tag:theconversation.com,2011:/uk/topics/drug-marketing-26365/articlesDrug marketing – The Conversation2022-07-07T21:01:59Ztag:theconversation.com,2011:article/1863612022-07-07T21:01:59Z2022-07-07T21:01:59Z$150M is not enough: Canada’s proposed Purdue Pharma settlement for opioid damages is paltry and won’t prevent future crises<figure><img src="https://images.theconversation.com/files/472872/original/file-20220706-95-jgs9g3.jpg?ixlib=rb-1.1.0&rect=273%2C62%2C2627%2C2070&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">OxyContin, an opioid drug heavily marketed by Purdue Pharma, is associated with billions of dollars of health-care costs in Canada related to the opioid crisis.</span> <span class="attribution"><span class="source">(AP Photo/Toby Talbot)</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/150m-is-not-enough--canada-s-proposed-purdue-pharma-settlement-for-opioid-damages-is-paltry-and-won-t-prevent-future-crises" width="100%" height="400"></iframe>
<p>On June 29, Canadian federal and provincial governments reached a proposed <a href="https://www.theglobeandmail.com/canada/article-purdue-canada-agrees-to-pay-150-million-over-opioid-harms/">$150-million settlement with Purdue Pharma Canada</a>, makers of OxyContin, an opioid-based pain medication. The settlement is intended to recover the health-care costs related to the damaging effects from the sale and marketing of OxyContin.</p>
<p>While this is the largest settlement of a governmental health-care cost claim in Canadian history, it is also a paltry amount compared to the approximately <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/sacklers-will-pay-up-6-bln-resolve-purdue-opioid-lawsuits-mediator-2022-03-03/">US$6 billion</a> that Purdue will pay in the United States. A population-equivalent Canadian settlement would have been closer to CA$900 million. </p>
<p>Until this $150-million fine, there is no record of any drug company ever having been fined for its promotion of one of its prescription drug products in Canada. Despite illegal drug promotion documented in the United States, Health Canada did not investigate whether such practices were also present in Canada. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774/pdf/221.pdf">One example</a> was the distribution of 15,000 copies of a video in the U.S. claiming, without any substantiation, that opioids caused addiction in fewer than one in 100 patients.</p>
<p>When asked why, <a href="https://www.thestar.com/news/canada/2014/06/26/dangers_of_offlabel_drug_use_kept_secret.html">agency officials responded</a> that Health Canada “has not been made aware of any specific similar issue in Canada and has not received complaints.” </p>
<p>Equally concerning, however, is the intense focus on financial settlements at the expense of regulatory changes.</p>
<h2>Regulatory loopholes</h2>
<p>Since the opioid crisis emerged, researchers and journalists have identified a range of strategies and policy loopholes that companies took advantage of to push their products. These included: </p>
<ul>
<li><p><a href="https://doi.org/10.2105%2FAJPH.2007.131714">industry influence over clinical practice guidelines</a>, which are <a href="https://www.ncbi.nlm.nih.gov/books/NBK390308/">recommendations for patient care</a>, </p></li>
<li><p><a href="http://dx.doi.org/10.1136/medethics-2013-101343">funding that can bias medical education</a>, </p></li>
<li><p>providing health-care professionals with <a href="https://doi.org/10.1016/j.amjmed.2017.12.045">free trips to exotic locations in order to listen to “expert opinions,”</a></p></li>
<li><p>insufficient transparency around <a href="https://www.motherjones.com/crime-justice/2019/08/unsealed-documents-show-how-purdue-pharma-created-a-pain-movement/">funding of non-profit organizations</a> and </p></li>
<li><p>a government-sanctioned culture of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3999539/">self-regulation, enabling the pharmaceutical industry to regulate its own promotion practices</a>. </p></li>
</ul>
<p>Despite this knowledge, virtually all of these strategies remain entirely legal.</p>
<h2>Funding transparency</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Protesters with signs and a skeleton made of pill bottles outside a building" src="https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=426&fit=crop&dpr=1 600w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=426&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=426&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=535&fit=crop&dpr=1 754w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=535&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=535&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Protesters outside a Boston, Mass. courthouse in 2019, during a lawsuit against Purdue Pharma over its role in the national drug epidemic. The company’s U.S. settlements for OxyContin lawsuits total about US$6 billion.</span>
<span class="attribution"><span class="source">(AP Photo/Charles Krupa)</span></span>
</figcaption>
</figure>
<p>Transparency around pharmaceutical funding of health-care professionals and non-profit organizations remains virtually non-existent in Canada. The United States passed the <a href="https://www.healthaffairs.org/do/10.1377/hpb20141002.272302/full/">Physician Payments Sunshine Act</a> in 2010 requiring transparency of financial relationships between physicians and the health-care industry. Yet no such system of transparency exists in Canada. </p>
<p>In fact, the federal government has <a href="https://www.cbc.ca/news/health/pharmaceutical-drug-company-doctor-physician-payment-disclosure-transparency-1.4169888">explicitly rejected setting up a similar mechanism</a>. The one attempt to do so in Ontario was <a href="https://doi.org/10.1503/cmaj.109-5718">terminated in 2018</a> when Doug Ford’s Progressive Conservatives took office. Such a system would have significantly increased transparency around the types of physician payments that directly influenced opioid prescription patterns. </p>
<h2>Funding medical education</h2>
<p>Pharmaceutical companies are <a href="https://www.thestar.com/news/investigations/2019/02/11/family-doctors-can-no-longer-claim-ritzy-drug-dinners-as-professional-training.html"><em>still</em> permitted</a> to fund groups putting on accredited medical education events for Canadian doctors. This is despite <a href="https://doi.org/10.1371/journal.pmed.1000352">significant evidence</a> that industry funding leads to a bias in prescriptions and few improvements in prescribing. </p>
<p><a href="https://nationalpost.com/news/canada/the-selling-of-oxycontin">This type of funded “medical education”</a> was one of the main avenues through which Purdue Pharma and other companies managed to convince health-care professionals of the benefits of their products, while minimizing the products’ overall risk of addiction. </p>
<p>There is little evidence that removing industry funding would create an information gap, and it is <a href="https://doi.org/10.1371/journal.pmed.1000352">likely to drastically reduce overall industry influence over the profession</a>. Yet the federal government has often done little to use such practices to ensure appropriate drug prescribing and use, putting it at odds with governments in many other <a href="https://www.nps.org.au">wealthy industrialized countries</a>.</p>
<h2>Product monographs</h2>
<figure class="align-center ">
<img alt="White pills scattered on a black background" src="https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=431&fit=crop&dpr=1 600w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=431&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=431&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=541&fit=crop&dpr=1 754w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=541&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=541&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Since the opioid crisis emerged, researchers and journalists have identified a range of strategies and policy loopholes that companies took advantage of to push their products.</span>
<span class="attribution"><span class="source">(AP Photo/Keith Srakocic)</span></span>
</figcaption>
</figure>
<p>Canadian regulators have revealed little about how they plan to reduce industry influence over product monographs, which provide detailed information for doctors about specific drugs. </p>
<p><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/frequently-asked-questions-product-monographs-posted-health-canada-website.html">Health Canada states</a> that a product monograph should be a “factual, scientific document on a drug product … devoid of promotional material.” </p>
<p>Despite this, Oxycontin’s original Canadian product monograph in 1996 recommended increased use of the product in cases of “<a href="https://www.gov.nl.ca/hcs/files/publications-oxycontin-final-report.pdf">breakthrough pain</a>,” a term that had previously appeared in Oxycontin advertisements. Moreover, the product monograph <a href="https://doi.org/10.1111/add.14929">provided no recommended maximum dose</a>, meaning there was no upper dose threshold for OxyContin when it was marketed. </p>
<p>Despite this, there has been no formal inquiry into how this scientific document could be so significantly affected by industry interests, or how to prevent similar influence from recurring.</p>
<h2>Gifts to health-care professionals</h2>
<p>The pharmaceutical industry continues to provide non-research-related transfers to health-care professionals. These transfers include gifts of food and drink, all-expenses paid travel to conferences and marketing-related consultancies. Again, <a href="https://nationalpost.com/news/canada/the-selling-of-oxycontin">this form of funding was repeatedly used by opioid manufacturers</a> to influence health-care professionals, with companies even flying them out to exotic locations to listen to “key opinion leaders” speak on the benefits of Oxycontin and other opioids.</p>
<p>Despite virtually no rationale for the “educational” value of these events, such financial transfers continue today. In 2020, 10 of the 47 drug company members of Innovative Medicines Canada, the organization that represents the pharmaceutical industry, <a href="https://www.doi.org/10.12927/hcpol.2022.26729">spent over $28 million on fees and travel for health-care providers</a>.</p>
<p>The settlement with Purdue Pharma Canada is <a href="https://www.cbc.ca/news/canada/british-columbia/purdue-bankruptcy-filings-provinces-68b-us-opioid-crisis-oxycontin-1.5799580">frustratingly small in comparison to the billions in health-care costs of the opioid crisis</a>. But it also shouldn’t distract from the bigger issue: despite the many lessons learned from the crisis, there have been very few regulatory changes made in Canada since. </p>
<p>Unless something radically changes in how the pharmaceutical industry is regulated, there is little reason to assume a similar crisis won’t occur again.</p><img src="https://counter.theconversation.com/content/186361/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Daniel Eisenkraft Klein receives funding from a Social Sciences and Research Council Doctoral Fellowship and through internal grants from Johns Hopkins University's Opioid Industry Documents Archive. He is presently a part-time Policy Analyst in the Tobacco Control Directorate at Health Canada. </span></em></p><p class="fine-print"><em><span>In 2019-2021, Joel Lexchin received payments for writing a brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>The Purdue Pharma settlement is paltry compared to costs of the opioid crisis. Without major changes to pharma industry regulation, there is little reason to think a similar crisis won’t occur again.Daniel Eisenkraft Klein, PhD Candidate, Dalla Lana School of Public Health, University of TorontoJoel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/925812018-03-07T02:54:09Z2018-03-07T02:54:09ZPhenibut, online drug markets and the limits of law enforcement<p>Seven high school students in Queensland were taken to hospital last month after <a href="https://www.sbs.com.au/news/queensland-students-critical-overdose-suspected">reportedly</a> overdosing on a substance identified as <a href="https://theconversation.com/weekly-dose-phenibut-the-russian-anti-anxiety-drug-linked-to-gold-coast-teens-overdoses-92339">Phenibut</a>. It’s an anti-anxiety drug developed for Russian cosmonauts that also has cognitive-enhancing qualities.</p>
<p>According to the Australian Therapeutic Goods Administration, Phenibut is a <a href="https://www.tga.gov.au/book-page/33-phenibut">Schedule 9 prohibited substance</a>, which means that it cannot be sold legally in this country. Nevertheless, according to <a href="http://www.news.com.au/lifestyle/health/health-problems/police-seize-mobile-phones-in-investigation-into-school-overdose/news-story/ace12f1eadfe40bd2bcce3c471a4d05f">reports</a>, the students were able to buy the drug online and have it delivered to them on the Gold Coast. </p>
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Read more:
<a href="https://theconversation.com/weekly-dose-phenibut-the-russian-anti-anxiety-drug-linked-to-gold-coast-teens-overdoses-92339">Weekly Dose: phenibut – the Russian anti-anxiety drug linked to Gold Coast teens' overdoses</a>
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<p>This incident reveals the limits of law enforcement practices developed over the 20th century in relation to more traditional drug markets. Current strategies for policing drugs would not have prevented these young people from gaining access to Phenibut. </p>
<h2>Why are online drug markets different?</h2>
<p>While conventional illicit drug markets have relied on physical exchanges of drugs, the internet has created new opportunities for illicit drug markets to flourish through both the “dark” net and the “surface” net.</p>
<p>“Dark net marketplaces” or <a href="https://theconversation.com/explainer-what-are-drug-cryptomarkets-64596">cryptomarkets</a> operate in the hidden portion of the internet. Cryptomarkets are online forums that enable the trade of goods between individuals who use digital encryption to conceal their identities. Although cryptomarkets offer many types of illegal goods and services (and some legal services), the most commonly purchased items are illicit drugs. </p>
<p>Most illicit drugs sold through cryptomarkets are those taken by recreational drug users (for example, cannabis-related products, stimulants, pharmaceuticals). The heavy presence of recreational drugs is linked to the fact that planning purchases ahead of time and waiting for shipments will not suit individuals who need immediate access to illicit substances, such as dependent drug users.</p>
<p>In contrast to buying Phenibut from the surface net, as the Gold Coast students allegedly did, purchasing from a cryptomarket is a technologically challenging endeavour. These websites are not accessible through familiar search engines; a specialised anonymising browser, the specific URL address of the marketplace, and the possession of cryptocurrency (such as <a href="https://theconversation.com/what-is-bitcoin-it-is-not-that-complicated-if-you-ignore-the-geek-speak-46512">Bitcoin</a>) are required to perform the transaction. </p>
<p>The term surface web refers to all of the content accessible through popular search engines (such as Google). It contains the sites most people use in their everyday browsing. Drug markets that operate through the surface net often fall into legal grey areas. This is a consequence of significant legislative variation across jurisdictions regarding the production, distribution and possession of some drugs – particularly those that are not specifically identified as illicit in various international conventions and protocols. </p>
<p>The drugs most commonly sold in the surface web drug markets are new psychoactive substances (otherwise known as “research chemicals”, “legal highs” and “bath salts”) and counterfeit versions of prescription-required pharmaceuticals. The surface web drug trade mostly revolves around access to lifestyle drugs such as performance and image-enhancing substances.</p>
<p>This is the context in which people are able to get Phenibut with relative ease. It could be bought through the surface web, using Google to locate a web store willing to ship the product to Australia after an electronic funds transfer. </p>
<p>Even though Phenibut is a scheduled substance in Australia, it is likely that the servers for many of these retail web stores are located in countries where it is entirely legal to manufacture, possess and distribute the drug.</p>
<h2>What does this mean for drug control strategies?</h2>
<p>Dominant models for controlling illicit drugs mostly work through a combination of prohibition and targeted law enforcement crackdowns on local drug markets. These approaches are grounded in broader criminological understandings that offenders rationally consider the costs and benefits of an act, and that the perceived and actual threat of punishment deters crime. Such models have been <a href="http://www.ijdp.org/article/S0955-3959(05)00056-3/abstract">widely criticised</a> for their ineffectiveness and negative health consequences.</p>
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<strong>
Read more:
<a href="https://theconversation.com/small-potent-doses-of-illegal-drugs-are-evading-authorities-but-having-a-huge-impact-87081">Small potent doses of illegal drugs are evading authorities but having a huge impact</a>
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<p>Admittedly, online drug markets represent only a small portion of the overall global drug trade. Taking into account the ubiquitous nature of the surface web, and the relative ease of acquiring drugs like Phenibut, such markets are likely to grow.</p>
<p>Following the Queensland case, police were quick to <a href="http://www.news.com.au/national/queensland/crime/police-crackdown-on-online-drug-trade/news-story/16cea5d388f39bc110e3c590787db43e">announce</a> a number of seizures of various illicit substances that had been “trafficked” through the domestic mail stream. </p>
<p>Methods for policing online drug markets are relatively new and still being developed. These appear to adopt <a href="https://www.businessinsider.com.au/methods-that-police-use-to-catch-deep-web-drug-dealers-2016-8">similar approaches</a> to those used to address conventional drug markets, even though it is likely that online markets attract different types of customers and operate according to different principles. New strategies are needed that help to reduce harm by better understanding the nature of buyers in these digital domains.</p><img src="https://counter.theconversation.com/content/92581/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The increasing availability of drugs online raises questions about policing methods that were developed to deal with more traditional drug markets.Andrew Childs, Doctoral Candidate, Griffith UniversityMelissa Bull, Associate Professor, School of Criminology and Criminal Justice, Griffith UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/783952017-07-03T04:26:20Z2017-07-03T04:26:20ZWho’s paying for lunch? Here’s exactly how drug companies wine and dine our doctors<figure><img src="https://images.theconversation.com/files/173735/original/file-20170614-21325-1uxqo3v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Now you can find out who's wining and dining our doctors, nurses and pharmacists with publicly available data of drug company funded events.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/571821898?src=TmrktekrTjHO6OM4a6e84g-1-19&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>In June 2015, 24 Australian cancer specialists flew to Chicago to attend a five-day conference. Drug giant Amgen funded the trip, including registration, transfers and wining and dining. It cost almost A$270,000. </p>
<p>In December 2013, in a teaching hospital in New South Wales, 11 pharmacists and pharmacy technicians attended a 45-minute presentation by a pharmaceutical representative from a company called Menarini. The presentation was accompanied by a lunch that included sandwiches, wraps, sushi and fruit juice. Lunch cost A$200.</p>
<p>These are just two very different examples of the more than 116,000 events for Australian health professionals that drug companies funded in a recent four-year period, which we analysed in a study just published in <a href="http://bmjopen.bmj.com/content/7/6/e016701">BMJ Open</a>. </p>
<p>You can examine the <a href="https://researchdata.ands.org.au/pharmaceutical-industry-funded-sept-2015/941218">data</a> yourself.</p>
<p>Since 2007, drug companies <a href="https://www.accc.gov.au/media-release/australian-competition-tribunal-affirms-acccs-decision-on-extra-reporting-for?pageDefinitionItemId=16940">have been required</a> to publish detailed reports of how they sponsor educational events for health professionals. </p>
<p>They have had to list the number of attendees, the name of the restaurant, resort or clinic, and the costs of food and drink. But so far, they have not had to list the names of the doctors enjoying it. </p>
<p>Until today there has been little analysis of these reports. This is because despite being publicly available, the millions of bits of data were “trapped” in PDF files. Now the information is available for anyone to analyse.</p>
<h2>What did we find?</h2>
<p>The data shows the routine, yet influential, ways health professionals interact with pharmaceutical companies when it comes to professional education.</p>
<p>Between 2011 and 2015, pharmaceutical companies sponsored more than 116,000 events - on average more than 600 a week. While many of the breakfasts, lunches and dinners were held in hotels and fancy restaurants across the country, most took place inside hospitals or doctors’ offices, suggesting drug companies have a pervasive presence in everyday clinical practice.</p>
<p>Most of the events (82%) included medical doctors, but many included different types of health professionals. For example, 39.6% included nurses, 38.3% trainees and 8.4% pharmacists. </p>
<p>Oncology or cancer – a field where there is increasing concern about the use of high-cost medicines – was the most frequent area of focus of the events, accounting for 19.7% of the functions.</p>
<h2>Why does this matter?</h2>
<p>Industry sponsored events for health professionals are commonly termed “educational” events. However, they are a <a href="http://annals.org/aim/article/727539/narrative-review-promotion-gabapentin-analysis-internal-industry-documents">key pillar</a> of the pharmaceutical industry’s marketing strategy. </p>
<p>Although health professionals often <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2801075/">fail to perceive commercial biases</a> in such events, their educational content <a href="http://jme.bmj.com/content/41/10/859.long">can be biased</a> in favour of the sponsor. The prescription rate of the sponsor’s drug <a href="http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2520680">has also been shown to increase</a> afterwards.</p>
<p>Even the provision of free meals, which are commonly provided at sponsored events, can influence clinical practice. Evidence of this comes from the United States, where thanks to the <a href="https://www.congress.gov/bill/111th-congress/senate-bill/301">Sunshine Act</a>, pharmaceutical companies have to report all payments to individual doctors.</p>
<p>Prescribing drugs based on exposure to industry-sponsored events <a href="https://theconversation.com/drug-companies-are-buying-doctors-for-as-little-as-a-16-meal-61364">raises concerns</a> about the unhealthy effects on patient care and increasing health care costs when newer, expensive and aggressively promoted drugs are prescribed.</p>
<p>A recent <a href="http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2528290">study</a> conducted in the US found the receipt of even a single sponsored meal worth as little as US$16 was associated with an increase in prescribing of promoted drugs. </p>
<h2>Disappearing data</h2>
<p>The analysis published today is timely considering two <a href="https://medicinesaustralia.com.au/wp-content/uploads/sites/52/2010/01/20150617-PUB-Code-Edition-18-FINAL.pdf">major changes</a> to drug company reporting that have recently been implemented in Australia. </p>
<p>From October 2015, drug companies have no longer had to report on these influential “educational” events. Instead, they are now required to report on payments they make to individual health professionals, and to name those individuals. </p>
<p>This could improve transparency in some ways. For instance, people could check if their own doctor has attended an educational event sponsored by a drug company. But the new rules contain loopholes.</p>
<p>For example, they explicitly exclude the need for drug companies to report how much they spend on food and beverages. As 90% of the events analysed included the provision of food and beverage, a large proportion of potentially influential payments from drug companies to health professionals are now invisible.</p>
<h2>The value of transparency and independence</h2>
<p><a href="https://www.cmu.edu/dietrich/sds/docs/loewenstein/PitfallsdisclosingCOI.pdf">As some authors have pointed out</a>, transparency is not going to solve the problem of unhealthy industry influence as it does not eliminate the conflicts of interest that arise when health professionals interact with pharmaceutical companies. </p>
<p>The most important issue is not just transparency, but if it is appropriate for health professionals to receive meals from and rely on information provided by drug companies in the first place.</p>
<p><a href="https://www.ncbi.nlm.nih.gov/books/NBK22942/">Evidence</a> suggests that it is time to forge much greater independence between the companies marketing the drugs, and the doctors prescribing them.</p>
<p>Policies to limit health professionals’ interactions with pharmaceutical companies can be a more effective measure than disclosure to reduce and eliminate unhealthy commercial influence on clinical practice and professional education. </p>
<p>For example, some medical institutions in the US <a href="http://amsascorecard.org">have limited interactions</a> between their students and doctors and the pharmaceutical industry, banning gifts and free food by manufacturers and regulating pharmaceutical representatives visits to physicians. These policies <a href="http://jamanetwork.com/journals/jama/article-abstract/2623607">have been associated </a> with changes in prescribing behaviours.</p>
<p>Another example of a policy to provide greater independence comes from the Australian Medical Students Association, which has a <a href="https://www.amsa.org.au/sites/amsa.org.au/files/Pharmaceutical%20Sponsorship%20%282014%29.pdf">strict ban</a> on accepting drug company funding for its conferences - unlike most doctors groups which accept it.</p>
<p>However, notwithstanding the limits of disclosure, there are still enormous opportunities for designing effective and inclusive transparency policies. </p>
<p>Ten years ago, Australia introduced a world-first scheme to disclose every single drug company-funded event for doctors. Since then the US Sunshine Act created a new international benchmark, revealing all payments and naming the doctors who receive them.</p>
<p>Today it seems that Australia has dropped the ball, with moves towards individual disclosure overshadowed by abandoning transparency around routine wining and dining, and is slipping backwards into the darkness of secrecy.</p><img src="https://counter.theconversation.com/content/78395/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Alice Fabbri receives a PhD scholarship from the University of Insubria (Varese, Italy).</span></em></p><p class="fine-print"><em><span>Lisa Bero receives funding from The University of Sydney for a program in Pharmaceutical Policy. She is Co-chair of the Governing Board of Cochrane.</span></em></p><p class="fine-print"><em><span>Dr Ray Moynihan is a National Health and Medical Research Council Early Career Fellow. </span></em></p>Drug companies funded more than 116,000 educational events for doctors over four years. Now you can find out exactly which companies footed the bills and how much they paid.Alice Fabbri, PhD student, University of SydneyLisa Bero, Chair professor, University of SydneyRay Moynihan, Senior Research Fellow, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/694882016-12-19T03:25:45Z2016-12-19T03:25:45ZDodgy claims for complementary medicines? Here’s how the drug watchdog could have more bite<figure><img src="https://images.theconversation.com/files/150426/original/image-20161216-26071-k71cid.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Advertisements for complementary medicines don't always reflect what's in the bottle.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/432958402?src=3HtFGSwDxdg_WNVXzc307A-1-14&id=432958402&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>Complementary medicine suppliers are getting away with breaching advertising requirements because Australia’s medicines regulatory authority has no bite, new data confirms.</p>
<p>This means consumers can have little confidence in advertising claims for listed medicines, mainly complementary medicines like herbal, vitamin and mineral supplements.</p>
<p>Instead, we need a robust regulatory system that protects consumers against misleading and deceptive statements.</p>
<p>The <a href="https://www.tga.gov.au/">Therapeutic Goods Administration</a> (TGA) has <a href="https://www.tga.gov.au/book/export/html/731370">recently published data</a> on <a href="https://www.tga.gov.au/listed-complementary-medicine-compliance-reviews#request">post-marketing reviews</a> for listed medicines.</p>
<p>The number of medicines with verified breaches increased from 73% of 212 cases investigated in 2014-15 to 80% of 473 cases investigated in 2015-16. The most common problem was failure to produce evidence to support product claims.</p>
<p>In 2015-16, the independent <a href="http://www.tgacrp.com.au/">Therapeutic Goods Advertising Complaints Resolution Panel</a> found 98% of 141 complaints justified. When the panel requested suppliers fix their breaches, in 40% of cases they refused to do so. This is because the panel has no power to enforce its determinations. These statistics are a sad reflection on the failure of the regulators to bring the complementary medicines industry into check over many years. </p>
<p>In mid-2015, the <a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/Expert-Review-of-Medicines-and-Medical-Devices-Regulation">Expert Review of Medicines and Medical Devices Regulation</a> made seven recommendations about regulation of therapeutic goods advertising.</p>
<p>In September 2016, <a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/MMD-govresp">the government accepted</a> all seven recommendations. The TGA is now consulting with the public about how to implement these. These are the three most important.</p>
<h2>Approving adverts</h2>
<p>One recommendation is to abandon the process of pre-approving adverts for therapeutic products in favour of a more self-regulatory regime. </p>
<p>Currently, two industry associations pre-approve advertisements for listed products, but these are limited to medicines advertised to the public in “specified media”, mainly television, radio and print advertisements, not the internet.</p>
<p>So why should we be concerned? The pre-approval process is efficient; it reviews about 2,000 advertisements a year with an average turnaround time of seven days. Most advertisements reviewed need changes to avoid breaches; sometimes wholesale revisions are needed. Pre-approval is the only defence between a misleading advertisement on prime-time television and the unwitting consumer. Other avenues such as complaints and post-marketing reviews take a long time to remove such advertisements.</p>
<p>A better alternative to abandoning pre-approval is to extend the process to all advertisements for complementary medicines in all media. Prevention is better than cure.</p>
<p>The self-regulatory regime the government favours is unlikely to be effective as not all companies are members of an industry association, so not all can be self-regulated.</p>
<h2>How to manage complaints?</h2>
<p>Another recommendation is for a new body to manage complaints about advertising of therapeutic goods. The controversy is about who should manage and be involved in the new system, which is important because current bodies differ in how effectively they resolve complaints.</p>
<p>The TGA seems to be positioning itself to take over. This would involve acquiring similar powers to the <a href="https://www.accc.gov.au/">Australian Competition and Consumer Commission</a> (ACCC) and abolishing existing bodies such as the complaints panel.</p>
<p>In doing so, the TGA would take over a role once shared with stakeholders (consumer, health professional, industry and media organisations). There is additional concern the TGA lacks a consumer protection culture, is perceived to be too close to industry, has failed to address long-standing problems, and is not transparent about the outcomes of complaints it handles.</p>
<p>Some vocal groups advocate handing the complaint system to the ACCC. The ACCC has a consumer protection culture, excellent investigative and compliance powers under <a href="https://www.accc.gov.au/about-us/australian-competition-consumer-commission/compliance-enforcement-policy">Australian Consumer Law</a> and the necessary legal expertise. It has also taken on several cases involving the advertising of therapeutic goods, for example <a href="http://www.abc.net.au/news/2016-12-16/nurofen-fined-6m-for-misleading-consumer/8126450">Nurofen targeted pain relief</a> and <a href="http://www.accc.gov.au/media-release/court-finds-homeopathy-plus-vaccine-claims-misleading">Homeopathy Plus!</a>.</p>
<p>But the ACCC receives many thousands of complaints a year covering a wide range of areas. Given current resources it can only pursue a small number of cases through the courts. Moving the complaint system to the ACCC would mean most complaints would not be dealt with, effectively providing <em>no</em> controls. The ACCC has also consistently argued that where there is a need for specialist regulators, they should not be rolled into the ACCC.</p>
<p>A more innovative suggestion is closer partnership between the ACCC and the TGA in the transition to, and in the initial phase of, a new complaint system. This could involve seconding a senior enforcement manager from the ACCC to the TGA to oversee the new system (and change the TGA’s culture, as outlined above) while keeping the best of the current system and fixing its flaws.</p>
<h2>Sanctions and penalties</h2>
<p>The third recommendation is for legislative power to impose substantial fines and the publication of retractions as ways of enforcing determinations against misleading advertising. This is long overdue as any sanctions and penalties must be sufficient to counter the commercial return from breaching the regulations.</p><img src="https://counter.theconversation.com/content/69488/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Harvey represents Choice (the Australian Consumers' Association) on the Therapeutic Goods Advertising Complaint Resolution Panel and the Therapeutic Goods Advertising Code Council. </span></em></p><p class="fine-print"><em><span>Sasha Hall and Tiana Moutafis do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Consumers can’t always be confident claims for complementary medicines stack up. Here’s how to foster truth in advertising.Ken Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash UniversitySasha Hall, Biomedical Science/ Law student, Monash UniversityTiana Moutafis, Biomedical Science/Law student, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/613642016-06-23T02:02:00Z2016-06-23T02:02:00ZDrug companies are buying doctors – for as little as a $16 meal<figure><img src="https://images.theconversation.com/files/127695/original/image-20160622-19764-ew0bis.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Even cheap dinners were found to influence prescribing habits.</span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p><a href="http://archinte.jamanetwork.com/article.aspx?articleid=2528290">An important new study</a> in the United States has found doctors who receive just one cheap meal from a drug company tend to prescribe a lot more of that company’s products. The damming findings demonstrate the value of new transparency laws in the US, and remind Australians we’re still very much in the dark about what our doctors get up to behind closed doors.</p>
<p>Just published in the leading Journal of the American Medical Association (JAMA) Internal Medicine, this study is well worth a look for anyone interested in the hidden influences on how doctors prescribe. </p>
<p>Together with a host of other recent work, it adds to the growing mountain of evidence suggesting doctors who expose themselves to marketing strategies – from seeing attractive drug reps to attending sponsored “education” – are doing patients and the wider public a grave disservice. </p>
<h2>Need for transparency</h2>
<p>The new study took advantage of a new government-run and <a href="https://openpaymentsdata.cms.gov/search">publicly available database</a> which discloses all drug company payments to doctors. Researchers looked at how often doctors prescribed four popular brand-name drugs, and linked prescribing rates to how often those doctors received meals from the drugs’ manufacturer.</p>
<p>They found that receiving just one company-funded meal was associated with a 20% increase in prescribing of Astra Zeneca’s cholesterol-lowering statin, Crestor, compared to other drugs in the same class. </p>
<p>For two other heart drugs, the increase was in the order of 50%. For Pfizer’s anti-depressant Pristiq, taking one free meal was linked to a 100% increase, or a doubling of the rate of prescriptions. </p>
<p>The average cost of the meals drug companies gave these doctors was between US$12 (A$16) and US$18 ($A24).</p>
<p>And when doctors ate sponsored meals on more than four occasions, their prescribing of the brand-name drugs rose dramatically. Perhaps unsurprisingly, doctors who got more expensive meals tended to have bigger prescribing increases.</p>
<h2>Association not cause and effect</h2>
<p>Perhaps the most important caveat, as the study’s authors stressed, is that “the findings represent an association – not a cause and effect relationship”. Nevertheless, the results reinforce similar findings from recent studies also using the new transparency data in the US.</p>
<p>In March investigative journalists at <a href="https://www.propublica.org/article/doctors-who-take-company-cash-tend-to-prescribe-more-brand-name-drugs">ProPublica</a> found doctors who received drug company payments or gifts – mostly free meals – wrote scripts for brand-name drugs at much higher rates compared to doctors who didn’t take industry money.</p>
<p>In May, in the <a href="http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0155474">journal PLOS One</a>, researchers found almost half of the 700,000 doctors in the US had received payments from drug companies. Specialties receiving the highest industry payments had the highest prescribing costs per patient.</p>
<p>And also in May, the <a href="http://archinte.jamanetwork.com/article.aspx?articleid=2520680">JAMA Internal Medicine</a> published a small study from the state of Massachusetts, similarly uncovering an association between payments from industry and modest increases in rates of prescribing brand-name statins (cholesterol-lowering medication).</p>
<h2>So why does this matter?</h2>
<p>The main concern in all the recent US studies is the unnecessary cost to patients and the health system when brand-name drugs are prescribed instead of cheaper generic alternatives. </p>
<p>But perhaps the more serious concern is the danger of doctors prescribing under the influence of drug company marketing – which always favours the latest new drug, rather than what’s in the patient’s best interest.</p>
<p>As <a href="https://theconversation.com/we-cant-trust-drug-companies-to-wine-dine-and-educate-doctors-about-the-drugs-they-prescribe-56990">The Conversation</a> has covered recently, newer and aggressively promoted drugs can have very limited advantages over older ones, if any, and sometimes carry very serious side effects – particularly for the elderly. </p>
<p>There is already evidence many older Australians are at risk of harm from taking too many inappropriate medicines – and <a href="https://www.mja.com.au/journal/2014/201/7/first-do-no-harm-real-need-deprescribe-older-patients">there is a growing push</a> to promote “de-prescribing”, which means taking people off drugs they don’t need. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=360&fit=crop&dpr=1 600w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=360&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=360&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=453&fit=crop&dpr=1 754w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=453&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=453&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Drug companies often promote new and expensive drugs – and they’re not always the ones in the patient’s best interest.</span>
<span class="attribution"><span class="source">from www.shutterstock.com</span></span>
</figcaption>
</figure>
<h2>Australia still in dark</h2>
<p>Compared to the new transparency regime in the US, Australia has fallen way behind. Under <a href="https://medicinesaustralia.com.au/wp-content/uploads/sites/52/2010/01/20140812-detailed-summary-of-amendments-Code-Ed-18_.pdf">new rules</a> some payments to some individual doctors will have to be disclosed from this August, but there are too many loopholes.</p>
<p>As a result of horse trading about the new rules – between the doctors, the drug companies and public authorities – any funding of meals costing less that A$120 will not have to be disclosed. And if doctors who have received payments don’t want their names disclosed in August, they won’t be. </p>
<p>Also, all of the roughly 25,000 events, including breakfasts, lunches and dinners which doctors and other health professionals regularly attend annually, will from now on remain totally secret – until there is regulatory reform. </p>
<p>Consumer groups are angry that citizens remain in the dark, and many doctors are horrified by the wining and dining of their colleagues, with <a href="https://theconversation.com/why-i-dont-see-drug-reps-a-gps-take-on-big-pharma-spruiking-32435">some cutting their ties</a>: refusing to see the attractive sales reps and seeking “education” elsewhere. </p>
<h2>Disclosure on its own is no panacea</h2>
<p><a href="https://theconversation.com/forget-tea-and-biscuits-why-should-doctors-get-any-gifts-from-pharma-companies-18752">As others have pointed out</a>, disclosure on its own is not a panacea, and it’s legitimate to ask why doctors should receive any free gifts or meals at all. </p>
<p>Already there’s been <a href="https://theconversation.com/pharma-payments-to-doctors-stay-behind-closed-doors-for-now-15279">one legislative attempt</a> to enforce more independence between doctors and drug companies in Australia, and it is likely more will emerge in the future.</p>
<p>Until then, it might be wise to inquire whether your doctor still takes the free meals – and perhaps seek your care elsewhere if the answer is yes.</p><img src="https://counter.theconversation.com/content/61364/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Ray Moynihan is a chief investigator within the NHMRC funded Wiser Health Care research collaboration, and has had a long time interest in writing about and researching interactions between industry and health professions. </span></em></p>An important new study in the United States has found doctors who receive just one cheap meal from a drug company tend to prescribe a lot more of that company’s products.Ray Moynihan, Senior Research Fellow, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/569902016-04-06T20:12:32Z2016-04-06T20:12:32ZWe can’t trust drug companies to wine, dine and educate doctors about the drugs they prescribe<figure><img src="https://images.theconversation.com/files/117581/original/image-20160406-28970-1pjczsx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Medicines drug companies peddle as safe aren't always. </span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>If a drug company treats a doctor to a nice lunch and a presentation on their newest products, is prescribing affected? Doctors generally think not, but the <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000352">research evidence</a> overwhelmingly says yes. And if these events do affect doctors’ decisions on patient care, should we be worried? </p>
<p>An <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">exposé</a> last week described over A$43 million worth of industry spending on health professionals in Australia over just six months. This included big-ticket items such as a “A$176,000 junket to Vancouver for nine dermatologists”.</p>
<p>The response, unsurprisingly, is divided. The Australian Medical Association’s president <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">describes</a> industry-sponsored educational events as “in the best interest of patients”. Medicines Australia, the industry trade association, defends the industry’s role <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">because</a>: “No one knows medicines as well as those who make them”. </p>
<p>On the other hand, the Consumer Health Forum <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">raises concerns</a> that such industry largesse may lead to prescribing that is “…not in the best interests of patients”. </p>
<h2>What the research says</h2>
<p>A <a href="https://www.propublica.org/article/doctors-who-take-company-cash-tend-to-prescribe-more-brand-name-drugs">study</a> by investigative journalism group Pro Publica released in March provides important insights into the influence of industry payments on prescribing. The study combined reports of payments to doctors under the US Sunshine Act with prescribing records. </p>
<p>The more money doctors received, the more brand-name drugs they prescribed. Those who were paid to speak at conferences or sponsored events prescribed more brand-name drugs than those just getting free meals. </p>
<p>Newer, on-patent, brand-name drugs are overwhelmingly the medicines that companies actively promote. And whether patients pay for medicines themselves or have them covered by a public or private insurance, less expensive, equally effective alternatives are often available. </p>
<p>Beyond the higher price, rapid uptake of new medicines is often not in patients’ best interest. When a medicine is first approved, little is known about rare or longer-term harmful effects. Serious harmful effects often become known during the first few years of use. Older people, and those with several serious health conditions, are usually not included in pre-market studies. </p>
<p>This happened with dabigatran (Pradaxa), an anticoagulant that was used to prevent stroke. Despite lack of pre-market testing in people over 85, it was soon commonly prescribed to this age group. Older, frail people are at higher risk of bleeding, a harmful drug side-effect, and dabigatran rapidly became a leading cause of <a href="https://www.tga.gov.au/alert/dabigatran-pradaxa-and-risk-bleeding-information-health-professionals">reports to regulators</a> of life-threatening bleeds. </p>
<p>We expect newer products to be better than the ones they replace. But this is not a requirement for a new medicine to be approved. The manufacturer needs only to show effects compared to a placebo or “sugar pill”. Many new medicines are no better or even worse than existing treatments. </p>
<p><a href="http://english.prescrire.org/en/Summary.aspx">Prescrire International</a>, a French independent bulletin, evaluates every new medicine. Over the past ten years, it found that only 7% of 1,035 offered even modest treatment advantages. More than twice as many were less safe or effective than existing options. Most of the rest were no better or worse. </p>
<p>Doctors get a very different message in drug promotion. Colleagues in Canada, the United States, France and I <a href="http://www.ncbi.nlm.nih.gov/pubmed/23558775">studied the safety information</a> doctors get from sales representatives. More than 250 doctors participated in the study, reporting on nearly 1,700 drug-specific promotions during sales visits. </p>
<p>Fewer than 2% of promotions included “minimally adequate” information for safe prescribing in any of the three countries. </p>
<p>We carried out this study just before the use of the diabetes drug rosiglitazone (Avandia) was restricted due to heart attack risks. Nearly all of the promotional claims were of safety: “Avandia is safe even in patients with heart disease”; “new studies indicate safety”. </p>
<h2>What about ‘educational events’?</h2>
<p>There are many reports of educational events also leading to bias in documents that have become public in US legal cases on fraudulent marketing. For example, sponsored education was a major tactic used by Parke-Davis to promote the epilepsy drug <a href="http://www.ncbi.nlm.nih.gov/pubmed/16908919">gabapentin (Neurontin)</a> for a range of unapproved uses. </p>
<p>And it is hard to see a <a href="http://ajmf.org.au/wp-content/uploads/2014/07/AJMF-VIC-Aug-2014-meeting-Kimberly-Gardens2.pdf">dinner event</a> on “The Anxious, Depressed Patient”, sponsored by AstraZeneca in August 2014 at Kimberly Gardens in St Kilda, as anything but promotional when the invitation features the same image as an advertisement for quetiapine (Seroquel).</p>
<p>Such events often feature physician “key opinion leaders”. This is one of the most insidious forms of promotion, as it’s harder for the audience to clearly see that this is sales. </p>
<p>A first step towards change would be a firewall between continuing professional education and industry sponsorship. Australian doctors can access excellent independent medicines information through <a href="http://www.nps.org.au/">NPSMedicineWise</a>, the <a href="https://shop.amh.net.au/">Australian Medicines Handbook</a> and <a href="http://www.tg.org.au/">Therapeutic Guidelines</a>. Funding for independent continuing professional education could also be expanded. </p>
<p>The view of many doctors that “I don’t let myself be influenced” might be the biggest barrier to change. But A$43 million in six months is a lot of money for drug companies to spend if they’re having no influence.</p><img src="https://counter.theconversation.com/content/56990/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Barbara Mintzes has received funding from the Canadian Institutes of Health Research for research on drug promotion. She has also acted as an expert witness on behalf of plaintiffs in Canadian class action lawsuits on hormone replacement therapy and testosterone. She is affiliated with the Therapeutics Initiative, an independent research group that provides an information bulletin for doctors and pharmacists, and Health Action International, a global consumer network working to promote more rational use of medicines. </span></em></p>The view of many doctors that “I don’t let myself be influenced” might be the biggest barrier to change.Barbara Mintzes, Senior Lecturer, Faculty of Pharmacy, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/570612016-04-06T20:12:13Z2016-04-06T20:12:13ZInvisible influence: why sales reps are forming relationships with nurses<figure><img src="https://images.theconversation.com/files/117614/original/image-20160406-28973-rdbdkk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Nurses do influence decisions on which medical products and equipment to buy.</span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>Last week Fairfax Media <a href="http://theconversation.com/we-cant-rely-on-drug-companies-to-wine-dine-and-educate-doctors-about-the-drugs-they-prescribe-56990">revealed</a> pharmaceutical companies are spending lavish amounts treating Australian doctors to lunches, dinners and overseas trips.</p>
<p>However, it is not only doctors who are courted in this way. The <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">article</a> reported that Pfizer Australia paid A$56,628 to send four endocrinology nurses to Savannah, Georgia, for a two-day conference.</p>
<p>Globally, countries are adopting regulation that aims to bring transparency to the financial relationships between doctors and pharmaceutical and medical device companies. These <a href="http://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2013/11/11/persuading-the-prescribers-pharmaceutical-industry-marketing-and-its-influence-on-physicians-and-patients">relationships are associated</a> with the increased prescription of high-cost, brand-name drugs and devices that often have a limited track record for safety. </p>
<p>However, when policymakers and researchers discuss marketing to health professionals, the relationships between nurses and industry are seldom considered. And these relationships remain almost entirely invisible to the public.</p>
<h2>Nurses have more influence than most think</h2>
<p>As doctors’ relationships with industry come under public scrutiny, researchers suggest nurses are increasingly becoming a <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0050005">“soft” target</a> for marketing and a regulatory “back door” to prescribers and patients. </p>
<p>This could mean that efforts to protect clinical decision-making from marketing influence are undermined, potentially driving up health-care costs or exposing patients to unnecessary or even unsafe treatments.</p>
<p>Australia is one of the few countries where payments and gifts to nurses are reported. A <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000128">2009 study</a> found that Australian pharmaceutical companies sponsored almost 600 educational events for health professionals a week at a cost of about A$1 million per week. Nurses were present at 26% of these events – nearly as often as family doctors.</p>
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<a href="https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=246&fit=crop&dpr=1 600w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=246&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=246&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=309&fit=crop&dpr=1 754w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=309&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=309&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 medical trade show.</span>
<span class="attribution"><span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>Yet, many wonder, if nurses cannot prescribe treatments, why would companies spend money marketing to them?</p>
<p>Our <a href="http://annals.org/article.aspx?articleID=2511011">new study</a> paints a preliminary picture of the routine yet influential ways registered nurses interact with sales representatives in day-to-day clinical practice. </p>
<p>We explored why policymakers have overlooked marketing to nurses. This involves deeply held assumptions about the nature of nurses’ work – namely, that because nurses do not prescribe, they have no influence on treatment decisions. Thus, interactions between nurses and industry are subject to little scrutiny. </p>
<p>We interviewed and observed registered nurses working in four acute care hospitals in the United States who interacted with sales representatives from the “medically related industry”. This consisted of pharmaceutical, medical device and equipment, nutrition and infant formula, and health technology companies.</p>
<p>Nurses interacted with industry in similar ways to doctors. They attended sponsored dinners, served as paid speakers for companies, met one-on-one with sales representatives and were offered free samples or small gifts. </p>
<p>But nurses also described daily contact with industry in the course of patient care. This included in-service education conducted by sales representatives, sales representatives providing product support in the operating theatre or presenting product information to purchasing committees. </p>
<p>For example, when hospitals purchase medical equipment, they often contract the company to have a sales representative teach the nursing staff how to use it. As product experts, sales representatives are an obvious source of product information. </p>
<p>However, nurses in the study described the challenges of keeping sales representatives “on message”. They struggled to identify biased information and with “upselling” when sales representatives tried to introduce related or upgraded products. </p>
<p>Participants in the study, including staff nurses up to hospital administrators, echoed the general assumption that nurses who do not prescribe have little control over treatment decisions. Thus, marketing directed to them is seen as being of little consequence to patients or the health system. </p>
<p>Hospital administrators asserted that nurses did not normally interact with industry at all. Nurses wondered “why they invite us” to sponsored drug dinners. </p>
<p>At the same time, nurses offered many examples of instances where they had influence over treatment and purchasing decisions.</p>
<h2>Policies need to include nurses</h2>
<p>Nurses frequently influence treatment decisions through recommending medications to patients and prescribers, as well as providing feedback on treatment outcomes. They play a vital role in medication adherence, ensuring that patients can fill and refill their medications. </p>
<p>Nurse managers oversee large departmental operating budgets. They play key roles in researching, evaluating and selecting the medical products, devices and equipment a hospital must purchase. </p>
<p>Nurses in the United States and Australia have a similar scope of practice. Similarly, the sales representatives nurses encountered in this study worked for multinational companies. Thus, Australian nurses may be subject to similar interactions and marketing influence. </p>
<p>As policymakers, researchers and the public focus on physicians, nurses increasingly interact with sales representatives on a daily basis and may be susceptible to marketing influence. </p>
<p>By forming relationships with nurses, the for-profit medically related industry gains “behind the scenes” access to and influence over health-care decisions. </p>
<p>To protect clinical decision-making from marketing influence, nurses’ power and expertise must be recognised. That means policies must include the disclosure and management of nurses’ relationships with industry.</p><img src="https://counter.theconversation.com/content/57061/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Quinn Grundy received funding from the United States Agency for Healthcare Research and Quality (AHRQ) and the Canadian Institutes of Health Research (CIHR). </span></em></p>Just because they can’t prescribe medications that does not mean nurses have no influence on important decisions for patient care.Quinn Grundy, Postdoctoral Fellow, University of SydneyLicensed as Creative Commons – attribution, no derivatives.