tag:theconversation.com,2011:/global/topics/jama-8670/articlesJAMA – The Conversation2023-03-07T13:44:09Ztag:theconversation.com,2011:article/1851112023-03-07T13:44:09Z2023-03-07T13:44:09ZLeading American medical journal continues to omit Black research, reinforcing a legacy of racism in medical knowledge<figure><img src="https://images.theconversation.com/files/483105/original/file-20220906-16-z1jwf1.jpg?ixlib=rb-1.1.0&rect=0%2C6%2C3637%2C2709&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Medical research is one of the keys in providing health care. </span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/8hHxO3iYuU0">SJ Objio for Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>The leading U.S. medical journal, read regularly by doctors of all specialties, systematically ignores an equally reputable and rigorous body of medical research that focuses on Black Americans’ health. </p>
<p>The American Medical Association created a segregated “whites only” environment more than 100 years ago to <a href="https://www.sciencedirect.com/science/article/abs/pii/S0027968415309354">prohibit Black physicians</a> from joining their ranks. This exclusionary and racist policy prompted the creation in 1895 of the <a href="https://www.nmanet.org/page/History">National Medical Association</a>, a professional membership group that supported African American physicians and the patients they served. Today, the NMA represents more than 30,000 medical professionals. </p>
<p>In 2008, the AMA publicly apologized and pledged to right the wrongs that were done through <a href="https://journalofethics.ama-assn.org/article/american-medical-association-and-race/2014-06">decades of racism</a> within its organization. Yet our research shows that despite <a href="https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/ama-history/ama-apology-african-americans.pdf">that public reckoning</a> 15 years ago, the opinion column of the AMA’s leading medical journal does not reflect the research and editorial contributions by NMA members. </p>
<p>Invisibility in the opinion column of one of the <a href="https://www.healthwriterhub.com/top-medical-journals/">most prominent medical journals</a> in the U.S. is another form of subtle racism that continues to <a href="https://www.journals.elsevier.com/journal-of-the-national-medical-association">lessen the importance of</a> equitable medical care and health issues for Black and underserved communities. </p>
<p>As <a href="https://scholar.google.com/scholar?hl=en&as_sdt=0%2C38&q=mya+poe&btnG=">rhetoricians</a> and <a href="https://scholar.google.com/scholar?hl=en&as_sdt=0%2C38&q=gwendolynne+reid&oq=gwendolynne+r">researchers</a> who study scientific communication, we look at the ways scientific writing perpetuates or addresses racial inequity. Our <a href="https://blog.petrieflom.law.harvard.edu/2022/06/07/citational-racism-how-leading-medical-journals-reproduce-segregation-in-american-medical-knowledge/">recent study</a> traced how research is referenced by medical professionals and colleagues, known as citations, of flagship journals of the NMA and AMA: the <a href="https://www.nmanet.org/page/History">Journal of the National American Association</a> and the <a href="https://jamanetwork.com/journals/jama">Journal of the American Medical Association</a>. </p>
<h2>Invisible research</h2>
<p>Our research began with a question: Has the <a href="https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/ama-history/ama-apology-african-americans.pdf">AMA’s 2008 apology</a> had any effect on the frequency with which JAMA opinion writers draw on insights and research of JNMA scholars and authors? </p>
<p>We studied opinion columns, also referred to as editorials, precisely because they are useful <a href="https://www.peterlang.com/document/1043716#document-details-anchor">indicators of current and future research as well as priorities and agendas</a>. The <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3190447/">purpose of editorials</a> is to critically analyze and sift through various opinions and evidence. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3190447/">Effective editorials</a> in scientific journals are especially rich forums for debate within the medical community. </p>
<p>Medical publications like JNMA and JAMA do not simply convey knowledge. They also establish professional community values through the topics that are studied and who is credited for ideas related to research. When writers choose to reference or cite another scholar, they are acknowledging and highlighting that expertise. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/492834/original/file-20221101-26-bicird.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="X-ray of a chest, several ribs, shoulder bone." src="https://images.theconversation.com/files/492834/original/file-20221101-26-bicird.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/492834/original/file-20221101-26-bicird.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=375&fit=crop&dpr=1 600w, https://images.theconversation.com/files/492834/original/file-20221101-26-bicird.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=375&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/492834/original/file-20221101-26-bicird.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=375&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/492834/original/file-20221101-26-bicird.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=471&fit=crop&dpr=1 754w, https://images.theconversation.com/files/492834/original/file-20221101-26-bicird.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=471&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/492834/original/file-20221101-26-bicird.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=471&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">Influential medical journals serve to inform and shape health care.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/ouyjDk-KdfY">Harlie Raethel for Unsplash</a></span>
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<p>As such, citations play an important role in the visibility of research. Articles and authors with more citations are more likely to have a greater effect on the scientific community and patient care. Opinion pieces can shape the broader conversation among medical professionals, and citations can widen that circle of communication. </p>
<h2>Invisible racism</h2>
<p>We <a href="https://blog.petrieflom.law.harvard.edu/2022/06/07/citational-racism-how-leading-medical-journals-reproduce-segregation-in-american-medical-knowledge/">traced how frequently</a> JAMA and JNMA opinion writers referenced one another from 2008 to 2021 by reviewing the 117 opinion pieces published in JNMA and 1,425 published in JAMA during this 13-year period. We found that JAMA opinion columns have continued to, in effect, uphold racial bias and segregation by ignoring JNMA findings. </p>
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<a href="https://images.theconversation.com/files/492836/original/file-20221101-18-bfntf0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A Black medical professional adjusts gloves in front of a mirror." src="https://images.theconversation.com/files/492836/original/file-20221101-18-bfntf0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/492836/original/file-20221101-18-bfntf0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/492836/original/file-20221101-18-bfntf0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/492836/original/file-20221101-18-bfntf0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/492836/original/file-20221101-18-bfntf0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/492836/original/file-20221101-18-bfntf0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/492836/original/file-20221101-18-bfntf0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">The work of Black medical proessionals is being overlooked in national medical journals.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/kJwZxH6jins">Piron Guillaume for Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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<p>Even when focusing on race, racism and health disparities, topics that JNMA has explored in great detail, JAMA opinion columns did not reference JNMA colleagues or research. Only two <a href="https://blog.petrieflom.law.harvard.edu/2022/06/07/citational-racism-how-leading-medical-journals-reproduce-segregation-in-american-medical-knowledge/">JNMA articles</a> were credited and referenced in the 1,425 JAMA opinion pieces that we reviewed.</p>
<p>Editors at JAMA did not respond to our requests for their comments on our analysis.</p>
<h2>Racial equity in medicine</h2>
<p>The story of the AMA and NMA is not only a reminder of the racist history of medicine. It demonstrates how the expertise of Black professionals and researchers continues to be ignored today. The lack of JNMA citations in JAMA research undercuts the <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2780911">AMA’s own work on racial equity</a> and potentially compromises the quality of medical knowledge published in its journals. </p>
<p>For example, a recent study in the <a href="https://doi.org/10.1073/pnas.1915378117">Proceedings of the National Academy of Sciences</a> found that scientists from underrepresented groups innovate, or contribute novel scientific findings, at a higher rate than those from majority groups.</p>
<p>An article published in the weekly medical journal of the <a href="https://doi.org/10.1371/journal.pmed.1001918">Public Library of Science</a> noted that diverse research teams are often more successful in developing new knowledge to help treat women and underrepresented patients with greater precision. </p>
<h2>Dissolving systemic bias</h2>
<p>One way to intentionally tackle racial bias and segregation in medical knowledge is by deliberately referencing Black researchers and their work. To change this dynamic of racial bias, medical journals must pay attention to how much and how often the Black medical establishment is referenced. Health issues in underserved communities would likely become more visible and achieve greater quality of care in keeping with the <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2780911">AMA’s commitment to social justice</a>.</p>
<p>Journal editors could tell writers and editorial staff to prioritize citation practices. Individual authors might conduct research and evaluate their reading habits to intentionally include research from the Black medical community. </p>
<p>However, this work must go beyond individuals. Undoing decades of collective habits and embedded racism requires collaborations that work across systems, institutions and disciplines. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/492838/original/file-20221101-28600-4atxo6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="One hand holds a bottle of pills and the other hand holds three white pills." src="https://images.theconversation.com/files/492838/original/file-20221101-28600-4atxo6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/492838/original/file-20221101-28600-4atxo6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/492838/original/file-20221101-28600-4atxo6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/492838/original/file-20221101-28600-4atxo6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/492838/original/file-20221101-28600-4atxo6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/492838/original/file-20221101-28600-4atxo6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/492838/original/file-20221101-28600-4atxo6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Racial disparities in health care often result in lower-quality medical treatment and worse health care outcomes for Black Americans.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/s/photos/medicine">Towfiqu Barbhuiya for Unsplash</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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<p>For example, libraries, databases, and search engines that help researchers find and evaluate medical publications might review today’s research tools. It is hard to contribute to a research conversation if your work is invisible or can’t be found.</p>
<p>Many tools, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4150161/">like impact factors</a>, rank research according to how influential it is. If research begins in a category of less importance, it can be harder for the technology to rank it equitably. JNMA’s work was already marginalized when the tools that rank research were developed. </p>
<p>Thus, search results can hinder efforts of individual authors to work toward equitable citation practices. Black researchers and their research of Black health were excluded from the beginning, and existing systems of sharing knowledge and drawing attention to important studies incorporate that structural racism.</p>
<p>The <a href="https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/ama-history/ama-apology-african-americans.pdf">AMA apology</a> in 2008 and its recent progress on <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2780911">addressing racism</a> in its publication process are promising steps. Influential medical journals serve to inform and shape health care. Who is referenced in these journals matters to the medical establishment, research funders and, ultimately, to the patients that are served by innovations in medicine.</p>
<p>Attention to citation can help <a href="https://www.sciencedirect.com/science/article/abs/pii/S0165178121005904?via%3Dihub">reduce systemic bias</a> in medical knowledge to achieve greater fairness in health care and, in the long run, help increase attention and resources that will help solve health issues in underserved communities.</p><img src="https://counter.theconversation.com/content/185111/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>The lack of visibility by Black researchers and physicians in scientific literature perpetuates systemic racism in medicine.Cherice Escobar Jones, PhD Candidate, Northeastern UniversityGwendolynne Reid, Assistant Professor of English, Emory UniversityMya Poe, Associate Professor of English, Northeastern UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/689762016-11-17T07:53:05Z2016-11-17T07:53:05ZCranberries can’t cure UTIs, and other good reasons to publish negative research results<figure><img src="https://images.theconversation.com/files/146320/original/image-20161117-13340-y1jpgx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/29682030@N00/312237886/in/photolist-tAirQ-48ncaK-3j2eQt-8WDaJV-8P37f3-7uBwM-aMZqqp-pPMfS5-rz3qN9-e7N7hS-96FYBT-iSBSrk-5PwEUe-iFL3iq-48xhJJ-pmFctB-924bM7-7vydSu-7hdJJj-8Jrqvb-e7N1K1-bG7b8x-8Jon6X-t2TAN-67UzLs-aYHrur-7MuAP-4a5R35-aMZqrF-tdp47-9aky1o-5qGqQ-aMZqtD-4cKgft-8XtAox-d8amm5-nuz8x-4a5QRq-4iPjgC-8njGik-7fABWt-4fTd86-8JksYP-7vydSU-8pWzX-gsfLUt-95AXuG-8JojXg-8Jou6L-6SKW5v">Bruce Foster/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span></figcaption></figure><p>Cranberries, the little red berries from North America, are not effective for curing urinary tract infections. This piece of information is bound to disappoint the women who have been swallowing cranberry capsules for years in the hope that it was. But, alas, this is what science shows. </p>
<p>These results <a href="http://jamanetwork.com/journals/jama/fullarticle/2576822">were published</a> on October 27 in the prestigious medical journal JAMA. For the experiment, older women living in nursing homes were administered cranberry capsules for a year, while others were given a placebo pill. The comparison did not reveal any significant difference in the presence of bacteria in their urine. </p>
<p>This work is the latest example of publication of a study yielding results that were <a href="https://theconversation.com/pourquoi-il-faut-faire-plus-attention-aux-resultats-negatifs-des-etudes-cliniques-60964">the opposite</a> of what was expected.</p>
<p>In the editorial that <a href="http://jamanetwork.com/journals/jama/fullarticle/2576821">was published in the same journal</a>, a Canadian researcher acknowledges this disappointment and writes that cranberry <a href="https://www.anses.fr/fr/content/canneberge-et-infections-urinaires">once constituted a nice hope</a> in the fight against urinary tract infections, but that it is now time <a href="http://www.h2mw.eu/redactionmedicale/2016/10/le-jama-et-la-plupart-des-revues-prestigieuses-publient-des-r%C3%A9sultats-n%C3%A9gatifs-mais-il-faut-que-ces-.html">to move on to something else</a>. </p>
<p>This proves that a so-called “negative study” is anything but useless.</p>
<p>Negative studies like this one are scarce in scientific journals today. Indeed, researchers tend to practice self-censorship; they don’t even submit negative studies for publication. So my colleagues and I have created an online journal exclusively dedicated to the subject, called <a href="http://www.negative-results.org">Negative Results</a>. </p>
<p>We <a href="http://www.negative-results.org/index.php/about-our-company/">four founders</a> are all young French researchers in biology: Antoine Muchir, Rémi Thomasson, Yannick Tanguy and Thibaut Marais. We’re motivated by the same purpose, namely that scientific quests resulting in failure should be considered for what they are worth. And their <a href="http://www.la-croix.com/Sciences/Sciences/Que-nous-apprennent-etudes-scientifiques-negatives-2016-10-18-1200797011">results should be accessible to everyone</a>.</p>
<p>Leading international figures have joined our editorial committee and will help us guarantee the quality of the publications that will be put online. The American Alzheimer’s researcher <a href="http://www.utsa.edu/biology/faculty/GeorgePerry.html">George Perry</a>, from the University of Texas in San Antonio, has decided to join our team, as has Columbia University nephrologist Simone Sanna-Cherchi. We aim to publish our first research articles by the end of the year.</p>
<h2>Why publish negative results?</h2>
<p>One year ago, the four of us were sitting in an amphitheatre at Pierre and Marie Curie University, in Paris. A colleague was defending her PhD thesis there. In our field, a thesis represents three years of strenuous work spent between lab benches and computer screens. </p>
<p>The point is to verify an original hypothesis, which quickly leads to a multitude of secondary hypotheses that must also be tested. All these experiments must result in scientific publications if doctoral students want to earn recognition from the scientific community and to make progress. Their future careers largely depends on this.</p>
<p>On that day, the future doctor in biology passed with distinction. But, despite the quality of her research, she had failed to publish a single article in peer-reviewed journals. Why? Because the results she obtained did not confirm her starting hypothesis. She had invalidated her hypothesis, demonstrating that it was false.</p>
<h2>Not duplicating experiments to no avail</h2>
<p>It seemed inconceivable to us that this student’s considerable work and effort should leave no trace in the field of research and that no one beyond us, the audience of that day, should ever know that the lead this researcher had followed led to nowhere. </p>
<p>What if another researcher tried to undertake the same project tomorrow, only to end at the same impasse? In biology, taking into account the equipment and the researcher’s time, one year of research costs an average of €60,000. It is costly to duplicate fruitless experiments.</p>
<p>Negative Results emerged from the shared idea that there must be a way to avoid such waste. Publishers frequently say that “negative” data fails to draw readership and is therefore of little value to the journal because it limits its impact and citations. We are of a different opinion: even invalidated hypotheses must be made available to everyone. </p>
<p>On occasion, negative studies do get published, like JAMA’s debunking of cranberries’ medicinal uses. But it’s just the tip of the iceberg. <a href="http://www.nature.com/news/social-sciences-suffer-from-severe-publication-bias-1.15787">According to a 2014 article in Nature</a>, only 20% of negative studies see the light of day; the other 80% remain in the shadowy depths. </p>
<p>We do not deny the fact that some efforts have been made in recent years to overcome this difficulty. The open-access publication mode has reshaped the landscape of scientific publications. And, here and there, journals do accept negative results. </p>
<h2>Pharmaceutical drugs</h2>
<p>This is particularly true in pharmaceutical drug research. In that field, historically, clinical trials are considered an “advance” only when their final results allow the launch of new pharmaceutical drugs on the market.</p>
<p>But in 2007 the United States made it mandatory for pharmaceutical laboratories to publish the results of all their trials <a href="https://clinicaltrials.gov">on a public register</a>. The European Union voted for <a href="http://ec.europa.eu/health/human-use/clinical-trials/regulation/index_en.htm">a similar ruling</a> in 2014, but it is not yet in force. </p>
<p>Despite these improvements, the results are published as simple data, not as easy-to-understand, argued and annotated publications. In addition, this progress concerns only clinical studies. As for fundamental and pre-clinical studies, there is very little out there.</p>
<h2>Ineffective or toxic molecules</h2>
<p>The disdain for negative results lead to the impoverishment of scientific knowledge, and mobilises resources (time, personnel, money) in vain. These are regrettable, but there are worse implications, too. </p>
<p>Sometimes, the fact that negative results are not published constitutes an ethical breach. In the private sector, start-ups and pharma labs are conducting cell and tissue experiments to test certain molecules, only to find that they are ineffective, or even toxic. But more often than not, even though these results would further scientific knowledge, they are not published. Without having this information, how do we know the development of these molecules is stopped?</p>
<p>We might be idealists, but we are certainly not utopians. Rather than penalising researchers who produce negative results, or pointing a finger at them, we offer them a gratifying alternative. We hope that the creation of Negative Results will help people realise interest in all results, negative as well as positive. </p>
<p>We aim to provide a database that both researchers and pharmaceutical companies can consult to optimise their research. They will thus be able to meet the expectations of society, namely to further knowledge in all the fields of biology of the living, while preserving the health and integrity of patients who agree to participate in clinical trials.</p><img src="https://counter.theconversation.com/content/68976/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rémi Thomasson works for Negative Results. He received funding from the Ile-de-France region, Labex GR-EX , and AMA (Agence Mondiale Antidopage) and AFLD (Agence Française de Lutte contre le Dopage).</span></em></p><p class="fine-print"><em><span>Antoine Muchir works for Negative Results.</span></em></p>There are good reasons why ‘negative data’ and wrong hypotheses should be made available to everyone.Rémi Thomasson, Docteur en sciences et techniques des aptitudes physiques et sportives, Université Paris CitéAntoine Muchir, chercheur à l'Institut de myologie, Sorbonne UniversitéLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/223192014-01-22T15:44:57Z2014-01-22T15:44:57ZPublic misinformed about seal of approval from US drug agency<figure><img src="https://images.theconversation.com/files/39673/original/9yqbgkzx-1390393046.jpg?ixlib=rb-1.1.0&rect=1%2C55%2C1024%2C689&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Signed, sealed, delivered, not yours.</span> <span class="attribution"><span class="source">Adactio</span></span></figcaption></figure><p>Between 2005 and 2011, nearly half of all new drug formulations in the US were approved without companies having to demonstrate a tangible benefit, such as relieving disease symptoms, extending life, or improving someone’s ability to go about normal activities.</p>
<p>What patients really want is evidence that the drug they are taking will actually improve their condition. But the FDA, the American drug regulator, doesn’t routinely <a href="http://content.healthaffairs.org/content/24/1/67.full">consider this</a> for new molecular entities (NMEs) – drugs that have innovative chemical structures that have never been marketed before.</p>
<p>The findings come <a href="http://jama.jamanetwork.com/article.aspx?articleid=1817794">in a new paper</a> by Nicholas Downing of Yale University and colleagues, part of a series on the drug approval process published in the Journal of the American Medical Association (JAMA), that found there was wide variation in the quality of evidence considered by the FDA. They also found that nearly two out of five drugs approved by the FDA was brought to market after a single pivotal trial.</p>
<p>A <a href="http://jama.jamanetwork.com/article.aspx?articleid=1817796">second paper</a> in the series documented the lack of data required by the FDA when it considers approvals for medical devices – the study found that only 14% of high-risk medical devices, such as pacemakers and other cardiovascular implants, were assessed in one randomised control trial.</p>
<p>Both studies strongly suggest that the FDA is approving products that may not have accurate risk-benefit profiles, which could place patients at risk.</p>
<h2>Sleeping watchdog?</h2>
<p>While patients and physicians rely on the FDA to serve as an appropriate gatekeeper and watchdog, opinion polls reveal the public is misinformed as to what the FDA seal of approval actually means. For example, a national randomised trial conducted in 2011 <a href="https://archinte.jamanetwork.com/article.aspx?articleid=1105910&link=xref">found that</a> 39% of US adults believe the FDA approves only “extremely effective” drugs, and 25% believe the agency only approves drugs that do not have serious side effects.</p>
<p>In addition to debunking these commonly held myths, the Downing paper is part of a long line of comprehensive studies that have highlighted <a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1964025">the limitations</a> of the FDA’s review process for new drugs before they hit the market. </p>
<p>Because pre-market studies are limited in duration and scope, they often fail to capture later adverse events, or adverse effects that only happen to a small percentage or sub-population of patients. At the same time, pre-market studies often include research subjects who are not representative of “real-world” patients. For example, studies typically don’t include patients who are taking multiple medications.</p>
<p>The findings also affirm what commentators and FDA Commissioners have long argued – that the FDA should take a more proactive role in reviewing drugs and medical devices once they hit the market, to make sure adverse events are logged and considered. </p>
<p>No one wants an approval process <a href="https://theconversation.com/stopping-23andme-will-only-delay-the-revolution-medicine-needs-20743">that drags</a> on for a long time. So when it comes to catching later problems, the only meaningful alternative is to require that drug and medical device manufacturers actively review post-market data and report their findings to the FDA – something that needs manufacturers to actively engage with.</p>
<h2>Inside the FDA</h2>
<p>Since the 1960s, the total number of drugs approved <a href="https://theconversation.com/why-there-may-be-fewer-truly-new-drugs-hitting-the-market-22315">has been falling</a> on average, according to data collated by The Conversation. This is happening at the same time as the cost of research and development is going up. In <a href="http://jama.jamanetwork.com/article.aspx?articleid=1817795">another study</a> in the JAMA series, six FDA scientists looked at the reasons why approvals for drugs might be delayed or denied. According to the paper, between 2000 and 2012 a half of NMEs were approved when first submitted to the agency and nearly 75% were ultimately approved. Some of the reasons why new compounds failed to earn FDA approval included inadequate performance and problems with doses. </p>
<p>It’s a hugely important paper because information from the FDA on why drugs aren’t approved is limited, due to <a href="http://jama.jamanetwork.com/article.aspx?articleid=1817770">data sharing issues</a> (despite <a href="http://www.fda.gov/aboutfda/transparency/publicdisclosure/executivesummary/ucm210718.htm#productapps">recommendations</a> from its own transparency taskforce). </p>
<p>The study is sure to provide meaningful guidance to pharmaceutical companies as they contemplate, prepare or conduct pre-market studies. At the same time, however, the article raises complex questions as to the proper role of the FDA as regulator, industry collaborator, and promoter of public health. In many respects the FDA and industry are collaborators – industry’s responses to new regulations are taken seriously by the agency, and lobby groups have long had significant influence over the legislation that sets the legal limits of FDA’s authority. Yet, the agency’s primary mission is to ensure that marketed products are safe and effective, though the FDA characterises itself as a public health agency <a href="http://www.nejm.org/doi/full/10.1056/NEJMp0903764">that must</a> “promote health, prevent illness, and prolong life”.</p>
<p>As Marcia Angell, former editor of the New England Journal of Medicine, <a href="http://www.nybooks.com/articles/archives/2010/sep/30/agency-can-be-dangerous/">has observed</a>, “there is growing evidence that … [the FDA] has become the servant of the industry it regulates.”</p>
<p>Taken together, the articles support calls for the FDA to be more robust in the surveillance of marketed drugs and medical products. Simply stated, we need to know if the products we are using actually work. As the Downing study shows, the FDA’s pre-market review process isn’t clear on this and the public remain none the wiser. </p>
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<p><em>Related: <a href="https://theconversation.com/why-there-may-be-fewer-truly-new-drugs-hitting-the-market-22315">Why there may be fewer truly new drugs hitting the market</a></em></p><img src="https://counter.theconversation.com/content/22319/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Efthimios Parasidis 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>Between 2005 and 2011, nearly half of all new drug formulations in the US were approved without companies having to demonstrate a tangible benefit, such as relieving disease symptoms, extending life, or…Efthimios Parasidis, Assistant Professor of Law, The Ohio State UniversityLicensed as Creative Commons – attribution, no derivatives.