10.03.17

GHL LLM Students Observe Global Health Governance in Action

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Last week, students of Georgetown’s Global Health Law LLM program attended the 29th Pan American Sanitary Conference (Conference) in Washington, D.C.

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Posted in Global Health, Global Health Law LL.M., Global Health Law LL.M. Program, WHO; Tagged: , , , , .

09.29.17

Investment in Tuberculosis R&D Is an Urgent Human Rights Issue

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Photo: Treatment Action Campaign 

Tuberculosis (TB) is a preventable and treatable disease which kills more people globally than any other infectious disease, approximately 5,000 every day. Despite grim statistics and the plethora of human rights violations that occur in the context of TB, there is inadequate funding, and limited public awareness that TB remains a public health crisis. Non-prioritization, and even disinterest in TB, is reflected by the lack of R&D, which is decreasing instead of increasing, as well as by the limited media coverage, discussion and discourse on TB.

Quick Facts

In 2015:

  • There were 10.4 million cases of TB and 1.8 million deaths;
  • TB killed more people than any other infectious disease globally;
  • TB killed more women than all causes of maternal mortality combined;
  • TB killed more children of all ages than any other infectious disease globally;
  • The gap between TB notifications and estimated incidents of TB was approximately 4.3 million, due to underreporting and underdiagnoses;
  • 480,000 people developed multi-drug resistant TB; and
  • TB drug resistance was the leading cause of antimicrobial resistance deaths.

The WHO, civil society and other stakeholders have repeatedly highlighted the dearth of new TB medicines, particularly for drug resistant forms. For example, last week WHO released a report which highlights the lack of treatment options available for drug-resistant forms of TB, including multi-drug resistant TB and extensively drug resistant TB, “which can cause severe and often deadly infections that pose a particular threat in hospitals and nursing homes.”

In the last 70 years, only two new TB medications have been developed and while there have been advances with diagnostics despite the limited available funding, existing TB diagnostic tools have serious limitations. Some diagnostic tools remain prohibitively expensive—one Gene Xpert machine costs approximately $17,000 USD at the reduced rate for developing countries, in addition to the price of cartridges. Notably, some diagnostic tools may be ineffective in locations with electrical interruptions or ‘load shedding,’ or require a laptop to use which may be a barrier in developing countries, among other barriers and challenges. Reflecting access challenges, diagnostic limitations, as well as a wide range of financial, logistical and human rights barriers which may be especially prevalent in countries with high TB burdens, TB is severely underdiagnosed; the gap between TB notifications and incidents is approximately 4.3 million, though this gap is also attributed to underreporting. People with TB who have not been diagnosed are of course not on treatment, and thus at risk of poor health, mortality and unknowingly spreading TB to their families and communities.

These cost and other barriers to preventing, diagnosing and treating tuberculosis remain significant human rights issues. Because TB disproportionately impacts developing countries, particularly the most vulnerable members of society—the poor, migrants, indigenous persons, prisoners, children, people living with HIV, mine workers, among others, there is limited interest and less financial incentive for TB R&D than for medicines and tools with markets primarily in high income countries. There are few TB medications in the pipeline and the funding gap for R&D is approximately 800 million per year. While there are initiatives to address some of the funding gap, much more commitment is urgently needed.

In 2016, it was announced that there would be the first ever High Level Meeting on TB, including a ministerial meeting in Moscow in November 2017 and tuberculosis will be a key agenda item at the UN General Assembly meeting in 2018. These are unparalleled opportunities for the international community to meaningfully address pressing TB and human rights issues, including drug resistance and the major funding gaps for critically needed, life-saving TB research. Concrete, meaningful and specific outcomes and actions to urgently increase funds are crucial to address these R&D issues (not to mention concrete actions to address the many additional human rights barriers to preventing, diagnosing and treating TB), lest the End TB Strategy, which aims to end TB by 2035, remains just another piece of paper.

 

Photo: Médecins Sans Frontières (MSF)

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

09.22.17

The Debate About Cultural Appropriation

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A simple definition of cultural appropriation is the idea of someone adopting something from a culture that is not their own.  At first glance, it appears that this is a harmless act.  Well, think again.  A deeper understanding of what cultural appropriation is digs up issues of whether it is offensive and even racist.  The idea of cultural appropriation generally involves a power dynamic and an unfair balance of power in which the appropriated culture has a history of being systematically oppressed by the dominating appropriating culture.

A prime example of this power dynamic is the Washington Redskins NFL team, which has been accused of cultural appropriation, particularly their mascot of an American Indian wearing a headdress.  American Indians have a long history of being mistreated and pushed off their land by white settlers in the United States, thus the use of the name, along with the mascot, serves as a harsh reminder  of the years of oppression and mistreatment suffered by American Indians.

 

The term Redskin is particularly offensive because of its origins.  There are debates about its origin but everyone agrees that it is offensive.  One explanation dates back to a time in history when colonial and state governments paid white people to kill Native Americans and were encouraged to cut off their scalps and even genitalia (“red skins“) to prove their “Indian kill.”  In this context, it is understandable why this term would be offensive to native peoples.  There are websites designed specifically to bring attention to this issue.  One in particular is called Native Appropriations and is dedicated to providing a forum to show how many  American Indian, Alaska Native, Native Hawaiian, First Nations, and other Indigenous Peoples disapprove of the Redskins in an initiative called “Natives Against Redsk*ns.”

The American Psychological Association (APA) recommends retiring the use of American Indian mascots altogether.   Studies have found that the stereotypical images are harmful to the self-esteem and development of American Indian students and that the portrayals have a negative effect on all students.

Urban Dictionary takes a completely different stance on the subject and defines cultural appropriation as: “The ridiculous notion that being of a different culture or race (especially white) means that you are not allowed to adopt things from other cultures.  This does nothing but support segregation and hinder progress in the world.  All it serves to do is to promote segregation and racism.”

So this begs the question: does the idea of cultural appropriation help or hinder racism and segregation, and is a dominant culture’s adoption of another’s culture inherently racist?

There is a big debate about this.  There is also a large spectrum of what is considered to be cultural appropriation.  For some people, white Americans walking around in traditional east African garb, for example, is considered cultural appropriation.  Others would argue it is a form of self-expression and shows appreciation and respect of another culture.  Alternatively, a white American wearing a sari to a traditional Indian wedding ceremony is considered by many not to be cultural appropriation, but instead is showing respect of the culture and tradition.

There are many other examples of cultural appropriation in main-stream media.  The Kardashian-Jenners, reality television stars and designers, have often been criticized for cultural appropriation.  Kylie Jenner, for example, has been called out on social media for posting a picture with her hair braided in cornrows, a popular hairstyle among black men and women.  More recently, Kendall Jenner was highly criticized for a Pepsi commercial she starred in that critics say trivialized, commercialized, and semi-whitewashed movements such as Black Lives Matter.  Kendall and Kylie were also targeted when their clothing line produced t-shirts with printed photos of dead rappers Biggie Smalls and Tupac Shakur with images of the sisters overlaid on the top.

 

It seems the debate often comes down to one’s intention and whether one is intending to appreciate the culture they are adopting or intending to mock or belittle it.  However, it isn’t always that simple.  It can be argued that many of the examples people use to define cultural appropriation did not intend to offend.  So, the real question should be whether someone from the culture that is being appropriated would be offended by the demonstration of their culture.  For example, if a white American male is debating whether or not to buy a t-shirt with an American Indian in a headdress on the front, he should ask himself if he thinks an American Indian would be offended by the shirt—or better yet, he should ask an American Indian what he finds the shirt offensive of his culture.

 

 

Posted in Uncategorized;

09.14.17

Chagas Drug Gets FDA Approval: A Victory over Shkreli-esque Pharmaceutical Price Gouging

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Left: Martin Shkreli (photo courtesy of The Source).  Right: A “kissing bug” (photo courtesy of Scienceline).

 

On August 29th, the U.S. Food and Drug Administration granted approval to benznidazole for use in children ages 2 to 12 years with Chagas disease. The approval is the first treatment of its kind to be approved in the U.S., and comes on the heels of a heated confrontation between advocates and pharmaceutical investors, including the now-jailed Martin Shkreli.

Chagas disease, or American trypanosomiasis, is caused by the Trypanosoma cruzi parasite and is transmitted by triatomine bugs, blood-sucking insects that have been given the horrific nickname “kissing bugs”, due to their tendency to bite (and subsequently feed upon blood from) people’s faces while they sleep. After the blood meal is taken, the bugs defecate infectious waste that easily can come in contact with victims’ eyes, mouth, or any open wounds. The disease can also be passed from mother to child during pregnancy, blood transfusions, and contaminated foods. It cannot be passed via direct transmission from person-to-person.

The acute phase of Chagas disease may be asymptomatic, but is otherwise mild: fever, fatigue, myalgia, headache, rash, loss of appetite, vomiting, and diarrhea. Swelling of the eye nearest the location of the bite is a marker for the disease. All these symptoms disappear within weeks, though 5% of young children experience severe infection or inflammation of the brain or heart muscle, which can lead to death.

The chronic phase of Chagas disease occurs decades later, when the parasite’s long-term presence within the body results in severe cardiac or intestinal complications that are irreversible, and can lead to death. These complications can include difficulty in digesting or passing food, irregular heartbeats, thinning tissues, and even heart failure. Persons infected with the parasite are 30% likely to suffer from these chronic symptoms later in life.

The disease is considered to be a neglected tropical disease (NTD), as it does not receive as much attention/funding as other diseases. Like other NTDs, it disproportionately affects the poorest people of the world. The triatomine bug vectors tend to inhabit domiciles made of more inexpensive and porous materials, such as thatch, straw, or adobe, which afford the insects a means of entering the homes and places to hide. Pharmaceutical companies are disinclined to produce treatments for NTDs as the most commonly afflicted persons cannot afford to pay for them, and thus costs are difficult to recover.

However, Chagas disease is a serious public health concern, as more than 60 million people are at risk for the disease throughout Latin and Central America, and more than 8 million people are infected with the disease. The CDC reports that more than 300,000 persons with T. cruzi infections are living in the U.S., though most of these people are assumed to have acquired the infections in countries endemic to the disease. A recent study of Latin-American born residents of Los Angeles county found that 1.24% tested positive for the disease.

The recently approved benznidazole can cure infants and young children with the disease with a 60-day course of treatment. Though it has been around for nearly fifty years and has received use in Central and South America, benznidazole had not been approved by the FDA for use in the U.S.; the CDC had been known to give it to doctors to dispense for compassionate treatment, but infrequently. In order to get the FDA to approve the drug, a pharmaceutical company needed to have registered it, and as previously discussed, this rarely happens with NTD treatments. This changed with respect to Chagas in 2015, when the FDA added the disease to the list of NTDs whose product applications could result in the award of priority review vouchers. Pharmaceutical companies that obtain these vouchers are able to fast-track production of applicable treatments… or sell these vouchers to other companies.  Enter Martin Shkreli.

Shkreli, whose reputation is arguably best known for his 2015 acquisition of Daraprim–a drug for treating different parasitic infections (toxoplasmosis and cystoisosporiasis)–and subsequent inflation of the drug price $13.50 to $750, also had his eye on benznidazole, for similar reasons. In fact, Shkreli’s investor group announced that they would increase the price of benznidazole 100-fold, to $63,000-$95,000, should they acquire the voucher.

Activists within the medical and public health communities have since made known that price-gouging tactics such as Mr. Shkreli’s have dire consequences for patients who need these drugs, and are nowhere near financially well-off enough to pay at such inflated prices. For benznidazole, a plan was developed by Drugs for Neglected Disease Inititative (DNDI), a non-profit that specialized in bringing drugs for NCDs to market. The plan involved partnering with Chemo Group, another pharmaceutical company that had tried to register benznidazole prior to Chagas being added to the FDA’s list. Chemo Group was persuaded to produce benznidazole and price the drug at or below cost. DNDI also partnered with a non-profit associated with Chemo Group, Mundo Sano Foundation, that would put half of voucher profits toward programs that diagnose and treat those infected with T. cruzi.

The August 29th awarding of Chemo Group the voucher to produce benznidazole in the U.S. accomplishes several things. It makes the drug available in the U.S. for use against T. cruzi infections. It also sets a benchmark for collaborative agreements between pharmaceutical companies and public health non-profits that are set on providing treatments for NCDs. Finally, the Chemo Group approval potentially sets a precedent for eliminating the loophole in the priority review voucher process that has been exploited by unscrupulous persons looking to profit off of drugs that help the poorest people in the world. Perhaps similar partnerships as the Chemo Group’s will see this precedence and emerge to take on approvals for other NCD drugs.

 

Posted in Uncategorized;

09.12.17

Taking health in all policies seriously: health impact assessments, WHO leadership, and international law

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Max Phillips (Jeremy Buckingham MLC)

[This blog was co-authored by Eric A. Friedman and Gian Luca Burci, and first appeared as a Lancet Global Health blog.]

Government approval of a new mining operation. A policy to deport undocumented immigrants. An international agreement that enhances pharmaceutical patent protections. All will affect health and health equity, but will policymakers factor these effects into their decisions?

The law could ensure that it becomes standard practice to assess and take into account anticipated health and health equity effects of significant policy decisions. These assessments can then inform the decisions so that they protect health and uphold people’s rights. This is beginning to happen through health impact assessments (HIAs), with several jurisdictions requiring HIAs in certain circumstances (see Panel at end). Environmental impact assessments (EIAs) remain the most common legal route to assess activities’ impact on health, though they often contain inadequate health analyses.

The potential of HIAs extends beyond protecting against policies that may undermine health to expanding health-promoting policies to better advance health and health equity. Can a program to provide schoolchildren with nutritious meals be extended to the most vulnerable children—those not in school? Does an initiative to build new urban parks locate them where opportunities for exercise are most limited?

EIAs provide a model for incorporating such analyses into law. The Convention on Environmental Impact Assessments in a Transboundary Context (CEIA) requires states to undertake an EIA for activities “likely to cause a significant adverse transboundary impact”, and to incorporate findings from the assessment and related consultations in their final decision.

A protocol to the CEIA extends the assessment requirement to the domestic realm. Meanwhile, in contrast to the handful of national requirements to conduct HIAs, by 2005 more than 100 countries had laws or regulations on EIAs.

It is time to bridge the gap between legal norms and the tremendous potential of HIAs. The importance of Health in All Policies is now universally recognized, with HIAs a critical tool to implementing this approach. The potential of HIAs to help ensure a coherent and fully integrated focus on human health across the diverse Sustainable Development Goal agenda is added reason for the rapid scale-up of HIAs. Meanwhile, expanding experience with HIAs, guidance from numerous jurisdiction, and emerging examples of domestic legislation provide ever-surer footing for international legal norms.

It is time, therefore, for states to negotiate a global legal instrument to establish common international standards on HIAs and ensure accountability to them. As in the environmental realm, the instrument that would best achieve this is an international treaty, although it may be a stepwise process to reach that point. In any case, the ultimate goal should be a solid, legally-based commitment among states to institutionalize HIAs, providing operational guidance and a framework for states’ accountability. And as with the CEIA in concert with its Protocol, the instrument should cover both policies with transboundary and those with only domestic effects. With the capacity to carry out HIAs varying widely, it will need to include commitments to capacity-building and international cooperation.

Guidance should include such issues as when HIAs are needed, any differences between HIAs with transboundary and with purely domestic effects, and possible conflicts between the findings of environmental and health impact assessments. The instrument should also address implementation of findings, process benchmarks, accountability and remedies for non-implementation, incorporation of HIA outcomes into policies, and an assessment of how implemented policies impact health and health equity.

Guidance can come from international practice on the right to health, as elaborated in General Comment 14 of the UN Committee on Economic, Social and Cultural Rights and subsequent legal developments. This could also inform how states should respond to HIA findings: ensuring that all policies conform to their right to health and other human rights obligations. EIA good practices could provide further guidance.

How HIAs are conducted is vitally important for their legitimacy, particularly the central role of the public and potentially affected communities. HIAs must not become technocratic or top-down exercises, but rather should consistently ensure the population’s right to participation “in all health-related decision-making.” Further guidance can come from the Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, with its provisions on facilitating early, effective, and informed participation, and ensuring that decisions take into account the outcome of the participation. An HIA legal instrument might go further still, facilitating participation and ensuring the free and informed consent of highly marginalized communities.

In its role of global health leader, WHO should take the lead in developing this instrument. Newly elected Director-General Tedros Adhanom Ghebreyesus should include a legal instrument on the HIAs among his priorities. His stated commitment to the right to health and health at the center of global policymaking is encouraging in this respect. The potential of HIAs to move people’s health and rights nearer the center of policy considerations is too great to leave that potential untapped.

Panel: Institutionalizing health impact assessments

Countries with laws requiring health impact assessments:

* Thailand (constitutional requirement for an HIA and public hearing for projects or activities that may seriously affect health, while the National Health Act empowers individuals to request and participate in upon an HIA for a public policy)

Slovakia (Public Health Act empowers public health authorities to require HIAs for development and other projects that may have possible negative effects on public health)

Lithuania (Law on Public Health requires a public HIA to commence or expand economic activities that pose a risk to human health)

Sub-national jurisdictions with laws requiring health impact assessments:

* USA (multiple states have laws requiring HIAs or broader assessments that may encompass health, in sectors including the environment, energy, transportation, food and agriculture, and waste disposal)

* Canada (Quebec’s Public Health Act requires the province’s health minister to be consulted on laws and regulations that may significantly affect the health of the population, a requirement that has led to an inter-ministerial HIA mechanism)

* Australia (Victoria’s Public Health and Wellbeing Act authorizes the state’s minister of health to require the health ministry to conduct an HIA)

A number of other countries have health agencies that are actively promoting HIAs. Among them are FinlandNew ZealandSwitzerland, the UK, and the USA.

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

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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