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	<title>eDrugSearch Blog &#187; big pharma</title>
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		<title>Healthcare amendment would delay access to &#8220;generic&#8221; versions of life-saving biologics</title>
		<link>/edsblog/healthcare-amendment-would-delay-access-to-generic-versions-of-life-saving-biologics/</link>
		<comments>/edsblog/healthcare-amendment-would-delay-access-to-generic-versions-of-life-saving-biologics/#comments</comments>
		<pubDate>Mon, 02 Nov 2009 23:32:27 +0000</pubDate>
		<dc:creator>Sarah</dc:creator>
				<category><![CDATA[Big Pharma]]></category>
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		<description><![CDATA[<p style="text-align: left">Healthcare reform isnâ€™t just about the public option and paying for doctorâ€™s visits â€” itâ€™s also about equal, affordable access to life-saving medications for all Americans. Thatâ€™s why <a target="_blank" href="http://www.dailykos.com/storyonly/2009/10/28/797874/-Pay-or-die:-Deadly-Pharma-amendment-in-HCR-going-right-under-the-radar">many Big Pharma watchdogs are so disappointed</a> with a recent amendment slipped into healthcare legislation that proposes extending patent protection on biologic drugs, [...]]]></description>
				<content:encoded><![CDATA[<p style="text-align: left"><img class="aligncenter size-full wp-image-2775" src="/edsblog/wp-content/uploads/2009/11/biologics.jpg" alt="biologics" width="507" height="239" />Healthcare reform isnâ€™t just about the public option and paying for doctorâ€™s visits â€” itâ€™s also about equal, affordable access to life-saving medications for all Americans. Thatâ€™s why <a target="_blank" href="http://www.dailykos.com/storyonly/2009/10/28/797874/-Pay-or-die:-Deadly-Pharma-amendment-in-HCR-going-right-under-the-radar">many Big Pharma watchdogs are so disappointed</a> with a recent amendment slipped into healthcare legislation that proposes extending patent protection on biologic drugs, delaying for years the publicâ€™s access to affordable follow-on versions.</p>
<p style="text-align: left">What are â€œbiologicsâ€? Theyâ€™re the next big wave in medicine â€” drugs made not from simple chemical formulations, but from biological components. Theyâ€™re very expensive, and <a target="_blank" href="http://www.fiercepharma.com/story/biologics-top-pharma-sales-2014/2009-06-18">poised for enormous success</a>:</p>
<blockquote><p>By 2014, the biggest-selling meds will be biologics, according to an analysis from Evaluate Pharma. Taking the place of Pfizer&#8217;s gargantuan drug <a href="/web.php?q=lipitor&amp;butSearch.x=0&amp;butSearch.y=0&amp;st=7">Lipitor</a> will be Roche&#8217;s Avastin, a cancer med expected to account for $9.23 billion in 2014 sales. (Even when you factor in the recent trial disappointments.) The next five top sellers, in order, are expected to be <a href="/web.php?q=humira&amp;butSearch.x=0&amp;butSearch.y=0&amp;st=7">Humira</a> (Abbott Labs), Rituxan (Roche), <a href="/web.php?q=enbrel&amp;butSearch.x=0&amp;butSearch.y=0&amp;st=7">Enbrel</a> (Wyeth/Amgen), <a href="/web.php?q=lantus&amp;butSearch.x=0&amp;butSearch.y=0&amp;st=7">Lantus</a> (Sanofi-Aventis), and Herceptin (also Roche).</p>
<p>Evaluate also predicts that <strong>half of the top 100 drugs in 2014 will be biotech meds</strong> â€” a huge change from last year&#8217;s level of 28 percent and 11 percent in 2000.</p></blockquote>
<p style="text-align: left">Because biologics are so complex, the system we all know â€” where patented brand names enjoy a period of exclusivity, then eventually make way to cheaper generics â€” doesnâ€™t translate perfectly. <a target="_blank" href="http://www.merck.com/mmhe/sec02/ch017/ch017c.html">Biologic â€œgenericsâ€</a> are called â€œbiosimilars,â€ and they are not seen as generic equivalents. They must be submitted for approvals as new drugs and do their own clinical trials, etc.Â <em></em></p>
<p style="text-align: left">The Eshoo-Barton amendment, named for sponsoring Representatives Anna Eshoo (D â€“ Calif.) and Joe Barton (R â€“ Texas), would give brand-name biologic drugmakers 12 years of market exclusivity. By comparison, President Obama favors seven years, and Rep. Henry Waxman (D â€“Calif.) feels that the public should have access to â€œgenericâ€ biologics after just five years. By contrast, says <a target="_blank" href="http://www.medicalnewstoday.com/articles/143037.php">Medical News Today</a>, <em>â€œThe Biotechnology Industry Organization maintains that there should be a minimum 14 years of exclusivity to account for a development process that on average takes <strong>10 years and $1.2 billion</strong> for a product to reach market.â€ </em></p>
<p style="text-align: left">5, 7, 12, or 14 years? As you can see, there is a real difference of opinion on this subject. One person who has written extensively on this is author James Love on the Huffington Post. <a target="_blank" href="http://www.huffingtonpost.com/james-love/eshoo-and-barton-team-up_b_248847.html">Here he explains why this amendment is harmful</a>:</p>
<blockquote><p>The Eshoo/Barton amendment, which has the support of many newly pro-PhRMA democrats, will extend the period of monopolies for biologic medicines, when compared to the original Waxman text. The only question is how long. Part of the harm will be the longer period prohibiting generic suppliers from relying upon evidence that medicines are safe and provide therapeutic benefits. Much of the other harm will come from a number of technical changes in the bill that make it much easier for incumbent firms to block entry through technical issues, extended litigation, and ever-greening of protection from small medically unimportant changes in protected medicines.</p></blockquote>
<p style="text-align: left">This is essentially a case of innovation versus access. Drug companies want protection from the risks and costs borne in the creation and testing of new drugs; patient advocates say that Big Pharma (or Big Biotech, if you like) already make large profits and that the public deserves access to affordable biosimilars in a more timely fashion. <em>â€œEntities that support longer periods of exclusivity â€” such as universities, biotech companies and venture capitalists â€” are â€˜fighting to protect inventors&#8217; rights and ensure more thorough clinical trials.â€™ On the other side, consumer groups, labor unions, insurers and generic drug manufacturers â€˜see shorter exclusivity as the way to deliver safe, affordable and quality drugs to patients and open the marketplace to increased competition,â€™â€</em> <a target="_blank" href="http://www.medicalnewstoday.com/articles/143037.php">explains <em>Medical News Today</em></a>.</p>
<p style="text-align: left">The latest high-emotion development is blogger Jane Hamsherâ€™s â€œ<a target="_blank" href="http://fdlaction.firedoglake.com/2009/10/27/are-you-or-someone-you-know-paying-50000-a-year-for-drugs/">Are You Or Someone You Know Paying $50,000 A Year For Drugs?</a>â€ It paints an ugly picture of what happens to people who cannot affording life-saving biologics. A few days later, Rep. Eshoo responded to this and other online attention with a blog post on <em>The Hillâ€™s Congress Blog</em> titled â€œ<a target="_blank" href="http://thehill.com/blogs/congress-blog/healthcare/65647-setting-the-record-straight-on-our-health-care-legislation-rep-anna-eshoo">Setting the record straight on our health care legislation</a>.â€ If you check in with these two articles, you&#8217;ll have the latest from both side of the &#8220;biologic generics&#8221; debate.</p>
<p style="text-align: left">Our mission, as always, at <a href="/about/">EDrugSearch.com</a> is to improve the American public&#8217;s access to safe, quality medications at an affordable cost.</p>
<p style="text-align: left">For more information:</p>
<ul style="text-align: left">
<li><a target="_blank" href="http://newspoodle.posterous.com/should-we-be-ok-with-the-phrma-deal-with-whit">Should We Be OK With The PhRMA Deal With White House?</a></li>
<li><a target="_blank" href="http://online.wsj.com/article/SB124917341780899303.html">US House Panel Backs Exclusivity for Biologic Drugs</a></li>
<li><a target="_blank" href="http://www.dailykos.com/storyonly/2009/10/28/797874/-Pay-or-die:-Deadly-Pharma-amendment-in-HCR-going-right-under-the-radar">Pay or die: Deadly Pharma amendment in HCR going right under radar</a></li>
</ul>
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		<title>Senator Klobuchar: Let&#8217;s put an end to drug company price-gouging</title>
		<link>/edsblog/senator-klobuchar-lets-put-an-end-to-drug-company-price-gouging/</link>
		<comments>/edsblog/senator-klobuchar-lets-put-an-end-to-drug-company-price-gouging/#comments</comments>
		<pubDate>Fri, 13 Feb 2009 13:56:22 +0000</pubDate>
		<dc:creator>Cary Byrd</dc:creator>
				<category><![CDATA[Drug costs]]></category>
		<category><![CDATA[Pharmaceutical companies]]></category>
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		<description><![CDATA[<p><a href='/edsblog/wp-content/uploads/2009/02/340x.jpg'></a></p> <p>Amy Klobuchar, the freshman U.S. Senator from Minnesota, has penned an opinion piece on &#8220;sudden and dramatic&#8221; price increases in prescription drugs that she argues are not only wrong, but in many cases illegal. Here&#8217;s an excerpt from <a target="_blank" href="http://www.hutchinsonleader.com/commentary-drug-company-s-price-gouging-not-just-wrong-it-s-illegal-102">Klobuchar&#8217;s article</a>:</p> <p>Two years ago, Jesse and Lisa Benson became the proud parents [...]]]></description>
				<content:encoded><![CDATA[<p><a href='/edsblog/wp-content/uploads/2009/02/340x.jpg'><img src="/edsblog/wp-content/uploads/2009/02/340x-219x300.jpg" alt="klobuchar prescription drugs" title="72150734AW013_Meet_The_Pres" width="219" height="300" class="alignnone size-medium wp-image-1006" /></a></p>
<p>Amy Klobuchar, the freshman U.S. Senator from Minnesota, has penned an opinion piece on &#8220;sudden and dramatic&#8221; price increases in prescription drugs that she argues are not only wrong, but in many cases illegal.  Here&#8217;s an excerpt from <a target="_blank" href="http://www.hutchinsonleader.com/commentary-drug-company-s-price-gouging-not-just-wrong-it-s-illegal-102">Klobuchar&#8217;s article</a>:</p>
<blockquote><p>Two years ago, Jesse and Lisa Benson became the proud parents of twin girls, Anna and Sophia. However, Sophia was born with a rare heart condition called patent ductus arteriosis, known as PDA, a disorder that prevents holes from healing in the hearts of premature infants.</p>
<p>At Children&#8217;s Hospitals and Clinics of Minnesota, Sophiaâ€™s heart condition was treated successfully with intravenous <a href="/web.php?q=Indomethacin">indomethacin</a>, a drug sold under the name Indocin IV. The drug has been around for several decades and is the standard nonsurgical treatment for this life-threatening condition.</p>
<p>What the Bensons did not know at the time, but the hospital did, was that the price for this drug had just increased by nearly 1,300 percent, from $108 to $1,500 per unit.</p>
<p>The sudden and dramatic price increase was not in response to new research, marketing or legal costs. The only thing that had changed was the fact that an Illinois-based company, Ovation Pharmaceuticals, had cornered the market for drug treatments of PDA&#8230;</p>
<p>As it turns out, Ovation has made a specialty of acquiring the rights to drugs that are essential for treating serious medical conditions.  For example, Ovation acquired three other drugs from Merck and then quickly jacked up the prices:</p>
<ul>
<li> Cosmegen, used to treat pediatric cancers, went up 3,437 percent.</li>
<li> Mustargen, used to treat brain tumors and certain lymphomas, increased 979 percent.</li>
<li> Diuril sodium, a diuretic used in infants and neonatals, increased 864 percent.</li>
</ul>
<p>Ovation may be among the worst, but it is far from the only offender.</p>
<p>Researchers at the University of Minnesota College of Pharmacy have found many examples of â€œextraordinaryâ€ drug price increases, defined as cases where the price at least doubles overnight. The incidence of these price increases has also been rising sharply in recent years&#8230;</p>
<p>We can all be grateful for the wonders of modern medicine, including life-saving and life-enhancing pharmaceutical drugs. But our gratitude is no excuse for drug companies to engage in monopolistic and illegal price-gouging.</p></blockquote>
<p>Amen, Amy.  It&#8217;s so nice to hear a U.S. senator stand up for the people as opposed to the big drug companies.  We&#8217;ll be watching your career with interest.</p>
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		<title>Pharma links for 02-27-08</title>
		<link>/edsblog/pharma-links-for-02-27-08/</link>
		<comments>/edsblog/pharma-links-for-02-27-08/#comments</comments>
		<pubDate>Wed, 27 Feb 2008 16:38:17 +0000</pubDate>
		<dc:creator>Cary Byrd</dc:creator>
				<category><![CDATA[Big Pharma]]></category>
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		<description><![CDATA[<a target="_blank" href="http://diabetesupdate.blogspot.com/2008/02/big-pharma-lives-to-cheat-again.html">Big Pharma Lives to Cheat Again</a> (Diabetes Update) <a target="_blank" href="http://zakstar.wordpress.com/2008/02/25/antidepressants-as-effective-as-placebo-big-pharma-on-the-defensive/">Antidepressants as effective as placebo: Big Pharma on the defensive</a> (SchizoFrenetic) <a target="_blank" href="http://swfreedomlover.wordpress.com/2008/02/26/this-is-how-much-the-fda-cares-about-us/">This Is How Much The FDA Cares About Us</a> (What Is Going On?) <a target="_blank" href="http://pharmafraud.wordpress.com/2008/02/24/big-pharma-has-created-a-thriving-enterprise-for-two-bit-criminals/">Big Pharma has Created a Thriving Enterprise for Two-bit Criminals</a> (PharmaFraud) <p>Subscribe to the <a [...]]]></description>
				<content:encoded><![CDATA[<li>
<ul>
<li><a target="_blank" href="http://diabetesupdate.blogspot.com/2008/02/big-pharma-lives-to-cheat-again.html">Big Pharma Lives to Cheat Again</a> (Diabetes Update)
<li><a target="_blank" href="http://zakstar.wordpress.com/2008/02/25/antidepressants-as-effective-as-placebo-big-pharma-on-the-defensive/">Antidepressants as effective as placebo: Big Pharma on the defensive</a> (SchizoFrenetic)
<li><a target="_blank" href="http://swfreedomlover.wordpress.com/2008/02/26/this-is-how-much-the-fda-cares-about-us/">This Is How Much The FDA Cares About Us</a> (What Is Going On?)
<li><a target="_blank" href="http://pharmafraud.wordpress.com/2008/02/24/big-pharma-has-created-a-thriving-enterprise-for-two-bit-criminals/">Big Pharma has Created a Thriving Enterprise for Two-bit Criminals</a> (PharmaFraud)
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		<title>How the drug patent process protects Big Pharma&#8217;s profits</title>
		<link>/edsblog/how-the-drug-patent-process-protects-big-pharmas-profits/</link>
		<comments>/edsblog/how-the-drug-patent-process-protects-big-pharmas-profits/#comments</comments>
		<pubDate>Tue, 21 Nov 2006 14:24:33 +0000</pubDate>
		<dc:creator>Cary Byrd</dc:creator>
				<category><![CDATA[Big Pharma]]></category>
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		<description><![CDATA[<p>Patents were created to protect inventors&#8217; right to their discoveries and to promote the progress of society. But over time, the drug industry has come to know patents as a money-printing machine. Today, drug patents actually work against their original purpose &#8212; discouraging real innovation in the pharmaceutical industry.</p> <p>The most profitable venture for drug [...]]]></description>
				<content:encoded><![CDATA[<p>Patents were created to protect inventors&#8217; right to their discoveries and to promote the progress of society.  But over time, the drug industry has come to know patents as a money-printing machine.  Today, drug patents actually work against their original purpose &#8212; discouraging real innovation in the pharmaceutical industry.</p>
<p>The most profitable venture for drug companies is stretching out the patent of a billion-dollar drug.  Patents make it illegal for a competitor to sell the same drug for a certain period of time.  The longer a drug company can stretch out the patent life, the more money it can make.  Extending a patent a few extra months translates into millions of dollars of added revenue.  </p>
<p>Once a drug company&#8217;s patent expires, generic versions of the patented drug can be produced and sold.  Since brand-name drugs never lower their prices in response to competition, drug sales plummet.  Pharmagossip discusses this further in its post, <a target="_blank" href="http://pharmagossip.blogspot.com/2006/11/big-pharmas-big-problem-contd-rise-of.html">Big Pharma&#8217;s Big Problem contd. &#8211; the rise of generics in the US</a>. If only one generic is produced, sales of the brand-name drug remain relatively high because generics only lower their prices in response to competition.  But if 50 generics are released, prices fall drastically and the life of the brand-name drug is essentially over.</p>
<p>For this reason, Big Pharma focuses most of its new product development efforts on &#8220;gaming&#8221; the federal government to extend patent and exclusivity rights.  Drug makers essentially retest the same drug for other uses in order to lengthen the exclusivity period.</p>
<p>A good example is Schering-Plough&#8217;s Claritin, the antihistamine.  Claritin&#8217;s patent and exclusivity rights were nearing expiration, so the drug maker retested Claritin with the FDA for slightly different uses and called it Clarinex.  Schering-Plough then launched a huge promotional campaign to switch users from Claritin to Clarinex because it was an &#8220;improvement&#8221; over the existing drug, even though its chemical composition is almost identical.  More on this common practice <a target="_blank" href="http://pipeline.corante.com/archives/2006/04/04/once_more_into_the_patent_breech.php">here</a>, with a specific discussion of Claritin/Clarinex <a target="_blank" href="http://pipeline.corante.com/archives/2002/05/06/claritin_and_clarinex.php">here</a>.</p>
<p>How long will consumers put up with this kind of duplicity?</p>
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