tag:theconversation.com,2011:/nz/topics/drugs-1588/articlesDrugs – The Conversation2024-03-28T12:50:35Ztag:theconversation.com,2011:article/2259912024-03-28T12:50:35Z2024-03-28T12:50:35ZThe amazing story of the man who created the latest narco-state in the Americas, and how the United States helped him every step of the way − until now<p>When Juan Orlando Hernández was <a href="https://apnews.com/article/honduras-president-juan-orlando-hernandez-corruption-trial-7c43423f12ff71859c370be2fc6ac5b0">convicted by a federal jury</a> in Manhattan in early March 2024, it marked a spectacular fall from grace: from being courted in the U.S. as a friendly head of state to facing the rest of his life behind bars, convicted of cocaine importation and weapons offenses.</p>
<p>“Juan Orlando Hernández abused his position as President of Honduras to operate the country as a narco-state where violent drug traffickers were allowed with virtual impunity,” said <a href="https://www.justice.gov/opa/pr/juan-orlando-hernandez-former-president-honduras-convicted-manhattan-federal-court">U.S. Attorney General Merrick Garland</a> following the jury conviction. <a href="https://www.justice.gov/opa/pr/juan-orlando-hernandez-former-president-honduras-convicted-manhattan-federal-court">Anne Milgram</a>, administrator of the Drug Enforcement Administration, added: “When the leader of Honduras and the leader of the Sinaloa Cartel work hand-in-hand to send deadly drugs into the United States, both deserve to be accountable.”</p>
<p>The conviction was a victory for the Justice Department and the DEA. During Hernández’s two terms in office, from 2014 to 2022, he and his acolytes transported more than 400 tons of cocaine into the United States, <a href="https://www.justice.gov/opa/pr/juan-orlando-hernandez-former-president-honduras-convicted-manhattan-federal-court">according to U.S. prosecutors</a>. The former head of state now faces a mandatory sentence of up to 40 years in prison; sentencing is scheduled for June 26. </p>
<p>But there’s more to this story. </p>
<p>As I explore in the book “<a href="https://www.routledge.com/21st-Century-Democracy-Promotion-in-the-Americas-Standing-up-for-the-Polity/Heine-Weiffen/p/book/9780415626378">21st Century Democracy Promotion in the Americas: Standing Up for the Polity</a>,” written in collaboration with the <a href="https://www.open.ac.uk/people/bw4844">Open University’s Britta Weiffen</a>, Honduras is a tragic example of what happens when a country becomes a narco-state. While its people suffer the consequences – the World Bank reports that about <a href="https://www.worldbank.org/en/country/honduras/overview">half the country currently lives under poverty</a> – its leaders grow rich through the drugs trade.</p>
<p>Furthermore, the way Hernández came to power and maintained that position for so long could provide “Exhibit A” in any indictment of U.S. policy toward Central America – and Latin America more generally – over the past few decades. </p>
<h2>Growing ties with cartels</h2>
<p>Up to <a href="https://apnews.com/article/us-supreme-court-arrests-united-states-honduras-extradition-207d739fe73c844ad5cf182eec030a8a">Hernández’s arrest in Tegucigalpa</a>, the Honduran capital, and extradition to the United States in January 2022, his biggest enabler had been none other than the U.S. government itself. </p>
<p>Presidents <a href="https://obamawhitehouse.archives.gov/the-press-office/2014/01/15/president-obama-announces-presidential-delegation-honduras-attend-inaugu">Barack Obama</a>, <a href="https://www.washingtonpost.com/world/the_americas/honduras-president-narcotrafficking-hernandez/2021/02/11/1fa96044-5f8c-11eb-ac8f-4ae05557196e_story.html">Donald Trump</a> <a href="https://obamawhitehouse.archives.gov/the-press-office/2015/06/18/readout-vice-president-bidens-meeting-honduran-president-juan-orlando">and Joe Biden</a> all backed Hernández and allowed him to inflict enormous harm to Honduras and to the United States in the process.</p>
<p>How so? To answer this question, some background is needed. </p>
<p>On June 28, 2009, <a href="https://www.theguardian.com/world/2009/jun/28/honduras-coup-president-zelaya">a classic military coup took place</a> in Honduras. In the wee hours of the morning, while still in his pajamas, President Manuel “Mel” Zelaya was unceremoniously escorted by armed soldiers from his home and <a href="https://www.sandiegouniontribune.com/sdut-lt-honduras-divided-070709-2009jul07-story.html">flown to a neighboring country</a>. The coup leaders alleged that, by calling for a referendum on reforming the Honduran Constitution, the government was moving toward removing the one-term presidential term limit enshrined in the country’s charter and opening the door to authoritarianism.</p>
<p>Initially, then-President Barack Obama <a href="https://www.reuters.com/article/idUSTRE55S5J2/">protested the coup</a> and took measures against those responsible – the right-wing opponents of Zelaya. </p>
<p>But the administration eventually relented and <a href="https://www.reuters.com/article/idUSN07503526/">allowed the coup leaders to prevail</a>, largely due to pressure from Republicans, who saw Zelaya as being <a href="https://www.cfr.org/interview/honduran-politics-and-chavez-factor">too close to Venezuela’s Hugo Chavez</a>, whose leftist agenda was deemed by the GOP as a threat to U.S. interests. </p>
<p>The coup-makers simply ran the clock against the upcoming election date and installed their own candidate in the presidency, <a href="https://www.theguardian.com/world/2009/nov/30/honduras-lobo-president">Porfirio Lobo of the National party</a>, whose son Fabio was also later convicted of cocaine trafficking. </p>
<h2>Washington looks the other way</h2>
<p>Lobo laid the foundations of Honduras as the <a href="https://www.bbc.com/news/world-latin-america-56947595">new century’s first narco-state</a>, allowing drug cartels to infiltrate the highest echelons of government and the security apparatus as cocaine trade became an increasingly central plank of the country’s economy.</p>
<p>All the while, the U.S. <a href="https://www.theguardian.com/commentisfree/2016/jul/08/american-funding-honduran-security-forces-blood-on-our-hands">pumped tens of millions of dollars</a> <a href="https://www.newyorker.com/news/news-desk/should-the-u-s-still-be-sending-military-aid-to-honduras">into building up Honduras’ police and military</a>, despite widespread allegations of being engaged in corruption, complicit in the drugs trade and engaged in <a href="https://www.hrw.org/world-report/2016/country-chapters/honduras">human rights abuses</a>.</p>
<p>The dollars continued to flow when Lobo was succeeded in 2013 by his buddy and fellow National party member, Juan Orlando Hernández.</p>
<p>In 2017, Hernández – an ardent supporter of the 2009 coup – ran for a second term after the Supreme Court of Honduras <a href="https://www.reuters.com/article/idUSKBN0NE2T9/">pronounced this to be perfectly legal</a>.</p>
<p>Many Hondurans believe Hernández <a href="https://www.thenation.com/article/archive/the-honduran-government-is-trying-to-steal-an-election/">stole the November 2017 elections</a>. The vote count was suspended in the middle of the night as Hernández was running behind, and when the polls opened in the morning, he <a href="https://www.thenation.com/article/archive/the-honduran-government-is-trying-to-steal-an-election/">miraculously emerged as a winner</a>.</p>
<p>Despite widespread allegations of election fraud, the U.S. quickly recognized the result, congratulating <a href="https://www.cnn.com/2017/12/22/politics/us-honduras-election-results/index.html">Hernández on his win</a>.</p>
<p>Emboldened by his success, Hernández continued to build up Honduras as the new century’s first narco-state of the Americas.</p>
<p>In 2018, the president’s brother, Juan Antonio “Tony” Hernández, a former member of the Honduran Parliament, was arrested in the United States for his association with the Cartel de Sinaloa, the Mexican drug cartel. This entity valued his services so much that <a href="https://www.justice.gov/usao-sdny/pr/former-honduran-congressman-tony-hern-ndez-sentenced-life-prison-and-ordered-forfeit">they named a particular strain of cocaine after him</a>, stamping the bags as “TH.” Tony Hernández was convicted on four charges in 2019, sentenced to 30 years in prison, and has been in U.S. federal prison ever since. </p>
<p>President Hernández denied any association with the cartel, but the evidence pointed to the contrary. As <a href="https://www.economist.com/the-americas/2021/03/18/a-court-case-rocks-the-president-of-honduras">reported in The Economist</a>, in a New York City trial, one accused drug trafficker alleged that Hernández took bribes for “helping cocaine reach the United States.” Another witness testified that the president had taken two bribes in 2013, before being elected; a former cartel leader testified that the president had been paid $250,000 to protect him from being arrested.</p>
<h2>‘Complicit or gullible’</h2>
<p>Given Hernández’s history in Honduras, the <a href="https://www.washingtonpost.com/world/2024/03/08/juan-orlando-hernndez-honduras-convicted/">repeated claims of U.S. government officials</a> that they simply didn’t know of his crimes ring hollow.</p>
<p>Honduras became a narco-state, in part, because U.S. policymakers looked the other way as it did so. They embraced Hernández because he was ideologically more palatable and subservient to Washington’s wishes compared with his rival, Zelaya. But as the trial verdict in Manhattan makes clear, it was a decision with disastrous consequences.</p>
<p>As one State Department official put it, “Today’s verdict makes all of us who collaborated with (Hernández) <a href="https://www.washingtonpost.com/world/2024/03/08/juan-orlando-hernndez-honduras-convicted/">look either complicit or gullible</a>.” </p>
<p>The latter may be the more charitable assessment. But the truth is more uncomfortable.</p><img src="https://counter.theconversation.com/content/225991/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>I am a member of the Party for Democracy in Chile and and affiliated with the Foro de Political Exterior, a Chilean foreign policy think tank.</span></em></p>Washington looked the other way as coup leaders and drugs cartels conspired to turn Honduras into a center of the cocaine trade.Jorge Heine, Interim Director of the Frederick S. Pardee Center for the Study of the Longer-Range Future, Boston UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2257152024-03-26T17:01:41Z2024-03-26T17:01:41ZMany drugs are prescribed for conditions they weren’t tested for – here’s what you need to know<p>All prescription drugs need a licence from a regulator to treat a specific condition. But licensed drugs can be prescribed for conditions they haven’t been tested for in a clinical trial. This is known as “off-label” prescribing – and it’s very common.</p>
<p>The UK doesn’t have current figures on overall off-label prescribing, but a <a href="https://pubmed.ncbi.nlm.nih.gov/16682577/">US study</a> found that one in five prescriptions was off label.</p>
<p>It is important to note that off-label medicine use is not the same as experimental use. Legally, once a medicine has obtained a licence, it can be used for any condition in any patient. A licence is evidence a medicine is safe, effective and of good quality. </p>
<p>So why is off-label prescribing so common? This practice is <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6677268/">most common in</a> children, older people, pregnant women and psychiatric patients, usually with changes in dosing and formulations. It is unusual for drugs to have been tested in these groups of patients. </p>
<p>Obtaining a new license for a medicine (to treat a different condition) is time-consuming, often taking up to <a href="https://www.nature.com/articles/3901619#Sec2">eight years</a> to get approval. It is also very expensive, with the new revenue for the additional uses often not being enough to offset the cost of running new clinical trials, marketing and re-labelling the drug.</p>
<p>To determine if a medicine can and should be prescribed off-label, a prescriber may consider several factors. There may be common features in two similar conditions that ensure there should be a degree of cross-effectiveness. For example, a medicine licensed for anxiety might reasonably be used to treat post-traumatic stress disorder. And a drug approved to treat one type of cancer could reasonably be expected to target other types of cancer. </p>
<p>Some off-label uses have been found by accident. <a href="https://www.migraineagain.com/beta-blockers-migraine-prevention/">Beta-blockers</a> were licensed in the 1960s to treat heart conditions. People who were prescribed these drugs and who suffered from migraines found that their migraine symptoms improved after they started taking the drug. Today, these drugs are commonly prescribed for migraine.</p>
<p>On occasion, off-label medicine use can become the primary treatment option for a particular condition. Amitriptyline, an older type of antidepressant, is now often used to treat nerve pain.</p>
<p>Usually, a prescriber will have considered all other medical options for a patient and will have reviewed the evidence to support any off-label prescribing. This includes “evidence summaries” provided by the <a href="https://cks.nice.org.uk/about/">National Institute for Health and Care Excellence</a>. These are available to GPs to support safe decision-making. </p>
<p>The summaries look at current guidelines and reviews as well as research studies, such as clinical trials and observational studies, and expert opinions. Although the guidelines mainly focus on licensed drugs, they also discuss off-label uses that are common in practice. </p>
<p>Some off-label drugs may also be listed in the British National Formulary, a reference book that contains prescribing information about drugs available in the UK.</p>
<h2>Great responsibility</h2>
<p>Whether there is a wealth of evidence or not, there is a greater responsibility for the prescriber when prescribing drugs off label. </p>
<p>One risk is the absence of information from the patient leaflet. The metformin patient leaflet, for instance, discusses its use in diabetes, but there is no information about its alternative use to treat polycystic ovary syndrome, which can confuse patients. </p>
<p>A bigger risk is the incidence of side-effects, which increase when off-label prescribing is not based on strong medical evidence. Alternatively, the drug may not work at all. </p>
<p>Despite being strongly advocated at the time by some doctors and politicians, a <a href="https://www.nature.com/articles/s41467-021-22446-z">2021 review</a> debunked the use of hydroxychloroquine to treat COVID and found an increased risk of death with its use.</p>
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Read more:
<a href="https://theconversation.com/coronavirus-scientists-promoting-chloroquine-and-remdesivir-are-acting-like-sports-rivals-138051">Coronavirus: scientists promoting chloroquine and remdesivir are acting like sports rivals</a>
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<p>Recently, <a href="https://www.diabetes.org.uk/about-us/news-and-views/ozempic-and-weight-loss-facts-behind-headlines#:%7E:text=People%20with%20type%202%20diabetes%20who%20use%20Ozempic%20can%20lose,you%20stay%20full%20for%20longer.">Ozempic</a> (semaglutide) caused a storm, with celebrities promoting its miraculous weight-loss effects. This off-label prescribing has led to continuing drug shortages affecting people with diabetes. But it also to the development of Wegovy for weight loss.</p>
<h2>No legal duty</h2>
<p>While there is no legal duty to tell a patient they have been prescribed an off-label medicine, prescribers follow professional guidelines. These state it is good practice to tell patients if a drug is being prescribed off label. </p>
<p>Patients should be told information about the medicine, including potential side-effects and the reasons why they have been prescribed an off-label medicine versus a licensed medicine.</p>
<p>A patient who has been told or suspects their medicine is off-label should ask why they have been prescribed this medicine and what the risks versus the benefits are. They could ask what the likelihood is of this medicine working and what might happen if they do not have the medicine. </p>
<p>Off-label drugs do not have the same medical evidence as licensed drugs and inappropriate use could lead to more side-effects. However, for some people, off-label drugs could be the best or only option and they must receive honest and accurate information about their treatment.</p><img src="https://counter.theconversation.com/content/225715/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dipa Kamdar does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>There is no legal duty to tell a patient they have been prescribed a drug ‘off label’.Dipa Kamdar, Teaching Fellow in Pharmacy Practice, Kingston UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2262232024-03-20T22:21:47Z2024-03-20T22:21:47ZElon Musk says ketamine can get you out of a ‘negative frame of mind’. What does the research say?<p>X owner Elon Musk <a href="https://thenightly.com.au/business/cnbc-elon-musk-suggests-his-prescription-ketamine-use-is-good-for-investors-c-14000709?utm_source=sendgrid&utm_medium=email">recently described</a> using small amounts of ketamine “once every other week” to manage the “chemical tides” that cause his depression. He says it’s helpful to get out of a “negative frame of mind”.</p>
<p>This has caused a range of reactions in the media, including on X (formerly Twitter), from strong support for Musk’s choice of treatment, to allegations he has a drug problem.</p>
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<p>But what exactly is ketamine? And what is its role in the treatment of depression?</p>
<h2>It was first used as an anaesthetic</h2>
<p>Ketamine is a <a href="https://doi.org/10.3389/fnhum.2016.00612">dissociative anaesthetic</a> used in surgery and to relieve pain. </p>
<p>At certain doses, people are awake but are disconnected from their bodies. This makes it useful for paramedics, for example, who can continue to talk to injured patients while the drug blocks pain but without affecting the person’s breathing or blood flow. </p>
<p>Ketamine is also used to sedate animals in veterinary practice. </p>
<p>Ketamine is a mixture of two molecules, usually referred to a S-Ketamine and R-Ketamine.</p>
<p>S-Ketamine, or esketamine, is stronger than R-Ketamine and was approved in 2019 in the United States under the drug name Spravato for serious and long-term <a href="https://doi.org/10.1080/14740338.2022.2066651">depression</a> that has not responded to at least two other types of treatments.</p>
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Read more:
<a href="https://theconversation.com/fda-approves-promising-new-drug-called-esketamine-for-treatment-resistant-depression-111966">FDA approves promising new drug, called esketamine, for treatment-resistant depression</a>
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<p>Ketamine is thought to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6717708/">change chemicals in the brain</a> that affect mood.
While the exact way ketamine works on the brain is not known, scientists think it changes the amount of the neurotransmitter glutamate and therefore changes symptoms of <a href="https://doi.org/10.3389/fnhum.2016.00612">depression</a>. </p>
<h2>How was it developed?</h2>
<p>Ketamine was first synthesised by chemists at the Parke Davis pharmaceutical company in Michigan in the United States as an anaesthetic. It was tested on a group of prisoners at Jackson Prison in Michigan in 1964 and found to be fast acting with <a href="https://pubs.asahq.org/anesthesiology/article/113/3/678/10426/Taming-the-Ketamine-Tiger">few side effects</a>.</p>
<p>The US Food and Drug Administration <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5126726/">approved</a> ketamine as a general anaesthetic in 1970. It is now on the World Health Organization’s core list of essential medicines for health systems worldwide as an <a href="https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02">anaesthetic drug</a>. </p>
<p>In 1994, following patient reports of improved depression symptoms after surgery where ketamine was used as the anaesthetic, researchers began studying the effects of low doses of ketamine on <a href="https://pubmed.ncbi.nlm.nih.gov/8122957/">depression</a>. </p>
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<img alt="Depressed woman looks down" src="https://images.theconversation.com/files/583066/original/file-20240320-16-cf5ntq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/583066/original/file-20240320-16-cf5ntq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/583066/original/file-20240320-16-cf5ntq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/583066/original/file-20240320-16-cf5ntq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/583066/original/file-20240320-16-cf5ntq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/583066/original/file-20240320-16-cf5ntq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/583066/original/file-20240320-16-cf5ntq.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">Researchers have been investigating ketamine for depression for 30 years.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/young-attractive-latin-woman-lying-home-1147331690">SB Arts Media/Shutterstock</a></span>
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<p>The first clinical trial results were <a href="https://www.biologicalpsychiatryjournal.com/article/S0006-3223(99)00230-9/abstract">published in 2000</a>. In the trial, seven people were given either intravenous ketamine or a salt solution over two days. Like the earlier case studies, ketamine was found to reduce symptoms of depression quickly, often within hours and the effects lasted up to seven days. </p>
<p>Over the past 20 years, researchers have studied the effects of ketamine on <a href="https://doi.org/10.1016/j.neuropharm.2022.109305">treatment resistant depression, bipolar disorder</a>, <a href="https://theconversation.com/ketamine-can-rapidly-reduce-symptoms-of-ptsd-and-depression-new-study-finds-216077">post-traumatic sress disorder</a> <a href="https://pubmed.ncbi.nlm.nih.gov/34199023/">obsessive-compulsive disorder, eating disorders and for reducing substance use</a>, with generally positive results. </p>
<p>One study in a <a href="https://www.sciencedirect.com/science/article/pii/S0165032723006110">community clinic</a> providing ketamine intravenous therapy for depression and anxiety found the majority of patients reported improved depression symptoms eight weeks after starting regular treatment.</p>
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Read more:
<a href="https://theconversation.com/ketamine-injections-for-depression-a-new-study-shows-promise-but-its-one-of-many-options-209591">Ketamine injections for depression? A new study shows promise, but it's one of many options</a>
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<p>While this might sound like a lot of research, it’s not. A <a href="https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00304-8/fulltext">recent review</a> of randomised controlled trials conducted up to April 2023 looking at the effects of ketamine for treating depression found only 49 studies involving a total of 3,299 patients worldwide. In comparison, in 2021 alone, there were 1,489 studies being conducted on <a href="https://www.centerwatch.com/articles/25599-oncology-trials-outpacing-rest-of-the-field-in-complexity-and-duration-study-shows#:%7E:text=The%20number%20of%20investigational%20drugs,genetic%20sequencing%20technologies%2C%20CSDD%20says.">cancer drugs</a>. </p>
<h2>Is ketamine prescribed in Australia?</h2>
<p>Even though the research results on ketamine’s effectiveness are encouraging, scientists still don’t really know how it works. That’s why it’s not readily available from GPs in Australia as a standard depression treatment. Instead, ketamine is mostly used in specialised clinics and research centres. </p>
<p>However, the clinical use of ketamine is increasing. <a href="https://www.tga.gov.au/sites/default/files/auspar-esketamine-hydrochloride-210507-pi.pdf">Spravato nasal spray</a> was <a href="https://www.tga.gov.au/resources/auspmd/spravato">approved</a> by the Australian Therapuetic Goods Administration (TGA) in 2021. It must be administered under the <a href="https://adf.org.au/insights/ketamine-treat-depression/">direct supervision</a> of a health-care professional, usually a psychiatrist. </p>
<p>Spravato <a href="https://www.tga.gov.au/resources/auspmd/spravato">dosage</a> and frequency varies for each person. People usually start with three to six doses over several weeks to see how it works, moving to fortnightly treatment as a maintenance dose. The nasal spray <a href="https://www.unsw.edu.au/newsroom/news/2023/10/why-low-cost-ketamine-is-still-inaccessible-to-many-with-severe-">costs</a> <a href="https://www.medicalrepublic.com.au/esketamine-snubbed-by-pbac-again/17835">between A$600 and $900</a> per dose, which will significantly limit many people’s access to the drug. </p>
<p>Ketamine can be prescribed “off-label” by GPs in Australia who can prescribe schedule 8 drugs. This means it is up to the GP to assess the person and their medication needs. But <a href="https://www.medicalrepublic.com.au/caution-as-esketamine-approved-for-depression/4975#:%7E:text=GPs%20and%20other%20clinicians%20can,8%20drug%20poses%20serious%20risks.">experts in the drug</a> recommend caution because of the lack of research into negative side-effects and longer-term effects. </p>
<h2>What about its illicit use?</h2>
<p>Concern about use and misuse of ketamine is heightened by highly publicised deaths connected to the <a href="https://www.pbs.org/newshour/arts/autopsy-report-shows-actor-matthew-perry-died-from-effects-of-ketamine">drug</a>. </p>
<p>Ketamine has been used as a recreational drug since the 1970s. People report it makes them feel euphoric, trance-like, floating and dreamy. However, the amounts used recreationally are typically higher than those used <a href="https://pubmed.ncbi.nlm.nih.gov/16529526/">to treat depression</a>. </p>
<p>Information about deaths due to ketamine is limited. Those that are reported are <a href="https://journals.sagepub.com/doi/10.1177/02698811211021588">due to accidents or ketamine combined with other drugs</a>. No deaths have been reported in <a href="https://pubmed.ncbi.nlm.nih.gov/36410032/">treatment settings</a>.</p>
<h2>Reducing stigma</h2>
<p>Depression is the third leading cause of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6717708/">disability worldwide</a> and effective treatments are needed. </p>
<p>Seeking medical advice about treatment for depression is wiser than taking Musk’s advice on <a href="https://www.washingtonpost.com/wellness/2022/05/04/wellbutrin-elon-musk-antidepressant/">which drugs to use</a>. </p>
<p>However, Musk’s public discussion of his mental health challenges and experiences of treatment has the potential to reduce stigma around depression and help-seeking for mental health conditions. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/ketamine-can-rapidly-reduce-symptoms-of-ptsd-and-depression-new-study-finds-216077">Ketamine can rapidly reduce symptoms of PTSD and depression, new study finds</a>
</strong>
</em>
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<p><em>Clarification: this article previously referred to a systematic review looking at oral ketamine to treat depression. The article has been updated to instead cite a review that encompasses other routes of administration as well, such as intravenous and intranasal ketamine.</em></p><img src="https://counter.theconversation.com/content/226223/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Julaine Allan receives funding from the Australian Government to conduct research on mental health and substance use interventions, treatments and outcomes. </span></em></p>What exactly is ketamine and what is its role in the treatment of depression?Julaine Allan, Associate Professor, Mental Health and Addiction, Rural Health Research Institute, Charles Sturt UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2256382024-03-15T12:09:55Z2024-03-15T12:09:55ZHow meth became an epidemic in America, and what’s happening now that it’s faded from the headlines<figure><img src="https://images.theconversation.com/files/582056/original/file-20240314-20-ipf1yd.jpg?ixlib=rb-1.1.0&rect=163%2C92%2C4570%2C3009&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Police detectives sort through evidence after raiding a suspected meth lab. </span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/UrbanMeth/62442edc986247c08ccfff109e7b07e0/photo?Query=meth%20AND%20rural&mediaType=photo&sortBy=creationdatetime:desc&dateRange=Anytime&totalCount=7&currentItemNo=6">AP Photo/Jeff Roberson</a></span></figcaption></figure><p><em>Rural America has long suffered from an <a href="https://theconversation.com/when-hes-not-on-drugs-hes-a-good-person-one-communitys-story-of-meth-use-and-domestic-violence-176069">epidemic of methamphetamine use</a>, which accounts for <a href="https://news.illinois.edu/view/6367/548454463">thousands of drug overdoses and deaths every year</a>.</em></p>
<p><em>William Garriott, an anthropologist at Drake University, explored meth’s impact on communities and everyday life in the U.S. in his 2011 book “<a href="https://nyupress.org/9780814732403/policing-methamphetamine/">Policing Methamphetamine: Narcopolitics in Rural America</a>.” Since then, the problem has only gotten worse.</em></p>
<p><em>The rural news site <a href="https://dailyyonder.com">the Daily Yonder</a> spoke with Garriott about what has been driving the <a href="https://www.nih.gov/news-events/nih-research-matters/trends-us-methamphetamine-use-associated-deaths">surge in meth use in recent decades</a> and what prompted him to focus on meth in his work. The Conversation has collaborated with The Daily Yonder to share the interview with you.</em></p>
<p><strong>How’d you get interested in methamphetamine as an academic subject?</strong></p>
<p>When I started my Ph.D in anthropology in 2003, I knew I wanted to focus on the Appalachian region of the United States. At the time, I was curious about religious life in the region and its contribution to the growth of Pentecostalism and evangelicalism around the world.</p>
<p>But I had also just taken a course with medical anthropologist Arthur Kleinman. He says that we should seek to understand “<a href="https://tannerlectures.utah.edu/_resources/documents/a-to-z/k/Kleinman99.pdf">what’s at stake</a>” or “<a href="https://global.oup.com/academic/product/what-really-matters-9780195331325?cc=us&lang=en&">what really matters</a>” for people in their everyday lives.</p>
<p>And what really mattered to people in places like eastern Kentucky at the time was drugs. We now know we were at the beginning of the opioid epidemic. OxyContin was already taking a toll on local communities, and there was little national concern because it was seen as an isolated regional problem (the derogatory term “hillbilly heroin” was <a href="https://www.theguardian.com/world/2001/jun/25/usa.julianborger">getting thrown around a lot</a> at the time).</p>
<p>When I started my dissertation research, methamphetamine had become the primary concern, both regionally and nationally. When the <a href="https://www.justice.gov/archive/ll/highlights.htm#%22%22">Patriot Act</a> was reauthorized in 2005, the only significant addition was anti-meth legislation called the <a href="https://www.deadiversion.usdoj.gov/meth/cma2005.html">Combat Meth Epidemic Act</a>.</p>
<p><strong>In what sense was the meth surge of the ’90s and early 2000s a rural phenomenon?</strong></p>
<p>Lots of ways. The internet gave people access to meth recipes, and meth cooks tended to be located in rural areas. It was easier to hide and access key ingredients like <a href="https://www.justice.gov/archive/ndic/pubs13/13853/product.htm">anhydrous ammonia</a>. In fact, the number of meth labs grew so quickly that huge swaths of the rural U.S. were labeled <a href="https://www.jstor.org/stable/10.5816/anthropologynow.5.1.0027">High Intensity Drug Trafficking Areas</a> – something that had only been applied to cities like New York and Los Angeles before.</p>
<p>The rural economy was also changing. Jobs weren’t paying as well or were going away altogether. Meth found a niche as a kind of performance enhancement drug for people working long hours at physically demanding jobs – something <a href="https://nyupress.org/9780814732403/policing-methamphetamine/">I saw</a> in the poultry industry in West Virginia, journalist <a href="https://www.bloomsbury.com/us/methland-9781608192076/">Nick Reding</a> found in the pork industry in Iowa, and anthropologist <a href="https://www.upress.umn.edu/book-division/books/the-alchemy-of-meth">Jason Pine</a> found in general in Missouri. Eventually some folks just left these jobs to work in the meth economy full time.</p>
<p>I think it’s also important to mention how meth was being portrayed in national media as the drug of choice for <a href="https://pubmed.ncbi.nlm.nih.gov/29733233/">poor white people</a>. From there, it doesn’t take much to connect it to rural communities, given how those communities are often thought of as predominantly white and poor in the public imagination.</p>
<p>Anti-meth programs like the <a href="https://montanameth.org/">Montana Meth Project</a> and <a href="https://www.oregonlive.com/pacific-northwest-news/2004/12/the_faces_of_meth.html">Faces of Meth</a> played a big part in this. They were very visual campaigns that focused on the damage meth does to the body. All of the people they pictured appeared to be white. They had sores, scars and sunken eyes. They also were often missing teeth. All of that invokes a lot of stereotypes. Sociologists Travis Linnemann and Tyler Wall have a great <a href="https://journals.sagepub.com/doi/10.1177/1362480612468934">journal article on this</a>.</p>
<p>With all of that said, it is important to keep in mind that meth is just as much an urban and suburban problem as a rural one, particularly now. Sociologist <a href="https://www.rutgersuniversitypress.org/women-on-ice/9780813554594/">Miriam Boeri</a> has made this point really clearly. Also, something to keep in mind about Faces of Meth: It was created by a jail deputy in Oregon who used mugshots of people booked into the county jail. The jail is in Portland, so the folks featured probably weren’t living in rural communities at the time.</p>
<p><strong>Your book was called “Policing Methamphetamine.” I’m curious – what made you zero in on that element of meth culture, its policing?</strong></p>
<p>When I began my research, I thought my focus would be on the treatment experiences of people who use methamphetamine. But what I quickly found was that those experiences couldn’t be understood outside of the criminal justice system. Many people only got treatment after an arrest, and often as a condition of probation. One officer told me that people came up to him on the street and asked to be taken to jail so they could stop using drugs. Community members also often channeled their concerns into calls for increased enforcement.</p>
<p>In retrospect, none of this should have been surprising. U.S. drug policy has long focused on <a href="https://www.britannica.com/topic/war-on-drugs">enforcement</a>. This puts police and the criminal justice system on the front lines whenever and wherever a new drug problem emerges. There is no exception to this dynamic for rural communities. What’s more, the justice system is likely to be the most visible and well-resourced state institution in the community (which is not to say it is sufficiently resourced).</p>
<p><strong>What are the questions you still have about meth in American life?</strong></p>
<p>Today, the most pressing question from my perspective is how meth and opioids are converging. One of the more unfortunate developments is that people have started <a href="https://www.health.state.mn.us/communities/opioids/basics/intravenous.html">injecting meth</a>. There is also the broad contamination of the drug supply with fentanyl.</p>
<p>All of this creates additional public health challenges, particularly in rural communities.</p>
<p>Something else I’m thinking about a lot is what happens when drugs like meth stop making headlines and get replaced by the next drug scourge. Today, people are much more likely to <a href="https://www.texastribune.org/2023/06/19/texas-fentanyl-drugs/">talk about fentanyl than meth</a>. This is understandable given the overdose risks, as well as the way news media works. But what are the consequences of this for the communities where meth is still a major concern?</p>
<p>Bigger picture, I’m thinking about meth in the broader context of U.S. drug policy. My next book is about marijuana legalization and justice reform. It’s been interesting because the conversation around cannabis is so different from the conversation around meth. One of the big questions I have is if the kinds of reforms that are following cannabis legalization will do anything to change the conversation around the broader punitive approach to drugs. <a href="https://www.opb.org/article/2024/03/04/oregon-drug-misdemeanor-new-convictions-arrests/">The debate happening right now in Oregon over Measure 110</a> is something I’m watching very closely. It’s a major test case for whether or not a different, less punitive approach to drugs is possible.</p>
<p><em><a href="https://dailyyonder.com">The Daily Yonder</a> provides news, commentary and analysis about and for rural America. The interview accompanies a five-part series on its <a href="https://open.spotify.com/show/41tCRxV4af8cl7CuJi6NsN?si=868e20efc47142e4">Rural Remix podcast</a>.</em></p><img src="https://counter.theconversation.com/content/225638/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Will Garriott received funding for his meth research from the National Science Foundation. His current work on marijuana legalization and cannabis policy reform has been funded by the Wenner Gren Foundation, Drake University, and the Center for the Humanities at Drake University.
</span></em></p>An anthropologist who wrote a book exploring meth’s impact on rural communities explains what drove the epidemic and how it’s changed.William Garriott, Professor of Law, Politics, and Society, Drake UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2228582024-03-08T13:38:33Z2024-03-08T13:38:33ZAsthma meds have become shockingly unaffordable − but relief may be on the way<figure><img src="https://images.theconversation.com/files/579691/original/file-20240304-18-r33cu5.jpg?ixlib=rb-1.1.0&rect=25%2C51%2C8538%2C5469&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Its price will take your breath away.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/man-using-blue-asthma-inhaler-medication-royalty-free-image/1179346207?">Brian Jackson/Getty Images</a></span></figcaption></figure><p>The <a href="https://www.businessinsider.com/cost-asthma-medication-doubled-unjust-2023-7">price of asthma medication has soared</a> in the U.S. over the past decade and a half. </p>
<p>The jump – in some cases from around <a href="https://doi.org/10.1001/jamainternmed.2015.1665">a little over US$10</a> <a href="https://www.singlecare.com/blog/albuterol-sulfate-hfa-proventil-hfa-without-insurance/">to almost $100</a> for an inhaler – has meant that patients in need of asthma-related products <a href="https://www.businessinsider.com/cost-asthma-medication-doubled-unjust-2023-7">often struggle</a> to buy them. Others simply <a href="https://asthma.net/living/cannot-afford-inhalers">can’t afford</a> them. </p>
<p>To make matters worse, asthma <a href="https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs">disproportionately affects</a> lower-income patients. Black, Hispanic and Indigenous communities have the <a href="https://aafa.org/asthma-allergy-research/our-research/asthma-disparities-burden-on-minorities/">highest asthma rates</a>. They also shoulder <a href="https://aafa.org/asthma-allergy-research/our-research/asthma-disparities-burden-on-minorities/">the heaviest burden</a> of asthma-related deaths and hospitalizations. Climate change will likely <a href="https://www.hsph.harvard.edu/c-change/subtopics/climate-change-and-asthma/">worsen asthma rates</a> and, consequently, these disparities.</p>
<p>I’m a health law professor at <a href="https://www1.villanova.edu/university/law/faculty-scholarship/faculty-directory/profiles/AnaSantosRutschman.html">Villanova University</a>, <a href="https://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=2667484">where I study</a> whether patients can get the medicines they need. And I’ve been watching this affordability crisis closely.</p>
<p>In many ways, it shows what happens when law and policy decisions aren’t aligned with public health needs. The good news, however, is that there finally seems to be some political will to rein in the price of asthma meds.</p>
<h2>Why inhaler prices are skyrocketing</h2>
<p>In 2008, the U.S. Food and Drug Administration <a href="https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/transition-cfc-propelled-albuterol-inhalers-hfa-propelled-albuterol-inhalers-questions-and-answers">banned inhalers</a> that use chlorofluorocarbons, or CFCs – which were once widely used as propellants – because they can damage the ozone layer. The FDA was following a timeline set by an environmental treaty, the <a href="https://www.unep.org/ozonaction/who-we-are/about-montreal-protocol">Montreal Protocol</a>, which the U.S. ratified in the late 1980s. </p>
<p>From 2009 onward, CFC inhalers were phased out and replaced with hydrofluoroalkane, or HFA, ones, which are more environmentally friendly. They’re also a lot pricier. For patients with insurance, the average out-of-pocket cost of an inhaler rose from $13.60 per prescription in 2004 to $25 immediately after the 2008 ban, <a href="https://doi.org/10.1001/jamainternmed.2015.1665">a 2015 study found</a>.</p>
<p>Today, the <a href="https://www.singlecare.com/blog/albuterol-sulfate-hfa-proventil-hfa-without-insurance/">average retail price</a> of an albuterol inhaler is $98. Unlike CFC inhalers, which have <a href="https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs">generic versions</a>, HFA inhalers are <a href="https://www.scientificamerican.com/article/unlikely-victims-of-banning-cfcs/">covered by patents</a>. While <a href="http://doi.org/10.1089/jamp.2016.1297">the drug itself</a> hasn’t changed, the switch to a different device allowed companies to increase their prices.</p>
<p>In 2020, the FDA finally approved the <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm">first generic version</a> of an albuterol inhaler. But generic competition still isn’t robust enough to lower prices meaningfully.</p>
<p>Patients with good insurance <a href="https://allergyasthmanetwork.org/advocacy-updates/united-healthcare-albuterol-epinephrine-cost/">may pay very little</a> or even nothing. But uninsured patients face steep market prices, and as of 2023, there were <a href="https://aspe.hhs.gov/sites/default/files/documents/e06a66dfc6f62afc8bb809038dfaebe4/Uninsured-Record-Low-Q12023.pdf">over 25 million</a> uninsured Americans. <a href="https://www.cdc.gov/asthma/asthma_stats/insurance_coverage.htm">Even insured patients may have trouble</a> affording their asthma meds, the CDC has found. </p>
<p>The same asthma medication for which U.S. patients pay top dollar is available elsewhere at much cheaper prices. Consider the following case for inhalers. The pharmaceutical company Teva sells <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ccd3aaec-4892-40d0-ad60-3e570178fbe1">QVAR RediHaler</a>, a corticosteroid inhaler, <a href="https://doi.org/10.1016/S2213-2600(24)00012-2">for $286</a> in the U.S.</p>
<p>In Germany, Teva sells that same inhaler for $9.</p>
<h2>Seeking meds from Mexico and Canada</h2>
<p>Some U.S. patients have traveled abroad to obtain cheaper asthma medication. After the 2008 ban on CFCs, it became common for patients to <a href="https://doi.org/10.1177/8755122515595052">visit border towns in Mexico</a> to purchase albuterol inhalers. They were sold for <a href="https://doi.org/10.1177/8755122515595052">as little as $3 to $5</a>. </p>
<p>A study of inhalers available to U.S. patients in Nogales, Mexico – about an hour south of Tucson, Arizona – found that Mexican products were <a href="http://doi.org/10.1177/8755122515595052">generally comparable to U.S. inhalers</a>. But researchers found some differences in performance, suggesting that American patients who use them could be getting a slightly different dose than their usual.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Asthma medication is seen on the shelves of a Mexican pharmacy." src="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/580250/original/file-20240306-24-xrc96u.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">Asthma meds are considerably more affordable south of the border.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/the-interior-of-farmacia-san-pablo-news-photo/1041982048">Jeffrey Greenberg/Universal Images Group via Getty Images</a></span>
</figcaption>
</figure>
<p>There have also been reports of Americans turning to Canadian pharmacies to purchase asthma inhalers at much cheaper prices. In one case, a U.S. pharmacy would have charged $857 for a three-month supply. A patient obtained it for <a href="https://www.seattletimes.com/life/wellness/canadian-pharmacy-provided-inhaler-at-a-fraction-of-us-cost/">$134 from a pharmacy in Canada</a>.</p>
<h2>One potential fix: Importing cheaper meds</h2>
<p>U.S. law has long <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/frequently-asked-questions-about-drugs">prohibited</a> personal importation of pharmaceutical drugs. However, a recent development could <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-allow-florida-import-cheaper-drugs-canada-2024-01-05">pave the way for states</a> to import cheaper asthma drugs.</p>
<p>In January 2024, the <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-allow-florida-import-cheaper-drugs-canada-2024-01-05/">FDA authorized</a> the importation of certain prescription drugs from Canada for the first time. <a href="https://www.kff.org/policy-watch/what-to-know-about-the-fdas-recent-decision-to-allow-florida-to-import-prescription-drugs-from-canada/">For now</a>, this authorization is limited to Florida, and it covers only drugs for HIV/AIDS, prostate cancer and certain mental health conditions.</p>
<p>Should it prove successful, the program could serve as a blueprint for other states.</p>
<h2>Another possible solution: Price-capping</h2>
<p>Policymakers could also try borrowing a page from the insulin playbook. Insulin prices <a href="https://doi.org/10.1001/jamanetworkopen.2023.18074">climbed for almost two decades</a> before Congress acted, capping the cost of insulin for Medicare patients. The 2022 <a href="https://www.congress.gov/bill/117th-congress/house-bill/5376/text">Inflation Reduction Act</a> established an out-of-pocket ceiling of $35 per month for prescription-covered insulin products. </p>
<p>If this cap had been in effect two years earlier, it would have saved 1.5 million Medicare patients about $500 annually, <a href="https://www.hhs.gov/about/news/2023/08/16/first-anniversary-inflation-reduction-act-millions-medicare-enrollees-savings-health-care-costs.html">a recent study estimated</a>. It also would have saved Medicare <a href="https://www.hhs.gov/about/news/2023/08/16/first-anniversary-inflation-reduction-act-millions-medicare-enrollees-savings-health-care-costs.html">$761 million</a>.</p>
<p>A similar approach could be taken for asthma meds.</p>
<p>Congress could create an asthma-specific rule similar to the insulin case. Or it could place provisions for asthma-med prices into a larger piece of legislation.</p>
<p>While this approach depends on the political environment, there are signs the government is becoming more willing to act. In January 2024, the U.S. Department of Health and Human Services <a href="https://www.hhs.gov/about/news/2024/01/29/readout-hhs-officials-meeting-private-sector-patient-advocacy-leaders-improve-national-access-important-asthma-medications.html">hosted a meeting</a> to discuss the problem with manufacturers and other stakeholders.</p>
<p>It’s a start. And – together with other measures – it brings some hope that asthma meds might soon become more affordable to those in need.</p><img src="https://counter.theconversation.com/content/222858/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ana Santos Rutschman does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>An inhaler that costs nearly $300 in the US goes for just $9 in Germany. What gives?Ana Santos Rutschman, Professor of Law, Villanova School of LawLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2250662024-03-06T17:58:43Z2024-03-06T17:58:43ZCanadians need to know how much money Big Pharma gives health-care providers, but this information is far too difficult to find<figure><img src="https://images.theconversation.com/files/579973/original/file-20240305-18-ban0k5.jpg?ixlib=rb-1.1.0&rect=310%2C120%2C5216%2C3449&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Patients need to know that treatments are recommended based on patient need, not pharma company interests. That's why it's important to know how much Big Pharma is paying to health-care providers and organizations.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Drug companies often give payments to physicians, other health-care workers and health-care organizations for things like consulting fees, sitting on advisory boards, speaking at sponsored events or funding research, as well as meals and travel expenses. However, in Canada, it’s difficult to know how much was paid to whom.</p>
<p>Prominent on the website of <a href="https://innovativemedicines.ca/about/ethics/">Innovative Medicines Canada</a> (IMC) — the organization that represents the research-based drug companies operating in Canada — is the statement:</p>
<blockquote>
<p>“As part of our commitment to high ethical standards and enhancing trust, Innovative Medicines Canada has developed a Voluntary Framework on Disclosure of Payments made to health-care professionals and organizations.” </p>
</blockquote>
<p>Based on that commitment, starting in 2016, <a href="https://doi.org/10.12927%2Fhcpol.2022.26729">10 companies</a> — fewer than one-quarter of IMC’s members — have been reporting how much in total they gave to doctors and organizations.</p>
<p>In order to maintain faith in the integrity of treatments that doctors and other health-care providers and organizations offer their patients, it’s vital that the public knows that the choice of therapy is based on the patient’s best interest and not on the interest of the company that makes the drug.</p>
<h2>Lack of transparency</h2>
<p>When the disclosures began, the president of IMC said the <a href="https://www.theglobeandmail.com/news/national/canadian-drug-makers-assailed-for-lack-of-transparency-over-payments/article35392284/">revelations were only the first step in increased transparency</a>, and that more companies were expected to disclose payments in the coming years. However, since that time, there has not been an increase in the amount of information disclosed nor in the number of companies participating.</p>
<figure class="align-center ">
<img alt="A person in a business suit shaking hands with someone in a white coat who is holding a box" src="https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.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">Canada’s disclosure guidelines don’t require pharma companies to disclose which doctors and organizations have received payments, or what they have done to earn the money.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>In fact, two companies have stopped disclosing information altogether so now only eight companies out of the 48 that belong to IMC make even these minimum disclosures. Another company has not disclosed payments since 2021. The IMC website still lists 10 participating companies. </p>
<p>The disclosures are not centrally collected by IMC; anyone interested has to hunt around on the individual companies’ websites to find the reports. Of course, there are no penalties for failing to disclose because it’s voluntary.</p>
<p>What do we know from the information that has been disclosed? Over seven years (2016-2022) the 10 disclosing companies gave over $236 million to doctors and almost $213 million to organizations. </p>
<p>Which doctors and organizations have received these payments, what have they done to earn the money? We don’t know, because the disclosures don’t name names or give the specific purpose of the payments. And since names are withheld, the amounts given to individual doctors or organizations are also not available.</p>
<h2>Transparency in other countries</h2>
<p>In asking for the disclosure of so little information, IMC is unique among pharmaceutical industry associations in high-income countries. Disclosure systems in Australia, most European countries, <a href="https://doi.org/10.1186/s12992-022-00902-9">Japan</a>, <a href="https://www.medicinesnz.co.nz/our-industry/transparency-guidelines">New Zealand</a> and the United Kingdom are run by their respective industry associations. In some cases, they are still voluntary and there are also weaknesses in what they reveal — for example individual doctors can opt out of being named.</p>
<p>But they all also require that companies provide far more information than IMC does. The <a href="https://www.efpia.eu/media/413643/efpia_about_disclosure_code_updated-july-2019.pdf">European Federation of Pharmaceutical Industries and Associations</a> requires all member companies to disclose the names of professionals and organizations that have received payments or other transfers of value from them. They have to disclose the total amounts of value transferred by type of activity such as grants, consultancy fees, travel payments and registration fees to attend a medical education congress.</p>
<figure class="align-center ">
<img alt="A person in a white coat out of focus in the background with a prescription bottle in the foreground" src="https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.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">Research has shown that even a $20 meal is enough to influence prescribing behaviour.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>These disclosures can tell us a lot about how companies and health-care professionals interact. In the <a href="https://doi.org/10.1136/bmjopen-2017-016701">four years up to September 2015</a>, 42 Australia-based companies sponsored 116,845 events for health professionals, on average 608 per week with 30 attendees per event. The median cost per event was $263 and over 90 per cent included food and beverages.</p>
<p><a href="https://haiweb.org/wp-content/uploads/2017/03/Sunshine-Act.pdf">France, Denmark, Greece, Romania, Latvia, Italy</a>, <a href="https://www.policymed.com/2017/08/sunshine-act-takes-effect-in-south-korea.html">South Korea</a> and especially the United States with its <a href="https://doi.org/10.1056/NEJMp1305090">Physician Payments Sunshine Act</a> go even further and have legislation making reporting a legal requirement. </p>
<p>The U.S. Sunshine Act mandates that pharmaceutical and medical device companies report gifts or any other transfer of value of US$10 or greater to physicians and teaching hospitals. The types of payments that need to be reported include consulting fees, honoraria, gifts, entertainment, food and beverages, travel and lodging, education, research, charitable contributions, royalties or licenses, ownership or investment interests, speakers’ fees and grants. </p>
<p>All of this information is publicly available in the <a href="https://doi.org/10.1007/s11606-021-06657-0">Open Payments database</a> maintained by the Centers for Medicare and Medicaid Services.</p>
<p>A key feature of the Open Payments database is the requirement for companies to name the product(s) that their payments are tied to. This feature has allowed researchers to examine links between doctors’ payments and prescribing. As a result, we know that a $20 meal — not much more than the price of a Quarter Pounder, fries and a Coke at McDonalds — is <a href="https://doi.org/10.1001/jamainternmed.2016.2765">enough to increase prescribing</a> of the drug(s) made by the company providing the meal.</p>
<p>Ontario was poised to go even further than the Sunshine Act. Before the 2019 election, the government was finalizing regulations for <a href="https://www.ontario.ca/laws/statute/s17025">Bill 160</a>, which would have required that all drug and device manufacturers that provided a “transfer of value” to individual health-care practitioners and health-care organizations, including patient groups, report those transfers to a public registry. The <a href="https://doi.org/10.1503/cmaj.109-5718">election of a Progressive Conservative government</a> killed that initiative.</p>
<p>Canadians deserve more transparency about pharma companies’ payments to health-care providers. Multiple studies, including <a href="https://doi.org/10.1371/journal.pmed.1000352">one that I participated in</a>, have looked at what happens when doctors take payments from drug companies. Their prescribing almost never improves. It either stays the same or, more worrisome, it gets worse. Canadians need to know what Big Pharma is paying to whom, since these payments may not be to the benefit of patients.</p><img src="https://counter.theconversation.com/content/225066/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Between 2020-2024, Joel Lexchin received payments for writing a brief on the role of promotion in generating prescriptions for a legal firm, for being on a panel about pharmacare and for co-writing an article for a peer-reviewed medical journal. He is a member of 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. He is participating in research funded by the Canadian Institutes of Health Research.</span></em></p>Canada has a lack of transparency about Big Pharma’s payments to health-care providers and organizations. Disclosure is voluntary, and there’s no central data on even the few companies that do report.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2235392024-02-27T17:35:27Z2024-02-27T17:35:27ZGovernments must avoid policies that stigmatize those recovering from addiction<p>British Columbia is experiencing an <a href="https://app.powerbi.com/view?r=eyJrIjoiMmIzN2UyYTItNmM0Yi00MGZhLWI1NDUtOTRhZGNjYTBhZDJlIiwidCI6IjZmZGI1MjAwLTNkMGQtNGE4YS1iMDM2LWQzNjg1ZTM1OWFkYyJ9">unprecedented opioid crisis</a>. Drug overdoses are the <a href="https://www.timescolonist.com/bc-news/overdoses-the-leading-cause-of-death-in-bc-for-those-aged-for-10-to-59-coroner-7908352#:%7E:text=Opinion-,Overdoses%20the%20leading%20cause%20of%20death%20in%20B.C.%20for%20those,ten%20months%20of%20this%20year">leading cause of death</a> in the province for those aged 10 to 59. B.C., and all of Canada, are <a href="https://www.canada.ca/en/health-canada/services/substance-use/canadian-drugs-substances-strategy.html">trying hard to help</a> those with substance abuse problems and addictions. </p>
<p>Among the responses are <a href="https://www2.gov.bc.ca/gov/content/overdose/reducing-stigma">calls to destigmatize addiction</a>. Mostly, these calls encourage us to consider how the language we use can stigmatize people struggling with addiction. Language does of course have a powerful impact, but not as powerful as policy.</p>
<p>I am the executive director of a <a href="https://www.fraserhealth.ca/Service-Directory/Services/mental-health-and-substance-use/substance-use/bed-based-treatment-services">bed-based treatment facility</a> in Metro Vancouver. We help people dealing with substance abuse get better. My doctoral research is on addiction stigma. It gives me a unique perspective on the roadblocks to getting out of addiction. </p>
<p>In my work, we often come across B.C. government policies requiring a minimum amount of sobriety, usually a year, before enrolment. Most commonly, these are associated with educational programs for those doing work connected to mental health and addictions. It also occurs in provincial programs aimed at employment or re-training. </p>
<p>We say we want to destigmatize addictions. But if we are refusing to help people in recovery get back to work or school, what are we actually doing?</p>
<h2>Policies discouraging recovery</h2>
<p>These policies <a href="https://doi.org/10.1080/07347324.2021.1917323">stigmatize</a> people in <a href="https://doi.org/10.1080/1556035X.2010.523364">early recovery</a> by essentially telling them they aren’t sober enough to invest in. This discourages them from staying in recovery. We are saying they aren’t good enough and, in some cases, they hear that they’ll <a href="https://doi.org/10.1007/s11673-017-9784-y">never be good enough</a>.</p>
<p>These policies are, in part, about risk aversion. Why put money into helping someone re-train if they are at high risk of relapsing? The average taxpayer may even agree that we should restrict who can access government programs along these lines. However, these policies are <a href="https://doi.org/10.1097/yco.0000000000000351">rooted in stigma</a>. They <a href="https://doi.org/10.1177/0261018319839158">fundamentally change how people experience the programs</a>, and risk aversion does more harm than good.</p>
<p>Let’s say, on average, the policy is that someone needs to be clean and sober for a year before they can access certain government services. This means the people who access the services will generally be pretty successful in completing those programs, considering they already have been sober a year. People get to school or work, agencies get a completion statistic, and we all get to feel good for helping someone get back on their feet. The policy means that people with a year sober get the help they deserve.</p>
<p>It also means <a href="https://doi.org/10.1080/10826080701681473">fewer people</a> will reach that year mark. <a href="https://doi.org/10.1080/10826080802289762">Recovery capital</a> is a concept that says having more support makes overcoming addiction easier. These supports are holistic and can include things like counsellors or mental health supports, but also hobbies, friends, and life fulfilment. School and work are big parts of recovery capital. People in recovery want to <a href="https://doi.org/10.1080/02791072.2018.1517909">feel like they are moving forward</a>. A rolling stone gathers no moss.</p>
<p>If someone is unable to count in their recovery capital the social support and life-meaning that school and work provide, they are less likely to succeed. We weaken people’s recovery capital when we exclude them from pursuing fulfilment. It can mean the difference between someone staying in recovery and <a href="https://doi.org/10.1080/16066359.2022.2039912">going back to their old ways</a>. </p>
<h2>Destigmatizing language</h2>
<p>B.C.’s strategy for destigmatizing addiction focuses on considering the language that we use. Stigmatizing language is damaging. It is mean and <a href="https://doi.org/10.1097/yco.0000000000000351">stops people from asking for help</a>. But part of my doctoral research asks: what is the worst of the worst? The answer I have so far is that stigmatization is at its worst when it <a href="https://doi.org/10.1111/j.1468-2435.1992.tb00776.x">marginalizes an individual</a>.</p>
<p>In terms of addiction and treatment, marginalization means socially separating someone who has nowhere else to go. When someone who has grappled with addiction throughout their entire life makes an effort to break free from its grip, only to encounter rejection, they experience marginalization. They don’t want to go back to addiction, but because of policies on sobriety, they cannot move forward.</p>
<p>Recovery requires <a href="https://www.routledge.com/Addiction-Behavioral-Change-and-Social-Identity-The-path-to-resilience/Buckingham-Best/p/book/9781138934085">re-learning how we see ourselves</a>. It is taking the jump from <a href="https://doi.org/10.3109/16066359.2015.1075980">one life to another</a>. It means getting vulnerable and asking for help. I’ve seen firsthand how important it is for people to feel accepted. It makes sense, considering they are putting themselves out there to start a new life. This feeling of insecurity is something we can all relate to. </p>
<p>We can destigmatize addictions and support people in recovery by creating policies that recognize the <a href="https://doi.org/10.1016/j.drugpo.2022.103609">difference between addictions and recovery</a>. We should not just tell people they are good enough; we should help them see themselves as worthy. </p>
<h2>Find balance in policy</h2>
<p>I’m not saying to completely do away with policies on sobriety requirements that provide structure for government services. There are <a href="https://www.worksafebc.com/en/health-safety/hazards-exposures/substance-use-impairment#:%7E:text=Impairment%20from%20substance%20use%20can,reaction%20time%2C%20and%20sensory%20perception">safety concerns</a> that agencies are not specialized in accommodating. But we need to recognize the impact that these policies have and seek balance. </p>
<p>In my experience, someone with three months of sobriety starting to get back into work or school is just as steadfast in their recovery as someone who has stayed sober for a year. This begs the question of who these policies are actually helping. Is someone who has been sober for months still struggling with addiction? Are we inadvertently marginalizing someone new to recovery by labeling them by their past rather than present? </p>
<p>We should not be afraid to give people in recovery a chance at getting a new life. By reconsidering these policies, we stand a better chance at destigmatizing addiction in a meaningful way. Hopefully, we can even save lives. </p>
<p>If you or someone you know is struggling with substance abuse, <a href="https://www.canada.ca/en/health-canada/services/substance-use/get-help-with-substance-use.html">know that there is help available</a>. Do not be afraid to ask for it.</p><img src="https://counter.theconversation.com/content/223539/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Max Weselowski is affiliated with InnerVisions Recovery Society of BC, a non-profit bed-based treatment provider. He is also affiliated with InnerStart Training & Education, which provides addictions-specific training programs. </span></em></p>Calls to destigmatize language around drug addiction must be combined with action to change policies that stigmatize people in early recovery.Max Weselowski, Doctoral student, College of Interdisciplinary Studies, Royal Roads UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2215042024-02-20T14:27:38Z2024-02-20T14:27:38ZLagos: drugs, firearms and youth unemployment are creating a lethal cocktail in Nigeria’s commercial capital<p>Lagos is the <a href="https://www.statista.com/statistics/1218259/largest-cities-in-africa/#:%7E:text=Lagos%2C%20in%20Nigeria%2C%20ranked%20as,living%20in%20the%20city%20proper.">most populous</a> city in Africa and a regional economic giant, having west Africa’s busiest seaport. It is the centre of commercial and economic activities in Nigeria.</p>
<p>The city’s <a href="https://www.un.org/africarenewal/magazine/april-2019-july-2019/africa%E2%80%99s-megacities-magnet-investors">population</a> is estimated to be 20 million people. The existence of informal settlements makes it difficult to come up with a more precise number.</p>
<p>Lagos has <a href="https://www.african-cities.org/wp-content/uploads/2021/12/ACRC_Lagos_City-Scoping-Study.pdf">grown</a> rapidly since Nigerian independence in 1960, when its estimated population was 763,000 people. In the 1980s, its population reached 2.7 million. The government of Lagos state estimates that <a href="https://insidebusiness.ng/18245/rapid-urbanization-86-migrants-enter-lagos-every-hour-ambode/">86 young migrants</a> arrive every hour.</p>
<p>This rapid urbanisation has been poorly managed. The result is crumbling public infrastructure, poor sanitation, poverty, and shortages of employment opportunities, food, social services, housing and public transport. </p>
<p>These challenges combine to make the city susceptible to criminal activities. Organised crime and violent conflicts are a public safety and security challenge. </p>
<p>The issue of crime has been with Lagos for years. In 1993, the Nigerian government <a href="https://ludi.org.ng/2023/07/10/crime-prevention-through-public-space-design-a-lagos-story/#:%7E:text=The%20rapid%20population%20growth%20without,leading%20to%20high%20crime%20rates.">described</a> Lagos as the “crime capital of the country” with the emergence of the “<a href="https://reliefweb.int/report/nigeria/nigeria-area-boys-growing-menace-streets-lagos">Area Boys</a>”, a group of social miscreants. </p>
<p>The 2017 <a href="https://nigerianstat.gov.ng/elibrary/read/786">statistics</a> on reported crime incidences in Nigeria by the <a href="https://www.nigerianstat.gov.ng/">National Bureau of Statistics</a> shows that Lagos has remained in a class of its own. Lagos State had the highest percentage share of total cases reported with <a href="https://nigerianstat.gov.ng/elibrary/read/786#:%7E:text=Lagos%20State%20has%20the%20highest,205(0.2%25)%20cases%20recorded.">50,975</a> (37.9%) cases recorded. </p>
<p>I have been <a href="https://scholar.google.com/citations?user=jDncA6MAAAAJ&hl=en">researching</a> various aspects of crime and insecurity in Nigeria, particularly in the country’s south-west. I currently lead the <a href="https://www.african-cities.org/">African Cities Research Consortium</a> safety and security domain research in Lagos.</p>
<p>I contributed to a recent <a href="https://www.african-cities.org/wp-content/uploads/2024/02/ACRC_Working-Paper-7_February-2024.pdf#page=26">paper</a> about residents’ experiences and perceptions of safety in six African cities: Nairobi, Bukavu, Freetown, Mogadishu, Lagos and Maiduguri. </p>
<p>My research identified various drivers of insecurity in Lagos. They included youth migration and unemployment; inequality and poverty; the visible network of organised youth criminal groups; proliferation of small arms and drugs; inadequate preparedness of the city government; police corruption; the high rate of out-of-school children; and poor urban planning.</p>
<p>I argue that for residents to feel secure, the government needs to include these drivers in approaches to solving security challenges in Lagos. </p>
<h2>Unemployment, firearms and drugs</h2>
<p>In my African Cities Research Consortium safety and security domain research in Lagos, unemployment and the proliferation of small firearms and drugs stand out as trends. </p>
<p>A <a href="https://medium.com/@olaoyeleye09/navigating-unemployment-in-lagos-nigeria-1a55c2a5e0b5">survey</a> on Navigating Unemployment in Lagos, Nigeria revealed that 48.31% of the respondents were unemployed and the majority were between 25 and 34 years old.</p>
<p>In Lagos, youth of 18-40 years make up about half of the <a href="https://www.urbanet.info/youth-employment-in-lagos/#:%7E:text=In%20Lagos%2C%20youth%20are%20believed,equalling%20over%2010%20million%20people.">population</a>, equalling over ten million people facing high rates of unemployment. I do not have current unemployment data but in its fourth quarter 2020 nationwide survey, the National Bureau of Statistics <a href="https://mepb.lagosstate.gov.ng/wp-content/uploads/sites/29/2022/02/MACRO-ECONS-FLYER-DECEMBER-2021-edition-1.pdf">estimated</a> a 37.14% unemployment rate in Lagos, and 4.52% underemployment rate.</p>
<p>According to my research participants, drug abuse and illicit arms have become serious issues. Some of the city precincts in communities such as Ikorodu, Somolu, Agege, Bariga, Ojo, Oshodi, Mushin and Badagry have become warehouses and destinations for firearms and drugs. </p>
<p>A <a href="https://enactafrica.org/research/ocwar-t/silencing-the-guns-in-cities-urbanisation-and-arms-trafficking-in-bamako-and-lagos">recent survey</a> published by <a href="https://enactafrica.org/research/organised-crime-index#:%7E:text=The%20ENACT%20Africa%20Organised%20Crime,organised%20crime%20across%20the%20continent.&text=The%20ENACT%20Index%20is%20a,organised%20crime%20on%20the%20continent.">ENACT Transnational</a> on organised crime in Africa has shown that between 2010 and 2017, the largest supply of live ammunition transported into Nigeria illegally was intercepted at Lagos. This was made up of 21,407,933 items of live ammunition and 1,100 pump action guns.</p>
<p>Most of the illegal weapons pass through ports in west Africa; some are imported over land borders. While the country’s <a href="https://omaplex.com.ng/an-overview-of-the-gun-regulations-in-nigeria-the-current-stance-and-the-way-forward/">law forbids</a> random possession of firearms, my research respondents say it is surprisingly common for young miscreants to carry firearms in Lagos.</p>
<p>The police have <a href="https://www.premiumtimesng.com/regional/ssouth-west/409520-blacksmith-two-others-arrested-for-illegal-firearms-fabrication.html">confirmed</a> that hooligans acquire illicit firearms from local blacksmiths who make them, and from corrupt security officers. </p>
<p>In 2022, the National Drug Law Enforcement Agency <a href="https://www.thisdaylive.com/index.php/2022/09/23/the-lagos-drug-bust">discovered</a> a warehouse in a residential estate in Ikorodu with 1.8 tonnes of cocaine. This was the largest single cocaine seizure in the country’s history.</p>
<p>In November 2023, security agents <a href="https://leadership.ng/navy-intercepts-boats-with-n200m-illicit-drugs-in-lagos/">intercepted</a> cannabis in Ibeshe, Iworoshoki and Badagry, and in January 2024, the drug law enforcement agency <a href="https://www.premiumtimesng.com/news/top-news/656790-nigerian-authorities-intercept-hard-drugs-from-us-arrest-suspect-official.html">intercepted</a> cannabis at Ikeja.</p>
<h2>Impacts of unemployment, small arms and drugs in Lagos</h2>
<p>Findings from <a href="https://www.african-cities.org/wp-content/uploads/2024/02/ACRC_Working-Paper-7_February-2024.pdf#page=26">my research</a> in Lagos show respondents perceive high levels of violent crime in the city. Youth aged 13 to 40 are mostly the perpetrators.</p>
<p>While there are no accurate statistics of daily violent crime incidences, residents are <a href="https://punchng.com/daredevil-daylight-robbers-return-to-lagos-streets/">complaining</a>. </p>
<p>In 2022, the police <a href="https://securityandsafetymatters.wordpress.com/2022/11/24/lagos-police-says-over-three-hundred-people-brutally-murdered/">reported</a> that no fewer than 345 people were murdered in Lagos – the highest number in years. </p>
<p>Young people have formed themselves into street gangs. My research respondents spoke of violent encounters in which their assailants used firearms and were often under the influence of alcohol or drugs or both. This was the experience of 18 respondents, out of a sample of 50 randomly selected respondents.</p>
<p>Some respondents described street gangs in Lagos who are constantly high on drugs and have no regard for human life. Other respondents said drugs were accessible and affordable even for unemployed youth. Respondents believed that a combination of a large youth population, unemployment and easy access to drugs and illicit firearms was proving deadly.</p>
<h2>Preventing and treating the issues</h2>
<p>The crime triangle in Lagos – youth unemployment, drugs and illicit arms – requires urgent attention. </p>
<p>My study in Lagos shows that a widespread sense of economic hopelessness exacerbates the use of drug and firearms by young people in Lagos. Youth who embrace this culture of violence are those who feel that they have no stake in the city and no trust in the government to provide opportunities for them.</p>
<p>Thus, the state and communities must address the lack of opportunities and alternatives, reaching out to marginalised youth and providing them with an environment in which they can lead a fulfilling life. An effective strategy is one that provides legitimate activities and job opportunities for them. </p>
<p>Government action is required to ensure that opportunities exist for training in a trade or life skill. This would enable youth to make better choices and find productive employment. They could be socially responsible and play an active role in the city rather than becoming a threat in their communities.</p>
<p>Government has the authority to control the supply and use of firearms and drugs. </p>
<p>Special operations should be directed at drug addicts and unlicensed firearms carriers. The approach should be to disrupt the market for illicit arms and drugs. </p>
<p>Security agencies can work with communities to discover new dealing locations and make buyers feel vulnerable and uncomfortable through sting operations – pretending to be dealers or users. </p>
<p>Urban planning approaches could also be applied such as inclusive planning of informal settlements, installation of security cameras and street lighting, limiting access to problematic streets through road changes, removal of transport stops used by drug and firearms users and their dealers, and improved signage.</p><img src="https://counter.theconversation.com/content/221504/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Adewumi I. Badiora 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>Youth migration, unemployment, proliferation of small arms and drugs are some of the drivers of violent crimes in Lagos.Adewumi I. Badiora, Senior Lecturer, Department of Urban and Regional Planning, Olabisi Onabanjo UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2193942024-02-18T19:51:14Z2024-02-18T19:51:14ZTaking expensive medicines or ones unavailable in Australia? Importing may be the answer<figure><img src="https://images.theconversation.com/files/572982/original/file-20240202-17-nh9fym.jpg?ixlib=rb-1.1.0&rect=2%2C1%2C995%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/redhead-nutritionist-working-home-on-laptop-2264305089">shurkin_son/Shutterstock</a></span></figcaption></figure><p>The cost-of-living crisis may be driving some Australians to look for cheaper medicines, especially if those medicines are not subsidised or people don’t have a Medicare card. Options can include buying their medicines from overseas, in a process called
“<a href="https://www.tga.gov.au/products/unapproved-therapeutic-goods/personal-importation-scheme">personal importation</a>”.</p>
<p>Others also use this option to import medicine that is not available in Australia.</p>
<p>Here’s what’s involved and what you need to know about the health and legal risks.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/medicare-turns-40-since-1984-our-health-needs-have-changed-but-the-system-hasnt-3-reforms-to-update-it-217264">Medicare turns 40: since 1984 our health needs have changed but the system hasn't. 3 reforms to update it</a>
</strong>
</em>
</p>
<hr>
<h2>Cost-of-living crisis bites</h2>
<p>Many Australians, particularly those with long-term illnesses, are finding it increasingly hard to afford health care.</p>
<p>The <a href="https://www.abs.gov.au/statistics/health/health-services/patient-experiences/latest-release#barriers-to-health-service-use">Australian Bureau of Statistics</a> reports the proportion of people who delayed or did not see a GP due to cost doubled in 2022-23 (7%) compared with 2021-22 (3.5%). </p>
<p>A <a href="https://australianhealthcareindex.com.au/wp-content/uploads/2022/11/Australian-Healthcare-Index-Report-Nov-22.pdf">survey</a> published in 2022 of over 11,000 people found more than one in five went without a prescription medicine due to the cost. </p>
<p>For those with a Medicare card it’s usually best (and cheapest) to get medicines locally, especially if you also have a concession card. However, for some high-cost medicines, personal importation may be cheaper. That’s when an individual arranges for medicine to be sent to them directly from an overseas supplier.</p>
<p>A 2023 study found <a href="https://www.publish.csiro.au/AH/AH23143?jid=AHv47n6&xhtml=5AA1F839-38C8-45E8-A458-79DCDB7597FB">1.8%</a> of Australians aged 45 or older had imported prescription medicines in the past 12 months. That indicates potentially hundreds of thousands of Australians are importing prescription medicines each year. </p>
<p>Almost half of the survey respondents indicated they would consider importing medicines to save money.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/last-year-half-a-million-australians-couldnt-afford-to-fill-a-script-heres-how-to-rein-in-rising-health-costs-178301">Last year, half a million Australians couldn't afford to fill a script. Here's how to rein in rising health costs</a>
</strong>
</em>
</p>
<hr>
<h2>What’s involved?</h2>
<p>Australia’s drug regulator, the Therapeutic Goods Administration (TGA), allows individuals to import up to three months’ supply of medicines for their own personal use (or use by a close family member) under the <a href="https://www.tga.gov.au/products/unapproved-therapeutic-goods/personal-importation-scheme">personal importation scheme</a>.</p>
<p>This often involves ordering a medicine through an overseas website. </p>
<p>If the medicine would require a prescription in Australia, you must also have a legally valid prescription to import it. </p>
<p>Selling or supplying these medicines to others outside your immediate family is strictly prohibited.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Female doctor looking at computer screen, female patient looking on" src="https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/572985/original/file-20240202-15-68qdfj.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">If the medicine would require a prescription in Australia, you must also have a legally valid prescription to import it.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/consultant-discussing-test-results-patient-284516642">Monkey Business Images/Shutterstock</a></span>
</figcaption>
</figure>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/heres-what-new-60-day-prescriptions-mean-for-you-and-your-hip-pocket-211412">Here's what new 60-day prescriptions mean for you and your hip pocket</a>
</strong>
</em>
</p>
<hr>
<h2>How could this help?</h2>
<p>For some high-cost medicines, personal importation may be cheaper than having the medicine dispensed in Australia. This is most likely for medicines not subsidised by the <a href="https://www.pbs.gov.au/info/about-the-pbs">Pharmaceutical Benefits Scheme</a> (the PBS). People who do not hold a Medicare card may also find it cheaper to import certain medicines as they do not have access to PBS-subsidised medicines.</p>
<p>For example, for people with a specific type of leukaemia, treatment with sorafenib is not covered by the PBS. For these patients it could be up to about ten times more expensive to have their treatment dispensed in Australia as it is to import. That’s because there is a cheaper generic version available overseas.</p>
<p>Personal importation may also allow you to access medicines that are available overseas but are not marketed in Australia.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-we-can-overcome-the-lack-of-treatment-options-for-rare-cancers-83486">How we can overcome the lack of treatment options for rare cancers</a>
</strong>
</em>
</p>
<hr>
<h2>What are the risks?</h2>
<p>All medicines carry risks, and medicine sold online can pose additional dangers. The TGA does not regulate medicines sold overseas, so the safety and quality of such medicines can be uncertain; they may not be produced to <a href="https://www.tga.gov.au/what-tga-regulates">Australian standards</a>. </p>
<p>While similar regulatory agencies exist in other countries, when ordering medicines from overseas websites it can be difficult to determine if the product you are buying has been assessed to ensure it is safe and will do what it says it will do.</p>
<p>The medicines purchased could be counterfeit or “fake”. Products bought through unverified or overseas websites may have undisclosed ingredients, contain a dose that differs from that on the label, or lack the active ingredient entirely. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"842375297823571969"}"></div></p>
<p><a href="https://www.tga.gov.au/importing-therapeutic-goods">Not all medicines</a> can be legally imported through the personal importation scheme. Certain medicines are never allowed to be imported into Australia, and others can only be imported by a medical professional on behalf of a patient. </p>
<p>So if you attempt to import a restricted medicine, the Australian Border Force <a href="https://www.abf.gov.au/entering-and-leaving-australia/can-you-bring-it-in/categories/medicines-and-substances">may seize it</a>. Not only would you lose your medicine, but you could also receive a fine or face <a href="https://www.tga.gov.au/news/blog/can-i-import-medicine-personal-use#:%7E:text=If%20you%20try%20to%20import,a%20fine%20or%20jail%20time.">jail time</a>.</p>
<p>As with any purchase from an overseas business, there is also a risk you may lose your money and you might not be protected by Australian consumer laws. </p>
<p>If you do choose to import medicines by buying them from an overseas website, you should also consider what could happen if delivery is delayed and you don’t get your medicine in time.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-fake-drugs-end-up-in-our-public-health-system-and-how-to-spot-them-73594">How fake drugs end up in our public health system (and how to spot them)</a>
</strong>
</em>
</p>
<hr>
<h2>Where can I get more advice?</h2>
<p>If you are thinking about importing medicines you should first discuss this with a health professional, such as your GP or pharmacist. </p>
<p>They can help you determine if personal importation is permitted for the medicine you need. You can also discuss if this is the best option for you. </p>
<p>If you are having difficulty covering the cost of your medicines your doctor or pharmacist can also explore other potential alternatives to ensure you are receiving the most cost-effective treatment available in Australia.</p>
<h2>Where do I go online?</h2>
<p>If you then decide to import, here are some reputable sites to help navigate the global online medicines market: </p>
<ul>
<li><p><a href="https://everyone.org/">everyone.org</a> helps people everywhere in the world access the latest medicines not available in their own countries</p></li>
<li><p><a href="https://buysaferx.pharmacy/">Alliance for Safe Online Pharmacies</a> is a not-for-profit organisation that collates information on how to find safe online pharmacies based in different regions of the world</p></li>
<li><p><a href="https://www.pharmacychecker.com/accredited-online-pharmacies/">PharmacyChecker</a> has also collated a list of trusted online pharmacies that ship medicines internationally.</p></li>
</ul>
<p>Australian government websites about importing medicines include those from <a href="https://www.tga.gov.au/news/blog/can-i-import-medicine-personal-use">the TGA</a> and on what to consider when buying medicines online from <a href="https://www.healthdirect.gov.au/buying-medicines-online#overseas">overseas</a>.</p><img src="https://counter.theconversation.com/content/219394/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jacinta Lee Johnson is employed as the Senior Pharmacist for Research within SA Pharmacy and is a Board Director for the Society of Hospital Pharmacists of Australia. In the last five years, she has received research funding or consultancy funds (for development and delivery of educational materials) from SA Health, the Medical Research Future Fund, the Hospital Research Foundation – Parkinson's, the Pharmaceutical Society of Australia, the Pharmacy Guild of Australia, the Society of Hospital Pharmacists of Australia, the Australian College of Pharmacy, Mundipharma Pty Ltd, Aspen Pharmacare Australia Pty Ltd, Reckitt Benckiser (Australia) Pty Ltd and Viatris Pty Ltd.</span></em></p><p class="fine-print"><em><span>Kirsten Staff 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>But this comes with legal and health risks. Here’s what you need to know before importing medicine for yourself or your immediate family.Jacinta L. Johnson, Senior Lecturer in Pharmacy Practice, University of South AustraliaKirsten Staff, Senior Lecturer in Pharmacy, University of South AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2230042024-02-11T19:07:40Z2024-02-11T19:07:40ZHILDA survey at a glance: 7 charts reveal we’re smoking less, taking more drugs and still binge drinking<p>Australians’ vices, including drinking, smoking and illicit drugs, have been revealed in the latest <a href="https://melbourneinstitute.unimelb.edu.au/hilda/publications/hilda-statistical-reports">HILDA survey</a>.</p>
<p>The <a href="https://melbourneinstitute.unimelb.edu.au/hilda">Household, Income and Labour Dynamics in Australia survey tracks</a> the same 17,000 Australians each year, with participants followed over the course of their lifetime. The survey collects information on many facets of life and is the only study of its kind in Australia.</p>
<h2>Smoking is declining, but young people are more likely to vape</h2>
<p>There has been substantial progress in reducing smoking rates since 2001, when 25% of males and 20% of females aged 15 and over reported being smokers. In 2021, these rates had dropped to 16% for males and 12% for females. This likely reflects the effects of tobacco control measures, as well as increased public awareness of the harmful health effects of smoking.</p>
<p>Declines have been biggest for young people, which reflects the fact that it is easier to prevent the take-up of smoking than it is to get smokers to quit. Indeed, HILDA shows that over 60% of people who quit smoking take it up again within three years.</p>
<p><iframe id="QZYJ2" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/QZYJ2/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>The progress on reducing smoking appears to have been somewhat offset by the rise in vaping or using e-cigarettes. In 2021, 14.1% of people aged 15 and over reported having tried vaping, and 16% of these people vaped daily.</p>
<p>Vaping is very much a young person’s activity. It is most common among people aged 15 to 24, and also relatively common among people aged 25 to 29. Many people who report vaping also report being smokers.</p>
<p><iframe id="zHKVU" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/zHKVU/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
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<h2>Binge drinking remains common, especially for young men</h2>
<p>Risky drinking, here defined as usually consuming five or more standard drinks on each occasion, is relatively common, applying to over 20% of males and about 10% of females who ever drink alcohol. </p>
<p>After rising slightly between 2003 and 2009, there has since been a small decline in this measure of risky drinking for males. There has been little change in this measure for females. </p>
<p>Another measure of risky drinking, presented in the figure, is “excessive binge drinking”, defined as drinking at least five (if female) or seven (if male) drinks per occasion at least twice per month. This measure of risky drinking is more prevalent, but it has declined for both males and females since 2007.</p>
<p><iframe id="hOh4n" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/hOh4n/2/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>Risky drinking is most common among men aged 20 to 24, followed by men aged 25 to 29. However, for both males and females, <em>regular</em> (but not necessarily “risky”) consumption of alcohol (drinking on five or more days per week) is more common in older age groups, and highest among people aged 60 and over.</p>
<p><iframe id="ORe6u" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/ORe6u/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<hr>
<h2>30 to 34 year-olds had the largest increase in using drugs</h2>
<p>The HILDA survey shows use of illicit drugs, such as marijuana, methamphetamine and cocaine, increased between 2017 and 2021, with annual use increasing from 15.7% to 17.6% for males and from 8.6% to 11% for females.</p>
<p><iframe id="R1Byp" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/R1Byp/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>People aged 20 to 24 are the most likely to use illicit drugs, but the increase in use was greatest for people aged 30 to 34.</p>
<p><iframe id="fTNBL" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/fTNBL/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>The use of multiple types of illicit drugs, known as polydrug use, is common for users of methamphetamine, cocaine and ecstasy, but much less common for users of marijuana.</p>
<p><iframe id="sUmMT" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/sUmMT/1/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/hilda-data-show-womens-job-prospects-improving-relative-to-mens-and-the-covid-changes-might-have-helped-222897">HILDA data show women's job prospects improving relative to men's, and the COVID changes might have helped</a>
</strong>
</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/223004/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Roger Wilkins receives funding from the Australian Research Council.</span></em></p>Some 17,000 people told us exactly how much they drank, smoked and used illicit drugs. Here’s a unique snapshot of Australians’ vices.Roger Wilkins, Professorial Fellow and Deputy Director (Research), HILDA Survey, Melbourne Institute of Applied Economic and Social Research, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2201342024-01-22T13:32:06Z2024-01-22T13:32:06ZAlcohol and drugs rewire your brain by changing how your genes work – research is investigating how to counteract addiction’s effects<figure><img src="https://images.theconversation.com/files/569941/original/file-20240117-21-ycbpim.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C3600%2C1810&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Alcohol and other drugs can overpower the reward pathways of the brain.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/illustration-of-a-brain-cocktail-isolate-don-a-royalty-free-image/1263367270">Simona Dumitru/Moment via Getty Images</a></span></figcaption></figure><p>Many people are wired to <a href="https://www.penguinrandomhouse.ca/books/306396/the-compass-of-pleasure-by-david-j-linden/9780143120759">seek and respond to rewards</a>. Your brain interprets food as rewarding when you are hungry and water as rewarding when you are thirsty. But addictive substances like alcohol and drugs of abuse can <a href="https://doi.org/10.1016/S2215-0366(16)00104-8">overwhelm the natural reward pathways</a> in your brain, resulting in intolerable cravings and reduced impulse control. </p>
<p>A popular misconception is that addiction is a result of low willpower. But an explosion of knowledge and technology in the field of <a href="https://plato.stanford.edu/entries/molecular-genetics/">molecular genetics</a> has changed our basic understanding of addiction drastically over the past decade. The general consensus among scientists and health care professionals is that there is a <a href="https://www.penguinrandomhouse.ca/books/557515/never-enough-by-judith-grisel/9780525434900">strong neurobiological and genetic basis</a> for addiction.</p>
<p>As a <a href="https://scholar.google.com/citations?user=XgunjGkAAAAJ&hl=en">behavioral neurogeneticist</a> <a href="https://www.kaunlab.com">leading a team</a> investigating the molecular mechanisms of addiction, I combine neuroscience with genetics to understand how alcohol and drugs influence the brain. In the past decade, I have seen changes in our understanding of the molecular mechanisms of addiction, largely due to a better understanding of how genes are dynamically regulated in the brain. New ways of thinking about how addictions form have the potential to change how we approach treatment.</p>
<h2>Alcohol and drugs affect brain gene activity</h2>
<p>Each of your brain cells has your genetic code stored in long strands of DNA. For all that DNA to fit into a cell, it needs to be packed tightly. This is achieved by winding the DNA around “spools” of protein <a href="https://www.genome.gov/genetics-glossary/histone">called histones</a>. Areas where DNA is unwound contain active genes coding for proteins that serve important functions within the cell.</p>
<p>When gene activity changes, the proteins your cells produce also change. Such changes can range from a single neuronal connection in your brain to how you behave. This genetic choreography suggests that while your genes affect how your brain develops, <a href="https://theconversation.com/brains-work-via-their-genes-just-as-much-as-their-neurons-47522">which genes are turned on or off</a> when you are learning new things is dynamic and adapts to suit your daily needs.</p>
<p>Recent data from animal models suggests that alcohol and drugs of abuse directly influence <a href="https://doi.org/10.1523/JNEUROSCI.1649-20.2020">changes in gene expression</a> in areas of the brain that help drive memory and reward responses. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/567627/original/file-20240103-29-mcair4.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram magnifying the nucleus of a neuron, showing spirals of DNA wound around bundles of protein" src="https://images.theconversation.com/files/567627/original/file-20240103-29-mcair4.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/567627/original/file-20240103-29-mcair4.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=358&fit=crop&dpr=1 600w, https://images.theconversation.com/files/567627/original/file-20240103-29-mcair4.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=358&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/567627/original/file-20240103-29-mcair4.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=358&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/567627/original/file-20240103-29-mcair4.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=449&fit=crop&dpr=1 754w, https://images.theconversation.com/files/567627/original/file-20240103-29-mcair4.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=449&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/567627/original/file-20240103-29-mcair4.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=449&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Within each neuron in the brain, how tightly DNA is wound around or bound to histones and other proteins determines which genes are expressed and which proteins are produced.</span>
<span class="attribution"><span class="source">Karla Kaun and Vinald Francis</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>There are <a href="https://doi.org/10.1523/JNEUROSCI.1649-20.2020">many ways</a> addictive substances can change gene expression. They can alter which proteins bind to DNA to turn genes on and off and which segments of DNA are unwound. They can change the process of how DNA is read and translated into proteins, as well as alter the proteins that determine how cells use energy to function.</p>
<p>For example, alcohol can cause an alternative form of a gene to be expressed in the memory circuits <a href="https://doi.org/10.1534/genetics.120.303101">in flies</a> <a href="https://doi.org/10.1038/s41598-023-30926-z">and people</a>, resulting in changes in dopamine receptors and transcription factors involved in reward signaling and neuronal function. Similarly, cocaine can cause an alternative form of a gene to be expressed in the <a href="https://doi.org/10.1016/j.neuron.2021.08.008">reward centers</a> <a href="https://doi.org/10.1016/j.biopsych.2017.11.027">of mice</a>, leading them to seek out more cocaine.</p>
<p>Exactly how these drugs cause changes in gene regulation is unknown. However, a direct link between alcohol consumption and changes in gene expression in mice provides a clue. A byproduct of alcohol being broken down in the liver called acetate can cross the blood-brain barrier and <a href="https://doi.org/10.1038/s41586-019-1700-7">unwind DNA from histones</a> in mouse memory circuits. </p>
<p>Alcohol, nicotine, cocaine and opioids also all activate important signaling pathways that are <a href="https://doi.org/10.1111/jnc.12725">central regulators of metabolism</a>. This suggests they can also affect many aspects of neuronal function and consequently affect which genes are expressed.</p>
<h2>Changing brain gene activity with lifestyle</h2>
<p>How addictive substances change cell function is complex. The version of a gene you’re born with can be modified in many ways before it becomes a functional protein, including exposure to alcohol and drugs. Rather than discouraging researchers, this complexity is empowering because it provides evidence that changes to gene expression in your brain aren’t permanent. They can also be altered by medications and lifestyle choices.</p>
<p>Many commonly prescribed medications for mental health disorders also affect gene expression. <a href="https://doi.org/10.1038%2Fs41398-019-0589-0">Antidepressants and</a> <a href="https://doi.org/10.1016/j.jpsychires.2013.05.028">mood stabilizers</a> can change how DNA is modified and which genes are expressed. For example, a commonly prescribed drug for depression called escitalopram affects how tightly wound DNA is and can change the expression of genes important to brain plasticity.</p>
<p>Additionally, <a href="https://theconversation.com/customizing-mrna-is-easy-and-thats-what-makes-it-the-next-frontier-for-personalized-medicine-a-molecular-biologist-explains-216127">mRNA-based therapies</a> can specifically change which genes are expressed to treat diseases like cancer. In the future, we may discover similar therapies for alcohol and substance use disorder. These treatments could potentially target important <a href="https://doi.org/10.1016%2Fj.tins.2021.09.006">signaling pathways linked to addiction</a>, altering how brain circuits function and how alcohol and drugs affect them.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/569945/original/file-20240117-29-n459lb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Close-up of person sitting with crossed legs on a yoga mat, hands resting on knees with pointer finger touching thumb" src="https://images.theconversation.com/files/569945/original/file-20240117-29-n459lb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/569945/original/file-20240117-29-n459lb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/569945/original/file-20240117-29-n459lb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/569945/original/file-20240117-29-n459lb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/569945/original/file-20240117-29-n459lb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/569945/original/file-20240117-29-n459lb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/569945/original/file-20240117-29-n459lb.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">Exercise and other lifestyle choices can affect gene regulation.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/indonesian-woman-is-meditating-in-a-half-lotus-royalty-free-image/1391023941?adppopup=true">Afriandi/Moment via Getty Images</a></span>
</figcaption>
</figure>
<p>Lifestyle choices can also affect gene expression in your brain, though researchers don’t yet know whether they can alter the changes induced by addictive substances. </p>
<p>Like alcohol and drugs, <a href="https://theconversation.com/what-you-eat-can-reprogram-your-genes-an-expert-explains-the-emerging-science-of-nutrigenomics-165867">dietary changes</a> can affect gene expression in many ways. In flies, a high sugar diet can <a href="https://doi.org/10.1126/sciadv.abc8492">reprogram the ability to taste sweetness</a> by tapping into a gene expression network involved in development.</p>
<p><a href="https://doi.org/10.1016/j.cpnec.2022.100152">Intensive</a> <a href="https://doi.org/10.1016/j.psyneuen.2013.11.004">meditation</a>, even after only <a href="https://doi.org/10.1016/j.bbi.2019.11.003">one day</a>, can also affect gene regulation in your brain through similar mechanisms. Attending a <a href="https://doi.org/10.1016/j.cpnec.2022.100152">monthlong meditation retreat</a> reduces the expression of genes that affect inflammation, and experienced meditators can reduce inflammatory genes after just <a href="https://doi.org/10.1016/j.bbi.2019.11.003">one day of intensive meditation</a>. </p>
<p>Work in animal models has also shown that exercise changes gene expression by altering both <a href="https://doi.org/10.1016/j.brainres.2020.147191">histones</a> <a href="https://doi.org/10.1016/j.molmet.2021.101398">and the</a> <a href="https://doi.org/10.1111/j.1460-9568.2010.07508.x">molecular tags</a> directly attached to DNA. This increases the activity of genes important to the activity and plasticity of neurons, supporting the idea that <a href="https://theconversation.com/high-intensity-exercise-improves-memory-and-wards-off-dementia-127001">exercise improves learning and memory</a> and can decrease the risk of dementia.</p>
<p>From <a href="https://doi.org/10.1037/hea0000297">Dry January</a> and beyond, many factors can have profound effects on your brain biology. Taking steps to reduce consumption of alcohol and drugs and picking up healthy lifestyle practices can help stabilize and bring long-lasting benefits for your physical and mental health.</p><img src="https://counter.theconversation.com/content/220134/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Karla Kaun receives funding from the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse and the National Institute of General Medical Sciences.</span></em></p>Improved understanding of the molecular mechanisms of addiction can change how researchers and clinicians approach treatments.Karla Kaun, Associate Professor of Neuroscience, Brown UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2209112024-01-12T20:28:23Z2024-01-12T20:28:23ZHow Ecuador went from being Latin America’s model of stability to a nation in crisis<figure><img src="https://images.theconversation.com/files/568975/original/file-20240111-15-p90s4s.jpg?ixlib=rb-1.1.0&rect=36%2C85%2C8142%2C5371&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Ecuador looks set to entrust its anti-gang fight to the military.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/military-elements-guard-the-car-with-president-of-ecuador-news-photo/1915341584?adppopup=true">Franklin Jacome/Agencia Press South/Getty Images</a></span></figcaption></figure><p><a href="https://english.elpais.com/international/2023-08-13/once-ecuador-was-a-peaceful-country-now-it-is-one-of-the-regions-most-violent.html">Ecuador was until relatively recently</a> seen as <a href="https://www.telesurenglish.net/news/Ecuador-on-Track-to-Become-the-Safest-Country-in-Latin-America-20150621-0009.html">one of the safest countries</a> in Latin America.</p>
<p>That reputation has surely now been destroyed.</p>
<p>On Jan. 9, 2024, images of hooded <a href="https://www.theguardian.com/world/2024/jan/09/ecuador-gangs-wave-terror-state-of-emergency">gunmen storming a TV studio</a> were broadcast around the world. It was one of a number of violent incidents that took place that day, including <a href="https://www.nytimes.com/2024/01/09/world/americas/ecuador-gang-prison-emergency.html">prison riots, widespread hostage-taking</a>, the <a href="https://www.hindustantimes.com/world-news/seven-police-kidnapped-in-ecuador-as-president-declares-security-emergency-101704828141894.html">kidnapping of several police officers</a> and a <a href="https://crisis24.garda.com/alerts/2024/01/ecuador-criminal-groups-launch-attacks-jan-9-following-declaration-of-state-of-emergency-and-curfew-update-3">series of car explosions</a>.</p>
<p>I have been <a href="https://pir.fiu.edu/people/faculty-a-z/eduardo-gamarra1/eduardo-gamarra.html">tracking how gang crime has affected states in Latin America</a> for 38 years. When I started, few would have projected that Ecuador would descend into the crisis it finds itself today. But the story of Ecuador reflects a wider story of how countries across Latin America have struggled with organized crime and transnational drug gangs and how they have responded.</p>
<p>Ecuador now looks set to follow the recent <a href="https://www.washingtonpost.com/world/2023/09/19/bukele-salvador-gang-crackdown/">path of El Salvador under President Nayib Bukele’s leadership</a> in trying to crack the gang problem through the use of military and the suspension of democratic norms. In the aftermath of the Jan. 9 violence, Ecuadorean President Daniel Noboa named 22 gangs as terrorist organizations – a designation that makes them legitimate military targets. He has also <a href="https://www.bbc.com/news/world-latin-america-67930452">imposed a 60-day state of emergency</a>, during which Ecuadorians will be subject to curfews while armed forces try to restore order in the streets and the country’s gang-controlled prisons.</p>
<h2>Ecuador: Victim of geography</h2>
<p>To understand why Ecuador has become the epicenter of gang violence, you need to understand both the geography and history of Latin America’s drug trade.</p>
<p><iframe id="NQYh1" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/NQYh1/2/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>Ecuador, a nation of 18 million people, is situated between Colombia in the north and Peru in the east and south. Colombia and Peru are the <a href="https://www.barrons.com/news/colombia-sets-new-cocaine-production-record-un-832dac7c">two top producers of cocaine in the world</a>. Further, Ecuador has a near-1,400 mile (2,237-kilometer) coastline through which drugs from the continent can be <a href="https://insightcrime.org/investigations/ecuador-a-cocaine-superhighway-to-the-us-and-europe/">taken to markets in Europe and the United States</a>.</p>
<p>But it wasn’t until the <a href="https://www.commondreams.org/news/ecuador-war-on-drugs">U.S.-led “war on drugs</a>” put the squeeze on cartels in other countries that Ecuador became the preserve of narco gangs.</p>
<h2>Plan Colombia</h2>
<p>In the 1980s and 1990s, Colombia was the <a href="https://doi.org/10.1093/acrefore/9780199366439.013.504">center of the international illegal drug trade</a>. This is hardly surprising, given that it was the <a href="https://www.unodc.org/pdf/andean/Andean_report_Part4.pdf">top producer of coca leaves</a>.</p>
<p>But beginning in 2000, a joint initiative between Colombian authorities and the U.S., known as <a href="https://www.americasquarterly.org/fulltextarticle/plan-colombia-a-retrospective/">Plan Colombia</a>, <a href="https://crsreports.congress.gov/product/pdf/R/R43813">pumped billions</a> of dollars into an effort to clamp down on the Colombian cocaine trade.</p>
<p>While it may have been successful in <a href="https://www.usglc.org/media/2017/04/USGLC-Plan-Columbia.pdf">supressing drug cartels</a> in Colombia itself, it has had a balloon effect elsewhere in the region: Squeeze in one place, the bulge appears elsewhere.</p>
<p>In this case, it was Mexico’s cartels that “bulged” first. Over the past decade, there has been a <a href="https://www.cfr.org/backgrounder/mexicos-long-war-drugs-crime-and-cartels">massive growth in Mexican cartels</a>, led by the Sinaloa cartel and the Jalisco Nueva Generación, or Jalisco New Generation. In fact, a study last year found that Mexican cartels were in effect the country’s <a href="https://www.science.org/content/article/cutting-cartel-recruitment-could-be-only-way-reduce-mexico-s-violence">fifth-largest employer</a>.</p>
<p>These cartels came to dominate the illegal drug trade in Latin America, not just for cocaine, but also the trafficking of heroin and more lately fentanyl. Aligning themselves with <a href="https://www.aljazeera.com/news/2022/5/12/terrifying-days-of-terror-under-colombias-gulf-clan-cartel">Clan Del Golfo</a> – a Colombian paramilitary organization formed from the remnants of the gangs dismantled under joint Colombian-U.S. operations – the cartels helped traffic drugs through Ecuador and out of South America.</p>
<p>They were joined by European gangs, <a href="https://www.americasquarterly.org/article/ecuadors-crime-wave-and-its-albanian-connection/">notably from Albania</a>, who began to show up in Ecuador.</p>
<p>The impact locally of these outside gangs has been disastrous for Ecuador.</p>
<h2>Prior immunity</h2>
<p>European and Mexican organizations ran local operatives as enforcers and transporters. And these are the people who have become the backbone of Ecuador’s gang problem today.</p>
<p>Ecuadorian gangs such as <a href="https://insightcrime.org/news/rise-fall-choneros-ecuador-drug-trafficking-pioneers/">Los Choneros</a> developed as a de facto subsidiary of the Sinaloa and other cartels. The <a href="https://www.france24.com/en/americas/20240111-what-we-know-about-fito-ecuador-s-notorious-gang-leader-who-escaped-jail">escape from jail</a> of Los Choneros’ leader, Jose Adolfo Macias, on Jan. 7, 2024, set off the latest explosion of violence. </p>
<figure class="align-center ">
<img alt="A man stands with his hands cuffed behind his back. Two men stand either side of him." src="https://images.theconversation.com/files/568973/original/file-20240111-23-10j7t3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/568973/original/file-20240111-23-10j7t3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=415&fit=crop&dpr=1 600w, https://images.theconversation.com/files/568973/original/file-20240111-23-10j7t3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=415&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/568973/original/file-20240111-23-10j7t3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=415&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/568973/original/file-20240111-23-10j7t3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=521&fit=crop&dpr=1 754w, https://images.theconversation.com/files/568973/original/file-20240111-23-10j7t3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=521&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/568973/original/file-20240111-23-10j7t3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=521&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Police officers arrest a gunman who burst into a studio of the state-owned TC television.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/police-officers-arrest-one-of-the-unidentified-gunmen-who-news-photo/1913161165?adppopup=true">STR/AFP via Getty Images</a></span>
</figcaption>
</figure>
<p>But Ecuador’s descent into violence and chaos has also been aided by the very fact that for so long it was immune from the worst of the gang violence of the region.</p>
<p>For many years, Ecuador had <a href="https://www.economist.com/the-americas/2024/01/10/how-ecuador-became-latin-americas-deadliest-country">one of the lowest homicide rates</a> in Latin America – an indicator of low gang activity. As a result, it hadn’t developed a robust police and military response to gangs. Ecuador, in comparison to Colombia, El Salvador and other countries, was seen as a “soft touch” to organized crime bosses. </p>
<p>This became ever more the case in 2009 when former President Rafael Correa <a href="https://en.mercopress.com/2009/09/19/last-us-forces-abandon-manta-military-base-in-ecuador">closed down the U.S. air base in Manta</a>, from where American AWAC surveillance planes had been monitoring and trying to disrupt drug trafficking.</p>
<h2>Militarizing the response</h2>
<p>Explaining how Ecuador became the epicenter of drug gang violence is one thing. Trying to find a way out for the country now is another.</p>
<p>Across Latin America, countries have employed different models to counter organized crime, with varying degrees of success. Colombia, with extensive U.S. assistance, transformed its military and police and went to war with the cartels. The strategy somewhat successfully dismantled organized crime groups in the country, even if it failed to halt drug trafficking itself or lower the high levels of <a href="https://www.washingtonpost.com/outlook/2021/06/08/us-war-drugs-helped-unleash-violence-colombia-today/">violence in Colombia</a>.</p>
<p>Mexican authorities have tried a different approach and have been reluctant to confront the country’s drug cartels head-on. Instead, Mexico has employed a more hands-off approach, allowing drug gangs to essentially govern their states – the state of Sinaloa is <a href="https://www.brookings.edu/articles/how-the-sinaloa-cartel-rules/">run largely by the cartel</a> that shares its name. </p>
<p>Mexican President Andrés Manuel López Obrador has touted this “<a href="https://www.cfr.org/blog/amlos-hugs-not-bullets-failing-mexico">hugs not bullets</a>” approach, but under it the power of the cartels <a href="https://cbsaustin.com/news/nation-world/mexican-cartels-grow-in-power-and-influence-with-calls-to-change-tactics-in-fighting-back-kidnapping-killings-murders-homicides-matamoros-border-crisis">has only grown</a>.</p>
<p>And then there is the Salvadoran model.</p>
<p>For many years, El Salvador suffered from organized crime, with the <a href="https://www.bloomberglinea.com/english/who-are-the-maras-the-gangs-that-el-salvador-and-honduras-are-waging-war-against/">Maras gang</a> behind much of the country’s violence. Then in 2019 the electorate voted in Nayib Bukele on a law-and-order platform. Since then, he has <a href="https://insightcrime.org/news/gamechangers-2022-el-salvador-gang-crackdown-steep-human-rights-cost/">militarized the country</a>, adopted draconian security measures and <a href="https://apnews.com/article/el-salvador-prison-gangs-bukele-42315f24691e0a3136d005ab7c0bee6a">jailed some 72,000 alleged gang members</a>, often without due process.</p>
<p>As a result, El Salvador is now perceived as <a href="https://www.washingtonpost.com/opinions/2023/09/25/el-salvador-crime-human-rights-prisons/">one of the safest places</a> in Latin America. This has been achieved at the expense of human rights, critics say. But, nonetheless, Bukele’s methods have enormous popular appeal.</p>
<h2>Path of El Salvador</h2>
<p>With an unprecedented wave of violence in Ecuador, it looks like President Noboa is looking to take his country down the same path as El Salvador. He has ordered the Ecuadorian military to “<a href="https://www.france24.com/en/americas/20240109-gunmen-burst-into-ecuador-tv-studio-threaten-journalists-live-on-air">neutralize” the criminal gangs</a> that operate in the country.</p>
<p>Whether the approach will work is another matter; Ecuador is in a weaker position than El Salvador.</p>
<p>Whereas many of the gangs were imported into El Salvador – many members of Maras had been deported from the U.S. – in Ecuador, they are homegrown and have become more sophisticated. Further, Noboa – despite taking office in December – has only 15 months of his presidency left before a <a href="https://www.nytimes.com/2023/08/20/world/americas/ecuador-election-assassination-explainer.html">general election takes place in May 2025</a>. </p>
<p>Yet, the adoption of Bukele’s methods might be seen as an election winner.</p>
<p>Like in El Salvador, the majority of Ecuador’s citizens appear ready for an iron fist approach to counter the gangs – even at the expense of some civil liberties. If you speak to the average Ecuadorian, many would no doubt tell you that talk of human rights violations is bogus at a time when they live under the fear of being murdered simply by leaving their homes.</p>
<p>As one man <a href="https://apnews.com/article/ecuador-violence-prisons-television-studio-gangs-72a3df45debae4459663c462304bcf91">told The Associated Press</a> in the aftermath of Jan. 9’s violence, the government needs to employ “a firmer hand, to have no mercy, no tolerance or (respect for) the human rights of criminals.”</p><img src="https://counter.theconversation.com/content/220911/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Eduardo Gamarra has received funding from foundations, US government agencies, multilateral organizations and private donors. </span></em></p>Widespread violence tied to Ecuadorian drug gangs has left the country looking at a draconian response.Eduardo Gamarra, Professor of Politics and International Relations, Florida International UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2151992024-01-04T13:45:37Z2024-01-04T13:45:37ZDrugs of the future will be easier and faster to make, thanks to mRNA – after researchers work out a few remaining kinks<figure><img src="https://images.theconversation.com/files/567750/original/file-20240103-21-2oxdyb.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2448%2C1224&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Two hurdles mRNA drugs face are a short half-life and impurities that trigger immune responses.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/on-white-background-royalty-free-image/1411871727">BlackJack3D/iStock via Getty Images Plus</a></span></figcaption></figure><p>Vaccines have been reliably and affordably protecting people from diseases worldwide <a href="https://theconversation.com/from-smallpox-to-polio-vaccine-rollouts-have-always-had-doubters-but-they-work-in-the-end-161803">for centuries</a>. Until the COVID-19 pandemic, however, vaccine development was still a long and idiosyncratic process. Traditionally, researchers had to tailor manufacturing processes and facilities for each vaccine candidate, and the scientific knowledge gained from one vaccine was often not directly transferable to another. </p>
<p>But the COVID-19 mRNA vaccines brought a new approach to vaccine development that has far-reaching implications for how researchers make drugs to treat many other diseases. </p>
<p><a href="https://scholar.google.com/citations?user=C49y7YQAAAAJ&hl=en">I am a biochemist</a>, and <a href="https://www.umassmed.edu/LiLab/">my lab</a> at UMass Chan Medical School focuses on developing better ways to use mRNA as a drug. Although there are <a href="https://theconversation.com/customizing-mrna-is-easy-and-thats-what-makes-it-the-next-frontier-for-personalized-medicine-a-molecular-biologist-explains-216127">many possibilities</a> for what researchers can use mRNA to treat, some important limitations remain. Better understanding how mRNA-based drugs interact with the immune system and how they are degraded in human cells can help lead to safe, durable and effective treatments for a wide range of diseases.</p>
<h2>Some basics of mRNA drugs</h2>
<p>Messenger RNA, or mRNA, is made of four building blocks denoted by the letters A, C, G and U. The sequence of letters in an mRNA molecule conveys genetic information that directs how a protein is made. </p>
<p>An mRNA drug comprises two essential components: mRNA molecules, which code for desired proteins, and the lipid molecules – such as phospholipids and cholesterol – that encapsulate them. These <a href="https://doi.org/10.1016/j.jconrel.2015.08.007">mRNA-lipid nanoparticles, or LNPs</a>, are tiny spheres <a href="https://doi.org/10.1016/j.ymthe.2017.03.013">about 100 nanometers in diameter</a> that protect mRNA from degradation and facilitate its delivery into target cells. </p>
<p>Once inside cells, mRNA molecules instruct the cell’s machinery to produce the target protein required for a desired therapeutic effect. For example, the mRNA in the Pfizer-BioNTech and Moderna <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">COVID-19 vaccines</a> directs cells to produce a harmless version of the virus’ spike protein that trains the immune system to recognize and better prepare for potential infection. </p>
<figure>
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<figcaption><span class="caption">The science behind COVID-19 mRNA vaccines has been decades in the making.</span></figcaption>
</figure>
<p>From a drug development perspective, mRNA drugs offer significant advantages over traditional drugs because they are <a href="https://theconversation.com/customizing-mrna-is-easy-and-thats-what-makes-it-the-next-frontier-for-personalized-medicine-a-molecular-biologist-explains-216127">easily programmable</a>. Hundreds of pounds of mRNA can be made from readily available DNA templates, such that producing a different mRNA drug is as simple as changing the corresponding DNA templates. </p>
<p>More importantly, different mRNA drugs produced by the same set of methods will have similar properties. They will be delivered to the same tissues, trigger similar levels of immune responses and degrade in similar ways. This predictability significantly reduces the development risks and financial costs of developing mRNA drugs.</p>
<p>In addition to being easy to program, mRNA drugs have several other unique properties. For example, just like the mRNAs your body naturally produces, therapeutic mRNAs have a short half-life in cells: <a href="https://doi.org/10.1016%2Fj.jconrel.2015.08.007">about one day</a>. As a result, current mRNA technology is ideal for treatments that aren’t meant to last long in the body. </p>
<p>This is why vaccines are popular candidates for mRNA technology: They provide long-term protection against disease after brief exposure to the drug with few side effects. There are currently <a href="https://www.mdpi.com/1422-0067/24/3/2700">more than 30 mRNA vaccine candidates</a>, not including vaccines for COVID-19, in clinical trials.</p>
<h2>Self vs. nonself</h2>
<p>Another critical feature of mRNA drugs is their intrinsic ability to stimulate the immune system. This may sound paradoxical – after all, your cells already contain large amounts of mRNAs. Why would other mRNAs activate your immune system? How does your immune system distinguish between self and nonself mRNAs?</p>
<p>The first reason involves location. Therapeutic mRNAs enter cells using endosomes – sacs made of the cell’s membrane that take in materials from the cell’s environment. Your immune system can detect mRNA in endosomes because this is usually a sign of an RNA virus infection – cellular mRNAs normally don’t enter endosomes. When your immune system labels therapeutic mRNAs as viral material, it triggers <a href="https://doi.org/10.1016/j.immuni.2005.06.008">a strong inflammatory response</a> that can lead to severe side effects. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/567748/original/file-20240103-25-lqiluh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram showing molecules entering a depression in the cell membrane which closes off to form a sac" src="https://images.theconversation.com/files/567748/original/file-20240103-25-lqiluh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/567748/original/file-20240103-25-lqiluh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/567748/original/file-20240103-25-lqiluh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/567748/original/file-20240103-25-lqiluh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/567748/original/file-20240103-25-lqiluh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/567748/original/file-20240103-25-lqiluh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/567748/original/file-20240103-25-lqiluh.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">Endocytosis is the process by which material outside the cell, such as mRNA molecules, is engulfed within the cell.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/endocytosis-process-cells-absorb-external-royalty-free-illustration/1621615509">alfa md/iStock via Getty Images Plus</a></span>
</figcaption>
</figure>
<p>One solution to this problem is to modify mRNA’s building blocks – specifically, changing the U, or uridine, to its chemical cousins, <a href="https://doi.org/10.1016/j.immuni.2005.06.008">pseudouridine</a> and <a href="https://doi.org/10.1016/j.jconrel.2015.08.051">N1-methylpseudouridine</a>. This subtle chemical change prevents the unwanted immune response while allowing the therapeutic mRNA to <a href="https://doi.org/10.1038%2Fmt.2008.200">direct the cell to make the protein it encodes</a>. The <a href="https://theconversation.com/tenacious-curiosity-in-the-lab-can-lead-to-a-nobel-prize-mrna-research-exemplifies-the-unpredictable-value-of-basic-scientific-research-214770">2023 Nobel Prize in physiology or medicine</a> was awarded to the scientists who made this breakthrough discovery. Both the Pfizer-BioNTech and Moderna <a href="https://doi.org/10.1021/acscentsci.1c00197">COVID-19 mRNA vaccines</a> use this technique.</p>
<p>The second source of unwanted immune response is impurities from mRNA production. To prepare mRNA from a DNA template, scientists use a protein called <a href="https://www.nature.com/scitable/definition/rna-polymerase-106/">RNA polymerase</a> that tends to make a small amount of side product called <a href="https://doi.org/10.1093/nar/gkr695">double-stranded RNA</a>. Unlike mRNA, which is single-stranded, double-stranded RNA has two chains that form a double helix. RNA viruses also form double-stranded RNA when they replicate, and exposing cells to double-stranded RNA can lead to a strong immune response.</p>
<p>Removing double-stranded RNA is challenging, especially at the industrial scale. Fortuitously, for mRNA vaccines, the residual amount of double-stranded RNA can stimulate the immune system to <a href="https://doi.org/10.1038/s41590-022-01163-9">enhance antibody responses</a>. However, for applications other than vaccines, a cleaner RNA product is necessary to reduce side effects.</p>
<h2>Moving beyond vaccines</h2>
<p>Although mRNA has the potential to transform drug development for various medical purposes, careful consideration is required to identify targets that align with the technology’s strengths.</p>
<p>For example, because there is currently a limit to how long mRNA can last in the body, treatments that need a protein to be present for only a short period of time to achieve a lasting therapeutic effect are ideal. One promising example in development is using mRNA that encodes CRISPR-Cas9 gene-editing proteins to knock out genes that cause specific diseases.</p>
<p>Researchers are exploring this strategy to develop a single-dose treatment for <a href="https://doi.org/10.1056/NEJMoa2107454">hereditary transthyretin amyloidosis</a>, a rare genetic disease caused by the accumulation of misfolded proteins in the heart and nerves. This disease is an ideal target for mRNA-based CRISPR gene therapy because the target protein is produced by the liver. Because most drugs pass through the liver, this makes it easier to deliver CRISPR-Cas9 mRNA to its target. In the next few years, a new generation of more precise <a href="https://doi.org/10.1038/d41586-023-03797-7">mRNA-based genome editing therapies</a> will enter clinical trials.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/567751/original/file-20240103-17-vch2ou.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Microscopy image of SARS-CoV-2 virus particles lining the a few vesicles in a cell" src="https://images.theconversation.com/files/567751/original/file-20240103-17-vch2ou.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/567751/original/file-20240103-17-vch2ou.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=449&fit=crop&dpr=1 600w, https://images.theconversation.com/files/567751/original/file-20240103-17-vch2ou.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=449&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/567751/original/file-20240103-17-vch2ou.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=449&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/567751/original/file-20240103-17-vch2ou.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=564&fit=crop&dpr=1 754w, https://images.theconversation.com/files/567751/original/file-20240103-17-vch2ou.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=564&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/567751/original/file-20240103-17-vch2ou.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=564&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Because the virus that causes COVID-19 (gold) and other RNA viruses enter cells through endosomes, mRNA drug impurities can elicit similar immune responses.</span>
<span class="attribution"><a class="source" href="https://flic.kr/p/2mrqrnx">NIAID/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>For treatments that need a specific protein to be present in the body for long periods of time or need to prompt little to no immune reaction, further advancements in mRNA technology are necessary to extend mRNA’s half-life and eliminate immune-triggering contaminants. Notable new developments in these areas include using <a href="https://doi.org/10.1101/2021.03.29.437587">computational algorithms</a> to optimize mRNA sequences in ways that enhance their stability and <a href="https://doi.org/10.1038/s41587-022-01525-6">engineering RNA polymerases</a> that introduce fewer side products that may cause an immune response. </p>
<p>Further advancements have the potential to enable a new generation of safe, durable and effective mRNA therapeutics for applications beyond vaccines.</p><img src="https://counter.theconversation.com/content/215199/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Li Li receives funding from NIH. </span></em></p>The COVID-19 pandemic demonstrated the promise of using mRNA as medicine. But before mRNA drugs can go beyond vaccines, researchers need to identify the right diseases to treat.Li Li, Assistant Professor of Biomedical Sciences, UMass Chan Medical SchoolLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2200642023-12-20T14:01:10Z2023-12-20T14:01:10ZGeneration X hardest hit as drug deaths rise yet again in England and Wales<figure><img src="https://images.theconversation.com/files/566838/original/file-20231220-18278-uaocdf.jpg?ixlib=rb-1.1.0&rect=26%2C53%2C4422%2C2921&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/drug-syringe-cooked-heroin-on-spoon-355085264">one photo/Shutterstock</a></span></figcaption></figure><p>It’s another tragic record. A new report has confirmed yet another rise in drug related deaths in <a href="https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2022registrations#drug-poisonings-in-england-and-wales">England and Wales</a>. The Office for National Statistics (ONS) reports that 4,907 “drug poisoning” deaths were recorded in 2022 (84.4 deaths per 1,000,000 of the population), the highest on record.</p>
<p>While there was a slight fall in deaths in men (from 3,275 in 2021 to 3,240 in 2022), this was masked by a corresponding increase in women (from 1,584 in 2021 to 1,667 in 2022). This reflects a longer term trend of females catching up with male mortality. Drug-related suicides, <a href="https://sites.manchester.ac.uk/ncish/reports/annual-report-2023/">a topic that doesn’t usually receive much attention</a> in discussions about drug-related harms, were also higher in women than men. </p>
<p>Most deaths involved multiple substances, however opiates were detected in just under half of all deaths (2,261 cases). </p>
<p>Of concern are cocaine deaths (857 cases), which have now increased for 11 consecutive years. It’s not possible to determine whether these related to use of powder or crack cocaine. But we know there’s been an increase in the use of cocaine as well as a boost in the <a href="https://www.emcdda.europa.eu/publications/eu-drug-markets/cocaine_en">global production, supply, purity, affordability and availability</a> of the drug, despite frequent <a href="https://www.nationalcrimeagency.gov.uk/news/seven-men-charged-in-national-crime-agency-investigation-into-140m-cocaine-seizure">large seizures</a> by law enforcement agencies.</p>
<p>Cocaine has become more potent and more affordable in recent years. Both factors increase the risk of harm including fatal overdose. We’ve also lagged behind developing support for people who use cocaine compared to those who use opioids.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/566840/original/file-20231220-27-vu9xne.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Actor Matthew Perry, who died of a ketamine overdose." src="https://images.theconversation.com/files/566840/original/file-20231220-27-vu9xne.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/566840/original/file-20231220-27-vu9xne.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=879&fit=crop&dpr=1 600w, https://images.theconversation.com/files/566840/original/file-20231220-27-vu9xne.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=879&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/566840/original/file-20231220-27-vu9xne.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=879&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/566840/original/file-20231220-27-vu9xne.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1105&fit=crop&dpr=1 754w, https://images.theconversation.com/files/566840/original/file-20231220-27-vu9xne.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1105&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/566840/original/file-20231220-27-vu9xne.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1105&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Actor Matthew Perry died after taking ketamine.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/los-angeles-aug-01-matthew-perry-71462893">DFree/Shutterstock</a></span>
</figcaption>
</figure>
<p>Surprisingly, despite its popularity <a href="https://www.ons.gov.uk/peoplepopulationandcommunity/crimeandjustice/articles/drugmisuseinenglandandwales/yearendingmarch2023">in recreational settings</a>, ketamine is not included in the data – and it is unclear why. <a href="https://pubmed.ncbi.nlm.nih.gov/34092131/">Other research</a> suggests there are around 30 deaths each year in England, which is lower than the number of ecstasy deaths (50 in 2022), despite <a href="https://www.thetimes.co.uk/article/how-ketamine-became-the-uks-hidden-campus-killer-9mp3pm6ht">being used by more people</a>. </p>
<p>As for fentanyl, there were <a href="https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates#:%7E:text=Overall%2C%20drug%20overdose%20deaths%20rose,overdose%20deaths%20reported%20in%202021.">tens of thousands of deaths</a> in the US each year. However, in England and Wales these have remained low (57) and stable. </p>
<p>That’s reassuring, but it’s important not to be complacent. There has been recent concern about the emergence of other types of <a href="https://www.gov.uk/government/news/synthetic-opioids-will-be-banned-as-government-acts-to-stop-drug-deaths">even more potent opioids</a>, with many experts predicting that these drugs will become more prevalent if opium production in Afghanistan <a href="https://www.vice.com/en/article/7kxw3b/the-talibans-opium-ban-has-become-an-existential-problem-for-the-west">continues to decline</a> – leading to fears of even greater increases in drug deaths. </p>
<p>There were also sharp geographical differences in death rates, with those in more deprived areas in the north east and north west of England much higher than other areas. While there were higher rates of <a href="https://www.gov.uk/government/publications/opiate-and-crack-cocaine-use-prevalence-estimates/estimates-of-opiate-and-crack-use-in-england-main-points-and-methods">opioid and crack use</a> in these regions, this also <a href="https://www.health.org.uk/news-and-comment/charts-and-infographics/male-healthy-life-expectancy-from-birth">reflects wider health and social inequalities</a>.</p>
<h2>Age as a risk factor</h2>
<p>The highest rate of deaths occurred in the 40- to 49-year-old age group, and the average age at death continued to rise. This is mainly the “Generation X” cohort born in the 1970s, who came of age when there was a rapid rise in the availability of heroin, and when general population rates of drug use were at their highest in the 1990s. </p>
<p>These premature deaths reflect <a href="https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/addiction-health">poorer</a> physical and psychological health, such as compromised respiratory and cardiovascular functioning, which increases the risk of dying from drugs. Many of these health problems could be <a href="https://www.emcdda.europa.eu/publications/topic-overviews/prevention-drug-related-deaths_en">treated</a> if people accessed health services, but unfortunately too few do – adding to the risk of premature death. </p>
<p>The data doesn’t reveal everything though. It is also possible that coroners may record a physical health issue as the cause of death, rather than use of drugs. This adds to an <a href="https://backup.ons.gov.uk/wp-content/uploads/sites/3/2018/08/Drug-related-deaths-deep-dive-into-coroners-records.pdf">underestimation</a> of the number of people dying from drugs.</p>
<p>Synthetic opioids, implicated in <a href="https://www.bbc.co.uk/news/uk-67589364">local spikes in deaths</a>, aren’t fully captured in the latest ONS figures either. This is because there are <a href="https://theconversation.com/drug-deaths-in-england-and-wales-rise-for-eighth-consecutive-year-145498">delays</a> between when a death occurs, when it is officially recorded by the coroner and when it is included in ONS reports. The latest report includes deaths which occurred in 2021 and 2022, and even as far back as 2017. </p>
<p>While rapid response investigatory panels have been set up in some local areas, these continuing delays hinder rapid assessment of threats to public health. </p>
<p>It may seem paradoxical that overall drug use is <a href="https://www.ons.gov.uk/peoplepopulationandcommunity/crimeandjustice/articles/drugmisuseinenglandandwales/yearendingmarch2023#:%7E:text=1.-,Main%20points,(around%201.1%20million%20people).">declining</a> while drug-related deaths are rising. But this can be explained by the time taken to develop dependent use of drugs and the accompanying problems and risk to health. </p>
<h2>Reversing fatalities</h2>
<p>The government commissioned Dame Carol Black to advise on how the record number of drug related deaths could be reversed. <a href="https://www.gov.uk/government/publications/review-of-drugs-phase-two-report">Her report</a>, published in 2020 and 2021, provided several suggestions including increasing investment in drug treatment which the government has accepted. </p>
<p>While provision of evidence-based drug treatment reduces the risk of death, increased investment will take time to have an impact. It comes after a decade of austerity, which severely affected provision of drug services. Currently, only about <a href="https://fingertips.phe.org.uk/search/drug">half of people</a> who might benefit from formal support are accessing treatment services. </p>
<p>There is no single intervention that will reduce death rates, and the complex profile of the illicit drug market and the cocktail of drugs implicated in deaths means that a whole systems response is required. Most importantly, recent uplifts in funding of treatment services need to be maintained. This will be challenging given the economic pressure on public services. </p>
<p>The priority should be an increase in the community provision of <a href="https://theconversation.com/uk/topics/naloxone-7974">naloxone</a>, the opioid overdose reversal drug. This can already be distributed through drug services, and an increasing number of <a href="https://www.bbc.co.uk/news/uk-england-beds-bucks-herts-66293181">police officers</a> are also carrying it. Supervised drug consumption facilities, such as the one due to be <a href="https://www.bbc.co.uk/news/uk-scotland-scotland-politics-66796575">trialled</a> in Glasgow in 2024 <a href="https://www.emcdda.europa.eu/publications/technical-reports/drug-consumption-rooms_en">may reduce</a> risks in some more vulnerable groups, including those who are experiencing street homelessness.</p>
<p>City-based <a href="https://www.crew.scot/the-scottish-drug-checking-project/">drug checking services</a> and local early warning systems can also help to identify the local emergence of harmful substances. The government is also <a href="https://www.gov.uk/government/news/5-million-fund-to-tackle-fatal-drug-deaths-across-the-uk#:%7E:text=As%20part%20of%20the%20Reducing,in%20potential%20drug%2Drelated%20deaths.">funding pilot projects</a> that may provide technological and data driven innovations. </p>
<p>There remains a worrying lack of innovation in the response to non-opioid drugs such as benzodiazepines (544 deaths this year). Considering the high proportion of deaths attributed to long-term health conditions, it is essential that we continue to break down barriers to accessing timely healthcare in all its forms, including <a href="https://www.antistigmanetwork.org.uk/home">stigma</a> and poor quality care.</p><img src="https://counter.theconversation.com/content/220064/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Harry Sumnall receives and has received funding from public grant awarding bodies for alcohol and other drugs research, and consultation fees from (international) not for profit and government Ministries for consultation work. He is an unpaid member of the Scientific Advisory Board of the Mind Foundation. </span></em></p><p class="fine-print"><em><span>Ian Hamilton does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Women are catching up with men’s drug use.Ian Hamilton, Honorary Fellow, Department of Health Sciences, University of YorkHarry Sumnall, Professor in Substance Use, Liverpool John Moores UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2195722023-12-14T13:10:22Z2023-12-14T13:10:22ZCRISPR and other new technologies open doors for drug development, but which diseases get prioritized? It comes down to money and science<figure><img src="https://images.theconversation.com/files/565611/original/file-20231213-19-56i402.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2070%2C1449&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">So many diseases to treat, so little money and time.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/covid-19-vaccine-loop-royalty-free-image/1288570747">Andriy Onufriyenko/Moment via Getty Images</a></span></figcaption></figure><p>Prescription drugs and vaccines revolutionized health care, dramatically decreasing death from disease and improving quality of life across the globe. But how do researchers, universities and hospitals, and the pharmaceutical industry decide which diseases to pursue developing drugs for?</p>
<p>In <a href="https://scholar.google.com/citations?user=lWAD9d8AAAAJ&hl=en">my work</a> as director of the <a href="https://pharmacy.uconn.edu/hopes/">Health Outcomes, Policy, and Evidence Synthesis</a> group at the University of Connecticut School of Pharmacy, I assess the effectiveness and safety of different treatment options to help clinicians and patients make informed decisions. My colleagues and I study ways to create new drug molecules, deliver them into the body and improve their effectiveness while reducing their potential harms. Several factors determine which avenues of drug discovery that people in research and pharmaceutical companies focus on.</p>
<h2>Funding drives research decisions</h2>
<p>Research funding amplifies the pace of scientific discovery needed to create new treatments. Historically, <a href="https://doi.org/10.1001/jamahealthforum.2023.1921">major supporters of research</a> like the National Institutes of Health, pharmaceutical industry and private foundations funded studies on the most common conditions, like heart disease, diabetes and mental health disorders. A <a href="https://doi.org/10.18553%2Fjmcp.2022.28.7.732">breakthrough therapy</a> would help millions of people, and a small markup per dose would generate hefty profits.</p>
<p>As a consequence, research on rare diseases was not well-funded for decades because it would help fewer people and the costs of each dose had to be very high to turn a profit. Of the <a href="https://www.fda.gov/patients/rare-diseases-fda">more than 7,000 known rare diseases</a>, defined as <a href="https://rarediseases.info.nih.gov/about">fewer than 200,000 people affected</a> in the U.S., <a href="https://www.ncbi.nlm.nih.gov/books/NBK56187/">only 34 had a therapy approved</a> by the Food and Drug Administration before 1983.</p>
<p>The passage of the <a href="https://doi.org/10.1371%2Fjournal.pmed.1002191">Orphan Drug Act</a> changed this trend by offering tax credits, research incentives and prolonged patent lives for companies actively developing drugs for rare diseases. From 1983 to 2019, <a href="https://doi.org/10.1186/s13023-021-01901-6">724 drugs</a> were approved for rare diseases.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Person sluicing a bucket of ice water over another person's head" src="https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.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>
<figcaption>
<span class="caption">The viral ALS ice bucket challenge in 2014 was a fundraising success.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/IceBucketChallenge/4dd78b9ab4044aef8a09a6f7d688b168">Elise Amendola/AP Photo</a></span>
</figcaption>
</figure>
<p>Emerging social issues or opportunities can significantly affect funding available to develop drugs for certain diseases. When COVID-19 raged across the world, funding from <a href="https://www.nationaldefensemagazine.org/articles/2023/9/19/learning-lessons-from-mrap-operation-warp-speed">Operation Warp Speed</a> led to vaccine development in record time. Public awareness campaigns such as the <a href="https://www.npr.org/2022/10/01/1126397565/the-ice-bucket-challenge-wasnt-just-for-social-media-it-helped-fund-a-new-als-dr">ALS ice bucket challenge</a> can also directly raise money for research. This viral social media campaign provided 237 scientists <a href="https://www.als.org/stories-news/ice-bucket-challenge-dramatically-accelerated-fight-against-als#">nearly US$90 million</a> in research funding from 2014 to 2018, which led to the discovery of five genes connected to amyotrophic lateral sclerosis, commonly called Lou Gehrig’s disease, and new clinical trials.</p>
<h2>How science approaches drug development</h2>
<p>To create breakthrough treatments, researchers need a basic understanding of what disease processes they need to enhance or block. This requires developing <a href="https://doi.org/10.1002/jcph.1569">cell and</a> <a href="https://theconversation.com/expanding-alzheimers-research-with-primates-could-overcome-the-problem-with-treatments-that-show-promise-in-mice-but-dont-help-humans-188207">animal models</a> that can simulate human biology. </p>
<p>It can <a href="https://www.fda.gov/drugs/development-approval-process-drugs">take many years</a> to vet potential treatments and develop the finished drug product ready for testing in people. Once scientists identify a potential biological target for a drug, they use <a href="https://theconversation.com/discovering-new-drugs-is-a-long-and-expensive-process-chemical-compounds-that-dupe-screening-tools-make-it-even-harder-175972">high-throughput screening</a> to rapidly assess hundreds of chemical compounds that may have a desired effect on the target. They then modify the most promising compounds to enhance their effects or reduce their toxicity. </p>
<p>When these compounds have lackluster results in the lab, companies are likely to <a href="https://doi.org/10.1186%2Fs12967-016-0838-4">halt development</a> if the estimated potential revenue from the drug is less than the estimated cost to improve the treatments. Companies can charge more money for drugs that <a href="https://digital.kwglobal.com/publication/?i=456831&p=13&view=issueViewer&pp=1">dramatically reduce deaths or disability</a> than for those that only reduce symptoms. And researchers are more likely to continue working on drugs that have a greater potential to help patients. In order to obtain FDA approval, companies ultimately need to show that the drug causes more benefits for patients than harms. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/2sAGtqm3o1g?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Casgevy, a CRISPR-based treatment for sickle cell anemia, is considered a milestone in gene therapy.</span></figcaption>
</figure>
<p>Sometimes, researchers know a lot about a disease, but available technology is insufficient to produce a successful drug. For a long time, scientists knew that <a href="https://doi.org/10.1056/NEJMoa2031054">sickle cell disease</a> results from a defective gene that leads cells in the bone marrow to produce poorly formed red blood cells, causing severe pain and blood clots. Scientists lacked a way to fix the issue or to work around it with existing methods. </p>
<p>However, in the early 1990s, basic scientists discovered that bacterial cells have a mechanism to <a href="https://theconversation.com/human-genome-editing-offers-tantalizing-possibilities-but-without-clear-guidelines-many-ethical-questions-still-remain-200983">identify and edit DNA</a>. With that model, researchers began painstaking work developing a <a href="https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crispr-timeline">technology called CRISPR</a> to identify and edit genetic sequences in human DNA. </p>
<p>The technology finally progressed to the point where scientists were able to successfully target the problematic gene in patients with sickle cell and edit it to produce normally functioning red blood cells. In December 2023, <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease">Casgevy became the first CRISPR-based drug</a> approved by the FDA.</p>
<p>Sickle cell disease made a great target for this technology because it was caused by a single genetic issue. It was also an attractive disease to focus on because it affects around 100,000 people in the U.S. and is <a href="https://doi.org/10.2147/ijgm.s257340">costly to society</a>, causing many hospitalizations and lost days of work. It also <a href="https://theconversation.com/sickle-cell-disease-can-be-deadly-and-the-persistent-health-inequities-facing-black-americans-worsen-the-problem-212434">disproportionately affects Black Americans</a>, a population that has been <a href="https://theconversation.com/yes-black-patients-do-want-to-help-with-medical-research-here-are-ways-to-overcome-the-barriers-that-keep-clinical-trials-from-recruiting-diverse-populations-185337">underrepresented in medical research</a>.</p>
<h2>Real-world drug development</h2>
<p>To put all these pieces of drug development into perspective, consider the <a href="https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm">leading cause of death in the U.S.</a>: cardiovascular disease. Even though there are several drug options available for this condition, there is an ongoing need for more effective and less toxic drugs that reduce the risk of heart attacks and strokes. </p>
<p>In 1989, epidemiologists found that patients with <a href="https://doi.org/10.1001/jama.300.11.1343">higher levels of bad, or LDL, cholesterol</a> had more heart attacks and strokes than those with lower levels. Currently, <a href="https://www.cdc.gov/cholesterol/facts.htm#">86 million American adults</a> have elevated cholesterol levels that can be treated with drugs, like the popular statins Lipitor (atorvastatin) or Crestor (rosuvastatin). However, <a href="https://www.pharmacypracticenews.com/Clinical/Article/06-22/Using-National-Guidelines-to-Determine-Hyperlipidemia-Treatment/67209">statins alone</a> cannot get everyone to their cholesterol goals, and many patients develop unwanted symptoms limiting the dose they can receive.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two blister packs of burnt orange pills with days of the week listed on each dose" src="https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=386&fit=crop&dpr=1 600w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=386&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=386&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=485&fit=crop&dpr=1 754w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=485&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=485&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">There are several statins on the market to treat high cholesterol levels.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/daily-statin-dose-royalty-free-image/643755285">Peter Dazeley/The Image Bank via Getty Images</a></span>
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<p>So scientists developed models to understand how LDL cholesterol is created in and removed from the body. They found that LDL receptors in the liver removed bad cholesterol from the blood, but a <a href="https://doi.org/10.1177/1074248418769040">protein called PCSK9</a> prematurely destroys them, boosting bad cholesterol levels in the blood. This led to the development of the drugs <a href="https://doi.org/10.1177/1074248418769040">Repathy (evolocumab) and Praluent (alirocumab)</a> that bind to PCSK9 and stop it from working. Another drug, <a href="https://doi.org/10.1002/jcph.2045">Leqvio (inclisiran)</a>, blocks the genetic material coding for PCSK9. </p>
<p>Researchers are also developing a <a href="https://www.pharmacypracticenews.com/Online-First/Article/12-23/Novel-Gene-Therapy-Slashes-LDL-in-Patients-With-Hypercholesterolemia/72152">CRISPR-based method</a> to more effectively treat the disease.</p>
<h2>The future of drug development</h2>
<p>Drug development is driven by the priorities of their funders, be it governments, foundations or the pharmaceutical industry. </p>
<p>Based on the market, companies and researchers tend to study highly prevalent diseases with devastating societal consequences, such as <a href="https://pubmed.ncbi.nlm.nih.gov/33756057/">Alzheimer’s disease</a> and <a href="https://www.cdc.gov/opioids/data/index.html">opioid use disorder</a>. But the work of advocacy groups and foundations can enhance research funding for other specific diseases and conditions. Policies like the Orphan Drug Act also create successful incentives to discover treatments for rare diseases. </p>
<p>However, in 2021, 51% of drug discovery spending in the U.S. was directed at <a href="https://www.evernorth.com/articles/specialty-drug-trends-and-utilization">only 2% of the population.</a>. How to strike a balance between providing incentives to develop <a href="https://theconversation.com/the-price-of-a-miracle-should-we-limit-spending-on-lifesaving-drugs-79609">miracle drug therapies</a> for a few people at the expense of the many is a question researchers and policymakers are still grappling with.</p><img src="https://counter.theconversation.com/content/219572/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>C. Michael White does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Drug development takes a great deal of time, money and effort. While future profits play a big factor in which diseases gets prioritized, advocacy and research incentives can also tilt the scale.C. Michael White, Distinguished Professor of Pharmacy Practice, University of ConnecticutLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2195992023-12-12T03:46:44Z2023-12-12T03:46:44ZPlanning to use drugs at a festival on a scorching summer day? Here’s why extreme heat might make MDMA riskier<figure><img src="https://images.theconversation.com/files/565079/original/file-20231212-29-chp7fb.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5176%2C3453&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/crowds-enjoying-themselves-outdoor-music-festival-184911032">Monkey Business Images/Shutterstock</a></span></figcaption></figure><p>Sydney and other parts of Australia have just experienced <a href="https://news.sky.com/story/australia-temperatures-in-sydney-climb-to-nearly-40c-as-authorities-issue-bushfire-warnings-13027266">a significant heatwave</a>, with temperatures reaching highs of well over 40°C. In Sydney in particular, the extreme heat has coincided with a bustling schedule of <a href="https://www.canberratimes.com.au/story/8453863/crowds-bake-at-sydney-concerts-as-mercury-soars/">live music events</a>, attracting large crowds despite the sweltering conditions.</p>
<p>Drug experts <a href="https://www.abc.net.au/news/2023-12-09/nsw-heat-drug-overdose-festival-deaths/103205522">raised concerns</a> ahead of the sold-out Epik festival which took place at Sydney Olympic Park on Saturday, cautioning revellers against the dangers of taking illicit drugs in extreme heat.</p>
<p>Reports have since emerged that <a href="https://www.abc.net.au/news/2023-12-10/nsw-sydney-epik-music-dance-festival-drug-hospitalisations/103211208">four festival patrons</a> were taken to hospital for reasons relating to drugs. </p>
<p>While illicit drug use is dangerous no matter the circumstances, extremely hot weather may make it even more risky.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/5-reasons-why-climate-change-may-see-more-of-us-turn-to-alcohol-and-other-drugs-217894">5 reasons why climate change may see more of us turn to alcohol and other drugs</a>
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<h2>Drug use at festivals</h2>
<p>We know the use of recreational drugs is common at live music events such as festivals. Studies have shown people who frequently <a href="https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-017-0205-7">attend music festivals</a> and dance events tend to have <a href="https://substanceabusepolicy.biomedcentral.com/articles/10.1186/1747-597X-6-18">more experience with illegal substances</a> than their counterparts who don’t attend these events. </p>
<p>Wastewater analyses <a href="https://www.sciencedirect.com/science/article/pii/S0048969718351490?casa_token=ZMgSdR0MnjYAAAAA:iseXbDHWCT8i4O4FqGUUrooAUleX9TXqSce89xbPVDjONBubOHB-rrpsCkHUl-if5m3DYgFW6Eg">have confirmed</a> the prevalence of drug use at music festivals.</p>
<p>In Australia and overseas, several live music events have been marred by tragedies linked to drug use. As recently as October, two men, aged 21 and 26, died following <a href="https://cityhub.com.au/two-men-die-from-suspected-drug-overdose-after-attending-sydney-music-festival/">suspected drug overdoses</a> at the Knockout music festival in Sydney. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1708729898116808711"}"></div></p>
<p>At these sorts of events, MDMA (or ecstasy) is among the <a href="https://www.tandfonline.com/doi/full/10.1080/15563650.2017.1360496?casa_token=qppYTfu_IBcAAAAA%3ANwXWLwMFiKcBWE0e8DIGu-97pJNnqynSjjiwYhg-gNDbOEcqhNI2MOccCvzszG4QCRewZhiDTPH_MQ">most commonly used substances</a>. And when taken during extreme heat, the risks could be much greater.</p>
<h2>MDMA and hot weather</h2>
<p>MDMA triggers the release of substances that interfere with our <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008716/">temperature regulation</a>, leading the body to generate more heat than usual. This effect is known as hyperthermia (as opposed to hypothermia, when the body gets too cold). </p>
<p>This elevation in body temperature happens even if the person using drugs is not exerting themselves and not in a hot environment. In this context, the effect can still <a href="https://sunrisehouse.com/ecstasy-abuse/effects/">cause dehydration</a>.</p>
<p>However, the effects may be greater if a person is exerting themselves in hot, crowded settings. Studies have shown that on average, for a person who takes MDMA somewhere like a dance club, their body temperature can increase by <a href="https://www.sciencedirect.com/science/article/abs/pii/S0376871611003577">more than 1°C</a>.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/taylor-swifts-brazil-concert-was-hammered-by-extreme-heat-how-to-protect-crowds-at-the-next-sweltering-gig-218341">Taylor Swift's Brazil concert was hammered by extreme heat. How to protect crowds at the next sweltering gig</a>
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<p>In extreme cases, a sharp increase in body temperature <a href="https://www.nih.gov/news-events/news-releases/mdma-can-be-fatal-warm-environments">can lead to</a> organ failure and even death. </p>
<p>Extreme heat may compound the hyperthermia induced by taking the drug. A <a href="https://www.jneurosci.org/content/34/23/7754.short">study in rats</a> showed a moderate dose of MDMA that is typically non-fatal in cool, quiet environments can be fatal in rats exposed to conditions that mimic the hot, crowded settings where people often use the drug.</p>
<figure class="align-center ">
<img alt="One person passing a small packet of pills to another person." src="https://images.theconversation.com/files/565081/original/file-20231212-15-71opww.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/565081/original/file-20231212-15-71opww.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/565081/original/file-20231212-15-71opww.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/565081/original/file-20231212-15-71opww.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/565081/original/file-20231212-15-71opww.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/565081/original/file-20231212-15-71opww.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/565081/original/file-20231212-15-71opww.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">Taking MDMA interferes with the body’s temperature regulation.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/drug-dealer-selling-ecstasy-pills-addict-1331364980">Impact Photography/Shutterstock</a></span>
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<h2>What now?</h2>
<p>Illicit drugs pose significant dangers to people who use them at music festivals and elsewhere. </p>
<p>Meanwhile, with climate change, we are set to face <a href="https://www.climatechange.environment.nsw.gov.au/impacts-climate-change/weather-and-oceans/heatwaves">more frequent and intense</a> heatwaves in the future. So it’s important to better understand how the weather might intensify the risks of drug use. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/testing-festival-goers-pills-isnt-the-only-way-to-reduce-overdoses-heres-what-else-works-118827">Testing festival goers' pills isn't the only way to reduce overdoses. Here's what else works</a>
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<p>The principles of harm reduction recognise that, despite our best efforts to educate people about the risks associated with substance use, some people will continue to experiment with drugs at music festivals. So it becomes essential to minimise potential harms through evidence-based strategies, such as <a href="https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-017-0205-7">pill testing</a>.</p>
<p>Harm reduction messages play a vital role in educating music festival attendees about the dangers of drug use, especially in hot conditions. These messages must encourage seeking medical help without fear of repercussions, staying hydrated, taking regular breaks, and wearing appropriate clothing for sun protection. Public officials, event organisers, families and friends can all contribute to spreading these messages, though attendees also need to exercise personal responsibility.</p>
<p>Messaging should also stress the importance of patrons looking out for their friends, highlighting everyone has a role in maintaining a safe environment at these events.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/its-extremely-hot-and-im-feeling-weak-and-dizzy-could-i-have-heat-stroke-215084">It's extremely hot and I'm feeling weak and dizzy. Could I have heat stroke?</a>
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<img src="https://counter.theconversation.com/content/219599/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Milad Haghani receives funding from the Australian Research Council (Grant No. DE210100440). </span></em></p><p class="fine-print"><em><span>Dr Pegah Varamini has received funding from the National Breast Cancer Foundation, Therapeutic Innovation Australia (TIA), Pipeline Accelerator Grant, SPARK Oceania, Tour de Cure, Sydney Catalyst, Controlled Release Society, and Australian Pain Society. She is a lecturer and the head of Breast Cancer Targeting & Drug Delivery laboratory at the University of Sydney Pharmacy School. Pegah is affiliated with the World Health Organisation as a scientific advisor within the Global Breast Cancer Initiative and is the Co-Chair of NanoPharma cluster within NanoHealth Initiative at the Sydney Nano Institute.</span></em></p>Taking MDMA can raise our body temperature higher than it should be. Extreme heat may compound this effect.Milad Haghani, Senior Lecturer of Public Safety & Disaster Risk, UNSW SydneyPegah Varamini, Senior Lecturer in Pharmacy and Pharmacology, Head of Breast Cancer Targeting and Drug Delivery Laboratory, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2190032023-12-06T19:07:29Z2023-12-06T19:07:29ZWhat is needle spiking, and how can I protect myself?<figure><img src="https://images.theconversation.com/files/563813/original/file-20231206-15-s2excn.jpg?ixlib=rb-1.1.0&rect=6%2C0%2C4115%2C2747&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/trippy-night-image-people-dancing-outdoors-1861215565">Mircea Moira/Shutterstock</a></span></figcaption></figure><p>Last week two young Australian women <a href="https://www.abc.net.au/news/2023-11-30/travellers-warn-needle-spiking-overseas/103030942">spoke candidly</a> to the ABC about being sexually assaulted while on holidays. The alleged incidents occurred in Greece in 2022 and in Hawaii in 2019.</p>
<p>Both women described common symptoms of being drugged, including being unable to move or speak, blurred vision, lack of coordination and memory loss.</p>
<p>Both found a needle mark after they woke up and believe they were “needle spiked”.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1729946300450533813"}"></div></p>
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Read more:
<a href="https://theconversation.com/what-is-drink-spiking-how-can-you-know-if-its-happened-to-you-and-how-can-it-be-prevented-160538">What is drink spiking? How can you know if it's happened to you, and how can it be prevented?</a>
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</p>
<hr>
<h2>What is needle spiking?</h2>
<p>Needle spiking is when a person is injected with a drug without their consent. Reports of needle spiking started to emerge in the <a href="https://www.psychologytoday.com/au/blog/its-catching/202202/the-british-needle-spiking-panic">UK in 2021</a> but it’s now been reported around the world, including <a href="https://www.abc.net.au/news/2022-01-28/police-concerned-about-needle-spiking-at-echuca-newcastle/100787224">in Australia</a>.</p>
<p>Needle spiking is usually reported by people who have been at a crowded bar or party. It’s generally reported by women but <a href="https://www.abc.net.au/news/2023-06-07/needle-spiking-sydney-warning/102444708">some men</a> have also reported being needle spiked. </p>
<p>We don’t have data on how often needle spiking happens, but we think it’s <a href="https://journals.sagepub.com/doi/10.1177/00220426231197826">very rare</a>. There have been only a few reports of needle spiking in Australia but none of them have been able to be confirmed.</p>
<p>Often these types of incidents are not reported at all because often victims don’t remember what happened or there’s no way to identify the perpetrator.</p>
<p>We don’t know exactly what drugs might be used in needle spiking incidents, but they would likely be similar to drugs commonly used for drink spiking. These include colourless, odourless sedatives like Rohypnol, <a href="https://www.betterhealth.vic.gov.au/health/healthyliving/GHB#bhc-content">GHB</a> and <a href="https://adf.org.au/drug-facts/ketamine/">ketamine</a>.</p>
<p>People who suspect they were needle spiked may have <a href="https://www.gmp.police.uk/advice/advice-and-information/spiking-advice/spiking/what-to-do-if-someone-has-spiked-you/#">blood or urine testing</a> afterwards. But there’s no real way to be sure any drugs detected in someone’s system were from a needle incident. And often <a href="https://www.psychologytoday.com/au/blog/its-catching/202202/the-british-needle-spiking-panic">no sedatives</a> are detected by the time testing happens.</p>
<h2>How does it happen?</h2>
<p>It’s very difficult to inject someone without them noticing, especially in a crowded venue where people are moving a lot. Needles need to be injected fairly carefully and it would take several seconds to get enough of a drug into the system to have an effect. It would also be almost impossible to inject enough of a drug to incapacitate someone through clothing.</p>
<p>So generally, a person would probably feel the prick of the needle and notice the drug going in. </p>
<p>It is theoretically possible to inject someone without them knowing, using a very thin needle. They may be less likely to notice if they’ve had a couple of drinks. But also it’s less likely you would find a needle mark with a very thin needle.</p>
<p>If needle spiking occurs, a more likely scenario may be that someone has their drink spiked, and the injection happens after they’re incapacitated from the drink spiking. This might be done to ensure someone stays sedated, but we don’t know the reasons for sure.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/weekly-dose-ghb-a-party-drug-thats-easy-to-overdose-on-but-was-once-used-in-childbirth-73266">Weekly Dose: GHB, a party drug that's easy to overdose on but was once used in childbirth</a>
</strong>
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<p>Drink spiking is much easier and is <a href="https://journals.sagepub.com/doi/10.1177/00220426231197826">probably much more common</a> than needle spiking, although we don’t have good data on the prevalence of drink spiking either.</p>
<p>By far the most commonly used drug in drink spiking is <a href="https://www.betterhealth.vic.gov.au/health/healthyliving/drink-spiking">alcohol</a>. Extra or stronger alcohol might be added to an alcoholic or non-alcoholic drink.</p>
<p>More rarely other drugs are used such as <a href="https://www.betterhealth.vic.gov.au/health/healthyliving/benzodiazepines#:%7E:text=Benzodiazepines%20(or%20benzos)%20are%20depressant,sedatives%20(or%20sleeping%20pills)">benzodiazepines</a> (like Rohypnol), <a href="https://www.betterhealth.vic.gov.au/health/healthyliving/GHB#bhc-content">GHB</a> or <a href="https://adf.org.au/drug-facts/ketamine/">ketamine</a>. These drugs have <a href="https://www.webmd.com/mental-health/addiction/date-rape-drugs">sedative effects</a> that can result in loss of consciousness, memory loss and sometimes hallucinations or feeling like you are outside your body.</p>
<p>There is minimal data about sexual assault after drink spiking as most incidents are not reported, but some data suggests around <a href="https://www.parliament.nsw.gov.au/la/papers/Pages/tabled-paper-details.aspx?pk=84446#:%7E:text=Drink%20spiking%20is%20sometimes%20referred,being%20reported%20to%20the%20police.">one-third</a> of drink spiking incidents end in sexual assault. </p>
<h2>What to do if think you’ve been spiked</h2>
<p>If you were injected with any of the substances mentioned above you would feel the effects nearly immediately. If your drink has been spiked, it takes longer for the substances to enter your system, so you might feel the effects with enough time to get help. </p>
<p>Some of the warning signs you may have been spiked include:</p>
<ul>
<li>feeling lightheaded</li>
<li>feeling sick or unusually tired</li>
<li>feeling drunk despite only having a very small amount of alcohol</li>
<li>feeling like you might faint or pass out, or you actually pass out</li>
<li>feeling confused when you wake up</li>
<li>being unable to remember what happened the previous night.</li>
</ul>
<p>If you think you’ve been drink or needle spiked, you should ask someone you trust to help get you to a safe place, or talk to venue staff or security if you’re at a licensed venue. </p>
<p>If you feel very unwell you should seek medical help, such as at an emergency department.</p>
<h2>How can you protect yourself?</h2>
<p>Stick to venues you know and that have a good reputation for safety. If you’re at a venue where you don’t feel comfortable, don’t stay.</p>
<p>Keep your drink close to you and don’t leave it unattended. Don’t share drinks with other people, especially if you don’t know them well, and buy your drinks yourself. If you’re offered a drink by someone you don’t know well, go to the bar with them and watch the bartender pour your drink.</p>
<p>If you think your drink tastes weird, or you start to feel strange or unwell, tell someone you trust straight away. Keep an eye on your friends and their drinks too.</p>
<hr>
<p><em>If you’ve been a victim of drink or needle spiking and want to talk to someone confidentially, you can call the National Alcohol and other Drug Hotline on 1800 250 015.</em></p>
<p><em>For information about sexual assault, or for counselling or referral, you can call The National Sexual Assault, Family and Domestic Violence Counselling Line – 1800 RESPECT (1800 737 732).</em></p><img src="https://counter.theconversation.com/content/219003/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicole Lee is CEO at Hello Sunday Morning and also works as a consultant in the alcohol and other drug sector and a psychologist in private practice. She has previously been awarded funding by Australian and state governments, NHMRC and other bodies for evaluation and research into alcohol and other drug prevention and treatment.</span></em></p>Needle spiking is when a person is injected with a drug without their consent. Reports started to emerge in the UK in 2021 but this has now been reported around the world, including in Australia.Nicole Lee, Professor at the National Drug Research Institute (Melbourne), Curtin UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2148952023-11-30T17:23:43Z2023-11-30T17:23:43ZBuvidal: is it really a ‘game changer’ in the treatment of problematic opioid use?<p>To overcome problematic opioid use, traditional forms of opioid substitution therapy, such as <a href="https://www.nhs.uk/medicines/methadone/">methadone</a> and <a href="https://www.nhs.uk/medicines/buprenorphine-for-pain/">oral buprenorphine</a>, have become valuable tools. <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD002209.pub2/full?highlightAbstract=opioid">Research</a> shows that patients receiving substitution therapy are more likely to stay in treatment and stop using heroin than patients receiving treatments that do not involve substitutes – such as counselling or group therapy.</p>
<p>But not all those on substitute medication are able to stop using illicit opioids. Some continue to use them in addition to the substitute. One <a href="https://www.sciencedirect.com/science/article/abs/pii/S0376871621001460">barrier</a> to success is the need to attend a clinic or pharmacy every day, or every few days, to obtain the substitute. </p>
<p>In early 2019, a new form of substitute treatment, long-acting injectable buprenorphine, was approved for use in the UK. Unlike methadone and oral buprenorphine, <a href="https://www.nice.org.uk/advice/es19/evidence/evidence-review-pdf-6666819661#:%7E:text=Buprenorphine%20prolonged%2Drelease%20injection%20is,buprenorphine%20prolonged%2Drelease%20injection%20subcutaneously.">long-acting injectable buprenorphine</a> is administered via an injection either weekly or monthly. The treatment – also known by its brand names Buvidal or Sublocade – has been heralded as a “<a href="https://nation.cymru/news/welsh-university-carries-out-game-changer-drug-treatment-research/">game changer</a>” by both doctors and patients. </p>
<h2>Opioids</h2>
<p>In 2021, nearly 5,000 drug-related deaths were <a href="https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2021registrations">registered</a> in England and Wales. About half of those involved an opioid. </p>
<p>Opioids are a class of drugs that include substances derived from the opium poppy. They include <a href="https://www.nhs.uk/medicines/morphine/">morphine</a> and <a href="https://www.emcdda.europa.eu/publications/drug-profiles/heroin_en">heroin</a>, as well as synthetic alternatives that mimic the effects of naturally occurring opioids such as <a href="https://www.nhs.uk/medicines/tramadol/">tramadol</a> and <a href="https://bnf.nice.org.uk/drugs/fentanyl/">fentanyl</a>.</p>
<p>Opioids work in the brain to produce a variety of effects, including pain relief. They also produce feelings of euphoria, joy and pleasure. Opioids have a depressant effect on the body, so if someone overdoses, they can stop breathing and may die. Overdose is a particular risk for those who use illegally obtained opioids of unknown strength, such as heroin.</p>
<p>Often people are unable to stop using opioids despite the risk of death and the serious negative health and social consequences. Such drugs are hard to give up, partly because stopping causes painful physical and psychological withdrawal symptoms.</p>
<h2>Opioid substitution therapy</h2>
<p>An effective form of treatment for problematic opioid use is opioid substitution therapy, where illegally obtained opioids are substituted for prescribed alternatives. </p>
<p>Providing a legal substitute of known purity is useful in many ways. Most notably, it removes the need to buy and use illicit opioids. This reduces the risk of <a href="https://www.bmj.com/content/357/bmj.j1550">overdose</a> and the need to commit crimes like <a href="https://academic.oup.com/bjc/article-abstract/49/4/513/2747197">theft and shoplifting</a> to get money to pay for drugs.</p>
<p>But while daily attendance and supervised consumption may help to minimise the risk of misuse, it also has its drawbacks. For example, it can bring patients into regular contact with their former drug-using networks and can require time-consuming journeys that interfere with employment, education and other responsibilities.</p>
<p>Long-acting injectable buprenorphine does not have these drawbacks. It is not unlike <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8369037/">long-acting</a> forms of contraception, in that the medicine releases slowly over time, thereby avoiding the peaks and troughs associated with oral formulations.</p>
<p>When the pandemic broke and the UK went into lockdown, <a href="https://www.emcdda.europa.eu/publications/topic-overviews/covid-19-and-people-who-use-drugs_en">concerns</a> were raised by experts that daily attendance at clinics or pharmacies for opioid substitution medication might increase the risk of COVID transmission. </p>
<p>Keen to stop the spread of the virus while also providing safe and continuous treatment to patients, the Welsh government <a href="https://committees.parliament.uk/writtenevidence/107535/pdf/">agreed</a> to fund the roll-out of long-acting injectable buprenorphine to drug services across Wales. </p>
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<figcaption><span class="caption">Two doctors discuss Buvidal from the perspective of lived experience.</span></figcaption>
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<p>That decision was supported by <a href="https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01348-5">emerging evidence</a> of the effectiveness of the medication from a drug service in south Wales that had been piloting the medicine before the pandemic. </p>
<h2>Results</h2>
<p>While the primary aim at that time was to stop the spread of COVID, it quickly became clear that the medication was benefiting patients in many other ways. </p>
<p>Patients taking part in a <a href="https://kaleidoscope68.org/app/uploads/2022/05/Kaleidoscope-Peer-led-Buvidal-Review..pdf">survey</a> about the new medication reported reductions in cravings, lower levels of anxiety, reductions in offending and abstinence from illicit opioids. They described rebuilding their lives, getting jobs, reconnecting with family members and heralded long-acting injectable buprenorphine as a “game changer”, “life changing” and even a “miracle”. </p>
<p>Positive results have also been reported in <a href="https://www.jsatjournal.com/article/S0740-5472(22)00058-7/fulltext">systematic reviews</a> that summarise the findings of the currently small, and not very robust, body of evidence on the effectiveness of the medication.</p>
<p>However, alongside the reports of success, less positive <a href="https://kaleidoscope68.org/app/uploads/2022/05/Kaleidoscope-Peer-led-Buvidal-Review..pdf">stories</a> have emerged suggesting that the treatment may not be a silver bullet. Some patients have found the transition onto the medication challenging because it required them to be in full withdrawal before their first dose. </p>
<p>Others have been overwhelmed with emotions because the medication made them feel so clear-headed that their past traumas – suppressed by years of illicit opioid use – had begun to resurface. There have also been <a href="https://kaleidoscope68.org/app/uploads/2022/05/Kaleidoscope-Peer-led-Buvidal-Review..pdf">reports</a> of an increase in crack cocaine use among some patients and concerns about the reduced amount of contact (from daily to monthly) with drug services.</p>
<p>Even though there is a “<a href="https://pubmed.ncbi.nlm.nih.gov/16764215/">ceiling effect</a>” that reduces the risk of overdose, this medication still carries a risk of respiratory depression. This risk is <a href="https://pubmed.ncbi.nlm.nih.gov/15957155/">greater</a> among those using alcohol, benzodiazepines or other opioids such as heroin.</p>
<p>Long-acting injectable buprenophine is still in its infancy worldwide, so the evidence for its effectiveness is slim. To determine if it really is a “game changer”, experts will need to look at its impact across a wider range of outcomes, over longer periods and with larger samples than have been considered to date.</p><img src="https://counter.theconversation.com/content/214895/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Katy Holloway receives funding from Welsh Government and is a member of Welsh Government's National Implementation Board for Drug Poisoning Prevention. </span></em></p><p class="fine-print"><em><span>Fabrizio Schifano receives funding from Welsh Government. Currently a World Health Organization (WHO) member of the Expert Committee on Drug Dependence (ECDD; 2023). Previously, Schifano was a member of the ACMD UK and an expert advisor of the European Medicines Agency (EMA) for Psychiatry. </span></em></p>Long-acting injectable buprenorphine is also known by the brand names Buvidal or Sublocade.Katy Holloway, Professor of Criminology, University of South WalesFabrizio Schifano, Chair in Clinical Pharmacology and Therapeutics, University of HertfordshireLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2165402023-11-20T00:54:20Z2023-11-20T00:54:20ZHow can you define a ‘drug’? Nobody really knows<p>What’s a medical drug? Ask someone on the street and they’re likely to tell you it’s the kind of thing you take when you’re unwell.</p>
<p>This understanding is wrong, as we will see. But after a thorough investigation, my colleagues and I found no other potential definitions are any better. </p>
<p>Despite their centrality to medicine, we have no idea what medical drugs are. We can’t even tell the difference between drugs and food, let alone drugs and so-called “natural” alternatives.</p>
<h2>A Goldilocks definition</h2>
<p>In a <a href="https://academic.oup.com/jmp/advance-article/doi/10.1093/jmp/jhad035/7206006">recent article</a> in the Journal of Medicine and Philosophy, my colleagues (Sara Linton, a pharmacist, and Maureen O’Malley, a philosopher of biology) and I tried to nail down a viable definition of medical drugs.</p>
<p>A viable definition should be broad enough to include everything classified as a drug. To get a sense of this “everything”, we used the <a href="https://go.drugbank.com/about">drug bank</a> compiled by the Canadian Institutes for Health Research, which lists more than 16,000 substances.</p>
<p>A definition should also be narrow enough to exclude substances not typically considered drugs. Take food, for example. Eating a sandwich is usually never thought of as taking a drug.</p>
<p>In short, a viable definition of what drugs are should occupy a “Goldilocks” zone between these two demands: big enough to include all drugs, small enough to exclude everything else.</p>
<p>Based on an initial study of pharmacology textbooks, we found three broad ways to define drugs: in terms of what they are, how they work and what they’re used for.</p>
<p>Unfortunately, none of these options fall within the Goldilocks zone. </p>
<h2>Are drugs specific chemicals?</h2>
<p>If all drugs were a particular type of chemical, then defining drugs would be easy. But this idea is hopeless: there is nothing, chemically speaking, all drugs have in common.</p>
<p>It is also tempting to think drugs are “artificial” chemicals, made in a lab, whereas “natural” supplements come from nature, and that’s the difference.</p>
<p>But many drugs are “natural” in this sense. Aspirin, for instance, is derived from willow bark.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/modern-medicine-has-its-scientific-roots-in-the-middle-ages-how-the-logic-of-vulture-brain-remedies-and-bloodletting-lives-on-today-213702">Modern medicine has its scientific roots in the Middle Ages − how the logic of vulture brain remedies and bloodletting lives on today</a>
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</em>
</p>
<hr>
<p>This has immediate implications for so-called “natural” supplements, such as fish oil. </p>
<p>If “drugs” are chemically indistinguishable from “natural” supplements, supplements should not be considered a “safe” alternative. Supplements are no less, and no more, safe than many drugs. </p>
<h2>Do drugs perform a specific function?</h2>
<p>Perhaps drugs can be defined in terms of what they do. This idea initially seems promising, as many drugs work by binding to receptor molecules in the body. </p>
<p>Think of a lock and key: the receptor molecule is the lock, and the drug is the key that opens it. </p>
<p>The discovery of receptor molecules is significant. For some, it is the “big idea” of the science of pharmacology. </p>
<p>But this definition of medical drugs is also hopeless. Many drugs don’t bind to receptors. Antacids, for instance, work simply by changing the level of acidity (pH) in a person’s body.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/explainer-what-is-the-placebo-effect-and-are-doctors-allowed-to-prescribe-them-55219">Explainer: what is the placebo effect and are doctors allowed to prescribe them?</a>
</strong>
</em>
</p>
<hr>
<p>Many placebos also bind to receptors. Placebos are often contrasted with drugs, but defining drugs as “things that bind to receptor molecules” would include many placebos in the definition. So this definition won’t work either.</p>
<p>Is there a way to define placebos that clearly distinguishes them from drugs? This is not obvious, since defining placebos is also quite hard.</p>
<p>For instance, one might think placebos are substances that have no therapeutic effects. But placebos can have therapeutic effects (the so-called placebo effect), so this definition won’t work. A number of other definitions face similar problems.</p>
<p>Our research paves the way toward an explanation of why it is so hard to define placebos. To properly define placebos, we need to differentiate them from drugs, which we can’t do without a definition of what drugs are.</p>
<h2>Drugs make me better</h2>
<p>This brings us back to wellness. On this view, a medical drug is just any chemical substance used in medical treatment. </p>
<p>This does better: it captures the full range of substances used as drugs in medical contexts.</p>
<p>But now there is absolutely no hope of keeping food and nutrients out. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/poison-or-cure-traditional-chinese-medicine-shows-that-context-can-make-all-the-difference-163337">Poison or cure? Traditional Chinese medicine shows that context can make all the difference</a>
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<p>Consider, for example, total parenteral nutrition. This is a chemical infusion given to people who have trouble absorbing nutrients in the normal way.</p>
<p>Total parenteral nutrition is used in medical treatment. But what it does for your body isn’t really different from what a good sandwich does.</p>
<p>Any treatment-based account of drugs inevitably wipes out the contrast with food.</p>
<h2>So what?</h2>
<p>In our day-to-day lives, we make choices that rely on an implicit understanding of what drugs are. </p>
<p>For instance, we take paracetamol because it is a drug. Many of us may also take fish oil precisely because we believe it isn’t a drug.</p>
<p>Without an account of what drugs are, we risk making serious mistakes.</p>
<p>We might take substances we think are “inert” (placebos) because they are “natural” (like fish oil) when in fact they are active drugs. </p>
<p>Similarly, all legal regulation of medical drugs assumes we already know what a drug is. </p>
<p>But we don’t: our understanding is clearly evolving. This means regulation must also continually change. Substantial resources must therefore be devoted to reworking legislation as we continue to rethink what medical drugs are, as the <a href="https://www.sbs.com.au/news/article/mdma-and-psilocybin-will-be-come-legal-from-1-juy-heres-who-can-get-it/jpf6gj4di">recent reclassification</a> of MDMA and psilocybin as medicines in Australia demonstrates.</p>
<p>Then there’s food. Food is not administered or regulated like a drug in a hospital, with the exception of total parenteral nutrition and similar substances.</p>
<p>But if doctors use food like a drug to contribute to patient wellbeing, then perhaps it should be subject to the same standards.</p>
<p>This may require radically rethinking the way meals are provided in a hospital. Perhaps meals should be administered, and regulated, with the same care as drugs. </p>
<p>Hospital lunches might never be the same. But that could be a good thing.</p><img src="https://counter.theconversation.com/content/216540/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sam Baron receives funding from the Australian Research Council.</span></em></p>Everybody thinks they know what drugs are, but a clear definition is surprisingly elusive.Sam Baron, Associate Professor, Philosophy of Science, Australian Catholic UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2167872023-11-14T13:25:49Z2023-11-14T13:25:49ZInsulin injections could one day be replaced with rock music − new research in mice<figure><img src="https://images.theconversation.com/files/558688/original/file-20231109-21-ic46x7.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2120%2C1414&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Turns out pop songs and movie soundtracks are key to a new system to deliver insulin.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/cheering-audience-at-music-concert-royalty-free-image/1384296998">Sammyvision/Moment via Getty Images</a></span></figcaption></figure><p>More than <a href="https://www.cdc.gov/diabetes/basics/diabetes.html">37 million people</a> in the U.S. have diabetes. According to the American Diabetes Association, <a href="https://www2.diabetes.org/newsroom/press-releases/2022/american-diabetes-association-announces-support-for-insulin-act-at-senate-press-conference">8.4 million Americans</a> needed to take insulin in 2022 to lower their blood sugar. Insulin, however, is <a href="https://doi.org/10.1111/jphp.12852">tricky to deliver</a> into the body orally because it is a protein easily <a href="https://theconversation.com/many-drugs-cant-withstand-stomach-acid-a-new-delivery-method-could-lead-to-more-convenient-medications-183421">destroyed in the stomach</a>.</p>
<p>While researchers are developing <a href="https://www.acs.org/pressroom/presspacs/2023/january/another-step-toward-an-insulin-tablet.html">pills that resist digestion</a> in the stomach and <a href="https://samueli.ucla.edu/smart-insulin-patch/">skin patches</a> that monitor blood sugar and automatically release insulin, the most reliable way currently to take insulin is through frequent injections.</p>
<p>I am a professor of <a href="https://medicine.iu.edu/faculty/13502/sullivan-william">pharmacology and toxicology</a> at Indiana University School of Medicine, where my colleagues and I study drug delivery systems. Researching innovative new ways to get medications into the body can improve how well patients respond to and comply with treatments. An easier way to take insulin would be music to the ears of many people with diabetes, especially those who aren’t fans of needles.</p>
<p>In a recent study in <a href="https://doi.org/10.1016/S2213-8587(23)00153-5">The Lancet Diabetes & Endocrinology</a>, researchers engineered cells to release insulin in response to specific sound waves: the music of the band Queen. Though it still has a long way to go, this new system may one day replace the insulin injection with a dose of rock ’n’ roll.</p>
<h2>What is diabetes?</h2>
<p><a href="https://www.mayoclinic.org/diseases-conditions/diabetes/symptoms-causes/syc-20371444">Diabetes is a chronic disease</a> that arises when the body fails to make enough insulin or respond to insulin. <a href="https://my.clevelandclinic.org/health/articles/22601-insulin">Insulin is a hormone</a> the pancreas makes in response to the rise in sugar concentration in the blood when the body digests food. This crucial hormone gets those sugars out of the blood and into muscles and tissues where it is used or stored for energy.</p>
<p>Without insulin, <a href="https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631">blood sugar levels remain high</a> and cause symptoms that include frequent urination, thirst, blurry vision and fatigue. Left untreated, this hyperglycemia can be life-threatening, causing organ damage and a diabetic coma. According to the U.S. Centers for Disease Control and Prevention, diabetes is the <a href="https://www.cdc.gov/diabetes/basics/diabetes.html">No. 1 cause</a> of kidney failure, lower-limb amputations and adult blindness, making it the eighth most common cause of death in the U.S.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/Q6rLXPJ6j_I?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Diabetes results when the body either doesn’t produce enough insulin or is no longer responsive to it.</span></figcaption>
</figure>
<p>Treating diabetes is straightforward: When the body is lacking insulin, give it more insulin. Scientists have <a href="https://www.vox.com/2019/4/3/18293950/why-is-insulin-so-expensive">mastered how to make the hormone</a>, but direct injection is the only effective way to get it into the body. Diabetic patients usually have to carry insulin vials and needles wherever they go. Considering that <a href="https://theconversation.com/over-half-of-adults-unvaccinated-for-covid-19-fear-needles-heres-whats-proven-to-help-161636">many people fear needles</a>, this may not be an ideal way to manage the disease.</p>
<p>This challenge has sparked researchers to look into new ways to deliver insulin more easily.</p>
<h2>What is cellular engineering?</h2>
<p>Cells are the basic unit of life. Your body is composed of <a href="https://pubmed.ncbi.nlm.nih.gov/35832316/">hundreds of different types of cells</a> that carry out specialized functions. In some diabetic patients, the pancreatic beta cells that make insulin have malfunctioned or died. What if there were a way to replace these defective cells with new ones that could produce insulin on demand?</p>
<p>That’s where cellular engineering comes in. <a href="https://doi.org/10.1126/science.adf8627">Cellular engineering</a> involves genetically modifying a cell to perform a specific function, like producing insulin. <a href="https://medlineplus.gov/genetics/gene/ins/">Installing the gene that makes insulin</a> into cells is not difficult, but controlling when the cell makes it has been a challenge. Insulin should be made only in response to high blood sugar levels following a meal, not at any other time.</p>
<p>Scientists have been exploring the idea of using <a href="https://www.britannica.com/science/ion-channel">ion channels</a> – proteins embedded in a cell’s membrane that regulate the flow of ions such as calcium or chloride – like a remote-controlled device to activate cellular activity. Cells with specific types of ion channel in their membranes can be <a href="https://doi.org/10.1126/science.abb9122">activated in response to certain stimuli</a>, such as light, electricity, magnetic fields or mechanical stimulation. Such ion channels exist naturally as sensory devices to help cells and organisms respond to light, magnetism, touch or sound. For example, <a href="https://doi.org/10.1016/j.neuron.2018.07.033">hair cells in the inner ear</a> have mechanosensitive ion channels that respond to sound waves. </p>
<h2>Combining cellular engineering with Queen</h2>
<p>Bioengineering professor <a href="https://scholar.google.com/citations?user=Re5ypoQAAAAJ&hl=en">Martin Fussenegger</a> of ETH Zurich, a university in Basel, Switzerland, led a recent study that used a mechanosensitive ion channel as a remote control to signal cells to <a href="https://doi.org/10.1016/S2213-8587(23)00153-5">make insulin in response to specific sound waves</a>.</p>
<p>These “MUSIC-controlled, insulin-releasing cells” – MUSIC is short for music-inducible cellular control – were cultured in the lab next to loudspeakers. His team tested a variety of musical genres of different intensities and speeds.</p>
<p>Among the songs they played were pop songs like Michael Jackson’s “Billie Jean,” Queen’s “We Will Rock You” and the Eagles’ “Hotel California”; classical pieces such as Beethoven’s “Für Elise” and Mozart’s “Alla Turca”; and movie themes such as Soundgarden’s “Live To Rise,” which was featured in “The Avengers,” a Marvel film. They found that pop music heavy in low bass and movie soundtracks were better able to trigger insulin release compared with classical music, and cells were able to release insulin within minutes of exposure to the song.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/558690/original/file-20231109-27-tjh26u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Close-up of person injecting insulin into upper arm" src="https://images.theconversation.com/files/558690/original/file-20231109-27-tjh26u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/558690/original/file-20231109-27-tjh26u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/558690/original/file-20231109-27-tjh26u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/558690/original/file-20231109-27-tjh26u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/558690/original/file-20231109-27-tjh26u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/558690/original/file-20231109-27-tjh26u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/558690/original/file-20231109-27-tjh26u.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">Many people with diabetes have to take frequent insulin injections to control their blood sugar levels.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/taking-an-insulin-shot-at-home-royalty-free-image/1426368585">Caíque de Abreu/E+ via Getty Images</a></span>
</figcaption>
</figure>
<p>In particular, they found that the Queen song “<a href="https://www.youtube.com/watch?v=-tJYN-eG1zk">We Will Rock You</a>” most faithfully mimicked the rate of insulin release in normal pancreatic beta cells.</p>
<p>The team then implanted the MUSIC-controlled, insulin-releasing cells into diabetic mice. Listening to the Queen song for 15 minutes once a day returned the amount of insulin in their blood to normal levels. Blood sugar levels returned to normal as well. In contrast, mice that were not exposed to the song remained hyperglycemic.</p>
<h2>Could music make insulin in people?</h2>
<p>Despite these promising results, much more research is needed before this musical approach to producing insulin can be considered for human use.</p>
<p>One concern is the possibility of making too much insulin, which can also cause <a href="https://www.mayoclinic.org/diseases-conditions/hypoglycemia/symptoms-causes/syc-20373685">health problems</a>. Fussenegger’s study found that talking and background noise such as the racket made by airplanes, lawn mowers or firetrucks did not trigger the insulin production system in mice. The music also needed to be played close to the abdomen where the MUSIC-controlled, insulin-releasing cells were implanted.</p>
<p>In an email, Fussenegger explained that extensive clinical trials must be performed to ensure efficacy and safety of the technique and to determine how long the cellular implants can last. As with introducing any foreign material into the body, <a href="https://medlineplus.gov/ency/article/000815.htm">tissue rejection</a> is also a concern.</p>
<p>Cellular engineering may one day provide a much-needed alternative to frequent injections of insulin for the millions of people with diabetes around the world. In the future, different cell types could be engineered to release other drugs in the body more conveniently.</p><img src="https://counter.theconversation.com/content/216787/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bill Sullivan receives funding from the National Institutes of Health.</span></em></p>Researchers successfully treated diabetes in mice by engineering cells to make insulin in response to the music of Queen.Bill Sullivan, Professor of Pharmacology & Toxicology, Indiana UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2154862023-10-24T10:55:14Z2023-10-24T10:55:14ZHow substance use services can better support LGBTQ+ people<figure><img src="https://images.theconversation.com/files/555281/original/file-20231023-29-56xt8z.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C9504%2C6331&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Many LGBTQ+ people do not access drug and alcohol support services because they fear stigma and discrimination.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/pride-rainbow-flag-balloon-flies-high-2312602051">Old Town Tourist/Shutterstock</a></span></figcaption></figure><p>LGBTQ+ people in the UK face significant barriers to accessing substance use services, due to a number of <a href="https://clok.uclan.ac.uk/9598/1/POTP%204th%20Year%20Report.pdf">factors</a>, including fear of discrimination and stigma. Our <a href="https://www.tandfonline.com/doi/full/10.1080/09687637.2023.2238118">research</a> has shed light on these barriers and offers ideas for better helping this community.</p>
<p>We asked 38 LGBTQ+ people about their experiences of using alcohol and other drugs, getting treatment and how they think support and treatment services could improve.</p>
<p>Some LGBTQ+ people face challenges like rejection, stigma and abuse that can negatively impact their self-esteem. Lacking other social outlets, commercial venues like pubs and clubs may become their only connection to community, potentially leading to substance use. </p>
<p>Participants noted challenges such as the normalisation of drinking and clubbing culture within the community. As one explained: “Being part of the LGBTQ+ community can, for some people, be stressful in itself. The club scene in some areas is very drug/alcohol fuelled and focused”.</p>
<p>Another participant also pointed out: “Historically I think recreational drugs have been associated with the queer community, especially among men, this could lead to people thinking that since ‘everyone takes drugs’ they should too”.</p>
<p>Many respondents did not access support services because they feared stigma, discrimination and barriers to treatment. Some also doubted the effectiveness of treatment services or had negative experiences seeking help in the past.</p>
<p>One participant told us: “I didn’t think I would get any help if I sought it because I didn’t get help for other things when I sought and needed it, and because I wasn’t as bad as some other people”.</p>
<p>An important aspect of this research was to listen to the voices of those with lived and living experience of substance use and engagement with drug treatment services. In doing so we identified five suggestions for improving LGBTQ+ engagement:</p>
<h2>1. Training</h2>
<p>Training staff on LGBTQ+ identities, experiences and needs could help to ensure that treatment services are more welcoming and sensitive. This may reduce fears of stigma or discrimination that deter LGBTQ+ people from accessing support.</p>
<h2>2. Recruitment</h2>
<p>Feeling uncomfortable talking about sex or gender identity was cited as something which prevented people from accessing services.</p>
<p>For example, one participant explained the difficulty of talking to heterosexual professionals about <a href="https://www.shwales.online/chemsex.html">chemsex</a>, which is the use of drugs before or during planned sexual activity to enhance, disinhibit or facilitate the experience. Chemsex typically takes place at parties or gatherings organised specifically for this purpose. </p>
<p>Treatment providers need to understand LGBTQ+ culture to help people to feel more comfortable discussing intimate issues like chemsex, which many heterosexual or straight professionals may be less familiar with.</p>
<p>Employing LGBTQ+ staff members from diverse backgrounds could also help make services feel more inclusive and supportive.</p>
<h2>3. Cultural competence</h2>
<p>While some people valued existing inclusive services, more than half of participants said they still faced barriers when trying to access them. Many of our participants suggested that having tailored LGBTQ+ services would be helpful. </p>
<p>But it would also help if existing treatment providers learned more about LGBTQ+ cultures. This is called “<a href="https://www.e-lfh.org.uk/programmes/cultural-competence/">cultural competence</a>”, which means being aware of your own cultural beliefs and values, and how they may differ from those of people from other cultures. It also means being open to learning about different cultures so you can understand and meet the needs of the community. </p>
<p>Group services designed for and by LGBTQ+ people could reduce the risk of feeling marginalised in mixed groups. An LGBTQ+ culturally competent provider would be educated about LGBTQ+ experiences, mindful of their own potential biases, and able to offer a welcoming space for open discussion without judgement or misunderstanding.</p>
<h2>4. Outreach</h2>
<p>Attending Pride events and community spaces could help to build trust and make better connections with LGBTQ+ people. This could also make services more visible, approachable and accessible to the people who need them.</p>
<h2>5. Advertising</h2>
<p>Visible signals of LGBTQ+ inclusion was also important to our respondents. Symbols like rainbow flags and explicitly stating “LGBTQ+ welcome” in promotional materials could help to communicate that services affirm LGBTQ+ identities and are safe spaces. </p>
<p>One person told us: “Generally, if they were vocally welcoming of LGBT people, it would maybe lessen any worry”.</p>
<figure class="align-center ">
<img alt="An LGBTQ+ flag hangs out of a bag" src="https://images.theconversation.com/files/555280/original/file-20231023-15-tij0b7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/555280/original/file-20231023-15-tij0b7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/555280/original/file-20231023-15-tij0b7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/555280/original/file-20231023-15-tij0b7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/555280/original/file-20231023-15-tij0b7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/555280/original/file-20231023-15-tij0b7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/555280/original/file-20231023-15-tij0b7.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">Everyone deserves compassionate and inclusive care for substance use issues.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/york-england-united-kingdom-june-3-2312590215">Old Town Tourist/Shutterstock</a></span>
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</figure>
<p>We now need to work much harder to understand these complex issues with bigger and more diverse groups of LGBTQ+ participants.</p>
<p>All people deserve affirming, compassionate care for substance use issues. Thoughtfully engaging with LGBTQ+ communities and listening to their perspectives is crucial for providing equitable services. Implementing LGBTQ+ inclusive practices requires commitment but is entirely feasible.</p>
<p>Substance use services willing to learn, adapt and grow can successfully create welcoming environments for LGBTQ+ people. Small steps towards inclusion ultimately enable greater access to support for communities that have felt left out for far too long.</p><img src="https://counter.theconversation.com/content/215486/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shannon Murray received funding from the University of South Wales' Knowledge Exchange Innovation Fund (KEIF) and was awarded funding through the Civic Action Fund for this research. Shannon works for the University of South Wales as a research assistant in the Substance Use Research Group (SURG) and is a doctoral student at Cardiff University researching gay and bi men's experiences of Intimate Partner Violence (IPV). </span></em></p>LGBTQ+ people face barriers to accessing substance use services, but research shows there are ways to make them more inclusive and supportive.Shannon Murray, Research assistant at the Substance Use Research Group and PhD Candidate, University of South WalesLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2157912023-10-22T23:03:19Z2023-10-22T23:03:19ZNovel drugs are leading to rising overdose deaths in Victoria – drug checking services could help<figure><img src="https://images.theconversation.com/files/554906/original/file-20231019-22-zbi79a.jpg?ixlib=rb-1.1.0&rect=0%2C17%2C6000%2C3970&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/mans-hand-holds-two-transparent-plastic-2268792263">Farion_O/Shutterstock</a></span></figcaption></figure><p>Many of the harms people experience from using illegal drugs are a result of <a href="https://www.sciencedirect.com/science/article/pii/S0376871622001648">unregulated supply</a>. Drugs may be contaminated, or completely substituted with something unexpected. They may also be of variable and unknown dosage or strength. </p>
<p>Any of these factors can and do lead to overdoses. That’s why <a href="https://www.vaada.org.au/aod-advocacy/drug-checking-and-early-warning-systems-knowing-the-harms-can-prevent-the-harms/">77 health and community organisations</a> are urging the Victorian government to implement drug checking services. These could reduce overdose deaths, and provide an early warning system to flag any unusually dangerous substances in circulation. </p>
<p>The Victorian statement adds to similar calls in other Australian jurisdictions. Notably, in New South Wales, a <a href="https://www.theage.com.au/politics/nsw/nsw-labor-mp-speaks-out-in-support-over-pill-testing-20231019-p5edgw.html">Labor MP last week broke rank</a> with his party to voice his support for the implementation of drug checking services.</p>
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<strong>
Read more:
<a href="https://theconversation.com/drug-checking-and-an-early-warning-network-in-victoria-could-save-lives-new-coroners-report-157684">Drug checking and an early warning network in Victoria could save lives: new coroner's report</a>
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<h2>What’s the problem?</h2>
<p>In the <a href="https://www.unodc.org/res/WDR-2023/WDR23_Exsum_fin_DP.pdf">past 15 years</a>, the number of new psychoactive substances detected in drug markets has increased dramatically around the world. It’s easier for suppliers to circumvent laws that prohibit more traditional drugs (such as cocaine, heroin, MDMA or methamphetamine) by producing newer synthetic drugs. These drugs are also often cheaper to produce. </p>
<p>They then get added to or sold as other more established drugs. This means people don’t always know what they’re taking, or how strong it is.</p>
<p>According to the <a href="https://www.coronerscourt.vic.gov.au/">Coroners Court of Victoria</a>, novel substances were detected in three deaths in 2017-18. This figure has risen significantly over the past five years, to 47 deaths in 2021-22.</p>
<p>Escalating deaths involving novel substances are being identified nationally. For example, there have been 40 deaths involving <a href="https://doi.org/10.1016/j.forsciint.2021.111140">novel benzodiazepines</a> in Australia since 2015.</p>
<figure class="align-center ">
<img alt="A number of round, white pills on a table." src="https://images.theconversation.com/files/554912/original/file-20231020-25-akslzl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/554912/original/file-20231020-25-akslzl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/554912/original/file-20231020-25-akslzl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/554912/original/file-20231020-25-akslzl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/554912/original/file-20231020-25-akslzl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/554912/original/file-20231020-25-akslzl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/554912/original/file-20231020-25-akslzl.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">Illegal drugs can be contaminated with unexpected substances.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/backlit-white-pills-opioid-prescription-medication-694514731">Tomas Nevesely/Shutterstock</a></span>
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<p>While harder to track, unexpectedly strong substances have been implicated in further deaths. In 2019, the <a href="https://coroners.nsw.gov.au/coroners-court/download.html/documents/findings/2019/Music_Festival_Redacted_findings_in_the_joint_inquest_into_deaths_arising_at_music_festivals_.pdf">NSW Coroner’s Court</a> investigated six deaths at music festivals resulting from consumption of unusually high-dose MDMA capsules. Last month, <a href="https://www.coronerscourt.vic.gov.au/highly-potent-mdma-pill-prompts-call-drug-testing-services">Victoria’s coroner</a> investigated a death that similarly followed consumption of an unexpectedly high-dose MDMA tablet. </p>
<p>Meanwhile, synthetic opioid drugs are causing an epidemic of <a href="https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates">drug fatalities</a> in <a href="https://www.sciencedirect.com/science/article/pii/S2667193X2300011X?via%3Dihub">North America</a>. Some of these novel opioids have recently been detected in Australia, including a new class called <a href="https://pubmed.ncbi.nlm.nih.gov/35983900/">nitazenes</a>, which have been identified in <a href="https://www.health.act.gov.au/public-health-alert/public-health-alert-dangerous-drug-warning-canberrans">the ACT</a>, <a href="https://www.health.nsw.gov.au/aod/public-drug-alerts/Pages/heroin-found-to-contain-nitazenes.aspx">NSW</a>, <a href="https://www.health.vic.gov.au/drug-alerts/yellow-powder-containing-protonitazene-may-be-sold-as-ketamine">Victoria</a>, and <a href="https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/public+health/alerts/health+alerts/protonitazene+cases+in+south+australia">South Australia</a>.</p>
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<strong>
Read more:
<a href="https://theconversation.com/nitazenes-synthetic-opioids-more-deadly-than-fentanyl-are-starting-to-turn-up-in-overdose-cases-212589">Nitazenes: synthetic opioids more deadly than fentanyl are starting to turn up in overdose cases</a>
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<h2>What is drug checking?</h2>
<p>Often called “pill testing” in Australia, the term drug checking reflects that these services are inclusive of multiple drug forms (for example, powders and liquids in addition to pills) as well as multiple drug types (for example, cocaine, ketamine, heroin, methamphetamine and MDMA). </p>
<p><a href="https://www.emerald.com/insight/content/doi/10.1108/DHS-01-2022-0007/full/html">Drug checking services</a> can be at a permanent location or mobile (for example, on-site at venues and festivals). People visit these facilities to find out the content and strength of drugs they plan to use, including whether they contain unexpected substances or higher-than-usual doses.</p>
<p>Service users also have the opportunity to discuss the test results in a meeting with a health-care worker, in a conversation about their broader drug use and health.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-drug-checking-and-why-do-we-need-it-in-australia-51578">What is 'drug checking' and why do we need it in Australia?</a>
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<h2>How does it help?</h2>
<p>A recent <a href="https://onlinelibrary.wiley.com/doi/10.1111/add.15734">systematic review</a> analysing 90 studies found that drug checking services positively influenced the behaviour of people who use drugs. </p>
<p>In two recent studies conducted in <a href="https://www.sciencedirect.com/science/article/abs/pii/S0955395921001675">the UK</a> and <a href="https://www.tandfonline.com/doi/abs/10.1080/09687637.2022.2072187">Portugal</a>, most service users (86% in Portugal, 69% in the UK) who received test results indicating that the drug was different than expected didn’t consume the substance. About half of service users (50% in Portugal, 59% in the UK) whose test results indicated that their drugs were stronger than expected took a smaller dose.</p>
<p>Drug checking service data also provides real-time information about the status of local drug markets. Alerts can be published to rapidly warn people if an unusually dangerous substance is circulating. For example, the ACT drug checking service CanTEST has so far published <a href="https://directionshealth.com/cantest-health-drug-checking-service/">six community alerts</a> alongside monthly drug market snapshot reports.</p>
<h2>Responding to critiques</h2>
<p>One argument levelled against drug checking is that such services provide a “<a href="https://onlinelibrary.wiley.com/doi/abs/10.1046/j.1360-0443.2001.96811397.x">shine of safety</a>” to drug use. But, as noted by an established drug checking service in <a href="https://www.trimbos.nl/aanbod/webwinkel/product/af1677-the-drugs-information-and-monitoring-system-dims">The Netherlands</a>, services never provide an endorsement of quality. Instead, they warn people how unpredictable drug markets can be by providing credible and relevant information.</p>
<p>Similarly, evidence doesn’t support claims that the availability of drug checking services leads to increased drug use. A recent <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/dar.13259">Australian study</a> that surveyed festival-goers about drug checking scenarios found the existence of a drug checking service wouldn’t increase intention to use ecstasy.</p>
<h2>What’s happening elsewhere?</h2>
<p>Drug checking services are now operating in <a href="https://hri.global/wp-content/uploads/2022/11/HRI_GSHR-2022_Full-Report_Final.pdf">at least 28 countries</a>, having expanded significantly around the world in recent years.</p>
<p>In 2021, <a href="https://www.health.govt.nz/our-work/regulation-health-and-disability-system/drug-checking">New Zealand</a> passed legislation to make drug checking services fully legal.</p>
<p>Australia’s experience so far with government-sanctioned drug checking has included fixed-site and mobile <a href="https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00708-3">drug checking trials in Canberra</a>, and recently-announced approval for drug checking services to <a href="https://statements.qld.gov.au/statements/97250">commence in Queensland</a>. An <a href="https://www.health.act.gov.au/sites/default/files/2023-01/Interim%20Report%20Submitted%2019_12-22.pdf">interim report</a> on a pilot in Canberra’s city centre supports the continuation and development of the service.</p>
<figure class="align-center ">
<img alt="Three young people socialising at a festival." src="https://images.theconversation.com/files/554911/original/file-20231020-21-zkg0oy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/554911/original/file-20231020-21-zkg0oy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=447&fit=crop&dpr=1 600w, https://images.theconversation.com/files/554911/original/file-20231020-21-zkg0oy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=447&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/554911/original/file-20231020-21-zkg0oy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=447&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/554911/original/file-20231020-21-zkg0oy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=562&fit=crop&dpr=1 754w, https://images.theconversation.com/files/554911/original/file-20231020-21-zkg0oy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=562&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/554911/original/file-20231020-21-zkg0oy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=562&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Drug checking services could be set up at music festivals and other events.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/group-young-friends-sitting-on-ground-1563349978">Ground Picture/Shutterstock</a></span>
</figcaption>
</figure>
<h2>Support is growing</h2>
<p>In Australia, the implementation of drug checking services has been recommended by numerous <a href="https://www.nsw.gov.au/the-cabinet-office/resources/special-commissions-of-inquiry/drug-ice">government inquiries</a> and <a href="https://www.coronerscourt.vic.gov.au/highly-potent-mdma-pill-prompts-call-drug-testing-services">coronial inquests</a>, including the 2018 Parliament of Victoria <a href="https://new.parliament.vic.gov.au/get-involved/inquiries/inquiry-into-drug-law-reform/">Inquiry into Drug Law Reform</a> and the <a href="https://coroners.nsw.gov.au/coroners-court/download.html/documents/findings/2019/Music_Festival_Redacted_findings_in_the_joint_inquest_into_deaths_arising_at_music_festivals_.pdf">2019 inquest</a> into the death of six patrons at NSW music festivals.</p>
<p>In terms of public support, a <a href="https://onlinelibrary.wiley.com/doi/epdf/10.1111/dar.13211">nationally representative survey</a> found that in 2019, 63% of Australians supported drug checking. Some 22% were opposed while 15% were unsure or didn’t answer.</p>
<p>The Victorian statement <a href="https://www.vaada.org.au/aod-advocacy/drug-checking-and-early-warning-systems-knowing-the-harms-can-prevent-the-harms/">released today</a> demonstrates support from a wide range of social and community organisations. These include professional societies representing medical and pharmaceutical sectors, such as the <a href="https://www.racgp.org.au/">Royal Australian College of General Practitioners</a> and the <a href="https://www.psa.org.au/">Pharmaceutical Society of Australia</a>. </p>
<p>Implementing drug checking will help prevent further overdose deaths that result from unregulated drug supplies.</p><img src="https://counter.theconversation.com/content/215791/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In the last 5 years, Monica Barratt has received funding from the National Health and Medical Research Council, the National Centre for Clinical Research into Emerging Drugs, the Criminology Research Council, New Zealand’s Marsden Fund and the U.S. National Institutes of Health. In addition to her academic role, she also serves as the Executive Director of Bluelight.org, a global drug harm reduction community, and leads research activities for The Loop Australia, a charity aiming to conduct drug checking interventions both at festivals and in the community.
</span></em></p><p class="fine-print"><em><span>Isabelle Volpe receives PhD stipends from the Australian Government Research Training Program and UNSW Arts, Design & Architecture, and has previously received funding from the National Centre for Clinical Research into Emerging Drugs. She volunteers with The Loop Australia (overseeing the communication of information about drug checking and drug alerts) and DanceWize NSW (providing care and education to music event attendees).</span></em></p>Drug checking services could also provide an early warning system to flag any unusually dangerous substances in circulation.Monica Barratt, Vice Chancellor’s Senior Research Fellow, Social Equity Research Centre and Digital Ethnography Research Centre, RMIT UniversityIsabelle Volpe, PhD Candidate, Drug Policy Modelling Program, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2146222023-10-12T12:31:00Z2023-10-12T12:31:00ZHorseshoe crab blood is vital for testing intravenous drugs, but new synthetic alternatives could mean pharma won’t bleed this unique species dry<figure><img src="https://images.theconversation.com/files/552874/original/file-20231010-19-onfdw4.jpg?ixlib=rb-1.1.0&rect=33%2C8%2C5579%2C3728&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Horseshoe crabs in spawning season at Reeds Beach, N.J., on June 13, 2023.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/HorseshoeCrabHarvest/053d4f924f9c453f808a4d3724a87e73/photo">AP Photo/Matt Rourke</a></span></figcaption></figure><p>If you have ever gotten a vaccine or received an intravenous drug and did not come down with a potentially life-threatening fever, you can thank a horseshoe crab (<em>Limulus polyphemus</em>).</p>
<p>How can animals that are <a href="https://www.britannica.com/animal/horseshoe-crab">often called living fossils</a>, because they have barely changed over millions of years, be so important in modern medicine? Horseshoe crab blood is used to produce a substance called limulus amebocyte lysate, or LAL, which scientists use to test for <a href="https://www.britannica.com/science/endotoxin">toxic substances called endotoxins</a> in intravenous drugs. </p>
<p>These toxins, produced by bacteria, are ubiquitous in the environment and can’t be removed simply through sterilization. They can cause a reaction historically referred to as “<a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/pyrogens-still-danger">injection fever</a>.” A strong concentration can lead to shock and even death. </p>
<p>Identifying LAL as a highly sensitive detector of endotoxins was a 20th-century medical safety breakthrough. Now, however, critics are raising questions about environmental impacts and the process for reviewing and approving synthetic alternatives to horseshoe crab blood.</p>
<p>We study <a href="https://scholar.google.com/citations?user=Dd_T980AAAAJ&hl=en&authuser=1&oi=ao">science, technology</a> and <a href="https://www.linkedin.com/in/jolie-crunelle/%20student">public policy</a>, and recently published a <a href="https://osf.io/3tm9g/">white paper</a> examining social, political and economic issues associated with using horseshoe crabs to produce LAL. We see this issue as a test case for complicated problems that cut across multiple agencies and require attention to both nature and human health.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/CgRn3T7vcMw?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Protecting horseshoe crabs will require persuading the heavily regulated pharmaceutical industry to embrace change.</span></figcaption>
</figure>
<h2>An ocean solution</h2>
<p>Doctors began injecting patients with various solutions <a href="https://doi.org/10.1016/j.socscimed.2004.06.044">in the mid-1800s</a>, but it was not until the 1920s that biochemist <a href="https://lemelson.mit.edu/resources/florence-seibert">Florence Seibert</a> discovered that febrile reactions were due to contaminated water in these solutions. She created a method for detecting and removing the substances that caused this reaction, and it became the medical standard in the 1940s.</p>
<p>Known as the <a href="https://www.matresearch.com/pyrogen-testing/">rabbit pyrogen test</a>, it required scientists to inject intravenous drugs into rabbits, then monitor the animals. A feverish rabbit meant that a batch of drugs was contaminated.</p>
<p>The LAL method was discovered by accident. Working with horseshoe crabs at the <a href="https://www.mbl.edu/">Marine Biological Laboratory</a> at Woods Hole, Massachusetts, in the 1950s and ’60s, <a href="https://www.goldengooseaward.org/01awardees/horseshoe-crab-blood">pathobiologist Frederik Bang and medical researcher Jack Levin</a> noticed that the animals’ <a href="https://hub.jhu.edu/magazine/2021/summer/horseshoe-crabs-covid19-medical-uses/">blue blood</a> coagulated in a curious manner. Through a series of experiments, they isolated endotoxin as the coagulant and devised a method for extracting LAL from the blood. This compound would gel or clot nearly instantaneously in the presence of fever-inducing toxins.</p>
<p>Academic researchers, biomedical companies and the U.S. Food and Drug Administration refined LAL production and measured it against the rabbit test. By the 1990s, LAL was the <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/bacterial-endotoxinspyrogens">FDA-approved method</a> for testing medicines for endotoxin, largely replacing rabbits.</p>
<p>Producing LAL requires harvesting horseshoe crabs from oceans and beaches, <a href="https://www.theatlantic.com/technology/archive/2014/02/the-blood-harvest/284078/">draining up to 30% of their blood</a> in a laboratory and returning the live crabs to the ocean. There’s dispute about <a href="https://www.scientificamerican.com/article/medical-labs-may-be-killing-horseshoe-crabs/">how many crabs die in the process</a> – estimates range from a few percent to 30% or more – and about possible harmful effects on survivors. </p>
<p>Today there are five FDA-licensed <a href="https://asmfc.org/uploads/file/645bf065HSC_Biomedical_BMPs_2023.pdf">LAL producers</a> along the U.S. East Coast. The amount of LAL they produce, and its sales value, are proprietary. </p>
<h2>Bait versus biotech</h2>
<p>As biomedical LAL production ramped up in the 1990s, so did harvesting horseshoe crabs to use as bait for other species, particularly eel and whelk for foreign seafood markets. Over the past 25 years, hundreds of thousands – and in the early years, millions – of horseshoe crabs have been harvested each year for these purposes. Combined, the two fisheries kill <a href="https://asmfc.org/species/horseshoe-crab">over half a million</a> horseshoe crabs every year.</p>
<p>There’s no agreed total population estimate for <em>Limulus</em>, but the most recent <a href="https://asmfc.org/uploads/file/63d2ed62HSCAssessment_PeerReviewReport_May2019.pdf">federal assessment of horseshoe crab fisheries</a> found the population was neither strongly growing nor declining.</p>
<p>Conservationists are worried, and not just about the crabs. Millions of shorebirds <a href="https://atlanticflywayshorebirds.org/">migrate along the Atlantic coast</a>, and many stop in spring, when horseshoe crabs spawn on mid-Atlantic beaches, to feed on the crabs’ eggs. Particularly for <a href="https://www.allaboutbirds.org/guide/Red_Knot/overview">red knots</a> – a species that can migrate up to 9,000 miles between the tip of South America and the Canadian Arctic – gorging on horseshoe crab eggs provides a critical energy-rich boost on their grueling journey.</p>
<p>Red knots were <a href="https://www.federalregister.gov/documents/2014/12/11/2014-28338/endangered-and-threatened-wildlife-and-plants-threatened-species-status-for-the-rufa-red-knot">listed as threatened</a> under the Endangered Species Act in 2015, largely because horseshoe crab fishing threatened this key food source. As biomedical crab harvests came to equal or <a href="https://asmfc.org/species/horseshoe-crab">surpass bait harvests</a>, conservation groups began calling on the LAL industry to find new sources.</p>
<p><div data-react-class="InstagramEmbed" data-react-props="{"url":"https://www.instagram.com/p/Ct2Aji4xcPJ/?utm_source=ig_web_copy_link\u0026igshid=MzRlODBiNWFlZA==","accessToken":"127105130696839|b4b75090c9688d81dfd245afe6052f20"}"></div></p>
<h2>Biomedical alternatives</h2>
<p>Many important medicines are derived from living organisms. Penicillin, the first important antibiotic, was <a href="https://www.sciencemuseum.org.uk/objects-and-stories/how-was-penicillin-developed">originally produced from molds</a>. Other medicines currently in use come from sources including <a href="https://www.goodrx.com/well-being/diet-nutrition/medications-that-contain-animal-byproducts">cows, pigs, chickens and fish</a>. The ocean is a <a href="https://oceanexplorer.noaa.gov/facts/medicinesfromsea.html">promising source</a> for such products.</p>
<p>When possible, synthesizing these substances in laboratories – especially widely used medications like <a href="https://www.cityofhope.org/breakthroughs/art-riggs-tribute">insulin</a> – offers many benefits. It’s typically cheaper and more efficient, and it avoids putting species at risk, as well as addressing <a href="https://www.uspharmacist.com/article/animal-derived-medications-can-be-problematic-for-some-patients">concerns some patients have</a> about using animal-derived medical products.</p>
<p>In the 1990s, researchers at the National University of Singapore <a href="https://patents.google.com/patent/WO1999015676A1/en?inventor=Jeak+Ling+Ding">invented and patented</a> the first process for creating a synthetic, endotoxin-detecting compound using horseshoe crab DNA and <a href="https://www.genome.gov/genetics-glossary/Recombinant-DNA-Technology">recombinant DNA technology</a>. The result, dubbed recombinant Factor C (rFC), mimicked the first step in the three-part cascade reaction that occurs when LAL is exposed to endotoxin. </p>
<p>Later, several biomedical firms <a href="https://www.americanpharmaceuticalreview.com/Featured-Articles/569887-Historical-Milestones-and-Industry-Drivers-in-the-Development-of-Recombinant-Lysate-for-Bacterial-Endotoxin-Testing/">produced their own versions</a> of rFC and compounds called recombinant cascade reagents (rCRs), which reproduce the entire LAL reaction without using horseshoe crab blood. Yet, today, LAL remains the dominant technology for detecting endotoxins in medicine. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A vial partly filled with pale blue fluid" src="https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.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>
<figcaption>
<span class="caption">A sample of horseshoe crab blood.</span>
<span class="attribution"><a class="source" href="https://flic.kr/p/riAZsU">Florida Fish and Wildlife Commission</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>The main reason is that the <a href="https://www.usp.org/">U.S. Pharmacopeia</a>, a quasi-regulatory organization that sets safety standards for medical products, considers rFC and rCR as “alternative” methods for detecting endotoxins, so they require case-by-case validation for use – a potentially lengthy and expensive process. The FDA generally defers to the U.S. Pharmacopeia.</p>
<p>A few large pharmaceutical companies with deep pockets have committed to <a href="https://www.esg.lilly.com/environmental/biodiversity?redirect-referrer=https%3A%2F%2Fwww.google.com%2F#case-studies">switching from LAL to rFC</a>. But most drug producers are sticking with the tried-and-true method. </p>
<p>Conservation groups want the U.S. Pharmacopeia to <a href="https://www.audubon.org/magazine/summer-2018/inside-biomedical-revolution-save-horseshoe-crabs">fully certify rFC</a> for use in industry with no extra testing or validation. In their view, LAL producers are stalling rFC and rCR approval to protect their <a href="https://www.npr.org/2023/06/10/1180761446/coastal-biomedical-labs-are-bleeding-more-horseshoe-crabs-with-little-accountabi">market in endotoxin detection</a>. The U.S. Pharmacopeia and LAL producers counter that they are doing due diligence to <a href="https://hsc.criver.com/#lal-endo">protect public health</a>.</p>
<h2>Change in the offing</h2>
<p>Change may be coming. All major LAL producers now have their own recombinant products – a tacit acknowledgment that markets and regulations are moving toward <em>Limulus</em>-free ways to test for endotoxins. </p>
<p>Atlantic fisheries regulators are currently considering <a href="https://www.asmfc.org/home/2023-annual-meeting">new harvest limits for horseshoe crabs</a>, and the U.S. Pharmacopeia is <a href="https://www.uspnf.com/notices/86-bet-using-recombinant-tests-gen-annc-20230822">weighing guidance</a> on recombinant alternatives to LAL. Public comments will be solicited over the winter of 2024, followed by U.S. Pharmacopeia and FDA review. </p>
<p>Even if rFC and rCR don’t win immediate approval, we believe that collecting more complete data on horseshoe crab populations and requiring more transparency from the LAL industry on <a href="https://asmfc.org/uploads/file/645bf065HSC_Biomedical_BMPs_2023.pdf">how it handles the crabs</a> would represent progress. So would directing medical companies to use recombinant products for testing during the manufacturing process, while saving LAL solely for final product testing. </p>
<p>Making policy on complex scientific issues across diverse agencies is never easy. But in our view, incremental actions that protect both human health and the environment could be important steps forward.</p><img src="https://counter.theconversation.com/content/214622/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>This material is based upon work supported by the National Science Foundation under Award No. 2121146, as well as the Leverhulme Trust through a Leverhulme Trust Research Project Grant. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation or the Leverhulme Trust.</span></em></p><p class="fine-print"><em><span>Jolie Crunelle receives funding from the Aberg Family Fellowship at Rochester Institute of Technology. </span></em></p>Horseshoe crabs play a unique role in medicine, but they’re also ecologically important in their home waters along the Atlantic coast. Can regulators balance the needs of humans and nature?Kristoffer Whitney, Associate Professor of Science, Technology and Society, Rochester Institute of TechnologyJolie Crunelle, Master's Degree Student in Science, Technology, and Public Policy, Rochester Institute of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2093122023-09-15T12:31:41Z2023-09-15T12:31:41ZCan at-home DNA tests predict how you’ll respond to your medications? Pharmacists explain the risks and benefits of pharmacogenetic testing<figure><img src="https://images.theconversation.com/files/545852/original/file-20230831-15-xftd5k.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2070%2C1449&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Pharmacogenetic testing is a form of precision medicine, using your genes to personalize your care.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/medicine-concept-royalty-free-image/815702424">D3Damon/E+ via Getty Images</a></span></figcaption></figure><p>Have you ever wondered why certain medications <a href="https://theconversation.com/why-prescription-drugs-can-work-differently-for-different-people-168645">don’t seem to work as well</a> for you as they do for others? This variability in drug response is what pharmacogenomic testing hopes to explain by looking at the genes within your DNA. </p>
<p><a href="https://www.cdc.gov/genomics/disease/pharma.htm">Pharmacogenomics, or PGx</a>, is the study of how genes affect your response to medications. <a href="https://www.genome.gov/genetics-glossary/Gene">Genes are segments of DNA</a> that serve as an instruction manual for cells to make proteins. Some of these proteins break down or transport certain medications through the body. Others are proteins that medications target to generate a desired effect.</p>
<p><a href="https://www.pharmacy.pitt.edu/people/kayla-rowe">As pharmacists</a> <a href="https://scholar.google.com/citations?user=9Np7_DYAAAAJ&hl=en">who see</a> <a href="https://scholar.google.com/citations?user=LKG31OkAAAAJ&hl=en">patients who</a> have stopped multiple medications because of side effects or ineffectiveness, we believe pharmacogenomic testing has the potential to help guide health care professionals to more precise dosing and prescribing.</p>
<h2>How do PGx tests work?</h2>
<p><a href="https://medlineplus.gov/lab-tests/pharmacogenetic-tests/">PGx tests</a> look for variations within the genes of your DNA to predict drug response. For instance, the presence of one genetic variant might predict that the specific protein it codes for is unable to break down a particular medication. This could potentially lead to increased drug levels in your body and an increased risk of side effects. The presence of another genetic variant might predict the opposite: It might predict that the protein it codes for is breaking down a medication more rapidly than expected, which may decrease the drug’s effectiveness.</p>
<p>For example, <a href="https://doi.org/10.1002/cpt.2903">citalopram is an antidepressant</a> broken down by a protein called CYP2C19. Patients with genetic variants that code for a version of this protein with a reduced ability to break down the drug may have an increased risk of side effects.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/dGMIyzCRl-A?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">PGx is a form of personalized or precision medicine.</span></figcaption>
</figure>
<p>Currently, there are over 80 medications with <a href="https://cpicpgx.org/">prescribing recommendations</a> based on PGx results, including treatments for depression, cancer and heart disease. There are commercially available PGx tests that patients can have sent directly to their doorstep with or without the involvement of a health care professional. These direct-to-consumer PGx tests collect DNA from either a saliva sample or cheek swab that is then sent to the laboratory. Results can take anywhere from a few days to a few weeks depending on the company. </p>
<p>Some companies <a href="https://doi.org/10.1038%2Fnature15817">require a consultation</a> with a health care provider, often a pharmacist or genetic counselor, who can facilitate a test order and discuss any medication changes once the results come back. </p>
<h2>Limitations of PGx testing</h2>
<p>PGx testing will not be able to predict how you will respond to all medications for several reasons.</p>
<p>First, most PGx tests <a href="https://doi.org/10.3390/genes11121456">do not look for every possible variant</a> of every gene in the human genome. Instead, they look only at a limited number of genes and variants strongly linked to specific drugs. PGx tests can predict how you will respond only to medications associated with the genes it tests for. </p>
<p>Some drugs are broken down in very complicated pathways entailing multiple proteins and byproducts, and the usefulness of PGx testing for them remains unclear. For example, the <a href="https://www.pharmgkb.org/pathway/PA166170276">antidepressant bupropion</a> has three major pathways involved in its breakdown and forms three active byproducts that can interact with other drugs or body processes. This makes predicting how you will respond to the drug much more challenging because there is more than one variable involved. In many cases, there also isn’t conclusive data to confidently predict the general function of a protein and how it would affect your response to a drug.</p>
<p>The applicability of PGx test results is additionally limited by a <a href="https://theconversation.com/uncovering-the-genetic-basis-of-mental-illness-requires-data-and-tools-that-arent-just-based-on-white-people-this-international-team-is-collecting-dna-samples-around-the-globe-185997">lack of diversity of study participants</a>. Typically, populations of European ancestry are overrepresented in clinical trials. An ongoing research initiative by the National Institutes of Health called the <a href="https://allofus.nih.gov/">All of Us Research Program</a> aims to address this issue by collecting genetic samples from people of diverse backgrounds. </p>
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<figcaption><span class="caption">The All of Us research program seeks to conduct research that is more representative of a diverse population.</span></figcaption>
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<p>Another limitation of direct-to-consumer PGx tests is that they can predict drug response based only on your genetics. <a href="https://my.clevelandclinic.org/health/diagnostics/21093-pharmacogenomics">Lifestyle and environmental factors</a> such as your age, liver or kidney function, tobacco use, drug interactions and other diseases can heavily influence how you may respond to medication. For example, leafy greens with high amounts of vitamin K can <a href="https://www.pennmedicine.org/updates/blogs/heart-and-vascular-blog/2015/june/consistency-not-avoidance-the-truth-about-blood-thinners-leafy-greens-and-vitamin-k">lower the effectiveness</a> of the blood thinner warfarin. But PGx tests don’t take these factors into account.</p>
<p>Finally, your PGx results may predict that you may respond to medications differently, but this does not guarantee that the medication won’t have its intended effect. In other words, PGx testing is predictive rather than deterministic.</p>
<h2>Risks of PGx testing</h2>
<p>PGx testing carries the risk of not telling the whole story of drug response. If variations within the gene are not found, the testing company often assumes the proteins those genes code for function normally. Because of this assumption, someone carrying a rare or unknown variant may receive inaccurate results.</p>
<p>It may be tempting for some people to see their results and want to change their dose or discontinue their medications. However, this can be dangerous. Abruptly stopping some medications may cause withdrawal effects. Never change the way you take your medications without consulting your pharmacist and physician first.</p>
<p>Sharing your PGx test results with all the clinicians involved in your care can help prevent medication failure and improve safety. Pharmacists are increasingly trained in pharmacogenomics and can serve as a resource to address medication-related questions or concerns.</p>
<p>PGx tests that are not authorized by the Food and Drug Administration cannot be clinically interpreted and therefore cannot be used to inform prescribing. Results from these tests should not be added to your medical record.</p>
<h2>Benefits of PGx testing</h2>
<p>Direct-to-consumer PGx testing can empower patients to advocate for themselves and be an active participant in their health care by increasing access to and knowledge of their genetic information.</p>
<p>Patients’ knowledge of their PGx genetic profile has the potential to improve treatment safety. For example, a 2023 study of over 6,000 patients in Europe found that those who used their PGx results to guide medication therapy were <a href="https://doi.org/10.1016/s0140-6736(22)01841-4">30% less likely</a> to experience adverse drug reactions.</p>
<p>Most PGx test results stay valid throughout a patient’s life, and <a href="https://mhealthfairview.org/services/pharmacogenomics">retesting is not needed</a> unless additional genes or variants need to be evaluated. As more research on gene variants is conducted, prescribing recommendations may be updated. </p>
<p>Overall, genetic information from direct-to-consumer PGx tests can help you collaborate with health care professionals to select more effective medications with a lower risk of side effects.</p><img src="https://counter.theconversation.com/content/209312/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 organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Genetic testing can help take the guesswork out of finding the right treatment. For certain diseases. To an extent.Kayla B. Rowe, Fellow in Clinical Pharmacogenomics, University of PittsburghLucas A. Berenbrok, Associate Professor of Pharmacy and Therapeutics, University of PittsburghPhilip Empey, Associate Professor of Pharmacogenomics, University of PittsburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2130412023-09-11T23:27:09Z2023-09-11T23:27:09ZWith a pharmacare bill on the horizon, Big Pharma’s attack on single-payer drug coverage for Canadians needs a fact check<figure><img src="https://images.theconversation.com/files/547294/original/file-20230908-23-s1i9fc.jpg?ixlib=rb-1.1.0&rect=201%2C23%2C4974%2C3243&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Under a pharmacare plan, a single bargaining agent negotiates for lower prices from drug companies.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/with-a-pharmacare-bill-on-the-horizon-big-pharmas-attack-on-single-payer-drug-coverage-for-canadians-needs-a-fact-check" width="100%" height="400"></iframe>
<p>Health Minister Mark Holland <a href="https://www.cbc.ca/news/politics/mark-holland-health-minister-pharmacare-1.6938470">announced in August</a> that the federal government intends to introduce pharmacare legislation in the fall. Now the battle lines are being drawn.</p>
<p>One of the many virtues of pharmacare — a universal drug coverage plan — is that there will be a single bargaining agent looking for lower prices from the drug companies. Australia has a single buyer and has brand-name prices that are on average <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html">29 per cent lower than Canada’s</a>. That difference on Canadian annual sales of $17.4 billion translates into savings of about $5 billion.</p>
<p>Pharmaceutical and insurance industries that stand to lose profit through lower drug prices are not happy about pharmacare. They are speaking out and mobilizing their allies. </p>
<h2>‘Fill in the gaps’</h2>
<p>Innovative Medicines Canada, the lobby group for Big Pharma, is pushing for a “<a href="https://innovativemedicines.ca/newsroom/all-news/imc-calls-on-canadas-premiers-to-improve-patient-access-to-medicines/">fill in the gaps</a>” model. That means providing coverage for people who don’t have drug insurance, but leaving the current system otherwise untouched.</p>
<p>Québec already has “filled in the gaps.” However, it <a href="https://doi.org/10.1503/cmaj.170726">hasn’t achieved the solutions shown in countries with pharmacare</a>. Québec spends more per capita on drugs than other provinces. A greater percentage of people in Québec (8.7 per cent) report spending more than $1,000 on prescription drugs in one year, compared to comparable countries with pharmacare (three per cent) or even the rest of Canada (4.8 per cent).</p>
<p>In Québec, nine per cent of its residents report that they go without their medications because they cannot afford them. While this is an improvement on the rest of the country, with 11 per cent of Canadians in other provinces skipping medications due to costs, it is still significantly higher than the numbers in most comparable countries with pharmacare (six per cent or less).</p>
<h2>The 97 per cent myth</h2>
<p>GreenShield, a not-for-profit health benefits provider and a member of the Canadian Life and Health Insurance Association (CLHIA), appears to share the insurance industry’s stand against pharmacare. In July it <a href="https://www.theglobeandmail.com/business/article-greenshield-cares-essential-medicines-low-income/">announced a pilot program</a> that will offer up to $1,000 in drug coverage to low-income Canadians who do not have public or private prescription drug insurance.</p>
<p>In making the announcement, GreenShield’s chief executive Zahid Salman repeated the myth that 97 per cent of Canadians already have drug coverage. That 97 per cent number is theoretical. Having some form of coverage does not necessarily make drugs affordable. For example, if you live in <a href="https://www.gov.mb.ca/health/pharmacare/estimator.html">Manitoba</a> and your family income is $47,500, you’ll first have to pay $2,760 out of pocket. Anything less and there’s no public coverage. </p>
<p>According to a recent report from <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">Statistics Canada</a>, 33 per cent of seniors in Manitoba don’t have drug coverage. (That figure might be lower if some seniors who are eligible for provincial insurance didn’t register or were unaware that they were covered.)</p>
<h2>Not everyone has workplace benefits</h2>
<p>CLHIA came out swinging after the federal NDP tabled a <a href="https://www.ctvnews.ca/politics/ndp-attempts-to-prod-liberals-into-action-on-pharmacare-by-tabling-its-own-bill-1.6439036">pharmacare bill</a> in June. The NDP’s bill called for a federal, universal, public and single-payer drug plan. In other words, a plan similar to what Canadians already enjoy for doctor and hospital services. </p>
<p>Denis Ricard, chair of the CLHIA’s board of directors, has claimed that “<a href="https://breachmedia.ca/greenshield-insurance-industry-fights-liberal-ndp-pharmacare/">a fully one-payer national pharmacare is going to be a disaster for this country</a>.”</p>
<p>The <a href="https://betterhealthbenefits.ca/">Better Health Benefits, Together</a> campaign being run by the CLHIA warns that Canadians “can’t afford to lose their workplace benefits because of politics…Done the wrong way, Canadians will lose access to medicines they use today.” </p>
<p>The campaign fails to mention that workplace benefits do not cover everyone, and exclude those experiencing unemployment, which affects some populations more than others. For example, <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">racialized Canadians have a higher unemployment rate</a> than the rest of the population and therefore are less likely to have work-based drug coverage. </p>
<p>Nor does the campaign mention that, according to <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">Statistics Canada</a>, “the majority of insurance coverage changes due to the pandemic were negative,” with immigrants faring worse than non-immigrants.</p>
<h2>High deductibles</h2>
<p>Joining the battle against pharmacare is <a href="https://www.thestar.com/opinion/contributors/canada-has-in-fact-achieved-universal-drug-insurancecoverage/%2520article_65bc7a1e-8fb2-56d5-abb8-1b5890909597.html">Brett Skinner</a>, the CEO of the free market Canadian Health Policy Institute. Skinner’s message is that a national government-run drug insurance program is not necessary and will be bad for patients and costly for taxpayers. </p>
<p>He argues that private plans cover more drugs, and cover new drugs more quickly than public plans, and that if Canadians are faced with high deductibles there are provincial programs to deal with them.</p>
<p>He neglects to mention that <a href="https://doi.org/10.1177%2F20542704231166620">only about 10 to 15 per cent of new drugs provide any substantial new benefits</a> compared to existing drugs. He fails to note that a third of the difference in the time between public and private coverage is because <a href="https://doi.org/10.9778/cmajo.20220063">drug companies don’t take advantage of the opportunity to apply for coverage as quickly as they could</a>. </p>
<p>Skinner also ignores the fact that <a href="https://doi.org/10.1503%2Fjpn.180051">people living in Manitoba</a> with an annual income of just over $55,000 who are taking three drugs a day are faced with deductibles of up to $350 every three months. British Columbia residents aren’t far behind at $300 every three months.</p>
<p>Big Pharma, the insurance industry and free market zealots are all motivated by money and ideology. In a battle over people’s health, greed shouldn’t be the winner.</p><img src="https://counter.theconversation.com/content/213041/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Between 2019-2023, Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of 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. Between 2017 and 2023 he was a coinvestigator on four different projects funded by the Canadian Institutes of Health Research.</span></em></p>Pharmaceutical and insurance industries that could lose profit through lower drug prices are not happy that a pharmacare bill is planned for fall. They are speaking out and mobilizing their allies.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.