09.24.14

3 Issues to Consider before Voting in November

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On November 4, many Americans will go to the polls to vote in the midterm elections. And like all election seasons, issues threatening public health are chief among this nation’s top concerns.

Vote_Health_for_all_3

 

 

 

 

In researching for this post, I came up with a fairly long “short-list” of pressing public health issues – women’s health and contraception, states that have not expanded Medicaid, food insecurity, domestic violence, immigration, climate change, tobacco control – to name a few. Each of these issues is socially and politically complicated, nuanced, and frankly not new. We will be fighting these issues this year, in four years and sadly in eight and twelve.

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Posted in FDA, Health reform, National Healthcare, Uncategorized, Updates; Tagged: , , , , , , , .

09.19.14

10 Resources to Help You Get a Handle on the Ebola Epidemic

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This post was written by O’Neill Institute Law Fellows Sarah Roache and Daniel Hougendobler

The West African Ebola epidemic is an international public health crisis, and a threat to international security. For so many of us – the public health community, humanitarian and aid organizations, governments, ethicists, policy-makers, and engaged citizens – the epidemic triggers important and complex questions.

Why, for example, is this epidemic spreading at exponential rates, while more than 20 previous outbreaks subsided with relatively few deaths? Why did the international community take so long to ramp up its response, and are we doing enough to contain the epidemic? How can we quickly improve the level of care available to those who are infected? How do we build trust in medical personnel among people who believe that Ebola does not exist? How can we prevent future infectious disease outbreaks from becoming endemic?

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Posted in Global Health, Uncategorized; Tagged: , , .

09.18.14

Eight Gaps in the International Response to the West African Ebola Crisis Following U.S. Troops and UN Needs Assessment

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Photo Courtesy of UN Photo /Staton Winter

Photo Courtesy of UN Photo / Staton Winter

This post was written by Eric A. Friedman, O’Neill Institute Associate, Lawrence O. Gostin, O’Neill Institute Faculty Director, Sarah Roache, O’Neill Institute Law Fellow and Daniel Hougendobler, O’Neill Institute Law Fellow. For questions or comments about this post please contact Lawrence Gostin at gostin@law.georgetown.edu.

Yesterday, on the same day that the United Nations issued an appeal for nearly $1 billion to control Ebola, President Obama announced several new U.S. measures in the global fight, focusing on the worst-hit country, Liberia. The President’s pledge is commendable, encompassing perhaps the first major military deployment to stem an ongoing epidemic. The U.S. military is uniquely positioned to provide sorely needed logistical support and engineering know-how, with troops well trained in dealing with the risks of hemorrhagic fevers. But even with a surge response by the U.S., global efforts are still wholly incommensurate with the enormity of the needs on the ground.

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Posted in Uncategorized; Tagged: , , , , , , , , , .

09.15.14

16 years of GMO agriculture – No meaningful health findings in multiple generations of animals

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cornA new study – Prevalence and impacts of genetically engineered feedstuffs on livestock populations – published last week has brought more evidence to the forefront on the safety profile of genetically modified food (aka GMO).

Transgenic GMO agriculture was first authorized for use in the United States in 1996. Genetic modification of food through the use of artificial selection has been part of agriculture since agriculture started centuries ago. However, since 1996 there’s been a consistent allegation that GMO food is unhealthy for a variety of reasons, primarily stemming from concerns regarding pesticide usage. While I won’t discuss it here, it’s important to remember that pesticides were used before GMO and continue to be used in both GMO and organic farming today.

The authors of this study have taken a novel approach to evaluating whether GMO foods have any negative health effects. Whilst referring to the literally hundreds of safety studies that have been done on transgenic GMO crops since their introduction, the authors looked at the health outcomes of animals raised through the meat and dairy industry. Data on livestock health and productivity have been kept by the USDA since at least 1983 and the authors have compared the data relating to the more than 100 billion animals that have been raised in the United States since the introduction of GMO foods (the primary consumers of GMO foods) to the data on animals raised prior to the introduction of GMO to determine whether there’s been any discernible change in the health of the animals. The results are below:

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Posted in Uncategorized;

09.10.14

The UN Security Council Should Mobilize an International Force to Contain the West African Ebola Epidemic: A Call to Action

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call to actionThis post was written by Lawrence O. Gostin, Faculty Director, O’Neill Institute for National and Global Health Law, and Sarah Roache, Law Fellow, O’Neill Institute for National and Global Health Law. For more information or questions about this post, please contact Sarah Roache at sar234@georgetown.edu.

The West African Ebola epidemic has become a national and global security threat, with Médecins Sans Frontières (MSF) calling for an international military mobilization. An entire region is facing not only a health crisis, but also a humanitarian and security crisis. The epidemic has severely disrupted essential goods and services such as food, clean water, and basic healthcare; travel, trade, and commerce; and peace and security. Ultimately, we believe the United Nations Security Council should authorize international peacekeeping troops to provide security for health workers and facilities; logistical support for essential health facilities and equipment; and a disciplined chain of command—answering the much asked question on the ground: who is in charge?

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Posted in Uncategorized; Tagged: , , , , , , , .

09.04.14

Ebola and September 11: National traumas, heroes, enduring legacies, and a Framework Convention on Global Health

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Josephine Sellu, a nurse survivor in Sierra Leone. Courtesy of the New York Times [http://www.nytimes.com/2014/08/24/world/africa/sierra-leone-if-they-survive-in-ebola-ward-they-work-on.html]

Josephine Sellu, a nurse survivor in Sierra Leone. Courtesy of The New York Times

343. For many Americans, that number will always be shorthand for heroism and sacrifice, for risking your own life to save others. It is the number of firefighters who died in the September 11 attack on the World Trade Center, among the 414 emergency workers killed that day. (The actual toll due to increased levels of cancer and respiratory illnesses among first responders is higher.)

134. That number, almost sure to grow, represents the health workers in Liberia, Sierra Leone, Guinea, and Nigeria who have fallen victim so far to Ebola during the present West African outbreak.

The firefighters of September 11, the health workers on the frontline of Ebola, both have placed the lives of others above their own, risking all to carry out the life-saving responsibilities of their chosen professions. A New York Times article details the tragedy, resilience, and heroism of workers at one government hospital in Sierra Leone, which lost 22 health workers to Ebola. Fifteen nurses died there, most early in the outbreak when they lacked the full body personal protective equipment that health workers treating people with Ebola require. We are reminded, too, of the commitment of often forgotten members of health teams, such as cleaners at high risk of coming into contact with body fluids of Ebola victims, drivers who bring Ebola victims to the hospital, and people who handle the bodies of those who have succumbed to the virus.

Josephine Finda Sellu, the hospital’s deputy nurse matron, is one of only three nurses who were at the hospital at the start of the Ebola outbreak and have managed to avoid infection. She captures the courage of so many health workers who have remained at their posts despite the immense risk: “You have no options. You have to go and save others. You are seeing your colleagues dying, and you still go and work.”

After September 11, New York City took steps to create a safer future for NYC firefighters, giving them and other emergency workers a greater chance of surviving a future disaster by improving the NY Fire Department communications systems, including better integration with the police and other emergency services.

What will be the legacy of Ebola? Will the legacy be akin to that of September 11, with focused, important steps – such as the improved communication systems – but with a broader legacy of missed opportunity and even misdirected responses? Read More

Posted in Global Health, Human Rights; Tagged: , , , , , , .

09.04.14

Ebola: The Global Health Tragedy of Our Times and How Law is Essential in Preventing Public Health Catastrophes

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By Ana Ayala and Tanya Baytor

Despite the World Health Organization (WHO) declaring the Ebola outbreak in West Africa an international public health emergency and mobilizing international assistance to stop further spread of the virus, we continue to see the number of cases and deaths rise, particularly in the countries with the lowest resources, namely Liberia, Guinea, and Sierra Leone. WHO recently reported that we are now at more than 1,900 deaths from Ebola in Africa. It is projected that 10,000 people will be infected by September 24, and WHO predicts that the caseload will rise to 20,000, of which half will die, in the next nine months. The international community’s response has been reactive, mainly because there is no other option. With the Ebola tragedy now attracting worldwide attention, it would be a missed opportunity not to underscore the importance of law in preventing such devastating international public health crises in the future. Read More

Posted in Global Health, Health reform, Uncategorized, WHO; Tagged: , , , , .

08.26.14

#icebucketchallenge: A Public Health Practitioner’s Perspective

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I work in the field of public healO'Neill Iceth. If you are reading this post, you probably do too. And if you think like me, you see the ALS ice bucket challenge with a mixture of awe, bewilderment and general frustration that you didn’t think of it first.

The ice bucket challenge has proven to be a brilliant marketing tactic that happened accidentally. A series of cold water dumping events for various charities happening sporadically around the world quickly became focused on ALS. The roots of the challenge are debatable. Depending on who you ask, either a pro golfer challenged friends to raise money for ALS or a former Boston College baseball player, who was diagnosed with ALS in 2011, challenged friends and celebrities (including NFL quarterbacks Tom Brady and Matt Ryan) to take the ice bucket challenge to “strike out ALS.” The Internet disagrees about the challenge’s origin, but this Slate piece sums up the history well.

The idea of cultivating social pressure to raise money for a particular disease or charity is not new at all. How many times has a friend asked you to donate in support of a race she is running, cookies he is baking or mountains they are climbing for a particular cause? Social pressure to raise money works. As evidenced by the ice bucket challenge, social media can generate tremendous social pressure to raise funds and boost awareness.

At the O’Neill Institute, my work has largely focused on public-private partnerships and a little known, but increasingly growing area of research funding called venture philanthropy. In the rare disease space, venture philanthropy means a non-profit disease foundation or its affiliate raises capital in order to directly fund scientists and drug companies to do research on various stages of drug development from understanding the basic etiology of disease to actual drug discovery. Return on this investment typically funds more research.

The story of Kalydeco, a miracle treatment for a specific gene mutation that causes cystic fibrosis, represents the power of crowd sourced fundraising and boasts the kind of breakthrough the ALS society hopes to achieve from its new fortune. Spurred by the fundraising efforts of desperate parents, the Cystic Fibrosis Foundation (CFF) created the Cystic Fibrosis Foundation Therapeutics Inc. to finance the research that eventually lead to a drug. To be clear, much of the research that led to the discovery of Kalydeco was built on years of NIH-funded research about the basic biology of the disease. However, the money available was simply not enough to incentivize a pharmaceutical company to develop a new drug. Without the drive and financing from CFF, that research many never have turned into a fantastic therapy.

Movember is a great example of turning a fun stunt into a well-sustained, money- generating program. In 2003, while joking about the waning prominence of the mustache in a bar in Australia, two friends decided to encourage 30 others to grow mustaches and donate $10 to charity in the month of November. Since 2003, there have been 4,026,562 Mo Bros and Mo Sistas growing mustaches and raising money for men’s health issues. According to Dr. Jonathan Simons, CEO and President of the Prostate Cancer Foundation:

Movember has initiated a growing international dialog on prostate cancer and men’s health and is an invaluable partner in energizing the global research enterprise for prostate cancer. Here in the US, unrestricted funding from Movember is helping the Prostate Cancer Foundation accelerate the world’s most promising research, enabling game-changing projects from whole genome sequencing and the development of innovative therapies. These will help men with advanced prostate cancer live longer, more productive lives than ever before.

Venture philanthropy dollars are revolutionizing medical product research and development and, in some cases, providing an antidote to declining federal research dollars (for more, see FasterCures). In 2010, the budget of the National Institutes of Health (NIH) peaked at $31.2 billion, but has since fallen to $30.2 billion in 2014. This number is actually lower when accounting for medical inflation and the 2013 sequester’s automatic 5 percent cut to the NIH budget. Both CFF and Movember are supported by money raised through social fundraising, largely over the internet. Each of these campaigns has produced tangible results for patients and their families.

As Mary Wholley, CEO of Research!America explained, venture philanthropy dollars may not be enough to fund a cure, but privately raised money, like that from the ice bucket challenge also “makes it possible for some young scientist to get a start to try out their new hypothesis before they are ready to submit a proposal to NIH.” Woolley added, “[i]t may also bridge some dry spells they’re feeling right now because the NIH is really strapped.”

Like any social media campaign, the ice bucket challenge is not without its critics. In 2010, the economist Malcolm Gladwell proclaimed that “facebook activism succeeds not by motivating people to make a real sacrifice but by motivating them to do the things that people do when they are not motivated enough to make a real sacrifice.” In step with this line of thought, critics of the ice bucket challenge have questioned whether people even know they are supposed to donate money at all, whether motivation to participate is catalyzed by the cause or just the trend, or to show off a nice body in a wet t-shirt.

I would counter these critics by asking so what? In the context of medical research and scientific discovery, the most significant way the vast majority of the public can participate is with their wallets. Raising awareness encourages others to open their wallets as well. An individual’s motivation for giving is simply irrelevant.

Whoever was the actual first to direct the ice bucket challenge towards ALS research had one goal: to raise awareness and money for ALS. Mission accomplished on both fronts.

When it comes to medical research and new therapeutics, private financing is a significant vehicle to supplement public financing. Venture philanthropy allows motivated parents, caregivers, siblings and friends to catalyze their energy into medical research. As evidenced by the ice bucket challenge, strangers with no connection to a particular disease can be motivated to action as well. I am glad the public caught on to the ALS ice bucket challenge and hope it will succeed in advancing health outcomes for people living with ALS.

I look forward to the next challenge. Perhaps I will even come up with it on my own.

 

 

Posted in FDA, Global Health; Tagged: , , , , , , , , .

08.13.14

Pandas, pandemics, and public health: A fond farewell to the O’Neill Institute

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Once upon a time, in a faraway land, there was a young law student. She felt lost and alone, realizing that she didn’t want to practice at Big Soulless Law Firm, Inc, but unsure about what else to do.

She did enjoy her course in public health, however, and wondered if there might be a way to combine this interest with her law degree. After a cursory search of the online catalogue, she ventured into a quiet section of the law library. There, on the bottom shelf, she found a book called Public Health Law: Power, Duty, Restraint, by a certain Lawrence O. Gostin. Well, she thought, that’s a thing. Maybe that’s something I can do.

Fast forward ten years, and that student finished her law degree, got a PhD,  and came to work for the O’Neill Institute. She also got sick of writing in the third person.

I’ve only had a year at the O’Neill Institute, but what a year it’s been. Working for the Institute was a dream come true – literally. I could talk about my inspiring colleagues, the interesting and challenging work, or the many food trucks just around the corner from Georgetown Law, but rather than bore you with the details, here’s a roundup of ten favorite memories from my time in DC.

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08.08.14

“Right to Try” Laws Offer No Meaningful Solutions and Undermine Science

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“Right to Try” laws have come into fashion with the success of the beautifully crafted and acted Dallas Buyer’s Club. That the movie was simply a movie with significant historical inaccuracies and that demonized the one drug (AZT) in the film that was actually effective at fighting HIV has apparently been lost on policy makers. Several states – some citing to the movie directly – are now pushing forward with legislation to supposedly improve access to investigational new drugs (INDs) for terminally ill patients. These right to try laws have now passed in Colorado, Missouri, and Louisiana and several more states are considering them. Additionally, federal legislation has recently been introduced that would go even further at a federal level.

The basic outline of these laws will be given below, but it’s important to note here that the “right to try” movement has been pushed forward by the Goldwater Institute and it’s model legislation. This is relevant only to the extent that the Goldwater Institute’s understanding of medical science are severely questionable. In their policy report Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of their Treatment, they state the following:

After the enactment of the FDCA, the FDA began to require pre-market testing for drug safety, however pre-market testing for efficacy was not required until the 1960’s with the passage of the Kefauver-Harris Amendments. The Kefauver-Harris Amendments were enacted as a direct result of worldwide Thalidomide-caused birth defects. Although Thalidomide was sold in 46 countries, it was never approved for sale in the United States due to the FDA’s lingering safety concerns. While over 10,000 children worldwide were born with birth defects attributed to Thalidomide, only 17 of those children were born in the United States, where access to the drug was limited to those patients undergoing the FDA safety trial. The Kefauver-Harris Amendments drastically expanded the FDA’s regulatory authority by requiring drug manufacturers to prove efficacy prior to being approved for sale.

This vast new granting of power was unwarranted. Thalidomide presented a safety problem (over which the FDA already had authority) – not an efficacy problem. As a result of the Kefauver-Harris Amendments, no drug could be sold within the United
States until it had been deemed both safe and effective by the FDA.

In response, the FDA designed a clinical trial process which is substantially the same practice still in place today. During the ensuing 50 years, everything in the medical world — from the way diseases are diagnosed and treated to the way medical records are kept — has been modernized, but the FDA continues to adhere to an approval process that is half a century old.

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Posted in FDA, Health reform, Human Rights; Tagged: .

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