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Consuming Risk Free Food & Beverages

Author: Debashree Chakrabarti, MSc., Biological Sciences, UMass Lowell (Expected May 2016)

Leading researchers and medical health professionals have raised their concern about the over all declining status of health and well being world wide. A rising trend in childhood obesity, cardiovascular diseases, clinical depression syndrome in young adults is reason enough to try and broaden the scope of plausible agents which result in people making bad health decisions.  As a witness to the emerging dietary trends adopted by children and young adults, it is natural to question the ethics of processed food and beverages industry. Does it seem reasonable the 2L bottles of soda cost $2 USD? There are more people claiming to not like water since it is flavorless. 100% fresh juices are subject to scrutiny for their lack of adequate fiber content and excess presence of sugars. Products with high fructose corn syrups, added preservatives in processed meat, ‘read to eat’ meals are agreeably cost effective and saves a lot of time, however the over riding damage is in the long run with deficient immune system and gain of unnatural toxins which the body finds hard to eliminate. Another marketing frenzy is visible in the neutraceuticals range of instant energy drinks, protein shakes and over the counter pills. The focus is towards having the visibly attractive, muscular body regardless of the compromised health. The companies do their bit of limiting the usage by adding a precaution statement and dosage remarks on the product labels. This is however not translated as useful information to the young consumers who do not foresee the detrimental outcomes in advance.

As the prices of insurance packages and medical aid is negotiated, the same effort needs invested in the regulation of consumer dietary products. We do not want a ban on Colas however, we do not also need them to be sold at prices cheaper than water. Fresh fruits and vegetables need not be price tagged astronomically driving population to adopt a risk driven lifestyle. Taking initiatives to promote urban farming and local gardens, reaching out to the people about their choices and how it impacts the global financial predicament is a need of the hour. We are ok with the attitude of “Don’t tell me how to live my life” in a world relying heavily on subsidized medicines. This has to change. Subsidized medicine is a privilege and should be benefited to those responsible. Researchers and big pharma companies are not the only stake holders in this fight against an exponentially growing illness of misinformed decisions. People need to be brought in and educated. This includes strong arming anyone who feels they have a right to abuse their health or the health of the world.

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Another paradigm to this discussion is the need for more extensive research hubs world wide and making the accessibility of advanced medicines available to the dense population regions in Asia, Africa and Middle East Arab countries which host the majority of the population and have the least of the resources. We need 100 Massachusetts world wide with cutting edge researchers deep diving and venture capitalists backing them up. A vision for 2050 must encompass every individual being aware of what it takes to damage a human body which is a very robust machine. Eating right and being able to afford health must not be difficult. Choices available in the stores must be rational to the level where the most ignorant of the lot is still consuming risk free substances. Given the fantastic evolutionary armaments we have, it takes a lot to be unwell and yet we seem to making it fairly easy to catch cold. Healthy people translate to healthy economy.

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Poverty and the American Dream

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

 

Brookings Institute: Poverty Report

http://www.brookings.edu/~/media/Research/Files/Reports/2015/12/aei-brookings-poverty-report/Chapter-1.pdf

Chapter 1:

Introduction

In 1931, the writer James Truslow Adams coined the term “The American Dream.” His definition holds up well today. The dream, he said, is of a land in which: life should be better and richer and fuller for everyone, with opportunity for each according to ability or achievement. It is a difficult dream for the European upper classes to interpret adequately, and too many of us ourselves have grown weary and mistrustful of it. It is not a dream of motor cars and high wages merely, but a dream of social order in which each man and each woman shall be able to attain to the fullest stature of which they are … capable, and be recognized by others for what they are, regardless of the fortuitous circumstances of birth or position.1

Today, many Americans fear that our country is no longer a land of opportunity. Although social mobility overall seems not to have decreased in recent decades,2 there is evidence that it is lower in America than in many other advanced economies.3 Scholars on both the left and the right are also increasingly worried that children growing up today in lower-income families have fewer social supports and pathways into the middle class than in past generations. As Robert Putnam showed in his recent book Our Kids, 4 children from wellto-do families today enjoy more material, emotional, and educational support than ever before, but children from low-income families often grow up in homes, schools, and communities that are in disarray. Charles Murray reached similar conclusions in Coming Apart. 5

The trends aren’t entirely bleak, and poor children today are better off in several ways than they were a few decades ago. They have better access to healthcare, fewer of them are born to teen mothers, their parents have more education, they are exposed to fewer environmental toxins and violence, and fewer live in foster care. We should celebrate these advances. But the circumstances and outcomes of upper-income children have improved even more rapidly, leading to ever-widening inequality in the human and financial resources that boost child development. And on a few important factors, such as family stability, the circumstances of poor children have gotten worse.

The reasons for the increasing gaps between childhoods in different social classes are many and intertwined, including: the loss of manufacturing jobs, stagnating wages for workers without a college degree, labor-saving technological changes, changing relationships between workers and management, the increasing importance of education and training in a post-industrial economy, a less energetic civil society, high rates of incarceration, weaker attachment to the labor force among less-educated men, and the rising prevalence of single-parent families among the less-educated.

The poor prospects for children born into poor families are an urgent national concern. This state of affairs contradicts our country’s founding ideals. It weakens the promise that inspired so many immigrants to uproot themselves from everything familiar to seek freedom, self-determination, and better lives for their children in America. It holds particularly grave implications for the well being of blacks and for the future of racial equality so courageously fought for over the course of generations.

At its best, the American credo of freedom and individual initiative has been uniquely able to unleash the energy and imagination of its citizens, inspiring them, as Adams put it, “to attain to the fullest stature of which they are capable.”6 For many American families—including many low-income families—that dream is still possible. But large numbers of children live in disadvantaged and often chaotic homes and communities, attend schools that don’t prepare them to navigate an increasingly complex economy, and have parents (often a single parent) who work in low-wage jobs with variable and uncertain hours. The massive waste and loss of this human potential costs the United States in economic terms, and it is a tragedy in human terms. Most Americans would agree that we can do better.

The political difficulty arises when we turn to solutions. Most new ideas for helping the poor are controversial and expensive, and when one political party offers a proposal, the other party usually disagrees with its premises or specifics. The parties often have deep philosophical differences, but research also shows that the mere fact that one party proposes an idea can motivate partisans on the other side to dismiss it.7 And yet, points of agreement are emerging that could serve as a foundation for consensus. Most Americans and their political representatives tend to agree on several key points.

  1. First, for able-bodied Americans, it is far better to earn money than to depend on public assistance, although economic conditions sometimes prevent people from becoming self-sufficient.
  2. Second, children are on average better off growing up with two parents committed to each other for the long term, an arrangement most likely to occur within the context of marriage.
  3. And third, our schools don’t adequately prepare the young for the economic and social environment in which they must make their way.

THE AEI-BROOKINGS WORKING GROUP

Our report has three distinctive features.

  1. the diversity of our perspectives and experiences.    We share an intense belief that poverty and opportunity are profoundly consequential and that our nation’s future prosperity and our common humanity compel us to work together to find credible strategies to reduce poverty and increase economic mobility.
  2. we consider three major domains of life simultaneously: family, work, and education.    they are highly interconnected. Improving family stability helps children succeed in school; improving the fit between schools and jobs helps teenagers transition into the labor force; when young people can find work that pays well, they create more stable families, and the cycle continues.
  3. it is grounded in values—the three broadly shared American values of opportunity, responsibility, and security. Focusing on these shared values has made it easier for us to work together and find many points of agreement.

OPPORTUNITY The concept of “opportunity” draws nearly universal support among Americans, and it’s the core concept of the American Dream. We endorse Truslow Adams’ definition of opportunity as the state of affairs when “each man and each woman shall be able to attain to the fullest stature of which they are capable,” regardless of the circumstances of their birth.8

RESPONSIBILITY America is a free society, but freedom comes with responsibilities. Responsibility is the state of being accountable for things over which one has control, or has a duty of care. Family life is a network of mutual responsibilities. So is work life. So is democratic citizenship.

The values of responsibility and opportunity are closely linked in the American mind. We can see the link in a line from President Clinton’s 1993 Labor Day speech that has had bipartisan resonance: We’ll think of the faith of our parents that was instilled in us here in America, the idea that if you work hard and play by the rules, you’ll be rewarded with a good life for yourself and a better chance for your children.10 The converse of this assertion is that if you fail to be responsible—if you don’t work hard or don’t play by the rules, then you aren’t entitled to a reward. These linked values of responsibility and opportunity were the linchpins of the bipartisan welfare reform law of 1996—whose official name included both “Personal Responsibility” and “Opportunity.”11

SECURITY Despite our best efforts to care for ourselves, we all know that life sometimes resembles a lottery.   The central idea of insurance is that we are all better off pooling some of the risks of life, and hoping that we never get to recover our insurance premiums.

Friedrich Hayek, an economist who was wary of collectivism in most forms and who is widely admired by conservatives, endorsed the value of security in 1944 in this famous passage from The Road to Serfdom: There is no reason why, in a society which has reached the general level of wealth ours has . . . should not be guaranteed to all . . . some minimum of food, shelter and clothing, sufficient to preserve health. Nor is there any reason why the state should not help to organize a comprehensive system of social insurance in providing for those common hazards of life against which few can make adequate provision.12

Several decades of research show that increasing security for children can better prepare them to break the cycle of poverty and grow up to be more responsible adults. A child’s brain is highly malleable. In the early years, when it is growing rapidly, the young brain responds to cues about the kind of environment that surrounds it. When children are raised in a chaotic and unpredictable environment, they become more attracted to immediate rewards, rather than larger but more distant rewards.13   Although children have great resilience and the capacity to overcome their early environment, some children—especially if they don’t have the benefit of interventions that reduce the stress to which they are exposed—are overwhelmed by early stress and trauma and suffer permanent damage.16

Conversely, when children are raised in more stable and predictable environments, they are more likely to learn that it pays to defer gratification and reap larger rewards in the future. Low stress, high predictability, and strong, stable relationships with caring adults all help children become measurably better at self-regulating, delaying gratification, and controlling their impulses.17 If we want adult citizens who can exercise responsibility, we should do as much as we can to improve the security of childhood, especially among the poor.

These three values guide the rest of our report. We offer a comprehensive plan for reducing poverty and promoting economic opportunity in the United States. In each chapter, we evaluate the best evidence about current approaches and then recommend policies that will increase opportunity, encourage people to take greater responsibility for their own lives, and increase security, especially among lower-income Americans and their children.

In the final chapter, we summarize our recommendations and suggest how the nation can pay for the policies we propose. We also lay out a path by which our recommendations might be carried out, evaluated, and improved, despite America’s political polarization. We have negotiated and compromised to create a plan that we believe is the best way forward. We are all enthusiastic about the final product because we believe it will reduce poverty and increase opportunity in America.

 

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Ebola therapy breakthrough

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Updated 11/23/2015

Giant Molecules Inhibit Ebola Infection

Nov 11, 2015   http://www.technologynetworks.com/medchem/news.aspx?ID=185080

European researchers have designed a “giant” molecule formed by thirteen fullerenes covered by carbohydrates which, by blocking this receptor, are able to inhibit the cell infection by an artificial ebola virus model.

 

Different studies have demonstrated that the ebola virus infection process starts when the virus reaches the cellular DC-SIGN receptor to infect the dendritic cells (of the immune system).

In this study researchers from the Universidad Complutense de Madrid/IMDEA-Nanociencia, the Instituto de Investigación Sanitaria Hospital 12 de Octubre (Madrid), and the Instituto de Investigaciones Químicas del CSIC-Universidad de Sevilla have collaborated, together with three european research groups (CNRS/Université de Strasbourg, France and Université de Namur, Belgium).

“Fullerenes are hollow cages exclusively formed by carbon atoms”, explains Nazario Martín, Professor of Organic Chemistry in the UCM and main author of the study. In this work, scientists have employed C60 fullerene, which is formed by 60 carbon atoms and has the shape of a truncated icosahedron, which resembles a football ball.

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These molecules decorated with specific carbohydrates (sugars) present affinity by the receptor used as an entry point to infect the cell and act blocking it, thus inhibiting the infection.

Researchers employed an artificial ebola virus by expressing one of its proteins, envelope protein GP1, responsible of its entry in the cells. In a model in vitro, this protein is covering a false virus, which is able of cell infection but not of replication.

“We have employed a cell model previously described in our lab which consists in a cell line of human lymphocytes expressing DC-SIGN receptor, which facilitates the entry of the virus in Dendritic Cells”, points out Rafael Delgado, researcher of the Hospital 12 de Octubre, and other of the authors of the study.

By blocking this receptor and inhibiting the virus infection, the authors think that the dissemination of the virus would decrease and the immune response increase, but this idea has still to be developed with in vivo studies.

The biggest fullerene system in the lab

The system designed by the chemists, based on carbon nanostructures developed in the UCM, mimic the presentation of carbohydrates surrounding virus like ebola or VIH.

The team has achieved an unprecedented success in fullerene chemistry and dendritic growth: connecting in one synthetic step twelve fullerene units, each with ten sugars, to other central fullerene, creating a globular superstructure with 120 sugar moieties on its surface, “this is the fastest dendrimeric growth developed in a laboratory up to now” says Beatriz Illescas, Professor in the UCM and coauthor of the work.

According to scientists, the results highlight the potential of these giant molecules as antiviral agents. “This work open the door to the design and preparation of new systems to inhibit the pathogens infection in cases where the current therapies are not effective or are inexistent, as occurs with the ebola virus”, clarifies Martín.

After these experiments on the cellular level, researchers will study the behavior of these systems in animal models, starting with mice. “We will study, on the one hand, the pharmacokinetics and, on the other, the antiviral activity in vivo” explains Javier Rojo, researcher of the Instituto de Investigaciones Químicas del CSIC and other of the authors of the study. Once the most effective compound has been identified, studies using the true ebola virus could be carried out.

 

 

http://www.sciencedirect.com/science/article/pii/S0092867400806935

DCSIGN, which is abundantly expressed by DC both in vitro and in vivo, … Whereas ICAM-3 binding by monocytes is for the greater part LFA-1 … The specificity of this adhesion receptor on DC for ICAM-3 is demonstrated by the ….

 

http://www.bloodjournal.org/content/100/5/1780.full.pdf

This subset coexpresses CD14, CD16, and CD33 and is thus of myeloid origin. In contrast to. CD14 monocytes, DCSIGN blood cells.

 

http://www.jimmunol.org/content/168/5/2118.full

Mar 1, 2002 Several receptors expressed by immature DCs belong to the C-type lectin superfamily, … Here, DCSIGN efficiently transmits the virus to T lymphocytes

 

http://journals.plos.org/plospathogens/article%3Fid%3D10.1371/journal.ppat.0020070

Jul 14, 2006 Although B cells that express DCSIGN do not replicate HIV-1, they serve as … receptors [12–15], with conflicting reports on expression of DCSIGN[16,17]. …..
human herpesvirus 8 infects DC and macrophages via DCSIGN …

 

http://www.jci.org/articles/view/25105/files/pdf

Results. The effect of human milk on direct HIV-1 infection of CD4+ T lymphocytesexpressing the DCSIGN receptor (Raji-DCSIGN) (8).

 

 

An indictment of Ebola response  

Panel calls for reform of global public health system in wake of epidemic

By B. D. Colen, Harvard Staff Writer

http://news.harvard.edu/gazette/story/2015/11/an-indictment-of-ebola-response/

 

http://media.news.harvard.edu/gazette/wp-content/uploads/2015/11/110515_Ebola_020_605.jpg

“The most egregious failure was by WHO in the delay in sounding the alarm,” said Harvard’s Ashish Jha.

An independent group of 19 international experts, convened by theHarvard Global Health Institute and the London School of Hygiene and Tropical Medicine (LSHTM), today issued a scathing analysis of the global response to the 2014-15 Ebola outbreak in West Africa.

The members of the Harvard-LSHTM Independent Panel on the Global Response to Ebola said that while the 2014-15 Ebola outbreak “engendered acts of understanding, courage, and solidarity,” it also caused “immense human suffering, fear and chaos, largely unchecked by high-level political leadership or reliable and rapid institutional responses.”

The report, published in the prestigious British medical journal The Lancet, is especially hard on the World Health Organization (WHO), which the panel contends failed to provide the leadership and support needed to deal properly with the outbreak of hemorrhagic fever that infected more than 28,000 people and claimed more than 11,000 lives.

The authors of the report, who were affiliated with, but functioned independently from, such disparate organizations as the Council on Foreign Relations, Médecins Sans Frontières, Indiana University law school, and theAIDS Health Care Foundation, reminded readers that the Ebola epidemic “brought national health systems to their knees, rolled back hard-won social and economic gains in a region recovering from civil wars, sparked worldwide panic, and cost at least several billion dollars in short-term control efforts and economic losses.”

“The most egregious failure was by WHO in the delay in sounding the alarm,” said Ashish Jha, director of the Harvard Global Health Institute, K.T. Li Professor of International Health at the Harvard T.H. Chan School of Public Health, and a professor of medicine at Harvard Medical School. “People at WHO were aware that there was an Ebola outbreak that was getting out of control by spring … and it took until August to declare a public health emergency … Those were precious months,” said Jha.

The panel was co-chaired by Professor Peter Piot, director of the LSHTM and co-discoverer of the Ebola virus. Piot said, “We need to strengthen core capacities in all countries to detect, report, and respond rapidly to small outbreaks, in order to prevent them from becoming large-scale emergencies. Major reform of national and global systems to respond to epidemics are not only feasible, but also essential so that we do not witness such depths of suffering, death, and social and economic havoc in future epidemics. The AIDS pandemic put global health on the world’s agenda. The Ebola crisis in West Africa should now be an equal game-changer for how the world prevents and responds to epidemics.”

Liberian Mosoka Fallah of Action Contre la Faim International and a member of the panel said, “The human misery and deaths from the Ebola epidemic in West Africa demand a team of independent thinkers to serve as a mirror of reflection on how and why the global response to the greatest Ebola calamity in human history was late, feeble, and uncoordinated. The threat of infectious disease anywhere is the threat of infectious disease everywhere. The world has become one big village.”

The global response to Ebola is being examined by a number of different panels, Jha said, including a group at WHO and another at the United Nations. During the height of the epidemic in fall, 2014, Jha met with Julio Frenk, then the dean of the Harvard Chan School, and Suerie Moon, research director and co-chair of the Harvard Kennedy School’s Forum on Global Governance for Health, and a Harvard Chan faculty member. Together, they “decided this deserves independent examination; we can’t let this happen again,” Jha said.

“The Ebola outbreak is a stark reminder of the fragility of health security in an interdependent word,” the report reads, “and of the importance of building a more robust global system to protect all people from such risks.

“A more humane, competent, and timely response to future outbreaks requires greater willingness to assist affected populations, and systematic investments to enable the global community to perform four key functions: strengthen core capacities within and among countries to prevent, detect, and respond to outbreaks when and where they occur; mobilize faster and more effective external assistance when countries are unable to prevent an outbreak from turning into a crisis alone; rapidly produce and widely share relevant knowledge, from community mobilization strategies to protective measures for health workers, from rapid diagnostic tools to vaccines; [and] provide stewardship over the whole system, entailing strong leadership, coordination, priority setting, and robust accountability from all involved actors.”

Though it pulls no punches in its criticism of the ways institutions and nations responded to the Ebola crisis, the Harvard-LSHTM report is also a positive document, offering 10 concrete recommendations to strengthen public health systems and future responses.

Those recommendations fall into four areas: preventing major disease outbreaks; responding to outbreaks; producing and sharing data, knowledge, and technologies; and improving the governance of the global health system, “with a focus on the World Health Organization.”

One recommendation is that WHO create a dedicated center “for outbreak response, with strong technical capacity, protected budget, and clear lines of accountability,” and that that center be governed by a separate board independent of the WHO bureaucracy.

“Our primary goal is to convince the high-level political leaders, north and south, to seize the moment to make necessary and enduring changes to better prepare for future outbreaks, while memories of the human health costs of inaction remain vivid and fresh,” the report said.

“There is a high risk here of not learning our lessons,” said Jha. “We’ve had outbreaks like this before, and often you get thoughtful reviews, and august bodies that look at it, and people say, ‘We will get to this right away,’ and then other things draw our attention. I think we owe it to the more than 11,000 people who died in West Africa to see that that doesn’t happen this time.”

 

The Lancet 2015

http://www.thelancet.com/campaigns/ebola

Ebola—lessons learned: Authors from Harvard’s Global Health Institute and the London School of Hygiene and Tropical Medicine outline 10 proposals to help prevent future health catastrophes, based on experiences from the 2014-15 Ebola outbreak in west Africa.

Timeline infographic

Illustration demonstrating pathogenesis of vascular leak in Ebola virus disease - Copyright: Elsevier
http://www.thelancet.com/pb/assets/raw/pb/assets/raw/lancet/campaigns/ebola/ebola-main-281114.jpg

The current outbreak of Ebola in west Africa is both a public health emergency of international concern and a human tragedy.

The Lancet Ebola Resource Centre contains all related resources from The Lancet family of journals offered with free access to assist health workers and researchers in their important work to bring this outbreak to a close a quickly as possible.

Find out more about Ebola in The Lancet’s Seminar.

 

WORLD REPORT
Expert panel slams WHO’s poor showing against Ebola
John Maurice
The Lancet, July 13, 2015;Vol. 386, No. 9990, e1

Criticism of WHO’s response to the west African Ebola crisis spawned an expert review that this week proposed several solutions to restore the agency’s performance. John Maurice reports.

WHO suffers from an incapacity “to deliver a full emergency public health response” against a severe epidemic. So concluded a panel of six international health experts in a damning report released on July 7. They prescribed 21 actions aimed at restoring WHO’s “pre-eminence as the guardian of global public health”.

The panel was commissioned by WHO Director-General Margaret Chan in response to widespread criticism that WHO had mishandled its response to the west African Ebola epidemic. The panel corroborated many of the criticisms. Chief among them was the “unjustifiable” time it took WHO to declare the outbreak a “public health emergency of international concern”. Chan made this declaration 5 months after the escalating spread of Ebola had become evident. WHO officials claim that the delay in making the official declaration did not affect its operations involving some 100 staff in the field in the early months of the epidemic.

WHO’s Member States also drew sharp criticism from the panel. Many applied travel bans during the epidemic without WHO authorisation, thereby contravening the International Health Regulations (IHR) and “causing negative political, economic and social consequences for the affected countries”. Perhaps the most damning criticism of WHO came from Médecins sans Frontières (MSF), whose teams were among the first to arrive at the scene of the outbreak in March, 2014. An MSF reportpublished in March, 2015, describes how MSF was unable to convince WHO that the epidemic was out of control. “WHO officials”, the report notes, “called us alarmists”.

Four of the panel’s recommendations stand out: countries should be given incentives to comply with the IHR and disincentives, such as sanctions, when they flout them; a brand-new WHO Centre for Emergency Preparedness and Response should be created; a contingency fund of US$100 million to be used solely to finance outbreak responses should be established; and an intermediate trigger should be set up to alert the health community to a health crisis before it becomes an emergency.

Asked whether the panel’s report meets her concerns, MSF president Joanne Liu tells The Lancet: “It has many strong points for us. But how they will translate into real action on the ground” is unclear. Liu is particularly pleased with the panel’s call for greater community engagement in epidemic response efforts. “As regards an intermediate alert”, she says, “it should be based on the needs of the affected communities, not just on a perceived security risk for other countries. MSF didn’t wait for an official declaration before going into the field.”

David Heymann, head and senior fellow at the Centre on Global Health Security in Chatham House, London, wonders whether the panel’s recommendations for fundamental changes in the decision-making processes can be implemented. “WHO has a flawed structure and I’m not sure its Member States have the will to change that.” He commends the panel’s call for strengthening existing emergency response mechanisms, such as the Global Outbreak Alert and Response Network (GOARN). “This is an agile, sustainable network of epidemiologists, logisticians, and other field-support experts from WHO Member States. It goes immediately into action to prevent outbreaks from becoming emergencies of international concern and has worked extremely well in previous Ebola outbreaks and in the 2003 SARS epidemic.” He believes that the existence of GOARN, with an added external advisory group, obviates the need for the new WHO emergency response centre proposed by the panel.

Will WHO implement the recommendations? “If it doesn’t implement them now”, says Jeremy Farrar, director of the Wellcome Trust, “it will never do so, because the Ebola epidemic has really shocked people and has exposed the structural weaknesses in WHO. Reforming its emergency response capabilities means reducing the bureaucracy and speeding up its capacity to respond. And that means appointing the very best people.” Farrar is enthusiastic about the proposed creation of a new WHO emergency response body. “It should be overseen by an independent board and needs to be outside the influence of politics and truly independent. It also needs to be given the right authority, the right budget, and the right mandate in order to attract the right leadership.”

Rick Brennan, director of WHO’s emergency operations, found the panel’s report constructive. “Work has already begun on several of the recommendations, such as increasing staff and funds for emergency operations and integrating our health security and humanitarian work. I’m convinced that we will implement the rest of the recommendations, including the creation of a new WHO health emergency centre.”

Experts were unanimous on one point made in the report. With 20–30 cases occurring every week, Ebola in west Africa is not over and many eyes are now on WHO’s role in ending it.

EDITORIAL
A plan to protect the world—and save WHO
The Lancet July 11, 2015
The Lancet, Vol. 386, No. 9989, p103

“WHO must reestablish its pre-eminence as the guardian of global public health.” These words resonate throughout the final report of the Ebola Interim Assessment Panel, requested by WHO’s Executive Board, chaired by Dame Barbara Stocking, and published this week. The findings of the panel present a devastating critique of WHO and the chronic inaction of its member states, which together created the conditions for an Ebola virus disease outbreak of unprecedented ferocity and human tragedy. The Stocking Report, as it will come to be known, sets out in agonising detail how the entire global health system fatally let down the people of west Africa.

Stocking reserves her harshest criticism for WHO. The delays in announcing a Public Health Emergency of International Concern (it took 5 months from announcing an “unprecedented outbreak” in April, 2014, to declaring a public health emergency on August 8) was “unjustifiable”. The agency’s culture is unfit to manage an emergency response. Independent and courageous decision-making by the Director-General of WHO and her team “was absent in the early months of the Ebola crisis”. The agency was slow and reactive to events. WHO has lost its position as the authoritative body on health emergencies. It thought it could manage Ebola through polite behind-the-scenes international diplomacy. It failed to recognise that Ebola was a health emergency, not a diplomatic puzzle. And WHO’s communication strategy for Ebola simply “failed”. The agency failed to communicate proactively and it failed to establish itself as the authoritative voice on the Ebola outbreak. Member States of WHO are not spared. They have persistently failed to take the International Health Regulations (IHR, 2005) seriously—a position that is “irresponsible” and “untenable” for global health security. They should adopt the notion of “shared sovereignty”. They need to invest in WHO (the Panel proposes a modest 5% increase in assessed contributions in 2016).

The Panel’s recommendations are clear and forthright. Although WHO was severely criticised, Stocking argues that the agency should still take the lead for emergency health responses. But to do so, WHO must undergo “significant transformation”—not least, adequate funding and a change in culture. It must provide costed plans for establishing core public health capacities as set out in the IHR (2005). It should establish a new WHO Centre for Emergency Preparedness and Response, with an independent board that publishes a report on Global Health Security annually. WHO country and regional offices should be strengthened. The agency should take its role in accelerating the research and development of diagnostics, vaccines, and medicines more seriously. And WHO should do more to coordinate its activities with other parts of the humanitarian community. The IHR Review Committee should examine the value of an intermediate alert for a public health emergency, lowering the threshold at which the world can be warned of a new health risk. And sanctions against countries that violate the IHR should be considered.

The Panel makes clear that global health must be put at the centre of the global security agenda. But while its recommendations are cogent, there are three important omissions that deserve attention. First, the Panel does not address the vicious cycle within which WHO is caught. The reason why WHO is so poorly resourced is that it lacks the confidence of donors. As the agency continues to underperform because of chronic underinvestment, so that lack of confidence (and the resultant unwillingness to invest) only worsens. The Panel presents no way out of this endless circle of failure. Second, one of the most important responsibilities for governments is the preservation of public order and national security. In the context of Ebola (indeed, any health crisis), this means creating resilient health systems to protect populations from unexpected shocks, as explained by Mosoka Fallah and colleagues in a letter from Liberia’s Ministry of Health this week. Universal health coverage should have been emphasised as a crucial instrument in building global health security. Finally, the Panel rightly notes that, “While WHO has already accepted the need for transformation of its organisational culture and delivery, it will need to be held accountable to ensure that this transformation is achieved”. However, nowhere does the Panel recommend the accountability mechanism to monitor and review the implementation of its recommendations. Our fear is that the unique opportunity presented by the Stocking Report will be squandered. We have little confidence that the governing bodies of WHO will deliver on the expectations of Stocking and her team. The responsibility for action therefore falls to WHO’s Director-General. Dr Margaret Chan has 20 months to save her agency from further and possibly irreversible reputational damage.

ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study
Mara Jana Broadhurst, John Daniel Kelly, Ann Miller, Amanda Semper, Daniel Bailey, et al.

The Lancet, June 25, 2015; Vol. 386, No. 9996, p867–874    http://dx.doi.org/10.1016/S0140-6736(15)61042-X    
Background  At present, diagnosis of Ebola virus disease requires transport of venepuncture blood to field biocontainment laboratories for testing by real-time RT-PCR, resulting in delays that complicate patient care and infection control efforts. Therefore, an urgent need exists for a point-of-care rapid diagnostic test for this disease. In this Article, we report the results of a field validation of the Corgenix ReEBOV Antigen Rapid Test kit.
Methods   We performed the rapid diagnostic test on fingerstick blood samples from 106 individuals with suspected Ebola virus disease presenting at two clinical centres in Sierra Leone. Adults and children who were able to provide verbal consent or assent were included; we excluded patients with haemodynamic instability and those who were unable to cooperate with fingerstick or venous blood draw. Two independent readers scored each rapid diagnostic test, with any disagreements resolved by a third. We compared point-of-care rapid diagnostic test results with clinical real-time RT-PCR results (RealStar Filovirus Screen RT-PCR kit 1·0; altona Diagnostics GmbH, Hamburg, Germany) for venepuncture plasma samples tested in a Public Health England field reference laboratory (Port Loko, Sierra Leone). Separately, we performed the rapid diagnostic test (on whole blood) and real-time RT-PCR (on plasma) on 284 specimens in the reference laboratory, which were submitted to the laboratory for testing from many clinical sites in Sierra Leone, including our two clinical centres.
Findings   In point-of-care testing, all 28 patients who tested positive for Ebola virus disease by RT-PCR were also positive by fingerstick rapid diagnostic test (sensitivity 100% [95% CI 87·7–100]), and 71 of 77 patients who tested negative by RT-PCR were also negative by the rapid diagnostic test (specificity 92·2% [95% CI 83·8–97·1]). In laboratory testing, all 45 specimens that tested positive by RT-PCR were also positive by the rapid diagnostic test (sensitivity 100% [95% CI 92·1–100]), and 214 of 232 specimens that tested negative by RT-PCR were also negative by the rapid diagnostic test (specificity 92·2% [88·0–95·3]). The two independent readers agreed about 95·2% of point-of-care and 98·6% of reference laboratory rapid diagnostic test results. Cycle threshold values ranged from 15·9 to 26·3 (mean 22·6 [SD 2·6]) for the PCR-positive point-of-care cohort and from 17·5 to 26·3 (mean 21·5 [2·7]) for the reference laboratory cohort. Six of 16 banked plasma samples from rapid diagnostic test-positive and altona-negative patients were positive by an alternative real-time RT-PCR assay (the Trombley assay); three (17%) of 18 samples from individuals who were negative by both the rapid diagnostic test and altona test were also positive by Trombley.
Interpretation   The ReEBOV rapid diagnostic test had 100% sensitivity and 92% specificity in both point-of-care and reference laboratory testing in this population (maximum cycle threshold 26·3). With two independent readers, the test detected all patients who were positive for Ebola virus by altona real-time RT-PCR; however, this benchmark itself had imperfect sensitivity.
Malaria morbidity and mortality in Ebola-affected countries caused by decreased health-care capacity, and the potential effect of mitigation strategies: a modelling analysis
Patrick G T Walker, Michael T White, Jamie T Griffin, Alison Reynolds, Neil M Ferguson, Azra C Ghani
The Lancet Infectious Diseases, April 23, 2015; Vol. 15, No. 7, p825–832  http://dx.doi.org/10.1016/S1473-3099(15)70124-6    
Background  The ongoing Ebola epidemic in parts of west Africa largely overwhelmed health-care systems in 2014, making adequate care for malaria impossible and threatening the gains in malaria control achieved over the past decade. We quantified this additional indirect burden of Ebola virus disease.
Methods  We estimated the number of cases and deaths from malaria in Guinea, Liberia, and Sierra Leone from Demographic and Health Surveys data for malaria prevalence and coverage of malaria interventions before the Ebola outbreak. We then removed the effect of treatment and hospital care to estimate additional cases and deaths from malaria caused by reduced health-care capacity and potential disruption of delivery of insecticide-treated bednets. We modelled the potential effect of emergency mass drug administration in affected areas on malaria cases and health-care demand.
Findings  If malaria care ceased as a result of the Ebola epidemic, untreated cases of malaria would have increased by 45% (95% credible interval 43–49) in Guinea, 88% (83–93) in Sierra Leone, and 140% (135–147) in Liberia in 2014. This increase is equivalent to 3·5 million (95% credible interval 2·6 million to 4·9 million) additional untreated cases, with 10 900 (5700–21 400) additional malaria-attributable deaths. Mass drug administration and distribution of insecticide-treated bednets timed to coincide with the 2015 malaria transmission season could largely mitigate the effect of Ebola virus disease on malaria.
Interpretation  These findings suggest that untreated malaria cases as a result of reduced health-care capacity probably contributed substantially to the morbidity caused by the Ebola crisis. Mass drug administration can be an effective means to mitigate this burden and reduce the number of non-Ebola fever cases within health systems.

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Physicians’ View of Supreme Court on an Issue of Public Health

Curator: Larry H. Bernstein, MD, FCAP

  • Where has the reason gone?

https://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

  • Justice Ginsberg written dissent – Third Part

https://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

  • The physicians’ view of Supreme Court on an issue of public health

https://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

  •  Reason in Hobby Lobby

https://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

 

Physicians’ View of Supreme Court on an Issue of Public Health

The physicians are under considerable stress.  They have a minimum of 8 years of post graduate university education to practice as a generalist or  in a medical, pediatric, gynecological or surgical related specialty.  A significant loss is incurred in the cost of loans for education to many. A significant sacrifice is made in time for family.  A primary obligation is incurred toward the wellbeing of the patient, and the community that has to be respected and protected by civil law.

 

Supreme Court Issues Hobby Lobby Decision

By Joyce Frieden, News Editor, MedPage Today  Published: Jun 30, 2014

The Supreme Court has struck down the Affordable Care Act requirement that employers must include no-cost contraceptive coverage in employee health insurance plans. The 5-4 decision decision issued today in the Hobby Lobby case (Burwell v. Hobby Lobby Stores, Inc.) follows conflicting appellate court rulings in cases involving businesses that objected to the ACA’s birth control requirement on religious grounds. The businesses said the ACA stepped on their religious freedoms.

The 2010 health law mandates that all health plans provide preventive services — including birth control — free of cost-sharing. But some corporations — most notably arts-and-crafts giant Hobby Lobby and its sister company Mardel, a Christian bookstore chain — sued the Department of Health and Human Services to be exempted from having to comply with the mandate. In its 5-4 decision, written by Justice Samuel Alito, the Court ruled that the mandate violates the Religious Freedom Restoration Act of 1993, “which prohibits the ‘Government [from] substantially burden[ing] a person’s exercise of religion’” unless it shows that doing so is “in furtherance of a compelling governmental interest” and “is the least restrictive means” of doing do. The decision summary also notes that the Department of Health and Human Serivces (HHS) “argues that the companies cannot sue because they are for-profit corporations, and that the owners cannot sue because the regulations apply only to the companies, but that would leave merchants with a difficult choice:

  • give up the right to seek judicial protection of their religious liberty or forgo the benefits of operating as corporations.

RFRA’s text shows that Congress designed the statute to provide very broad protection for religious liberty and did not intend to put merchants to such a choice.” Donna Harrison, MD, executive director of the American Association of Pro-Life Obstetricians & Gynecologists (AAPLOG), noted that Hobby Lobby was in particular objecting to very specific contraceptives — the emergency contraceptive Ella and intrauterine devices, which she noted are capable of killing embryos, either by preventing their implantation or killing them after they have been implanted.

Art Caplan, PhD, director of the medical ethics division at the NYU Langone Medical Center in New York City, oberved “decision could have a very negative impact” on women’s ability to obtain contraception,  and “it could affect many women even if only a small percentage of companies followed suit.” “The other problem,” he told MedPage Today in a video interview, “is that if your employer says ‘I’m not covering contraception,’ you may decide to go with methods that don’t involve pharmaceutical control, or you may rely on something like emergency contraception” — decisions that could lead to more abortions, which would be

  • an ironic outcome since many employers’ objections to contraception revolve around their objections to abortion.

Harrison, of AAPLOG, noted that the decision should be reassuring to physicians who object to prescribing particular forms of contraception that they see as abortifacients, since insurers may have been considering excluding such doctors from their provider networks if the mandate had been upheld. “This will help incentivize insurers to not exclude ‘conscientious doctors’ from their networks,” she said.

More Physician Groups Weigh In

Many of the other physician groups issuing statements today expressed disappointment in the ruling.

“Allowing for-profit employers to exclude coverage for contraception is itself deeply concerning because of the demonstrated adverse impact it will have on women’s health,” David Fleming, MD, president of the American College of Physicians, said in a statement. “And, “the ruling clearly does not preclude for-profit employers from challenging such mandates (vaccinations), or the courts from granting further coverage exemptions.”

Rebecca Sokol, MD, president of the American Society for Reproductive Medicine in Washington, said in a statement that her organization “profoundly disagrees” with the decision. “Allowing an employer to impose their beliefs about reproduction on their staff is simply wrong, particularly when those beliefs are

  • so clearly misinformed on the scientific and medical facts,” Sokol said.

“In no other field of medicine do we allow employers to substitute their judgment for that of patients and physicians; it should not be allowed just because the subject matter is reproduction.”

Between Women and Their Physicians

Lin-Fan Wang, MD, reproductive health advocacy fellow at Physicians for Reproductive Health in New York City, said in a video interview that

  • “decisions about contraception should really be made between a woman and her doctor, and not by her employer.”

Wang recounted the story of one of her own patients, a woman who had recently had a baby and then went back to work, and was having trouble remembering to take her birth control pills. “She chose one of the intrauterine devices … because it was one of the most effective forms of contraception and she didn’t have to think about it every day,” she said. “Luckily her insurance plan covered the cost of this very expensive form of contraception, but

  • under the ruling today, patients like [her] might not be able to choose that method

and she may end up having to choose a method that is hard for her to take or she’s not happy with.” Reproductive rights groups also expressed their concerns. Bebe Anderson, JD, director of the U.S. Legal Program at the Center for Reproductive Rights in New York City, called the decision “an affront to women of this country.”

“As Justice [Ruth Bader] Ginsburg recognized in her dissent, this decision makes it very difficult for women to get some of the best long-acting reversible forms of contraception,” Anderson told MedPage Today in a video interview. “For example, IUDs are as expensive as 1 month’s pay for someone working at minimum wage.”

Cecile Richards, president of the Planned Parenthood Action Fund, called the ruling “stunning.” On a call with reporters she said it was no coincidence that the majority opinion was decided by five male justices. “It is endlessly frustrating for women that decisions about their healthcare are being made by people who never need to use birth control, and it is no coincidence that all three women on the court signed today’s dissent,” Richards said. On the same call, Marcia Greenberger, co-president of the National Women’s Law Center, said the decision was “a bitter pill for women to swallow …These [plaintiffs] and other closely held companies

  • will now have license to harm their female employees in the name of the company’s religion, and
  • ignore the moral and practical considerations of women themselves.”

Other Implications

Several commenters noted that, although the majority opinion specifically states that this ruling does not apply to religious objections to other healthcare benefits such as vaccinations and blood transfusions, this opens up the way for plaintiffs to sue about those as well. “Regardless of what they said, they’ve opened Pandora’s box and set a precedent,” said Ilyse Hogue, president of NARAL Pro-Choice America. The Tenth Circuit Court of Appeals in Denver ruled in June 2013 that

  • Hobby Lobby should be given the opportunity to show its religious beliefs would be violated by either complying with the law or being forced to pay large fines.

Hobby Lobby faced penalties amounting to $1.3 million a day starting in the summer of 2013 if it didn’t provide FDA-approved contraceptive methods in its self-insured health plans, which cover 13,000 employees. But a court issued an injunction in July that prevented the penalty from taking effect.

A rule from HHS finalized last summer exempted churches and other nonprofit religious organizations that object to contraceptive coverage. But private businesses such as Hobby Lobby weren’t exempt. UPDATE: This article, originally published on June 30 at 10:18 EDT, was updated with new material at 19:12 EDT.  

When Religious Freedom Clashes with Access to Care

Glenn Cohen, J.D., Holly Fernandez Lynch, J.D., M.Bioethics, and Gregory D. Curfman, M.D.

July 2, 2014 DOI: 10.1056/NEJMp1407965

At the tail end of this year’s Supreme Court term, religious freedom came into sharp conflict with the government’s interest in providing affordable access to health care. In a consolidated opinion inBurwell v. Hobby Lobby Stores and Conestoga Wood Specialties Corp. v. Burwell (collectively known as Hobby Lobby) delivered on June 30, the Court sided with religious freedom, highlighting the limitations of our employment-based health insurance system.

Hobby Lobby centered on the contraceptives-coverage mandate, which derived from the Affordable Care Act (ACA) mandate that many employers offer insurance coverage of certain “essential” health benefits, including coverage of “preventive” services without patient copayments or deductibles. The ACA authorized the Department of Health and Human Services (HHS) to define the scope of those preventive services, a task it delegated to the Institute of Medicine, whose list included all 20 contraceptive agents approved by the Food and Drug Administration. HHS articulated various justifications for the resulting mandate, including the fact that many Americans have difficulty affording contraceptives despite their widespread use and

  • the goal of avoiding a disproportionate financial burden on women.

Under the regulation, churches are exempt from covering contraception for their employees, and nonprofit religious organizations may apply for an “accommodation,” which shifts to their insurance companies (or other third parties) the responsibility for providing free access. However,

  • HHS made no exception for for-profit, secular businesses with religious owners.

Hobby Lobby, a craft-store chain with more than 13,000 employees, is a closely held, for-profit corporation owned by a Protestant family that operates the business in accordance with its Christian principles — for example, donating a portion of proceeds to Christian missions and remaining closed on Sundays. The family does not object to providing coverage for some contraceptives, but

  • it challenged the mandate because it includes contraceptive methods that the family believes cause abortion by preventing implantation of a fertilized egg.

The challenge in Hobby Lobby was not about the Constitution or its First Amendment. Rather, it hinged on the Religious Freedom Restoration Act of 1993 (RFRA), which was Congress’s response to a Supreme Court decision holding that

  1. even if a law in fact burdened religion, it could stand as long as it was not intended to burden religion (was “neutral”),
  2. applied without regard to religious beliefs or practices (was “generally applicable”), and
  3. was rationally related to a legitimate government interest — a low bar.

RFRA applies when a federal law is deemed to “substantially” burden a person’s exercise of religion, even if it is neutral and generally applicable. Such laws may be enforced against religious objectors only when they further a compelling government interest using the least restrictive means available. This is the most demanding standard of judicial review, and few laws meet its requirements. In a 5-to-4 decision the Court found that the contraceptives-coverage mandate did not.

In its RFRA analysis, the Court had to address several key questions:

  1. Are closely held, for-profit corporations “persons” for the purposes of RFRA protection?
  2. Can corporations exercise religion?
  3. Does the contraceptives-coverage mandate substantially burden religion?
  4. Does the mandate advance a compelling government interest? And
  5. are there less restrictive alternatives that would achieve the same result?

In a ruling in which Justice Samuel Alito wrote for the majority (joined by Chief Justice John Roberts and Justices Antonin Scalia, Anthony Kennedy, and Clarence Thomas), the mandate came up short. The majority concluded that RFRA was intended to protect even for-profit corporations and that

  • corporations may exercise religion,
  • rejecting as unreasonable any definition of “person” that would include some but not all corporations.

The majority also concluded that the mandate did place a substantial burden on the companies’ religious beliefs, given the dramatic financial consequences of noncompliance (for example, Hobby Lobby would have faced a fine of $475 million per year) and

  • the fact that the government had extended other exemptions and accommodations in recognition of that burden.

The majority assumed that the government has a compelling interest in promoting free access to contraceptive agents, but it held that

  • the government had failed to advance that interest in the least restrictive way, given
  • the possibility of extending its existing exemptions and accommodations to for-profit corporations

Thus, the Court held that as applied to closely held, for-profit corporations with religious objections, the mandate violates RFRA. It was careful, however, to restrict the decision to the case before it, refraining from opining on the implications for other types of employers or objections to other health care services, which it cautioned must be addressed on a case-by-case basis. Nonetheless, the case may have broad practical impact, since

  • approximately 90% of all U.S. companies are closely held, and
  • “closely held” is not synonymous with “small.”

Justice Ruth Bader Ginsburg issued a sharp dissent, in which she was joined by Justice Sonia Sotomayor and in large part by Justices Elena Kagan and Stephen Breyer. Delivering her opinion from the bench, Justice Ginsburg underscored the burden that the majority decision would allow to be placed on women in favor of religious objectors:

“Today’s potentially sweeping decision . . . discounts the disadvantages religion-based opt outs impose on others, in particular, employees who do not share their employer’s religious beliefs.”

Hobby Lobby‘s outcome is of concern to U.S. health care professionals because

  • our health insurance system is still largely dependent on employers.
  • Employers and employees may have fundamentally different perspectives on which medical interventions are acceptable,
  • particularly when the employer’s fundamental mission is not to advance specific religious beliefs and
    • its employees are therefore unlikely to be drawn exclusively from its own religious group.

The Court’s decision allows the beliefs of employers of various sizes and corporate forms to trump the beliefs and needs of their employees, potentially influencing the types of care that will be affordable and accessible to individuals and permitting employers to intrude on clinician–patient relationships.

The case also has important implications for efforts to achieve compromise between religious freedom and health care access. The Obama administration’s attempts to compromise on the contraceptives-coverage mandate ultimately backfired, since its efforts were used to demonstrate that

  • applying the mandate even to secular employers was not necessarily the only way to achieve the government’s interests.

In the future, regulators may be less willing to seek compromise lest their efforts be similarly used against them — and it is bad news for all of us if health policy can be made only through polarization and rancor rather than compromise. On the other hand, in other contraceptives-mandate cases working their way through the courts, nonprofit religious employers argue that the government’s accommodations do not go far enough in protecting their religious freedom, essentially requiring them to deputize a third party to commit what they think is a sin on their behalf.

Finally, in the wake of Hobby Lobby, we may anticipate challenges to other medical services that some religions find objectionable, such as vaccinations, infertility treatments, blood transfusions, certain psychiatric treatments, and even hospice care. Hobby Lobby‘s implications may also extend into civil rights law, with employers asking to “opt out” of laws intended to protect people from employment and housing discrimination based on religion, race, sex, national origin, or pregnancy status. Although the majority deemed these slippery-slope concerns unrealistic, the dissent expressed serious concerns.

Though the decision applies only to closely held, for-profit corporations, it sets a precedent for religious exemptions that could have sweeping implications — and reflects the Supreme Court’s great potential impact on U.S. health care. Yet the Court was applying Congress’s statute, and

  • Congress could, if it chose, scale back the protection offered to religious objectors — a good reason to share public reactions to the decision with our elected representatives.

BUFFER ZONES, BUBBLE ZONES, AND ABORTION CLINICS — ANOTHER WOMEN’S HEALTH CASE

In 2000, concerned about clashes between antiabortion protesters and women seeking abortions, the Massachusetts legislature established an 18-ft radius around the entrances and driveways of facilities providing abortions and specified that within that area, no person could, without consent, approach within 6 ft of another person (a so-called “bubble zone”) for the purpose of protesting, leafleting, counseling, or education. In 2007, the legislature concluded that law was not effective enough and increased its stringency, imposing a 35-ft fixed buffer zone with few exceptions. The law was challenged on free-speech grounds in a case called McCullen v. Coakley, and on June 26, 2014, the U.S. Supreme Court unanimously struck it down as unconstitutional.

The lead opinion by Chief Justice John Roberts, joined by four other justices, noted that sidewalks and public ways hold a “special position in terms of First Amendment protection because of their historic role as sites for discussion and debate.” Although it was abortion that had motivated the statute, the Court held that the law was content- and viewpoint-neutral: it did not focus on what was said but on where it was said, and it burdened all speech, not merely disfavored speech.

On this point, the four remaining justices disagreed. Nevertheless, the Court held that the statute failed the second part of the relevant constitutional test because it was not “narrowly tailored to serve a significant governmental interest.” In particular, though the Court recognized that the buffer zones furthered the state’s interests in “ensuring public safety” on streets and sidewalks and in “preserving access to adjacent healthcare facilities,” it determined that

  • the law problematically criminalized not only protests,
  • but also sidewalk counseling, which could not be done at a distance of 35 ft.
  • It also found that the buffer zones burdened “substantially more speech than necessary to achieve” the state’s interest

and suggested a plethora of less intrusive means the state could have used instead, some of which are used in other states.

Although the decision deals another blow to abortion rights, that blow is not as substantial as some had feared: the finding that the law was content- and viewpoint-neutral allows for the possibility that Massachusetts and other states could pass similar but narrower laws. Moreover, the Court left open the future of the floating “bubble zone” around women approaching clinics for abortions — the strategy that Massachusetts had used from 2000 to 2007 and one that the Court upheld in a Colorado case in 2000. Several justices, however, indicated a willingness to revisit that decision in future litigation.

See §§2000bb–1(a), (b) (requiring the Government to “demonstrat[e] that application of [a substantial] burden to the person . . . is the least restrictive means of furthering [a] compelling governmental interest” (emphasis added)).

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Costs for breast screening are being driven higher by increased use of new imaging technologies such as digital mammography and MRI, workflows incorporating 2nd and 3rd remote-readings as quality control measure, use of computer-aided detection (CAD) applications and growth in aged population.

According to recent publication in JAMA, 40% of the annual spending is for screening women ages 75 and older. Under existing guidelines routine screening is not recommended for this age group since “There is insufficient evidence to assess the benefits and harms of screening mammography”

The study population comprised women of 66 to 100 years old. “Forty-two percent of the women in the study were younger than age 75, and almost 60% of this group had one or more screening mammograms. Women ages 75 to 85 represented 40% of the total; 42% of this group had mammograms. Women 85 years and older represented 18% of the total; only 15% of this group had mammograms. Women with multiple chronic health conditions were much less likely to have a mammogram (26.6%) than healthy women (47.4%).”

“Abstract

The Cost of Breast Cancer Screening in the Medicare Population.

Cary P. Gross, MD; Jessica B. Long, MPH; Joseph S. Ross, MD, MHS; Maysa M. Abu-Khalaf, MD; Rong Wang, PhD; Brigid K. Killelea, MD, MPH; Heather T. Gold, PhD; Anees B. Chagpar, MD, MA, MPH, MSc; Xiaomei Ma, PhD

JAMA Intern Med. 2013;():1-7. doi:10.1001/jamainternmed.2013.1397. Published online January 7, 2013

Background  Little is known about the cost to Medicare of breast cancer screening or whether regional-level screening expenditures are associated with cancer stage at diagnosis or treatment costs, particularly because newer breast cancer screening technologies, like digital mammography and computer-aided detection (CAD), have diffused into the care of older women.

Methods Using the linked Surveillance, Epidemiology, and End Results–Medicare database, we identified 137 274 women ages 66 to 100 years who had not had breast cancer and assessed the cost to fee-for-service Medicare of breast cancer screening and workup during 2006 to 2007. For women who developed cancer, we calculated initial treatment cost. We then assessed screening-related cost at the Hospital Referral Region (HRR) level and evaluated the association between regional expenditures and workup test utilization, cancer incidence, and treatment costs.

Results In the United States, the annual costs to fee-for-service Medicare for breast cancer screening-related procedures (comprising screening plus workup) and treatment expenditures were $1.08 billion and $1.36 billion, respectively. For women 75 years or older, annual screening-related expenditures exceeded $410 million. Age-standardized screening-related cost per beneficiary varied more than 2-fold across regions (from $42 to $107 per beneficiary); digital screening mammography and CAD accounted for 65% of the difference in screening-related cost between HRRs in the highest and lowest quartiles of cost. Women residing in HRRs with high screening costs were more likely to be diagnosed as having early-stage cancer (incidence rate ratio, 1.78 [95% CI, 1.40-2.26]). There was no significant difference in the cost of initial cancer treatment per beneficiary between the highest and lowest screening cost HRRs ($151 vs $115; P = .20).

Conclusions The cost to Medicare of breast cancer screening exceeds $1 billion annually in the fee-for-service program. Regional variation is substantial and driven by the use of newer and more expensive technologies; it is unclear whether higher screening expenditures are achieving better breast cancer outcomes.”

The study is mainly addressing the difference in costs between different regions of referrals. It would be interesting to explore the situation in the age group of 40 to 66 years old.

Written by:  Dr. Dror Nir, PhD.

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Reporter: Aviva Lev-Ari, PhD, RN

Simulations Show Young Surgeons Face Special Concerns With Operating Room Distractions

Article Date: 03 Dec 2012 – 1:00 PST

A study has found that young, less-experienced surgeons made major surgical mistakes almost half the time during a “simulated” gall bladder removal when they were distracted by noises, questions, conversation or other commotion in the operating room.

In this analysis, eight out of 18, or 44 percent of surgical residents made serious errors, particularly when they were being tested in the afternoon. By comparison, only one surgeon made a mistake when there were no distractions.

Exercises such as this in what scientists call “human factors engineering” show not just that humans are fallible – we already know that – but work to identify why they make mistakes, what approaches or systems can contribute to the errors, and hopefully find ways to improve performance.

The analysis is especially important when the major mistake can be fatal.

This study, published in Archives of Surgery, was done by researchers from Oregon State University and the Oregon Health and Science University, in the first collaboration between their respective industrial engineering and general surgery faculty.

“This research clearly shows that at least with younger surgeons, distractions in the operating room can hurt you,” said Robin Feuerbacher, an assistant professor in Energy Systems Engineering at OSU-Cascades and lead author on the study. “The problem appears significant, but it may be that we can develop better ways to address the concern and help train surgeons how to deal with distractions.”

The findings do not necessarily apply to older surgeons, Feuerbacher said, and human factors research suggests that more experienced people can better perform tasks despite interruptions. But if surgery is similar to other fields of human performance, he said, older and more experienced surgeons are probably not immune to distractions and interruptions, especially under conditions of high workload or fatigue. Some of those issues will be analyzed in continued research, he said.

This study was done with second-, third- and research-year surgical residents, who are still working to perfect their surgical skills. Months were spent observing real operating room conditions so that the nature of interruptions would be realistic, although in this study the distractions were a little more frequent than usually found.

Based on these real-life scenarios, the researchers used a virtual reality simulator of a laparoscopic cholecystectomy – removing a gall bladder with minimally invasive instruments and techniques. It’s not easy, and takes significant skill and concentration.

While the young surgeons, ages 27 to 35, were trying to perform this delicate task, a cell phone would ring, followed later by a metal tray clanging to the floor. Questions would be posed about problems developing with a previous surgical patient – a necessary conversation – and someone off to the side would decide this was a great time to talk about politics, a not-so-necessary, but fairly realistic distraction.

When all this happened, the results weren’t good. Major errors, defined as things like damage to internal organs, ducts and arteries, some of which could lead to fatality, happened with regularity. 

Interrupting questions caused the most problems, followed by sidebar conversations. And for some reason, participants facing disruptions did much worse in the afternoons, even though conventional fatigue did not appear to be an issue.

“We’ve presented these findings at a surgical conference and many experienced surgeons didn’t seem too surprised by the results,” Feuerbacher said. “It appears working through interruptions is something you learn how to deal with, and in the beginning you might not deal with them very well.” 

SOURCE:

http://www.medicalnewstoday.com/releases/253456.php

 

Events that should never occur in surgery (“never events“) happen at least 4,000 times a year in the U.S. according to research from Johns Hopkins University.

 

The findings, published in Surgery, is the first of its kind to reveal the true extent of the prevalence of “never events” in hospitals through analysis of national malpractice claims. They observed that over 80,000 “never events” occurred between 1990 and 2010.

They estimate that at least 39 times a week a surgeon leaves foreign objects inside their patients, which includes stuff like towels or sponges. In addition surgeons performing the wrong surgery or operating on the wrong body part occurs around 20 times a week.

Marty Makary, M.D., M.P.H., an associate professor of surgery at the Johns Hopkins University School of Medicine, said:

“There are mistakes in health care that are not preventable. Infection rates will likely never get down to zero even if everyone does everything right, for example. But the events we’ve estimated are totally preventable. This study highlights that we are nowhere near where we should be and there’s a lot of work to be done.”

The researchers believe that this finding could help ensure that better systems are developed to prevent these “never events” which should never happen. 

The study examined data from the National Practitioner Data Bank which handles medical malpractice claims to calculate the total number of wrong-site-, wrong-patient and wrong-procedure surgeries.

Over 20 years. they found more than 9,744 paid malpractice claims which cost over $1.3 billion. Of whom 6.6% died, while 32.9% were permanently injured and 59.2% were temporarily injured. 

Around 4,044 never events occur annually in the U.S., according to estimates made by the research team who analyzed the rates of malpractice claims due to adverse surgical events. 

Many safety procedures have been implemented in medical centers to avoid never events, such as timeouts in the operating rooms to check if surgical plans match what the patient wants. In addition to this, an effective way of avoiding surgeries that are performed on the wrong body part is using ink to mark the site of the surgery. In order to prevent human error, Makary notes that electronic bar codes should be implemented to count sponges, towels and other surgical instruments before and after surgery. 

It is a requirement that all hospitals report the number of judgments or claims to the NPDB. Makary did note, however, that these figures could be low because sometimes items left behind after surgery are never discovered. 

Most of these events occurred among patients in their late 40s, surgeons of the same age group accounted for more than one third of the cases. More than half (62%) of the surgeons responsible for never events were found to be involved in more than one incident. 

Makary comments the importance of reporting never events to the public. He stresses that by doing so, patients will have more information about where to go for surgery as well as putting pressure on hospitals to maintain their quality of care. Hospitals should report any never events to the Join Commission, however this is often overlooked and more enforcement is necessary. 

Written by Joseph Nordqvist 
Copyright: Medical News Today 

SOURCE:

http://www.medicalnewstoday.com/articles/254426.php

 

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