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	<title>Triple Helix Online &#187; Law</title>
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		<title>Supreme Healthcare Reform: Can the Court Resolve the Debate?</title>
		<link>http://triplehelixblog.com/2011/12/supreme-healthcare-reform-can-the-court-resolve-the-debate/</link>
		<comments>http://triplehelixblog.com/2011/12/supreme-healthcare-reform-can-the-court-resolve-the-debate/#comments</comments>
		<pubDate>Wed, 28 Dec 2011 12:00:49 +0000</pubDate>
		<dc:creator>Alida Miranda-Wolff</dc:creator>
				<category><![CDATA[Latest]]></category>
		<category><![CDATA[Law]]></category>
		<category><![CDATA[uchicago]]></category>
		<category><![CDATA[Affordable Care Act]]></category>
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		<category><![CDATA[Health care in the United States]]></category>
		<category><![CDATA[Health care reform in the United States]]></category>
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		<description><![CDATA[On November 14, 2011, the Supreme Court granted review to a challenge of the Patient Protection and Affordable Care Act (ACA), announcing that it would rule on fundamental questions regarding the law’s constitutionality and role in determining the authority of the states versus the authority of the federal government.1 While the 2,700-page Act addresses many [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://triplehelixblog.com/wp-content/uploads/2011/12/SCOTUS-courtroom.jpg"><img class="alignleft size-medium wp-image-2804" src="http://triplehelixblog.com/wp-content/uploads/2011/12/SCOTUS-courtroom-300x225.jpg" alt="" width="300" height="225" /></a>On November 14, 2011, the Supreme Court granted review to a challenge of the Patient Protection and Affordable Care Act (ACA), announcing that it would rule on fundamental questions regarding the law’s constitutionality and role in determining the authority of the states versus the authority of the federal government.<span style="vertical-align: super;">1</span></p>
<p>While the 2,700-page Act addresses many different health-care related issues, the two elements that the Supreme Court will review are the “individual mandate”, which requires Americans who do not purchase a health care policy to pay a fine by January 1, 2014, and the expansion of Medicaid to a greater number of citizens, which states must comply with in order to retain their funding for Medicaid.<span style="vertical-align: super;">1,2</span></p>
<p>The ACA’s individual mandate is currently at the forefront of the debate, though the Medicaid provision has also faced opposition. Conservative activists claim that the mandate is unconstitutional, while the Obama Administration contends that the mandate is supported by the Commerce Clause of the Constitution, which provides that Congress shall have the power to “regulate Commerce with foreign Nations, and among several States, and with the Indian Tribes”.<span style="vertical-align: super;">1,3,4</span> However, neither argument has been decisively upheld by the lower courts, creating confusion and contention. In the meantime, the individual mandate has become the most unpopular measure of the ACA, with only a 27 percent approval rating among Americans.<span style="vertical-align: super;">3</span></p>
<p>Polls show that Americans are more receptive to the ACA if they do not know that failure to purchase health insurance results in a penalty fee similar to a tax.<span style="vertical-align: super;">3</span> Basically, Americans support Obama’s health care plan so long as they do not have to pay for it. However, the government cannot fund the health care plan without incurring debt and driving the price of insurance up if Americans do not purchase insurance or pay the fine.<span style="vertical-align: super;">1</span></p>
<p>Proponents of the ACA argue that the individual mandate benefits individuals because health insurance companies are required to offer affordable insurance to a greater number of people regardless of their preexisting conditions.<span style="vertical-align: super;">1,4</span> This aspect of the mandate is especially important because people who acquire health insurance after being diagnosed with an illness are forced to pay exorbitantly high premiums they often times cannot afford, forcing them to choose between treatment and financial stability. Moreover, health insurance companies will not experience extreme losses because the premiums purchased by healthy people will offset the cost of premiums purchased by sick people.<span style="vertical-align: super;">3</span></p>
<p>Nevertheless, challengers dispute both arguments, characterizing the mandate as a way for Congress to aggrandize its own power. Essentially, the argument holds that by imposing penalties on the “inactive” Americans who do not purchase health care under the umbrella of the Commerce Clause, Congress expands the Commerce Clause to the point that it can be relied upon for nearly any purpose.<span style="vertical-align: super;">1</span></p>
<p><a href="http://triplehelixblog.com/wp-content/uploads/2011/12/kagan.jpg"><img class="alignright size-medium wp-image-2806" src="http://triplehelixblog.com/wp-content/uploads/2011/12/kagan-300x200.jpg" alt="" width="300" height="200" /></a>If the Supreme Court upheld the Act as constitutional, it would break away from the conservative trend set by the Rehnquist Court, which limited Congress’s power under the Commerce Clause in cases like <em>United States v. Lopez</em>, <em>United States v. Morrison, </em>and <em>Eldred v. Ashcroft</em>. A decision in favor of Obama’s health care plan would not only impact policy, once again affirming that the Supreme Court’s powers go beyond mere interpretation of the Constitution, but also signify a change in both its treatment of Commerce Clause cases and the powers of Congress. By awarding Congress more control over commerce, the Supreme Court will elevate federal powers above state powers, outraging conservatives who fear big government and autocracy.</p>
<p>The divisiveness of the health care reform argument has not escaped the lower courts. The Sixth Circuit Court of Appeals rejected the argument that the individual mandate was not constitutional, the Eleventh Circuit took the opposite stance, and the Fourth Circuit dismissed both health reform cases on the grounds that the Anti-Injunction Act, which is a preexisting law that says a tax cannot be challenged until it has been imposed, barred the mandate’s challenge in court until its implementation in 2014.<span style="vertical-align: super;">4</span> Consequently, both proponents and opponents are anxious to see the issue resolved by the Supreme Court, which intends to review the individual mandate in March.</p>
<p>The first and most important question the Court will decide is whether the Anti-Injunction Act prevents the individual mandate from being challenged in court until it takes effect in 2014.<span style="vertical-align: super;">4,6</span> If the Court rules that it cannot, the case will not be decided, leaving the entire bill open to repeal in the event of an administration change as a result of the 2012 election. However, if the Court does not favor this argument, it can use the three remaining questions to broaden its control over the legislative and, to an extent, the executive branches. Those remaining questions include whether the individual mandate is constitutional, whether the rest of the Act can remain in effect even if the individual mandate is unconstitutional, and whether the Act’s expansion of the Medicaid program is constitutional.</p>
<p>The Court’s decision to rule on the Patient Protection and Affordable Care Act has already stirred controversy from liberals, conservatives, and ethics-in-government activists. Both Justice Clarence Thomas, who has established relationships with health insurance companies like Pfizer and whose wife is an anti-ACA activist, and Justice Elena Kagan, who acted as Solicitor General in the Obama Administration when the bill was enacted, have been asked to recuse themselves from considering challenges to the ACA.<span style="vertical-align: super;">7</span> However, both Justice Thomas and Justice Kagan maintain that their relationships with the bill will not affect the judicial integrity of their final decisions and have given no indication of recusal.</p>
<p>The fact that neither Justice Thomas nor Justice Kagan has recused complicates predictions about the outcome of the health care debate, mainly because the former represents one of the most conservative seats on the Court and the latter one of the most liberal. If one party had recused and the other had not, the decision could have easily become more politicized, pursuing the agenda of a party rather than determining the constitutionality of the individual mandate or the expansion of Medicaid. Ultimately, if the Supreme Court chooses to dismiss the Anti-Injunction Act argument and answer the three remaining questions, its primary goal will not be to favor one side in this incredibly partisan argument, but determine its own role and power in the establishment and maintenance of policy.<strong> </strong></p>
<p><strong>References</strong></p>
<p><strong> </strong></p>
<ol>
<li>Amy Howe, The health care grants: In Plain English, SCOTUSblog (Nov. 17, 2011, 1:00 PM), <a href="http://www.scotusblog.com/2011/11/the-health-care-grants-in-plain-english/">http://www.scotusblog.com/2011/11/the-health-care-grants-in-plain-english/</a></li>
<li>Amy Howe, Health care amici appointed, SCOTUSblog (Nov. 18, 2011, 2:44 PM), <a href="http://www.scotusblog.com/2011/11/health-care-amici-appointed/">http://www.scotusblog.com/2011/11/health-care-amici-appointed/</a></li>
<li>Stolberg, Sheryl. &#8220;Insurance Mandate May Be Health Care&#8217;s Undoing.&#8221; The New York Times. 15 Nov. 2011. The New York Times. 18 Nov. 2011 &lt;<a href="http://www.nytimes.com/2011/11/16/health/policy/insurance-mandate-may-be-health-bills-undoing.html?_r=1&amp;partner=rssnyt&amp;emc=rss">http://www.nytimes.com/2011/11/16/health/policy/insurance-mandate-may-be-health-bills-undoing.html?_r=1&amp;partner=rssnyt&amp;emc=rss</a>&gt;.</li>
<li> Lyle Denniston, Analysis: Health care’s “sleeper issue”, SCOTUSblog (Nov. 22, 2011, 12:04 AM), <a href="http://www.scotusblog.com/2011/11/analysis-health-cares-sleeper-issue/">http://www.scotusblog.com/2011/11/analysis-health-cares-sleeper-issue/</a></li>
<li> “Article 1, Section 8, Clause 3.&#8221; The Constitution of the United States of America as amended: unratified amendments, analytical index. Washington: U.S. G.P.O., 2007.</li>
<li> &#8220;Court asks 2 lawyers to argue in health care case.&#8221; The Associated Press 18 Nov. 2011. 30 Nov. 2011 &lt;<a href="http://www.google.com/hostednews/ap/article/ALeqM5gbn_EoENqyeQMq-6RKY53mpAeaiw?docId=5a0e5efaa6ee48c789bb3f9bb1657d87">http://www.google.com/hostednews/ap/article/ALeqM5gbn_EoENqyeQMq-6RKY53mpAeaiw?docId=5a0e5efaa6ee48c789bb3f9bb1657d87</a>&gt;.</li>
<li> Oliphant, James. &#8220;Scalia and Thomas dine with healthcare law challengers as court takes case &#8211; Los Angeles Times.&#8221; Featured Articles From The Los Angeles Times. 14 Nov. 2011. 30 Nov. 2011 &lt;<a href="http://articles.latimes.com/2011/nov/14/news/la-pn-scalia-thomas-20111114">http://articles.latimes.com/2011/nov/14/news/la-pn-scalia-thomas-20111114</a>&gt;.</li>
<li>kenudigit. &#8220;US Supreme Court Court Room.&#8221; flickr. 4 Oct. 2010 &lt;<a href="http://www.flickr.com/photos/toshio1/215411503/sizes/m/in/photostream/">http://www.flickr.com/photos/kenudigit/5065652061/</a>&gt;.</li>
<li>Doc Searls. “Elena Kagan.” flickr. 12 Sep. 2008 &lt;<a href="http://www.flickr.com/photos/techweet/5400824364/sizes/o/in/photostream/">http://www.flickr.com/photos/docsearls/2853041660/</a>&gt;.</li>
</ol>
<p><em>Alida Miranda-Wolff is a second-year English and Law, Letters, and Society double major pursuing a path in law. <em>Follow The Triple Helix Online on <a href="http://www.twitter.com/tthepub">Twitter</a> and join us on <a href="http://www.facebook.com/triplehelixonline">Facebook</a>.</em></em></p>
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		<title>Stem Cell Research: Effects of the Patenting Landscape</title>
		<link>http://triplehelixblog.com/2011/05/stem-cell-research-effects-of-the-patenting-landscape/</link>
		<comments>http://triplehelixblog.com/2011/05/stem-cell-research-effects-of-the-patenting-landscape/#comments</comments>
		<pubDate>Thu, 12 May 2011 08:08:37 +0000</pubDate>
		<dc:creator>Emmanuel Aryee</dc:creator>
				<category><![CDATA[Latest]]></category>
		<category><![CDATA[Law]]></category>
		<category><![CDATA[Medicine]]></category>
		<category><![CDATA[ethics]]></category>
		<category><![CDATA[European Union law]]></category>
		<category><![CDATA[Jurisdiction]]></category>
		<category><![CDATA[morality]]></category>
		<category><![CDATA[Patent]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Stem Cells]]></category>
		<category><![CDATA[United States law]]></category>

		<guid isPermaLink="false">http://triplehelixblog.com/?p=2220</guid>
		<description><![CDATA[Ever since stem cell research began in the late 1900’s, the field has been fraught with a variety of issues including bioethics, funding, and general skepticism. The debate on stem cells has been unrelenting, and policies on the field are usually contentious topics during political campaigns. Apart from bone marrow transplantation [1], all other potential [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://triplehelixblog.com/wp-content/uploads/2011/05/Human_embryonic_stem_cells.png"><img class="alignleft size-medium wp-image-2221" title="Human_embryonic_stem_cells" src="http://triplehelixblog.com/wp-content/uploads/2011/05/Human_embryonic_stem_cells-300x198.png" alt="" width="300" height="198" /></a>Ever since stem cell research began in the late 1900’s, the field has been fraught with a variety of issues including bioethics, funding, and general skepticism. The debate on stem cells has been unrelenting, and policies on the field are usually contentious topics during political campaigns. Apart from bone marrow transplantation [1], all other potential stem cell treatments are either experimental or in trial phases under the stringent oversight of various regulating bodies [2]. Today, however, it is a different issue that is shaping this field of research. While politicians and the public debate about ethics and funding, the leading researchers in the field are turning their focus on the issue of intellectual property [3]. The subject of patents, who issues them to whom, and what they cover is gradually shaping approaches to research and affecting progress by stifling cooperation.</p>
<p>Prior to President Obama’s elimination of restrictions on federal funding for embryonic stem cell research in 2009 [4], private resources provided most of the funding and often reserved broad rights over the research. James Thomson, a scientist at the University of Wisconsin who was responsible for developing and maintaining the first human embryonic stem cell (hESC) line, received funding from the Geron Corporation in exchange for rights on consequent patents [3]. Patents on his work were also secured for the Wisconsin Alumni Research Foundation (WARF), a group in charge of patents from scientists at the university. Over the years, access to and licensing of these patents have become a source of controversy and has led to legal battles between public interest groups, the Geron Corporation, and WARF. Challenges from groups such as Consumer Watchdog and other advocates of stem cell research have criticized the extensive breadth and restrictions of the WARF patents. Even though WARF and the Geron Corporation later came to an agreement on patent sharing, they had disagreements on the licensing of the patent to other researchers. While none of the suits against WARF were successful in revoking the patents, they did lead to a substantial relaxation on the restrictions on licensing [3].</p>
<p>The controversy surrounding the patenting of stem cells is not limited to the United States, nor is it limited to the relatively restrictive terms of patents. In Europe, the European Patent Office (EPO) issued a directive in regards to the patenting of hESCs under the European Patent Convention (EPC) that includes a morality clause stating that no patent would be issued to an invention whose commercial use was contrary to the public order or morality [5]. It seems that in Europe the main opposition to patents on embryonic stem cells is tied to the ethical questions of morality and human dignity. A couple of patents have been contested as a result. The controversial “Edinburgh” patent that was issued for a method developed to isolate stem cells in Europe was successfully challenged and later restricted to exclude hESCs [6]. WARF, which had to deal with opposition to the restrictive nature of their patents in the United States, was denied a European patent, in 2004, because of the morality clause of the EPC [5]. A later appeal to the EPO’s Enlarged Board of Appeal (EBoA) in 2008 also turned out to be futile [5]. The acquisition of patents in Europe is further complicated by the fragmented legal landscape of the continent. A patent granted by the EPO to Oliver Bruestle, a German scientist on neuroprogenitor stem cells, was rendered partially invalid by the German Federal Patent Court [7]. An appeal by Bruestle was referred to the European Court of Justice (ECJ) leading to additional questions on the roles of supranational institutions such as the EPO and ECJ in the issuance of patents [7].</p>
<p>Stem cell technologies have advanced since the initial work of James Thomson. With the development of induced pluripotent stem cells (iPSCs) [8], one has to wonder how this new innovation and any other future advancement will affect patents on stem cells. Even though scientists working with iPSCs are less likely to be subjected to the same level of ethical controversy as their colleagues working with hESCs, they will probably be expected to follow policies and regulations formed as a result of the disagreements surrounding embryonic stem cells [8]. Following the reexamination of Thomson’s initial patents in 2007, the United States Patent and Trademark Office (USPTO) was able to provide a framework for determining the patentability of pluripotent stem cells by claiming that “the lack of stage-specific embryonic antigen-1 (SSEA-1) cell surface markers is a characteristic only of pluripotent hESCs, but not of other pluripotent kinds of human stem cells” [9]. While human iPSCs are not derived from embryos, they are very much like human embryonic stem cells in terms of “morphology, proliferation, surface antigens, gene expression, epigenetic status of pluripotent cell–specific genes and telomerase activity”. However, almost all lack SSEA-1 cell surface markers [9]. This important distinction may mean that the patentability of iPSCs and other future innovations in the field may be judged not by their function but by their physical characteristics [9].</p>
<p>In light of all the controversy and issues related to stem cell research, it has become imperative that scientists and relevant interest groups work together to advance the field. Support for stem cell research is usually justified with promises of its economic potential [10], and considering the fact that the most important patents in the field are held equally between public and private sectors [11], it is necessary that these two branches cooperate to ensure future success. The conflict between WARF and the Geron Corporation regarding Thomson’s work was not only representative of the friction between the private and public sectors, but also indicative of how private financing can fund groundbreaking research that would have been impossible otherwise due to limitations on public funding [3]. Besides the fact that most patent offices around the world seem to lack the needed infrastructure to keep up with the fast paced advancement in the field, there is also the issue of inaccessibility of a patent database and newly published information [7].</p>
<p>In an attempt to foster international cooperation, the Hinxton Group [12], a consortium of professionals with a vested interest in stem cells, proposes establishing databases for patents and currently used stem cell lines [13]. Their proposals include the creation of an international human tissue and stem cell bank and the provision of conditional funding to improve data sharing. They also suggest implementing patenting policies that will encourage easy access and cooperation [13]. While some of the recommendations proposed by the Hinxton Group do not currently seem feasible, they do represent a positive motion of stem cell supporters. Furthermore, the formation of groups such as the NIH Stem Cell Task Force [14] and their European counterparts, the European Stem Cell Group [15] with similar goals as the Hinxton Group reinforces the determination of the stem cell community to work together and show their commitment to reduce conflicts and promote advancements in the field.</p>
<p>Stem cells represent the potential future of medicine and the continual advancement of the field translates into future treatments and therapies for diseases and medical disorders we currently have no effective medication for. The nature of stem cell research and its funding however has resulted in disputes over patents on cell lines and experimental procedures. These patent wars and their accompanied lack of cooperation have threatened to stifle progress in the field.  However, the stem cell community is fighting back with renewed proposals for policies and forming groups that will allow for better cooperation among its members. With adequate funding and effective collaboration between stem cell researchers, we can be hopeful that a cure for cancer and other diseases is on the horizon.</p>
<p>References</p>
<ol>
<li>Ammann A. J, Meuwissen H. J, Good R. A and Hing R. Successful Bone Marrow Transplantation with Humoral and Cellular Immunity Deficiency. Clin. Exp. Immunol. 1970;7: 343-353.</li>
<li>Magnus D. Translating Stem Cell Research: Challenges at the Research Frontier. J<em> </em>Law Med Ethics. 2010;38(2):267-76</li>
<li>Golden, John M. WARF&#8217;s stem cell patents and tensions between public and private sector approaches to research. J Law Med Ethics. 2010; 38(2):314-31.</li>
<li>Robertson JA. Embryo stem cell research: ten years of controversy. J Law Med Ethics. 2010;38(2):191-203</li>
<li>Treichel P. Patenting of human embryonic stem cells in Europe. Biotechnol J. 2009; 4(4):462-4</li>
<li>Times Higher Education. &#8220;Edinburgh&#8221; patent limited after European Patent Office opposition hearing [document on the Internet].Munich: 2002 [updated 2002 July 25; cited 2011 March 4]. Available from: http://www.timeshighereducation.co.uk/story.asp?storyCode=170621&amp;sectioncode=26 .</li>
<li>Aurora Plomer. Stem Cell Patents in a Global Economy: The Legal Challenges. Stanford Journal of Law, Science &amp; Policy. 2010; 3: 5-15.</li>
<li>Caulfield T, Scott C, Hyun I, Lovell-Badge R, Kato K, Zarzeczny A. Stem cell research policy and iPS cells. Nat Methods. 2010; 7(1):28-33.</li>
<li>Vrtovec, Katja Triller &amp; Scott, Christopher Thomas. Patenting pluripotence: the next battle for stem cell intellectual property. Nat Biotechnol. 2008; 26(4):393-5</li>
<li>Caulfield Timothy. Stem cell research and economic promises. J Law Med Ethics. 2010; 38(2):303-13.</li>
<li>Konski AF, Spielthenner DJ. Stem cell patents: a landscape analysis. Nat Biotechnol. 2009; 27(8):722-6.</li>
<li>Hinxton Group. [internet site]. 2006. [cited 2011 March 4]. Available from http://www.hinxtongroup.org/</li>
<li>Brice P. Will patents hinder equitable access to stem cell medicine? [document on the Internet]. The Phg Foundation; 2011. [updated 2011 January 30; cited 2011March 4]. Available from   http://www.phgfoundation.org/news/7458/.</li>
<li>NIH Stem Cell Task Force. [internet site]. 2008. [updated 2008 November 13; cited 2011 March 4]. Available from http://stemcells.nih.gov/policy/taskforce/</li>
<li>European Stem Cell Group. [internet site]. 2009. [cited 2011 March 4] Available from <a href="http://www.eurosystemproject.eu/news/european_group">http://www.eurosystemproject.eu/news/european_group</a></li>
<li>Benvenisty, N. [photograph] 2005. Available at: <a href="http://commons.wikimedia.org/wiki/File:Human_embryonic_stem_cells.png">http://commons.wikimedia.org/wiki/File:Human_embryonic_stem_cells.png</a></li>
</ol>
<p><em>Emmanuel Aryee is a fourth-year biology major at the University of Chicago. <em>Please join The Triple Helix Online on <a href="http://www.facebook.com/#%21/triplehelixonline" target="_blank">Facebook</a>. Follow The Triple Helix Online on <a href="http://twitter.com/tthepub" target="_blank">Twitter</a>.</em></em></p>
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		<title>Hidden Obstacles in Cancer Research</title>
		<link>http://triplehelixblog.com/2011/05/hidden-obstacles-in-cancer-research/</link>
		<comments>http://triplehelixblog.com/2011/05/hidden-obstacles-in-cancer-research/#comments</comments>
		<pubDate>Mon, 09 May 2011 10:00:44 +0000</pubDate>
		<dc:creator>Isabelle Boni</dc:creator>
				<category><![CDATA[Health]]></category>
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		<category><![CDATA[Law]]></category>
		<category><![CDATA[Medicine]]></category>
		<category><![CDATA[cancer]]></category>
		<category><![CDATA[Clinical trials]]></category>
		<category><![CDATA[drug development]]></category>
		<category><![CDATA[Innovation]]></category>
		<category><![CDATA[Intellectual Property]]></category>
		<category><![CDATA[Patent]]></category>
		<category><![CDATA[Pharmaceuticals]]></category>
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		<guid isPermaLink="false">http://triplehelixblog.com/?p=2142</guid>
		<description><![CDATA[While undeniable strides in medical research over the past few decades have proven invaluable in the search for a cancer cure, there is no shortage of obstacles that remain to be addressed. Perhaps the most evident are complications in the biology of the disease itself: among these, problems pertaining to cell identification and treatment specificity. [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://triplehelixblog.com/wp-content/uploads/2011/05/Boni.jpg"><img class="alignleft size-medium wp-image-2143" title="Test tubes and other recipients in chemistry lab" src="http://triplehelixblog.com/wp-content/uploads/2011/05/Boni-199x300.jpg" alt="" width="199" height="300" /></a>While undeniable strides in medical research over the past few decades have proven invaluable in the search for a cancer cure, there is no shortage of obstacles that remain to be addressed. Perhaps the most evident are complications in the biology of the disease itself: among these, problems pertaining to cell identification and treatment specificity. Equally problematic, however, are setbacks in research policy. Such setbacks include a biased drug development process and inefficient clinical trial system, both of which delay the transition from medical discovery to clinical application.</p>
<p>In large part, translational research is mediated by the pharmaceutical industry. One of the largest disincentives to cancer drug development— and a driving force behind negotiations on the Biologics Price Competition and Innovation Act of 2009— has been the development of cheaper derivative biosimilars. This act vaguely defines biosimilars as “‘highly similar’ to the reference product ‘notwithstanding minor differences in clinically active components’” [1]. The research costs associated with developing reference biologics, or original molecules upon which these patented biosimilars are based, are significant and include large expenditures on production technology and clinical trials [2]. While there has been some debate about the amount of time necessary for a drug company to receive a return on its original investments, PhRMA (Pharmaceutical Manufacturers Association) has controversially pushed 12 years as the “bare minimum” for market exclusivity, a standard currently supported by the International Intellectual Property Institute [2, 3].</p>
<p>When considering the competing motivations of the pharmaceutical industry and its clients, it is important to reconcile the interests of each stakeholder. This was the primary aim behind the Biologics Price Competition and Innovation Act. Because they monopolize the market, biologics remain some of the most expensive drugs available, rendering 12 years of patent exclusivity highly restrictive. On the other hand, current legislation permits competitors to run tests on the original product and to develop generic alternatives while its patent is still in effect. This allows “a generic product to be marketed virtually the moment the [original] patent expires” [2]. The market, originally under-stocked and overpriced, quickly becomes saturated with derivative generics because of the lack of financial incentive to research novel drugs.</p>
<p>One temporary solution proposed for the initial cost problem has been governmental subsidy, granted directly to the pharmaceutical company or indirectly to patients. The former idea, while intended to lower prices and foster development of new bio-technologies, has been criticized for placing too much power in the hands of large bio-tech companies. There looms the possibility that companies might use the spare money to “tinker with” existing products, rather than investing it in the more costly task of developing new formulas [4]. The latter idea, through the distribution of pharma coupons, tends to favor “commercially insured eligible patients”, yet excludes the uninsured or those with publicly funded health insurance plans [5]. For different reasons, neither of these solutions arrives at the root of the problem.</p>
<p>Might there be a better way to defray development costs—and concurrently, lower pricing? The answer could lie in formal collaboration. While highly prolific, academic institutions do not always experience the practical application of their research. Drug companies, on the other hand, have the resources to disseminate facets of this research at large. Governmental support for pharmaceutical initiatives is tentative at best. Universities, however, tend to be attractive candidates for federal funding. Jose Carlos Gutierrez-Ramos—Head of the Immuno-Inflamation Center of Excellence for Drug Discovery—comments on his partnership with the Immune Disease Institute at Harvard University: “[we wish to] capitalize on their science and on our ability to develop drugs…in a way that is mutually beneficial—certainly for society but also for the principal investigator and the organization” [6]. Admittedly, the motivations of each party may not always align. For instance, the desire of academics to publish their research may conflict with the industry’s wish to protect proprietary information for marketing purposes. Nonetheless, the benefits of an academic-industrial alliance generally outweigh its potential disadvantages, and these collaborations are making an impact on the global scale. In March 2011 Europe witnessed the launch of OncoTrack, a five year, $35.6 million project to evaluate and implement new techniques in the treatment of colon cancer [7].</p>
<p>The second, critical barrier between bench and bedside is the inefficiency of clinical trials, and their associated misconceptions. While trials are capable of granting patients the most scientifically advanced treatments available, they fail to attract more than 5% of adults diagnosed with cancer each year [8]. One recent study at the Department of Radiation Oncology explored reasons for low clinical trial participation rates, revealing noteworthy trends amongst certain cohorts of the population [9]. In this particular study, minority groups were 12% more likely to decline participation than non-minority groups. This finding is attributed to possible mistrust in the healthcare system, exacerbated by the lack of minority physicians who might help overcome said mistrust.  Another surprising finding revealed that married patients were more likely to decline participation than single patients. Because consent forms for cancer clinical trials are notoriously lengthy (on the order of 50 pages) and explicit (listing in detail every potential side effect, in many cases including death), they are thought to elicit spouse dissuasion. This attitude might be symptomatic of a larger misunderstanding of the comparative benefits and disadvantages of clinical trial participation, making effective, intuitive liaisons between researchers and the general public all the more pressing.</p>
<p>The National Cancer Institute (NCI) has proven instrumental in facilitating clinical trial participation (one of its many services) but is not perfect by any means. A 2010 report by the Institute of Medicine outlines several suggestions for improvement [10]. For one, the report recommends a tighter methodological uniformity amongst clinical trials, which would facilitate subsequent “comparative effectiveness studies” [11]. These studies are designed to draft an informative hierarchy of the most efficient clinical treatments. Moreover, in order to ensure the broadest applicability of trial results (considering the inconsistent features of different cancers and the highly variable genetic makeup of distinct individuals), the NCI might expand patient advocacy programs to recruit subjects of diverse backgrounds, and principal investigators may reconsider eligibility restrictions when formulating clinical trial protocols.</p>
<p>Furthermore, the NCI is in the position to advocate better recognition (i.e. pay raises, more generous tenure considerations) of physicians working in clinical trials, and to support emerging physicians (i.e. grants, fellowships), thus encouraging sustained interest in medical research [12].</p>
<p>Finally, the NCI could more aggressively lobby for insurance coverage of non-experimental patient healthcare costs while they are enrolled in clinical trials [10]. Currently, insurance companies widely believe that the expense of putting their clients through clinical trials outstrips that of pursuing traditional medical treatment. However, one 2001 study showed this to be a misconception. In this study, Dr. Thomas N. Chirikos and colleagues examined the hospital billing records for nearly 2,000 cancer patients participating in clinical trials and compared them to those of patients who received regular treatment. “When the researchers adjusted the data to isolate the effect of trial participation alone, the investigators found that in all but one case, there was no statistically significant difference in the costs of care for patients who were enrolled in trials compared to those who were not” [11].</p>
<p>Although particularly worrisome when dealing with serious diseases like cancer, the policy pitfalls that prevent effective research and application can be applied to any medical context. The first step in streamlining the research-healthcare pipeline is to raise awareness, and thereafter, to enact legislation that expedites the development pathway from research labs to hospitals— resulting in one that is efficient, yet still adheres to acceptable standards of ethics and scientific rigor.</p>
<p>References:</p>
<ol>
<li>Loren R. New Law! The Biologics Price Competition and Innovation Act of 2009. Martindale [Internet]. 2010 Apr. Available from: <a href="http://www.martindale.com/health-care-law/article_Edwards-Angell-Palmer-Dodge-LLP_976250.htm">http://www.martindale.com/health-care-law/article_Edwards-Angell-Palmer-Dodge-LLP_976250.htm</a></li>
<li>Lehman B. The Pharmaceutical Industry and the Patent System. [Internet]. 2003 Dec. Available from: <a href="http://www.earth.columbia.edu/cgsd/documents/lehman.pdf">http://www.earth.columbia.edu/cgsd/documents/lehman.pdf</a></li>
<li>Tumulty K, Scherer M. How Drug-Industry Lobbyists Won on Health-Care. Time [Internet]. 2009 Oct 22. Available from: <a href="http://www.time.com/time/politics/article/0,8599,1931595-2,00.html">http://www.time.com/time/politics/article/0,8599,1931595-2,00.html</a></li>
<li>Holden C. Research on Contraception Still in the Doldrums. Science [Internet]. 2002 Jun 21; 296:5576. p. 2172-2173. Available at: <a href="http://www.sciencemag.org/content/296/5576/2172.full">http://www.sciencemag.org/content/296/5576/2172.full</a></li>
<li>Wellsphere. Pharma Coupons: Enriching the Drug Companies. Wellsphere [Internet]. 2001 Jan 11. Available from: <a href="http://www.wellsphere.com/healthcare-industry-policy-article/pharma-coupons-enriching-the-drug-companies/1327876">http://www.wellsphere.com/healthcare-industry-policy-article/pharma-coupons-enriching-the-drug-companies/1327876</a></li>
<li>Hughes B. Pharma pursues novel models for academic collaboration. Nature [Internet]. 2008 Aug; 7. p. 631-632. Doi: 10.1038/nrd2648. Available from: <a href="http://www.nature.com/nrd/journal/v7/n8/full/nrd2648.html">http://www.nature.com/nrd/journal/v7/n8/full/nrd2648.html</a></li>
<li>GenomeWeb. OncoTrack Consortium Launches $35.6M Colon Cancer Initiative. GenomeWeb [Internet]. 2011 Mar 11. Available at: <a href="http://www.genomeweb.com/oncotrack-consortium-launches-356m-colon-cancer-initiative">http://www.genomeweb.com/oncotrack-consortium-launches-356m-colon-cancer-initiative</a></li>
<li>American Association for Cancer Research. Cancer Policy Issue Briefs. ARC [Internet]. Available at: <a href="http://www.aacr.org/home/public--media/science-policy--government-affairs/cancer-policy-issue-briefs/cancer-research.aspx#D">http://www.aacr.org/home/public&#8211;media/science-policy&#8211;government-affairs/cancer-policy-issue-briefs/cancer-research.aspx#D</a></li>
<li>Marinucci M. Barriers to Participation in Cancer Clinical Trials: Improvement Recommendations for Missed Opportunities to Address Disparities. Jefferson Health Policy Capstone 5 [Internet]. 2009 Aug 4. Available at: <a href="http://aisr3.jefferson.edu:880/ess/echo/presentation/d5349536-a4d5-4c7e-bb05-7b3279450b99">http://aisr3.jefferson.edu:880/ess/echo/presentation/d5349536-a4d5-4c7e-bb05-7b3279450b99</a></li>
<li>Institute of Medicine. A National Cancer Clinical Trials System for the 21<sup>st</sup> Century: Reinvigorating the NCI Cooperative Group Program. IOM [Internet]. 2010 Apr 15. Available at:  <a href="http://www.iom.edu/Reports/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-Century-Reinvigorating-the-NCI-Cooperative.aspx">http://www.iom.edu/Reports/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-Century-Reinvigorating-the-NCI-Cooperative.aspx</a></li>
<li>National Cancer Institute. Cancer Trials Appear Not to Drive Up Cost of Cancer Treatment. NCI [Internet]. 2003 Jan 27. Available at:  <a href="http://www.cancer.gov/clinicaltrials/conducting/developments/notcostly0103">http://www.cancer.gov/clinicaltrials/conducting/developments/notcostly0103</a></li>
<li>Nelson R. NCI Cooperative Group Program in Need of an Overhaul. Medscape [Internet]. 2010 Apr 16. Available at: <a href="http://www.medscape.com/viewarticle/720386">http://www.medscape.com/viewarticle/720386</a></li>
<li> Varian, H. [photograph] 2008. Available at:  <a href="http://www.flickr.com/photos/horiavarlan/4273968004/">http://www.flickr.com/photos/horiavarlan/4273968004/</a></li>
</ol>
<p><em>Isabelle Boni is a third-year biology and psychology major at the University of Chicago. Please join The Triple Helix Online on <a href="http://www.facebook.com/#%21/triplehelixonline" target="_blank">Facebook</a>. Follow The Triple Helix Online on <a href="http://twitter.com/tthepub" target="_blank">Twitter</a>.</em></p>
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		<title>Is All Fair in Love and Sport?</title>
		<link>http://triplehelixblog.com/2011/05/is-all-fair-in-love-and-sport/</link>
		<comments>http://triplehelixblog.com/2011/05/is-all-fair-in-love-and-sport/#comments</comments>
		<pubDate>Mon, 09 May 2011 10:00:03 +0000</pubDate>
		<dc:creator>Evan WooSuk Choi</dc:creator>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[Latest]]></category>
		<category><![CDATA[Law]]></category>
		<category><![CDATA[Medicine]]></category>
		<category><![CDATA[Science]]></category>
		<category><![CDATA[ethics]]></category>
		<category><![CDATA[Genetics]]></category>
		<category><![CDATA[Performance enhancing drugs]]></category>
		<category><![CDATA[Sports]]></category>
		<category><![CDATA[steroids]]></category>

		<guid isPermaLink="false">http://triplehelixblog.com/?p=2190</guid>
		<description><![CDATA[In the world of competitive sports, one hundredth of a second – the time it takes for lightning to strike – can define an athlete. One hundredth of a second can mean the difference between winning or losing, fame or anonymity, millions of dollars in endorsements or none. Because we handsomely reward strength, speed, and [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://triplehelixblog.com/wp-content/uploads/2011/05/SteroidpillsDEA.jpg"><img class="alignleft size-full wp-image-2191" title="SteroidpillsDEA" src="http://triplehelixblog.com/wp-content/uploads/2011/05/SteroidpillsDEA.jpg" alt="" width="200" height="170" /></a>In the world of competitive sports, one hundredth of a second – the time it takes for lightning to strike – can define an athlete. One hundredth of a second can mean the difference between winning or losing, fame or anonymity, millions of dollars in endorsements or none. Because we handsomely reward strength, speed, and endurance, athletes are pushed to do anything and everything to gain even the smallest of competitive advantages. Winning is everything – an athlete will train for thousands of hours, hire a world-renowned coach, wear the newest brand of footwear technology, and even inject performance enhancing drugs (PEDs) – just to win.</p>
<p>It is thus no surprise that the advantages athletes cultivate to win have come under a high level of scrutiny. Whether these advantages are lauded or vilified turns on whether they are perceived as natural or unnatural – that is, fair or unfair. But while the public lauds swimming competitively by the age of six, why does it scorn the use of PEDs? Many would-be figure skating champions begin training on the ice before they have even learned to read. In the world of beauty competitions, coloring one’s hair, reshaping one’s nose or implanting silicone is considered normal and even rewarding. Are PEDs any more unnatural? What, indeed, <em>is</em> natural?</p>
<p>In short, PEDs are not the only performance enhancers in sports. It is not immediately obvious that PED-use is fundamentally different or any more unfair than other enhancers. A wealthy or pushy parent, for instance, could be the difference between success or failure. Golf and tennis players are often endowed with wealthy parents capable of affording the high costs associated with the sport, while baseball players such as Ichiro Suzuki of the Seattle Mariners were hitting baseballs by the age of three in large part due to highly determined fathers. But should overbearing parents be banned as well? Millions of teenagers would probably agree that they should.</p>
<p>PEDs became widely used throughout the sporting world since the 1950s when weight lifters in Russia injected themselves with anabolic steroids. By the end of the decade, elite athletes all over the world had discovered the drugs, and despite stringent testing procedures, PEDs continue to follow the Olympic Games, the Tour de France, Major League Baseball, and other professional and amateur sports. PEDs can range from anabolic steroids, human growth hormone, sedatives, to even certain types of painkillers. Anabolic steroids are by far the most common drugs in the sporting world as their short-term benefits are relatively easy to replicate: strength and stamina are significantly enhanced. Anabolic steroids increase the production of proteins and substantially reduce recovery time by blocking the effects of the stress hormone cortisol on muscle tissue [1]. They also affect the number of cells that develop into fat-storage cells by favoring cellular differentiation into muscle cells instead, and they reduce fat by increasing the body’s base metabolic rate [2]. Steroids are membrane permeable and thus operate by affecting the nucleus of cells directly, penetrating the membrane of the target cell and binding to the androgen receptor located within the cytoplasm [3]. The compound hormone-receptor then diffuses into the nucleus, where it alters the expression of genes or activates processes that send signals to other parts of the cell [4].</p>
<p>While the benefits are enticing, many argue that the risks of biological alterations caused by PEDs heavily outweigh their benefits. For athletes, the risks range from mood swings to infertility [5]. For the pastimes they participate in, the risks involve an erosion of credibility and confidence in the idea of fairness, the foundation of all competitive sports.</p>
<p>But are competitive sports truly fair? The fact is that there has always been a certain degree of unfairness inherent in athletic contests. The general consensus in the scientific community is that elite athletic performance is a complex fitness phenotype substantially determined by genetic potential [6]. Research over the past decades has revealed a strong correlation between the natural genetic makeup of athletes and elite sporting status. Although training and nutrition significantly contribute to sporting performance, such factors alone are not sufficient; most students at the University of Chicago, for instance, will never achieve elite athlete status however hard they train. Athletes endowed with such genetic traits as cardio-respiratory and skeletal muscle efficiency will inevitably perform at higher levels of endurance [7].</p>
<p>For example, several studies have shown that sprint and endurance performance is affected by different genotypes of the gene encoding angiotensin-converting enzyme (ACE). The ACE gene has two alleles, termed “I” and “D;” the I allele is associated with lower ACE activity resulting in endurance [8] and efficiency of muscle contraction [9]. An increased frequency of the ACE I allele has been observed in elite endurance athletes [10]. In contrast, an increased frequency of the ACE D allele is associated with elite sprint performance [11]. It is likely that there is a trade-off between sprint and endurance traits as performance in the 100 meter sprint (which relies on explosive power and fast fatigue-susceptible muscle fibers), is negatively correlated with performance in the 1,500 meter race (which requires endurance and fatigue resistant slow fiber activity) [12].</p>
<p>Genetically, it is inevitable that some athletes simply perform better in certain areas of athleticism or are capable of enduring pain and physical stress more efficiently than their opponents. The use of PEDs, then, may be an attempt to provide a level playing field amongst disparate opponents. It may, on the other hand, deepen the already existing performance gap among athletes by favoring those with access to wealthy parents, coaches and sponsors. In any case, the question of whether PEDs are any more unnatural than the existing genetic gap still remains. In a world where athletes are pressured to do anything and everything to win, the unfair and unnatural boundaries of competitive advantages continue to be pushed.</p>
<p>References:</p>
<ol>
<li>Singh R, et al. Androgens stimulate myogenic differentiation and inhibit adipogenesis in C3H 10T1/2 pluripotent cells through an androgen receptor-mediated pathway. Endocrinology. 2003. p. 144.</li>
<li>Brodsky IG, Balagopal P, Nair KS. Effects of testosterone replacement on muscle mass and muscle protein synthesis in hypogonadal men – a clinical research center study. The Journal of Clinical Endocrinology &amp; Metabolism. 1996. http://jcem.endojournals.org/cgi/content/abstract/81/10/3469.</li>
<li>Lavery DN, McEwan IJ. Structure and function of steroid recepto AF1 transactivation domains: induction of active conformations. The Biochemical Society. 2005. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1276946/?tool=pubmed.</li>
<li>Cheskis BJ. Regulation of cell signalling cascades by steroid hormones. J Cell Biochem.<em> </em>2004. http://www.ncbi.nlm.nih.gov/pubmed/15352158.</li>
<li>Pagonis TA, et al. Psychiatric side effects induced by supraphysiological doses of combinations of anabolic steroids correlate to the severity of abuse. Eur. Psychiatry. 2006. p. 551–62.</li>
<li>MacArthur DG, North KN. Genes and human elite athletic performance, http://www.springerlink.com/content/kdrvbp3xlv1tct22/. February 22, 2005.</li>
<li>Montgomery HE, et al. Association of angiotensin-converting enzyme gene I/D polymorphism with change in left ventricular mass in response to physical training. Circulation. 1997. p.741–747.</li>
<li>Williams AG, Rayson MP, Jubb M, et al. The ACE gene and muscle performance. Nature. 2000. p. 614.</li>
<li>Gayagay G, Yu B, Hambly B, et al. Elite endurance athletes and the ACE I allele—the role of genes in athletic performance. Hum Genet. 1998. p. 48–50.</li>
<li>Niemi AK, Majamaa K. Mitochondrial DNA and ACTN3 genotypes in Finnish elite endurance and sprint athletes. European Journal of Human Genetics. 2005. http://www.nature.com/ejhg/journal/v13/n8/full/5201438a.html.</li>
<li>Van Damme R, Wilson RS, Vanhooydonck B, Aerts P. Performance constraints in decathletes. Nature. 2002. p. 755–756.</li>
<li>Drug Enforcement Administration. [photograph] 2007. Available at: http://commons.wikimedia.org/wiki/File:SteroidpillsDEA.jpg</li>
</ol>
<p><em>Evan WooSuk Choi is a third-year student at the University of Chicago pursuing a double major in political science and economics. Please join The Triple Helix Online on <a href="http://www.facebook.com/#%21/triplehelixonline" target="_blank">Facebook</a>. Follow The Triple Helix Online on <a href="http://twitter.com/tthepub" target="_blank">Twitter</a>.</em></p>
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		<title>Driving Under the Influence…of a Cell Phone</title>
		<link>http://triplehelixblog.com/2011/02/driving-under-the-influence%e2%80%a6of-a-cell-phone/</link>
		<comments>http://triplehelixblog.com/2011/02/driving-under-the-influence%e2%80%a6of-a-cell-phone/#comments</comments>
		<pubDate>Wed, 23 Feb 2011 17:21:58 +0000</pubDate>
		<dc:creator>Apurva Tandon</dc:creator>
				<category><![CDATA[Harker School]]></category>
		<category><![CDATA[Latest]]></category>
		<category><![CDATA[Law]]></category>
		<category><![CDATA[Media]]></category>
		<category><![CDATA[Cars]]></category>
		<category><![CDATA[cell phones]]></category>
		<category><![CDATA[driving]]></category>
		<category><![CDATA[multitasking]]></category>

		<guid isPermaLink="false">http://triplehelixblog.com/?p=1865</guid>
		<description><![CDATA[The United States wireless industry is fully taking advantage of its recent big break, with colorful ear buds and trendy covers being hauled in by the dozen. Over thirty states have outlawed driving with hand-held cell phones and have replaced them with hands-free devices instead [1]. Studies, however, continue to prove that the hands-free substitution [...]]]></description>
			<content:encoded><![CDATA[<p>The United States wireless industry is fully taking advantage of its recent big break, with colorful ear buds and trendy covers being hauled in by the dozen. Over thirty states have outlawed driving with hand-held cell phones and have replaced them with hands-free devices instead [1]. Studies, however, continue to prove that the hands-free substitution is much less beneficial than lawmakers, phone companies, and myriad other groups wish. Today’s fast-paced lifestyle lends itself to mastery of the art of multitasking, and the recent burgeoning of the media industry deserves much of the credit for the introduction of a more complex form of multitasking: continuous partial attention (term coined by Linda Stone in 1997), or CPA [2]. Unfortunately, increased reliance on CPA might not be very advantageous to drivers…or anyone, really.</p>
<p><strong>What is CPA?</strong></p>
<p><strong> </strong></p>
<p>The subtle difference between ordinary multitasking and CPA lies in the motivations behind each [2]. Traditional multitasking equally prioritizes simple tasks that necessitate minimal cognitive operation, like drinking coffee and filing papers, with the motivation to accomplish more in less time. In slight contrast, CPA is based on a different state of awareness, similar to that of a crisis. Keeping a threshold level of attention on a single higher priority task, the brain attempts to gather as much outside information as possible from all surrounding stimuli [2]. The reason for this is that most surrounding stimuli are forms of media, constant sources of information—CPA is basically a form of media multitasking. For example, while a person’s main focus is on dinner, he or she is also trying to take in the scene on TV while flipping through the newspaper and checking email on the trusty smart phone companion. The unconscious motivation of CPA is to collect as many details as possible, not just to expedite tasks and save time [2].</p>
<p><strong>Phone conversations while driving uniquely qualify as CPA</strong></p>
<p><strong> </strong></p>
<p>A fine line separates ordinary multitasking from CPA, no doubt, but there are three major reasons that a cell phone conversation in a car qualifies as reliance on CPA. First, it naturally becomes a high-priority task since it is an interaction with another person. Second, the driver is trying to take in information constantly, from the cell phone, the road, and any other stimuli in the environment. Third, the conversation is a constant source of new information, completely independent of the driver’s environment and not necessarily able to stop or adjust with driving conditions. Other possible disturbances such as a conversation with a passenger or the radio can easily stop or be turned off according to the needs of the driver. That makes driving while on the phone much more risky.</p>
<p><strong>Hands-free devices don’t solve</strong></p>
<p>Though lawmakers would like to think so, it does not make a difference whether a driver is holding a cell phone or using a Bluetooth device. Once a conversation is in session, the driver loses attention to it, not motor skills. The National Safety Council reports drivers impaired by cell phone conversations, whether hand-held or hands-free, twice as likely to miss traffic signals and react slower [3]. Brain imaging research at Carnegie Mellon demonstrates that driving while just listening to a cell phone (responding not included) reduces occipital lobe activity, as well as parietal lobe activity associated with driving, by 37 percent [4].</p>
<p><strong>Reliance on CPA adversely affects mental ability</strong></p>
<p>Not only is CPA dangerous while driving, but it can also have negative long-term effects on cognition. Stanford  University conducted a study in 2009, comparing the mental abilities of habitual “media multitaskers” to infrequent ones, and made some unsettling discoveries about people who are constantly splitting their attention. Contrary to popular belief, regular media multitaskers performed worse than their counterparts on three different tasks, including concentration, memory organization (of simple items like letters, numbers, and shape orientations), and, more shockingly, switching focus from one task to another. The researchers concluded that media multitaskers—reliant on CPA, by definition—were easily and continuously sidetracked by irrelevant information [5].</p>
<p>According to Stone, the very nature of CPA activates the fight-or-flight mechanism in conjunction with it, treating every event—from checking emails to answering phone calls at work—like an emergency. Stone asserts the harms of a constant adrenalized state: slower, poorer performance on tasks, accompanied by a completely unnecessary and avoidable cascade of stress hormones that bring about attention- and stress-related disorders [2].</p>
<p>Despite evidence imploring reconsideration of current driving regulations, it may be long before lawmakers quit trying to falsely legitimize the use of handheld devices. After all, alcohol and automobiles had coexisted for at least twenty years before DUI was even acknowledged as dangerous. CPA impairs both mental ability and attention, and hands-free devices are not a valid solution. Though preservation of basic cognitive skills outside the car is a personal choice, there is still much that the law can do to better protect lives.</p>
<p>References:</p>
<ol>
<li>Governors Highway Safety Association. &#8220;State Cell Phone Use and Texting While Driving Laws.&#8221; Washington, D.C.: Governors Highway Safety Association; [updated 2011 January; cited 2011 January 10]. Available from: http://www.ghsa.org/html/stateinfo/laws/cellphone_laws.html.</li>
<li>Stone L. Bloomberg<em>, </em>&#8220;Continuous Partial Attention—Not the Same as Multi-Tasking.&#8221; <em>Business Week; </em>[updated 2008 July 24; cited 2010 October 18]. Available from: http://www.businessweek.com/business_at_work/time_management/archives/2008/07/continuous_part.html.</li>
<li>U.S. Department of Transportation, Bureau of Transportation Statistics, <em>Transportation Statistics Annual Report </em>2001. 2002 [cited 2011 January 10] 298:[155] Available from: http://www.bts.gov/publications/transportation_statistics_annual_report/2001/pdf/entire.pdf.</li>
<li>Spice B. Carnegie Mellon  University. “Carnegie Mellon Study Shows Just Listening To Cell Phones Significantly Impairs Drivers: Brain Imaging Reveals Drivers Are Distracted Even if They Don&#8217;t Talk.” Pittsburgh, PA: Carnegie  Mellon University; [cited 2011 January 10]. Available from: http://www.cmu.edu/news/archive/2008/March/march5_drivingwhilelistening.shtml.</li>
<li>Gorlick A. Stanford  University. &#8220;Media multitaskers pay mental price, Stanford study shows.&#8221; Stanford, CA: <em>Stanford Report</em>; [updated 2009 August 24; cited 2010 November 7]. Available from: http://news.stanford.edu/news/2009/august24/multitask-research-study-082409.html.</li>
</ol>
<p><em>Apurva Tandon is a sophomore at the Harker School in California.</em></p>
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		<title>Medical Malpractice: Should Practitioners Be Allowed to Represent Themselves?</title>
		<link>http://triplehelixblog.com/2011/02/medical-malpractice-should-practitioners-be-allowed-to-represent-themselves/</link>
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		<pubDate>Tue, 01 Feb 2011 10:00:14 +0000</pubDate>
		<dc:creator>George Washington University</dc:creator>
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		<category><![CDATA[Medicine]]></category>
		<category><![CDATA[Doctors]]></category>
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		<category><![CDATA[Legal]]></category>
		<category><![CDATA[Malpractice]]></category>
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		<description><![CDATA[Using policy, law and medical arguments, this article discusses whether medical practitioners should be allowed to represent themselves in malpractice suits.]]></description>
			<content:encoded><![CDATA[<p><a href="http://triplehelixblog.com/wp-content/uploads/2010/10/THelix-OpEd-Photo.jpg"><img class="alignleft size-thumbnail wp-image-1142" title="THelix OpEd Photo" src="http://triplehelixblog.com/wp-content/uploads/2010/10/THelix-OpEd-Photo-150x150.jpg" alt="" width="150" height="150" /></a>By Jaishri Atri, George Washington University</p>
<p>Medicine today is arguably a defensive profession. In this litigious society, health care professionals must be on the constant lookout for attacks from their patients—in the form of legal papers of course. When damages are sustained by patients, whether in the form of physical loss of function, loss of dignity, or general abuse by a medical professional, they are within their rights to pursue a legal form of recompense. However, there is a dark side of patient care which can prove to be more harmful than a law suit. When patients become combative, for whatever reason, the very integrity of a medical infrastructure is compromised. Calling into question the safety of medical professionals throws the whole system into unbalance, and ultimately all suffer.</p>
<p>Self defense is one of those things that every citizen is allowed to employ. It is fully within an individual’s legal rights to take steps to insure their own personal safety, and in the circumstance of a physical altercation, retaliation in the form of self defense is accepted as an accepted practice. Doctors and health care professionals are legal citizens, and they do operate within the parameters of the law, so isn’t it within <em>their</em> rights to be able to exercise the law in their favor? Unfortunately, in some circumstances, healthcare professionals find themselves on the wrong side of the law and what is self defense outside the hospital, becomes malpractice within.</p>
<p>We put doctors and nurses and aides into hospitals so that they can treat anyone who comes through the doors—strung out drug addicts, abusers, psychos, and simply mean people included. We ask them to be fair and equal in administering their health care, we even ask them to swear an oath to do no harm. But if someone comes along and genuinely poses a threat to a health care professional that individual has a right to self defense. If we as a society deny these professionals this right, we are denying them safety of work place, and effectively tying the hands of those who are potentially at a very high risk to be hurt. Patients could disfigure or maim doctors or other patients, infect people with used needles or fluids, destroy expensive hospital equipment, cause emotional or psychological after-effects, and threaten the sense of security that other patients feel when they are in the protection of the hospital.</p>
<p>Violence may occur when during the course of treatment a patient becomes disturbed, decides to discontinue treatment, or becomes angry with health care professionals. It can be spontaneous, so doctors have little chance of predicting who will be violent when. In the high stress situations that individuals often find themselves in throughout the process of receiving diagnosis and care, tensions can arise and already stretched patience runs even thinner. All this combined can lead individuals to assault a medical worker. Most important however, is what options a medical worker has at this point: medical restraint in the form of drugs, physical restraint by way of holding or strapping the patient down, or retaliation when no other options are present. In most cases when medical or physical interventions are used the cause for these are apparent and acceptable. Physical retaliation however, in the form of shoving, pushing or whatever, is more taboo and is an action that can be taken to court on the grounds of assault, or worse, malpractice.</p>
<p>In the cases where the patient may be prone to unpredictable behavior such as those on drugs, those suffering from mental health issues, or those elderly patients who may have dementia or Alzheimer’s, the line is further blurred. All of these types of patients may be prone to behavior that can be combative, and it is common knowledge that these patients may resist necessary care by physical means.  In many cases physicians can determine, at some point during care, that the patient may start an altercation and they take measures such as assuring other staff are present, medical sedation, or physical restraints such as strapping patients down. These are preemptive forms of self defense and are perfectly accepted and even considered to be wise demonstrations of forethought. However, if a situation presents where a patient hits, bites, pinches, grabs, or otherwise attacks a physician, doctors should be able to make some motion to free themselves from their attackers—including physical self defense techniques.</p>
<p>Medical health professionals that come in contact with patients should be advised as to the options that they have in defending themselves against combative patients. Protocols should be set in place within hospitals that help doctors recognize the signs of potentially combative patients before any actual altercations take place, to prevent any situations where doctors or patients are put in harm’s way. In addition to this, there should be standards as to what options a physician can take once in a situation with a difficult patient, to help legal systems better judge what appropriate measures are.  In the meanwhile, while we are working to better serve and protect all those involved in the medical process, we should legally recognize the difficulties physicians face in dealing with difficult patients. The law is clear on how it deals with those who attack others—except when it involves physicians. Malpractice seems to be an easy way to mask self defense.</p>
<p>Patients are and should be at the center of any medical organization’s focus and mission. Their welfare and care is primary in all instances, however all patients are not created equally and while some may be cooperative with physicians and the administration of medical care, others are not as docile. While some of the problems that we face in health care today are seemingly monumental, and there is no clear answer as to how to improve what currently exists, the flaw in this situation is apparent. We in our society and legal system need to stop pitting the white coat against the sheriff’s badge and work cooperatively to help insure the safety and quality of experience that all people have when coming into contact with the medical world. Doctors are not commonly known to harm their patients, however in the medical world  it is common knowledge that a doctor will treat a dangerous patient at some point in their career. It’s only fair to give them a fighting chance to do the best for their patient and for themselves.</p>
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		<title>Cyberlaw &#8211; Evolution, Revolution or Retrofit?</title>
		<link>http://triplehelixblog.com/2009/10/cyberlaw-evolution-revolution-or-retrofit/</link>
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		<pubDate>Tue, 13 Oct 2009 16:35:15 +0000</pubDate>
		<dc:creator>TTHblog</dc:creator>
				<category><![CDATA[Law]]></category>
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		<description><![CDATA[In Cyberspace and the Law of the Horse, Chicago-area appeals judge, Frank Easterbrook mocks the idea that there can be such a thing as "Property in Cyberspace" or cyber-law in general, which he compares to the law of the horse.As Easterbrook explains, there is all kinds of law involving horses: racing commissions regulations, contracts over stud fees and veterinary malpractice, yet nobody claims to be a "horse lawyer,"  Similarly, as Professor Lawrence Lessig explains, Easterbrook's view is that the law of cyberspace is nothing more than "torts in cyberspace, contracts in cyberspace, property in cyberspace, etc." There is no "cyberlaw" any more than there is horse law.  Lessig disagrees, explaining "there is an important general point that comes from thinking in particular about how law and cyberspace connect;" specifically, "the limits on law as a regulator" and the "techniques for escaping those limits."Lessig claims cyberlaw is valuable because all law can draw from its lessons.  In this article I will, using the "commodification of music" as a case study, argue Lessig is correct.  And whether we can learn from these lessons is one of the central legal, cultural and policy questions facing the Internet, and society, today.]]></description>
			<content:encoded><![CDATA[<p><em>April 28, 2009<br />
By Christopher V. Langone, Guest Author, J.D. Northwestern</em></p>
<p>In <em>Cyberspace and the Law of the Horse</em>, Chicago-area appeals judge, Frank Easterbrook mocks the idea that there can be such a thing as &#8220;Property in Cyberspace&#8221; or cyber-law in general, which he compares to the law of the horse.<a name="_ednref"></a> As Easterbrook explains, there is all kinds of law involving horses: racing commissions regulations, contracts over stud fees and veterinary malpractice, yet nobody claims to be a &#8220;horse lawyer,&#8221;  Similarly, as Professor Lawrence Lessig explains, Easterbrook&#8217;s view is that the law of cyberspace is nothing more than &#8220;torts in cyberspace, contracts in cyberspace, property in cyberspace, etc.&#8221;<a name="_ednref"></a> There is no &#8220;cyberlaw&#8221; any more than there is horse law.  Lessig disagrees, explaining &#8220;there is an important general point that comes from thinking in particular about how law and cyberspace connect;&#8221; specifically, &#8220;the limits on law as a regulator&#8221; and the &#8220;techniques for escaping those limits.&#8221;<a name="_ednref"></a> Lessig claims cyberlaw is valuable because all law can draw from its lessons.  In this article I will, using the &#8220;commodification of music&#8221; as a case study, argue Lessig is correct.  And whether we can learn from these lessons is one of the central legal, cultural and policy questions facing the Internet, and society, today.</p>
<p><strong><span style="text-decoration: underline;">The ‘Private Property&#8217; Sign in Cyberspace</span></strong></p>
<p><em>There was a big high wall there, that tried to stop me</em></p>
<p><em>A sign was painted, said ‘private property&#8217;</em></p>
<p><em>But on the backside it didn&#8217;t say nothing </em></p>
<p><em>That side was made for you and me.</em></p>
<p><em> &#8211; Woody Guthrie, &#8220;This Land is Your Land&#8221;</em></p>
<p>For Frank Easterbrook the question of regulating cyberspace is easy, &#8220;develop a sound law of intellectual property and then apply it to cyberspace.&#8221;<a name="_ednref"></a> But here, he is far too facile; or perhaps, formalistic.  As Professor Radin explained &#8211; in critiquing Easterbrook&#8217;s intellectual cousin, Richard Epstein<a name="_ednref"></a> &#8211; &#8220;about property&#8230;he is an unabashed conceptualist and formalist.&#8221;<a name="_ednref"></a> Easterbrook and Epstein are conceptualists because they think &#8220;there is a concept of property that, in fact, is the right one or the only one.&#8221;<a name="_ednref"></a> And they are formalist because they think &#8220;<em>the</em> concept of property can be applied formally, <em>i.e</em>., logically and mechanically, to yield results that should be obvious to readers and legal decision makers.&#8221;<a name="_ednref"></a> But what if there is no <em>one</em>, &#8220;correct,&#8221; concept of property? (Or &#8220;intellectual property&#8221; for that matter.)</p>
<p>As Radin explains, &#8220;not only is property vague and evolving; it is also essentially contested.&#8221;<a name="_ednref"></a> For instance, French anarchist Pierre-Joseph Proudhon famously declared &#8220;property is robbery.&#8221;<a name="_ednref"></a> But even mainstream legal commentators are fractiously split on the idea of what constitutes property.  As Professor Mossoff has explained, there are essentially three theoretical conceptions of property in Anglo-American law:  the exclusion theory; the &#8220;bundle of rights&#8221; approach; and what Mossoff labeled the &#8220;integrated approach,&#8221; which essentially combines to two former approaches.<a name="_ednref"></a> Central to all conceptions is the &#8220;right to exclude.&#8221;</p>
<p>The reason it is not, as Easterbrook contends, &#8220;easy&#8221; to apply &#8220;current property principles&#8221;<a name="_ednref"></a> to cyberspace is because the raw material of cyberspace is information. And information is non-rival, which means that one person&#8217;s use does not prevent another&#8217;s.  Given this, a conception of property that depends on a &#8220;right to exclude&#8221; does not make any sense.  There is no reason to exclude anyone from using a non-rival good, as there is no zero-sum dynamic.  The more people that can use information can gain utility from it; and since one person&#8217;s use does not compete with another&#8217;s there is no need to exclude anyone, and certainly no basis to apply legal rules founded on a so-called right to exclude &#8211; at least not based at the level of &#8220;use.&#8221; The rejoinder, of course, is that &#8220;use&#8221; is not the issue &#8211; creation is.  In other words, while one could agree that unlike a law of trespass there is no need for exclusion-based property laws to prevent misappropriation of &#8220;my land&#8221; in cyberspace, the information will not be created without a property-like protection that permits economic exploitation of the information-based work. This, of course, is the rationale behind copyright and most &#8220;intellectual property.&#8221;<a name="_ednref"></a> But there is another approach, one akin to the folk tradition in music, which Radin calls &#8220;progressive naturalism.&#8221;</p>
<p><strong><span style="text-decoration: underline;">Creationism vs. Evolution &#8211; in the &#8220;property&#8221; context</span></strong></p>
<p><em>My computer is future shockin&#8217; Download this and you&#8217;ll start talkin&#8217;<br />
upgraded you&#8217;re now walkin&#8217; compatible with all that is rockin&#8217;<br />
comin&#8217; on fast it&#8217;s gettin&#8217; digital it&#8217;s so huge like a spiritual<br />
rippling out to every individual this is life it is a miracle</em></p>
<p><em>Evolution has exponential timing it&#8217;ll be</em></p>
<p><em>Half as long ‘til the next breakthrough that blows our mind<br />
It&#8217;s up to the people to brave on with experimentation; </em></p>
<p><em>Move forth the species by using our imagination</em><em> </em></p>
<p><em> &#8211; 311, &#8220;Evolution&#8221;</em></p>
<p>As noted earlier, Radin sees property law as &#8220;evolving&#8221; and articulates a view she calls progressive naturalism:</p>
<p>one could better respect the deep moral significance of some property by becoming a progressive naturalist. A progressive naturalist would say that there is a best conception of property, but we haven&#8217;t yet reached it. The history of changing property notions is describable as a history of rejecting bad parts of the institution and substituting better ones &#8211; a process that can continue indefinitely. This view would allow us to suppose we have reached a point in history when we can recognize that exclusionary rights&#8230;are wrong, and have always been wrong.<a name="_ednref"></a></p>
<p>Radin&#8217;s analogy to evolution is by no means a new one; in 1920 Judge Jethro Brown wrote in the <em>Yale Law Journal</em>, &#8220;I am in agreement with those who speak of the ‘evolution of law.&#8217; I find in legal history an inevitable tendency to change, a continuing adjustment to environment, and a process of survival of the fittest, in the course of which the rules of human conduct less fitted to a particular milieu are squeezed out of existence and give ways to rules best-fitted for that milieu.&#8221;<a name="_ednref"></a> We are currently observing such a changing milieu now, as Benkler argues in <em>The Wealth of Networks</em>, we are seeing a shift away from an industrial economy to a &#8220;networked information economy.&#8221;</p>
<p>But the &#8220;weary giants of flesh and steel&#8221;<a name="_ednref"></a> don&#8217;t want to release their hold on power.  As Benkler explains, &#8220;the economic and social forces are pushing at each other in opposite directions, and each is trying to mold the legal environment to better accommodate its requirements&#8230; we stand at a point where information production could be regulated so that, for most users, it will be forced back into the industrial model.&#8221;<a name="_ednref"></a> Benkler too, analogizes to evolution, citing Steven J. Gould&#8217;s theory of &#8220;punctuated equilibria&#8221; &#8211; <em>i.e</em>., evolutionary change takes place in rapid busts, separated by long periods of stasis.<a name="_ednref"></a> The problem with common law is that it evolves too slowly &#8211; the kind of ‘phyletic gradualism&#8217; that Gould and Eldridge were critiquing.  The answer then is not to slow the development of cyberspace by forcing it back into the industrial model (and its concomitant body of common law: torts, contract and property).  Rather, it is to speed the development of law, by forcing it to adapt to the fast-changing world of the Internet, supercharging precedent and allowing the kind of &#8220;rapid busts&#8221; (as Benkler says &#8211; the ‘shock&#8217; to the system) that results in meaningful change.</p>
<p>Under the industrial model, Easterbrook is clearly right &#8211; intellectual property was required in order to incentivize the creation of information-laden value.  But under the emerging networked information economy, he is clearly wrong &#8211; as Benkler convincingly demonstrates.  Indeed, intellectual property rights themselves were the legal mutations spawned by required adaptations to changing social and cultural environments, usually spurred by technological developments.  But just because an adaptation worked in the past, does not mean it will continue to work into the future.  So before we look forward, let&#8217;s first look back &#8211; at the fossil record, so to speak &#8211; to see that creators will indeed create in the absence of the limited monopoly-grant of so-called intellectual property rights. The species to be examined is music and musicians.</p>
<p>In his very insightful article &#8220;Whose Music Is It Anyway: How we Came to View Musical Expression as a Form of Property,&#8221; Professor Michael Carroll explores the history &#8211; from the ancient Greeks to the present day &#8211; of music.<a name="_ednref"></a> He concludes, &#8220;removing copyright protection from musical works and sound recordings would not eliminate professional music making. On the contrary, historical evidence strongly suggests that the demand for the services of a class of professional musicians and composers would be sufficient to induce society to find alternative means to enable this group to practice its art.&#8221;<a name="_ednref"></a> He explains: &#8220;By taking a panoramic view of the history leading up to the current controversy, I seek to create room in the discussion for cooler consideration of fundamental change. Historical evidence demonstrates that Western society has conceived of music&#8217;s social role and the roles of those who create and perform music quite differently over time. Rather than assume that music is a form of property and that the only challenge is how to protect it against new threats posed by digital technology, we should acknowledge that other means of stimulating musical creativity are feasible and were successful under different material and cultural conditions.&#8221;<a name="_ednref"></a></p>
<p><strong><span style="text-decoration: underline;">From the Harmony of the Spheres to Metal Machine Music</span></strong></p>
<p><strong><em> Ancient Times</em></strong></p>
<p><em>Oh, the streets of Rome are filled with rubble,<br />
Ancient footprints are everywhere &#8211; Bob Dylan (&#8220;When I Paint My Masterpiece&#8221;</em>)<em> </em></p>
<p>Pythagoras, who according to legend was inspired by the sounds made by blacksmiths hitting anvils with hammers of different weights,<a name="_ednref"></a> discovered the consonant musical relations between strings of difference lengths.  From this, he deduced that each of the planets, based on its distance from the Earth, produced a different note &#8211; the <em>Musica Mundana,</em> or harmony of the spheres. On this view, music was part of a larger set of mathematical, harmonic relations that govern the physical world. In Lessig&#8217;s terms, there was a musical architecture, based on mathematics, and music was viewed as &#8220;a force of nature not susceptible to individual claims of ownership.&#8221;<a name="_ednref"></a></p>
<p>Moreover, music was very heavily regulated (more by ‘norms&#8217; than ‘law&#8217;) and while youth underwent compulsory music education to help nurture their soul, among intellectuals &#8220;the performance of music outside the home was considered vulgar and inappropriate for any but slaves.&#8221;<a name="_ednref"></a> As Aristotle, perhaps anticipating karaoke, wrote: &#8220;no freeman would play or sing unless he were intoxicated or in jest.&#8221;<a name="_ednref"></a> In sum, &#8220;music was not a form of property in the ancient world. Instead, it was a gift from the gods expressed in a set of musical conventions to which composers and performers were expected to adhere and which reflected the greater mathematical order of the cosmos.&#8221; Nevertheless, we see the Lessig factors starting to emerge in the context of music, at least with respect to architecture and norms. While the Greeks may have developed some form of musical notation, it was lost during the Dark Ages.</p>
<p><strong><em>Medieval Times</em></strong></p>
<p><em>The only important thing these days, is rhythm and melody. </em></p>
<p><em>Rhythm &#8230;and melody </em></p>
<p><em>- Big Audio Dynamite II (&#8220;Rush&#8221;</em>)</p>
<p>During this time musical notation was (re)developed, thus enabling the objectification of musical expression by permitting music to &#8220;take on an external manifestation that could be read as well as heard.&#8221;<a name="_ednref"></a> Using notation, Pope Gregory wrote down certain chant melodies and the &#8220;Gregorian&#8221; chant was born. <!--[if gte vml 1]> <![endif]--></p>
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<p>By the eleventh century, staff notation was developed. Because staff notation freed music from dependence on oral transmission, as musical historians Donald Grout and Claude Pasilica stress, its development was &#8220;as crucial for the history of Western music as the invention of writing was for the history of language.&#8221;<a name="_ednref"></a> This technological change &#8211; which enabled new architecture (or musical &#8220;code&#8221;) &#8211; was a &#8220;system shock&#8221; that precipitated one of the first evolutionary developments in the commodification of music. Nevertheless, early staff notation did not specify the duration of notes, so rhythm was still subject to interpretation.</p>
<p>The late Middle Ages also saw the rise of polyphony,<a name="_ednref"></a> which involves the use of more than one melodic line, either in harmony or in different directions like a classical Bach fugue. When Pope Clement V moved his seat to Avignon in the fourteen century, secular French music started to influence the liturgy with polyphonic compositions. The Church resisted this move, and Pope John XXII commanded in his 1324 Bull <em>Docta Sanctorum Patrum</em> that &#8220;no one shall henceforth consider himself at liberty to use polyphony in the singing of canonical Office or in solemn celebrations of the Mass.&#8221;<a name="_ednref"></a> But the &#8220;increasing divided and corrupt Church authorities were losing control over the liturgy and the congregation: liturgical polyphony continued to flourish.&#8221; Norms, Lessig would say, were changing, and papal &#8220;law&#8221; could not constrain them.  By 1364, during the pontificate of Pope Urban V, composer and priest Guillaume de Machaut penned <em>La Messe de Notre Dame</em>, which became the first officially-sanctioned polyphony in sacred music.  Reactionary Popes, however, seem back in vogue.<a name="_ednref"></a> Here, over 600 years ago, we see norms and law competing over new musical architecture in a manner very similar to the disputes that exist on the internet today.</p>
<p><strong><em> Guilds and Jongeluers</em></strong></p>
<p><em>Histories of ages past; Unenlightened shadows cast; </em></p>
<p><em>Down through all eternity; The crying of humanity.<br />
&#8216;Tis then when the Hurdy Gurdy Man; Comes singing songs of love,</em></p>
<p><em>- Donovan (&#8220;Hurdy Gurdy Man&#8221;)</em></p>
<p>&#8220;The two secular developments most important for the commodification of music were the emergence of the troubadours<a name="_ednref"></a> in the latter Middle Ages and the formation of musicians&#8217; guilds. Although the troubadours and their ‘songs of love&#8217; signaled the emergence of self-aware singer/songwriters, who paid to have their compositions transcribed, they did not assert proprietary claims to their music.<a name="_ednref"></a> Musicians&#8217; guilds, in contrast, assert nascent proprietary interests in that only guild members could publicly perform music within city limits, a right vindicated by law.  So here &#8211; to again apply the Lessig factors &#8211; we start to see the emergence of market and law, in addition to norms and architecture, as influencing the direction music was taking.</p>
<p>As medieval cities grew (a literal change in the Lessig factor, architecture), &#8220;public performance of music came to rest in the control of a guild of specialized performers who had the exclusive right to perform music at public gatherings within the city walls.&#8221;<a name="_ednref"></a> This, notes Carroll, was another important development in the commodification of music &#8211; &#8220;Although the exclusive right to public performance appears to be more a regulation controlling labor than one creating property rights, musical notation was still not widely in use for secular music and therefore control over the musical laborer was a form of control over the music itself.&#8221;<a name="_ednref"></a> The guild structure was devised mainly to allow local musicians to secure themselves from economic (or market) competition by traveling minstrels and jongleurs. While this improved the social status of musicians, it affected the music in two ways: at one level, it retarded development as the &#8220;guild structure, with lengthy apprenticeships, appears to have stultified experimentation; on the other hand, it allowed musicians to hone their craft and develop increasingly complex polyphonic music.&#8221;<a name="_ednref"></a> A good example is the Bach family, which led many German guilds and, of course, produced a famous composer known as Johann Sebastian. The guild use of law to limit markets to protect themselves against competition from the jongleur is, as argued in more detail later in this paper, similar to the way that the RIAA is trying to protect themselves from competition by modern indie bands.</p>
<p><strong><em>The Renaissance</em></strong></p>
<p><em>Then she opened up a book of poems; And handed it to me<br />
Written by an Italian poet; From the thirteenth century.<br />
And every one of them words rang true; And glowed like burnin&#8217; coal<br />
Pourin&#8217; off of every page; Like it was written in my soul from me to you,<br />
Tangled up in blue.</em></p>
<p><em> &#8211; Bob Dylan (&#8220;Tangled Up in Blue&#8221;) </em></p>
<p>The Renaissance, of course, was ushered in by the invention of the printing press, a technological development whose effect on copyright and the development of intellectual property law has been much heralded and examined.<a name="_ednref"></a> As Professor Henry Perritt, Jr., Professor of Law at the Chicago-Kent College of Law, has explained:  &#8220;As technology changes, it increases and decreases the risks of certain kinds of market failure, altering the incentives to create and perform music.&#8221;<a name="_ednref"></a> He explains how before the printing press one had to be in the presence of the composer performing to hear the music, but the printing press &#8211; through sheet music &#8211; allowed performance of another&#8217;s music without any contact between composer and performer. And before sound recording, music consumers had to be present at a live performance. With each advance &#8211; phonographs, magnetic recording, digital recording, and digital compression resulting in increased bandwidth &#8211; &#8220;raised questions about the proper balance between law and technology in preserving appropriate incentives for producing and consuming music.&#8221;<a name="_ednref"></a> But, explains Perritt, &#8220;too often, observers only focus on the possibility for technological advances to reduce incentives to create and distribute music. Insufficient attention usually is given to the tendency of some of the same technological advances to increase incentives to create and produce because they reduce costs of original producers.&#8221;<a name="_ednref"></a></p>
<p>For instance, between 1809 and 1820 Beethoven arranged 176 Irish and Scottish folk songs<a name="_ednref"></a> for the Scottish publisher, George Thomson, who wanted only the best composers and poets to work on the project.  An example is &#8220;Oh! Who, my dear Dermot&#8221; &#8211; the melody is ‘Crooghan a Venee&#8217; with lyrics by William Smyth.  The song is about the Irish Parliament&#8217;s decision in 1800 to abolish itself after corrupt members were bribed by Lord Castlereagh&#8217;s ‘English gold,&#8217; and speaks metaphorically though the eyes of ‘Norah,&#8217; who represents Ireland.<a name="_ednref"></a> Beethoven designed these settings for amateur performers and some of them were recorded by folk-balladeer Richard Dyer-Benett. The Beethoven project demonstrates, in a significant way, a merging of folk and high culture &#8211; indeed, perhaps these compositions can be characterized as the first ‘mash ups.&#8217; But more significantly, they demonstrate the importance of the public domain and how culture, heritage and history become fused in music.</p>
<p>It was the technology of the printing press that allowed this, much like the technology of You Tube, computer-recording and mixing software such as ProTools and social-networking sites like MySpace have dramatically changed the need for economic and human capital previously needed to record and promote music.<a name="_ednref"></a></p>
<p><strong> <em>Metal Machine Music</em></strong></p>
<p><strong><em>&#8220;</em></strong><em>I have heard this record characterized as &#8220;anti-human&#8221; and &#8220;anti-emotional.&#8221; That it is, in a sense, since it is music made more by tape recorders, amps, speakers, microphones and ring modulators than any set of human hands and emotions. But so what? Almost all music today is anti-emotional and made by machines too.&#8221; &#8211; Lester Bangs<strong> </strong></em></p>
<p><em>Metal Machine Music</em> was an album by Lou Reed, widely reputed to have been made as a begrudging fulfillment of his contract to his label but argued by some, including legendary rock critic Lester Bangs, to be a brilliant genre-creating advancement in noise-rock.<a name="_ednref"></a> Disputes with record labels are legendary in rock music &#8211; from the Sex Pistols&#8217; EMI to the Floyd classic, Welcome to the Machine &#8211; and, until now, artists have been essentially dependant on the label&#8217;s A&amp;R (artist and repertoire) departments to ‘discover&#8217; and promote them.  This was, as Perritt explains, important to reduce &#8220;search costs&#8221; for consumers and connecting artists with fans.<a name="_ednref"></a> But those search costs don&#8217;t exist anymore, as &#8220;new technologies profoundly change the possible ways in which the functions performed by existing intermediaries can be performed and therefore threaten the embedded capital of major record labels. That is why they have been so militant in trying to slow the uptake of the technologies.&#8221;<a name="_ednref"></a></p>
<p><strong><span style="text-decoration: underline;">Evolution&#8230;Revolution</span></strong></p>
<p><em> &#8220;There was music in the cafes at night; and revolution in the air&#8221;</em></p>
<p><em> &#8211; Bob Dylan</em></p>
<p>Benkler says we are at a crucial time in history, as he says in the title to chapter 1 of his book, <em>The Wealth of </em>Networks, a moment of opportunity and challenge, which he describes at the end of Chapter One, as follows:</p>
<p>We are in the midst of a technological, economic, and organizational transformation that allows us to renegotiate the terms of freedom, justice, and productivity in the information society. How we shall live in this new environment will in some significant measure depend on policy choices that we make over the next decade or so. To be able to understand these choices, to be able to make them well, we must recognize that they are part of what is fundamentally a social and political choice &#8211; a choice about how to be free, equal, productive human beings under a new set of technological and economic conditions.</p>
<p>We have looked back at history, and seen how Lessig&#8217;s factors &#8211; market, architecture, norms and law &#8211; apply not only to the world of cyberspace, but to law and society generally.  They represent not the law of the horse &#8211; but the law of the horse &amp; carriage, and horseless carriage &#8211; the law of change.  It can advance; or it can restrain.  The primarily legal, cultural and policy issues that we face are whether we are going to advance law and culture, or retrofit the internet to fit old, outdated law and systems, as Frank Easterbrook seems to want.</p>
<p>I have looked at music as a case study, showing how the Lessig factors have influenced the evolution of music over time.  The lessons learned are that we should not slow the pace of change to that of the law.  Rather, as Perritt explains, &#8220;copyright law should be interpreted, or amended if necessary, to permit informal, non-commercial file-sharing &#8211; conduct which will occur in any event, regardless of what the law says, and which the law should not discourage because it actually encourages further creative effort. He also states, ‘Regardless of what the law says, however, the music industry will not prevail in the end, any more than protectors of the status quo have prevailed in the past. Technology and market forces will win. Consumers and producers of music &#8211; and society &#8211; will benefit.&#8221;<a name="_ednref"></a> He concludes, and I agree:</p>
<p>the bleak scenarios painted in public policy venues by the music industry about the risks posed by the new technologies are considerably exaggerated. The reality is that the new technologies do not threaten the position of musicianship and other creative actors but are rather the embedded capital of an elaborate, sophisticated, and arguably bloated system of intermediation that was designed to deal with old technologies.  The system that the RIAA and MPAA are suing school children to protect is obsolete, and never had much to do with creative effort.&#8221;<a name="_ednref"></a></p>
<p><a name="_ednref"></a></p>
<p><a name="_edn1"></a> Frank H. Easterbrook, <em>Cyberspace and the Law of the Horse</em>, 1996 U. Chi. Legal F. 207, 210 (1996) (comparing cyberlaw to &#8220;horse law&#8221; in that while there are numerous legal issues that arise in the context of horses &#8211; people being kicked by horses, horse racing law, care of horses by veterinarians &#8211; there is no &#8220;law of the horse,&#8221; which would inevitably be &#8220;shallow and miss unifying principles.&#8221;)</p>
<p><a name="_edn2"></a> Lawrence Lessig, <em>Commentaries</em> <em>- The Law of the Horse: What Cyberlaw Might Teach,</em> 113 Harvard L.R. 501, 502 (1999).</p>
<p><a name="_edn3"></a> <em>Id</em>. at 502 (these techniques include using &#8220;constraining tools&#8221; other than law, such as architectures, norms and markets).</p>
<p><a name="_edn4"></a> Easterbrook, 1996 U. Chi. Legal F. at 208.</p>
<p><a name="_edn5"></a> Easterbrook is a graduate of the University of Chicago; Epstein is the Director of the University of Chicago&#8217;s &#8220;law and economics&#8221; program. http://en.wikipedia.org/wiki/Richard_Epstein.  Both are associated with the &#8220;law and economics&#8221; movement.  http://en.wikipedia.org/wiki/Law_and_Economics.</p>
<p><a name="_edn6"></a> Margaret Jane Radin, <em>Symposium on Richard Epstein&#8217;s Takings: Private Property and the Power of Eminent Domain: The Consequences of Conceptualism</em>, 41 U. Miami L. Rev. 239, 239 (1986).</p>
<p><a name="_edn7"></a> <em>Id. </em> Easterbrook&#8217;s conceptualism, for instance, is exhibited by his query: how can we tackle the question whether new technologies have made copying too easy when we &#8220;have not solved the problems posed by yesterday&#8217;s technology?&#8221; (Easterbrook, 1996 U. Chi. Legal F. at 208); his reference to the &#8220;correct allocation&#8221; of domain names (<em>Id</em>. at 212); and talks about having &#8220;answers&#8221; to making &#8220;rights more precise.&#8221; <em>Id</em>. at 208.</p>
<p><a name="_edn8"></a> <em>Id. </em> (also stating &#8220;Epstein&#8217;s tacit acceptance of conceptualism and formalism goes a long way to explaining why he seems so blithely to believe that the results many readers find breathtakingly wrong are just obvious to rational people&#8221;).  From my experience with Easterbrook the same thing can be said &#8211; I find him breathtakingly wrong and he finds me irrational; or, as he once said to me in oral argument, &#8220;right out of the 60s&#8221;).</p>
<p><a name="_edn9"></a> <em>Id. </em>at 241</p>
<p><a name="_edn10"></a> Pierre-Joseph Proudhoun, What is Property? Or, an Inquiry into the Principle of Right and of Government (1840). It&#8217;s not hard to imagine what Proudhoun would say about the law and economics movement given he said the following about economists in the same treatise:  &#8220;I have been pitiless in my criticism of the economists: for them I confess that, in general, I have no liking.  The arrogance and the emptiness of their writings, their impertinent pride and their unwarranted blunders, have disgusted me.  Whoever, knowing them, pardons them, may read them.&#8221;</p>
<p><a name="_edn11"></a> Adam Mossoff, <em>What Is Property? Putting the Pieces Back Together</em>, 45 Arizona L.R. 371 (2003)(&#8220;What is property? Is it merely a linguistic term, denoting a complex aggregate of separate rights that have been merely bundled together for ease of reference? Is it a matter of only excluding other people from one&#8217;s possessions? Or is it something more &#8211; a concept that represents an integrated unity of the exclusive right to acquire, use and dispose of one&#8217;s things?&#8221;)</p>
<p><a name="_edn12"></a> Easterbrook, 1996 U. Chi. Legal F. at 210.</p>
<p><a name="_edn13"></a> <em>See, e.g., Harper &amp; Row, Publishers v. Nation Enters., Inc., </em>471 U.S. 539, 558 (1985)(&#8220;by establishing a marketable tight to the use of one&#8217;s expression, copyright supplies the economic incentive to create and disseminate ideas.&#8221;)</p>
<p><a name="_edn14"></a> Radin, 41 U. Miami L. Rev at 243.</p>
<p><a name="_edn15"></a> W. Jethro Brown, &#8220;Law and Evolution,&#8221; 29(4) <em>The Yale Law Journal</em> 394, 398 (1920).</p>
<p><a name="_edn16"></a> <em>See</em>, John Perry Barlow, &#8220;A Declaration of the Independence of Cyberspace,&#8221; http://homes.eff.org/~barlow/Declaration-Final.html.</p>
<p><a name="_edn17"></a> Yochai Benkler, The Wealth of Networks: How Social Production Transforms Markets and Freedom, (Yale University Press 2006) at http://www.congo-education.net/wealth-of-networks/ch-01.htm</p>
<p><a name="_edn18"></a> <em>See</em>, http://en.wikipedia.org/wiki/Punctuated_equilibrium; citing and linking to: Niles Eldredge and Stephen Jay Gould, 1972. &#8220;Punctuated equilibria: an alternative to phyletic gradualism&#8221; In T.J.M. Schopf, ed., <em>Models in Paleobiology</em>. San Francisco: Freeman Cooper. pp. 82-115. Reprinted in N. Eldredge <em>Time frames</em>. Princeton: Princeton Univ. Press. 1985.</p>
<p><a name="_edn19"></a> Michael W. Carroll, Whose Music Is It Anyway? How We Came to View Musical Expression as a Form of Property<em>, </em>72 U. Cin. L. Rev. 1405, 1412 (2004)(describing competing positions on whether music should be protected by copyright law and how much).</p>
<p><a name="_edn20"></a> Carroll, 72 U. Cin. L. Rev. at 1412.</p>
<p><a name="_edn21"></a> Carroll, 72 U. Cin. L. Rev. at 1416.</p>
<p><a name="_edn22"></a> John M. Steadman, <em>The ‘Inharmonious Blacksmith&#8217;: Spencer and the Pythagoras Legend,</em> 79(5) PMLA 664, 665 (1964). <em>See also, </em>http://www.gresham.ac.uk/printtranscript.asp?EventId=462 (&#8220;<em>hammers which gave the consonance of an octave were found to weigh in the ratio 2 to 1. He took that one which was double the other and found that its weight was four-thirds the weight of a hammer with which it gave the consonance of a fourth. Again he found that this same hammer was three-halves the weight of a hammer with which it gave the consonance of a fifth.&#8221;)</em></p>
<p><a name="_edn23"></a> Carroll, 72 U. Cin. L. Rev. at 1421.</p>
<p><a name="_edn24"></a> Carroll, 72 U. Cin. L. Rev. at 1430-31.</p>
<p><a name="_edn25"></a> Carroll, 72 U. Cin. L. Rev. at fn. 96.</p>
<p><a name="_edn26"></a> Carroll, 72 U. Cin. L. Rev. at 1438.</p>
<p><a name="_edn27"></a> Donald J. Grout &amp; Claude V. Palisca, A History of Western Music, at 57, as cited in Carroll, p. 1441.</p>
<p><a name="_edn28"></a> http://www.stanford.edu/~jrdx/medieval.html</p>
<p><a name="_edn29"></a> Carroll, 72 U. Cin. L. Rev. at 1443 &amp; n. 161 and http://en.wikipedia.org/wiki/Polyphony).</p>
<p><a name="_edn30"></a> &#8220;Pope to purge the Vatican of modern music,&#8221; <em>The Telegraph</em> 11/25/07, www.telegraph.co.uk /news/main .jhtml=/news/2007/11/20/wpope120.xml (&#8220;the Pope is considering a dramatic overhaul of the Vatican in order to force a return to traditional sacred music&#8230;the Pope wants to widen the use of Gregorian chant&#8230;The International Church Music Review recently criticized the choir, saying: ‘the singers want to overshout eachother, they were frequently out of tune, the sound uneven, the conducting without any artistic power, the organ and organ playing like a second-rank county parish&#8230;&#8221;)</p>
<p><a name="_edn31"></a> In Germany, troubadours were called &#8220;jongleurs&#8221; (derived from the Latin ‘joculare&#8217; &#8211; to entertain). In order to merit the label, norms required they know: how to invent, to make rhymes, to acquit himself well as a swordsman; know how to play drums, cymbals and the hurdy-gurdy well; know how to throw up little apples and catch them on the point of a knife; imitate the songs of birds; perform tricks with cards and jump through hoops; play the cittern, handle the clavichord and string the seven-stringed rote; to accompany well with the fiddle and to speak and sign pleasantly. (Carroll, citing Raynor, note 168). Jongleurs were seen as politically and religiously subversive.  One medieval theologian described them as &#8220;ministers of Satan&#8221; and royalty issued decrees setting boundaries for acceptable topics of composition. &#8220;Though enjoying great liberty from political regulation and a variety of social conventions, jongleurs lived a marginal existence with little prospect for financial security.&#8221; (Carroll, 72 U. Cin. L. Rev. at 1446.)</p>
<p><a name="_edn32"></a> <em>Id.</em></p>
<p><a name="_edn33"></a> <em>Id</em>.</p>
<p><a name="_edn34"></a> <em>Id.</em> at 1446.</p>
<p><a name="_edn35"></a> <em>Id.</em></p>
<p><a name="_edn36"></a> <em>Sony Corp. of America v. Universal City Studios, Inc., 464 U.S. 417, 430 (1984)</em> (discussing how copyright protection was not necessary prior to the printing press because hand copying literary works was too costly and time consuming to pose a threat to authors&#8217; interests). See also Marshall Leaffer, Protecting Author&#8217;s Rights in a Digital Age, <em>27 U. Tol. L. Rev. 1, 3 (1995)</em> (examining history of copyright law); Yuri Hur, Note, Tasini v. New York Times: Ownership of Electronic Copyrights Rightfully Returned to Authors, <em>21 Loy. L.A. Ent. L.J. 65 (2000)</em> (discussing development of copyright law).</p>
<p><a name="_edn37"></a> Henry H. Perrit, Jr., New Architectures for Music: Law Should Get Out of the Way<em>, 29 Hastings Comm. &amp; Ent. L.J. 259</em> (Spring, 2007) at 261.</p>
<p><a name="_edn38"></a> <em>Id.</em></p>
<p><a name="_edn39"></a> <em>Id.</em> at 277 (also noting &#8220;technologies for musical instruments changed the style of performance and created a niche for composers as distinct from singers). Printing technology changed the way music was disseminated, enlarging the possibilities of experiencing music for listeners beyond live performances. The development of the phonograph record influenced audience choice in favor of singers like Caruso, whose voice range matched the audio bandwidth capabilities of early phonographs.&#8221;)</p>
<p><a name="_edn40"></a> Lewis Jones, &#8220;Roll Over Beethoven, Dig that Celtic Folk,&#8221; http://www.tradsong.org/Beethoven.pdf</p>
<p><a name="_edn41"></a> Lewis Jones, p. 2.</p>
<p><a name="_edn42"></a> Perritt, 29 Hastings Comm. &amp; Ent. L.J. at 293-296.</p>
<p><a name="_edn43"></a> Evan Swandy, &#8220;Decades later, Lou Reed&#8217;s &#8216;Metal Machine Music&#8217; is re-discovered,&#8221; www.popmatters.com at http://www.chron.com/disp/story.mpl/ent/5307924.html. Some would dispute whether an album like <em>Metal Machine Music</em> is even &#8220;music&#8221;, as Carroll explains, &#8220;Music has no intrinsic definition. It is a cultural category consisting of any sounds that those in a society or culture designate as ‘music&#8217; instead of ‘noise.&#8221; (72 U. Cin. L. Rev. at 1417).</p>
<p><a name="_edn44"></a> Perritt, 29 Hastings Comm. &amp; Ent. L.J. 259 (Spring, 2007)(&#8220;Major record labels exist to perform intermediation in music markets as they have been structured by past technologies. They represent organizational capital devoted to recruiting new talent, vetting new music, overseeing the recording process, promoting new products, and distributing product to consumers.&#8221;)</p>
<p><a name="_edn45"></a> <em>Id. See also, </em>Brett J. Miller, The War Against Free Music: how the RIAA Should Stop Worrying and Learn to Love the MP3, 82 <em>U. Det. Mercy L. Rev.</em>, 303, 312 &#8220;the industry has not embraced new MP3 technology even though it could &#8220;virtually eliminate&#8230;marketing costs&#8221; because of fear from competition from independent bands). (p. 321-322); Andrew C. Humes, The Day the Music Died: The RIAA Sues its Consumers, 38 Ind. L. Rev. 239, 239 (2005)(noting over 9000 lawsuits have been filed against downloaders by the music industry).</p>
<p><a name="_edn46"></a> Perritt, 29 Hastings Comm. &amp; Ent. L.J. 263.</p>
<p><a name="_edn47"></a> Perritt at 262, citing Jessica Litman, <em>Sharing and Stealing, 27 Hastings Comm. &amp; Ent. L.J.</em>, 1, 2 (2004)(existing law was designed to facilitate a world in which music distributors needed a substantial capital investment in printing presses, trains or trucks, warehouses, broadcast towers or communication satellites).</p>
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