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	<title>Yale Journal of Medicine &#38; Law</title>
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	<link>http://www.yalemedlaw.com</link>
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		<title>Interview with Dr. Mark Fishman &#8217;72, President of the Novartis Institutes for BioMedical Research</title>
		<link>http://www.yalemedlaw.com/2013/04/interview-with-dr-mark-fishman-72-president-of-the-novartis-institutes-for-biomedical-research/</link>
		<comments>http://www.yalemedlaw.com/2013/04/interview-with-dr-mark-fishman-72-president-of-the-novartis-institutes-for-biomedical-research/#comments</comments>
		<pubDate>Wed, 17 Apr 2013 07:03:48 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Cover Interviews]]></category>
		<category><![CDATA[big pharma]]></category>
		<category><![CDATA[drug discovery]]></category>
		<category><![CDATA[pharmaceutical companies]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1837</guid>
		<description><![CDATA[Dr. Mark Fishman ’72 is the President of the Novartis Institutes for BioMedical Research, the research branch of the pharmaceutical company Novartis. Before joining Novartis in 2002, Dr. Fishman was chief of cardiology and director of the Cardiovascular Research Center at Massachusetts General Hospital, as well as a medical professor at Harvard Medical School. ]]></description>
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<p><em>Dr. Mark Fishman ’72 is the President of the Novartis Institutes for BioMedical Research, the research branch of the pharmaceutical company Novartis. Before joining Novartis in 2002, Dr. Fishman was chief of cardiology and director of the Cardiovascular Research Center at Massachusetts General Hospital, as well as a medical professor at Harvard Medical School. Reporter Clinton Wang talked to Fishman about his transition from clinical practice to the pharmaceutical industry, and how he sought to bring a stronger medical focus to the drug discovery process.</em></p>
<p><strong>How did you go from being a physician to leading a pharmaceutical company?</strong></p>
<p>My move from academia to Novartis was not my anticipated trajectory. At the time, I was at Mass General. Things were really going in about as positive a fashion as one could hope for. I was well supported, I ran the clinical service in cardiology, I ran a new institute there — the Cardiovascular Research Center — which I had founded, and we were doing work in the developmental biology and genetics of the developing embryo using zebrafish.</p>
<p>So there was very little reason for me to consider moving at the time, and I had very little contact with pharmaceutical companies. I was actually quite suspicious when I got a call out of the blue from them asking if I wanted to run research at Novartis. I’m not sure I even really knew anything about Novartis at the time. So I said no. &#8230; Later they asked me a second time, and I said no, I wasn’t negotiating. But my son said, “you know dad, I love your zebrafish, but don’t you think it’d be more important to make medicine?” And my daughter and wife agreed with that. I started to talk to them and I decided that it was pretty clear that if you really wanted to have a big impact on medicine, that’s how you do it, discover new medicine. So that’s why I moved over.</p>
<p><strong>What kind of changes did you make to the company?</strong></p>
<p>When I started, there were no physicians involved. And I felt it was important for physicians to be involved early on so that we know whatever we’re studying has a clinical foundation. So people are judged for quality of their science, not for some arbitrary numerical evaluation that you’d typically use in a company. The idea of moving from financially driven decision-making to medical decision-making has been a big change but quite productive. It’s now accepted throughout the entire company.</p>
<p>We took the company into new directions, such as a focus on rare diseases. Many rare diseases are quite well understood and it’s feasible to make drugs for them, but historically they’re not the focus of pharmaceuticals because they don’t have many patients so they aren’t profitable. But the advantage of working on a rare disease is we can usually get an answer quickly, and we learn that in many cases, the mechanisms that drive rare diseases are related to the mechanisms that drive more complex disease.</p>
<p><strong>How do you stay profitable when you prioritize clinical importance over financial considerations?</strong></p>
<p>We’re not only focused on rare diseases, we’re looking at fundamental mechanisms that underlie common diseases like heart failure. By moving away from portfolios that rely on big blockbuster drugs, we’re able to make money from a range of sources. But at the end of the day, the more innovative your medicine is, the better off your company will be.</p>
<p>And many companies now are quite desperate. The number of drugs has been fairly stable last year but by and large it hasn’t been not a lot. You have 20-25 new drugs a year approved by the FDA, and only a small subset — 7 or so — are truly new medicines. So there are signs of anxiety from many pharmaceutical companies. They’re lurching around, thinking that they can find something quickly. But long-term success is going to depend on those who are willing to commit to science and medicine over financial pressure, because drug discovery is a long and hard process.<br />
<strong><br />
How do you expect technology to transform drug discovery in the future?<br />
</strong><br />
Never put your faith in technology. Technology alone has never changed science without an interesting idea. When you have technology coupled to an important question, then you can get an important answer. But most of the technology that’s changed drug discovery has evolved over many years. The monoclonal antibody approach languished for many years as an interesting immunological approach before it was eventually worked out. Atomic spectroscopy, mass spec, all of these were major influences, but if you look at the number of new drugs per year over the last 20 years, there wasn’t even a blip, even after, for example, the first sequence of the human genome project, which people said would transform drug discovery.</p>
<p><em>Clinton Wang is a sophomore in Davenport College.</em></p>
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		<title>Government Control vs. Free Market Solutions: Is Health Care a Right or a Privilege?</title>
		<link>http://www.yalemedlaw.com/2013/04/government-control-vs-free-market-solutions-is-health-care-a-right-or-a-privilege/</link>
		<comments>http://www.yalemedlaw.com/2013/04/government-control-vs-free-market-solutions-is-health-care-a-right-or-a-privilege/#comments</comments>
		<pubDate>Wed, 17 Apr 2013 06:42:12 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Health Policy]]></category>
		<category><![CDATA[fee-for-service]]></category>
		<category><![CDATA[pay-for-performance]]></category>
		<category><![CDATA[physician reimbursement]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1833</guid>
		<description><![CDATA[We care about health care, and view health as a basic human right. It follows that we would then view health care as a right, too. When we are sick, we want to be able to seek affordable, high-quality, efficient medical care, and we tend to think that everyone should be able to. How far does the Patient Protection and Affordable Care Act go in making this a reality for all Americans?]]></description>
				<content:encoded><![CDATA[<p><a href="http://www.yalemedlaw.com/wp-content/uploads/2013/04/Ambulance.jpg" rel="lightbox[1833]"><img src="http://www.yalemedlaw.com/wp-content/uploads/2013/04/Ambulance-300x200.jpg" alt="Ambulance" width="300" height="200" class="alignleft size-medium wp-image-1841" /></a>“I think I’d rather be in the United States than in Britain if somebody in my family contracted a serious disease,” wrote American journalist T. R. Reid when comparing the American healthcare system to the British National Health Service, as cited by Peter Baldwin in The Narcissism of Minor Differences: How America and Europe Are Alike: An Essay in Numbers, published in 2009. Baldwin then goes on to extoll the availability of advanced medical technology and the frequency of complicated procedures in the U.S. </p>
<p>We can attribute both of these characteristics of healthcare in the U.S. to its system of private provision. These sophisticated procedures are routine because the healthcare system caters to those who can afford healthcare, and those are the patients who most often are able to pursue sophisticated procedures. In contrast, many pregnant women without health insurance do not receive prenatal care, which is a far less sophisticated and technology advanced form of care than, for example, heart surgery.</p>
<p>We care about health care, and view health as a basic human right. It follows that we would then view healthcare as a right, too. When we are sick, we want to be able to seek affordable, high-quality, efficient medical care, and we tend to think that everyone should be able to. You could instead say: When Americans are sick, they want to be able to seek affordable, high-quality, efficient medical care, and they should be able to. How far does the Patient Protection and Affordable Care Act go in making this a reality for all Americans?</p>
<p>As outlined by HealthCare.gov, the federal government website managed by the Department of Health and Human Services, the Affordable Care Act addresses various inequities. It does so by creating new coverage options for individuals with pre-existing conditions, mandating broader coverage of preventative services by insurance companies, and curbing retroactive insurance cancellations. Meanwhile, it retains elements of the free market approach,, such as: doctor choice, no health plan barriers to OB/GYN services, and access to out-of-network emergency room services. However, what it touts as its approach to filling gaps in coverage for the poorest Americans merely gives states the option to expand Medicaid to individuals under 65 years of age with income below 133 percent of the federal poverty level, albeit with substantial federal funding. Furthermore, though the individual mandate is designed to incentivize all individuals not covered by private or public insurance programs to purchase insurance, and includes federal subsidies for low-income individuals and families to do so, it still retains the key elements of the free market approach to health insurance. </p>
<p>In short, the Affordable Care Act primarily institutionalizes, regulates, and attempts to expand the system of private provision that we already have in place. Free market solutions can—and do—incentivize quality, in areas where there is high demand. That is, the quality of care one receives depends on one’s ability to exert force on the market. But what about the fifteen percent of Americans without health insurance, to whom Baldwin refers in passing? What will American health care look like now that most of them, too, will be able to afford health care on a regular basis? We can get an inkling of what that picture might include by returning once more to Reid, who says in 2008 Frontline “Q&#038;A with Correspondent T.R. Reid” that, when his family used the healthcare systems in Japan and Britain, “for the normal family medical problems—flu, measles, broken bones, earache, etc.—we got excellent care, with little or no waiting.” However, Reid is a strong advocate for universal healthcare in the U.S., as described in Dru Sefton’s article “When the producer’s take diverges from the reporters,” published in Current, April 27, 2009. In his 2008 Frontline “Sick Around the World” documentary, Reid showed that some of the best healthcare systems in other developed countries were single-payer systems. Reid then disowned what was to be the sequel (Frontline’s 2009 “Sick Around America” documentary) when he felt that the producers made it come off as supporting mandated private-insurance coverage. </p>
<p>As Daniel Callahan and Sherwin B. Nuland wrote in “The Quagmire: How American medicine is destroying itself,” published on June 9, 2011 in The New Republic, “It is essential that we find ways to push down the ever-expanding kind of care at the highest level to lower levels, and particularly to the public-health and primary-care levels.” One might argue, then, that the government should enable the poor to exert force on the market. The Affordable Care Act may enable this, to an extent, by getting everyone into the system. But how do we ensure that, once covered by insurance, they receive high-quality care? </p>
<p>A possible solution that has recently garnered support from a number of advocates at the is the push for performance-based financing of healthcare. Similar to the Affordable Care Act’s emphasis on improving the private provision model, performance-based financing takes what is good about the free market—the incentivizing of quality—and gets rid of the inequity that results from free market provision of healthcare.  </p>
<p>As Management Sciences for Health defines in the 2009 article “Performance-Based Financing,&#8221; in Healthcare Financing, performance-based financing is an approach to structuring the flow of resources to pay for results, which include desired goals, outcomes, and impacts. Because the flow of resources is structured to pay for results rather than for processes or activity costs, the purchaser transfers power and authority over strategies and activities to the provider, along with the potential for reward or loss. As Meessen et al write in their article “Performance-based financing: just a donor fad or a catalyst towards comprehensive health-care reform?” published by the World Health Organization in 2011, performance-based financing stands in contrast to a line item approach, which finances a health facility through the provision of inputs, such as medications and personnel. In other words, performance-based financing entails a shift from rewarding volume to rewarding value. Performance-based financing has been shown to increase use and quality of healthcare services, stabilize and decrease costs of these services, help use limited resources effectively, and improve staff motivation and moral, according to Management Sciences for Health.</p>
<p>Performance-based financing works (at least in part) because it grants autonomy to healthcare providers. As Meessen et al write, “Granted more autonomy in exchange for greater accountability for results, health facilities can tailor initiative to the populations they serve.” Furthermore, they write that health workers view health information systems differently under performance-based financing, because clearly completing and filing health information forms provides the basis for part of their remuneration. Thus, in granting greater accountability, performance-based financing leads to improvements in efficiency. To this end, the adoption of performance-based financing in countries such as Burundi and Rwanda has led to a reconsideration of roles and functions in the health system such that functions are bundled in coherent packages to maximize economies of scale and scope, according to Meessen et al.</p>
<p>Performance-based financing has been embraced as a means of improving healthcare structures, not just healthcare worker performance. Meessen et al. describe this potential: “Performance-based financing can catalyze comprehensive reforms and help address structural problems of public health services, such as low responsiveness, inefficiency, and inequity.” In “Quality-based financial incentives in health care: can we improve quality by paying for it?” published in 2009 in The Annual Review of Public Health, Conrad and Perry address the question of why this is, citing first the assumed primacy of patient health. “We assume that physicians and care organizations seek to maximize the patients’ health,” they write, but then continue: “However, the financial return constraint explicitly predicts the direction of incentives’ effects on different dimensions and levels of behavior…When there are conflicts between patient health benefit and the physician’s financial return, the resolution of those conflicts will be determined by the physician’s relative valuation of financial return versus patient health.” Thus, with performance-based financing, we can align the physician’s financial return with patient health and thereby remove this conflict of interest. </p>
<p>But how do we align healthcare workers’ financial returns with patient health? Ultimately, this alignment is a matter of balance. With performance-based financing, there are a number of tradeoffs to take into account. These include: absolute versus relative measures of performance; negative consequences for the quality of care; adverse effects on health worker motivation and performance (including the risk of multitasking, treating to the test, and the accompanying distortion effect); the cost-performance relationship; and rewards versus penalties. </p>
<p>To resolve these tensions, we might take the approach of Kirschner et al, as outlined in their article “Design choices made by target users for a pay-for-performance program in primary care: an action research approach”, published in 2012 by BMC Family Practice. They involved healthcare professionals in the goal setting, methods determining, and payment scheme setup process of developing a performance-based finance plan. Though one might argue that this approach would bias the healthcare providers by privileging their interests, rather than patient interests, it offered a definitive take on many of the dichotomies that are otherwise tricky to navigate. This approach also included the added bonus of enhancing the healthcare workers’ commitment to and motivation for the performance-based financing program, which could in turn increase the program’s impact.</p>
<p>More general arguments against performance-based financing tend to target its practicality. Ireland et al. argue in their article, “Can performance-based financing be used to reform health systems in developing countries?” published in 2011 by the World Health Organization, that a weakness of performance based financing is that it is very difficult to evaluate, because it is necessary to isolate the effect of incentives from the effect of increased resources. Ireland et al. also argue that the success of performance-based financing depends entirely on context, which means that multiple elements need to be in place for a program to be successful (such as management capacity at national and local level). However, they concede that results indicate that performance-based financing can play a role in increasing the productivity of health workers and have positive effects on health service utilization. As a way of reconciling these different viewpoints, Meessen et al. argue that much of the critique of performance-based financing reflects a view that it is solely a provider payment mechanism, thereby overlooking its potential to reform health systems.</p>
<p>In short, the Affordable Care Act is a step in the right direction, but it is improving a broken system in small ways. The U.S. seems poised for a groundbreaking overhaul of healthcare provision. If we can retain the benefits of a system of private provision—high quality, low wait time—while expanding to provide universal coverage, then we will have a system that works better for more people. Perhaps performance-based financing will be the key to keeping the best of the free market while moving ever further away from it toward a more equitable system. Performance-based financing’s potential to reform health systems is significant, and could ultimately make healthcare more affordable by achieving, in colloquial terms, “more bang for your buck.”  </p>
<p><em>Nina Russell is a sophomore in Timothy Dwight College majoring in Ethics, Politics, and Economics.</em></p>
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		<title>Hot Topic: The Legalization of Marijuana</title>
		<link>http://www.yalemedlaw.com/2013/04/hot-topic-the-legalization-of-marijuana/</link>
		<comments>http://www.yalemedlaw.com/2013/04/hot-topic-the-legalization-of-marijuana/#comments</comments>
		<pubDate>Wed, 17 Apr 2013 06:29:20 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Bioethics]]></category>
		<category><![CDATA[drug abuse]]></category>
		<category><![CDATA[legalization]]></category>
		<category><![CDATA[medical marijuana]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1828</guid>
		<description><![CDATA[Whether or not the federal government should legalize marijuana has been heavily debated since the 1970s. Since the 1970s, minor marijuana offenses have been decriminalized in 11 states and penalties have been significantly lowered in all others. Today, there exists an extreme disconnect between federal and state laws and attitudes toward marijuana decriminalization and legalization. ]]></description>
				<content:encoded><![CDATA[<p><a href="http://www.yalemedlaw.com/wp-content/uploads/2013/04/Marijuana.jpg" rel="lightbox[1828]"><img src="http://www.yalemedlaw.com/wp-content/uploads/2013/04/Marijuana-300x210.jpg" alt="Marijuana" width="300" height="210" class="alignleft size-medium wp-image-1846" /></a>Marijuana. To the medical community it is known as cannabis. To the general public, it bears many names: pot, weed, grass, mary jane, dope. You can smoke it, you can bake it into brownies, you can brew it with tea; you can use it to get high or you can use it to alleviate pain. But be warned: you cannot do so everywhere.</p>
<p>Whether or not the federal government should legalize marijuana has been heavily debated since the 1970s. Since the 1970s, minor marijuana offenses have been decriminalized in 11 states and penalties have been significantly lowered in all others [1]. Today, there exists an extreme disconnect between federal and state laws and attitudes toward marijuana decriminalization and legalization. In 1970, the federal government passed the Controlled Substances Act and since then the Drug Enforcement Agency (DEA) has classified marijuana as a “Schedule I” drug – one that has no accepted medical use. However, despite federal illegality, medical marijuana is legal in 18 states and legalization is being considered in 7 others [2].</p>
<p>On a broader basis, recreational use of marijuana has been considered illegal by the federal government since 1860 [3]. However, in Colorado, Amendment 64 took effect on December 10, 2012 and legalized personal use, private possession of up to one ounce and cultivation of up to six plants, as well as created taxes, regulations and punishments in a manner similar to alcohol [4]. In Washington, Initiative 502 took effect on December 6, 2012, with similar provisions to those of Amendment 64 [5]. Due to the massive amount of debate surrounding the issue and heterogeneity in state laws and attitudes, creating a federal policy of legalization or otherwise is nearly impossible. The Obama Administration has stated that the federal government opposes any form of drug legalization, but the outcomes of the Washington and Colorado legalizations may serve as bases for arguments for policymakers.</p>
<p>Pro-Legalization:</p>
<p>Leading the movement to decriminalize and legalize marijuana is the National Organization for the Reform of Marijuana Laws (NORML). Founded in 1970, its mission is “to move public opinion sufficiently to achieve the repeal of marijuana prohibition so that the responsible use of cannabis by adults is no longer subject to penalty.” According to NORML, marijuana is used by over 100 million Americans, 25 million within the past year and 14 million on a regular basis, so therefore prohibition of use is evidently a failure. By their calculations, enforcement of prohibition costs $10 billion annually and marijuana-related arrests – approximately 750,000 per year, 80% of which are for merely possession – account for more arrests than all violent crimes combined [5]. Proponents of decriminalization claim that decriminalization would not necessarily decrease police expenditures because 75% of these expenditures are fixed costs, but the main benefit lies in that decriminalization would remove many individuals from the criminal justice system and allow for reallocation of resources to more pressing crimes [6]. NORML also underlines that of the top three most commonly used recreational drugs – alcohol, tobacco and marijuana – marijuana is the least dangerous in that it is non-toxic and cannot cause death by overdose [5].</p>
<p>A key argument employed in favor of legalization is that there exists no clear evidence linking marijuana to crime. It is often claimed that legalization would increase use, which would in turn increase crime rates. First and foremost, NORML claims there is not sufficient evidence to support that use would even increase, as cannabis has little risk of addiction and marijuana use follows a more occasional use pattern, as compared with regular use patterns associated with addictions to alcohol or tobacco. Furthermore, studies that link marijuana to crime are conducted as cross-sectional analyses, indicating merely a high occurrence of marijuana use in criminals. However, as NORML argues, there could be many factors that generate this link other than a direct relationship between marijuana use and crime. For example, both marijuana use and crime could be caused by poor socioeconomic status, in which case marijuana use and crime would be related as common effects rather than existing in a cause-and-effect relationship [6].</p>
<p>In terms of combating the supposition that marijuana is associated with harmful health-related effects, pro-legalization proponents point to the health-related benefits of medical marijuana. Medical marijuana is prescribed to chemotherapy patients as it increases appetite and relieves pain and nausea. Medical marijuana has also been prescribed to glaucoma patients, as it decreases pressure on the eyeball and the optic nerve, and multiple sclerosis patients to alleviate pain. Proponents also note that alcohol is a legal drug, yet a study ranking the world’s most harmful drugs ranked alcohol as number one with a score of 72 of 100, while cannabis was ranked number eight with a score of only 20 [3].</p>
<p>Anti-Legalization:</p>
<p>Spearheading the movement against decriminalization and legalization of marijuana is Citizens Against Legalization of Marijuana (CALM), which “takes the position that Federal laws against the use, cultivation, and transportation of marijuana should be maintained and enforced and should not be relaxed or softened.” CALM underscores the facts that in 2006 the FDA found that marijuana causes harm, that 26.9% of seriously injured drivers test positive for marijuana, that 290,563 ER visits in 2006 were related to marijuana, the second highest number after those related to heroin, and that ER mention of marijuana in admissions of 12- to 17-year-olds rose 48% between 1989 and 2008. CALM also notes that the DEA and the government do not recognize marijuana as having medical benefits and that not enough research has been conducted to justify the legalization of medical marijuana, an opinion mirrored by the American Medical Association (AMA), the American Society of Addiction Medicine (ASAM), the American Cancer Society (ACS), and many others [7].</p>
<p>The federal government has also made its position regarding the legalization of marijuana quite clear. According to the White House fact sheet on marijuana, marijuana is harmful in that it causes dependence, respiratory and mental illness, poor motor function, impaired function of the cognitive and the immune systems and distorted perception, thinking, problem solving and memory, it is associated with anxiety, depression, suicide and schizophrenia, and marijuana smoke contains 50-70% more carcinogens than tobacco. According to those who oppose legalization, the likely consequences of legalization include a decrease in price, which would contribute to an increase in availability and therefore use and misuse, and an increased burden on the criminal justice system (based upon the argument that increased use increases harm done). Furthermore, the tax revenue gained by legalizing and taxing marijuana would be offset by the social costs (as shown by models of revenue offset in the legal use of alcohol and tobacco), and marijuana accounts for only a small portion of drug trafficking operations, so legalization would have little effect on drug violence and in all likelihood, cartels would merely undercut the taxed market prices to maintain their market share [8].</p>
<p>The Sides:</p>
<p>The pro-legalization camp consists of a wide array of parties. Doctors have been historically divided between support and opposition, with some claiming that marijuana is unhealthy, addictive or even deadly, and that too little scientific research exists, while others claim is has the potential to save lives and prevent pain. In the government, evidently policymakers in Washington and Colorado support legalization. According to a 2012 national poll conducted by Quinnipiac University, 66% of Republicans are against legalization and 31% support it, while 58% of Democrats support legalization and 36% oppose it [9]. However, the federal government remains opposed to legalization.</p>
<p>In the general public, according to the Quinnipiac poll, legalization is approved 51% to 44%. These numbers vary across different subsets of the population. Men favor legalization 59% to 36%, whereas women oppose legalization 52% to 44%. White and black people tend to favor legalization 50% to 46% and 57% to 37%, respectively, while Hispanics tend to oppose legalization 48% to 47%. Variation exists among age groups as well, with support for legalization decreasing with age. People aged 18-29 tend to favor legalization 67% to 29%, aged 30-44 favor legalization 58% to 39%, aged 45-64 marginally favor legalization 48% to 47% and aged 65 and older oppose legalization 56% to 35% [9]. This particular trend reflects the disproportionate use of marijuana by younger males [6].</p>
<p>Evidently, there is an enormous divide in public opinion regarding the legalization of marijuana. Equally legitimate arguments draw from many diverse fields, including medicine, economics, social acceptability, public safety, and more, therefore opposing factions have been relatively unsuccessful at resolving the conflict. The outcome of this heated debate has yet to be determined, but recent political initiatives, such as those in Washington and Colorado, indicate that a conclusion is on the horizon.</p>
<p><em>Jessica Schmerler is a sophomore in Jonathan Edwards College majoring in molecular, cellular, and developmental biology. </em></p>
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		<title>Patent Expiry and What It Means for Pharmaceutical Companies</title>
		<link>http://www.yalemedlaw.com/2013/04/patent-expiry-and-what-it-means-for-pharmaceutical-companies/</link>
		<comments>http://www.yalemedlaw.com/2013/04/patent-expiry-and-what-it-means-for-pharmaceutical-companies/#comments</comments>
		<pubDate>Wed, 17 Apr 2013 06:23:32 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Healthcare Economics and Management]]></category>
		<category><![CDATA[blockbuster]]></category>
		<category><![CDATA[drug discovery]]></category>
		<category><![CDATA[patent cliff]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1824</guid>
		<description><![CDATA[The patent cliff - the result of many major drug companies losing their patent protection over the course of 2013.  Several of the most profitable pharmaceutical companies, with brand name drugs such as Plavix and Lexapro, will be forced to share their massive profits with generic companies that can provide customers with lower priced versions of the previously exclusive drugs. ]]></description>
				<content:encoded><![CDATA[<p><a href="http://www.yalemedlaw.com/wp-content/uploads/2013/04/TobiPatentExpiryPic.png" rel="lightbox[1824]"><img src="http://www.yalemedlaw.com/wp-content/uploads/2013/04/TobiPatentExpiryPic-300x199.png" alt="(Tobi)PatentExpiryPic" width="300" height="199" class="alignleft size-medium wp-image-1825" /></a>The big names in the pharmaceutical industry have been dreading this day for years. </p>
<p>It’s called the patent cliff, and it’s the result of many major drug companies losing their patent protection over the course of 2013.  Several of the most profitable pharmaceutical companies, with brand name drugs such as Plavix and Lexapro, will be forced to share their massive profits with generic companies that can provide customers with lower priced versions of the previously exclusive drugs. </p>
<p>As Nuala Moran writes in the BioWorld Online article “Pharma Summits Patent Cliff in 2012,&#8221; according to pharmaceutical researcher EvaluatePharma, there will be roughly $290 billion in sales at risk due to patent expiry between this year and 2018. Plavix, a well-known and popular blood thinner in the pharmaceutical market, saw sales drop a remarkable 70% in the last year, and the numbers in the future could be even more dramatic, according a New York Times article published on December 3, 2012 titled &#8220;Generic Drug Makers See a Drought Ahead.&#8221; The end of pharmaceutical patent protection means that generic companies can now compete on the same level as the mega companies. </p>
<p>This level of parity is a definite cause of concern for major pharmaceuticals companies, but is it necessarily bad for the market as a whole? Patent expiry on this scale affords generic companies the ability to challenge patents and convince the FDA that their versions of the drug should be sold exclusively. Generic companies are providing cheaper prices for the customers, and are also trying ardently to find a niche in the recently open pharmaceutical field. This new focus on specialization will allow for greater levels of pharmaceutical progress and provide incentive for innovation. </p>
<p>But the question remains: will the loss of patents and revenue cause the major pharmaceutical companies to go away? This patent cliff provides major companies the unique opportunity to get away from the pressures of a demanding economy. Instead of focusing on the need to increase share price to by investing in risky pharmaceutical ventures, the companies can redirect their efforts. The most dedicated and thoughtful companies will possibly be able to turn this patent cliff into an opportunity to invest wisely and provide a product that is both beneficial to patients and lucrative to shareholders. </p>
<p><em>Oluwatobi Akinodoju is a freshman in Davenport College majoring in biomedical engineering.</em></p>
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		<title>Drug Discovery and Research Institutions</title>
		<link>http://www.yalemedlaw.com/2013/04/drug-discovery-and-research-institutions/</link>
		<comments>http://www.yalemedlaw.com/2013/04/drug-discovery-and-research-institutions/#comments</comments>
		<pubDate>Wed, 17 Apr 2013 06:00:47 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Pharmaceuticals]]></category>
		<category><![CDATA[basic research]]></category>
		<category><![CDATA[drug discovery]]></category>
		<category><![CDATA[pharmaceuticals]]></category>
		<category><![CDATA[scientific research]]></category>
		<category><![CDATA[university]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1820</guid>
		<description><![CDATA[Drug discovery has been, for the most part, a traditionally industrial conquest. Medical research through industry provides a direct, goal-oriented approach to investigating new molecules. By contrast, academic research primarily consists of basic research and focuses on scientific understanding over practicality. Partially due to the Bayh-Dole Act of 1980, which allows universities to use federal funding for research while retaining patent rights, the pharmaceutical world has begun to be shared by both industrial research and academic research.]]></description>
				<content:encoded><![CDATA[<p><a href="http://www.yalemedlaw.com/wp-content/uploads/2013/04/University-Research.jpg" rel="lightbox[1820]"><img src="http://www.yalemedlaw.com/wp-content/uploads/2013/04/University-Research-200x300.jpg" alt="University Research" width="200" height="300" class="alignleft size-medium wp-image-1850" /></a></p>
<p>Over the past half century, drug discovery within the research realm has greatly advanced with the advent of rapidly developing technology, and has to date been responsible for saving countless lives. However, recent years have seen a gradual decline in new drug breakthroughs, whether due to the diminishing number of readily remediable medical issues or a lack of inspired approaches to innovation. In fact, a study entitled “Changing Patterns of Pharmaceutical Innovation,” conducted by the National Institute for Health Care Management (NIHCM) in May 2002, found that between 1989 and 2000, only one-third of the prescription drugs approved by the U.S. Food and Drug Administration (FDA) were new treatments, of which less than half involved new molecular entities. In order to stimulate progress within the world of medical development, a new consideration has been emerging into the spotlight: the relationship between industry and academia with respect to drug discovery.</p>
<p>Drug discovery has been, for the most part, a traditionally industrial conquest involving multinational companies like Pfizer and Johnson &#038; Johnson. Medical research through industry provides a direct, goal-oriented approach to investigating new molecules, often with the latest resources and technology. In contrast, academic research – that is, research conducted in universities – primarily consists of basic research and focuses on scientific understanding over practicality. According to a study headed by the National Institute of Health (NIH’s) Mark Rohrbaugh, as described in “The Role of Public-Sector Research in the Discovery of Drugs and Vaccines” published on February 10th, 2011, in <em>The New England Journal of Medicine</em>, between 1990 and 2008, only 9.3% of drug discoveries were made by the public sector, which includes academia. Partially due to the Bayh-Dole Act of 1980, however, which allows universities to use federal funding for research while retaining patent rights, the pharmaceutical world has begun to be shared by both industrial research and academic research, ranging from simple collaboration to independent work.</p>
<p>Partnerships between industry and academia, while largely still in the nascent stage, have already been fruitful with respect to drug discovery. In the past, these cooperative efforts have mostly stemmed from industries hiring academic personnel without giving credit; today, support by academia has developed into a more organic, mutually beneficial relationship. The movement of more individualized efforts toward collaboration can be seen in Edward C. Taylor, a Princeton professor’s, cooperation with Eli Lilly scientists to develop a treatment for mesothelioma (lung tumors) and non-small-cell cancer, which eventually grew into an FDA-approved drug called Alimta. The Translational Medicine Research Collaboration (TMRC) in Scotland is another example on a larger scale of universities and industry coming together. As one of the first of these partnerships, Aberdeen, Dundee, Edinburgh, and Glasgow Universities teamed up with Wyeth Pharmaceuticals, Scottish Enterprise and NHS Scotland Grampian, Greater Glasgow, Lothian, and Tayside in order to research treatment for a variety of purposes, ranging from cardiovascular disease to oncology. Industries like the Novartis Institute for Biomedical Research and Genetech have also started to offer fellowships specifically for postdoctoral scientists to study with industrial researchers. Academic establishments benefit from collaboration through greater accessibility to translational efforts. At the same time, specialized knowledge from university researchers is particularly useful to industrial study of pharmaceuticals.</p>
<p>Research in academia alone has also started to increase in prevalence as a formidable force in drug discovery. Rohrbaugh’s study indicated that 21.2% of drug discoveries between 1990 and 2007 involving new molecular entities were a result of research in public sectors like universities. Furthermore, the National Center for Advancing Translational Sciences (NCATS), which was established in late 2011 with the intention of strengthening the link between basic research and practical drug creation, heads the Clinical and Translational Science Awards (CTSA) program, launched in 2006 by the NIH. The program is specifically designed to “create academic homes for clinical and translational research.” Conducting research in an academic environment provides unique advantages in that the restrictions of practicality are not always set in place as in the case of industrial research. According to Brent Stockwell, a professor at Columbia University speaking at the “Charting Chemical Space – Finding New Tools to Explore Biology” Horizon Symposium in May 2004, “academia can try riskier approaches,” which include “using novel types of compounds, novel types of assays, tackling orphan diseases and creating new animal models for disease.” Research in universities is also particularly useful as a “pipeline” between the early stages of drug discovery and the finalization of pharmaceutical development by industries. This is because academia is mostly involved in advances with respect to small molecules, which eventually build into the production of industrial drugs.  They are the “enabling chemical tools” that provide the basis of development for industries, which might consider these early stages too risky and expensive. The particulars of research in an academic setting, namely the innovative thinking inspired by basic research and the specialized knowledge in different fields, make universities an ideal place for initializing drug production. However, despite the fact that the number of small molecule drug discovery centers have doubled within the past six years, lack of interdepartmental collaboration has hindered the ability of public research to fully contribute to drug discovery.</p>
<p>The emergence of academia into medicinal research – whether partnered with, working alongside, or operating independently from pharmaceutical industries – has the potential to continue improving and enhancing the world of drug discovery. Progress in this field has been anything but stagnant; for instance, in 2013 the FDA approved an array of drugs ranging from the influenza vaccine Flublok to Tecfidera for multiple sclerosis treatment.  However, the trend of pharmaceuticals to tend towards modification rather than innovation is alarming when considering the amount of medical ground we must still cover with respect to treatment, which makes partnering with academia in drug discovery all the more imperative.</p>
<p><em>Kantiya Jindachomthong is a sophomore in Silliman College majoring in biomedical engineering.</em></p>
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		<title>Cost Fixing and Loopholes</title>
		<link>http://www.yalemedlaw.com/2013/04/cost-fixing-and-loopholes/</link>
		<comments>http://www.yalemedlaw.com/2013/04/cost-fixing-and-loopholes/#comments</comments>
		<pubDate>Wed, 17 Apr 2013 05:25:04 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Healthcare Economics and Management]]></category>
		<category><![CDATA[Public Health]]></category>
		<category><![CDATA[coverage]]></category>
		<category><![CDATA[health insurance]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1817</guid>
		<description><![CDATA[The recent activation of the Affordable Care and Patient Protection Act has had significant effects upon the current state of coverage, but many insurance company policies remain more or less unchanged. Although the ACA serves to aid in bringing down healthcare costs by targeting many private sector problems, a number of loopholes and exemptions have dampened and/or threaten to negate the effects of the reforms. ]]></description>
				<content:encoded><![CDATA[<p><a href="http://www.yalemedlaw.com/wp-content/uploads/2013/04/Blue-Scrub-Woman.jpg" rel="lightbox[1817]"><img src="http://www.yalemedlaw.com/wp-content/uploads/2013/04/Blue-Scrub-Woman-267x300.jpg" alt="Blue Scrub Woman" width="267" height="300" class="alignleft size-medium wp-image-1842" /></a>The ever fluid landscape of insurance policy and regulation has made it incredibly hard for the general public to clearly identify basic elements of health insurance coverage and its subsequent influence on the US healthcare economy. Indeed, the recent activation of the Affordable Care and Patient Protection Act has had significant effects upon the current state of coverage, but many insurance company policies remain more or less unchanged. In reality, although the ACA serves to aid in bringing down healthcare costs by targeting many private sector problems, a number of loopholes and exemptions have dampened and/or threaten to negate the effects of the reforms. </p>
<p>According to the CDC, just around 62 percent of Americans under 65 receive private health insurance. That leaves 20 percent of Americans under 65 who receive public health insurance while the remaining 18 percent are uninsured. Within the landscape of private health coverage, there existed, and continues to exist, a multitude of inefficiencies contributing to lack of coverage and subsequent rising costs. The uninsured differ in reasons for their lack of policies, but a large part of this gap can be attributed to the high end costs of insurance premiums—monthly payments for a plan. Many are also denied insurance coverage based on preexisting conditions. In addition, insurers have in the past been likely to employ methods of cost sharing for many preventative care services contributing to a situation in which those services become unattainable.  Health and Human Services estimate that due primarily to cost, Americans consume preventative services at about half the recommended rate. </p>
<p>As Kathleen Sebelius of HHS points out, one of the key ways in which the ACA attempts to reduce rising US healthcare costs is by combating uncompensated care for uninsured individuals. The ACA attempts to extend coverage in four major ways: by making it illegal for private insurers to deny coverage based on preexisting conditions, by requiring that dependents be allowed to remain on parental plans until age 26, by mandating small business employers provide health coverage to full time workers, and by extending access to certain preventative services through elimination of cost sharing. Law makers certainly had justification for targeting these aspects of the US care system. It was estimated by HHS that in 2009, 36 percent of Americans were denied health coverage by private individual insurers based on preexisting or family conditions. HHS went on to project that up to 129 million Americans could be denied healthcare coverage based on preexisting condition if reforms were not passed. When uninsured patients are treated at hospitals as part of pro bono requirements or emergency services, costs are eventually shifted onto insurance holders who must suffer the balancing measures. By taking action on preventative care, architects of the plan hope rising costs associated with treatment of the growing number of chronic disease cases will be curtailed. HHS estimates that 75 percent of healthcare expenditures are linked to chronic disease.  Treatments can bear more of a financial burden on the system when administered late in course or when provided by hospitals to those uninsured. By increasing the percentage of covered individuals, advocates of the new law hope that treatment of uninsured patients will decrease, while use of early chronic disease identification and prevention programs will increase. In both cases, costs associated with each respective aspect of healthcare should decrease. However, the landscape of health insurance coverage still remains convoluted and messy, and if one looks carefully, he can identify a number of loopholes and exemptions within this body of legislation which render solutions to the above mentioned problems almost useless.</p>
<p>The Georgetown University Center for Healthcare Reforms outlines provisions of the new healthcare law that prohibits private insurers from denying coverage to individuals with preexisting conditions, which do not take full effect until 2014. But, as Christine Monahan of The Georgetown University Center for Health Insurance Reforms notes, insurers can choose to push this date back another year if they alter their policies to end slightly before January 1. The act clearly stipulates that these reforms go into effect for policies beginning after New Year&#8217;s Day, so renewing insurance policies before the New Year would allow for private companies to maintain their existing policies until the end of 2014. The same problem could potentially apply to the dependent stipulation as well. The provision of the law requiring that all children be allowed to remain on plans as dependents until age 26 could be pushed back by insurers adjusting the renewal date. Additionally, both of the above mentioned provisions do not apply to grandfathered plans, meaning previously purchased policies will not have to observe these changes as outlined by the ACA. This could prove particularly problematic in striving to extend preventative service benefits. The ACA eliminates cost sharing for many basic preventative care services, but these new benefits could go unfelt by some individuals due to grandfathering and prolonging. </p>
<p>The small business employer stipulations come with a separate set of loopholes to worry about which can identified by simply reading the provision. Under the ACA, there is no actual requirement that small businesses—defined as 100 or fewer workers—provide health benefits to employees. Instead, the act puts forth a penalty of $2000 per uninsured employee. What’s more, employers can choose to bypass this effect entirely by choosing to administer self funded health plans. That is to say employers can elect to fund health benefits for employees with their own funds while stipulating a specific agreement of eligibility and coverage. Such plans are exempt from key aspects of the ACA and could prevent workers from acquiring many of the basic benefits needed to slow inefficient healthcare spending. Furthermore, these changes in policy only affect large businesses with over 50 employees. Those businesses with 50 or fewer workers are not stipulated to provide health coverage. Finally, employers of small business workers will not receive any penalties for choosing not to cover part time workers. Given this range of loopholes, it becomes easy for employers to avoid providing all or substantial amounts of coverage to workers—they can choose to employ fewer workers, more part time workers, or they can choose to self fund benefits altogether likely thereby diminishing the services available for coverage. </p>
<p>Loopholes like these, which can arise from political disagreement or simple legislative mechanisms, clearly undermine the influence of the law. As the ACA seeks to extend coverage, it faces off those who will attempt to exploit it at any and every chance. Indeed, it is perhaps safe to assume that any legislative attempt to institute reforms on a preexisting system will be vulnerable to loopholes. Subsequently it is still unclear to what level coverage will actually be extended primarily because we must wait and see to what extent the provisions are bypassed.</p>
<p>Extending coverage is just the tip of the iceberg with respect to needed health reforms, as inevitably loopholes will dilute positive effects. The fee-for-service nature of our healthcare payment system in general holds both the significant blame for and key to fixing the rise in US healthcare costs. When costs are based on the administration of individual services and not final products like actual health, it is easy to see how there is greater capacity for selective coverage and rate increase. Even those with basic forms of insurance coverage may find that certain essential services are not covered entirely or at all under their policies. According to a 2011 New York Times report on employer sponsored health plans, primary physician visits and in patient care were covered at rates of about 100 percent, but from there, coverage among these plans varied at lower rates. Only 91 percent of plans covered emergency room visits while only 85 covered outpatient mental health services. Organ and tissue transplants were covered for about 45 percent of the holders while services like sterilization, kidney dialysis, and diabetes management hovered between 26-27 percent. As Mitchell Rabkin of Harvard Medical School points out, until our fee-for-service system is remedied, we can expect no major changes in the trend of costs or, as some may add, coverage. One can easily see how even activation of specifically targeted reforms can be undermined by a complicated fabric of loopholes. If change in healthcare security and cost is truly wished, it is clear that more creative and fundamental restructuring is needed. For where loopholes are found to exist, they will certainly be exploited by those with power and resources. </p>
<p><em>Charles Baker is a freshman in Pierson College.</em></p>
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		<title>Dr. Average Joe: Self-medicating in the United States</title>
		<link>http://www.yalemedlaw.com/2013/04/dr-average-joe-self-medicating-in-the-united-states/</link>
		<comments>http://www.yalemedlaw.com/2013/04/dr-average-joe-self-medicating-in-the-united-states/#comments</comments>
		<pubDate>Wed, 17 Apr 2013 04:53:12 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Pharmaceuticals]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1811</guid>
		<description><![CDATA[In March of 2012, the U.S. Food and Drug Administration (FDA) began to explore the possibility of increasing the number of available over-the-counter (OTC) drugs, though no conclusion has been made regarding this topic. The people we once called patients, but should now more appropriately call consumers, will have access to a large numbers of drugs that previously required a prescription. ]]></description>
				<content:encoded><![CDATA[<p><a href="http://www.yalemedlaw.com/wp-content/uploads/2013/04/Prescription-Bottle.jpg" rel="lightbox[1811]"><img src="http://www.yalemedlaw.com/wp-content/uploads/2013/04/Prescription-Bottle-300x225.jpg" alt="Prescription Bottle" width="300" height="225" class="alignleft size-medium wp-image-1848" /></a>In March of 2012, the U.S. Food and Drug Administration (FDA) began to explore the possibility of increasing the number of available over-the-counter (OTC) drugs, though no conclusion has been made regarding this topic. The people we once called patients, but should now more appropriately call consumers, will have access to a large numbers of drugs that previously required a prescription. This significant change may decrease patient illness and disease, as consumers will have easy access to more medications. However, the potential dangers of this situation, such as adverse drug reactions, over-medication, and misdiagnosis, must be carefully considered. </p>
<p>If consumers are able to access more drugs more easily, this may lead to improper or over consumption of drugs, as consumers are unfamiliar with harmful drug interactions. Consumers are also uninformed about the proper treatments of even common illnesses, which often do not require drug treatment. For example, Dr. Ben Wedro, contributing author and editor for WebMD, explains that Ibuprofen could lead to stomach bleeding and should not be used by patients who are taking blood thinners. </p>
<p>Conversely, patients may under-medicate themselves by mistaking a serious illness for an insignificant affliction. Dr. Wedro cites the example of attributing symptoms such as wheezing to a simple case of asthma instead of congestive heart failure. It is easy to see that simply picking up the wrong box of pills, or misdiagnosing a symptom could be fatal. Unfortunately, it is also not difficult to imagine the frequent occurrence of such scenarios.</p>
<p>A study by Grant et al., which investigated the use of a system to self-monitor and self-treat high blood pressure, may give some indication of how a system of self-medication would be manifested. The National Center for Biotechnology Information (NCBI) defines self-medication as “the selection and use of medicines by individuals (or a member of the individuals’ family) to treat self-recognized or self-diagnosed conditions or symptoms.” Patients involved in the study by Grant et al. monitored and evaluated their own blood pressure at home using an automatic blood pressure cuff and an online IT-supported evaluation tool. Participants would then increase or decrease medication dosage as dictated by a predetermined scale developed for each patient by his or her doctor. Here it is important to note that patients were not completely autonomous in deciding treatment plans in this study. In many situations, this would not be the case if the FDA were to increase the number of available OTC drugs.</p>
<p>In the study by Grant et al., patients reported feeling more engaged in their treatment, with one patient stating that the system would “help me to take more responsibility for myself.” Patients also reported feeling more motivated to maintain their health, as they were more involved in tracking their progress. These are positive results that may increase health nation-wide. </p>
<p>However, patients also reported the following concerns: “variability of individual blood pressure readings, difficulty in correctly following a pathway, [and] concern about medication side effect.” These are all very real hesitations that could certainly be present in the FDA-proposed system of increased self-medication. If such concerns arose in the joint patient-and-physician-monitored program studied by Grant et al., these problems, and others, will undoubtedly be present in an even more patient driven system as well. </p>
<p>Intermediate programs, such as the one studied by Grant et al., may be helpful in making the FDA’s proposal successful. According to reporter Cal Woodward of the Canadian Medical Association Journal, the FDA intends to install pharmacy kiosks and online evaluation tools to either guide consumers to the right medication, or to suggest a visit with a physician. Dr. Wedro writes that the American Pharmacists Association agrees that pharmacists “are available to take the front line in screening patients, making diagnoses, and providing medication.” These will all be useful tools for consumers. </p>
<p>The FDA has also made attempts to ease the process of what they call “Self-Care” by providing information and warnings to consider when choosing an OTC medication. However, the advice they offer in itself gives great insight into the potential problems of this system. Some advice is valid, such as considering pediatric versus adult dosages, and paying attention to not only prescription and OTC drug interactions, but also food and drug interactions. However, other suggestions, such as “always use enough light” and “use your glasses or contact lenses” when reading drug labels, raise concern. Can consumers be trusted to accurately self-medicate, if they cannot remember to wear the glasses they need to read?</p>
<p>Despite these significant concerns and challenges, the Self-Care system may improve the health of Americans. Those who feel they do not have the time, money, or means of receiving professional medical care would be able to receive treatment. According to Woodward, the FDA is considering proposals for OTC diabetes, asthma, hypertension, migraine, and illicit drug overdose drugs. In some cases, these OTC medication may be at least temporarily sufficient, but the consumer would not receive any long-term treatments that a doctor might provide such as disease education or advice regarding lifestyle changes. In the long term, this may actually increase the prevalence or severity of disease. </p>
<p>For example, taking medication to counteract the effects of an illicit drug overdose may indeed be life saving, but the accessibility of this treatment may perpetuate the harmful behavior. Another example is the OTC morning-after pill, an emergency contraceptive that may prevent pregnancy after unprotected sex. Though there are benefits to having this drug easily available, does the accessibility promote unprotected, unsafe sex habits? If so, the prevalence of sexually transmitted diseases may increase. In addition, Woodward points out that eliminating the need for a prescription for certain drugs may be dangerous as physicians will not be able to monitor the progression of a disease, or identify a need to change the dosage of a medication.</p>
<p>Compensation will, of course, also be a factor. As Woodward wrote, many insurance companies cover the cost of prescription medications, but do not reimburse for OTC drugs. Thus, Self-Care would result in high costs for the consumer, but would reduce costs for primary care practices. Woodward believes this element makes the Self-Care system appealing to politicians and healthcare administrators.</p>
<p>Though the sentiment behind Self-Care is valid, the system raises many concerns. Self-medication by selection of OTC drugs may be sufficient for simple colds, or seasonal allergies, but in the maintenance of chronic diseases, the medical professional’s critical eye is necessary to monitor changes and make medication adjustment as necessary. Increasing the number of available OTC drugs may in fact lead to more illness, as consumers do not possess medical knowledge of adverse drug interactions or of the symptoms of serious diseases. Though the Self-Care system is feasible, many precautions must be taken to create a successful program.</p>
<p><em>Lesya Chopivsky is a sophomore in Branford College majoring in American Studies.</em></p>
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		<title>The ENCODE Project and Understanding the Human Genome</title>
		<link>http://www.yalemedlaw.com/2013/03/the-encode-project-and-understanding-the-human-genome/</link>
		<comments>http://www.yalemedlaw.com/2013/03/the-encode-project-and-understanding-the-human-genome/#comments</comments>
		<pubDate>Wed, 06 Mar 2013 01:54:29 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Health Policy]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1797</guid>
		<description><![CDATA[In the quest to discover why we are the way we are, the human genome may be the key.  It consists of the complete set of human genetic information—over three billion nucleotides of DNA for 23 chromosomes.  If we can understand this vast amount of information, we can then better our understanding of human biology, evolution, inheritance, disease, biotechnology, and medicine.  And that is only the beginning.]]></description>
				<content:encoded><![CDATA[<p>In the quest to discover why we are the way we are, the human genome may be the key.  It consists of the complete set of human genetic information—over three billion nucleotides of DNA for 23 chromosomes.  If we can understand this vast amount of information, we can then better our understanding of human biology, evolution, inheritance, disease, biotechnology, and medicine.  And that is only the beginning.</p>
<p>However, making sense of the human genome is no small task.  The first step was to sequence all 3.3 billion base pairs that make up the genome—a sequence long enough to fill about 3300 books of 1000 pages each.  Yet the Human Genome Project (HGP) succeeded in doing just that.  A collaborative international endeavor began in 1990, and the project published its final sequence in April 2003, providing the world with the first complete human genome.  Since then, the genomes of many other individuals have also been sequenced.</p>
<p>The Human Genome Project told us what the human genome is, but that still left much unexplained.  It is one thing to have the set of instructions for the human body, but it is another to be able to read them.  That is where the ENCODE project came in.  The Encyclopedia of DNA Elements (ENCODE) was another large collaborative project launched in 2003 by the National Human Genome Research Institute, which had also overseen HGP.  While the Human Genome Project mapped out our DNA, ENCODE aimed to identify all the functional elements in the genome, pinpoint their location and explain what they do.</p>
<p>ENCODE’s initial results were published in September 2012 in a set of 30 papers published in <i>Nature, Genome Biology</i>, and <i>Genome Research</i>.</p>
<p>Perhaps its most important finding is that what many had thought of as “junk DNA” is not junk at all.  It was known that only 1.5% of the genome actually coded for proteins, and it was unclear what purpose, if any, the non-coding majority of our DNA performed.  While researchers did find functions for some portions of the non-coding DNA, many maintained that much of the remaining 98.5% of the genome was in fact junk.  But ENCODE’s analysis has shown that at least 80% of the genome has a “biochemical function.”  Outside of the protein-coding 1.5%, functional parts of the genome include those that act as “switches” (sites where proteins could stick to DNA, most likely to switch a gene on or off), parts are read and transcribed into RNA molecules, others act as promoters (controlling whether or not other sections are transcribed), while others are enhancers (regulating the expression of more distant genes), amongst other things.</p>
<p>Some researchers are hopeful that the 80% figure will move closer to 100%.  ENCODE analyzed 147 types of cells, but there are thousands in the human body.  It is possible that portions of genome are functional in some types of cells, but not others.  Further analysis may unveil purposes for the remaining 20% of the genome.</p>
<p>Other scientists, however, are critical of ENCODE’s definition of functional, claiming that it is too loose to be meaningful and that just because a part of the genome can be implicated in a role does not mean it is necessary and not “junk.”</p>
<p>But ENCODE is still an ongoing project. As more data emerges, we will gain a clearer picture of how our genome works.</p>
<p>The information that ENCODE has provided, and will continue to provide, is of great importance to many fields of study.  For example, it will be key in the study of regulatory evolution (evolutionary change through proteins involved in gene regulation rather than direct changes in the protein-coding sequence), as the project has provided some of the first information on which genomic regions have regulatory activity.  And of course many hope a deeper understanding of the human genome will lead to better understanding of human disease and effective medicine.</p>
<p>Comprehensive research of the human genome is still relatively young, and we can be sure our understanding of our genetic material will expand dramatically as the years go on and further study is carried out.  Ambitious projects like the Human Genome Project and the Encyclopedia of DNA Elements have made important steps toward more complete knowledge of how our genes make us who we are.</p>
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		<title>mHealth: Healthcare Goes Mobile</title>
		<link>http://www.yalemedlaw.com/2013/02/mhealth-healthcare-goes-mobile/</link>
		<comments>http://www.yalemedlaw.com/2013/02/mhealth-healthcare-goes-mobile/#comments</comments>
		<pubDate>Fri, 22 Feb 2013 05:25:43 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Healthcare Economics and Management]]></category>
		<category><![CDATA[mhealth]]></category>
		<category><![CDATA[mobile]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1767</guid>
		<description><![CDATA[Recent efforts at healthcare reform within the public and private sectors have expanded coverage and access to treatment to millions more Americans than ever before. Despite those ongoing efforts, however, the system remains overtaxed and underequipped in virtually every way.]]></description>
				<content:encoded><![CDATA[<p><a href="http://www.yalemedlaw.com/wp-content/uploads/2013/02/mHealth.jpg" rel="lightbox[1767]"><img class="alignleft size-medium wp-image-1768" alt="mHealth" src="http://www.yalemedlaw.com/wp-content/uploads/2013/02/mHealth-300x199.jpg" width="300" height="199" /></a>Recent efforts at healthcare reform within the public and private sectors have expanded coverage and access to treatment to millions more Americans than ever before. Despite those ongoing efforts, however, the system remains overtaxed and underequipped in virtually every way. One person dies every six minutes from an infection developed after being hospitalized. Approximately $100 billion is spent annually on avoidable hospitalizations due to medication non-adherence. Estimates reveal that there will be a shortage of tens of thousands of physicians by 2020 due to the aging physician population, and hospitals face enormous Medicare deductibles due to high rates of readmission within thirty days – it is predicted that $280 million will be spent in 2013 due to readmissions resulting from heart attack, heart failure and pneumonia alone. In light of these ominous signs, numerous innovations are being developed to cope with the impending crisis in healthcare.</p>
<p>One of the most promising innovations aimed at increasing the efficiency of our healthcare system is Mobile Health, or “mHealth.” mHealth takes advantage of today’s technology-oriented society to create tech-based and user-friendly solutions to basic healthcare. According to PointClear Solutions, 80% of patients gather information regarding healthcare online, 80% of physicians have an iPhone and 30% use iPads for clinical purposes and more than 50% of mobile phone users in the US are smartphone users. Over 7,500 healthcare-related apps exist on iTunes, an increase of some 400% over the past three years, most of which are free, and supported by accompanying devices costing on average $100. An estimated 2.2 million patients worldwide use home-based remote monitoring devices. Those devices with cellular connectivity increased from 420,000 to 570,000 between 2010 and 2011 and are expected to reach 2.47 million by 2016, part of a market for home health monitoring worth an estimated $10 billion in 2010.</p>
<p>The classification “mHealth” refers to a plethora of new technologies aimed at advancing the current state of healthcare. One such technology that has dramatically improved the efficiency of health information exchange (HIE) is the Electronic Health Record (EHR). EHRs allow physicians easier access to patient information and can ultimately lead to the development of cognitive support for physicians made possible by the compilation of a large quantity of EHRs within a system of HIE. This system stores and transmits clinical and financial information, compiles this data to identify trends in utilization, cost and intensity of care, uses these trends to inform physicians on how to improve care coordination and decision-making at the point of care and finally facilitates the development of comprehensive and integrated solutions for population-based health. In other words, rather than having to read through a large quantity of files for each consult, physicians could consult an EHR that would provide an overview of the patient’s history, at-a-glance health information, figures, trend analysis and clinical support.</p>
<p>Another major innovation in mHealth technology is the development of smartphone apps geared towards health. Mobile apps cover a broad spectrum of applications in healthcare, including treatment management, medication adherence, patient education, care coordination and patient-physician communication. mHealth apps that allow patients to manage their health include DiabetesManager, iHealth blood pressure cuffs, wifi weight scales, Sanofi’s iBGStar/Telcare BGM for blood-glucose monitoring, Asthmapolis for tracking time, location and frequency of inhaler use, AliveCor’s iPhone ECG case and wrist-worn sensors to track emotional states. mHealth apps for medication adherence include those for medication reminders and those that promote ease of prescription filling at the pharmacy. One app developer, Leap of Faith Technologies, recently was awarded a grant of more than $1 million for its eMedonline app platform that showed a 98% patient adherence in clinical studies. Patient education apps include Blausan Human Atlas and Orca Health’s EyeDecide, which allow patients to access information to make informed health-related decisions. Apps that allow for improved care coordination include Aetna’s iTriage, which provides information regarding ER wait times, CareNow Web Check-In and the CVS MinuteClinic iPhone app, which provide information regarding the nearest retail clinics and appointment scheduling, and JiffPad, which allows for recording of treatment plans. Finally, mHealth apps that foster patient physician communication include Apple Wellness’s virtual doctor visits, Aycan’s Mobile Teleradiology for remote access to MRI/CT Scans and consequent diagnosis and apps allowing for remote patient monitoring.</p>
<p>According to MedApps, a mobile health monitoring corporation, “the exam room of the future will be wherever the patient is located,” and benefits of mHealth include reducing the need for in-office visits, enabling fewer physicians to provide coordinated and informed healthcare to a larger patient population, reducing hospitalizations and readmissions, increasing patient compliance to medications and treatment plans and eliminating unnecessary transport. The eHealth Initiative estimates that the implementation of EHRs would eliminate more than two million adverse drug effects, reduce over 190,000 unnecessary hospitalizations each year and reduce medication-processing time by 68% and problems with medication orders by 58%. On a more general level, EHRs would allow for the identification of gaps in healthcare and the subsequent development of more efficient and more standardized care models. In today’s system, patients often have to fill out the same paperwork each time they visit a physician’s office. EHRs would make this information accessible to all physicians, thereby saving time otherwise lost to redundant data entry and retrieval.</p>
<p>Undoubtedly the most important benefit of the implementation of mHealth initiatives is the accompanying increase in productivity and decrease in the cost of healthcare. The use of mHealth systems allows for a proactive rather than reactive approach toward healthcare through developments such as remote patient monitoring, enabling physicians to intervene before a patient’s condition worsens. Further, implementation of mHealth technologies reduces time spent out of work in doctors’ offices and sick time in general, allowing for further increases in productivity. An obvious parallel to this cost-productivity phenomenon presented by the mHealth initiative is that of one approach to addressing today’s obesity epidemic, which proposes a leveling of the cost of healthier foods with that of fatty “fast foods”, whose low cost and easy accessibility has made them standard fare for many Americans. In today’s healthcare system, a large number of hospitalizations arise from non-adherence resulting from lack of time or money to visit a doctor. Reducing the cost (both in dollars and time) of healthcare can help increase health quality. Such is the goal of the Accountable Care Organization (ACO), a revolutionary healthcare model based upon outcomes-based reimbursements that arose from the Patient Protection and Affordable Care Act of 2010. ACOs promote a shift from volume-based care to value-based care, and as the implementation of mHealth technologies would greatly foster positive outcomes and reduce the cost of healthcare, the movement of ACOs from the pilot stage to reality could facilitate the adoption of mHealth technologies.</p>
<p>While ACOs remain in the pilot stage, the implementation mHealth technologies is impeded. The Center for Medicare and Medicaid Service (CMS) currently follows a fee-for-service model that puts forth Current Procedural Terminology (CPT) codes that require physicians to see patients in-office in order to be reimbursed. mHealth technologies decrease rates of readmission and the need for in-office visits for follow-ups or minor ailments. While on the surface these appear to be major benefits of mHealth, these benefits lead to decreased reimbursements for physicians under the fee-for-service model. Until the CMS realigns the CPT codes, physicians will be dissuaded from adopting mHealth technologies and therefore their implementation is economically disfavored.</p>
<p>Another major obstacle to the implementation of mHealth technologies is the need for FDA approval. In order to be approved, mHealth technologies must undergo extensive amounts of 60601 testing to assure security and dependability. Many mHealth critics argue that it is difficult to verify the security of data stored as EHRs, and as EHRs date back only to the American Reinvestment and Recovery Act (ARRA) of 2009, their coordination in terms of data exchange is relatively underdeveloped. Multiple corporations have developed their own EHR systems, such as Microsoft HealthVault, Google Health, EPIC and Allscript, and until the FDA can adopt a single system of Wireless Medical Interoperability allowing medical devices to pair on a common protocol and exchange data seamlessly, the security of EHRs will remain in question.</p>
<p>Finally, there is the question of ethics in the implementation of mHealth technologies. By current definitions, most mHealth technologies require access to some form of satellite connectivity – be it via smartphone, personal computer or public internet access. The question then becomes whether a person receiving healthcare via mHealth technologies should be cut-off from access to healthcare if he/she is no longer able to pay for telecom services. To avoid this ethical concern, certain mHealth technologies would have to be federally subsidized, which introduces a further economic factor into the equation of mHealth implementation.</p>
<p>Ultimately, the implementation of mHealth innovative solutions has great potential to advance healthcare reform. While there are myriad obstacles, legislative initiatives, including the Federal Communication Commission’s National Broadband Plan, the HITECH (Health Information Technology for Economic and Clinical Health) Act and the Beacon Community Grants, exist to enable the realization of said reform. The current healthcare system in America is not equipped to handle the challenges posed by the influx of healthcare recipients due to the aging population, chronic disease epidemic and increased coverage. Advancements therefore must be developed and implemented to mirror these trends in healthcare. PointClear Solutions identifies six major trends that reflect the increased demand for “usability” – the measure of effectiveness, efficiency and satisfaction of the user – of healthcare: increased adoption of EHRs, increased level of patient engagement, mHealth becoming mainstream, movement towards accountable care, rise of retail health clinics and increased availability of care-at-home solutions. mHealth technology plays an important role in the development of these trends, and innovations in healthcare must incorporate mHealth solutions in order to meet modern popular healthcare demands.</p>
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		<title>Smartphones in Health Care</title>
		<link>http://www.yalemedlaw.com/2013/02/smartphones-in-health-care/</link>
		<comments>http://www.yalemedlaw.com/2013/02/smartphones-in-health-care/#comments</comments>
		<pubDate>Fri, 22 Feb 2013 05:09:29 +0000</pubDate>
		<dc:creator>YJML</dc:creator>
				<category><![CDATA[Healthcare Economics and Management]]></category>
		<category><![CDATA[smartphones]]></category>

		<guid isPermaLink="false">http://www.yalemedlaw.com/?p=1764</guid>
		<description><![CDATA[Cell phones are fully integrated into American society, and the medical field has not escaped the craze. Though there are advantages and disadvantages to the use of cellphones in medical care, more and more the argument seems to have shifted from “is cellphone technology good for healthcare” to “what technology is best for healthcare.”]]></description>
				<content:encoded><![CDATA[<p><a href="http://www.yalemedlaw.com/wp-content/uploads/2013/02/smartphone-health.jpg" rel="lightbox[1764]"><img class="alignleft size-medium wp-image-1765" alt="Smartphone" src="http://www.yalemedlaw.com/wp-content/uploads/2013/02/smartphone-health-300x300.jpg" width="300" height="300" /></a>Cell phones are fully integrated into American society, and the medical field has not escaped the craze. Though there are advantages and disadvantages to the use of cellphones in medical care, more and more the argument seems to have shifted from “<i>is</i> cellphone technology good for healthcare” to “what technology is <i>best</i> for healthcare.” According to a study by <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3329206/">Putzer and Park</a>, “in 2010, 50 percent of physicians were using smartphones or PDAs on a regular basis in clinical decision making.” As more advanced applications and devices are introduced, clinical providers identify the pros and cons of said advancements. However, despite flaws, and perhaps because of overwhelming benefits, cellphone use in the clinical setting is here to stay.</p>
<p>Cellphones have proven a positive contribution to the healthcare field in the areas of communication, efficiency, and care. In response to the fact that poor communication has been identified as a source of inefficiency and error in the healthcare field, <a href="http://onlinelibrary.wiley.com/doi/10.1002/jhm.775/abstract">Wu et al.</a> designed a study in which nurses were instructed to contact senior residents via the smartphone that each resident was given instead of the traditional method of paging the resident. Based on post survey comments, the new communication system was a success in that it facilitated communication both between physicians and between physicians and other health care providers. Residents also commented that the new system allowed for mobility during communication, which they felt increased efficiency.</p>
<p><a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3329206/">Putzer and Park</a>’s study also found that smartphones may increase efficiency. The 103 survey responses these researchers received from primary care and specialty physicians indicated that a doctor would be more likely to incorporate a smartphone into patient care if the device matched with other technology in the hospital, and if the physician believed the device would improve patient care. Putzer and Park believe smartphones would indeed improve patient care, as the devices have applications that allow physicians to monitor clinical signs, obtain laboratory values, view diagnostic results, access research studies to aide physicians in making clinical decisions, and submit electronic prescriptions. Putzer and Park believe that these capabilities will also decrease medical error.</p>
<p>Despite the widespread incorporation of smartphones in healthcare settings, there are still concerns associated with these devices. For example, the physician responses in the study by <a href="http://onlinelibrary.wiley.com/doi/10.1002/jhm.775/abstract">Wu et al.</a> indicate that the frequent telephone calls were disruptive. The physician either had to interrupt his or her current task to answer the call, or take at least one minute to retrieve the voicemail later, as opposed to the few seconds it takes to read a text or numeric page. When nurses saw that physicians were not responding to information left in a voicemail message, they responded by calling physicians repeatedly, thus also contributing to high call volume. By making it easier to contact physicians via smartphone, high-volume call times were almost unmanageable.</p>
<p><a href="http://psycnet.apa.org/index.cfm?fa=search.displayRecord&amp;UID=2010-15733-014">Josephson and Salman</a>, in their study of the National Institutes of Health Stroke Scale (NIHSS) Scorer smartphone application, identified another smartphone flaw. They found that “it took roughly 20 [seconds] longer to perform and record the NIHSS on the iPhone than it took on paper.” This is another potential downfall of smartphones, but the researchers pointed out that speed may improve with practice. Josephson and Salman also presented a potential practical downside of extensive smartphone use when they asked whether iPhones and iPads could endure repeated decontamination in settings where cleanliness is essential.</p>
<p>Smartphones are quickly becoming an intrinsic part of health care in America not only for the ease of communication and increase in efficiency that they facilitate, but also for the countless application that are available for use on a smartphone. <a href="http://cid.oxfordjournals.org/content/47/1/117.short">Burdette, Herchline, and Oehler</a> have presented information on several such applications. For example, the Hopkins Antibiotic guide is currently available through Skyscape and allows physicians access to syndromes, pathogens, and antibiotic sections. The guide also has an “author opinion” section, where users can select medications for an infection and receive author feedback on the selected treatment.</p>
<p>According to Burdette, Herchline, and Oehler, drug databases are “perhaps the most commonly accessed medical software,” with Epocrates being perhaps the most popular. This database provides physicians with access to information about “dosing, adverse reactions, drug interactions, and basic pharmacologic information.” One especially attractive feature of Epocrates is the “multi-check,” which allows users to enter 2-30 drugs that are then scanned in the database to screen for drug interactions. Medical calculators, the Sanford Guide, and infectious disease podcasts are also available in electronic format.</p>
<p>Burdette, Herchline, and Oehler also point out that patient billing via smartphone could provide physicians with access to patient history at all times, which could be beneficial for future care of that patient.</p>
<p>Smartphone applications in a medical setting can also be extended to patient use, as Modani and Eldrasi explain. <i>Vitaphone</i>, for example, equips regular cellphones with sensors, which then collect electrocardiogram readings. With <i>Vitaphone</i>’s GPS capability, medical assistance can be provided to the patient if needed. <i>GlucoPhone </i>allows users to send blood sugar level data to an online medical database, with an option to send data to the user’s personal physician as well. Finally, Modani and Eldrasi point out that cellphones can be used to provide health information to youth. In 2006, the San Francisco Department of Public Health introduced SexInfo, “a free service that answers youth questions about sex through text messaging.” SexInfo also provides “contact numbers and location of local clinics.”</p>
<p>Despite the invaluable tools, resources, and communication abilities smartphones provide, legal considerations in particular must be addressed. As Putzer and Park suggested, the issue of personal versus hospital-issued smartphone devices must be considered. In addition,  “password protection and encryption to ensure compatibility and security of information” would be essential in securing private patient information stored on smartphones.</p>
<p>It is clear that smartphones have become well integrated into the healthcare field. These devices provide a wealth of information and resources to physicians, while also speeding communication and improving efficiency. While it is inevitable that smartphones will remain an essential part of health care, the concern that the quality of the patient – physician interaction will decline is just as enduring. Society must decide, then, is it better to give more care, more efficiently, to more people, even if it means sacrificing the personal side of medicine?</p>
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