tag:theconversation.com,2011:/uk/topics/therapeutic-goods-administration-4118/articlesTherapeutic Goods Administration – The Conversation2024-02-13T19:08:35Ztag:theconversation.com,2011:article/2222802024-02-13T19:08:35Z2024-02-13T19:08:35ZA patch a day? Why the vitamin skin patches spruiked on social media might not be for you<figure><img src="https://images.theconversation.com/files/573945/original/file-20240207-18-9hjka6.jpg?ixlib=rb-1.1.0&rect=26%2C26%2C5824%2C4149&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/capsules-on-light-beige-top-view-2193561733">Shutterstock</a></span></figcaption></figure><p>Vitamin patches are <a href="https://www.tiktok.com/search?lang=en&q=vitamin%20patch&t=1707260917256">trending on social media</a> and advertised in <a href="https://www.instagram.com/reel/C0VBXJOrObo/">posts</a> and podcasts. </p>
<p>With patches marketed for sleep, detox, immunity and hangovers, they are being talked up as near magical fix-all stickers. Manufacturers claim they are easy-to-use, convenient and ethical when compared with other types of vitamin products. Some even come with <a href="https://www.vogue.com/article/barriere-vitamin-patches">cute floral designs</a>.</p>
<p>So do they work, are they safe, and why would you use one instead of just taking a vitamin tablet? </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/should-i-be-getting-my-vitamin-d-levels-checked-211268">Should I be getting my vitamin D levels checked?</a>
</strong>
</em>
</p>
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<h2>What are vitamin patches?</h2>
<p>Vitamin patches are adhesives designed to deliver vitamins or nutrients to your bloodstream directly through the skin.</p>
<p>You peel away the backing, place it on a hairless area of skin where it is less likely to be bumped, and then the patches release their vitamins over a period of 12 to 24 hours.</p>
<p>Two dominant <a href="https://thepatchremedy.com/">brands</a> that <a href="https://www.ultimatepatch.com.au/">market</a> in Australia sell patches that contain various chemical and plant ingredients. </p>
<p>There are patches for <a href="https://thepatchremedy.com/products/menopause">menopause symptoms</a> that claim to include plant extracts of gotu kola, damiana, black cohosh, valerian, skull cap, oat seed and ginger. Patches promising an <a href="https://www.ultimatepatch.com.au/products/energy-patch-vitamin-patches">energy boost</a> offer caffeine, taurine, gluconolactone, green tea extract and vitamins B3, B5 and B6. </p>
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<p>
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<strong>
Read more:
<a href="https://theconversation.com/can-taking-vitamins-and-supplements-help-you-recover-from-covid-182220">Can taking vitamins and supplements help you recover from COVID?</a>
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</em>
</p>
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<h2>Do they work and are they safe?</h2>
<p>In Australia, vitamins are considered pharmaceutical products and are regulated by the Therapeutic Goods Administration. Vitamins are generally approved as listed medicines, meaning the ingredients have been assessed for safety but not for efficacy (whether they do what they promise).</p>
<p>Being a listed medicine also means vitamins are manufactured in a factory with <a href="https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine/good-manufacturing-practice-gmp#:%7E:text=Good%20Manufacturing%20Practice%20(GMP)%20describes,into%20a%20batch%20of%20product">good manufacturing practices</a>, so you can be assured the ingredients listed on the packaging have been sourced properly and are provided at the correct concentration.</p>
<p>However, there are no items listed as vitamin patches on the Australian Register of Therapeutic Goods. This means they currently can not <a href="https://www.tga.gov.au/news/blog/how-are-vitamins-regulated-australia#:%7E:text=Depending%20on%20the%20vitamin%20and,their%20safety%20and%20quality%20only.">legally be supplied or purchased in Australia</a>. It doesn’t matter if they are being sold from a physical store or online within the country. The TGA won’t <a href="https://www.tga.gov.au/sites/default/files/australian-regulatory-guidelines-complementary-medicines-argcm.pdf">stop you from buying them from overseas</a>, but they advise you not to do so because you can’t be assured of quality and safety.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="clear capsules being produced by machine" src="https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/573949/original/file-20240207-30-751n5r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Vitamins and supplements listed by the TGA are produced in factories with stringent quality standards.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/fish-oil-gelatin-capsules-production-vitamins-2299877737">Shutterstock</a></span>
</figcaption>
</figure>
<p>There is also insufficient evidence that vitamins delivered in this way work. Not all drugs and chemicals can be delivered through the skin. Ordinarily, to be absorbed through the skin a chemical needs to be <a href="https://www.merriam-webster.com/dictionary/lipophilic">lipophilic</a>, meaning it likes fats and oils more than water. </p>
<p>So, the form in which the vitamins have been produced and supplied will dictate whether they will get into the skin. For example, a water extract of a plant is less likely to be absorbed when compared with an oil-based extract.</p>
<p><a href="https://pubmed.ncbi.nlm.nih.gov/31302845/">A small 2019 study</a> of patients at risk of nutrient deficiencies after bariatric (weight-loss) surgery gave some of them a daily multivitamin patch for a year. Those patients had lower blood concentrations of several vitamins and were more likely to have vitamin D deficiency when compared with patients given oral vitamins. The study concluded transdermal vitamin patches were not as effective as oral supplements. </p>
<p>Another issue with vitamin patches is that they contain very low concentrations of ingredients and you may therefore get an ineffective dose, even if all the vitamin in the patch is 100% absorbed through the skin. </p>
<p>For example, one particular patch that is marketed for immunity states that it contains 3 milligrams of vitamin C, which is likely insufficient if taken to supplement a low vitamin C diet. The health condition called <a href="https://www.ncbi.nlm.nih.gov/books/NBK493187/">scurvy</a> is thought to occur when daily vitamin C intake drops lower than <a href="https://www.healthdirect.gov.au/vitamin-c-and-your-health">7 milligrams per day</a>. </p>
<p>In contrast, a typical vitamin C tablet contains 500 milligrams. The recommended daily intake of vitamin C is around <a href="https://www.healthdirect.gov.au/vitamin-c-and-your-health">45 milligrams per day</a> – more if a woman is breastfeeding. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="person puts clear patch on skin of upper arm" src="https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/573947/original/file-20240207-22-3nunzy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Nicotine patches work by providing a sustained release of the drug into the skin.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/nicotine-patch-on-skin-quitting-smoking-438277147">Shutterstock</a></span>
</figcaption>
</figure>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/is-tiktok-right-will-eating-three-carrots-a-day-really-give-me-a-natural-tan-214270">Is TikTok right – will eating three carrots a day really give me a natural tan?</a>
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</em>
</p>
<hr>
<h2>Why not just take a tablet?</h2>
<p>When other medicines are supplied in a patch formulation it is usually because a constant supply of the drug is needed in the body; think smoking replacement nicotine patches, <a href="https://www.healthdirect.gov.au/hormone-replacement-therapy">menopausal hormone therapy</a> and some types of <a href="https://www.nps.org.au/radar/articles/fentanyl-patches-durogesic-for-chronic-pain">pain relief</a>.</p>
<p>There is no reason why you would need the slow release, continuous supply of vitamins that patches promise – but there may be other reasons to choose them over tablets and gummy products.</p>
<p>One selling point used by the marketers is that patches are a “cleaner” form of vitamins. A vitamin in tablet or gummy form will contain inactive ingredients called <a href="https://australianprescriber.tg.org.au/articles/pharmaceutical-excipients-where-do-we-begin.html">excipients</a>. Excipients do various tasks in medicines from binding ingredients together, making the medicine look and smell nice, to ensuring drugs don’t break down during storage. The presumption is that patches don’t contain and release any, or very few, excipients into your body. </p>
<p>But many patches don’t list all their ingredients – just the active vitamins – so this claim can not be tested. Some patches may still contain a large number of excipients, some of which may irritate the skin.</p>
<p>For example, one type of <a href="https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=203285&agid=%28PrintDetailsPublic%29&actionid=1">nicotine patch</a> contains 12 excipients including acrylic acid and vinyl acetate, which are chemicals used to help stick the patch to the skin.</p>
<p>A patch may be worth investigating for people who have trouble swallowing or chewing. In this instance it could be <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810703/">difficult to take a solid tablet</a> or gummy to get your vitamins. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/paracetamol-versus-ibuprofen-which-works-best-and-when-207921">Paracetamol versus ibuprofen – which works best and when?</a>
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</em>
</p>
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<h2>Should you buy them?</h2>
<p>As there are no vitamin patches approved by the TGA in Australia, you should not buy them. </p>
<p>If at some point in the future they become listed medicines, it will be important to remember that they may not have been assessed for efficacy. </p>
<p>If you remain curious about vitamin patches, you should discuss them with your doctor or local pharmacist.</p><img src="https://counter.theconversation.com/content/222280/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nial Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is a Fellow of the Royal Australian Chemical Institute, a member of the Australasian Pharmaceutical Science Association, and a member of the Australian Institute of Company Directors. Nial is the chief scientific officer of Vaihea Skincare LLC, a director of SetDose Pty Ltd a medical device company, and a Standards Australia panel member for sunscreen agents. Nial regularly consults to industry on issues to do with medicine risk assessments, manufacturing, design, and testing.</span></em></p><p class="fine-print"><em><span>Jasmine Lee does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>There are no vitamin patches listed on the Australian Register of Therapeutic Goods and there’s not enough evidence to show they work better than tablets.Nial Wheate, Associate Professor of the School of Pharmacy, University of SydneyJasmine Lee, Pharmacist and PhD Candidate, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2085682023-06-29T06:54:42Z2023-06-29T06:54:42ZPsychedelic medicine is on its way. But it’s not ‘doing shrooms with your shrink’. Here’s what you need to know<figure><img src="https://images.theconversation.com/files/534483/original/file-20230628-7269-u63go1.jpg?ixlib=rb-1.1.0&rect=1%2C0%2C997%2C666&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/focus-on-female-psychiatrist-writing-information-2160876067">Shutterstock</a></span></figcaption></figure><p>Many people in Australia, including psychiatrists, were <a href="https://theconversation.com/the-tga-has-approved-certain-psychedelic-treatments-the-response-from-experts-is-mixed-199290">surprised</a> when earlier this year the medicines regulator <a href="https://www.tga.gov.au/news/blog/understanding-changes-mdma-and-psilocybin-access">down-scheduled</a> MDMA, known colloquially as ecstasy, and psilocybin, from magic mushrooms.</p>
<p>This means that under certain circumstances from July 1, <a href="https://www.tga.gov.au/sites/default/files/2023-03/change-classification-mdma-psilocybin-enable-prescribing-authorised-psychiatrists_.pdf">authorised psychiatrists</a> will be able to prescribe MDMA to treat post-traumatic stress disorder and psilocybin to treat depression that has not responded to other treatments. Patients must also undergo psychotherapy (talking therapy). </p>
<p>It all sounds very certain but it’s not really.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/explainer-what-is-post-traumatic-stress-disorder-11135">Explainer: what is post-traumatic stress disorder?</a>
</strong>
</em>
</p>
<hr>
<h2>Beware the hype</h2>
<p>The Therapeutic Goods Administration decision has left a lot of <a href="https://theconversation.com/the-tga-has-approved-certain-psychedelic-treatments-the-response-from-experts-is-mixed-199290">questions unanswered</a> about how the new scheme will be implemented and operated, both effectively and safely.</p>
<p>There are a small number of countries where psychedelic-assisted therapies are used outside clinical trials – in a very limited manner. However, this is the first time a national government has altered the way these substances are formally classified.</p>
<p>So the world is watching closely how “psychedelic-assisted therapy”, as it’s officially called, is rolled out in Australia.</p>
<p>It’s a hot topic, with much <a href="https://www.abc.net.au/radio/programs/pm/australia-to-allow-psychiatric-treatment-with-psychedelics/102526508">public interest</a>. But for researchers, there are concerns the hype is getting way ahead of the research.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-tga-has-approved-certain-psychedelic-treatments-the-response-from-experts-is-mixed-199290">The TGA has approved certain psychedelic treatments: the response from experts is mixed</a>
</strong>
</em>
</p>
<hr>
<h2>The first steps</h2>
<p>The Royal Australian and New Zealand College of Psychiatrists this week <a href="https://www.ranzcp.org/clinical-guidelines-publications/clinical-guidelines-publications-library/therapeutic-use-of-mdma-for-ptsd-and-psilocybin-for-treatment-resistant-depression">released guidance</a> to their members about how this would work in practice.</p>
<p>As researchers in this field, we helped develop these guidelines. They cover topics such as patients’ suitability for this therapy, and how to administer and monitor it.</p>
<p>The guidelines also stress the importance of patient safety and appropriate training for prescribers, and advocates for continued research.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1673359318408650753"}"></div></p>
<h2>What does this mean for patients?</h2>
<p>This has several implications for potential patients: </p>
<ul>
<li><p>their existing psychiatrist may not be authorised to prescribe these psychedelics. So patients will have to ask their psychiatrist or GP for a referral to one who is</p></li>
<li><p>the psychiatrist authorised to prescribe these psychedelics will need to assess whether the therapy is suitable for each individual patient. This involves a detailed and comprehensive assessment. If the treatment is suitable, several sessions of further assessment and therapy are required before the actual dosing session</p></li>
<li><p>patients will be informed of what to expect before, during and after treatment, and need to give consent to proceed. We also recommend psychiatrists tell patients this therapy is not guaranteed to work, and provide patients with a clear account of the risks and possible negative side effects of psychedelic medications.</p></li>
</ul>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/psychedelics-how-they-act-on-the-brain-to-relieve-depression-183320">Psychedelics: how they act on the brain to relieve depression</a>
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</em>
</p>
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<h2>Expectations are high, but clear evidence is lacking</h2>
<p>Despite a growing <a href="https://www.ranzcp.org/getmedia/0cf57ea2-0bd7-4883-9155-d2ba1958df86/cm-therapeutic-use-of-mdma-for-ptsd-and-psilocybin-for-treatment-resistant-depression.pdf">body of evidence</a>, psychedelic-assisted therapies are in their infancy.</p>
<p>In a time when demand for mental health services <a href="https://theconversation.com/a-bigger-budget-for-mental-health-services-wont-necessarily-improve-australias-mental-health-160767">far outstrips supply</a>, exaggerated promises about the effectiveness of these drugs, before the research results are in, has many researchers worried. Patient expectations remain high but good clear evidence is still lacking.</p>
<p>Australian research is just getting under way and so far most psychedelic research has been done overseas. Yes, early findings have been <a href="https://www.ranzcp.org/getmedia/0cf57ea2-0bd7-4883-9155-d2ba1958df86/cm-therapeutic-use-of-mdma-for-ptsd-and-psilocybin-for-treatment-resistant-depression.pdf">quite promising</a>, but numbers are small, long-term follow-ups sparse, and potential risks and dangers still need to be explored.</p>
<p>Destigmatising these drugs has allowed us to begin our research, but sensationalising their effectiveness has the potential to disappoint and even harm patients because we really don’t know enough about how they work and who is suitable for this treatment.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/534487/original/file-20230628-19-xd13tl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Older man, sitting on sofa, palms together, with therapist taking notes" src="https://images.theconversation.com/files/534487/original/file-20230628-19-xd13tl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/534487/original/file-20230628-19-xd13tl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/534487/original/file-20230628-19-xd13tl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/534487/original/file-20230628-19-xd13tl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/534487/original/file-20230628-19-xd13tl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/534487/original/file-20230628-19-xd13tl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/534487/original/file-20230628-19-xd13tl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">We still don’t know who is suitable for this treatment.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/psychology-depression-elderly-asian-adult-man-2100727735">Shutterstock</a></span>
</figcaption>
</figure>
<p>Psychedelic-assisted therapy is no miracle cure. Espousing the benefits without a thorough examination of the risks and limitations is not only a misrepresentation of the science, it is arguably unethical.</p>
<p>Very few psychiatrists have had much experience in this fascinating but challenging field. We still have a lot to learn about the use of psychedelic medicines to treat psychiatric illness.</p>
<p>Undue haste in translating psychedelic-assisted therapy conducted in clinical trials to community clinics could affect how well these treatments work and their safety. Outside clinical trials, patients will also need to shoulder the <a href="https://theconversation.com/the-tricky-economics-of-subsidising-psychedelics-for-mental-health-therapy-201462">cost</a> of this therapy, raising equity issues.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-tricky-economics-of-subsidising-psychedelics-for-mental-health-therapy-201462">The tricky economics of subsidising psychedelics for mental health therapy</a>
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</em>
</p>
<hr>
<h2>There’s potential for harm</h2>
<p>Psychedelic-assisted therapy is not simply “doing shrooms with your shrink”.</p>
<p>There is potential for psychedelic substances to cause fear, panic or cause psychological damage if given to susceptible and vulnerable people who have been inadequately screened or assessed.</p>
<p>Paranoia, traumatisation, worsening depression, and even suicidal behaviour, among other <a href="https://pubmed.ncbi.nlm.nih.gov/36988924/">serious</a> <a href="https://pubmed.ncbi.nlm.nih.gov/36453037/">side-effects</a>, <a href="https://journals.sagepub.com/doi/full/10.1177/02698811211069100">have been observed</a> in some cases.</p>
<p>So we need ongoing monitoring of outcomes, including adverse events.</p>
<p>We also know psychedelic substances render patients particularly vulnerable. Boundary issues and safeguards are vital considerations for patient safety, particularly when patients are under the influence of the psychedelic drug. For instance, it is important to discuss and agree with patients beforehand about the nature and timing of any touch during treatment sessions, so any touch is appropriate and done with full informed consent.</p>
<h2>An exciting prospect</h2>
<p>Despite the potential harms, we remain excited at the prospect of psychedelic-assisted therapy becoming an established treatment to help a select group of patients.</p>
<p>But we want to do this in a safe, controlled and sustainable manner.</p>
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<p><em>If this article has raised issues for you, or if you’re concerned about someone you know, call Lifeline on 13 11 14.</em></p><img src="https://counter.theconversation.com/content/208568/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nigel Strauss is a psychiatrist and senior consultant with St Vincent’s Hospital Melbourne, an investigator on several psychedelic clinical trials, is on the scientific advisory board of the European Mind Foundation, and is the medical director of the Millswyn Clinic in Melbourne, a private psychiatric clinic. He has made his own philanthropic donation to Monash University for a trial of MDMA assisted psychotherapy for PTSD. The trials he's involved in have not personally received any funding.</span></em></p><p class="fine-print"><em><span>Colleen Loo receives research grant funding from the Australian NHMRC and MRFF. </span></em></p><p class="fine-print"><em><span>David Jonathan Castle has received grant monies for research from Servier, Boehringer Ingelheim; travel support and honoraria for talks and consultancy from Servier, Seqirus, Lundbeck, Mindcafe, Psychscene, Inside Practice. He is a founder of the Optimal Health Program (OHP) and holds 50% of the IP for OHP; and is part owner (5%) of Clarity Healthcare. He is an unpaid Chair of an Advisory Board of Psychae, an Australian not-for-profit institute specialising in psychedelic medicines research. He is a member of the Royal Australian and New Zealand College of Psychiatrists Psychedelic Assisted Therapy Working Group. He does not knowingly have stocks or shares in any pharmaceutical company.</span></em></p><p class="fine-print"><em><span>Steve Kisely was the first author of the report commissioned by the Therapeutic Goods Administration on the possible clinical benefits of MDMA and psilocybin. </span></em></p>From July 1, authorised psychiatrists will be able to prescribe MDMA and psilocybin in some circumstances. Here’s what we’re excited and concerned about.Nigel Strauss, Psychiatrist and Clinical Associate at The Centre of Mental Health, Swinburne University of TechnologyColleen Loo, Professor of Psychiatry, UNSW & Black Dog Institute, UNSW SydneyDavid Jonathan Castle, Chair of Psychiatry, The University of MelbourneSteve Kisely, Professor, School of Medicine, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2014622023-04-30T20:02:33Z2023-04-30T20:02:33ZThe tricky economics of subsidising psychedelics for mental health therapy<figure><img src="https://images.theconversation.com/files/522258/original/file-20230421-14-irzqf9.jpg?ixlib=rb-1.1.0&rect=0%2C270%2C4200%2C2087&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Australia is the world’s first country to legalise the medical use of psychedelics. But not everyone is sure the timing is right. There are still major issues to work out for this move to benefit those most in need. </p>
<p>In particular, there is the question of whether psychedelic medicines will be publicly subsidised, given the lack of data about their cost-effectiveness compared with other treatments. </p>
<p>From <a href="https://www.tga.gov.au/news/media-releases/change-classification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists">July 1 2023</a>, authorised psychiatrists will be able to prescribe psilocybin and MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression, to be used in conjunction with psychotherapy.</p>
<p>The Therapeutic Goods Administration (TGA), which regulates medicines and medical devices in Australia, made this decision in February, reclassifying psilocybin and MDMA from “Schedule 9” (prohibited substances, only legally available for use in research) to “Schedule 8” (controlled substances). </p>
<p>Many in the field were surprised. Advocacy group <a href="https://mindmedicineaustralia.org.au/psychedelic-assisted-therapies-in-australia-and-faqs/">Mind Medicine Australia</a>, which lobbied hard for the decision, was delighted. But mental health experts such as former <a href="https://australianoftheyear.org.au/recipients/professor-patrick-mcgorry-ao">Australian of the Year</a> Patrick McGorry <a href="https://www.smh.com.au/national/not-so-fast-controversial-mdma-drug-ruling-jumping-the-gun-20230206-p5cido.html">questioned</a> the sufficiency of evidence.</p>
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Read more:
<a href="https://theconversation.com/the-tga-has-approved-certain-psychedelic-treatments-the-response-from-experts-is-mixed-199290">The TGA has approved certain psychedelic treatments: the response from experts is mixed</a>
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<p>The TGA considered the effectiveness and safety of psilocybin and MDMA, as the regulator is supposed to do, but not their cost-effectiveness. This is not a requirement of TGA approval processes, but it is for the regulatory bodies that must approve these treatments for a public subsidy. </p>
<p>The paucity of such evidence is going to be a high hurdle. </p>
<h2>Will they be subsidised?</h2>
<p>How much will such therapy cost? One estimate is <a href="https://www.abc.net.au/news/2023-03-18/psychedelic-charity-accused-lobbying-tga-mdma-psilocybin/102103782">$20,000 to $30,000</a>, comprising the cost of the medication and therapists’ time for sessions. </p>
<p>The pharmaceutical-grade psilocybin and MDMA used in Australian clinical studies has largely been supplied free by US-based not-for-profit organisations such as the <a href="https://www.usonainstitute.org/">Usona Institute</a> and <a href="https://maps.org/">Multidisciplinary Association for Psychedelic Studies</a>. The bureaucratic requirements to import these medications include a permit from the TGA and an import licence and permit from the Office of Drug Control.</p>
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<img alt="Australian clinical trials with psilocybin and MDMA have relied on imports provided free by not-for-profit research groups such as the Multidisciplinary Association for Psychedelic Studies in California." src="https://images.theconversation.com/files/514375/original/file-20230309-18-9i5qvu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/514375/original/file-20230309-18-9i5qvu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/514375/original/file-20230309-18-9i5qvu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/514375/original/file-20230309-18-9i5qvu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/514375/original/file-20230309-18-9i5qvu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/514375/original/file-20230309-18-9i5qvu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/514375/original/file-20230309-18-9i5qvu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Australian clinical trials with psilocybin and MDMA have relied on imports provided free by not-for-profit research groups such as the Multidisciplinary Association for Psychedelic Studies in California.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
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<p>Increasing supply will require streamlining these import controls. There is also work to be done on the potential for local production. But for now the major determinant of costs for patients will be if the medicines and therapy are subsidised, as many psychological treatments and most psychiatric medications are now.</p>
<p>A subsidy for the psilocybin/MDMA component will require approval by the Pharmaceutical Benefits Advisory Committee, the independent body of medical experts that advises the federal health minister on which drugs should be listed on the Pharmaceutical Benefits Scheme.</p>
<p>This will require a detailed submission (usually from the pharmaceutical supplier) explaining how the medicine will be prescribed, its effectiveness, safety and cost-effectiveness compared with alternatives. Submissions must also include budget impact analysis – that is, how much it will cost if the medicine is listed on the PBS. </p>
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Read more:
<a href="https://theconversation.com/explainer-how-is-the-price-of-medicine-decided-in-australia-83633">Explainer: how is the price of medicine decided in Australia?</a>
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<p>A subsidy for the psychotherapy component will require listing on the Medicare Benefits Schedule, which funds services such as blood tests, diagnostics and allied health services. This will need endorsement from the <a href="http://www.msac.gov.au/internet/msac/publishing.nsf/Content/about-msac">Medicare Services Advisory Committee</a> (MSAC), which is not a statutory committee like the Pharmaceutical Benefits Advisory Committee but has <a href="https://www.valuehealthregionalissues.com/article/S2212-1099(20)30666-X/fulltext">a similar function</a>.</p>
<h2>Are they cost-effective?</h2>
<p>To date there are no published studies on psilocybin’s cost-effectiveness, and only three on MDMA – all on its use in treating PTSD. </p>
<p>The first of these studies was <a href="https://doi.org/10.1371/journal.pone.0239997">published in 2020</a>, the second <a href="https://doi.org/10.1371/journal.pone.0263252">in February 2022</a> and the third <a href="https://doi.org/10.1007/s40261-022-01122-0">in March 2022</a>. All three used economic modelling to to simulate long-term benefits and costs of MDMA-assisted psychotherapy compared with standard health care, extrapolated from the results of clinical trials (involving a few hundred people).</p>
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<img alt="alt text here" src="https://images.theconversation.com/files/523357/original/file-20230428-20-17qtn6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/523357/original/file-20230428-20-17qtn6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/523357/original/file-20230428-20-17qtn6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/523357/original/file-20230428-20-17qtn6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/523357/original/file-20230428-20-17qtn6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/523357/original/file-20230428-20-17qtn6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/523357/original/file-20230428-20-17qtn6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Phase 3 clinical trials show therapy with MDMA and psychotherapy substantially reduces PTSD symptoms compared to psychotherapy and placebo.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
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<p>All three conclude MDMA-assisted therapy is a potentially cost-effective treatment for people with chronic and severe PTSD. However, the modelling assumes the effects of MDMA-assisted psychotherapy taken from clinical trials of relatively short durations (with maximum follow up of 18 weeks) will extend over 10 to 30 years. This may be overly optimistic. They were also based on the treatment patterns and costs from the US that differ to those in Australia.</p>
<p>PBAC and MSAC will likely need to carefully weigh this type of evidence to make an assessment about cost-effectiveness.</p>
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Read more:
<a href="https://theconversation.com/psychedelics-researchers-balance-trippyness-with-scientific-rigor-after-history-of-legal-and-cultural-controversy-podcast-191502">Psychedelics researchers balance trippyness with scientific rigor after history of legal and cultural controversy – podcast</a>
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<h2>Estimating ‘off-label’ use</h2>
<p>Another issue to be carefully considered is how many people will likely use these medicines in routine practice. Such estimates are complicated by the risk of off-label use – psychiatrists prescribing psilocybin and MDMA for purposes not listed by the TGA. </p>
<p>An estimated 40–75% of anti-psychotic medicine use is “<a href="https://www1.racgp.org.au/ajgp/2021/may/off-label-medicine-use">off-label</a>”. For example, the anti-psychotic medicine quetiapine is registered for treating schizophrenia and bipolar disorder, but is <a href="https://www.nps.org.au/australian-prescriber/articles/concerns-about-quetiapine-1">often used off-label</a> for conditions such as anxiety or insomnia. This is despite the rules for prescribing quetiapine (the prescriber must state why they are prescribing it). </p>
<p>Allowing only authorised prescribers of psilocybin and MDMA may reduce the risk but not eliminate it. It could mean the cost of the medicines to the health budget ends up being a lot higher than estimated.</p>
<p>The upshot of all this means, in practice, Australia is still a way off from offering a public subsidy for these psychedelic treatments. Which means, come July 1, the number of Australians able to afford these treatments will be small.</p><img src="https://counter.theconversation.com/content/201462/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Cathy Mihalopoulos was a member of the Economics Sub-Committee of the Pharmaceutical Benefits Advisory Committee from 2012 to 2022. She receives funding from organisations including National Health and Medical Research Council, Medical Research Future Fund, Department of Health, the Butterfly Foundation. She is an investigator on a clinical trial evaluating psilocybin-assisted psychotherapy for treatment resistant depression with Swinburne University and Woke Pharmaceuticals.</span></em></p><p class="fine-print"><em><span>Christopher Langmead receives funding from the National Health and Medical Research Council, Medical Research Future Fund, Therapeutic Innovation Australia, and Servier Australia. He is co-founder and chief executive of Phrenix Therapeutics Pty Ltd, a biotechnology company developing new medicines for mental health disorders. </span></em></p><p class="fine-print"><em><span>Mary Lou Chatterton receives funding from multiple organisations including National Health and Medical Research Council, Medical Research Future Fund, Department of Health, and the Butterfly Foundation. She is an investigator on a clinical trial evaluating psilocybin-assisted psychotherapy for treatment resistant depression with Swinburne University and Woke Pharmaceuticals. She is also an investigator on a trial of MDMA-assisted therapy for alcohol use disorder and post-traumatic stress disorder funded through the Medical Research Future Fund. </span></em></p>Australia is the first country in the world to legalise the medical use of psychedelics. But without a public subsidy, few Australians will be able to afford them.Cathy Mihalopoulos, Professor, Monash UniversityChris Langmead, Professor, Monash UniversityMary Lou Chatterton, Senior research fellow, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2008952023-03-01T03:55:01Z2023-03-01T03:55:01ZWhy cough medicines containing pholcodine can be deadly even if you took them months before surgery<figure><img src="https://images.theconversation.com/files/512779/original/file-20230301-18-joknpv.jpg?ixlib=rb-1.1.0&rect=4%2C0%2C994%2C667&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/healthcare-people-medicine-concept-woman-pouring-512853772">Shutterstock</a></span></figcaption></figure><p>Cough medicines containing the active ingredient pholcodine are being withdrawn from sale due to safety concerns highlighted for years both in Australia and internationally.</p>
<p>Yesterday, Australia’s medicines regulator <a href="https://www.tga.gov.au/news/media-releases/pholcodine-cough-medicines-cancelled-tga-and-recalled-pharmacies-safety-reasons">announced</a> the immediate registration cancellation and recall of dozens of these over-the-counter cough medicines and lozenges.</p>
<p>This is because of the risk of a sudden, severe and life-threatening allergic reaction if people are also given specific muscle relaxant drugs while under a general anaesthetic.</p>
<p>That risk of anaphylaxis can remain weeks and months after taking the cough medicine.</p>
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Read more:
<a href="https://theconversation.com/still-coughing-after-covid-heres-why-it-happens-and-what-to-do-about-it-179471">Still coughing after COVID? Here's why it happens and what to do about it</a>
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<h2>What is pholcodine?</h2>
<p>Pholcodine (pronounced pho-co-dean) is an opioid-based medicine, which means it’s related to morphine and codeine. It works by binding to various opioid receptors in a part of the brain responsible for triggering the cough reflex.</p>
<p>As such, it is a common ingredient in many over-the-counter medicines used to treat a <a href="https://www.healthdirect.gov.au/cough">dry cough</a>. These include cough syrups and lozenges. Every product that contains pholcodine will list it prominently on the bottle or cardboard packaging. </p>
<p>Common brands that contain this ingredient include Benadryl, Bisolvon, Codral, Difflam, Difflam Plus and Duro-Tuss.</p>
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Read more:
<a href="https://theconversation.com/sore-throats-suck-do-throat-lozenges-help-at-all-184454">Sore throats suck. Do throat lozenges help at all?</a>
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<h2>Why the recall?</h2>
<p>The most common side effects of pholcodine are dizziness, nausea and sedation. But the Therapeutic Goods Administration (TGA) has recalled products containing it, as pholcodine can trigger anaphylaxis around the time of surgery.</p>
<p>The issue arises when pholcodine medicines are combined with types of muscle relaxants given during surgery known as <a href="https://www.cec.health.nsw.gov.au/keep-patients-safe/medication-safety/high-risk-medicines/neuromuscular-blocking-agents">neuromuscular blocking agents</a>.</p>
<p>This type of anaphylaxis can occur in people who have had a muscle relaxant before and been previously fine, or in people who receive a muscle relaxant drug for the first time.</p>
<p>Being <a href="https://www.sciencedirect.com/science/article/pii/S0007091220310072?via%3Dihub">obese</a> also places people at higher risk of this type of anaphylaxis.</p>
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<a href="https://images.theconversation.com/files/512777/original/file-20230301-3384-mk2uiz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Person under anesthesia during surgery, gas mask over face" src="https://images.theconversation.com/files/512777/original/file-20230301-3384-mk2uiz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/512777/original/file-20230301-3384-mk2uiz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/512777/original/file-20230301-3384-mk2uiz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/512777/original/file-20230301-3384-mk2uiz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/512777/original/file-20230301-3384-mk2uiz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/512777/original/file-20230301-3384-mk2uiz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/512777/original/file-20230301-3384-mk2uiz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=504&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Muscle relaxants given during surgery plus pholcodine can be a lethal mix.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/necessary-procedure-close-young-patient-lying-1220709154">Shutterstock</a></span>
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Read more:
<a href="https://theconversation.com/cough-syrup-can-harm-children-experts-warn-of-contamination-risks-199795">Cough syrup can harm children: experts warn of contamination risks</a>
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<h2>We’ve known about the risk for years</h2>
<p>We have actually known about the risks of pholcodine and muscle relaxants for some time, including in <a href="https://onlinelibrary.wiley.com/doi/10.1111/j.1399-6576.2004.00591.x">Scandinavian studies</a> in 2005.</p>
<p>In fact, it was because of these studies that pholcodine was withdrawn from the market in Norway <a href="https://onlinelibrary.wiley.com/doi/10.1111/j.1398-9995.2010.02518.x">in 2007</a>.</p>
<p>The European Medicines Agency recommended <a href="https://www.ema.europa.eu/en/news/ema-recommends-withdrawal-pholcodine-medicines-eu-market">the withdrawal of pholcodine</a> in Europe in December 2022.</p>
<p>In Australia, the <a href="https://www.psnetwork.org/ban-pholcodine/">PatientSafe Network</a> has been calling for its ban since at least 2017. </p>
<p>Over the past 12 months, there were nine reported cases of serious adverse effects to pholcodine reported to the TGA, including three deaths. The most recent case was in January this year. In three of the nine, pholcodine was the only suspected medicine involved. </p>
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<a href="https://images.theconversation.com/files/512764/original/file-20230228-2348-2al141.jpg?ixlib=rb-1.1.0&rect=72%2C591%2C3959%2C2323&q=45&auto=format&w=1000&fit=clip"><img alt="Some common products affected by the recall" src="https://images.theconversation.com/files/512764/original/file-20230228-2348-2al141.jpg?ixlib=rb-1.1.0&rect=72%2C591%2C3959%2C2323&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/512764/original/file-20230228-2348-2al141.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/512764/original/file-20230228-2348-2al141.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/512764/original/file-20230228-2348-2al141.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/512764/original/file-20230228-2348-2al141.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/512764/original/file-20230228-2348-2al141.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/512764/original/file-20230228-2348-2al141.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&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">These common cough syrups and lozenges are among products being recalled.</span>
<span class="attribution"><span class="license">Author provided</span></span>
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<h2>Why now?</h2>
<p>The TGA’s decision may come from a recent (but not yet peer reviewed) French <a href="https://www.medrxiv.org/content/10.1101/2022.12.12.22283353v1.full">study</a>. This found that when patients had taken pholcodine at any time in the 12 months before surgery that used a muscle relaxant, they were at much higher risk of anaphylaxis.</p>
<p>The French research is consistent with an earlier <a href="https://www.sciencedirect.com/science/article/pii/S0007091220310072?via%3Dihub">Western Australian study</a> which found anaphylaxis is 14 times more likely to occur when the two types of drugs are combined.</p>
<p>This is because pholcodine can linger in the body for long periods. After you swallow the medicine, the drug reaches its highest concentration in the blood stream <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1386567/">one to two hours later</a>. But both the drug and its metabolites can still be detected in the body <a href="https://www.medsafe.govt.nz/committees/marc/reports/180-3.2.1-Pholcodine.pdf">up to seven weeks later</a>.</p>
<h2>I have some at home. What now?</h2>
<p>As pholcodine can linger in the body, the TGA has warned that if you have taken a medicine containing pholcodine in the past 12 months you need to tell your doctor before you have surgery.</p>
<p>If you are taking one of these medicines you should stop immediately, even if you don’t think you’re going to have a medical procedure soon. </p>
<p>Take it to your local pharmacy for disposal. At that time, the pharmacist will be able to recommend a <a href="https://theconversation.com/health-check-do-cough-medicines-work-62425">different medicine</a> for your cough.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/health-check-do-cough-medicines-work-62425">Health Check: do cough medicines work?</a>
</strong>
</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/200895/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is a Fellow of the Royal Australian Chemical Institute, a member of the Australasian Pharmaceutical Science Association, and a member of the Australian Institute of Company Directors. Nial is the chief scientific officer of Vairea Skincare LLC, a director of SetDose Pty Ltd a medical device company, and a Standards Australia panel member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Associate Professor Tina Hinton has previously received funding from the Schizophrenia Research Institute (formerly Neuroscience Institute of Schizophrenia and Allied Disorders). She is currently a Board member of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists.</span></em></p>The risk of a severe allergic reaction when pholcodine is combined with common medicines used in anaesthesia has lead to their recall in Australia.Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyTina Hinton, Associate Professor of Pharmacology, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1858672022-06-29T05:42:35Z2022-06-29T05:42:35ZHow can we reverse the vaping crisis among young Australians? Enforce the rules<figure><img src="https://images.theconversation.com/files/471498/original/file-20220629-14-emka1y.jpg?ixlib=rb-1.1.0&rect=1%2C4%2C997%2C661&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">E-cigarettes and vape products are illegally imported into Australia. Some claim not to contain nicotine, but do.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/suffolk-uk-may-18-2019-new-1613347117">Simon Collins/Shutterstock</a></span></figcaption></figure><p>ABC TV’s Four Corners this week <a href="https://www.abc.net.au/4corners/vape-haze:-the-new-addiction-of-vaping/13948226">reported</a> how unlawful sale of e-cigarettes in Australia is out of control. </p>
<p>The program highlighted the effects on young people, in particular, including how easy it is for them to buy the products.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1539762788876181505"}"></div></p>
<p>How did this slow-moving public health train wreck unfold in broad daylight, almost a <a href="https://www.cancer.org.au/blog/extreme-caution-needed-on-electronic-cigarettes">decade after</a> the Cancer Council warned it was coming?</p>
<p>The answer is poor or non-existent enforcement of good laws.</p>
<h2>A growing problem</h2>
<p>The use of all harmful substances in young Australians is <a href="https://www.aihw.gov.au/reports/children-youth/alcohol-tobacco-and-other-drugs">declining</a> – except for e-cigarettes and <a href="https://www.aihw.gov.au/reports/illicit-use-of-drugs/national-drug-strategy-household-survey-2019/data">smoking in men</a> aged 18-24.</p>
<p>Lifetime use of e-cigarettes <a href="https://www.aihw.gov.au/reports/illicit-use-of-drugs/national-drug-strategy-household-survey-2019/data">increased</a> by 46% between 2016 and 2019 in non-smokers aged 18-24 – a huge spike in the use of a harmful substance in just three years.</p>
<p>Last week, an updated statement from the National Health and Medical Research Council <a href="https://www.nhmrc.gov.au/health-advice/all-topics/electronic-cigarettes/ceo-statement">reflected</a> increasing concerns from public health officials about the growing uptake of e-cigarettes, particularly by young people.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/471496/original/file-20220629-16-zlvpua.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="E-cigarettes: get the facts, public health campaign" src="https://images.theconversation.com/files/471496/original/file-20220629-16-zlvpua.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/471496/original/file-20220629-16-zlvpua.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=534&fit=crop&dpr=1 600w, https://images.theconversation.com/files/471496/original/file-20220629-16-zlvpua.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=534&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/471496/original/file-20220629-16-zlvpua.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=534&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/471496/original/file-20220629-16-zlvpua.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=672&fit=crop&dpr=1 754w, https://images.theconversation.com/files/471496/original/file-20220629-16-zlvpua.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=672&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/471496/original/file-20220629-16-zlvpua.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=672&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Public health officials are concerned about the growing use of e-cigarettes.</span>
<span class="attribution"><a class="source" href="https://www.nhmrc.gov.au/health-advice/all-topics/electronic-cigarettes/ceo-statement">NHMRC</a></span>
</figcaption>
</figure>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-damning-review-of-e-cigarettes-shows-vaping-leads-to-smoking-the-opposite-of-what-supporters-claim-180675">A damning review of e-cigarettes shows vaping leads to smoking, the opposite of what supporters claim</a>
</strong>
</em>
</p>
<hr>
<h2>But aren’t these illegal?</h2>
<p>Anyone using a nicotine e-cigarette without a valid doctor’s prescription has obtained the product unlawfully. Its importation was unlawful, as was its storage, sale and promotion.</p>
<p>Yet, as the Four Corners program showed, this is happening on an industrial scale. Merchants with a profit motive are promoting <a href="https://theconversation.com/a-damning-review-of-e-cigarettes-shows-vaping-leads-to-smoking-the-opposite-of-what-supporters-claim-180675">addictive products</a>, with no regard for the health of young people. </p>
<p>Retailers and online entrepreneurs are clearly not complying with current laws. And these laws are not being enforced.</p>
<h2>We need to target importation</h2>
<p>E-cigarettes are <a href="https://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/indepth-18b-e-cigarettes/18b-1-the-ecigarettemarket">not manufactured</a> in Australia. If their destination is not a pharmacy or someone with a valid prescription, their importation is <a href="https://www.tga.gov.au/nicotine-vaping-products-compliance-and-enforcement">unlawful</a>.</p>
<p>But it is clear, from the number of illegal e-cigarettes available in Australia, the federal government is not enforcing its own importation rules.</p>
<p>Attempts to amend <a href="http://www5.austlii.edu.au/au/legis/cth/num_reg_es/cianr2020202000791723.html">regulations</a> to further restrict imports were proposed in 2020. This would have enabled the Australian Border Force to intercept illegal e-cigarette imports.</p>
<p>However, the government assured the community that requiring all
non-tobacco nicotine products to only be available on prescription (<a href="https://www.tga.gov.au/nicotine-vaping-product-access">schedule 4 of the Poisons Standard</a>) would achieve the same result. It <a href="https://www.tga.gov.au/nicotine-vaping-product-access">said</a> this would protect young people from e-cigarettes.</p>
<p>It’s almost nine months since this came into effect in October 2021. Yet young people, in increasing numbers, are accessing e-cigarettes.</p>
<p>The scheduling standard and the rules underpinning it are clearly being ignored. The federal government must revisit proposals to allow interception of illegal e-cigarettes at the border or find another mechanism to block them.</p>
<h2>We need to target their sale</h2>
<p>Retailers and wholesalers are also breaking rules set out in <a href="https://www.tga.gov.au/media-release/tga-confirms-nicotine-e-cigarette-access-prescription-only">official advice</a> from the Therapeutic Goods Administration and corresponding information on state government <a href="https://www.health.nsw.gov.au/tobacco/Pages/e-cigarettes.aspx">websites</a>. </p>
<p>New South Wales Chief Health Officer Kerry Chant <a href="https://www.health.nsw.gov.au/news/Pages/20220516_00.aspx">has warned</a> that nicotine e-cigarette traders, other than pharmacies, could face prosecution, heavy fines and even jail.</p>
<p>Yet tobacconists, convenience stores and vape shops are still breaking the rules.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/471510/original/file-20220629-22-quxfkz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Rows of e-cigarettes for sale" src="https://images.theconversation.com/files/471510/original/file-20220629-22-quxfkz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/471510/original/file-20220629-22-quxfkz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=394&fit=crop&dpr=1 600w, https://images.theconversation.com/files/471510/original/file-20220629-22-quxfkz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=394&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/471510/original/file-20220629-22-quxfkz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=394&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/471510/original/file-20220629-22-quxfkz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=495&fit=crop&dpr=1 754w, https://images.theconversation.com/files/471510/original/file-20220629-22-quxfkz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=495&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/471510/original/file-20220629-22-quxfkz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=495&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">E-cigarettes and vaping products can be sold in plain view.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/kievukraine27-october2018-buy-new-vape-juice-1217375503">hurricane hank/Shutterstock</a></span>
</figcaption>
</figure>
<p>State and territory governments must enforce their laws, especially those being broken in plain view. Authorities can impose substantial fines for offenders, which would not only deter unlawful trade, it would fund additional enforcement.</p>
<p>There are also laws for the bulk storage and transport of schedule 4 poisons, such as nicotine. Four Corners showed how readily a film crew could expose breaches of these laws.</p>
<h2>If young people can find them, so can the authorities</h2>
<p>Young people told Four Corners they can access products without a prescription from online entrepreneurs importing, storing and selling nicotine e-cigarettes. </p>
<p>Seizing illegal imports will eventually dry up their supply, but there will be stockpiles. </p>
<p>If school children can access these suppliers and their products with a quick search on their smartphones, authorities can also find them and put them out of business.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/vaping-is-glamourised-on-social-media-putting-youth-in-harms-way-159436">Vaping is glamourised on social media, putting youth in harm's way</a>
</strong>
</em>
</p>
<hr>
<h2>What needs to happen next?</h2>
<p>E-cigarette use in young Australians is a crisis, but is fixable. The federal government must stop illegal imports, the states and territories must end the unlawful retail, wholesale and interstate trade.</p>
<p>The <a href="https://theconversation.com/a-damning-review-of-e-cigarettes-shows-vaping-leads-to-smoking-the-opposite-of-what-supporters-claim-180675">harms of e-cigarettes</a> are severe and far outweigh any modest benefits; there are laws to protect young people from them. </p>
<p>If the crisis worsens, more people will ask, how did this happen? The answer will be simple: governments made good laws, but they did not enforce them.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/its-safest-to-avoid-e-cigarettes-altogether-unless-vaping-is-helping-you-quit-smoking-123274">It's safest to avoid e-cigarettes altogether – unless vaping is helping you quit smoking</a>
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</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/185867/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Paul Grogan is employed by the Daffodil Centre, a joint cancer research venture between Cancer Council NSW and the University of Sydney. He is an investigator on a current research project on e-cigarette use in young people jointly funded by the NSW Government and the Minderoo Foundation, with in-kind support from Cancer Council NSW.</span></em></p>If the crisis worsens, more people will ask, how did this happen? The answer will be simple: governments made good laws, but they did not enforce them.Paul Grogan, Adjunct Senior Lecturer, The Daffodil Centre, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1715892021-11-12T05:02:04Z2021-11-12T05:02:04ZPfizer’s pill is the latest COVID treatment to show promise. Here are some more<figure><img src="https://images.theconversation.com/files/431597/original/file-20211111-21-1pw54ft.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C998%2C660&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/new-york-usa-november-2021-pfizer-2071222382">Shutterstock</a></span></figcaption></figure><p>Pfizer says its antiviral COVID treatment Paxlovid cuts the chance of ending up in hospital or dying <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">by 89%</a>. </p>
<p>What differentiates this from other medicines we have used since the start of the pandemic is it provides the opportunity for patients to be treated at home, with a combination of a capsule and a pill.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1456581881772785673"}"></div></p>
<p>The phase 2/3 trial data on which those hospitalisation rates are based have yet to be independently verified. Nor has the treatment been approved by any country for use outside a clinical trial. </p>
<p>Yet this development adds to our growing portfolio of potential options to directly target SARS-CoV-2, the virus that causes COVID-19, and to treat COVID symptoms.</p>
<h2>What is it?</h2>
<p>Paxlovid is a combination of two different drugs – the HIV drug <a href="https://www.nps.org.au/australian-prescriber/articles/ritonavir">ritonavir</a> (a capsule) and an experimental drug PF-07321332 (a pill).</p>
<p>Ritonavir protects the body from metabolising PF-07321332. It acts by being broken down by the body first (known as a sacrificial chemical) to ensure enough PF-07321332 reaches the virus intact.</p>
<p>PF-07321332 is a so-called <a href="https://www.healthline.com/health/hiv-aids/protease-inhibitors">protease inhibitor</a> (as is ritonavir). It blocks the action of a vital enzyme (protease) and stops SARS-CoV-2 from making copies of itself.</p>
<h2>What did the trial show?</h2>
<p>The trial included 1,219 “high risk” adults with COVID who were not in hospital. Each person had at least one characteristic or underlying medical condition associated with an increased risk of developing severe COVID. One group received the treatment, the other placebo.</p>
<p><a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">The trial’s interim results showed</a> a reduction in the risk of hospitalisation or death by 89% in the Paxlovid group compared to placebo. </p>
<p>At day 28, there were no deaths reported in the Paxlovid group, compared with ten deaths in the placebo group. Side-effects were similar in both groups and were generally mild.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/could-a-simple-pill-beat-covid-19-pfizer-is-giving-it-a-go-160988">Could a simple pill beat COVID-19? Pfizer is giving it a go</a>
</strong>
</em>
</p>
<hr>
<p>The company said the results were so promising it was recommended no new patients needed to be enrolled into the study. And the company was recommended to submit the data to the US Food and Drug Administration for emergency use approval.</p>
<p>Before the drug could be used in Australia, the Therapeutic Goods Administration (TGA) would need to assess its efficacy and safety. </p>
<p>Just as importantly, the TGA would need to decide who may prescribe it and under what conditions. This may include whether it would be available from GPs, and what sort of patient risk factors would be considered.</p>
<p><iframe id="tc-infographic-616" class="tc-infographic" height="400px" src="https://cdn.theconversation.com/infographics/616/0f14bd7141c03b8e4326bc62ffcacb1c6fdc697d/site/index.html" width="100%" style="border: none" frameborder="0"></iframe></p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-sotrovimab-the-covid-drug-the-government-has-bought-before-being-approved-for-use-in-australia-165802">What is sotrovimab, the COVID drug the government has bought before being approved for use in Australia?</a>
</strong>
</em>
</p>
<hr>
<h2>One of several potential antiviral drugs</h2>
<p>Paxlovid is one potential COVID drug for use at home. The idea is these could be prescribed at the first sign of infection to prevent serious illness and death. People would <a href="https://theconversation.com/how-can-i-treat-myself-if-ive-got-or-think-ive-got-coronavirus-134654">manage their own symptoms</a>, monitored while at home, and only be transferred to hospital if their condition deteriorates.</p>
<p>Merck has its own antiviral drug, <a href="https://theconversation.com/take-at-home-covid-drug-molnupiravir-may-be-on-its-way-but-vaccination-is-still-our-first-line-of-defence-169246">molnupiravir</a>, also for home use. It’s been approved for use in the UK, and is being considered for use in Australia.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1456235035862917129"}"></div></p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/take-at-home-covid-drug-molnupiravir-may-be-on-its-way-but-vaccination-is-still-our-first-line-of-defence-169246">Take-at-home COVID drug molnupiravir may be on its way — but vaccination is still our first line of defence</a>
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</em>
</p>
<hr>
<p>Then there’s AstraZeneca’s emerging <a href="https://www.theguardian.com/australia-news/2021/nov/10/astrazenecas-new-covid-treatment-what-is-it-and-how-does-it-work">COVID drug Evusheld</a>. The TGA has just given this “<a href="https://www.tga.gov.au/media-release/tga-grants-provisional-determination-astrazeneca-pty-ltd-covid-19-preventative-treatment-tixagevimab-and-cilgavimab-evusheld">provisional determination</a>”, meaning the company can now submit data for evaluation.</p>
<p>Evusheld contains two long-acting monoclonal antibody drugs – tixagevimab and cilgavimab. It’s an injection that could be given in hospital or as an outpatient to prevent infections from getting worse.</p>
<p><a href="https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html">Human trials</a> have shown when Evusheld was used before exposure to COVID, there were significantly fewer symptoms. </p>
<p>Although Evusheld may potentially be used to prevent COVID, it would not be a substitute for vaccination. But it could provide additional protection for people who may have an inadequate response to vaccination or who cannot be immunised. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1458548255457828865"}"></div></p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/stopping-blocking-and-dampening-how-aussie-drugs-in-the-pipeline-could-treat-covid-19-162349">Stopping, blocking and dampening – how Aussie drugs in the pipeline could treat COVID-19</a>
</strong>
</em>
</p>
<hr>
<h2>Treating COVID symptoms</h2>
<p>We also have a range of existing and emerging treatments for use in hospital to treat the symptoms of infection – inflammation on the lungs and difficulty breathing.</p>
<hr>
<p><iframe id="tc-infographic-615" class="tc-infographic" height="400px" src="https://cdn.theconversation.com/infographics/615/645fd6301a40a2be823b1ab347f0608d94071f90/site/index.html" width="100%" style="border: none" frameborder="0"></iframe></p>
<hr>
<p>If patients with mild COVID have certain risk factors for disease progression, such as <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html">diabetes or a heart condition</a>, doctors may consider using hospital administered treatments such as sotrovimab, Ronapreve, or inhaled budesonide to prevent disease progression.</p>
<p>According to Pfizer’s trial results, Paxlovid could be used as an alternative to in-hospital treatment for preventing disease progression in patients with the same risk factors.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/heres-what-happens-when-youre-hospitalised-with-covid-167544">Here's what happens when you’re hospitalised with COVID</a>
</strong>
</em>
</p>
<hr>
<h2>Where next?</h2>
<p>There are several steps before we can routinely expect to take COVID drugs at home to prevent the worst of the symptoms. We need independent verification of these drugs’ <a href="https://www.nature.com/articles/d41586-021-03074-5?utm_source=twt_nat&utm_medium=social&utm_campaign=nature">efficacy and safety</a>, and of course, regulatory approval.</p>
<p>Then there’s the <a href="https://www.forbes.com/sites/williamhaseltine/2021/10/08/anti-covid-drugs-are-coming-but-at-what-cost/?sh=1cbc33e577a1">issue of cost</a>. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1457471886066020357"}"></div></p>
<p>Developing new medicines, particularly at the pace required because of COVID, means these new drugs aren’t cheap. One consideration for state and federal governments will be balancing the costs of the medicines against health outcomes.</p>
<p>The <a href="https://www.canstar.com.au/health-insurance/hospital-stay-cost/">daily cost of a patient in hospital</a> is around A$5,000 for an uncomplicated (non-COVID) admission. This is much more than the <a href="https://scholar.harvard.edu/files/melissabarber/files/estimated_cost-based_generic_prices_for_molnupiravir_for_the_treatment_of_covid-19_infection.pdf">reported cost</a> of a full course of molnupiravir to the US government at US$700 (about A$960).</p>
<p>But the costs of Paxlovid, and other new COVID medicines, have not been released and may be very much higher than the hospital costs. Some medicines subsidised by the government for other conditions can cost almost <a href="https://www.pbs.gov.au/medicine/item/11332K-11333L-11337Q-11344C-11345D-11346E-11353M-11354N-11355P">A$19,000 per pack of tablets</a>.</p><img src="https://counter.theconversation.com/content/171589/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association. Nial is science director of the medicinal cannabis company Canngea Pty Ltd, a board member of the Australian Medicinal Cannabis Association, and a Standards Australia committee member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Elise Schubert is a registered pharmacist and a PhD Candidate receiving scholarship from the University of Sydney and Canngea Pty Ltd.</span></em></p>Paxlovid is one potential COVID drug for use at home. The idea is these can potentially be prescribed at the first sign of infection to prevent serious illness and death.Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyElise Schubert, Pharmacist and PhD Candidate, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1671782021-09-02T05:27:41Z2021-09-02T05:27:41ZThinking of trying ivermectin for COVID? Here’s what can happen with this controversial drug<figure><img src="https://images.theconversation.com/files/419019/original/file-20210902-18-njx5bl.jpg?ixlib=rb-1.1.0&rect=1%2C1%2C997%2C664&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/clamart-france-august-22-2021-box-2028959327">Shutterstock</a></span></figcaption></figure><p>Westmead Hospital in Sydney’s west says it has treated a patient <a href="https://www.news.com.au/lifestyle/health/health-problems/westmead-hospital-patient-overdoses-on-online-cure-for-covid19/news-story/d5cc0998a98791af3b43bcaef42578b9">who overdosed</a> after taking the drug ivermectin, an unproven and potentially dangerous treatment for COVID-19.</p>
<p>The person went to hospital seeking treatment for diarrhoea and vomiting side-effects, after taking the drug, which is usually used to treat parasites. The person had ordered this and other unproven COVID “cures” online.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1433020559349084160"}"></div></p>
<p>While the patient did not die, <a href="https://www.tga.gov.au/covid-19-treatments-information-consumers-and-health-professionals">health authorities are concerned</a> at the number of people taking ivermectin, and warn against it for anyone else who may have COVID symptoms or has been diagnosed with the virus.</p>
<p>Other known ivermectin side-effects range from mild to the life-threatening, including seizures and coma.</p>
<h2>Why are people taking it?</h2>
<p>Ever since researchers showed ivermectin could kill SARS-CoV-2 (the virus that causes COVID-19) in the laboratory, there has been interest in whether the drug would also work to kill the virus <a href="https://theconversation.com/head-lice-drug-ivermectin-is-being-tested-as-a-possible-coronavirus-treatment-but-thats-no-reason-to-buy-it-135683">in the human body</a>.</p>
<p>So far, there is <a href="https://theconversation.com/a-major-ivermectin-study-has-been-withdrawn-so-what-now-for-the-controversial-drug-164627">no clinical evidence</a> it works to treat or prevent COVID-19. And there is widespread consensus people should not take ivermectin at home for COVID-19. </p>
<p>Organisations that recommend against it include: the <a href="https://www.who.int/news-room/feature-stories/detail/who-advises-that-ivermectin-only-be-used-to-treat-covid-19-within-clinical-trials">World Health Organization</a>, Australia’s <a href="https://covid19evidence.net.au/faqs/#Ivermectin">National COVID-19 Clinical Evidence Taskforce</a> and <a href="https://www.nps.org.au/ivermectin-and-covid-19">NPS Medicinewise</a>, the United State’s <a href="https://www.fda.gov/animal-veterinary/animal-health-safety-and-coronavirus-disease-2019-covid-19/cvm-letter-veterinarians-and-retailers-help-stop-misuse-animal-ivermectin-prevent-or-treat-covid-19">Food and Drug Administration</a>, and the <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD015017.pub2/full">Cochrane Library</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-major-ivermectin-study-has-been-withdrawn-so-what-now-for-the-controversial-drug-164627">A major ivermectin study has been withdrawn, so what now for the controversial drug?</a>
</strong>
</em>
</p>
<hr>
<h2>How are people getting hold of it?</h2>
<p>Despite this, <a href="https://www.theguardian.com/australia-news/2021/sep/01/australian-pharmacists-report-rise-in-customers-refusing-to-say-what-ivermectin-prescription-is-for">community pharmacists</a> have reported increased demand for ivermectin, with people seeking the drug as a possible COVID treatment.</p>
<p>In Australia, ivermectin is <a href="https://www.tga.gov.au/covid-19-treatments-information-consumers-and-health-professionals">approved to treat parasite infections in humans</a>. It’s also widely used in veterinary medicine to treat and prevent parasite infections.</p>
<p>However, as a prescription-only human medicine (known as <a href="https://www.healthdirect.gov.au/medicines/brand/amt,3069011000036101/stromectol">schedule 4</a>), you can only access ivermectin legally in Australia after approval from a doctor.</p>
<p>This is because, like all medicines, ivermectin is not 100% safe. It does have possible harmful side-effects and a doctor’s judgement is necessary to decide if ivermectin is safe and appropriate for each patient.</p>
<p>So ivermectin is currently only recommended to treat and prevent COVID-19 when used <a href="https://covid19evidence.net.au/faqs/#Ivermectin">as part of a clinical trial</a>, where patients can be more safely selected and carefully monitored.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1432747015507779586"}"></div></p>
<p>As well as more patients presenting to pharmacies with scripts, the Therapeutic Goods Administration <a href="https://www.tga.gov.au/media-release/risks-importing-ivermectin-treatment-covid-19">warns</a> about the danger of importing ivermectin products of unknown quality, bought over the internet.</p>
<p>This is risky because products may not contain the stated drug, may contain dangerous contaminants or much more of the drug than thought, which may result in an overdose.</p>
<p>Of most concern are reports from <a href="https://www.abc.net.au/radio/programs/worldtoday/warnings-against-ivermectin/13524184">Australia</a> and <a href="https://www.theguardian.com/commentisfree/2021/aug/31/a-human-is-not-a-horse-so-why-is-a-livestock-drug-sweeping-america-covid-ivermectin">overseas</a> of people buying and taking ivermectin products intended for animal use. People may be resorting to these types of products where they have been unable to access a script for human formulations of ivermectin.</p>
<h2>What does it do to your body?</h2>
<p>We know very little about what the drug does to humans, and the little we do know mostly comes from <a href="https://pubmed.ncbi.nlm.nih.gov/34149064/">its use in animals</a>.</p>
<p>When taken at the recommended dose, the drug is generally well tolerated. But ivermectin is known to cause mild side-effects such as diarrhoea, nausea, dizziness and sleepiness. Less common, but serious, side-effects include severe skin rashes and effects on the nervous system (causing tremor, confusion and drowsiness). </p>
<p>In higher doses, and overdose cases, these side-effects can be <a href="https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19">more severe</a>. These include low blood pressure, problems with balance, seizures, liver injury, and it can even <a href="https://www.nejm.org/doi/full/10.1056/NEJMc1917344">induce comas</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/coronavirus-misinformation-is-a-global-issue-but-which-myth-you-fall-for-likely-depends-on-where-you-live-143352">Coronavirus misinformation is a global issue, but which myth you fall for likely depends on where you live</a>
</strong>
</em>
</p>
<hr>
<h2>The take-home message</h2>
<p>The public is understandably interested in medicines to treat and prevent COVID-19. However, <a href="https://theconversation.com/au/topics/covid-misinformation-103292">misinformation about ivermectin and others continues to circulate</a>. </p>
<p><a href="https://theconversation.com/how-well-do-covid-vaccines-work-in-the-real-world-162926">COVID-19 vaccination</a> remains the best way to reduce the risk of serious illness and death from COVID-19. Australia’s <a href="https://covid19evidence.net.au/">National COVID-19 Clinical Evidence Taskforce</a> provides the most up-to-date information about COVID-19 treatments and is a reliable source of information as new knowledge emerges.</p>
<hr>
<p><em>If you or a family member take ivermectin and have strong side-effects you should seek medical advice. Call the <a href="https://www.health.gov.au/contacts/poisons-information-centre">Poisons Information Centre</a> on 131 126. For life-threatening symptoms, call 000 for an ambulance.</em></p><img src="https://counter.theconversation.com/content/167178/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association. Nial is science director of the medicinal cannabis company Canngea Pty Ltd, a board member of the Australian Medicinal Cannabis Association, and a Standards Australia committee member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Andrew McLachlan receives research funding from the NHMRC and the Sydney Pharmacy School receives research scholarship funding from GSK for a PhD student under his supervision. Andrew has served as a paid consultant on Australian government committees related to medicines regulation. Andrew does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article.</span></em></p><p class="fine-print"><em><span>Slade Matthews has served the Australian Therapeutic Goods Administration as an external evaluator for the Therapeutic Goods Evaluation Panel. He also serves on the NSW Poisons Advisory Committee as the pharmacologist member. Slade does not work for, consult or own shares in or receive funding from any company of organisation that would benefit from this article.</span></em></p>Side-effects for this unproven and potentially dangerous treatment range from vomiting and diarrhoea to seizures and a coma.Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyAndrew McLachlan, Head of School and Dean of Pharmacy, University of SydneySlade Matthews, Senior Lecturer, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1648702021-07-27T05:02:54Z2021-07-27T05:02:54ZWhipping cream canisters have many uses beyond ‘nangs’. Banning them isn’t necessary<figure><img src="https://images.theconversation.com/files/413230/original/file-20210727-19-mf4uko.jpg?ixlib=rb-1.1.0&rect=6%2C0%2C4480%2C3000&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/closeup-hilarious-gas-n2o-metallic-siphon-1771037549">Shutterstock</a></span></figcaption></figure><p>Australia’s <a href="https://www.tga.gov.au/consultation-invitation/consultation-proposed-amendments-poisons-standard-acms-accs-and-joint-acmsaccs-meetings-march-2021">Therapeutic Goods Administration</a> (TGA) has been considering whether whipping cream canisters containing nitrous oxide should be placed in Schedule 10 of the Poisons Standard. </p>
<p>Schedule 10 is the <a href="https://www.legislation.gov.au/Details/F2021L00650">most restrictive category</a> within the Poisons Standard, reserved for “substances of such danger to health as to warrant prohibition of sale, supply and use”.</p>
<p>The canisters contain nitrous oxide, which, when mixed with cream in a whipping cream dispenser, creates high-quality whipped cream. This method is used by bakers and chefs worldwide. </p>
<p>There’s no evidence whipping cream canisters pose any risk to people who use them for their intended purpose. </p>
<p>So why has an application been made to the TGA to prohibit whipping cream canisters? </p>
<p>While the applicant hasn’t been named, the proposal is based on <a href="https://www.tga.gov.au/consultation-invitation/consultation-proposed-amendments-poisons-standard-acms-accs-and-joint-acmsaccs-meetings-march-2021">increasing concern</a> about people using the canisters to get high.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/explainer-what-is-nitrous-oxide-or-nangs-and-how-dangerous-is-it-108019">Explainer: what is nitrous oxide (or nangs) and how dangerous is it?</a>
</strong>
</em>
</p>
<hr>
<h2>Is nitrous oxide harmful?</h2>
<p>Nitrous oxide has been used in medicine and dentistry as an analgesic (a drug which relieves pain) and anaesthetic since it was first found to assist with the extraction of a tooth <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2606479/">in 1844</a>.</p>
<p>Commonly referred to as “laughing gas”, nitrous oxide continues to be used in clinical environments in Australia as a <a href="https://www.legislation.gov.au/Details/F2021L00650">Schedule 4 Medicine</a>. </p>
<p>However, no drug is risk-free. There are some harms associated with the recreational use of nitrous oxide (sometimes called “nangs”). </p>
<p>For example, there’s evidence regular heavy use of nitrous oxide can lead to a deficiency in vitamin B12 <a href="https://pubmed.ncbi.nlm.nih.gov/21112598/">resulting in peripheral neuropathy</a>. Peripheral neuropathy can be <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208100/">caused by a range of toxins and nutritional deficiencies</a>. Symptoms include unexplained pain, burning and numbness.</p>
<p>In unpublished data submitted to the TGA, 6% of almost 1,900 young Australians who reported nitrous oxide use (surveyed in 2018-2019) reported persistent numbness or tingling, consistent with peripheral neuropathy.</p>
<p>A <a href="https://journals.sagepub.com/doi/abs/10.1177/0269881119882532">large global study</a> of people who reported nitrous oxide use found persistent numbness/tingling in the hands or feet was rare (3%) and heavily dependent on dose. </p>
<p>There have also been <a href="https://www.9news.com.au/national/hamish-bidgood-schoolies-death-gold-coast-nitrous-oxide/8b4ea488-8de0-4f64-9c8c-5402f28471bb">reports of misadventure resulting in death</a> following its use.</p>
<figure class="align-center ">
<img alt="A woman receives nitrous oxide for pain relief during labour." src="https://images.theconversation.com/files/413228/original/file-20210727-20-1c6xg4s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/413228/original/file-20210727-20-1c6xg4s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/413228/original/file-20210727-20-1c6xg4s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/413228/original/file-20210727-20-1c6xg4s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/413228/original/file-20210727-20-1c6xg4s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/413228/original/file-20210727-20-1c6xg4s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/413228/original/file-20210727-20-1c6xg4s.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">Nitrous oxide is often used in medical settings.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/woman-active-labour-easing-pain-contraction-163572812">Shutterstock</a></span>
</figcaption>
</figure>
<h2>Some numbers</h2>
<p>The <a href="https://www.aihw.gov.au/reports/illicit-use-of-drugs/national-drug-strategy-household-survey-2019/contents/summary">2019 National Drug Strategy Household Survey</a> found roughly 1.7% of Australians had used inhalants in the previous 12 months. But this survey doesn’t specify which inhalants are used, so this number is likely to include many different inhalants, not just nitrous oxide.</p>
<p>The <a href="https://ndarc.med.unsw.edu.au/program/drug-trends">National Drug and Alcohol Research Centre</a> has interviewed people who regularly use MDMA and psychostimulants annually for nearly 20 years to understand more about the drug use habits of this group. </p>
<p>Around <a href="https://ndarc.med.unsw.edu.au/resource/australian-drug-trends-2020-key-findings-national-ecstasy-and-related-drugs-reporting">one-quarter</a> reported nitrous oxide use from 2003 to 2015. But this proportion doubled to 50% by 2018, and has remained at a similar level in 2020 (54%). </p>
<p>It’s important to note people who use nitrous oxide do so infrequently (on average less than once per month).</p>
<p>As use of nitrous oxide has increased among certain groups, we’ve also seen indications of increased rates of harm. For example, in New South Wales, <a href="https://pubmed.ncbi.nlm.nih.gov/31625166/">emergency department presentations</a> associated with nitrous nitrous oxide increased from ten cases per year in 2016 to 60 cases in 2018. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/weekly-dose-from-laughing-parties-to-whipped-cream-nitrous-oxides-on-the-rise-as-a-recreational-drug-83573">Weekly Dose: from laughing parties to whipped cream, nitrous oxide's on the rise as a recreational drug</a>
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</em>
</p>
<hr>
<h2>A proportional response?</h2>
<p>If the TGA was to make whipping cream canisters Schedule 10 under the Poisons Standard, these products would become prohibited in Australia. </p>
<p>Australian bakers and chefs could be forced to use carbon dioxide canisters, which are sold for Soda Stream machines. But use of carbon dioxide canisters has been <a href="https://www.creamright.com/blog/how-cream-chargers-work/">reported to result in</a> whipped cream that tastes acidic. It also creates large bubbles in the cream due to the different properties of the two chemicals.</p>
<p>We believe it’s unlikely the TGA will classify whipping cream canisters as being of such danger to health that their sale, supply and use becomes prohibited. </p>
<p>However, the TGA could make whipping cream canisters a Schedule 7 Dangerous Poison. This would mean culinary aficionados could be required to obtain a license to access whipping cream canisters from a limited number of suppliers licensed to sell them. We believe this would also be a disproportionate response.</p>
<p>There’s some <a href="https://pubmed.ncbi.nlm.nih.gov/31227419/">evidence</a> that when a drug becomes harder to access, people will substitute that drug with a more harmful drug. Making whipping cream canisters Schedule 7 or Schedule 10 could lead young people to use <a href="https://pubmed.ncbi.nlm.nih.gov/18043019/">volatile substances</a> more harmful than nitrous oxide instead (for example, spray paint, deodorant or petrol) since these are likely to be more accessible.</p>
<figure class="align-center ">
<img alt="A person preparing tarts with whipped cream on top." src="https://images.theconversation.com/files/413235/original/file-20210727-21-b1ont9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/413235/original/file-20210727-21-b1ont9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=409&fit=crop&dpr=1 600w, https://images.theconversation.com/files/413235/original/file-20210727-21-b1ont9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=409&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/413235/original/file-20210727-21-b1ont9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=409&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/413235/original/file-20210727-21-b1ont9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=513&fit=crop&dpr=1 754w, https://images.theconversation.com/files/413235/original/file-20210727-21-b1ont9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=513&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/413235/original/file-20210727-21-b1ont9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=513&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Nitrous oxide is used to make whipped cream.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/female-confectioner-decorating-tasty-tartlets-table-1323509417">Shutterstock</a></span>
</figcaption>
</figure>
<p>We’ve made submissions to the TGA arguing classifying whipping cream canisters as Schedule 10 in the Poisons Standard would be a disproportionate response to the harms associated with their use as a recreational drug. </p>
<p>Given they’re widely used by Australian bakers and chefs, we suggested the most pragmatic solution would be for the TGA to place the products in Schedule 5 or 6 of the Poisons Standard. </p>
<p>If the TGA was to list these products in Schedule 5, they would be required to contain warnings on the labelling. If they were placed in Schedule 6, similar restrictions to spray paint would apply, where retailers are required <a href="https://www.legislation.gov.au/Details/F2021L00650">to limit access to the products to minors</a>.</p>
<h2>Next steps</h2>
<p>The TGA is set to announce its <a href="https://www.tga.gov.au/update-interim-decision-nitrous-oxide">interim decision</a> on this proposal any day now.</p>
<p>The evidence indicates a minority of people, predominantly those who use nitrous oxide at very high doses, are at risk of developing serious neurological problems. </p>
<p>We should be raising community awareness of this risk as we carefully consider the consequences of tighter restrictions on the availability of a product which is generally safe, if used as directed.</p><img src="https://counter.theconversation.com/content/164870/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Stephen Bright is a Director of the not-for-profit company Psychedelic Science In Medicine & Research (PRISM) and a Director of the not-for-profit organisation Students for Sensible Drug Policy. </span></em></p><p class="fine-print"><em><span>Monica Barratt receives (or has recently received) funding from Australian (National Health and Medical Research Council, the Australian Institute of Criminology, the National Centre for Clinical Research into Emerging Drugs) and international (US National Institutes of Health, NZ Marsden Fund) sources. She has conducted commissioned research for the NSW Coroner's Office, the WA Mental Health Commission and the Victorian Department of Health. In addition to her role at RMIT, Monica is a visiting fellow at the National Drug and Alcohol Research Centre, UNSW Sydney. She is an editor for two peer-reviewed journals, the International Journal of Drug Policy and Drug and Alcohol Review. She also has leadership roles at two not-for-profit harm-reduction organisations: The Loop Australia and Bluelight.org.</span></em></p>Whipping cream canisters contain nitrous oxide, which some people use to get high. But going ahead with a proposal before the TGA to ban them altogether would be an overreaction.Stephen Bright, Senior Lecturer of Addiction, Edith Cowan UniversityMonica Barratt, Vice Chancellor’s Senior Research Fellow, Social and Global Studies Centre and Digital Ethnography Research Centre, RMIT UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1600002021-05-06T04:52:19Z2021-05-06T04:52:19ZHow do we actually investigate rare COVID-19 vaccine side-effects?<figure><img src="https://images.theconversation.com/files/399109/original/file-20210506-14-wffzox.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1000%2C666&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/smiling-young-woman-tshirt-showing-plaster-1954104319">from www.shutterstock.com</a></span></figcaption></figure><p>Investigations <a href="https://www.abc.net.au/news/2021-04-29/nsw-two-men-die-after-receiving-covid-19-vaccination/100103076">are under way</a> to determine whether the deaths of two people in New South Wales who developed blood clots are linked to the AstraZeneca vaccine.</p>
<p>We’ve also heard today that <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-06-05-2021">11 Australians</a> have so far developed blood clots (thrombosis with thrombocytopenia syndrome) linked with the vaccine.</p>
<p>But what are these investigations? And who decides whether events like these are actually linked to COVID-19 vaccines, or something else?</p>
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<strong>
Read more:
<a href="https://theconversation.com/im-over-50-and-can-now-get-my-covid-vaccine-is-the-astrazeneca-vaccine-safe-does-it-work-what-else-do-i-need-to-know-159814">I'm over 50 and can now get my COVID vaccine. Is the AstraZeneca vaccine safe? Does it work? What else do I need to know?</a>
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<h2>What triggers the process?</h2>
<p>There is a lot of interest in the safety of COVID-19 vaccines. So the public and health-care workers are “highly tuned in” to reporting suspected side-effects. </p>
<p>Anyone can <a href="https://www.tga.gov.au/covid-19-vaccine-safety-monitoring-and-reporting">report these</a> to Australia’s drug regulator, the Therapeutic Goods Administration (TGA). Alternatively, people who have been vaccinated can do so when prompted with a survey via the <a href="https://www.ausvaxsafety.org.au/">AusVaxSafety</a> system.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1369167449086554116"}"></div></p>
<p>This is a good thing as it means we are likely to pick up any serious or unusual events. Every report is valuable and contributes to our safety monitoring. However, just because an event happened after a vaccine does not mean the vaccine <em>caused</em> it.</p>
<p>A serious event could be caused by an underlying medical condition, a medication the person was taking at the time, or some other factor unrelated to the vaccine. </p>
<p>For example, before COVID-19 and vaccines against it, dozens of people across Australia developed blood clots, in their <a href="https://www.racgp.org.au/download/documents/AFP/2010/July/201007ho.pdf">legs, lungs</a>, <a href="https://www.ahajournals.org/doi/pdf/10.1161/strokeaha.116.013617">brain</a> and other parts of the body, every day, often without warning or clear cause. </p>
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Read more:
<a href="https://theconversation.com/covid-vaccines-have-been-developed-in-record-time-but-how-will-we-know-theyre-safe-153888">COVID vaccines have been developed in record time. But how will we know they're safe?</a>
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<h2>What happens next?</h2>
<p>When a person has a suspected vaccine side-effect it is usually <a href="https://www.tga.gov.au/reporting-adverse-events">reported</a> to the state or territory health department; some reports go directly to the TGA. </p>
<p>Most reactions reported after vaccination are mild to moderate. <a href="https://www.ausvaxsafety.org.au/safety-data/covid-19-vaccines">AusVaxSafety surveys</a> in more than 365,000 people in Australia confirm what we saw in vaccine trials. Up to two-thirds of people experience symptoms such as fever, muscle aches, joint pains and headache within the first one or two days after vaccination, which go away without treatment. This is the immune system responding to the vaccine.</p>
<h2>What if it’s serious?</h2>
<p>If the person dies or had a serious event needing hospitalisation within the days to weeks after vaccination — like the clotting cases you will have heard about, or there was an unusual unexpected event — there are further investigations. </p>
<p>Health department and TGA staff gather as much information as possible about the person, including their medical history, risk factors, any medications they are on, details and timing of the vaccine, hospitalisation records, any laboratory test results and whether they have recovered or have any ongoing issues. This will involve liaising with the person’s GP, specialists and the hospital.</p>
<p>Many states and territories then convene an <a href="https://www.health.nsw.gov.au/Infectious/covid-19/vaccine/Pages/clinicians.aspx">expert panel</a> of doctors to discuss a serious case. These panels often include the treating doctor, discuss the case in detail and may advise extra tests that may help them understand the event. </p>
<p>A full clinical dossier is then provided to the TGA, which then further reviews the case and decides whether a group of independent expert advisors, known as a “vaccine safety investigation group” or VSIG, is needed to review the case in detail and assess if the vaccine caused it.</p>
<p>The VSIG <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-2">often includes</a> independent medical experts in vaccine safety, infectious diseases, haematology, public health and vaccine confidence, other medical specialists, and a consumer representative.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Socially distanced meeting, with videocall" src="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">An independent panel of advisers meet to review the case in detail and to report to the TGA.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/online-video-conference-social-distancing-webinar-1818069497">from www.shutterstock.com</a></span>
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<p>The group reviews the clinical details of the event. It then uses an <a href="https://www.who.int/vaccine_safety/publications/CausalityAssessmentAEFI_EN.pdf?ua=1">internationally accepted method</a> to rate the level of certainty of a link between the serious event and the vaccine.</p>
<p>First, the group determines if there is enough clinical information to come to a decision, and if not, will request further information from the state/territory health department and may need to reconvene when that information is available.</p>
<p>The group then determines if the case is classified as:</p>
<ul>
<li><p>caused by the immunisation process (such as errors in vaccine technique) or the vaccine itself (the official terminology is “consistent causal association to immunisation”)</p></li>
<li><p>uncertain if the vaccine or immunisation process caused the event (“indeterminate”)</p></li>
<li><p>a coincidence (“inconsistent causal association to immunisation”). This could when because an underlying condition or something other than vaccine was the cause.</p></li>
</ul>
<p>The TGA then <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-3">publishes</a> the results of this independent assessment on its website. This is accompanied by a summary of the case(s) and extra clinical advice for doctors. The TGA also feeds the results back to the state/territory health department and treating doctor.</p>
<p>This information will also be included in <a href="https://www.tga.gov.au/communicating-covid-19-safety-information">weekly updates</a> published on the TGA website and is reviewed by other key advisory groups, including the <a href="https://www.health.gov.au/committees-and-groups/australian-technical-advisory-group-on-immunisation-atagi">Australian Technical Advisory Group on Immunisation</a> and the government, who monitor the progress of immunisation programs, including for COVID-19. </p>
<h2>Here’s the context</h2>
<p>While such serious vaccine-related events <a href="https://www.abc.net.au/news/2021-04-29/nsw-two-men-die-after-receiving-covid-19-vaccination/100103076">grab the headlines</a>, it’s important to remember they are <a href="https://theconversation.com/what-is-thrombocytopenia-the-rare-blood-condition-possibly-linked-to-the-astrazeneca-vaccine-158522">rare</a>. Most side-effects are mild-to-moderate and short-lived. On the other hand, the <a href="https://www.health.gov.au/resources/publications/covid-19-vaccination-weighing-up-the-potential-benefits-against-risk-of-harm-from-covid-19-vaccine-astrazeneca">benefits of COVID-19 vaccination</a> in ending the pandemic are enormous. </p>
<p>When concerning events occur after vaccination, it’s important to know Australia has strong systems to properly investigate them, look at any possible link and communicate the results to the public.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-balancing-act-between-benefits-and-risks-making-sense-of-the-latest-vaccine-news-158634">A balancing act between benefits and risks: making sense of the latest vaccine news</a>
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<img src="https://counter.theconversation.com/content/160000/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicholas Wood receives funding from the NHMRC for a Career Development Fellowship. He holds a Churchill Fellowship.</span></em></p><p class="fine-print"><em><span>Kristine Macartney is the Director of the National Centre for Immunisation Research and Surveillance (NCIRS). NCIRS receives funding from the Australian and state governments, the WHO, the Gavi Vaccine Alliance and the NHMRC. She is a member of numerous vaccine advisory groups, including ATAGI, ACV, and an independent expert on the WHO Global Advisory Committee on Vaccine Safety.</span></em></p>A serious event such as a blood clot could be caused by an underlying medical condition, a medication the person was taking at the time, or some other factor unrelated to the vaccine.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyKristine Macartney, Professor, Discipline of Paediatrics and Child Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1536402021-01-21T04:38:13Z2021-01-21T04:38:13ZHow will COVID-19 vaccines be approved for use in Australia?<figure><img src="https://images.theconversation.com/files/379835/original/file-20210120-23-4vdjra.jpg?ixlib=rb-1.1.0&rect=27%2C18%2C6154%2C4097&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption"></span> </figcaption></figure><p>Some Australians could be receiving a COVID-19 vaccine within weeks. </p>
<p>Amid the continued spread of the virus and emergence of <a href="https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html">highly contagious variants</a>, the federal government has <a href="https://theconversation.com/australias-vaccine-rollout-will-now-start-next-month-heres-what-well-need-152612">accelerated</a> the start of the roll out — initially set for March 2021 — to February. </p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/the-oxford-vaccine-has-unique-advantages-as-does-pfizers-using-both-is-australias-best-strategy-152976">The Oxford vaccine has unique advantages, as does Pfizer's. Using both is Australia's best strategy</a>
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<p>Other countries, who have been less successful in containing the virus, <a href="https://ourworldindata.org/covid-vaccinations">have already begun</a> vaccination programs. While this has been met by celebration around the world, there have also been <a href="https://theconversation.com/the-pfizer-vaccine-may-not-be-the-best-choice-for-frail-people-but-its-too-early-to-make-firm-conclusions-153445">concerns</a> about possible side-effects. </p>
<p>It is expected the <a href="https://www.tga.gov.au/">Therapeutic Goods Administration</a> (TGA) will <a href="https://www.canberratimes.com.au/story/7087511/first-covid-19-vaccine-could-be-approved-next-week-tga-boss-says/">approve the Pfizer vaccine</a> for use in Australia any day now. Approval for the AstraZeneca vaccine is expected in early February. </p>
<p>Given the uncertainty surrounding the virus and the speed at which vaccines have been developed, what processes are in place to assure Australians’ safety? </p>
<h2>What is the TGA?</h2>
<p>The TGA is part of the federal Health Department. Its job is to regulate any <a href="https://www.tga.gov.au/what-are-therapeutic-goods">product that carries a therapeutic claim</a>. This includes prescription drugs, medical devices, certain food supplements, and of course vaccines. </p>
<p>It maintains the <a href="https://www.tga.gov.au/australian-register-therapeutic-goods">Australian Register of Therapeutic Goods</a> (ARTG), which records every therapeutic good available in the country.</p>
<figure class="align-center ">
<img alt="Head of the Therapeutic Goods Administration Professor John Skerritt" src="https://images.theconversation.com/files/379848/original/file-20210121-15-nf5esp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/379848/original/file-20210121-15-nf5esp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/379848/original/file-20210121-15-nf5esp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/379848/original/file-20210121-15-nf5esp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/379848/original/file-20210121-15-nf5esp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/379848/original/file-20210121-15-nf5esp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/379848/original/file-20210121-15-nf5esp.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">Adjunct Professor John Skerritt is the Health Department official responsible for the TGA.</span>
<span class="attribution"><span class="source">Lukas Coch/AAP</span></span>
</figcaption>
</figure>
<p>The TGA regulates therapeutic goods in two main ways. First, it authorises products so they can be put on the ARTG and distributed. This involves its experts reviewing safety and efficacy data. </p>
<p>It then monitors products once they are in use. This includes collecting, analysing and reacting to data from health-care providers, patients, manufacturers, and overseas regulatory authorities.</p>
<h2>How does it work?</h2>
<p>The TGA says it adopts a “<a href="https://www.tga.gov.au/product-regulation-according-risk">risk-based approach</a>”. That is, it must be satisfied a vaccine or medication’s benefits outweigh its risks. </p>
<p>The TGA therefore is not tasked with the impossible goal of avoiding all risks. Rather, it must make sure that only products carrying acceptable risks can be marketed. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/bad-reactions-to-the-covid-vaccine-will-be-rare-but-australians-deserve-a-proper-compensation-scheme-150288">Bad reactions to the COVID vaccine will be rare, but Australians deserve a proper compensation scheme</a>
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<p>So, for example, common minor side effects (such as a stomach ache) associated with certain painkillers are deemed acceptable compared to their benefit. Similarly, a severe but rare side effect can be acceptable where the medical benefit is significant. This is the case with vaccines. </p>
<p>Along with internal scientific and medical staff, the TGA is advised by <a href="https://www.tga.gov.au/tga-statutory-advisory-committees">seven committees</a>, providing independent expert advice on scientific and technical matters. There includes a specific committee for <a href="https://www.tga.gov.au/committee/advisory-committee-vaccines-acv">vaccines</a>. </p>
<h2>Vaccine approval under ‘normal’ circumstances</h2>
<p>The TGA requires a manufacturer or importer (the “sponsor”) to demonstrate the safety and efficacy of their product. </p>
<p>That is, companies need to show not only that their product is not harmful, but it does what it is supposed to do. </p>
<figure class="align-center ">
<img alt="Vial of the Pfizer vaccine" src="https://images.theconversation.com/files/379834/original/file-20210120-13-1lpa8fp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/379834/original/file-20210120-13-1lpa8fp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/379834/original/file-20210120-13-1lpa8fp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/379834/original/file-20210120-13-1lpa8fp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/379834/original/file-20210120-13-1lpa8fp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/379834/original/file-20210120-13-1lpa8fp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/379834/original/file-20210120-13-1lpa8fp.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">Some at risk Australians are due to start receiving a COVID vaccine in February.</span>
<span class="attribution"><span class="source">Francois Mori/AP/AAP</span></span>
</figcaption>
</figure>
<p>Sponsors must submit a <a href="https://www.australianclinicaltrials.gov.au/what-clinical-trial">substantive body of clinical data</a>, gathered according to <a href="https://www.tga.gov.au/publication/note-guidance-good-clinical-practice">Good Clinical Practice</a> guidelines, which are developed in keeping with <a href="https://www.ich.org">world’s best practice</a>. </p>
<p>The TGA also reviews the data using <a href="https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-new-vaccines_en.pdf">internationally recognised guidelines</a> from the European Medicines Agency. </p>
<p><hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/australias-vaccine-rollout-will-now-start-next-month-heres-what-well-need-152612">Australia's vaccine rollout will now start next month. Here's what we'll need</a>
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<p>The <a href="https://www.ifpma.org/wp-content/uploads/2019/07/IFPMA-ComplexJourney-2019_FINAL.pdf">key data</a> for approval arises from the <a href="https://www.australianclinicaltrials.gov.au/what-clinical-trial/phases-clinical-trials">third phase of clinical trials</a>. These test a new product on very large groups, which can number in the tens of thousands. The TGA review can take <a href="https://www.tga.gov.au/prescription-medicines-overview">up to eleven months</a>. </p>
<p>If a therapeutic good is approved, but a problem later emerges, the TGA can <a href="https://www.tga.gov.au/about-australian-recall-actions">recall it</a>. </p>
<h2>Special provisions for COVID-19 vaccines</h2>
<p>The devastating speed of the COVID-19 pandemic has prompted regulatory authorities across the world to speed up approval processes. </p>
<p>Almost all have used existing special provisions to fast-track their reviews. Importantly, clinical trials have been conducted at unprecedented speed thanks to <a href="https://theconversation.com/less-than-a-year-to-develop-a-covid-vaccine-heres-why-you-shouldnt-be-alarmed-150414">unlimited funding and motivated volunteers</a>. </p>
<p>The scientific consensus is that the rigour of clinical evaluation <a href="https://theconversation.com/covid-19-vaccines-were-developed-in-record-time-but-are-these-game-changers-safe-150249">has not been compromised</a>.</p>
<figure class="align-center ">
<img alt="A UK couple leave a COVID vaccine centre in London." src="https://images.theconversation.com/files/379849/original/file-20210121-23-fp2ene.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/379849/original/file-20210121-23-fp2ene.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=398&fit=crop&dpr=1 600w, https://images.theconversation.com/files/379849/original/file-20210121-23-fp2ene.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=398&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/379849/original/file-20210121-23-fp2ene.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=398&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/379849/original/file-20210121-23-fp2ene.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=500&fit=crop&dpr=1 754w, https://images.theconversation.com/files/379849/original/file-20210121-23-fp2ene.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=500&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/379849/original/file-20210121-23-fp2ene.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 UK began vaccinating against COVID in December.</span>
<span class="attribution"><span class="source">Neil Hall/EPA/AP</span></span>
</figcaption>
</figure>
<p>Similarly, the TGA can conduct a speedier review of clinical data. </p>
<p>Instead of reviewing all the data prior to registration, the TGA conducts a <a href="https://www.tga.gov.au/covid-19-vaccine-approval-process">preliminary assessment</a>. This is followed by <a href="https://www.tga.gov.au/publication/provisional-registration-process#process-data-rolling">rolling submission</a> of clinical data, leading to provisional registration. In other words the process is accelerated by allowing the TGA to look at data on an ongoing basis.</p>
<p>This special pathway is in place for treatments or vaccines for life-threatening diseases.</p>
<p>A provisional registration means the vaccine is approved for a set period of time (to be determined by the TGA), during which vaccinations can start under close monitoring. Following this, the vaccine proceeds to full registration. </p>
<h2>Benefits outweigh risk</h2>
<p>Both the <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against">Pfizer</a> and <a href="https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html">AstraZeneca</a> vaccines have conducted phase three trials on tens of thousands of participants. Additionally, the <a href="https://www.tga.gov.au/publication/provisional-registration-process">TGA stresses</a> it will only approve provisional registrations when the data so far makes clear</p>
<blockquote>
<p>the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.</p>
</blockquote>
<p>In the context of COVID-19 vaccines, provisional registration reduces bureaucratic hurdles, while maintaining the highest possible scientific rigour.</p>
<h2>Working with the international community</h2>
<p>The TGA does not operate in a vacuum either. </p>
<p>Regulatory authorities worldwide and the World Health Organisation <a href="https://www.who.int/news/item/06-11-2020-who-icmra-joint-statement-on-the-need-for-improved-global-regulatory-alignment-on-covid-19-medicines-and-vaccines">have committed to work together</a> on COVID-19 vaccines and medicines to improve “regulatory alignment”. </p>
<figure class="align-center ">
<img alt="A woman received a COVID vaccine in India." src="https://images.theconversation.com/files/379851/original/file-20210121-19-1vjggq4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/379851/original/file-20210121-19-1vjggq4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=413&fit=crop&dpr=1 600w, https://images.theconversation.com/files/379851/original/file-20210121-19-1vjggq4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=413&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/379851/original/file-20210121-19-1vjggq4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=413&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/379851/original/file-20210121-19-1vjggq4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=518&fit=crop&dpr=1 754w, https://images.theconversation.com/files/379851/original/file-20210121-19-1vjggq4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=518&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/379851/original/file-20210121-19-1vjggq4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=518&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">India began its huge vaccination program in mid-January.</span>
<span class="attribution"><span class="source">Divyakant Solanki/EPA/AAP</span></span>
</figcaption>
</figure>
<p>The TGA is a member of the International Coalition of Medicines Regulatory Authorities, which has committed to <a href="http://www.icmra.info/drupal/en/covid-19">full cooperation and transparency</a> between its members, particularly with regard to sharing data. </p>
<p>The TGA is also part of the <a href="https://www.tga.gov.au/australia-canada-singapore-switzerland-united-kingdom-access-consortium">Access Consortium</a> alongside regulatory authorities from Singapore, Canada, Switzerland and the United Kingdom. </p>
<p>So, while the speed of development of the first COVID-19 vaccines is unprecedented, so is the level of global monitoring over their safety and efficacy.</p><img src="https://counter.theconversation.com/content/153640/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Marco Rizzi receives funding from the WA Department of Health.</span></em></p><p class="fine-print"><em><span>Katie Attwell receives funding from the Australian Research Council and the WA Department of Health. She is currently funded by ARC Discovery Early Career Researcher Award DE1901000158. She is a member of a government advisory committee, the Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 Working Group. All views presented in this article are her own and not representative of any other organisation. Dr Attwell has also received speaker's fees from Merck in the past.</span></em></p>Australia is set to get the green light to roll out the Pfizer vaccine any day now. There is a complex process behind this.Marco Rizzi, Senior Lecturer in Law, The University of Western AustraliaKatie Attwell, Senior Lecturer, The University of Western AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1536282021-01-20T19:07:54Z2021-01-20T19:07:54ZI’ve heard COVID is leading to medicine shortages. What can I do if my medicine is out of stock?<figure><img src="https://images.theconversation.com/files/379646/original/file-20210120-15-1rkrr09.jpg?ixlib=rb-1.1.0&rect=0%2C5%2C1000%2C660&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/middle-eastern-male-pharmacist-wearing-protective-1827869804">from www.shutterstock.com</a></span></figcaption></figure><p>You’ve just come from your monthly GP appointment with a new script for your ongoing medical condition. But your local pharmacy is out of stock of your usual medicine. Your condition is serious, and without it, your health is likely to suffer. What can you do?</p>
<p>While <a href="https://www.tga.gov.au/hubs/medicine-shortages">medicine shortages</a> happen from time to time, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7235598/">researchers</a> and <a href="https://www.abc.net.au/news/2021-01-20/australia-post-coronavirus-medication-shortage/13065076">the media</a> report COVID-19 is causing more shortages than normal for many life-saving medicines. In Australia, <a href="https://www.abc.net.au/news/2021-01-20/australia-post-coronavirus-medication-shortage/13065076">media reports indicate</a> this includes some medications used to treat hyperthyroidism, high blood pressure, or allergies.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1351605107289296896"}"></div></p>
<p>Unfortunately, you’ll only likely find out if this applies to you when you reach the pharmacy. If that happens, there are a few ways you may be able to obtain your prescription.</p>
<p>But if the stock shortage will last for an extended period of time, and you cannot find a supply, your doctor may need to consider prescribing a different medication. </p>
<h2>Why are there shortages?</h2>
<p>Unfortunately, medicine shortages are an all too common problem of the modern health-care system. When our medicines come from a global supply chain — where raw ingredients are made in one country, processed into medicines in another, then freighted by sea or air to Australia — a single break in the supply chain can result in medicines going out of stock.</p>
<p>So there have been calls for Australia <a href="https://www.afr.com/politics/federal/australia-looks-to-boost-drug-manufacturing-20200413-p54je6">to set up its own medicines manufacturing base</a>. But even if we do, that doesn’t help now during COVID.</p>
<p>Medicines shortages is a <a href="https://www.who.int/medicines/publications/druginformation/WHO_DI_30-2_Medicines.pdf?ua=1">growing issue globally</a>. That’s because of increasing demand, higher quality standards and fewer manufacturing sites. </p>
<p>Shortages have also been exacerbated in 2020 due to COVID-19. When workers are <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30459-1/fulltext">locked out of the factory</a> because of a local outbreak, medicines don’t get made. And when we <a href="https://www.freightaustralia.gov.au/annual-report/the-year-that-was/covid-19-impacts-on-freight">restrict the number of flights into Australia</a>, that prevents medicines from arriving.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/new-law-wont-safeguard-medicine-supply-itll-only-ensure-we-know-theres-a-shortage-103100">New law won't safeguard medicine supply – it'll only ensure we know there's a shortage</a>
</strong>
</em>
</p>
<hr>
<p>When a manufacturer knows there is likely to be a medicine shortage, for any reason, they are required to inform the Australian Therapeutic Goods Administration (TGA) so pharmacies can make other arrangements, such as stocking up on alternatives or sourcing supply from other companies.</p>
<p>When the medicine shortage is considered to have a critical patient impact, or if it is in the interest of the public to know about the shortage, then the information is added to the TGA’s <a href="https://apps.tga.gov.au/prod/MSI/search">shortages website</a>, which the public can search.</p>
<p>But this information is only useful at the government and wholesaler level; local GPs and community pharmacists don’t have the time to check the site every day.</p>
<p>Dealing with shortages efficiently is important because their impacts are wide ranging. Shortages <a href="https://doi.org/10.1371/journal.pone.0215837">result in</a> higher costs to patients when they have to buy branded rather than generic formulations; more drug errors due to the different strengths and brands dispensed; more side-effects and higher death rates because of changes to less appropriate medicines; and more complaints from patients.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/379676/original/file-20210120-19-ot4pnl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Pharmacist taking medicine off shelf" src="https://images.theconversation.com/files/379676/original/file-20210120-19-ot4pnl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/379676/original/file-20210120-19-ot4pnl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/379676/original/file-20210120-19-ot4pnl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/379676/original/file-20210120-19-ot4pnl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/379676/original/file-20210120-19-ot4pnl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/379676/original/file-20210120-19-ot4pnl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/379676/original/file-20210120-19-ot4pnl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">There’s not always enough medicine to go round. And shortages can affect a patient’s health.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/pharmacist-filling-prescription-pharmacy-drugstore-1281072733">www.shutterstock.com</a></span>
</figcaption>
</figure>
<h2>What if your local pharmacy is out of stock?</h2>
<p>It is best to speak to your pharmacist about your options when your medication is out of stock. There may be other brands still available and appropriate to swap. Alternatively, your pharmacist could dispense a different strength of the same medication. <a href="https://www.psa.org.au/coronavirus/regulatory-changes/">Regulations</a> brought in during the pandemic have allowed pharmacists to do this to help with medicine supply. </p>
<p>If there are no appropriate substitutes, in rare instances a local compounding pharmacy can manufacture certain products in store.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-to-manage-your-essential-medicines-in-a-bushfire-or-other-emergency-127516">How to manage your essential medicines in a bushfire or other emergency</a>
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</em>
</p>
<hr>
<p>If none of your local pharmacies stock your medicine, your next option is for an <a href="https://mymedkit.com.au/">Australian online pharmacy</a> to fill your script. It may be able to ship your medicine from another city or state.</p>
<p>It is not legal or safe for you personally to order prescription medications from online overseas suppliers. This is because they may not have been manufactured to Australian standards, and may be unsafe. But your pharmacist may do so on your behalf, under a special provision called <a href="https://www.tga.gov.au/ws-s19a-index">section 19A</a>.</p>
<p>If all else fails, you may need to contact your doctor about changing to a different medication. There are often many alternatives in the same drug class that work in the same, or very similar, way.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/health-check-what-should-you-do-with-your-unused-medicine-81406">Health Check: what should you do with your unused medicine?</a>
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</em>
</p>
<hr>
<p>Finally, and especially during COVID-19, for a large number of medicines pharmacists are only allowed to provide a <a href="https://www.tga.gov.au/media-release/limits-dispensing-and-sales-prescription-and-over-counter-medicines">maximum of one month’s supply</a> to each patient. </p>
<p>So if your medicine is actually in stock and you want extra, just in case, then by law they may not be able to dispense it to you. This is to prevent panic buying and to ensure the wider community has steady access to medicine; that is, to prevent further shortages.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-are-people-stockpiling-toilet-paper-we-asked-four-experts-132975">Why are people stockpiling toilet paper? We asked four experts</a>
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<img src="https://counter.theconversation.com/content/153628/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association. Nial is science director of the medicinal cannabis company Canngea Pty Ltd, a board member of the Australian Medicinal Cannabis Association, and a Standards Australia committee member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Elise Schubert is funded by a scholarship from the University of Sydney and Canngea Pty Ltd. </span></em></p>COVID-19 has resulted in higher than normal levels of medicine shortages. Here’s what to do if your local pharmacy is out of stock.Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyElise Schubert, Pharmacist and PhD Candidate, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1512872020-12-03T05:24:41Z2020-12-03T05:24:41ZShould Australians be worried about waiting for a COVID vaccine when the UK has just approved Pfizer’s?<figure><img src="https://images.theconversation.com/files/372667/original/file-20201202-21-klc000.jpg?ixlib=rb-1.1.0&rect=0%2C2%2C998%2C577&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/covid19-vaccine-concept-row-bottles-vial-1864191388">Shutterstock</a></span></figcaption></figure><p>The news that Pfizer’s COVID-19 vaccine has <a href="https://www.theguardian.com/society/2020/dec/02/pfizer-biontech-covid-vaccine-wins-licence-for-use-in-the-uk">gained emergency approval</a> in the United Kingdom and may be distributed to selected high-risk groups as early as next week is welcome.</p>
<p>Headlines also suggest people in the <a href="https://www.9news.com.au/world/coronavirus-vaccine-european-regulator-could-okay-first-covid19-shot-december-29/f6dba78d-1223-4787-8b2b-438a7de74c4f">United States and some other European countries</a> could start being vaccinated before the end of the year.</p>
<p>For instance, a US Food and Drug Administration (FDA) advisory committee is set to discuss the Pfizer vaccine on <a href="https://www.statnews.com/2020/12/02/u-k-approves-pfizers-covid-19-vaccine-putting-pressure-on-fda/">December 10</a> with a subsequent decision within a few weeks. And following the UK approval, there are reports the White House is <a href="https://www.statnews.com/2020/12/02/u-k-approves-pfizers-covid-19-vaccine-putting-pressure-on-fda/">putting pressure on the FDA</a> to move faster. </p>
<p>However, Australia is set to <a href="https://www.abc.net.au/news/2020-12-02/health-minister-greg-hunt-britain-approval-pfizer-vaccine/12944440">wait until March</a> for priority groups to be vaccinated, according to Federal Health Minister Greg Hunt. So why do Australians have to wait three months? And is that a worry?</p>
<h2>What just happened?</h2>
<p>According to Australia’s own drug regulator, the <a href="https://www.tga.gov.au/tga-statement-uk-government-emergency-use-authorisation-related-covid-19-vaccine-bnt162b2-supplied-pfizer-and-biontech">Therapeutic Goods Adminstration (TGA)</a>, the UK has provided an “emergency use” authorisation for the Pfizer vaccine, rather than going through the usual approval process. This emergency approval is temporary and is for a limited number of specific batches of the vaccine. </p>
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<p>Meanwhile, the TGA says it continues to assess the safety and efficacy of the Pfizer vaccine as that information is submitted, and is working with regulators around the world to discuss vaccine development.</p>
<p>Hunt <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/pfizer-vaccine-emergency-approval-in-the-uk">said</a> that despite the Pfizer news in the UK, Australia’s plans have not changed:</p>
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<p>Our advice remains that the timeline for a decision on approval is expected by the end of January 2021, and our planning is for first vaccine delivery in March 2021.</p>
</blockquote>
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<em>
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Read more:
<a href="https://theconversation.com/pfizer-vaccine-has-just-been-approved-heres-what-the-next-few-months-will-look-like-150790">Pfizer vaccine has just been approved: here's what the next few months will look like</a>
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<h2>Why the wait?</h2>
<p>One reason Australia might be able to afford to wait is that we are not facing the same acute public health emergency as the US, UK and some European countries.</p>
<p>The US is recording <a href="https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6">almost 200,000 new cases a day, and the UK more than 10,000</a>. Here in Australia, there have only been <a href="https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6">about 28,000 people infected since March</a>. There are currently hardly any cases of community transmission and since the end of October only <a href="https://www.covid19data.com.au/deaths">one person</a> has died. </p>
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<p>
<em>
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Read more:
<a href="https://theconversation.com/how-to-read-results-from-covid-vaccine-trials-like-a-pro-149916">How to read results from COVID vaccine trials like a pro</a>
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<p>There are also differences in how drug regulators around the world assess drug safety and efficacy.</p>
<p>In usual times, the TGA is <a href="https://web.archive.org/web/20200110095758/https:/www.cirsci.org/wp-content/uploads/2018/05/CIRS-RD-Briefing-67-04052018_FINAL.pdf">about 120 days slower</a> in approving drugs than the FDA. However, most studies show that there have been <a href="https://jamanetwork.com/journals/jama/fullarticle/2625319">more safety problems</a> with drugs fast-tracked by the FDA compared with drugs approved via its usual regulatory process. </p>
<p>The TGA is planning to use its <a href="https://www.tga.gov.au/covid-19-vaccine-approval-process">provisional approval pathway</a> which should speed up the process, but by how much is still a guess. </p>
<p>How fast is too fast? This is also unclear. The European Medicines Agency <a href="https://www.aljazeera.com/news/2020/12/2/eu-criticises-hasty-uk-approval-of-covid-19-vaccine">has criticised</a> the UK’s quick emergency approval and said its own procedure relies on more evidence and checks.</p>
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<h2>There are many stages ahead</h2>
<p>Regardless of the timing of regulatory approval, COVID vaccines still need to be made (and depending on the vaccine, imported), <a href="https://theconversation.com/we-modelled-how-a-covid-vaccine-roll-out-would-work-heres-what-we-found-150544">then distributed</a>.</p>
<p>While all eyes are on the Pfizer vaccine at the moment, this is <a href="https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/vaccines-and-treatments/australias-vaccine-agreements">one of four</a> for which the Australian government has agreements in place, should they prove safe and effective. Some of these vaccines are still in clinical trials.</p>
<p>Australia has also signed up for a shot at several other vaccines as part of the World Health Organization-backed <a href="https://theconversation.com/australias-just-signed-up-for-a-shot-at-9-covid-19-vaccines-heres-what-to-expect-146750">COVAX agreement</a>, should these prove safe and effective. Again, many of these are still in clinical trials.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/australias-just-signed-up-for-a-shot-at-9-covid-19-vaccines-heres-what-to-expect-146750">Australia's just signed up for a shot at 9 COVID-19 vaccines. Here's what to expect</a>
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<p>Finally, people still need to be willing to be vaccinated. An <a href="https://www.theguardian.com/australia-news/2020/sep/12/how-vaccine-hesitancy-could-undermine-australias-covid-response">analysis</a> of the Facebook page of the Australian Vaccination Risks Network, one of the country’s most prominent anti-vaccination groups, shows that since the start of the pandemic its page has attracted 36,962 likes and 32,350 comments; its posts have been shared 29,429 times.</p>
<p>In the meantime (and even for some time after vaccination), we will still need to wear masks when appropriate, physically distance and wash our hands. No vaccine will end the pandemic instantly.</p>
<h2>So, should Australians be worried about the delay?</h2>
<p>We don’t yet have long-term information about how long immunity will last and how common or serious any side-effects might be. There simply hasn’t been enough time.
This might be less important in an emergency situation, but Australia is no longer in an emergency. </p>
<p>Many of us can’t wait to open up to the world and it’s hard to remain patient. But Melburnians, with their second lockdown, have taught us a lot about patience this year.</p>
<p>Perhaps we owe it to them to do our bit for the health of all Australians, accepting that time is a necessary part of good decision-making and planning. </p>
<p>And that involves waiting for a safe and effective vaccine to help us return to something resembling normal life.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-will-australias-covid-vaccination-program-look-like-4-key-questions-answered-150748">What will Australia's COVID vaccination program look like? 4 key questions answered</a>
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<img src="https://counter.theconversation.com/content/151287/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2017-2020, Joel Lexchin received payments for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p><p class="fine-print"><em><span>Barbara Mintzes receives research funding from Australia's National Health and Medical Research Council (NHMRC) and is co-principal investigator on a research project funded by the Canadian Institutes of Health Research (CIHR). She is an expert witness for Health Canada on a legal case concerning marketing of an unapproved drug. She is a member of a non-profit associations supporting access to essential medicines and public interests in pharmaceutical policy, Health Action International (HAI-Europe) and of Association Mieux Prescrire, a French non-profit association that produces an independent drug bulletin, La Revue Prescrire (English version: Prescrire International).</span></em></p><p class="fine-print"><em><span>Kellia Chiu is a PhD candidate at The University of Sydney and is supported by the university's PhD Scholarship in the Community Pharmacy — Research into Policy.</span></em></p><p class="fine-print"><em><span>Lisa Parker is also a Career Medical Officer in Radiation Oncology, Royal North Shore Hospital, Sydney.</span></em></p>Australia is still aiming to start vaccinating high-risk groups from March. Why the delay?Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoBarbara Mintzes, Associate professor, School of Pharmacy and Charles Perkins Centre, University of SydneyKellia Chiu, PhD Candidate and Pharmacist, University of SydneyLisa Parker, Honorary Lecturer, School of Pharmacy, Charles Perkins Centre, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1441242020-08-12T05:38:52Z2020-08-12T05:38:52ZHow do I know if my mask actually works? What about the ‘candle test’?<figure><img src="https://images.theconversation.com/files/352426/original/file-20200812-21-11becbd.jpg?ixlib=rb-1.1.0&rect=0%2C1%2C1000%2C664&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/pensive-thoughtful-woman-wearing-protection-handmade-1689043420">Shutterstock</a></span></figcaption></figure><p>With mask wearing in public compulsory in Victoria and recommended in New South Wales, many Australians are buying, wearing or making face masks for the first time.</p>
<p><a href="https://www.theguardian.com/australia-news/2020/aug/06/hundreds-of-types-of-face-masks-withdrawn-from-sale-in-australia-amid-safety-fears">Reports</a> of counterfeit or potentially substandard masks on the market may lead some people to question whether their surgical or cloth mask actually works.</p>
<p>So what can you look out for when buying a mask to make sure it does what it’s supposed to do? </p>
<p>And how can you test one you’ve bought or made?</p>
<h2>What do I look for in a surgical mask?</h2>
<p>Surgical masks (also known as medical masks) are usually made of three or four layers, most commonly polypropylene. </p>
<p>Ideally, they should meet <a href="https://www.tga.gov.au/post-market-review-face-masks-overview">Australian standards</a> for how well they filter and how resistant they are to water.</p>
<p>Only masks the Therapeutic Goods Administration (TGA) approves as medical products (officially known as medical devices) can be used in hospitals.</p>
<p>If a mask meets Australian standards as a medical device, <a href="https://www.tga.gov.au/behind-news/regulation-personal-protective-equipment-and-covid-19">you will see</a> a label on the packaging, plus a code indicating the standards it has met, such as:</p>
<ul>
<li><p>AS/NZS 4381:2015</p></li>
<li><p>ASTM F2101-14 or EN 14683:2014</p></li>
<li><p>ISO 22609 or ASTM F1862/F1862M-13.</p></li>
</ul>
<p>If your surgical mask says “not for medical use”, it doesn’t necessarily mean it’s useless. It just means it has not been submitted to the TGA for approval as a medical device.</p>
<p>If that’s the case, you can assess it using one of the methods below.</p>
<h2>What do I look for in a cloth mask?</h2>
<p>Cloth masks are non-medical devices. But they can be <a href="https://wwwnc.cdc.gov/eid/article/26/10/20-0948_article">designed</a> to be reasonably protective.</p>
<p>If you’re buying one online or making one yourself, check <a href="https://www.bloomberg.com/news/articles/2020-07-23/homemade-face-masks-work-best-with-multiple-layers-study-finds?sref=3ZPWSuyv">how many layers</a> it has. A single-layered mask is better than no covering, but <a href="https://thorax.bmj.com/content/early/2020/07/24/thoraxjnl-2020-215748">two layers</a> are better than one, and three layers are better than two. <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31142-9/fulltext">More than three layers</a> are better still.</p>
<p>Look for a fine weave, high thread count and dense material. Flimsy or see-through material, or material with large gaps, is not adequate because droplets and aerosols can pass through the gaps.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/which-mask-works-best-we-filmed-people-coughing-and-sneezing-to-find-out-143173">Which mask works best? We filmed people coughing and sneezing to find out</a>
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<p>For a cloth mask, pure cotton is not a good choice for the outer layer, as it is absorbent. If someone else is coughing and sneezing near you, you want your mask to block those droplets rather than enable them to pass through the mask and infect you. A polyester or cotton-polyester blend is a better choice for this outer layer.</p>
<p>So for cloth masks, <a href="https://www.dhhs.vic.gov.au/sites/default/files/documents/202007/Design%20and%20preparation%20of%20cloth%20mask_0.pdf">aim for</a> at least three layers, including a water-resistant outer layer. The inner layer can be cotton, as that makes it more comfortable to wear, because it will absorb moisture from your breathing.</p>
<p>Check also that your mask fits well around your face. If you have gaps around the edges of your mask, you can breathe in unfiltered, contaminated air. </p>
<p>Look to see if there’s a nose bridge piece or other adjustable edge to help mould the mask around your nose and the top of your cheeks. If your mask is loose-fitting, a <a href="https://www.medrxiv.org/content/10.1101/2020.04.17.20069567v2">nylon stocking</a> over the top can improve the fit and seal. </p>
<p>And remember to wash your cloth mask daily.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/13-insider-tips-on-how-to-wear-a-mask-without-your-glasses-fogging-up-getting-short-of-breath-or-your-ears-hurting-143001">13 insider tips on how to wear a mask without your glasses fogging up, getting short of breath or your ears hurting</a>
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</em>
</p>
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<h2>How can I test my mask at home?</h2>
<p><strong>Test for good filtration and fit</strong></p>
<p>For filtration and fit, you can do some rather <a href="https://makermask.org/diy-mask-tests/">time-consuming experiments</a> at home.</p>
<p>But a much simpler method is the candle test, popularised by US science educator <a href="https://www.billnye.com/">Bill Nye</a>. If you can blow out a candle while wearing your mask, that’s a fail.</p>
<p>It means your mask doesn’t adequately stop the flow of air. If you can blow air out, air can also leak inward just as easily. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/pKk9GFur4Hc?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Put on your mask, light a candle, then try to blow out the flame.</span></figcaption>
</figure>
<p><strong>Test for water resistance</strong></p>
<p>The virus is carried on water droplets expelled when infected people talk, cough and sneeze. If these droplets land on your mask, you want the outer layer to repel them. </p>
<p>A TGA-approved mask will be water resistant. But <a href="https://makermask.org/diy-mask-tests/">not all</a> other masks are. So you can test a non-approved surgical mask or cloth mask at home. </p>
<p>If a drop of water on the outside surface is absorbed straight away, <a href="https://makermask.org/diy-mask-tests/">that’s a fail</a>. If the drop forms a bead, the mask is water-resistant.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-should-i-clean-my-cloth-mask-143974">How should I clean my cloth mask?</a>
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</em>
</p>
<hr>
<p>Whether you go for a surgical mask that’s an approved medical device, an unapproved surgical mask, or a cloth mask, these simple tips should help you assess it before leaving the house.</p>
<p>Masks are a simple method for helping <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31142-9/fulltext">reduce transmission</a> of the virus that causes COVID-19, alongside physical distancing, hand-washing and other infection control measures. If enough people wear them, they may even help <a href="https://www.sciencedirect.com/science/article/pii/S0025556420300560">avoid a lockdown</a>.</p><img src="https://counter.theconversation.com/content/144124/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>C Raina MacIntyre receives funding from NHMRC (Principal Research Fellowship and Centre for Research Excellence), the Medical Research Futures Fund (research grant on bushfire smoke and facemasks) and has received funding from Sanofi and Seqirus in the past five years for investigator driven research on influenza. She has consulted for Australian mask manufacturer, Detmold in 2020.</span></em></p>A few simple pointers can help you spot a quality mask from a dud.C Raina MacIntyre, Professor of Global Biosecurity, NHMRC Principal Research Fellow, Head, Biosecurity Program, Kirby Institute, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1237682019-09-24T05:02:47Z2019-09-24T05:02:47ZDo new cancer drugs work? Too often we don’t really know (and neither does your doctor)<figure><img src="https://images.theconversation.com/files/293510/original/file-20190923-23822-1kn8g6y.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4294%2C3027&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The effectiveness of a drug may be evaluated based on its potential to shrink tumours – but this doesn't necessarily equate to improved survival rates.</span> <span class="attribution"><span class="source">From shutterstock.com</span></span></figcaption></figure><p>It’s hard to find anyone who hasn’t been touched by cancer. People who haven’t had cancer themselves will likely have a close friend or family member who has been diagnosed with the disease. </p>
<p>If the cancer has already spread, the diagnosis may feel like a death sentence. News that a new drug is available can be a big relief. </p>
<p>But imagine a cancer patient asks their doctor: “Can this drug help me stay alive longer?” And in all honesty the doctor answers: “I don’t know. There’s one study that says the drug works, but it didn’t show whether patients lived longer, or even if they felt any better.”</p>
<p>This might sound like an unlikely scenario, but it’s precisely what a team of <a href="https://www.bmj.com/content/366/bmj.l5221">UK researchers</a> found to be the case when it comes to many new cancer drugs. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/we-dont-need-to-change-how-we-subsidise-breakthrough-cancer-treatments-87185">We don't need to change how we subsidise 'breakthrough' cancer treatments</a>
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</em>
</p>
<hr>
<h2>A look at the research</h2>
<p>A study published last week in the <a href="https://www.bmj.com/content/366/bmj.l5221">British Medical Journal</a> reviewed 39 clinical trials supporting approval of all new cancer drugs in Europe from 2014 to 2016.</p>
<p>The researchers found more than half of these trials had serious flaws likely to exaggerate treatment benefits. Only one-quarter measured survival as a key outcome, and fewer than half reported on patients’ quality of life.</p>
<p>Of 32 new cancer drugs examined in the study, only nine had at least one study without seriously flawed methods. </p>
<p>The researchers evaluated methods in two ways. First, they used a standard “risk of bias” scale that measures shortcomings shown to lead to biased results, such as if doctors knew which drug patients were taking, or if too many people dropped out of the trial early. </p>
<p>Second, they looked at whether the European Medicines Agency (EMA) had identified serious flaws, such as a study being stopped early, or if the drug was compared to substandard treatment. The EMA identified serious flaws in trials for ten of the 32 drugs. These flaws were rarely mentioned in the trials’ published reports.</p>
<h2>From clinical trials to treatment – faster isn’t always better</h2>
<p>Before a medicine is approved for marketing, the manufacturer must carry out studies to show it’s effective. Regulators such as the EMA, the US Food and Drug Administration (FDA) or Australia’s Therapeutic Goods Administration (TGA) then judge whether to allow it to be marketed to doctors. </p>
<p>National regulators mainly examine the same clinical trials, so the findings from this research are relevant internationally, including in Australia.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/spot-the-snake-oil-telling-good-cancer-research-from-bad-36344">Spot the snake oil: telling good cancer research from bad</a>
</strong>
</em>
</p>
<hr>
<p>There’s strong public pressure on regulators to approve new cancer drugs more quickly, based on less evidence, especially for poorly treated cancers. The aim is to get treatments to patients more quickly by allowing medicines to be marketed <a href="https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.59">at an earlier stage</a>. The downside of faster approval, however, is more uncertainty about treatment effects. </p>
<p>One of the arguments for earlier approvals is the required studies can be carried out later on, and sick patients can be given an increased chance of survival before it’s too late. However, <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2733561">a US study</a> concluded that post-approval studies found a survival advantage for only 19 of 93 new cancer drugs approved from 1992 to 2017.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">If the evidence for a new cancer drug is flawed, this leaves patients vulnerable to false hope.</span>
<span class="attribution"><span class="source">From shutterstock.com</span></span>
</figcaption>
</figure>
<h2>So how is effectiveness measured currently?</h2>
<p>Approval of new cancer drugs is often based on short-term health outcomes, referred to as “surrogate outcomes”, such as shrinking or slower growth of tumours. The hope is these surrogate outcomes predict longer-term benefits. For many cancers, however, they have been found to do a poor job of <a href="https://www.sciencedirect.com/science/article/pii/S095980491831476X?via%3Dihub">predicting improved survival</a>. </p>
<p><a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2729389">A study of cancer trials</a> for more than 100 medicines found on average, clinical trials that measure whether patients stay alive for longer take an extra year to complete, compared to trials based on the most commonly used surrogate outcome, called “progression free survival”. This <a href="https://ascopubs.org/doi/10.1200/JCO.2011.38.7571">measure</a> describes the amount of time a person lives with a cancer without tumours getting larger or spreading further. It’s often poorly correlated with overall survival.</p>
<p>A year may seem like a long wait for someone with a grim diagnosis. But there are policies to help patients access experimental treatments, such as participating in clinical trials or compassionate access programmes. If that year means certainty about survival benefits, it’s worth waiting for. </p>
<h2>Approving drugs without enough evidence can cause harm</h2>
<p>In an <a href="https://www.bmj.com/content/366/bmj.l5399">editorial</a> accompanying this study, we argue that exaggeration and uncertainty about treatment benefits cause direct harm to patients, if they risk severe or life-threatening harm without likely benefit, or if they forgo more effective and safer treatments. </p>
<p>For example, the drug <a href="https://english.prescrire.org/en/81/168/57219/0/NewsDetails.aspx">panobinostat</a>, which is used for multiple myeloma patients who have not responded to other treatments, has not been shown to help patients live longer, and can lead to serious infections and bleeding.</p>
<p>Inaccurate information can also encourage false hope and create a distraction from needed palliative care. </p>
<p>And importantly, the ideal of shared informed decision-making based on patients’ values and preferences falls apart if neither the doctor nor the patient has accurate evidence to inform decisions.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/if-we-dont-talk-about-value-cancer-drugs-will-become-terminal-for-health-systems-44072">If we don't talk about value, cancer drugs will become terminal for health systems</a>
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</em>
</p>
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<p>In countries with public health insurance, such as Australia’s Pharmaceutical Benefits Scheme (PBS), patients’ access to new cancer drugs depends not just on market approval but also on payment decisions. The PBS often refuses the pay for new cancer drugs because of <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/imj.13350">uncertain clinical evidence</a>. In the cases of the drugs in this research, some are available on the PBS, while others are not.</p>
<p>New cancer drugs are often very expensive. On average in the US, a course of treatment with a new cancer drug costs more than US$100,000 (A$148,000).</p>
<p>Cancer patients need treatments that help them to live longer, or at the very least to have a better quality of life during the time that they have left. In this light, we need stronger evidence standards, to be sure there are real health benefits when new cancer drugs are approved for use. </p>
<p><em>The article has been updated to reflect Agnes Vitry’s current role at the University of South Australia.</em></p><img src="https://counter.theconversation.com/content/123768/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Barbara Mintzes receives funding from the National Health and Medical Research Council (NHMRC) for a research project on post-market regulatory safety advisories on medicines. She is also a member of Health Action International (HAI-Europe), a network of health and consumer organisations that promotes access to essential medicines and quality use of medicines. </span></em></p><p class="fine-print"><em><span>Agnes Vitry is affiliated with Cancer Voices, SA.</span></em></p>National drug regulators use evidence from clinical trials to decide whether new cancer drugs will be approved for use. But these studies are often flawed.Barbara Mintzes, Senior Lecturer, Faculty of Pharmacy, University of SydneyAgnes Vitry, Senior lecturer, University of South AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1202812019-07-12T04:53:14Z2019-07-12T04:53:14ZThe TGA’s proposed breast implant ban exposes a litany of failures, and fails to protect women<figure><img src="https://images.theconversation.com/files/283810/original/file-20190712-173325-1pt3hyh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It's not just women who are the losers following the latest TGA announcement. People with all types of medical devices need better regulatory protection.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/192268697?src=kjE4cPpyMgy06bxX4_CuVg-1-7&studio=1&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">proposed ban</a> on some textured breast implants <a href="https://www.theguardian.com/australia-news/2019/jul/11/australian-ban-on-textured-breast-implants-recommended-over-apparent-cancer-link">announced</a> by the Australian pharmaceuticals and medical devices regulator earlier this week tells us something very disquieting about the effectiveness of consumer protection. </p>
<p>It will not reassure women living with breast implants concerned about their risk of cancer, or anyone else with an implantable medical device regulated by the Therapeutic Goods Administration (TGA).</p>
<p>It also exposes inadequacies in the regulatory system that have been apparent for years.</p>
<h2>What’s new?</h2>
<p>The proposed ban relates to the import and distribution of certain types of breast implants with a textured surface because of their <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">well documented link</a> with a rare type of cancer known as anaplastic large cell lymphoma. The proposal is unsurprising given bans in Europe.</p>
<p>But Australia’s proposal comes after months of <a href="https://www.abc.net.au/news/2019-04-09/implants-allowed-in-australia-after-crackdown-in-france/10985400">criticism</a> by consumers, medical specialists and legal <a href="https://blogs.crikey.com.au/croakey/2014/03/25/the-tga-a-watchdog-with-dentures/">academics</a> who wanted to see an earlier and better-communicated ban. </p>
<p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">TGA also says</a> it is seeking advice from Allergan, the manufacturer whose implants were the focus of restrictions in Europe.</p>
<p>Yet concerns about the <a href="https://theconversation.com/victims-of-faulty-breast-implants-were-let-down-by-the-tga-13074">safety</a> of a succession of implants and the <a href="https://theconversation.com/pip-breast-implant-controversy-shows-weve-learned-nothing-4896">inadequacy</a> of Australia’s regulatory responses are not new. Advice from Allergan should have been sought a year ago.</p>
<h2>Here’s what we asked the TGA last year</h2>
<p>In responding last year to our queries about implants, the TGA indicated that although importation of the textured implants had been stopped after the ban in France there were <em>no</em> restrictions on implanting those devices in Australia.</p>
<p>The TGA was unaware of how many implants were available for implantation. (Unawareness about what is on the shelf was also <a href="https://www.abc.net.au/news/2017-08-15/potentially-damaging-vaginal-mesh-kits-still-on-hospital-shelves/8805520">evident</a> regarding <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report">pelvic mesh</a>, a similar regulatory failure). </p>
<p>The TGA was not going to inform potential recipients of the implants, something that is at odds with its new-found <a href="https://www.abc.net.au/news/2019-04-04/medical-implants-overhaul-planned-after-icij-investigation/10964256">recognition</a> that patients are concerned about potential harms.</p>
<p>What we have now is a proposed rather than actual ban. It is driven by criticism rather than TGA initiative and does not provide much reassurance about the TGA’s capacity to prevent harms rather than slowly respond to harms.</p>
<h2>What if you are living with these implants?</h2>
<p>The proposal announced this week is restricted to import and distribution. It does not require removing all breast implants or all textured breast implants. It does however mean that people with the implants listed on the TGA website should be watchful.</p>
<p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">TGA lists</a> the affected breast implants on its website, and says the risk of anaplastic large cell lymphoma associated with these is between 1-in-1,000 and 1-in-10,000.</p>
<p>Yet it’s likely many women will experience fear, alongside anger or bewilderment that the TGA has taken so long to act. </p>
<p>Some people will deal with that fear through preemptive surgery: removal of the implants after getting specialist advice. Costs will come out of their own pockets. Some will talk to lawyers.</p>
<h2>What’s the legal issue?</h2>
<p>Uniquely, consumers cannot sue the TGA if it gets things wrong. The TGA has a special <a href="http://www.austlii.edu.au/cgi-bin/viewdoc/au/legis/cth/consol_act/tga1989191/s61a.html">exemption</a> in its Act regarding civil litigation.</p>
<p>However, people who are injured by implanted medical devices can take manufacturers and medical specialists to court. Their challenge is to prove that the devices caused cancer or other injury. </p>
<p>Litigation in Australia with defective <a href="https://www.afr.com/business/health/hip-replacements-metalonmetal-implant-failures-trigger-new-class-action-fears-20181122-h187ha">joint implants</a> demonstrates that manufacturers have deep pockets and will be adversarial when it comes to <a href="https://www.abc.net.au/news/2016-03-31/class-action-over-defective-hip-replacements-settles-for-$250m/7288350">class actions</a> (litigation by groups of injured people) or individual victims. Litigation will often take years. Injury compensation will sometimes be inadequate.</p>
<p>That is one reason why better regulation is fundamental. We need to prevent the injury through timely action by government agencies rather than trying to fix a <a href="https://theconversation.com/failing-medical-implants-are-causing-hundreds-of-thousands-of-people-misery-84230">foreseeable</a> serious harm via legal action once it has occurred (and hope victims have the strength to fight for their rights).</p>
<h2>How engaged is the regulator?</h2>
<p>The <a href="https://www.tga.gov.au/who-we-are-what-we-do">TGA</a> is funded by the businesses it <a href="https://www.theguardian.com/australia-news/2017/nov/08/therapeutic-goods-administration-rejects-claims-it-is-too-close-to-medical-industry">regulates</a>. Like its counterpart the FDA in the United States, it is <a href="https://www.youtube.com/watch?v=UVUHEtrbL7A">underfunded</a> and demoralised. It views its mission through the eyes of those businesses, an example of <a href="https://theconversation.com/vital-signs-when-watchdogs-become-pets-or-the-problem-of-regulatory-capture-111170">regulatory capture</a>. It has been the subject of numerous <a href="https://theconversation.com/tga-all-bark-no-bite-as-labor-botches-response-to-a-series-of-reviews-4640">inquiries</a> about its performance. </p>
<p>Regrettably, the TGA has been described as unresponsive. It is comfortable dealing with the businesses it is supposed to regulate. It is <a href="https://theconversation.com/regulator-silent-on-safety-of-indian-made-generic-drugs-24013">uncomfortable</a> dealing with the public. It faces ongoing criticism about its apparent <a href="https://theconversation.com/medical-watchdog-turns-its-back-on-implant-safety-complaints-5744">indifference</a>. In response to such <a href="https://www.abc.net.au/news/2018-11-26/implant-files-shine-light-on-medical-device-industry/10521480">criticism</a> it belatedly announced an <a href="https://www.icij.org/investigations/implant-files/australia-announces-medical-device-action-plan-to-address-patient-concerns/">action plan</a> regarding oversight of devices. There hasn’t been much action. </p>
<p>In practice, meaningful regulation of devices is being left to <a href="https://www.icij.org/investigations/implant-files/">investigative</a> <a href="https://www.abc.net.au/news/2018-11-26/implant-files-reveal-tga-failures-in-medical-device-trial/10547486">journalists</a>, academics with a specialisation in law and medicine, and consumer advocates. Neither the Coalition nor the ALP have wanted to grasp the TGA <a href="https://theconversation.com/consumers-lose-out-as-tga-reform-turns-into-a-hot-potato-13383">hot potato</a>, but reform is necessary. </p>
<h2>What is needed?</h2>
<p>Our forthcoming research demonstrates the cost of running the TGA is dwarfed by the cost to patients, national productivity and the taxpayer of the TGA’s failures. </p>
<p>TGA legislation needs to be amended, in particular to ensure that the protection of consumers comes ahead of relations between the regulator and business. Independence of manufacturers is imperative. Adequate resourcing is essential. So is a cultural change within the TGA, including meaningful engagement with consumers rather than closed-door consultations with business.</p>
<p>Underpinning those changes we need a comprehensive <a href="https://www.abc.net.au/news/2018-03-27/pelvic-mesh-implants-tracking-medical-devices/9588070">database</a> of implants and incidents, one readily accessible by epidemiologists. </p>
<p>We need trust in the health system and in gatekeepers such as the TGA. Anyone with an implant or considering an implant needs to know that the TGA will actively minimise harms rather than relying on assurances from businesses that have a vested interest in minimising disclosure. Good regulation involves more than a quiet life for regulators.</p><img src="https://counter.theconversation.com/content/120281/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The proposed Australian ban of some types of breast implants is too little, too late. It also reveals regulatory failures that need to be fixed if Australian consumers are to be protected.Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraWendy Bonython, Associate Professor of Law, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/945692018-04-06T04:37:57Z2018-04-06T04:37:57ZWhat is pentosan polysulphate sodium (PPS) and why are AFL players using it?<figure><img src="https://images.theconversation.com/files/213515/original/file-20180406-125155-4aenhf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Former Carlton player Andrew Walker was reportedly able to resume playing regional football after PPS treatment.</span> <span class="attribution"><span class="source">AAP</span></span></figcaption></figure><p>AFL players are <a href="https://www.theaustralian.com.au/sport/afl/malcolm-blight-warns-on-players-being-used-in-drug-trials/news-story/4c2cea793cfc4cc4f86006e2a22ec393">reportedly being treated</a> with injections of the drug pentosan polysulphate sodium (PPS) for knee and bone pain. </p>
<p>While PPS is approved for use in Australia in oral capsule form to treat bladder inflammation, it is not yet approved as an injection for joint problems. </p>
<p><a href="https://www.theaustralian.com.au/sport/afl/malcolm-blight-warns-on-players-being-used-in-drug-trials/news-story/4c2cea793cfc4cc4f86006e2a22ec393">Up to 50 current and former AFL players</a> are reported to have been given PPS over the past few months, under the <a href="http://www.tga.gov.au">Therapeutic Goods Administration’s</a> <a href="https://www.tga.gov.au/form/special-access-scheme">special access scheme</a>. </p>
<p><a href="https://www.globaldro.com/AU/search/ingredient-status/eG1oUGVWWXZnaGJSM2I4UG4xTXo2WEtSK05JdkhMY0M1">PPS is not prohibited</a> by the <a href="https://www.asada.gov.au/">Australian Sports Anti-Doping Authority (ASADA)</a>. The drug is neither an anabolic steroid nor an opioid-based pain reliever so is not considered to enhance performance.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/after-the-essendon-saga-any-reform-to-anti-doping-regimes-must-give-athletes-a-greater-say-53212">After the Essendon saga, any reform to anti-doping regimes must give athletes a greater say</a>
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<h2>Normal use</h2>
<p>Pentosan polysulphate sodium was first developed in 1949 by German researcher W. Benend to treat blood clots.</p>
<p>In Australia, PPS is available only by prescription, under the brand name Elmiron, for the treatment of interstitial cystitis, a type of chronic inflammation of the bladder wall. It is not commonly used, with only <a href="http://www.pbs.gov.au/statistics/asm/2011/australian-statistics-on-medicines-2011.pdf">400 scripts filled nationwide in 2011</a>.</p>
<p>The drug is a semi-synthetic chemical that works by passing through the kidneys into urine, where it is then able to coat the inner walls of the bladder. This prevents microorganisms attaching to the bladder and causing infections. </p>
<p>When taken in capsule form at a dose of 100 mg, the drug is effective after six to eight weeks of treatment.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/213520/original/file-20180406-125158-di7ebi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/213520/original/file-20180406-125158-di7ebi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/213520/original/file-20180406-125158-di7ebi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/213520/original/file-20180406-125158-di7ebi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/213520/original/file-20180406-125158-di7ebi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/213520/original/file-20180406-125158-di7ebi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/213520/original/file-20180406-125158-di7ebi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">PPS is available in Australia with a prescription under the brand name Elmiron.</span>
<span class="attribution"><span class="license">Author provided</span></span>
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</figure>
<p>Because it is also similar to <a href="https://www.ambulance.qld.gov.au/docs/clinical/dtprotocols/DTP_Heparin.pdf">heparin</a>, PPS also works an anti-blood clotting agent by inhibiting the action of an enzyme called <a href="http://www.enamine.net/index.php?option=com_content&task=view&id=52">activated factor Xa</a>, which plays a key role in helping blood cells stick together in clotting.</p>
<p>Common <a href="https://www.nps.org.au/medical-info/medicine-finder/elmiron-capsules">side effects of PPS</a> include swelling, headache, dizziness, nausea, indigestion or diarrhoea.</p>
<h2>Other uses</h2>
<p>The Australian pharmaceutical company Paradigm Biopharma is looking to repurpose PPS as a treatment for pain in people with osteoarthritis of the knee and lesions in the subchondral bone – the layer of bone just below the cartilage in joints which acts as a so-called “shock-absorber”.</p>
<p>The company is currently conducting a <a href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373400&isReview=true">randomised, placebo-controlled clinical trial</a> in Australia using an injectable form of the drug. Evidence of the benefit of PPS in osteoarthritis of the knee has been known from an <a href="https://www.ncbi.nlm.nih.gov/pubmed/24678076">early trial</a> which gave the drug as an intramuscular injection for a month. </p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/randomised-control-trials-what-makes-them-the-gold-standard-in-medical-research-78913">Randomised control trials: what makes them the gold standard in medical research?</a>
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<p>It’s not clear how PPS reduces joint pain, but Professor Jegan Krishnan, an orthopaedic surgeon at Flinders University, <a href="https://www.arthritiswa.org.au/news/view/a-breakthrough-treatment-for-osteoarthritis-could.html">suggests that the drug has anti-inflammatory effects</a> and seems to address the bone marrow lesions. By controlling the lesions, the drug prevents the pain.</p>
<p>The injectable form of PPS is not registered in Australia, or approved for sale. It can only be used through the TGA’s <a href="https://www.tga.gov.au/special-access-scheme-guidance-health-practitioners-and-sponsors">special access scheme</a>, which grants permission for use of unapproved drugs when other treatment options have been exhausted. </p>
<p>Paradigm Biopharma is not the only company looking to repurpose the drug. Clinical trials are also being conducted overseas by other companies to examine whether PPS is useful as a treatment for <a href="https://clinicaltrials.gov/ct2/results?cond=&term=pentosan&cntry=&state=&city=&dist=">psychotic disorders and prostate inflammation</a>.</p>
<h2>AFL player treatment</h2>
<p>Arthritis and joint pain are common injuries among elite sports people. These injuries are particularly <a href="http://sportsmedicinecentre.com.au/view/lib/aussie-rules-football-injuries/116">prevalent in Aussie rules players</a> because of the frequent jumping, running and tackling that the players undergo on a weekly basis.</p>
<p>As such, AFL players are one group of sportspeople who are likely to benefit from PPS injections.</p>
<p>PPS is administered as an injection to the players twice a week for a period of six weeks and <a href="http://www.proactiveinvestors.com.au/companies/news/194287/paradigm-biopharmaceuticals-achieves-pain-treatment-win-with-afl-players-194287.html">results have indicated</a> that PPS works well to control their knee pain. All players reportedly experienced significant drops in their pain levels.</p>
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<strong>
Read more:
<a href="https://theconversation.com/close-case-set-to-present-a-legal-headache-for-the-afl-92418">Close case set to present a legal headache for the AFL</a>
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<p>While these results are promising, any data obtained outside of the clinical trial must be treated with caution. Before routine prescribing of PPS for people with knee pain and bone lesions, the clinical trial must show the drug is safe in its injectable form and that any reduction is pain is at least as good as current treatments.</p><img src="https://counter.theconversation.com/content/94569/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association.</span></em></p><p class="fine-print"><em><span>Professor Andrew McLachlan receives research funding from NHMRC Centre for Research Excellence in Medicines and Ageing and Project research grants (especially related to low back pain and sciatica). He has also received in-kind research funding from Pfizer and GSK to support research into low back pain clinical trials. </span></em></p>While PPS is approved in oral capsule form to treat bladder inflammation, it is not yet approved as in injection for knee and bone problems. But AFL players have been given special access.Nial Wheate, Associate Professor | Program Director, Undergraduate Pharmacy, University of SydneyAndrew McLachlan, Head of School and Dean of Pharmacy, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/903142018-02-08T18:11:51Z2018-02-08T18:11:51ZProposed new regulations for 3D printed medical devices must go further<figure><img src="https://images.theconversation.com/files/204790/original/file-20180205-19944-1jpif2q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Advances in technology mean it's now possible to 3D print everything from prosthetic limbs to skin, bones and organs.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/armymedicine/14441713519/in/photolist-MbxEc2-o1ayhF-Aj615U-Q1tCyL-Q4brC2-NX3Tz5-NX3RnE-QbavUU-NZQnyt-PuVTAw">armymedicine/flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>3D printing has rapidly increased in quality and popularity over the past decade. In the medical sector, it has evolved from the creation of relatively simple prosthetics, to a silicon prototype of a functioning human heart.</p>
<p>Unfortunately regulation hasn’t kept pace with technological progress. </p>
<p>As the costs of 3D printing have reduced, patients are now able to manufacture their own prosthetics at home – <a href="http://enablingthefuture.org/2017/08/04/e-nable-in-education-st-gabriel-catholic-school/">or school</a> – under the “custom made” definition of the Therapeutic Goods Administration frameworks. Soon we will be able to print our own <a href="https://www.computerworld.com/article/3048823/3d-printing/this-is-the-first-3d-printed-drug-to-win-fda-approval.html">medicines</a>.</p>
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Read more:
<a href="https://theconversation.com/explainer-what-is-3d-printing-and-whats-it-for-9456">Explainer: what is 3D printing and what's it for?</a>
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<p>But who should be legally responsible as the manufacturer when 3D printed devices fail? </p>
<p>In what could serve as a watershed moment for additive manufacturing, the TGA is now proposing changes to the <a href="https://www.tga.gov.au/consultation/consultation-proposed-regulatory-changes-related-personalised-and-3d-printed-medical-devices">personalised and 3D printed medical devices</a> regulatory framework that have the potential to settle that question. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"960911440365355008"}"></div></p>
<h2>Access versus safety</h2>
<p>In January 2013, the US medical device company, DePuy, recalled their <a href="http://www.abc.net.au/radionational/programs/healthreport/artificial-knee-gone-wrong/2986700">knee and hip replacement systems</a>. The devices were made from layers of metal, and shavings had come loose – potentially harming the patient. There is a high possibility of similar problems occurring (called layer separation) in 3D printed parts.</p>
<p>The TGA’s <a href="https://www.tga.gov.au/consultation/consultation-proposed-regulatory-changes-related-personalised-and-3d-printed-medical-devices">proposed amendments</a> are part of an effort to increase oversight and prevent these kinds of issues. In doing so, the TGA must balance ease of access for patients with the need to protect the public from the harm posed by devices that are manufactured without adequate oversight and testing. All this within a medical system <a href="http://www.news.com.au/lifestyle/health/public-hospitals-already-failing-surgery-and-emergency-targets-face-60-billion-in-federal-funding-cuts/news-story/8ccee41f823f7ee5aed8df139a9f4fb4">already under pressure financially</a>. </p>
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Read more:
<a href="https://theconversation.com/3d-printers-a-revolutionary-frontier-for-medicine-83031">3D printers: A revolutionary frontier for medicine</a>
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<p>The current TGA framework breaks therapeutic goods into three areas: medicines, biologicals and medical devices. </p>
<p>Medicines are the pharmacological items we get from a chemist and biologicals are anything containing human cells. </p>
<p>Medical devices are ranked on a scale from Class I to Class III according to the <a href="https://www.tga.gov.au/product-regulation-according-risk">level of harm they may pose to a patient</a>. These devices are already subject to strict regulation and range from <a href="https://www.sculpteo.com/blog/2017/08/02/3d-printed-glasses-taking-the-eyewear-industry-to-the-next-level/">eye glasses</a> (Class I) to <a href="http://www.mccormick.northwestern.edu/news/articles/2016/10/3d-printing-customized-vascular-stents.html">custom vascular stents</a> (Class III). </p>
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<h2>The “custom made” exemption</h2>
<p>While a 3D printed prosthetic may be classified as Class I, or low risk, the technology has progressed to enable more advanced implants and tools to be produced that encompass Class III, or high risk, medical devices. </p>
<p>For example, <a href="https://link.springer.com/article/10.1007%2Fs00268-016-3814-5">full surgical intrument sets for space missions</a>, umbilical cord clamps for <a href="https://link.springer.com/content/pdf/10.1007/978-3-319-16247-8_4.pdf">disaster relief efforts</a> and new implantable medical devices to help <a href="https://www.adelaide.edu.au/news/news84742.html">heal fractured bones</a>.</p>
<p>If such devices are mass produced on a 3D printer, then high level, third party oversight of safety, quality and performance applies. However, if they fall under the custom made definition, third party oversight does not apply. </p>
<p>Devices made for a specific patient under the current framework are considered under the “custom made” definition. Historically, this made sense since custom made items were typically low risk and few in number. But as the number and complexity of custom made devices grows, we need to ensure they are subject to the same high level scrutiny as mass produced devices.</p>
<h2>Shifting definitions</h2>
<p>The custom made loophole isn’t the only issue with the current framework. There remains an ambiguity about who is legally responsible for the manufacture of a device.</p>
<p>Under the <a href="https://www.tga.gov.au/custom-made-medical-devices">existing rules</a>, </p>
<blockquote>
<p>“it is important to note that the person who adapts a medical device for an individual patient is not considered to be a manufacturer of a medical device if the adaptation does not alter its intended purpose… However, the device that requires modification is also required to be included on the Australian Register of Therapeutic Goods (ARTG) before it is supplied.” </p>
</blockquote>
<p>This is fine for items such as the raw material used for making dental crowns.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"874229841842798592"}"></div></p>
<p>But what about TGA approved filaments and other raw materials for 3D printing? </p>
<p>There is a risk that once raw materials are approved and included on the ARTG then any device could be printed and circumvent the definition of being a manufacturer. </p>
<p>For example, if a filament impregnated with copper was approved, we could print a custom made copper IUD contraceptive based on 3D scans <a href="https://www.ronen-kadushin.com/bearina-iud-concept/">similar in concept to this already open source device</a>. Given personal scans of the patient were integrated into the design it would meet the custom made definition, so paperwork related to it would only be required to be kept for five years. But a copper IUD can last anywhere from five to 12 years. Therefore, the risk of such a device causing permanent infertility would not be properly managed. </p>
<h2>Who is the manufacturer?</h2>
<p>This is proposed to be changed by including the <a href="https://www.tga.gov.au/sites/default/files/consultation-proposed-regulatory-changes-related-personalised-and-3d-printed-medical-devices.pdf">following addition in the framework</a>:</p>
<blockquote>
<p>“…the assembly or adaptation must be in accordance with validated instructions provided by the manufacturer of the device to be adapted; and that, if an individual modifies a device … in such a way that compliance with the essential principles may be affected, they shall assume the obligations incumbent on manufacturers…” </p>
</blockquote>
<p>This goes some way towards fixing the problem.</p>
<p>But if a hospital were to print devices for their patients by strictly following the instructions from the supplier, they would not be considered the manufacturer under this change.</p>
<p>So who would be responsible for the device? How do we treat the designs of products and their associated 3D files – the digital blueprints of a medical device?</p>
<p>Traditional definitions of manufacture do not encompass the designer. Generally speaking, we assume the business that designs an item will manufacture the item. That is not always going to be the case with the democratisation of 3D printing technology. </p>
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<strong>
Read more:
<a href="https://theconversation.com/speaking-with-mia-woodruff-about-using-3d-printing-to-replace-body-parts-75769">Speaking with: Mia Woodruff about using 3D printing to replace body parts</a>
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<h2>Future regulation</h2>
<p>I have previously <a href="https://theconversation.com/the-legal-minefield-of-3d-printed-guns-71878">written about</a> the Australian laws surrounding 3D Printed Firearms. I drew the conclusion that we need a unified approach to legislation that specifically speaks to the capabilities of 3D printers, and the digital blueprints devices are based on. </p>
<p>The TGA is beginning to address this by ensuring items that are now enabled by this technology are suitably captured by the existing legislation. What still isn’t clear is how digital blueprints will be treated in this new age of fabrication. </p>
<p>Comments submitted during the consultation process of the regulatory changes are now being reviewed by the TGA. If the TGA is serious about preventing harms caused by 3D medical devices, they must ensure these loopholes are closed.</p><img src="https://counter.theconversation.com/content/90314/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Richard Matthews is an elected member of The University of Adelaide Council, is an Additive Manufacturing consultant with the Entrepreneurship, Commercialisation and Innovation Centre at the University of Adelaide and is a current member of the South Australian branch of the Labor Party.</span></em></p>Who should be legally responsible when 3D printed devices fail? Proposed changes to the Therapeutic Goods Administration’s regulatory framework have the potential to settle that question.Richard Matthews, PhD Candidate, University of AdelaideLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/906252018-01-25T05:15:11Z2018-01-25T05:15:11ZScrapping pre-approval of medicine ads will put consumers at risk<figure><img src="https://images.theconversation.com/files/203351/original/file-20180125-107943-1t0oa6b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">vitamins</span> </figcaption></figure><p>A <a href="https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/Bills_Search_Results/Result?bId=r5977">government bill</a>, currently before a <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/TGA2017MeasuresNo1">Senate inquiry</a>, aims to simplify the process for advertising medicines. These include over-the-counter products such as Nurofen, and complementary medicines such as vitamins, herbals and homeopathic products. Advertising for prescription medication is not permitted in Australia. </p>
<p>If the bill passes, the current limited (but useful) process of pre-approving claims made in advertisements for medicines, to ensure they don’t mislead or deceive consumers, will be abandoned. This means advertisements are seen by two industry bodies before they are published or aired. Where problems are found, the bodies work with the advertiser to ensure compliance.</p>
<p>The government has argued removing the pre-approval process won’t put consumers at risk because other measures in the bill would compensate. These include greater surveillance when the product is on the market and increased penalties for regulatory violations. But <a href="http://regnet.anu.edu.au/news-events/events/7047/civil-society-hearing-therapeutic-goods-amendment-bill">civil society groups</a> want pre-approval to continue until these other measures have shown it’s no longer necessary. </p>
<h2>What is the current process for advertising?</h2>
<p>Advertisements for therapeutic goods directed at consumers must comply with the national <a href="https://www.legislation.gov.au/Details/F2015L01787">Therapeutic Goods Advertising Code 2015</a>. The object of the code is to ensure the marketing and advertising of therapeutic goods is conducted in a socially responsible manner that promotes their quality and safe use, and doesn’t mislead or deceive the consumer.</p>
<p>There are several other <a href="https://www.tga.gov.au/regulation-therapeutic-goods-advertising-australia">relevant laws and regulations</a>. For example, Section 22(5) of the Therapeutic Goods Act 1989 specifies advertising of a therapeutic good can only refer to indications or product claims that are included in the Australian Register of Therapeutic Goods (<a href="https://www.tga.gov.au/australian-register-therapeutic-goods">ARTG</a>). This is an electronic register on which information is entered by the manufacturer without oversight from the Therapeutic Goods Administration (TGA).</p>
<p>Manufacturers have worked around this provision by placing creative indications and claims on their ARTG entry, so they can make equally creative advertising claims.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/203372/original/file-20180125-107937-bgi87o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/203372/original/file-20180125-107937-bgi87o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/203372/original/file-20180125-107937-bgi87o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/203372/original/file-20180125-107937-bgi87o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/203372/original/file-20180125-107937-bgi87o.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/203372/original/file-20180125-107937-bgi87o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/203372/original/file-20180125-107937-bgi87o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/203372/original/file-20180125-107937-bgi87o.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">Pre-approval is only required for advertisements for medicines mainly in print, radio and TV – but not the Internet.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
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<p>The responsibility for authorising pre-approval has been delegated by the TGA to the advertising service managers of two industry associations: Australian Self Medication Industry (<a href="http://www.asmi.com.au/">ASMI</a>) and Complementary Medicines Australia (<a href="http://www.cmaustralia.org.au/">CMA</a>). </p>
<p>The assessments don’t usually extend to a detailed evaluation of the evidence used to support claims of efficacy, because of lack of time. Thus, pre-approval of an advertisement by one of the responsible industry bodies is not a guarantee the advertisement is compliant with all the requirements of the advertising framework. </p>
<p>Nurofen’s “<a href="https://www.accc.gov.au/media-release/court-finds-nurofen-made-misleading-specific-pain-claims">specific pain range</a>” is a good example of misleading claims that apparently slipped through the pre-approval system. The products were on <a href="http://www.adnews.com.au/news/nurofen-ad-pulled-pending-court-battle">sale and advertised</a> as targeting specifics types of pain (like migraine and backache), when they in fact contained the same ingredient. </p>
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<a href="https://theconversation.com/tga-failure-gives-nurofen-consumers-a-headache-8762">TGA failure gives Nurofen consumers a headache</a>
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<p>Pre-approval is only required for advertisements for medicines (but not medical devices) in specified media – mainly print, radio and TV – but not the Internet. This is a problem, as it means the process has not kept up with current advertising trends.</p>
<h2>Pre-approval the only defence</h2>
<p>Removing pre-approval is a reduction in red tape as part of <a href="https://www.cuttingredtape.gov.au/">government policy</a>, and was a trade-off for industry accepting greater post-market surveillance and increased penalties and sanctions for regulatory violations. The bill also includes a controversial list of <a href="https://theconversation.com/new-complementary-medicine-health-claims-lack-evidence-so-why-are-they-even-on-the-table-80896">permitted indications</a>, which was meant to limit the industry’s ability to make creative claims about their products’ effectiveness.</p>
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<a href="https://theconversation.com/new-complementary-medicine-health-claims-lack-evidence-so-why-are-they-even-on-the-table-80896">New complementary medicine health claims lack evidence, so why are they even on the table?</a>
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<p>The pre-approval process is a form of weak co-regulation in a sector where some businesses can game the system. But it does give vendors, publishers and broadcasters some certainty about what is acceptable. Importantly, it seeks to prevent seriously harmful ads going live. It’s preferable to prevent harm from occurring than trying to remedy that harm after the fact.</p>
<p>Pre-approval is the only defence against seriously misleading advertisements appearing on prime-time television or in national newspapers. The <a href="https://www.doctorportal.com.au/mjainsight/2016/38/advertising-reform-watering-down-consumer-protection/">current process</a> reviews over 2,000 advertisements per year, with an average turnaround time of seven days. Most require changes, sometimes wholesale revisions.</p>
<p>The complaint system takes a long time to remove bad advertisements. Meanwhile, the damage has been done. It is also more economically efficient, given fraudulent therapeutic claims create unnecessary health expenditure and divert scarce health resources from remedies that work to ones that don’t.</p>
<p>The bill comes with a proposal from government for a three-year independent review. Consumer groups argue continuing the pre-approval process until this review would provide a good performance indicator to judge whether the new advertising system is better than the old one. One would expect the number of pre-approved advertisements requiring revision to fall if other measures in the package are successful.</p>
<p>Submissions to the <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/TGA2017MeasuresNo1">Senate inquiry</a> into the bill have emphasised policy-making on the basis of solid data rather than industry self-interest. The Senate is due to report on the legislation on February 2.</p><img src="https://counter.theconversation.com/content/90625/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Harvey represents Choice (the Australian Consumers' Association) on the Therapeutic Goods Advertising Code Council and TGA stakeholder consultations on advertising and complementary medicine reform. He is also on the executive of Friends of Science in Medicine and a member of Skeptics Australia (Victorian Branch).
Asst Prof Arnold is a member of Friends of Science in Medicine.</span></em></p><p class="fine-print"><em><span>Bruce Baer Arnold is a member of Friends of Science in Medicine.</span></em></p>There is currently a weak process of checking claims made in advertisements for medicines, to ensure they don’t mislead or deceive consumers -this could be abandoned if a bill passes parliament.Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash UniversityBruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/833572017-09-07T03:54:07Z2017-09-07T03:54:07ZAssassination by pacemaker: Australia needs to do more to regulate internet-connected medical devices<figure><img src="https://images.theconversation.com/files/184831/original/file-20170906-9830-1sg515t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Australia's medical regulator needs to do more about cybersecurity.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/dddr-pacemaker-xray-image-cardiac-catheterization-441650620?src=blj2MLS4Anocx1W3Ze3OnQ-1-20">Korawig Boonsua/Shutterstock</a></span></figcaption></figure><p>In the future, people are going to be just a little bit cyborg. We’ve accepted hearing aids, nicotine patches and spectacles, <a href="https://www.embs.org/about-biomedical-engineering/our-areas-of-research/wearable-implantable-technologies/">but implanted</a> medical devices that are internet-connected present new safety challenges. Are Australian regulators keeping up?</p>
<p>A global recall <a href="https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm573669.htm">of pacemakers</a> has sparked new fears and splashy headlines about hacked medical devices. But the next 20 years of medicine will normalise the use of intelligent implants to control pain, provide data for diagnostic purposes and supplement ailing organs, which means we need proper security as well as access in case of emergency. </p>
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<a href="https://theconversation.com/three-reasons-why-pacemakers-are-vulnerable-to-hacking-83362">Three reasons why pacemakers are vulnerable to hacking</a>
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<p>Pharmaceuticals and medical devices in Australia are regulated by the <a href="https://www.tga.gov.au/tga-basics">Therapeutic Goods Administration</a> (TGA), an arm of the national Health Department. </p>
<p>Can we rely on Australia’s medical devices regime? Recurrent criticisms by parliamentary committees and government inquiries suggest the regulator may be struggling.</p>
<h2>The job of the TGA</h2>
<p>The TGA regulates medical devices such as stents, pacemakers, joint implants, <a href="https://theconversation.com/victims-of-faulty-breast-implants-were-let-down-by-the-tga-13074">breast implants</a>, and the controversial <a href="https://theconversation.com/vaginal-mesh-controversy-shows-collective-failure-of-the-tga-and-australias-specialists-78605">vaginal mesh</a> that has featured recently in the media (and a <a href="http://www.smh.com.au/national/pelvic-mesh-victims-blamed-by-asleep-at-wheel-health-system-inquiry-to-hear-20170719-gxehqv.html">Senate inquiry</a>) over claims it seriously injured patients.</p>
<p>The role of the TGA is vital, because defective devices can result in injury or death. They have a major cost for the public health system and affect patient quality of life. They often result in litigation, sometimes with <a href="http://www.reuters.com/article/us-johnson-johnson-verdict-hipimplants-idUSKBN13Q5XF">billion-dollar</a> <a href="http://www.abc.net.au/news/2016-03-31/class-action-over-defective-hip-replacements-settles-for-$250m/7288350">settlements</a>.</p>
<p>In undertaking its mission, the TGA looks to information from <a href="https://www.theguardian.com/australia-news/2017/jul/10/johnson-johnson-tried-to-prevent-report-about-pelvic-mesh-devices-court-hears">manufacturers</a> and distributors, from overseas regulators and its <a href="https://www.tga.gov.au/publication/therapeutic-product-vigilance">own staff</a>. </p>
<p>Like counterparts such as the US <a href="https://www.youtube.com/watch?v=UVUHEtrbL7A">Food and Drug Administration</a>, TGA staff are under pressure to get products into the marketplace and reduce “<a href="https://www.tga.gov.au/sites/default/files/tga-business-plan-2016-17.pdf">red tape</a>”.</p>
<h2>The TGA and cybersecurity</h2>
<p>Wireless medical devices need greater security than, say, an internet-connected fridge. It is axiomatic that they must work. </p>
<p>We need to ensure that information <a href="https://www.wired.com/2017/03/medical-devices-next-security-nightmare/">provided</a> by the devices is safeguarded and that control of the devices – <a href="https://spqr.eecs.umich.edu/papers/b1kohFINAL2.pdf">implantable</a> or otherwise – is not compromised. </p>
<p>To do that, we can use existing tools such as robust passwords, encryption and systems design. It also requires product vendors and practitioners to avoid negligence. Regulators must proactively foster and enforce standards. </p>
<p>Put simply, bodies like the TGA need to deal with software rather than simply bits of metal and plastic. It is unclear whether the TGA has the expertise or means to do so. </p>
<h2>Solutions, not panic</h2>
<p>The past decade has seen a succession of inquiries into the TGA, including the 2015 <a href="https://www.tga.gov.au/mmdr">Sansom Review</a> and 2012 Senate <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Completed_inquiries/2010-13/implants2012/report/index">PIP Inquiry</a>. Each has demonstrated that the TGA is not always <a href="https://theconversation.com/consumers-lose-out-as-tga-reform-turns-into-a-hot-potato-13383">keeping up</a> with its task. </p>
<p>Problems are ongoing: think defective joint implants, <a href="https://theconversation.com/victims-of-faulty-breast-implants-were-let-down-by-the-tga-13074">breast implants</a> and <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants">vaginal mesh</a>. But there are some potential paths towards improvement.</p>
<p><strong>Accountability</strong></p>
<p>One solution is to ensure the TGA is more accountable. </p>
<p>Currently, if someone wishes to bring a claim alleging a device was improperly permitted, the TGA has <a href="https://www.legislation.gov.au/Series/C2004A03952">immunity</a> from civil litigation about regulatory failure. </p>
<p>Removal of immunity will force it to focus on outcomes. That can be reinforced by giving it independence from the Department of Health, making it report direct to Parliament and ensuring the openness emphasised by the <a href="http://pandora.nla.gov.au/pan/141595/20130902-0954/www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr10-ck-ck005d526.htm?OpenDocument&yr=2010&mth=11">Pearce Inquiry</a>. </p>
<p><strong>Regulatory capture</strong></p>
<p>Medical products regulation in Australia has been a matter of penny wise, pound poor. The TGA is <a href="https://www.tga.gov.au/cost-recovery-implementation-statement-2016-17">funded</a> by fees from the manufacturers and distributors that it regulates, in addition to some government funding. </p>
<p>It needs a discrete budget that recoups costs but is not dependent on companies that complain regulation is expensive. It needs enough resources to do its job well in the emerging age of the internet of things, including access to independent expertise regarding cybersecurity and devices. </p>
<p><strong>A device register</strong></p>
<p>How many devices have been implanted and how many removed? The lack of data about medical devices is a problem.</p>
<p>The government has so far not embraced recommendations for a comprehensive device register, one allowing timely identification of what was implanted and by whom. </p>
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Read more:
<a href="https://theconversation.com/vaginal-mesh-controversy-shows-collective-failure-of-the-tga-and-australias-specialists-78605">Vaginal mesh controversy shows collective failure of the TGA and Australia's specialists</a>
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<p>Such a register would provide a means for determining problems with devices or medical practice. We need timely, consistent reporting of problems on a mandatory basis, as well as recall and <a href="http://pandora.nla.gov.au/pan/141595/20130902-0954/www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr10-ck-ck005d526.htm?OpenDocument&yr=2010&mth=11">transparent</a> investigation of what went wrong.</p>
<p><strong>Disclosure of interests</strong></p>
<p>The inquiry into vaginal mesh revealed the WA Branch of Australian Medical Association had a <a href="http://www.watoday.com.au/wa-news/australian-medical-association-president-confirms-ama-was-role-in-pelvic-mesh-scandal-20170822-gy1hzj.html">financial interest</a> in a device that may have seriously affected numerous women. </p>
<p>There must be full disclosure of such interests, with meaningful sanctions where disclosure has not been made. This requires action by the TGA, professional bodies and the government.</p>
<h2>So, what about assassination by wireless pacemaker?</h2>
<p>The cybersecurity of medical devices is a matter for everyone. </p>
<p>We need the TGA to work with manufacturers, distributors and health professionals to mandate best practice. Should, for example, manufacturers and practitioners ensure that implants do not rely on default passwords that are easily <a href="https://www.fastcompany.com/3061323/brainjacking-or-how-hackers-can-remote-control-your-medical-implants">crackable</a>? What about access by emergency services?</p>
<p>There is a fundamental need to develop and enforce a national safety standard regarding all wireless implants. For that we need thoughtful policy, not just headlines.</p><img src="https://counter.theconversation.com/content/83357/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bruce Baer Arnold 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>Australia’s Therapeutic Goods Administration must learn to deal with software rather than simply bits of metal and plastic.Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/833622017-09-04T06:47:21Z2017-09-04T06:47:21ZThree reasons why pacemakers are vulnerable to hacking<p>The US Food and Drug Administration (FDA) <a href="https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm573669.htm">recently recalled</a> approximately 465,000 pacemakers made by the company Abbott’s (formerly St. Jude Medical) that were vulnerable to hacking, but the situation points to an ongoing security problem.</p>
<p>The reason for the recall? The devices can be remotely “hacked” to increase activity or reduce battery life, potentially endangering patients. According <a href="http://www.abc.net.au/news/2017-08-31/pacemakers-recall-hacking-risk-australians-could-have-them/8860368">to reports</a>, a significant portion of the pacemakers are likely to be installed in Australian patients.</p>
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Read more:
<a href="https://theconversation.com/australias-car-industry-needs-cybersecurity-rules-to-deal-with-the-hacking-threat-82268">Australia's car industry needs cybersecurity rules to deal with the hacking threat</a>
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<p>Yet the qualities that make remotely-accessible human implants desirable – namely, low cost, low maintenance batteries, small size, remote access – also make securing such devices a serious challenge.</p>
<p>Three key issues hold back cyber-safety:</p>
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<li>Most embedded devices don’t have the memory or power to support proper cryptographic security, encryption or access control.</li>
<li>Doctors and patients prefer convenience and ease of access over security control.</li>
<li>Remote monitoring, an invaluable feature of embedded devices, also makes them vulnerable.</li>
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<h2>The Abbott’s situation</h2>
<p>A recall of Abbott’s pacemakers, <a href="https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm573669.htm">per the FDA</a>, would not involve surgery. Instead, the device’s firmware could be updated with a doctor.</p>
<p>The vulnerability of the pacemaker appears to be that someone with “commercially-available equipment” could send commands to the pacemaker, changing its settings and software. The “patched” version prevents this – it only allows authorised hardware and software tools to send commands to the device. </p>
<p>Abbott’s has <a href="http://abbott.mediaroom.com/2017-08-29-Abbott-issues-new-updates-for-implanted-cardiac-devices">downplayed the</a> risks, insisting that none of the 465,000 devices have been reported as compromised. </p>
<p>But fears about cybersecurity attacks on individual medical devices are <a href="http://theconversation.com/why-has-healthcare-become-such-a-target-for-cyber-attackers-80656">nothing new</a>.</p>
<p>Medical devices are now part of the “internet of things” (IoT), where small battery-powered sensors combined with embedded and customised computers and radio communications (technologies such as Wi-Fi, Bluetooth, NFC) are finding uses in areas where cybersecurity has not previously been considered. </p>
<p>This clash of worlds brings particular challenges.</p>
<h2>1. Power versus security</h2>
<p>Most embedded medical devices don’t currently have the memory, processing power or battery life to support proper cryptographic security, encryption or access control. </p>
<p>For example, using HTTPS (a way of encrypting web traffic to prevent eavesdropping) rather than HTTP, <a href="https://www.cs.cmu.edu/%7Ednaylor/CostOfTheS.pdf">according to</a> Carnegie Mellon researchers, can increase the energy consumption of some mobile phones by up to 30% because of the loss of proxies. </p>
<p>Conventional cryptography suites (the algorithms and keys used to prove identity and keep transmissions secret) are designed for computers, and involve complex mathematical operations beyond the power of small, cheap IoT devices. </p>
<p>An emerging solution is to <a href="http://www.eetimes.com/author.asp?section_id=36&doc_id=1331566">move the cryptography</a> into dedicated hardware chips, but this raises the cost. </p>
<p>The US National Institute of Standards and Technology (NIST) <a href="https://www.nist.gov/programs-projects/lightweight-cryptography">is also developing</a> “light-weight” cryptographic suites designed for low-powered IoT devices. </p>
<h2>2. Convenience versus security</h2>
<p>Doctors and patients don’t expect to always have to log into these medical devices. The prospect of having to keep usernames, passwords and encryption keys handy and safe is contrary to how they plan to use them. </p>
<p>No one expects to have to log into their toaster or fridge, either. Fortunately the pervasiveness of smart phones, and their use as interfaces to “smart” IoT devices, is changing users’ behaviour on this front. </p>
<p>When your pacemaker fails and the ambulance arrives, however, will you really have the time (or ability) to find the device serial number and authentication details to give to the paramedics?</p>
<h2>3. Remote monitoring versus security</h2>
<p>Surgical implants present clear medical risks when they need to be removed or replaced. For this reason, remote monitoring is undoubtedly a life-saving technology for patients with these devices. </p>
<p>Patients are no longer reliant on the low battery “buzz” warning, and if the device malfunctions, its software can be smoothly updated by doctors.</p>
<p>Unfortunately, this remote control feature creates a whole new type of vulnerability. If your doctor can remotely update your software, so can others. </p>
<h2>Securing devices in the future</h2>
<p>The security of connected, embedded medical devices is a “wicked” problem, but solutions are on the horizon. </p>
<p>We can expect low-cost cryptographic hardware chips and standardised cryptographic suites designed for low-power, low-memory and low-capability devices in the future. </p>
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<p>Perhaps we can also expect a generation who are used to logging into everything they touch, and will have ways of authenticating themselves to their devices easily and securely, but we’re not there yet. </p>
<p>In the interim, we can only assess the risks and make measured decisions about how to protect ourselves.</p><img src="https://counter.theconversation.com/content/83362/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>James H. Hamlyn-Harris 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>Pacemakers are Internet of Things devices for the human body, but they’re still not particularly secure.James H. Hamlyn-Harris, Senior Lecturer, Computer Science and Software Engineering, Swinburne University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/808962017-07-20T20:10:01Z2017-07-20T20:10:01ZNew complementary medicine health claims lack evidence, so why are they even on the table?<figure><img src="https://images.theconversation.com/files/178771/original/file-20170719-13534-1g6r575.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Australian drugs regulator is overhauling the health claims made by suppliers of complementary medicines, including homeopathic therapies. And some curious options are up for discussion.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/557763373?src=IytjhciZWcCOoNS_bLGpyw-1-61&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>Australia’s drugs regulator seems to be endorsing pseudoscientific claims about homeopathy and traditional Chinese medicine as part of its <a href="https://theconversation.com/which-supplements-work-new-labels-may-help-separate-the-wheat-from-the-chaff-73189">review</a> of how complementary medicines are regulated.</p>
<p>In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers (also known as sponsors) can claim their products do, known as “<a href="http://www.tga.gov.au/draft-list-permitted-indications">permitted indications</a>”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.</p>
<p>If approved, the suppliers can use this permitted indication to market its listed product, one of about 11,000 listed complementary medicines on the <a href="https://www.tga.gov.au/australian-register-therapeutic-goods">Australian Register of Therapeutic Goods</a> (indicated by “Aust L” on packaging).</p>
<p>However, the spreadsheet of <a href="http://www.tga.gov.au/sites/default/files/draft-list-permitted-indications.xlsx">1,345 draft permitted indications</a> includes many that seem to lack evidence to back them.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=236&fit=crop&dpr=1 600w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=236&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=236&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=297&fit=crop&dpr=1 754w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=297&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=297&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Complementary medicines are the subject of the latest TGA review of permitted health claims.</span>
<span class="attribution"><span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>For instance, despite the Therapeutic Goods Advertising Complaints Resolution Panel upholding complaints of a lack of evidence that <a href="http://www.tgacrp.com.au/complaint-register/?_search=magnesium">magnesium</a> (and <a href="http://www.tgacrp.com.au/complaint-register/?_search=restless+legs&_id=3101">homeopathy</a>) “relieves muscle cramps (and restless legs)”, this permitted indication is on its draft list.</p>
<p>Other examples include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”.</p>
<p>The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”.</p>
<p>There are also around 900 additional indications for unspecified “traditions”. These include, “Renal tonic”, “Helps healthy liver regeneration”, “Emmenagogue”, “Vermifuge” and “Vulnerary”.</p>
<h2>Endorsing traditional medicines without evidence they work</h2>
<p>Australia is a multicultural society, and it’s appropriate we <a href="https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam001_complementary_medicine_resource_clinicians_140409.pdf">respect and have some knowledge</a> of complementary medical traditions.</p>
<p>Some observations made in these traditions have led to valuable, efficacious medicines, such as <a href="https://theconversation.com/is-the-2015-nobel-prize-a-turning-point-for-traditional-chinese-medicine-48643">Artemisinin derivatives</a> isolated from a herb used in traditional Chinese medicine.</p>
<p>However, scientific investigation has not substantiated many other aspects of such traditions, such as the <a href="https://theconversation.com/no-evidence-homeopathy-is-effective-nhmrc-review-25368">homeopathic principles</a> of “like cures like” and <a href="https://theconversation.com/are-traditional-chinese-medicines-safe-and-legal-6373">traditional Chinese medicine</a> concepts of meridians through which the life-energy known as “qi” flows.</p>
<p>We also cannot assume traditional medicines are safe, as <a href="https://www.ncbi.nlm.nih.gov/pubmed/22374080">emerging data</a> highlights how common adverse reactions and drug interactions really are.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=300&fit=crop&dpr=1 600w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=300&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=300&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=377&fit=crop&dpr=1 754w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=377&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=377&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Just because complementary medicines are based on long-held traditions doesn’t mean they work or are safe, as international data show.</span>
<span class="attribution"><span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>For example, Hyland’s homeopathic baby teething products were recalled by the <a href="https://www.fda.gov/safety/recalls/ucm552934.htm">US Food and Drug Administration</a> and then <a href="https://www.tga.gov.au/alert/hylands-baby-homeopathic-teething-tablets">the TGA</a>. This was because lack of quality control over potentially toxic ingredients – belladonna alkaloids – associated with <a href="https://www.scientificamerican.com/article/hundreds-of-babies-harmed-by-homeopathic-remedies-families-say/">adverse events in hundreds of babies</a>. </p>
<p>In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, <a href="http://www.sda.gov.cn/WS01/CL0078/124407.html">traditional Chinese medicine represented around 17.3%</a> (equivalent to around 230,000 cases).</p>
<h2>What we propose</h2>
<p>Listed medicines, like those mentioned, are meant to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed.</p>
<p>So, to safeguard shoppers, consumer representatives (of which I was one), suggested the proposed list of permitted indications should be short and only contain modest claims such as, “may assist” or “may help”.</p>
<p>We also argued that, for consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the <a href="https://www.ftc.gov/system/files/documents/federal_register_notices/2016/12/homeopathic_drugs_frn_12-13-2016.pdf">US Federal Trade Commission uses for homeopathic products</a>. </p>
<p>For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.</p>
<p>However, industry representatives <a href="http://www.asmi.com.au/media/30081/asmi_response_to_cm_de-regulation_review__april_2015_.pdf">argued</a> they needed a long list of permitted indications to allow consumers to tell the difference between one product and another. They also argued that disclaimers for traditional medicines were unnecessary. Their wishes made it to the draft list, rather than ours.</p>
<p>While we welcome moves to <a href="https://theconversation.com/which-supplements-work-new-labels-may-help-separate-the-wheat-from-the-chaff-73189">better regulate</a> complementary medicines in Australia, this current list of permitted indications, without disclaimers, represents a government endorsement of pseudoscience.</p>
<p>Worse, it will encourage consumers to purchase often ineffective and sometimes dangerous products.</p><img src="https://counter.theconversation.com/content/80896/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ken Harvey has represented Choice (the Australian Consumers’ Association) on TGA consultations about regulatory reform of complementary medicines. He is also an executive member of Friends of Science in Medicine and a member of the Australian Skeptics Victorian Branch.</span></em></p>Would you trust a complementary medicine described as “vermifuge”, “vulnerary” or “emmenagogue”? That’s what new labelling proposes and not everyone’s happy about it.Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/786052017-06-06T19:21:24Z2017-06-06T19:21:24ZVaginal mesh controversy shows collective failure of the TGA and Australia’s specialists<figure><img src="https://images.theconversation.com/files/172197/original/file-20170605-20608-1x1wfgp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Hundreds of women have complained of adverse reactions from transvaginal mesh implants.</span> <span class="attribution"><a class="source" href="https://unsplash.com/search/older-women?photo=_EKlFRXUuvg">Anna Noack/Unsplash</a></span></figcaption></figure><p>Australian women are coming forward with <a href="http://www.abc.net.au/news/2017-05-31/how-a-vaginal-mesh-implant-destroyed-maessens-life/8573878">stories of the negative impacts on their lives of transvaginal mesh implants</a>, medical devices surgically inserted to prevent pelvic organ prolapse. </p>
<p>A recent <a href="http://www.abc.net.au/news/2017-05-31/more-women-mesh-implant-side-effects-than-thought-experts-say/8572840">Australian consumer group</a> survey reported more than 700 women said they had a mesh implant that had caused adverse effects. These included incontinence, severe chronic pain, problems walking, painful intercourse and even marriage breakdown. In the United Kingdom, hundreds of women are <a href="http://www.bbc.com/news/health-39567240">taking legal action</a> against the National Health Service and the makers of mesh implants. </p>
<p>The <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants">Senate is conducting an inquiry</a> into transvaginal mesh implants in Australia. The questions the inquiry aims to answer include why there is no accurate record of how many meshes have been inserted in Australia, and how we can guarantee safer introduction of new products in future.</p>
<p>So, how did we get to a place where hundreds of Australian women have allegedly had this surgery leading to lifelong complications? </p>
<h2>A history of transvaginal mesh</h2>
<p>The pelvic floor is a group of muscles in the pelvic area that support the bladder, vagina and rectum. About 50% of women who have had children <a href="http://www.ajog.org/article/S0002-9378(00)53840-X/abstract">experience pelvic floor dysfunction</a>. As many as 20% <a href="https://www.ncbi.nlm.nih.gov/pubmed/24807341">will require surgery</a> for these conditions.</p>
<p>Pelvic floor dysfunction includes prolapse (falling through) of pelvic organs, such as the bladder, bowel or uterus (womb), through the vagina. It also includes stress urinary incontinence, which is involuntary urine leakage with activity such as sport, coughing or even walking.</p>
<p>The surgery and the medical devices used differ between these two conditions.</p>
<p><strong>Stress incontinence</strong></p>
<p>In the late 1990s, <a href="https://www.ncbi.nlm.nih.gov/pubmed/7618052">an innovative treatment</a> for stress incontinence was introduced. This involved a <a href="https://www.thewomens.org.au/health-information/continence-information/urinary-incontinence/">permanent synthetic sling, called a mid-urethral sling</a>, placed under the urethra (the tube through which urine travels from the bladder) to give it support. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/172196/original/file-20170605-20575-160pays.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The mid-urethral sling is placed under the urethra for support.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
</figcaption>
</figure>
<p>By 2002, the mid-urethral sling became the most frequently performed incontinence surgery in Australia. This was <a href="https://www.ncbi.nlm.nih.gov/pubmed/12114234">because doctors saw</a> the procedure was equivalent to, or better than, alternative procedures. The blood loss and operating time were less and recovery times were shorter than older procedures. </p>
<p>This clinical experience was later <a href="https://www.ncbi.nlm.nih.gov/pubmed/14981369">confirmed in large trials</a>. But while we waited for the results of these, which were published from 2004 onward, many women gained from a highly effective and safe operation, demonstrating the benefits of the innovation.</p>
<p><strong>Pelvic organ prolapse</strong></p>
<p>Traditional surgery for pelvic organ prolapse involved repairing the torn connective tissue with sutures. This was called vaginal repair. Unfortunately, this <a href="https://www.ncbi.nlm.nih.gov/pubmed/9083302">surgery was associated</a> with a <a href="http://www.ajog.org/article/S0002-9378(01)99389-5/abstract">high rate of the prolapse</a> recurring.</p>
<p>Following the success of the sling tape in stress incontinence, and of mesh use for hernias, doctors and manufactures looked to <a href="http://www.ejog.org/article/S0301-2115(00)00341-9/abstract">introduce a mesh</a> product to treat vaginal prolapse. This involved sheets of mesh being placed under the bladder, or in front of the bowel, to stop prolapse and prevent recurrence.</p>
<p>The <a href="https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=2349C2AAB6E8898ECA2577DD0001C16B&agid=(PrintDetailsPublic)&actionid=1">Therapeutic Goods Association (TGA)</a> approved a variety of transvaginal mesh kits for pelvic organ prolapse from 2003. As with the mid-urethral sling four years earlier, little supporting data on the safety and efficacy of these kits was initially available. </p>
<p>Due to a lack of detail in the Medicare codes used to record the surgeries, we are unable to accurately determine how many women underwent surgery. I estimate that around 150,000 tapes for stress urinary incontinence and between 30,000 and 40,000 transvaginal meshes for pelvic organ prolapse have been performed to date.</p>
<h2>Problems with vaginal mesh</h2>
<p>Since the introduction of transvaginal mesh, long-term trials and <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012079/abstract">reviews have demonstrated</a> it has some advantages over traditional vaginal repair. These include reduced symptoms of prolapse and need to operate again. But the mesh kits also have disadvantages. </p>
<p>The mesh rubs or <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012079/abstrac">becomes exposed in the vagina</a> in as many as 14% of cases. For some women, the exposure has no symptoms, but others experience bleeding, discomfort and painful intercourse. </p>
<p>At least half of the women in the studies reviewed needed surgery to treat the exposed mesh and sew over the vaginal tissue. The surgical correction is relatively straightforward and is generally successful. </p>
<p>Another problem is <a href="http://www.ajog.org/article/S0002-9378(10)02270-2/abstract">vaginal and groin pain</a>, which affects 3-4% of women. Sometimes multiple surgeries are required to remove large portions of the mesh. The pain <a href="https://www.ncbi.nlm.nih.gov/pubmed/26506159">persists in as many as 25% of women</a>, even after mesh excision, and may become chronic and disabling. Some find it difficult to maintain employment and intimate relationships. </p>
<h2>What regulatory bodies did</h2>
<p>Following reports of these complications, the <a href="https://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/ucm262760.pdf">US Food and Drug Administration</a> (FDA) <a href="http://www.mdedge.com/obgmanagement/article/63461/fda-alert-transvaginal-placement-surgical-mesh-carries-serious-risks">issued alerts</a> in 2008 and 2011 that the mesh carried serious risks. Many transvaginal mesh kits were voluntarily removed from the market. Most doctors in Australia stopped using the mesh for prolapse from 2012.</p>
<p>While the evidence of the benefits of the mid-urethral sling for urinary incontinence is overwhelming, <a href="http://journals.lww.com/co-urology/Abstract/2004/11000/Trans_obturator_tape_procedure____inside_out_or.3.aspx">some changes to the tapes</a> were introduced from 2005 to decrease adverse events. The TGA approved these new mini-slings (or obturator slings) and specialists used these without evidence confirming whether they were safer or more effective than the traditional mid-urethral sling.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/172354/original/file-20170606-16849-6hfs7h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Disabling vaginal and groin pain can be a complication of vaginal mesh implants.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
</figcaption>
</figure>
<p>In 2015, an <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006375.pub3/abstract">extensive Cochrane review</a> showed 2-3% of women developed significant groin pain after surgery with the obturator slings. It also showed the obturator slings were not as effective as the traditional slings at the five-year mark. But the obturator slings were quicker to perform and had less bladder injury than the traditional mid-urethtral slings. </p>
<p>In 2016, specialist groups such as the Urogynaecology Society of Australia and the Australian College of Obstetricians and Gynaecologists undertook <a href="http://www.ugsa.org.au/data/MUS_Presentations/3.UGSA_MUS_SUI_treatment_Read-Only.pdf?COLLCC=3602805463&">educational courses and later issued statements</a> cautioning doctors about using the new slings.</p>
<p>Many of the affected women have asked how procedures could be performed on them when the full benefit-to-risk profile of the intervention was not yet known. It can be argued doctors wanted to provide new and better options. But, in hindsight, innovation and patient safety could have been far more closely aligned. </p>
<p>This could have been achieved if both the TGA and the specialists themselves had more thoroughly evaluated transvaginal meshes by ensuring these were used under the oversight of medical ethics committees. The well-established practice of performing large trials under the guidance of an ethics committee encourages innovation while ensuring patients are properly informed of the possible benefits and risks of the innovation. </p>
<p>While some Australian hospitals took this precautionary step, the fact it did not happen uniformly is a collective failure of both the TGA and specialists. </p>
<h2>Next steps</h2>
<p>The Senate review will evaluate how sponsoring manufacturers interact with doctors performing surgical interventions, and how the broader medical community and public are educated about new interventions. </p>
<p>It is hoped the inquiry will inform the general community, doctors and industry of a clear and transparent pathway that balances the need for innovation and the responsibility for protecting patients.</p>
<p>Finally, while waiting on the inquiry’s deliberations, women should remain confident mid-urethral slings used for stress incontinence are an excellent intervention. Those undergoing prolapse surgery should also be reassured that highly trained specialists will carefully evaluate and perform surgery without the need for transvaginal mesh. </p>
<p>Those affected by ongoing complications associated with transvaginal mesh can be reassured Australian specialists are leaders in the management of these problems. Not only were we among the first in the world to report large trials that evaluated transvaginal mesh, we’ve also reported on the safety, technique and efficacy of mesh-removal procedures for vaginal pain in peer-reviewed publications.</p>
<p>We are fully supportive of the women who have experienced complications of transvaginal mesh. We look forward to working collaboratively at a national and local level, under the auspices of the Senate enquiry, to ensure we learn from the mistakes made when introducing transvaginal mesh into clinical practice. </p>
<hr>
<p><em>Further information is available on the websites of the <a href="https://www.ranzcog.edu.au/Womens-Health/Patient-Information-Guides">College of Obstetricians and Gynaecology</a> (RANZCOG) and the <a href="http://www.ugsa.org.au/pages/patient-information.html">Urogynaecology Society of Australia</a> (UGSA).</em></p><img src="https://counter.theconversation.com/content/78605/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Christopher Maher 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>Regulatory bodies approved some medical devices to treat pelvic organ prolapse and urinary incontinence before having data to prove their safety and efficacy.Christopher Maher, Associate Professor, Urogynaecology Royal Brisbane and Women's and Wesley Hospitals Brisbane, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/743692017-03-15T00:05:04Z2017-03-15T00:05:04ZFaster access to new drugs doesn’t always mean better treatment<figure><img src="https://images.theconversation.com/files/160645/original/image-20170314-9634-uieodg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Weaker regulatory standards in the US can impact health everywhere.</span> <span class="attribution"><span class="source">from shutterstock.com</span></span></figcaption></figure><p>US President Donald Trump <a href="http://www.reuters.com/article/us-usa-health-fda-gottlieb-idUSKBN16H2AM">recently chose an adviser</a> to a large pharmaceutical company to lead the country’s drug regulation agency.</p>
<p>Scott Gottlieb – who reportedly sits on the boards of several small drug companies and is an adviser to GlaxoSmithKline – is expected to <a href="http://www.reuters.com/article/us-usa-health-fda-gottlieb-idUSKBN16H2AM">introduce greater flexibility</a> to the evidence standards used by the Food and Drug Administration (FDA) to evaluate the benefit and risks of new medicines. </p>
<p>This is consistent with Trump’s message to pharmaceutical executives in January, when <a href="https://www.nytimes.com/2017/01/31/health/trump-vows-to-ease-rules-for-drug-makers-but-prices-remain-a-focus.html">he said</a>:</p>
<blockquote>
<p>We’re going to be cutting regulations at a level nobody’s ever seen before […] You’re going to get your products – either approved or not approved – but it’s going to be a quick process.</p>
</blockquote>
<p>Trump’s views might seem extreme but his comments are not entirely out of step with the views of previous US governments. An example is the <a href="http://jamanetwork.com/journals/jama/article-abstract/2597296">21st Century Cures Act</a>, which was passed late last year after heated debate. This aims to speed up innovation and the search for cures by setting lower thresholds for evaluating the safety and effectiveness of new medicines. </p>
<p>The Act is an addition to a range of <a href="https://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm">expedited programs</a> the US already had in place for some time to permit drugs to enter the market based on less robust evidence than traditionally required. So Gottlieb already has the tools to make it easier to get drugs onto the market in the US.</p>
<p>But what does this mean for Australia? A recent comment piece published in the journal Nature noted that weaker regulatory standards in the US <a href="http://www.nature.com/news/show-drugs-work-before-selling-them-1.21582">can impact</a> health everywhere. One reason is companies will have far less incentive to run the expensive high-quality trials needed to inform decision-making if the biggest market in the world does not demand it.</p>
<h2>Dangers of deregulation</h2>
<p>Intuitively, it might seem desirable to speed up access to medicines. But this means more drugs will be approved that may subsequently prove unsafe or ineffective.</p>
<p>One could also argue regulatory standards are already lax. For example, <a href="http://jamanetwork.com/journals/jamaotolaryngology/article-abstract/1891387">one study showed</a> all the cancer drugs approved for solid tumours between 2002 and 2014 had only a minor effect on patients’ survival rates – a median increase of just more than two months. </p>
<p>And an FDA <a href="https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM535780.pdf">report released in January</a> outlined details of 22 drugs with early promise that either proved unsafe or ineffective in subsequent research. </p>
<p>Some may believe easing restrictions for companies to get their drugs to market will make investing in drug development less risky and more attractive, enhancing innovation. But true innovation demands taking greater risks.</p>
<p>If companies can get their drugs approved more quickly and make money off drugs that are less risky to develop, this actually takes away the incentive for innovation. In the case of <a href="http://jamanetwork.com/journals/jamaotolaryngology/article-abstract/1891387">cancer drugs development</a>, some experts have blamed the marginal improvements in outcomes on regulators and payers being too lax rather than too strict.</p>
<h2>Forces at play</h2>
<p>There are social and political forces dictating the push to deregulate the drug market. Pressure to speed up access to medicines is framed as being in the best interest of patients. But this debate can’t ignore that countries like the US have an economic interest in keeping the pharmaceutical industry producing medicines, and ensuring people buy them at a premium. </p>
<p>These companies also want to get their drugs onto the market as quickly as possible before generic (copycat) drugs come in and drive down prices. A report by consultancy group IMS Health <a href="https://www.imshealth.com/files/web/IMSH%20Institute/Reports/The%20Global%20Use%20of%20Medicines%20Outlook%20Through%202016/Medicines_Outlook_Through_2016_Report.pdf">predicted patent-protected medicines</a> will lose US$127 billion in revenue due to generic medicines entering the market by 2016. </p>
<p>In 2004, at the request of the US Congress, <a href="https://www.selectusa.gov/pharmaceutical-and-biotech-industries-united-states">the US Commerce Department</a> published a report about the implications of strategies used by other governments to limit medicine prices. If price controls were removed, it concluded, pharmaceutical revenues from patented medicines would increase significantly, including in Australia. </p>
<p>As US firms hold most of the intellectual property rights for new medicines, most of this income would then funnel back into the US and support US jobs. It should not be a surprise, then, that the US leads the way in deregulating pharmaceutical markets. </p>
<p>US Medicare, for instance, cannot negotiate prices and the FDA seems set to make it easier for drugs to enter the market. Trump has been open about his view that <a href="http://www.cnbc.com/2017/01/31/trump-tells-drugmakers-he-wants-them-to-manufacture-in-the-us.htmlhttp://www.cnbc.com/2017/01/31/trump-tells-drugmakers-he-wants-them-to-manufacture-in-the-us.html">foreign countries should pay more for drugs</a> and that foreign price controls are unfair for the United States.</p>
<p>This is understandable because the US economy has the most to lose from the reticence of regulators to approve medicines, and insurers to pay for them. A US biotech <a href="http://catalyst.phrma.org/nearly-4.5-million-jobs-and-counting">industry lobby group reports</a> the industry supports 4.5 million jobs and is responsible for US$1.2 trillion in economic output. It says the average employee in the bio-pharmaceutical sector is paid double the average US wage. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/160825/original/image-20170314-10763-1iap4ti.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/160825/original/image-20170314-10763-1iap4ti.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/160825/original/image-20170314-10763-1iap4ti.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/160825/original/image-20170314-10763-1iap4ti.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/160825/original/image-20170314-10763-1iap4ti.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/160825/original/image-20170314-10763-1iap4ti.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/160825/original/image-20170314-10763-1iap4ti.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/160825/original/image-20170314-10763-1iap4ti.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Patients in Australia may see new drugs becoming available overseas and wonder why they don’t have access to the same.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
</figcaption>
</figure>
<h2>How does all this affect Australians?</h2>
<p>When the US is more lenient in its regulatory processes, this creates a dilemma for Australia’s Therapeutic Goods Administration – our version of the FDA. It also creates issues for the Pharmaceutical Benefits Advisory Committee, which advises the government which drugs to subsidise. </p>
<p>Patients in Australia may see new drugs becoming available overseas and wonder why they don’t have access to the same. Australian regulators and payers are then accused of being old-fashioned, while patients believe they are missing out on the latest and greatest drugs. </p>
<p>This puts immense pressure on Australian regulators and payers to keep up with the rest of the developed world, which means becoming more lenient with evidence standards and prices.</p>
<p>This trend is evident in the case of cancer medicines. Australia’s <a href="http://www.cancerdrugsalliance.org.au/">Cancer Drug Alliance</a> claims Australian patients are already falling behind in access to new cancer medicines.</p>
<p>This sentiment was echoed in the Senate inquiry on the <a href="http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Cancer_Drugs">availability of new, innovative and specialist cancer drugs</a> in Australia conducted in 2014-2015. This highlighted concerns about “delays” in access to cancer medicines available overseas. </p>
<p>In parallel with this inquiry, the Australian government <a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/CCB4916435683A5BCA257FA100839F95/$File/govresp.pdf">set up an expert panel</a> in 2014 to review medicines regulation. The panel’s conclusion supported expediting access to medicines in Australia. </p>
<p>US pressure to deregulate medicine markets no doubt speeds up access to new drugs. But the rationale isn’t always to help patients. It often has more to do with the economic interests of countries with a strong research-based pharmaceutical industry.</p><img src="https://counter.theconversation.com/content/74369/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Narcyz Ghinea receives funding from the National Health and Medical Research Council for a project on improving funding/access of high cost cancer medicines in Australia.</span></em></p><p class="fine-print"><em><span>Wendy Lipworth receives funding from National Health and Medical Research Council. She is affiliated with DIA.</span></em></p>Intuitively, it might seem desirable to speed up access to medicines. But this means more drugs will be approved that may subsequently prove unsafe or ineffective.Narcyz Ghinea, Doctoral Researcher, Centre for Values, Ethics and the Law in Medicine, University of SydneyWendy Lipworth, Senior Research Fellow, Bioethics, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/731892017-02-20T19:24:29Z2017-02-20T19:24:29ZWhich supplements work? New labels may help separate the wheat from the chaff<figure><img src="https://images.theconversation.com/files/157255/original/image-20170217-4236-nzd71a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">How do you really know if vitamin and mineral supplements really 'help your heart' or 'boost your mood'?</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/517627717?src=_bg7SZGmIYpr6LlUowfYLw-3-39&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>New proposals from Australia’s drug regulator should give you a better idea if your complementary medicines do what they say on the packet.</p>
<p>One change proposed by the Therapeutic Goods Administration (TGA) is a “stamp of approval” on the packaging and promotional material of some vitamins, minerals, herbs and other supplements to tell you there is enough evidence to back health claims.</p>
<p>Other proposals include reducing the number of often unsubstantiated indications that manufacturers of complementary medicines currently make on their TGA application, which are then used as the basis for advertising claims. </p>
<p>The TGA also proposes incentives for companies to develop and market products with new active ingredients, or make new claims based on research.</p>
<p>The proposed changes, <a href="http://www.tga.gov.au/consultation/consultation-reforms-regulatory-framework-complementary-medicines-assessment-pathways">which are out for public consultation</a>, follow the recent <a href="http://www.abc.net.au/4corners/stories/2017/02/13/4616948.htm">ABC Four Corners program</a>, which highlighted long-standing problems with the way complementary medicines are currently regulated.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/TKyHvYgP_ZE?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">ABC Four Corners’ documentary “Swallowing it” highlights the shortcomings of how complementary medicines are regulated in Australia.</span></figcaption>
</figure>
<h2>What’s the problem?</h2>
<p>The TGA’s proposals are urgently needed to fix three major shortcomings of the current regulatory system.</p>
<p>First, consumer organisations and health professionals have lost confidence in the complementary medicines industry’s ability to regulate its own advertisements, and in the TGA’s ability <a href="https://theconversation.com/dodgy-claims-for-complementary-medicines-heres-how-the-drug-watchdog-could-have-more-bite-69488">to apply adequate sanctions</a> when companies don’t follow the rules.</p>
<p>Second, there is little incentive for the manufacturers of complementary medicines to research new innovative products or prove existing ones work.</p>
<p>There are about 11,000 listed complementary medicines on the <a href="https://www.tga.gov.au/australian-register-therapeutic-goods">Australian Register of Therapeutic Goods</a> (indicated by Aust L on packaging). Listed medicines are meant to contain pre-approved, relatively low-risk ingredients, produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed; post-marketing surveillance and upheld complaints show <a href="https://theconversation.com/dodgy-claims-for-complementary-medicines-heres-how-the-drug-watchdog-could-have-more-bite-69488">high levels of regulatory non-compliance</a>. </p>
<p>But there are only 35 <a href="https://www.tga.gov.au/list-evaluated-registered-complementary-medicines">registered complementary medicines</a> (indicated by Aust R on packaging) the TGA says have been thoroughly assessed for safety, quality and efficacy (there is also debate about whether many of these older products should still be on this TGA list). There are fewer products on this list because research to meet registration requirements is expensive, the public doesn’t understand the subtleties between an <a href="https://www.tga.gov.au/community-qa/whats-medicine-label">Aust L and Aust R product</a> and a better return on investment comes from promotional hype and celebrity endorsement of listed products. </p>
<p>Third, the TGA provides only limited transparency about companies and products that fail post-marketing evaluation or have complaints upheld. This information is currently regarded as commercial-in-confidence, fuelling the perception the TGA is more concerned with helping industry than protecting consumers.</p>
<h2>How could the new measures help?</h2>
<p>The proposal to restrict companies to only making pre-approved, “low-level” indications and claims for a product, such as, “may relieve the pain of mild osteoarthritis”, will minimise the risk of misleading consumers. But it is not yet clear how the list of allowed indications will be established nor how a specific product will be matched with an appropriate allowed indication.</p>
<p>The regulator also proposes manufacturers apply for “intermediate-level” health claims falling outside the permitted list (outlined above). An example might be, “our formulation of cranberry reduces the frequency of recurrent urinary infections in women”. For this, the TGA would have to assess the evidence substantiating the claim for a particular product. If the evidence stacks up (and there’s a debate about the type of evidence needed), the product could then carry a TGA “stamp of approval” on the label and any promotional material. But it is not clear what this “stamp of approval” will be. Is it text, a symbol or both?</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=588&fit=crop&dpr=1 600w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=588&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=588&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=739&fit=crop&dpr=1 754w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=739&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=739&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Not everyone agrees a TGA ‘stamp of approval’ should be in the form of a symbol, like this.</span>
<span class="attribution"><span class="source">(Unofficial mock-up created by Ken Harvey)</span></span>
</figcaption>
</figure>
<p>In preliminary TGA stakeholder consultations, consumer representatives supported a prominent visual identifier (like a logo or symbol) because of the failure of the existing Aust L and Aust R labelling to inform consumers. But industry representatives were concerned a highly visible identifier for a small number of evidence-based complementary medicines might affect sales of the bulk of listed products without one.</p>
<p>The TGA’s proposals encourage innovation because they will stimulate companies to engage in research to qualify for a TGA “stamp of approval”. The proposal also suggests companies that develop a TGA approved evidence-based claim would be awarded a three-year period of data protection to stop others freeloading on their research. </p>
<p>But the proposed changes do not yet address the need for greater transparency in the regulatory process. For instance, it is not clear whether the TGA’s assessment of evidence to back higher-level health claims for complementary medicines will be publicly available, as they are for <a href="https://www.tga.gov.au/australian-public-assessment-reports-prescription-medicines-auspars">prescription medicines</a>.</p>
<h2>What happens next?</h2>
<p>These proposed changes, which are out for public consultation until March 28, 2017, sit alongside <a href="https://theconversation.com/dodgy-claims-for-complementary-medicines-heres-how-the-drug-watchdog-could-have-more-bite-69488">other recommendations</a> aimed at improving the advertising complaints system. </p>
<p>If the TGA implements this package of recommendations, Australia will be a world leader in how complementary medicines are regulated. Despite the substantial and increasing use of supplements, no other country has developed a system that helps consumers and health professionals separate the evidence-based wheat from the chaff, improves confidence in the industry, stimulates more evidence-based products and has the potential to boost exports.</p><img src="https://counter.theconversation.com/content/73189/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ken Harvey has represented Choice (the Australian Consumers’ Association) on discussions about regulatory reform during TGA stakeholder consultations.
He is also an executive member of Friends of Science in Medicine.</span></em></p>If the Therapeutic Goods Administration implements new proposals to regulate complementary medicines, you can be more confident they actually do what they say on the packet.Ken Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/725662017-02-13T04:00:12Z2017-02-13T04:00:12ZAustralia’s looming e-cigarette ban robs smokers of a chance to quit<figure><img src="https://images.theconversation.com/files/156280/original/image-20170209-28704-1stqlfl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The effective ban on e-cigarettes in Australia forces people to access unregulated nicotine products to help them quit smoking.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/success?src=VWxpcpZrDJ-woEdZxYdAMA-1-2">from www.shutterstock.com</a></span></figcaption></figure><p>The Australian Therapeutic Goods Administration’s (TGA) recent interim <a href="https://www.tga.gov.au/book-page/21-nicotine">decision</a> to effectively ban nicotine-containing e-cigarettes is a harsh blow to smokers.</p>
<p>Australian smokers will be denied access to life-saving technology estimated to have helped millions of smokers to <a href="https://www.ncbi.nlm.nih.gov/pubmed/27338716">quit overseas</a>.</p>
<p>Those most affected will be from lower socio-economic and disadvantaged groups, which have the <a href="http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129549848">highest smoking rates</a> and are <a href="https://www.ncbi.nlm.nih.gov/pubmed/26094493">hardest hit</a> by the cost of smoking.</p>
<p>Currently, nicotine-containing e-cigarettes are effectively prohibited in Australia. If the TGA’s interim decision is made final in March 2017, e-cigarette users (or vapers) in Australia will still not be able to buy or import nicotine for vaping without a prescription. Their only legal option would be to ask their doctor for a prescription, which doctors are generally reluctant to provide.</p>
<p>If the current ban remains, vapers will still be forced to source nicotine solutions (e-liquids) from an unregulated and illegal black market, placing them at even greater risk. Without regulation, the contents of nicotine refill bottles are a mystery, labels are inaccurate, childproof bottles are not mandated and there is no quality control or manufacturing standard.</p>
<p>Other users will buy large quantities of highly concentrated nicotine online and mix their e-liquid at home, with the risk of exposure to children and dosage errors.</p>
<p>Meanwhile, vapers who try to quit smoking are branded criminals. The fine for possessing nicotine for vaping in Queensland is up to A$9,108 and the government encourages the public to <a href="https://www.health.qld.gov.au/public-health/topics/atod/tobacco-laws/electronic-cigarettes">report any offenders</a>. This fear will lead some vapers to return to smoking.</p>
<h2>Out of step</h2>
<p>The TGA’s decision also leaves Australia <a href="http://tobaccocontrol.bmj.com/content/early/2016/11/30/tobaccocontrol-2016-053179.long">out of step</a> with other similar countries. E-cigarettes with nicotine are legal and available, or are in the process of being legalised, in the United Kingdom, European Union, United States, Canada and New Zealand.</p>
<p>Their approach to smoking cessation products is in sharp contrast to policy in Australia, which has missed the opportunity to welcome e-cigarettes as a harm reduction tool, and a safer alternative, for smokers. Meanwhile, the most lethal nicotine products, cigarettes, are freely available in Australia and do not need TGA approval.</p>
<p>In making its decision, the TGA focussed on unsubstantiated risks, for example, e-cigarettes will increase smoking in young people and re-normalise smoking in the community. </p>
<p>However, <a href="https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update">comprehensive</a> <a href="https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0">independent</a> <a href="http://www.uvic.ca/research/centres/carbc/assets/docs/report-clearing-the-air-review-exec-summary.pdf">reports</a> have found no evidence for these claims. In fact, e-cigarettes may be <a href="http://www.uvic.ca/research/centres/carbc/assets/docs/report-clearing-the-air-review-exec-summary.pdf">diverting young people from smoking</a> and <a href="https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0">helping smoking rates decline</a>.</p>
<p>The TGA also says there is little evidence of the safety of long-term nicotine exposure via e-cigarettes. However, this ignores 50 years of experience with <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5129320">snus</a> (moist, oral tobacco used in Sweden) and 30 years of <a href="https://www.ncbi.nlm.nih.gov/pubmed/27699443">nicotine replacement products</a>.</p>
<p>The TGA also overlooks the huge potential public health gains from using e-cigarettes, or vaping. Based on <a href="https://www.ncbi.nlm.nih.gov/pubmed/27338716">overseas experience</a>, vaping can save the lives of hundreds of thousands of Australian smokers, making the risk-benefit balance very favourable. Smoking kills <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4339244/">up to two out of three</a> Australian smokers prematurely. So, it seems reasonable to tolerate a small amount of risk and uncertainty when such devastating harm can be reduced.</p>
<h2>Same evidence, different conclusions</h2>
<p>How is it possible researchers and policy makers are using the same evidence to come to vastly differing conclusions?</p>
<p>The TGA assessment appears clouded by a long-standing commitment to prohibition. Many tobacco activists and policy makers have followed a <a href="http://www.nejm.org/doi/full/10.1056/NEJMp1601154">total abstinence approach</a> for decades. In their view, anything that looks like a cigarette, is used like a cigarette or delivers nicotine cannot possibly be a good thing.</p>
<p>Harm minimisation supporters takes a more pragmatic view and understand some people <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4078589/">cannot quit smoking or nicotine</a>. E-cigarettes are a safer alternative, providing smokers with the nicotine to which they are addicted and the “smoking ritual”, without the smoke, tar, carbon monoxide and other toxic chemicals that cause almost <a href="https://www.ncbi.nlm.nih.gov/pubmed/21375611">all the harm</a>.</p>
<p>E-cigarettes are not completely safe. Nothing is. However, even the most ardent opponents admit e-cigarettes are <a href="https://theconversation.com/is-nicotine-really-as-safe-as-e-cigarette-supporters-make-out-61007">substantially safer than smoking</a>.</p>
<h2>Finding the regulatory sweetspot</h2>
<p>While there are still unknowns, the available evidence and risk-benefit balance <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4598199/">support a role</a> for e-cigarettes with nicotine to help smokers quit.</p>
<p>The ideal compromise is balanced, proportionate regulation of nicotine-containing e-cigarettes under the existing Australian Consumer Law with careful monitoring. This would allow and encourage smokers to switch to e-cigarettes by making products legally available and accessible. Such an approach would also allow responsible advertising to adult smokers and permit retail display to facilitate access and awareness. Vaping would also be approved in most public places.</p>
<p>Secondly, regulations should minimise any potential public health risks such as harm to children, for example by restricting sale to under 18-year-olds, mandating child resistant containers for nicotine liquid refills, restricting use in some confined spaces such as in cars with children under 16 years, and setting quality and safety standards.</p>
<p>According to the <a href="https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0">UK Royal College of Physicians</a>:</p>
<blockquote>
<p>‘… It is important to promote the use of e-cigarettes … as widely as possible as a substitute for smoking.</p>
</blockquote>
<p>Australia cannot afford to wait any longer.</p><img src="https://counter.theconversation.com/content/72566/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Colin Mendelsohn has received funding for consulting, teaching and conference expenses from Pfizer Australia, GlaxoSmithKline and Johnson & Johnson Pacific. He has no commercial or personal relationship with any e-cigarette or tobacco company.</span></em></p>The recent decision to effectively ban e-cigarettes will hurt poor and disadvantaged smokers the most.Colin Mendelsohn, Associate professor, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.