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: , , , , , .

09.06.17

I am the DREAM my ancestors dared to dream: Rescinding DACA makes the American “Dream” a mere fantasy

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Mola folk art of the indigenous Guna people of Panama.

(SPECIAL THANKS TO MY COUSIN XENEIDA FOR INSPIRING THIS ARTICLE. TE QUIERO MUCHO, PRIMA!)

First, let me state for the record that I was born in a hospital in Queens, New York in the U.S. of A, and I have the long form birth certificate to prove it, so no need to open that link to ICE’s online tip form. Now that we’ve cleared the air, I will also mention that my parents were immigrants to the United States from Panama. Their grandparents were immigrants to Panama from various different countries around the turn of the 20th century. The impetus for these immigration journeys were all the same: seeking a better life and opportunities for themselves and their family.

Many members of my family immigrated to Panama from Caribbean islands like Dominica and Grand Cayman to work on the building of the canal in the early 20th century. They were foreigners to the country. They didn’t speak the language. Some were of African heritage, and had darker skin than the European descendants and indigenous Panamanian natives. Their contribution to the workforce was integral to the completion of the canal and the economic prosperity of the country. Still, my ancestors were ostracized, discriminated against, degraded, called “chombos” (Spanish slur similar to the ‘n’ word), and largely relegated to segregated neighborhoods. There were regular calls for them to go back “where they came from” without any regard for their earned right to citizenship in Panama or the contributions they made to the country’s prosperity. Despite this adversity, they persevered. Most of the elders lived and died in Panama having learned little to no Spanish, but, if the opportunity arose, they sent their children to “Spanish” schools so they could better assimilate. As time went on, these assimilated descendants became assets to the governmental and commercial operations of Panama. The canal remained under U.S. control until 1999, and English is the universal language of commerce, so these naturally bilingual citizens held key positions in trade and government management, including working for the U.S. government and in the Canal Zone international commercial trade region. However, as time has passed, fewer and fewer of these “Zonians” (those who came to work on the Canal/in the Canal Zone) and their descendants speak English, having embraced Spanish as their sole language. I recall as a child during my yearly summer visits to Panama in the 1980s that I could all but guarantee that I could speak English to a dark-skinned Panamanian and they’d respond in kind. This comforted me and allowed me to reserve my New York accented/rusty Spanish for emergencies only. However, on my most recent visit to Panama this June after a 20 year hiatus, this was no longer the case. English is spoken far less frequently now, spurred both by the absence of the American government, and the assimilation of English-speaking immigrant groups into the Panamanian culture. Hmm…. where have I seen this phenomenon before?  Maybe during my childhood attending Catholic school in Brooklyn with a bunch of Italian-American kids whose mastery of Italian was reduced to the names of culinary dishes and curse words???  But, I digress…

My family’s ability to build a life in Panama and benefit from the opportunities of employment and education allowed for the second half of my family’s immigration experience. My father was able to work and save enough money to bring himself to the U.S. to attend college at Bowie State University. He went to classes during the day and worked as a busboy at night in a DC restaurant. Although he told me this story several times, it is still impossible for me to conjure an image of my dapper, never a hair out of place, NEVER owned a pair of jeans father bussing tables. But, he did what he had to do to make a better way for himself and the family he hoped to have with my mom. She eventually came to the U.S. as well, as did her sisters and my grandmother. Most of my generation – myself, my sister, and my cousins – were born in the U.S., but embrace our Afro-Panamanian heritage con mucho orgullo (with great pride).

But wait, this is a global health blog. How does this article relate? I am glad you asked. Global implies “international,” and addresses the health issues of people from varied cultures, backgrounds, and perspectives. That is what we do here at The O’Neill Institute, and we are some of the best in the business. Our expertise is informed by the international composition of our staff. Most of us are either the children of immigrants or immigrants ourselves. We appreciate the advantages afforded to us from living, being educated, and working in the U.S., and want to return the benefits to improve the lives of others throughout the world. I can attest to the fact that I do not take my good fortune for granted. I know what my family endured to get me where I am, and I feel that I owe it to them and to those still striving to make their way to pay it forward.

The American Dream is not reserved for a selected few. Nor is it sought arbitrarily by those working to get to America or to stay here. It is a matter of life and death for some fleeing war-torn countries. It is a future for themselves and their children that their ancestors could never fathom was possible. Those who have grown up in the United States deserve to become citizens, because it is the only home they’ve known. The story of immigrants IS The American Story, because America’s strength will only endure if it learns how to embrace all people and work together on a common mission to ensure liberty and justice FOR ALL.

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

08.29.17

The Hillside by Freetown: Terror of Another Sort

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Homes not built to last. Image from the Freetown mudslide courtesy of Ernest Henry/Reuters.

I have not yet heard back from a friend in Sierra Leone. I wrote to him after the devastating mudslide on the outskirts of Freetown early on the morning on August 14. I’m not too worried though. He is serving as a magistrate, working to construct a judiciary that advances human rights. I don’t think he would have lived in the shacks on the side of a hill. I don’t think he was poor enough to be a victim of that act of terror that left so many hundreds dead and threw a country into deep mourning.

An act of terror in Sierra Leone? Was this a terrorist attack? Were not all those who perished victims of heavy rains and the mudslide they caused victims of nature’s random wrath, not the violence of a perverted ideology?

This terror was indeed of another sort. It lacks a defining feature of terrorism, the malevolent intent of terrorists, to kill and maim and cause the terror and fear that come from guns, bombs, knives, speeding cars, exploding planes. But this other terror bears more similarities to terrorism than may first appear. Not caused simply by inevitable random act of nature, it too has human roots. It too has perpetrators who bear responsibility and have worldviews that enable these horrors. It too has a set of victims who are not as random as it may appears. And as with terrorism, there is much we can do to mitigate the harm caused, and even to help avoid the terror altogether.

This is the terror experienced by the families of Freetown, by the 230,000 killed in the 2010 earthquake in Haiti and those still struggling to rebuild, and by those who could not escape Hurricane Katrina in New Orleans. Why did they live where they did, where they would be the ones who perished and suffered? Why were least likely to escape nature’s course? The victims of these “natural disasters” share the common bond of being people living in precarious situations, with the fewest means to escape or live otherwise.

The victims of the Sierra Leone mudslide, which likely killed some 1,000 people, had been pushed to Freetown’s edge as the city’s population swelled, creating informal settlements (aka slums) of “mud huts and corrugated steel shelters” (or “little shacks and tin houses,” by another account). No one should have had to live there. An environmental group had warned of the dangers and even planted trees to try to prevent just this sort of disaster, but as the group’s leader later observed, “People, especially those with political influence, built houses in the very areas where we planted the trees.” The Sierra Leone mudslide came two days before a similar disaster in the fishing village of Tora in a northeast province in the Democratic Republic of Congo, killing at least 150200 people.

In Haiti, the fact that a strong earthquake struck so near the capital city of Port-au-Prince was a precondition of the enormous death toll, but that did not make it inevitable. The type of housing that most of the victims lived in was the other necessary factor – “poor and densely packed shantytowns and poorly constructed buildings” – the housing of the poor. And with corruption leading to shortcuts in construction, the housing was even worse than it would have otherwise been. Better construction could have “lowered the death toll enormously.”

And we remember the story of New Orleans. Who did not escape before portions of the city was laid to waste by the rising waters? Overwhelmingly, people who were black, less well educated, poor. They were the people without cars, people whom the city left behind. A disproportionate number suffered from some disability. Many of those who died were elderly. And as Hurricane Harvey pours rain and fear upon Houston and surrounding areas, people in poorer communities of color, people with disabilities, undocumented immigrants, and people who are homeless face the greatest risks.

Surely all these victims felt terror, those who woke to the roar of an encroaching mountainside only to have their own lives silenced in moments, those who experienced the world shaking before their world crumbled, those who watched the waters’ rapid rise but had no place to run to, no means of escape. They are representative of a more common terror not born of sudden cataclysms, but rather the daily terrors of parents who do not know whether their child can survive another day without food or drinkable water, of the mother who does not know whether she will survive the birth of her child, born in the worst of conditions, of the family whose members fear for their lives when stepping into the violent streets outside their homes but who cannot afford to live anywhere else.

Terrors come in many forms. We read most often of the terrors experienced by people targeted by their associations to certain symbols of power or economic engines – the World Trade Center in New York, the Parliament in the United Kingdom, the cafes and hotels of the middle- and upper-classes, or wealthier tourists, in Burkina Faso and Bangladesh, people attending the Bastille Day celebrations in France, and now walking along with other tourists and residents on Las Ramblas in Barcelona. The awfulness of this terrorism cannot be overstated, the dozens, hundreds, thousands of lives extinguished, virtually instantaneously, after an unthinkable moment of panic, or after prolonged suffering, victims of a cruelty that is difficult to comprehend.

We pay attention not only because of the shocking levels of depravity behind these attacks, but also because we see ourselves in the victims of these attacks. We pay less heed, too often, to terrorist attacks that are further removed from most of our lives, in countries where they seem to form a frightfully regular backdrop to daily life, in countries and regions experiencing war and conflict, like Syria, Iraq, Afghanistan, Pakistan, and Nigeria. As for those other terrors, without such clear perpetrators – for who is responsible for poverty, much less a random act of nature? – these seem to exist in a separate category altogether.

Yet not unlike terrorist attacks, the victims of this other sort of terror are not randomly selected. Only instead of being foreigners or people of the wrong religion or sect or people of a particularly hated country, they are poor and have little economic and political power. And though there is no mastermind criminal plotter or man with a gun or driving a truck, no readily identifiable twelve person terror cell, no organization of terror or hate to which they belong or that claims credit for the carnage, still there are perpetrators who bear much responsibility. They are those who contribute to the systems that perpetuate poverty and marginalization – individuals and groups who hold political and economic power but fail to use that power to redress these injustices, and through their policies and actions (and perhaps corruption), only serve to reinforce them. And they also hold ideologies and worldviews that drive their actions, a perverted understanding and acceptance of a world that allows deep inequalities to persist, perhaps even some sense of superiority, if not of race or religion, than of us over them, of me over you.

So as we look to prevent future acts of terror, let us consider both kinds of terrors – those stemming from hate and the noxious ideology of superiority of one’s race, religion, or ethnicity over another, but also the terrors that originate in social, political, economic, and environmental injustices, terrors born of indifference, of the misuse and misapplication of power, of wealth and greed, and of the all the root causes of poverty. Both terrors reflect a lack of humanity, compassion, and empathy, and an indifference to the value of human life. The solutions in each case are different, but the urgency to act decisively and quickly is ubiquitous and constant. As we commit to doing all we can to prevent another Charlestown, another Barcelona, more bombs in Baghdad and Kabul, let us also commit to doing all we can to prevent another Freetown, another Tora, and the too frequent terrors of poverty that they tragically — but not inevitably — represent.

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

08.28.17

Flooding in Freetown: a Post-Ebola Catastrophe

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Flooding is turning out to be a major news story this month. At the time of this publication, the catastrophic flooding in Houston has displaced thousands, and at least five are reported dead.  Meanwhile, in Freetown, the capitol of Sierra Leone, people are still searching for the missing after a mudslide and flood that has left an estimated 1,000 dead. What is taking place in Houston is an epic-sized natural disaster, and we are watching it unfold in real time. The city will need years to fully recover, and there will be people that will never recover their belongings or their homes.  However, as you watch on TV as families are airlifted out of homes to safety, or as shelter and hot meals are provided to Houstonians, think about how fortunate we are in this country to have infrastructures in place that allow us to respond to natural disasters. Think of Freetown.

Sierra Leone is one of the poorest countries in the world – the World Bank ranks it #174 out of 187 in GDP per capita (that’s 13 places from the bottom of the list). The World Health Organization ranks Sierra Leone last in life expectancy among all countries – the average Sierra Leonean is expected to live 50.1 years. These characteristics, among others, are the result of many factors, not the least of which include a brutal civil war that took place from 1991-2002, and the world’s worst Ebola outbreak that took place between 2013-2016. When these factors are combined with poor road/housing construction and an enormous amount of rainfall, the effects are catastrophic.

Freetown, in addition to rebuilding communities and locating missing persons, must now focus on the inevitable aftermath of flooding in developing countries. Cholera outbreaks are a near certainty, as drinking water and waste water have likely been cross-contaminated, and corpses have been lying in the flooded streets. Mosquito-borne illnesses, such as yellow fever and malaria, are likely to spike as breeding areas become more prevalent, and persons are displaced from their protective shelters.  Finally, there is the chance of more mudslides, compounding these problems, and setting back restorative efforts. The displaced in Houston are truly fortunate to not have to face these challenges.

The mudslide and flooding in Freetown have hit especially hard in the lingering shadow of the Ebola outbreak. Communities that have lost so much and faced such terror are now confronted with more loss and more terror. In the next few weeks, as you read about and think of Houston, please think, too, of Freetown.

 

Posted in Global Health;

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