits Advisory Committee which considered the effectiveness and cost-effectiveness of statins.</span></em></p>A panel convened by medical journal BMJ to investigate whether it was right to correct rather than retract two pieces featuring a mistake about side effects from statins has endorsed the journal’s decision…Jenny Doust, Professor of Clinical Epidemiology, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/283302014-06-23T23:14:38Z2014-06-23T23:14:38Z‘Fat blaster’ drug can give you weight loss to die for<figure><img src="https://images.theconversation.com/files/51894/original/zxp8xf6y-1403503669.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Used as a weight-loss or body-sculpting supplement, DNP can cause side effects when used in doses recommended by body-building websites.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/iancarroll/5058330466">Ian Carroll/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>Losing weight is very hard, so it’s not surprising many people succumb to the allure of miracle weight-loss pills and potions available online. But they do so at their own peril, as today’s Emergency Medicine Journal shows with a report on weight-loss drug from the 1930s that’s making a nasty comeback.</p>
<p>Anyone who has spent any time on the internet will know what it’s like to be constantly bombarded with advertisements for this or that “fat burner” or “fat buster”. </p>
<p>Many of these come from exotic origins, such as <a href="http://www.sciencebasedmedicine.org/index.php/dr-oz-and-green-coffee-beans-more-weight-loss-pseudoscience/">green coffee bean extract</a> to <a href="http://www.sciencebasedmedicine.org/garcinia-probably-works-but-is-far-from-a-weight-loss-miracle/">Garcinia Cambogia</a>. And none actually work; today’s fat buster is forgotten and replaced by yet another miracle compound tomorrow.</p>
<p>Usually, the only damage these alleged miracle drugs do is to your bank balance. But an old chemical known as <a href="http://en.wikipedia.org/wiki/2,4-Dinitrophenol">2,4-dinitrophenol</a>, or DNP, is making a comeback and it will literally give you fat loss to die for. </p>
<h2>What is it?</h2>
<p>2,4-dinitrophenol (DNP) is a synthetic, industrial chemical with multiple uses. I’ve previously used it in the lab to detect biological chemicals that would develop a colour when DNP reacted with them.</p>
<p>One of its original uses was in explosives manufacture, and it was developed as a weight-loss tablet after <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3589300/">munitions workers were observed to have lost weight</a>. It is, in fact, the original “fat blaster” and was used as a weight-loss aid in the 1930s </p>
<p>It makes the energy-generating organelles of our cells, the <a href="http://en.wikipedia.org/wiki/Mitochondria">mitochondria</a>, less efficient. You lose weight as the food you eat is turned into waste heat rather than productive work or being stored as fat.</p>
<p>People who take DNP report feeling hot and sweaty, or feverish, because of the waste heat caused by DNP preventing the mitochondria from working at full efficiency. But the waste heat has another important side effect: it can kill you.</p>
<p>If you raise your internal temperature enough, you can get lethal hyperthermia – death resulting from your body cooking in the inside. This is not the only serious, or even potentially lethal, DNP side effect, but it’s certainly the most attention grabbing one. </p>
<p>This lethality is why DNP was banned back in 1938.</p>
<p>But it’s back, despite being banned in numerous countries, and repeated warnings from various regulatory agencies. DNP is now available for purchase on the internet, and is promoted in body-building circles worldwide for “body sculpture”.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/51907/original/94nswkf2-1403505592.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/51907/original/94nswkf2-1403505592.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/51907/original/94nswkf2-1403505592.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/51907/original/94nswkf2-1403505592.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/51907/original/94nswkf2-1403505592.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/51907/original/94nswkf2-1403505592.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/51907/original/94nswkf2-1403505592.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">DNP makes people feel hot and sweaty as waste heat is created when the chemical prevents the mitochondria from working at full efficiency.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/doug88888/4489411222">Doug Wheller/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<h2>A resurgence</h2>
<p>The problem is that we have no clear idea of how many people are taking DNP, and the prevalence of adverse events. Today’s report in the Emergency Medicine Journal gives a bit of an answer but their information is only from the United Kingdom.</p>
<p>The study authors looked at the number of telephone enquiries to the UK’s National Poisons Information Service asking about DNP poisoning, as well as enquires to the online toxicity database. They found the figures soared between 2012 to 2013, after being low since 2007. </p>
<p>Searching the databases for professional enquiries made about the drug, they found 39 queries between 2007 and 2013, and five related deaths.</p>
<p>The figures suggest increased use, and are compatible with an increase in <a href="http://www.ncbi.nlm.nih.gov/pubmed/21739343">worldwide reported deaths from DNP</a> in the decade 2001 to 2010. </p>
<p>While the overall figures are low, (in 2013 there were 22 calls about DNP, less than 1% of all calls for paracetamol per year), the fact that this is a banned, or restricted, substance is of great concern. </p>
<p>Of greater concern still is the fact that a significant number of the adverse reactions to DNP recorded in the article were from doses that are generally recommended by Australian body-building websites.</p>
<p>What’s more, the increase in queries and reports suggest a continuing surge in usage. A growing number of people using DNP will mean a growing number of side effects and fatalities.</p>
<p>While the drug is not commercially available in Australia (or the United Kingdom), it’s easily bought over the internet, so the potential for misadventure is high. And as people buy it off the internet, it’s very difficult to know how many are actually using DNP for weight loss or body sculpting. </p>
<p>Australian body-building sites suggest “quite a few but not the majority”, but what this means in actual numbers is anyone’s guess. </p>
<p>These people are likely to either “push through” the side effects or stop using DNP when side effects appear, rather than reporting them to the doctor. So, again, we also have no real idea of how many are experiencing side effects.</p>
<p>Clearly, we need to renew warnings and education about DNP, targeting body-building groups who are more likely to press on with using this kind of substance while suffering side effects. </p><img src="https://counter.theconversation.com/content/28330/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ian Musgrave receives funding from the National Health and Medical Research Council to study the potential adverse effects of herbal medicines. He has previously received funding from the Australian Research Council to study chemicals that modify the toxicity of the toxic proteins found in Alzheimer's disease. He is a council Member of the Australasian Society for Clinical and Experimental Pharmacology and Toxicology, and a council member of the Australian Science Communicators (SA).</span></em></p>Losing weight is very hard, so it’s not surprising many people succumb to the allure of miracle weight-loss pills and potions available online. But they do so at their own peril, as today’s Emergency Medicine…Ian Musgrave, Senior lecturer in Pharmacology, University of AdelaideLicensed as Creative Commons – attribution, no derivatives.