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	<title>Diabetes &#8211; FDAReview.org</title>
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		<title>Trust Walmart’s Insulin to Save Lives</title>
		<link>https://www.fdareview.org/2019/08/27/trust-walmarts-insulin-to-save-lives/</link>
		
		<dc:creator><![CDATA[Raymond March]]></dc:creator>
		<pubDate>Tue, 27 Aug 2019 17:04:48 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[Diabetes]]></category>
		<category><![CDATA[Insulin]]></category>
		<category><![CDATA[Prescription Drug Prices]]></category>
		<guid isPermaLink="false">https://www.fdareview.org/?p=393</guid>

					<description><![CDATA[Josh Wilkerson had type 1 diabetes and depended on regular insulin injections to manage his blood glucose levels. Without them, he risked long-term complications from his condition or slipping into a diabetic coma. When he turned 27, he was no longer covered under his stepfather&#8217;s insurance. His employer-provided health insurance did not cover insulin treatments. [&#8230;]]]></description>
										<content:encoded><![CDATA[<p><a href="https://www.usatoday.com/story/news/nation/2019/08/09/man-dies-otc-insulin/1942908001/" target="_blank" rel="noopener noreferrer">Josh Wilkerson</a> had type 1 diabetes and depended on regular insulin injections to manage his blood glucose levels. Without them, he risked long-term complications from his condition or slipping into a diabetic coma. When he turned 27, he was no longer covered under his stepfather&#8217;s insurance. His employer-provided health insurance did not cover insulin treatments. Without coverage, Josh found himself paying nearly $1,200 a month for insulin, a burdensome expense for someone <a href="https://www.washingtonpost.com/local/he-lost-his-insurance-and-turned-to-cheaper-form-of-insulin-it-was-a-fatal-decision/2019/08/02/106ee79a-b24d-11e9-8f6c-7828e68cb15f_story.html" target="_blank" rel="noopener noreferrer">earning $16.50 an hour</a>.</p>
<p>To make financial ends meet, Josh switched to another insulin named ReliOn. ReliOn is available without a prescription at many pharmacies and some national retailers such as Walmart and CVS. More importantly, it is often considerably cheaper than most prescription insulins. A vial of ReliOn (about a month’s supply) <a href="https://www.walmart.com/ip/Novolin-ReliOn-Insulin-N/167672445?wmlspartner=wlpa&amp;selectedSellerId=0&amp;wl13=1627&amp;adid=22222222227000000000&amp;wl0=&amp;wl1=g&amp;wl2=c&amp;wl3=42423897272&amp;wl4=pla-51320962143&amp;wl5=9020759&amp;wl6=&amp;wl7=&amp;wl8=&amp;wl9=pla&amp;wl10=8175035&amp;wl11=local&amp;wl12=167672445&amp;veh=sem&amp;gclid=CjwKCAjw1_PqBRBIEiwA71rmtY9rdEBBbR_asAyy-jSewXImmQm-ceunjeplUrO63J6pwKjjExKz8BoCUCAQAvD_BwE" target="_blank" rel="noopener noreferrer">costs about $25</a>. A vial of Humalog, a comparable kind of insulin, typically costs <a href="https://www.nytimes.com/2019/03/04/health/insulin-price-humalog-generic.html" target="_blank" rel="noopener noreferrer">$275</a>.</p>
<p>But ReliOn’s lower price is not without its tradeoffs. Older insulins, such as ReliOn, have <a href="https://dtc.ucsf.edu/types-of-diabetes/type1/treatment-of-type-1-diabetes/medications-and-therapies/type-1-insulin-therapy/types-of-insulin/human-insulin/" target="_blank" rel="noopener noreferrer">more variable rates of absorption</a> compared to more recently developed ones. This leaves patients more susceptible to blood glucose fluctuations. Unfortunately, Josh struggled to keep his blood sugars under control once he switched. After his fiancé found him unconscious, he was taken to the emergency room. Tragically, he <a href="https://www.washingtonpost.com/local/he-lost-his-insurance-and-turned-to-cheaper-form-of-insulin-it-was-a-fatal-decision/2019/08/02/106ee79a-b24d-11e9-8f6c-7828e68cb15f_story.html" target="_blank" rel="noopener noreferrer">passed away</a> five days later.</p>
<p>Josh’s heartbreaking story has received widespread attention and is provoking many to call for action. Popular press headlines demanding action be taken to include “<a href="https://insulinnation.com/treatment/why-walmart-insulins-arent-the-answer-to-high-insulin-prices/" target="_blank" rel="noopener noreferrer">Walmart insulins are not the answer</a>,” “<a href="https://www.washingtonpost.com/outlook/2019/02/19/drug-prices-are-killing-diabetics-walmart-insulin-isnt-solution/" target="_blank" rel="noopener noreferrer">Drug prices are killing diabetics</a>,” and “<a href="https://www.usatoday.com/story/news/nation/2019/08/09/man-dies-otc-insulin/1942908001/" target="_blank" rel="noopener noreferrer">A man who switched to affordable insulin died</a>.” Others raise questions such as “<a href="https://nypost.com/2019/08/12/is-over-the-counter-cheap-insulin-really-safe/" target="_blank" rel="noopener noreferrer">Is over the counter, cheap insulin safe</a>?”</p>
<p>Frustration over <a href="https://www.reuters.com/article/us-usa-healthcare-diabetes-cost/u-s-insulin-costs-per-patient-nearly-doubled-from-2012-to-2016-study-idUSKCN1PG136">skyrocketing</a> insulin prices and the <a href="https://www.cbsnews.com/news/the-rising-cost-of-insulin-horror-stories-every-day/" target="_blank" rel="noopener noreferrer">challenges they pose</a> to many diabetics is undoubtedly justified. Unfortunately, many have erroneously declared retailers like Walmart have failed and task government to step in and make insulin cheaper. As a piece in the <a href="https://www.washingtonpost.com/outlook/2019/02/19/drug-prices-are-killing-diabetics-walmart-insulin-isnt-solution/" target="_blank" rel="noopener noreferrer"><em>Washington Post</em></a> states:</p>
<blockquote><p>Much to the relief of <a href="https://www.npr.org/sections/health-shots/2018/11/28/671659349/we-re-fighting-for-our-lives-patients-protest-sky-high-insulin-prices">insulin affordability advocates</a>, who have been raising awareness about costs and pushing for <a href="https://www.reuters.com/article/us-usa-healthcare-drugpricing/congress-holds-first-hearings-on-insulin-high-drug-prices-idUSKCN1PN2WJ?fbclid=IwAR1P_K7t1dNDgae3apjMrK-6D1IdZ2UnwjKyJhKSvE8JmcynE91YLjc0w8Q" target="_blank" rel="noopener noreferrer">policy changes</a>, the public is increasingly aware of this crisis. But instead of working with advocates to rectify the situation, too many people are simply promoting older, cheaper insulin…Such gestures come from a good place, but they put insulin-dependent people at greater risk and threaten to exacerbate the larger problem.</p></blockquote>
<p>Such claims are fallacious at best.</p>
<p>Is true that ReliOn and other “older cheaper, insulins” are not a solution? Yes. However, no insulin is a solution. Diabetes management requires strict dieting, healthy lifestyle choices, regular physician visits, consistent sleep schedules, and a personal commitment to regularly testing blood glucose levels. Although modern insulins have their advantages, they hardly constitute a “solution” for a demanding and taxing life-long condition.</p>
<p>Further, medical studies indicate personal choices are far more likely to <a href="https://care.diabetesjournals.org/content/31/4/830#ref-9" target="_blank" rel="noopener noreferrer">lead to premature death</a> and diabetic-related complications than the kind of insulin used. A 2008 <a href="https://care.diabetesjournals.org/content/31/4/714?ijkey=367aded7970f720183e0abcc9a277545710d9923&amp;keytype2=tf_ipsecsha" target="_blank" rel="noopener noreferrer">study</a> published in the peer-reviewed journal <em>Diabetes Care</em> found that consequences of mismanaged diabetes in Demark (where insulin is <a href="https://www.drugwatch.com/featured/us-drug-prices-higher-vs-world/" target="_blank" rel="noopener noreferrer">significantly cheaper</a>) were due to dietary and lifestyle choices. These findings, coupled with <a href="https://www.usatoday.com/story/news/nation/2019/08/09/man-dies-otc-insulin/1942908001/" target="_blank" rel="noopener noreferrer">medical testimony</a> that ReliOn is <a href="https://insulinnation.com/treatment/why-walmart-insulins-arent-the-answer-to-high-insulin-prices/" target="_blank" rel="noopener noreferrer">safe and effective</a>, undermine claims that such insulins “threaten to exacerbate the larger problem.”</p>
<p>Most importantly, we should hesitate to call on further policies to make insulin affordable. As I have argued <a href="https://blog.independent.org/2019/03/26/generic-insulin-now-available-after-nearly-one-hundred-years-of-regulatory-protection-from-competition/" target="_blank" rel="noopener noreferrer">before</a>, the primary reason insulin is so expensive in the United States is because of poorly designed policies that allow insulin producers to charge high prices. Under the FDA’s <a href="https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048341.htm" target="_blank" rel="noopener noreferrer">regulatory system</a>, insulin is considered a biological compound rather than a pharmaceutical. Biological compounds can have their patents extended as long as <a href="https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin" target="_blank" rel="noopener noreferrer">their chemical composition</a> is modified. This regulatory policy has allowed three insulin producers to encompass 99 percent of the insulin market for nearly one-hundred years, stifling competition and keeping their prices high. In that time, advocacy groups and government panels have failed to find any solution to the insulin problem.</p>
<p>In contrast, retailers like <a href="https://corporate.walmart.com/newsroom/2012/07/24/walmart-launches-effort-to-save-diabetes-patients-up-to-60-million-annually">Walmart</a> have done what policymakers, advocacy groups, and government panels could not: make life-saving medication widely available and affordable. In doing so, they have undoubtedly <a href="https://wgme.com/news/i-team/diabetics-turn-to-non-prescription-walmart-insulin-as-drug-prices-continue-to-spike" target="_blank" rel="noopener noreferrer">saved lives and provided financial relieve</a> for numerous patients in dire situations.</p>
<p>We should be extremely hesitant to chastise retailers for making cheaper insulins available. Their critics’ talk, unlike their solutions, is cheap.</p>
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		<item>
		<title>Generic Insulin Now Available After Nearly One Hundred Years of Regulatory Protection From Competition</title>
		<link>https://www.fdareview.org/2019/03/25/generic-insulin-now-available-after-nearly-one-hundred-years-of-regulatory-protection-from-competition/</link>
		
		<dc:creator><![CDATA[Raymond March]]></dc:creator>
		<pubDate>Mon, 25 Mar 2019 21:01:54 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[CDCP]]></category>
		<category><![CDATA[Diabetes]]></category>
		<category><![CDATA[Insulin]]></category>
		<guid isPermaLink="false">http://www.fdareview.org/?p=336</guid>

					<description><![CDATA[Diabetes is arguably the biggest epidemic of the twenty-first century. According to the federal Centers for Disease Control, more than 100 million Americans are diabetic or prediabetic. If left unmanaged, diabetes is fatal and can result in serious health complications, including nerve damage, heart disease, stroke, blindness, kidney disease, and damage to extremities requiring amputation. [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>Diabetes is arguably the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3068646/">biggest epidemic</a> of the twenty-first century. According to the federal Centers for Disease Control, more than <a href="https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html">100 million Americans</a> are diabetic or prediabetic. If left unmanaged, diabetes is fatal and can result in <a href="https://www.endocrineweb.com/conditions/type-2-diabetes/type-2-diabetes-complications">serious health complications</a>, including nerve damage, heart disease, stroke, blindness, kidney disease, and damage to extremities requiring amputation.</p>
<p>For an <a href="https://thehill.com/policy/healthcare/393378-skyrocketing-insulin-prices-provoke-new-outrage">increasing number</a> of people with diabetes, regular insulin injections are indispensable for managing their condition. Tragically, insulin in the United States is <a href="https://thehill.com/policy/healthcare/393378-skyrocketing-insulin-prices-provoke-new-outrage">alarmingly expensive</a>, taking a financial toll on many who need it to prolong their lives. A recent CBS News <a href="https://www.cbsnews.com/news/the-rising-cost-of-insulin-horror-stories-every-day/">article</a> reports finding “horror stories every day” of diabetics reducing and rationing their insulin doses, risking long-term complications or falling into a <a href="https://www.cbsnews.com/news/mother-fights-for-lower-insulin-prices-after-sons-tragic-death/">diabetic coma</a>.</p>
<p>Fortunately, these stories may now be a thing of the past.</p>
<p>Drug producer Eli Lilly and Company recently <a href="https://lillypad.lilly.com/entry.php?e=11295">released</a> Lispro, the first ever generic insulin to enter the U.S. market. Lispro is available in pen or vial form and lists for $137.35 per vial (or $265.20 for a pack of five pens), <a href="https://www.cnn.com/2019/03/04/health/insulin-price-humalog-generic-eli-lilly-bn/index.html">half the price</a> of Humalog, its brand-name alternative. Generic insulin provides much-needed financial relief. As Eli Lilly and Company CEO and Chairman Dave Ricks noted in a <a href="https://lillypad.lilly.com/entry.php?e=11295">statement</a>, “We don&#8217;t want anyone to ration or skip doses of insulin due to affordability. And no one should pay the full Humalog retail price.”</p>
<p>But many are still upset that a generic alternative is still expensive and is coming so late. Ben Wakana, executive director of the nonprofit advocacy group Patients For Affordable Drugs, echoes the frustrations of many when he <a href="https://www.cnn.com/2019/03/04/health/insulin-price-humalog-generic-eli-lilly-bn/index.html">expressed</a>, “Charging nearly $140 for a vial of insulin—a drug that was invented almost a century ago—is still too high.”</p>
<p>He has a point. Insulin has been available to treat diabetes <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3714061/">since 1922</a>. The first generic insulin was approved just a few weeks ago. Why?</p>
<p>Unlike pharmaceuticals, which enjoy 20 years of patent protection from competition, insulin is classified as a biological compound. Under the FDA’s <a href="https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048341.htm">regulatory system</a>, producers can extend patents for biological compounds by <a href="https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin">slightly modifying their product components</a>. This possibility creates an incentive for insulin producers to alter their products rather than releasing generic drugs and competing by offering patients lower prices.</p>
<p>As my coauthors and I note in an <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2669776">article</a> published in the <em>Journal of Entrepreneurship and Public Policy</em>, insulin has been adapted to enter the bloodstream quicker, to last longer by using different preservatives, and has also been extracted from different animals since first becoming available to patients. Many of these changes offered little medicinal benefits but protected producers from generic competitors. The result is that three insulin producers <a href="http://www.genfkd.org/monopoly-on-insulin">encompassed 99 percent</a> of the market for nearly one hundred years.</p>
<p>Offering a generic alternative for insulin is a much-welcomed addition to the diabetic care market. I expect this change to prolong and save many lives, which is certainly worth celebrating. However, the development of insulin in the United States also provides a cautionary tale of how devastating the misaligned incentives created by poorly designed regulations can be for patients.</p>
<p>It’s been a costly and long-lasting mistake. Let’s hope we learn from it.</p>
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