I would like to discuss the O’Neill Institute’s contribution to a recent public comment. The content of the public comment will be reviewed by the U.S. Preventive Services Task Force (USPSTF), but also may be of interest to general audiences. On March 22, 2017, Jeffrey S. Crowley and I partnered with researchers at The Fenway Institute and Emory University’s Rollins School of Pubic Health to submit comments on the USPSTF’s draft research plan for the use of pre-exposure prophylaxis (PrEP) in preventing the transmission of HIV. Once finalized, the research plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center and will form the basis of the USPSTF’s Recommendation Statement on PrEP. While it may take several months or even years before the USPSTF makes its final recommendation, we submitted comments to inform the process and encourage the USPSTF to consider specific issues and relevant evidence within its research plan. PrEP is an important HIV prevention tool, and the USPSTF’s recommendation has the potential to make PrEP more accessible to individuals and communities most impacted by HIV.
The USPSTF is a federally-appointed independent body of physicians and other experts that conducts evidence-based reviews of various prevention interventions. Once the USPSTF conducts a review, it provides a rating: An A or B rating means that the evidence is strong in support of an intervention, whereas a rating of a C means that an intervention is recommended, but that the evidence for it is weak. Medicare and health plans operating on health insurance marketplaces in accordance with the Affordable Care Act are required to provide prevention services free of enrollee cost-sharing for all interventions with an A or B rating by the USPSTF. Medicaid programs are encouraged to extend the same coverage, although state programs have the discretion to make their own coverage determinations.
Based on the draft research plan posted for public comment from February 23, 2017 through March 22, 2017, the USPSTF seeks to assess the benefits of PrEP use and how these benefits differ by regimen, dosing strategy, and population sub-groups. It also aims to assess rates of adherence and how adherence impacts the effectiveness of PrEP.
Our comments highlight research completed and underway. While it may be appropriate for the USPSTF to consider a range of PrEP agents in the future, we recommend that the USPSTF limit its current review to evaluating clinical effectiveness of oral tenofovir disoproxil fumarate and emtricitabine (TDF-FTC), the medication approved by the U.S. Food and Drug Administration in 2012 for use as PrEP for HIV prevention. Beyond assessing the effectiveness of PrEP regimens, the comments encourage the USPSTF to place emphasis on looking at how different population sub-groups benefit from PrEP. This is particularly important, given that certain population sub-groups (men who have sex with men, transgender people, and heterosexual women in communities with high HIV prevalence, i.e. Black and Latina women) are particularly at risk in the U.S. The comments also note that consideration should be given to a recommendation for persons that self-identify to their providers as being at high risk of HIV infection, which may be particularly important in the context of population sub-groups.
With respect to adherence, our comments emphasize that adherence rates should only be systematically reviewed from studies powered and designed to test the effectiveness of PrEP, not studies designed to demonstrate the initial efficacy of PrEP. Efficacy studies may demonstrate substantially lower adherence because researchers and participants do not know if the drug will produce the intended outcome even with perfect adherence. Placebo-controlled trials, for instance, have been found to have lower rates of adherence than primary care-based service delivery. Adherence counseling and support interventions can also increase adherence.
Given that the USPSTF has the potential to greatly facilitate access to PrEP, the O’Neill Institute will continue to work with partners on subsequent public comments. For more information on this work, please check out our webpage.
This post was written by Andrés Constantin. Andrés is an Adjunct Professor of Law at Universidad Torcuato Di Tella. Any questions or comments can be directed to firstname.lastname@example.org.
The opportunity has presented and it is time to seize it
The ruling party in El Salvador, Frente Farabundo Martí para la Liberación Nacional (FMLN) has proposed a law decriminalizing abortion in cases where the mother’s life is in danger or where the pregnancy is the result of rape to the Parliament.
It has been almost two decades since El Salvador criminalized abortion in all circumstances, despite the global commitment at the International Conference on Population and Development to prevent unsafe abortion. The criminalization of abortion forces women and girls to resort to unsafe abortions to save their own lives. Consequently, since 1998, women have been prosecuted and convicted on charges of induced abortion with sentences of up to 40 years imprisonment.
The health and human rights impact of restrictive abortion laws is devastating on women’s and girls’ life, leaving them at risk of preventable maternal deaths. Evidence shows that between 8% to 18% of maternal deaths worldwide are due to unsafe abortion. Indeed, the World Health Organization has noted that maternal mortality increases in countries that criminalize abortion. In a 2012 report on maternal mortality, the UN Human Rights Council noted that “[i]f abortion laws are overly restrictive, responses by providers, police and other actors can discourage care-seeking behavior,” leading women to choose between prison or death.
In this post, due to words constraints, I will just focus on the impact of criminalization of abortion on women’s right to life.
Decriminalization of abortion is necessary for the respect of the women’s right to life
El Salvador has ratified a number of human rights instruments, thus undertaking a legal obligation to protect and guarantee human and women’s rights, in particular. Moreover, the Salvadorian Constitution provides for the protection of the right to life, liberty and health, and further considers international treaties as laws of the country.
The right to life has been recognized as part of customary international law and is provided in several international and regional human rights treaties. In that sense, article 6 (1) of the International Covenant on Civil and Political Rights (ICCPR) provides that: “Every human being has the inherent right to life. This right shall be protected by law. No one shall be arbitrarily deprived of his life.” In 2011, the Special Rapporteur on violence against women stated that the total ban on abortion in El Salvador puts women’s and girls’ lives at risk, constituting a violation of the right to life.
Whereas some opponents of abortion have resorted to Article 6(1) in order to argue that the right to life includes the fetus, and consequently abortions violate this right by ending the life of a fetus, it must be noted first that it is generally recognized that international human rights conventions are not applicable before birth of a human being, and second that during the drafting of the ICCPR, a set of proposals protecting the right to life from the moment of conception were rejected and it was understood that Article 6(1) of the Covenant stipulates that the right to life is inherent to the “human being” understood as the person that is born.
Likewise, the CEDAW Committee, the body that monitors compliance with the Convention on the Elimination of All forms of Discrimination against Women (CEDAW), has stated that “unsafe abortion is a leading cause of maternal mortality and morbidity. As such, States parties should legalize abortion at least in cases of rape, incest, threats to the life and/or health of the mother, or severe fetal impairment, as well as provide women with access to quality post-abortion care, especially in cases of complications resulting from unsafe abortions. States parties should also remove punitive measures for women who undergo abortion.”
Similarly, the Committee on the Rights of the Child, which monitors the implementation of the Convention on the Rights of the Child, has urged States to “decriminalize abortion, ensure that girls have access to safe abortion, review legislation with a view to guaranteeing the best interests of pregnant adolescents, and ensure that their views are always heard and respected in abortion decisions.”
Moreover, the Committee on Economic, Social and Cultural Rights, which monitors compliance with the International Covenant on Economic, Social and Cultural Rights (ICESCR) in its General Comment No. 22 (2016) on the right to sexual and reproductive health, noted that denial of abortion often leads to maternal mortality or morbidity, which in turn constitutes a violation of the right to life or security and expressed its deep concern regarding the general prohibition of abortion with no exceptions.
Additionally, the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health noted that an “absolute prohibition [of abortion] under criminal law deprives women of access to what, in some cases, is a life-saving procedure” and recommended that states decriminalize abortion.
At this point, we should recognize that it is true that the American Convention on Human Rights provides the right to life from the moment of conception. However, Article 4 has been interpreted by both the Inter-American Commission on Human Rights and the Inter-American Court of Human Rights. The Commission, in 1981, found that the Convention’s founders “left open the possibility that states parties… could include in their domestic legislation ‘the most diverse cases of abortion’.” For its part, the Court stated that “it can be concluded from the words ‘in general’ that the protection of the right to life under this provision is not absolute, but rather gradual and incremental according to its development, since it is not an absolute and unconditional obligation, but entails understanding that exceptions to the general rule are admissible.”
Article 144 of El Salvador’s Constitution provides that in cases of conflict between domestic and international law, the latter should prevail. The Salvadorian Law prohibiting abortion in all circumstances clearly violates both El Salvador’s domestic and international obligations to protect women’s right to life. It is time for El Salvador to pay close attention to article 144 of its own Constitution and meet its international legal obligations.
Photo 2 source: pinterest.com
Posted in Human Rights;
If you were in New York City and its environs in the weeks and months after September 11, 2001, as I was – or, I expect, just about anywhere in the United States – you will recall the American flags in the storefront windows, outside homes, everywhere really. Those banners of solidarity reminded us, as one song of the time had it, we were all Americans. It was a time of solidarity in our unity, in our oneness. It was time of our national motto, e pluribus unum – out of many, one – with an emphasis on the unum.
I was reminded of this not long ago when I saw another window display in New York, at a synagogue in midtown Manhattan. It spoke of another kind of solidarity. “Our Diversity Is Our Strength,” read one sign. “Gay and Jewish Here!” proclaimed another. “Jews Support Our Muslims Neighbors,” affirmed a third. This was solidarity for modern times: solidarity in our diversity.
This is the solidarity of peoples who will not be divided. It a type of solidarity the global health movement knows well. Think of “I am HIV positive” t-shirts, worn by people living with HIV/AIDS — and by people without HIV, standing in solidarity.
And it is the type of solidarity we need now, to counter policies and rhetoric in the United States that would divide us, and further marginalize the marginalized. And what a toll these policies are taking. Research a few years ago revealed that “in families with one or more undocumented parents, the threat of detention and deportation is harming the mental and physical health of their children.” These effects included being twice as likely as other children not to have access to medical care and high rates of symptoms consistent with post-traumatic stress disorder. How much worse all this must be now, with no undocumented immigrant feeling safe from the threat of deportation. Another study reported similar findings and others, such the high likelihood that children of an undocumented parent who has been deported or detained will have insufficient food. This second study also found that partners of undocumented immigrants who have been deported have a lower income that is associated with a shortened lifespan.
Immigrants with legal documents, particularly Latinos, in California and elsewhere are canceling or not applying for the Supplemental Nutrition Assistance Program despite qualifying. They fear that legally present immigrants who access public assistance programs are next up for deportation, or that using public assistance programs will reduce their chances of becoming citizens. And they are reacting to the general atmosphere of fear from raids by the Immigration and Customs Enforcement agency. Health consequences of food insecurity include “increased rates of depression, diabetes and other chronic illnesses, and mental and behavioral problems in children.”
Like the signs in the New York synagogue, there are things we can all do, from speaking out and political activism to visible displays of solidarity, like posting our own signs, or waving flags proclaiming our oneness (rainbow flags, flags celebrating our diversity [in Spanish]), or wearing t-shirts of solidarity (how about taking a page from the HIV movement: “I am an undocumented immigrant, and America is my home”), to take a few possibilities.
There are also things that those of us in the health sphere can do. Along with speaking out against policies that harm people’s health – a failing of the obligation to respect the right to health, among other rights – and always ourselves being respectful towards all people, we can promote health policies and tools that reflect unity in our diversity. National health equity strategies could lead to comprehensive strategies to advance health equity, addressing each marginalized population and covering not only the health sector, but also all other spheres of life that are part of the social determinants of health. Regular use of health impact assessments – even where now rarely used, such as for immigration policies – would at the least make transparent the health harms of divisive policies, and may go a step further in insisting on a different approach. Globally, a Framework Convention on Global Health could embed approaches such as these into international law, and help create the spaces where those who now face disparagement and discrimination can make their voices heard.
We are one, and we are many. That is our strength. If we let the tempest of our time toss aside some of us, we let today’s storm toss us all into the sea of inhumanity. And that is why, if we are to stand for humanity, we will stand for each other.
Posted in Global Health, Human Rights, National Healthcare; Tagged: diversity, fcgh, Framework Convention on Global Health, health impact assessments, immigrants, national health equity strategies, SNAP, solidarity, unity.
Anyone who follows U.S. public health issues – or who reads my blog posts – knows that the cost of the drugs needed to treat Hepatitis C infections is very high. The cost of these drugs is of particular concern to state health authorities who are charged with providing health care for Medicaid recipients and the incarcerated. The result is many states limiting access to treatment only to Medicaid recipients with advanced liver damage, and not making treatment available at all to those incarcerated, despite a high prevalence in this population. Louisiana estimates that it would cost the state $764 million to treat all of 35,000 residents who depend on state-funded healthcare, which would account for a quarter of the state’s $3.6 billion health care budget. This cost is prohibitive to the state, so the health officials thought through possible options. After consultation with public health and legal authorities, Louisiana has proposed that the federal government use a 1910 patent law that allows regulators to appropriate inventions, such as pharmaceutical drugs, for the use of the greater public good. This would mean that the federal government would take exception to the general patent exclusivity given to pharmaceutical manufacturers, which allows them to control the pricing and manufacture of a drug formulation for 20 years from the initial patent application date.
28 U.S.C § 1498 and the Federal Government’s authority to ignore patent rights
(DISCLAIMER: To my lawyer friends and colleagues reading this, this is a simplified explanation of the laws and policies at issue. Do not take me to task for a lack of complex statutory interpretation.)
The law at issue is 28 U.S.C.§ 1498. It is a federal judicial procedure law that outlines the legal remedies available to a patent holder whose patent was breached by the U.S. Government. The law states, in summary, that the holder can sue the government for “reasonable and entire compensation for such use and manufacture.” So, if the U.S. were to utilize the patent information to manufacture an expensive drug – such as one of the patent-protected Hepatitis C treatments – the government would only need to pay the pharmaceutical company compensation for the manufacturing costs for the quantity the government diverted to a generic manufacturer under the breach, rather than the company-set market price for the quantity of the drug the government had manufactured.
The Takings Clause
The 5th Amendment of the U.S. Constitution provides, in relevant part, that the government cannot take private property for public use without providing just compensation. This Takings Clause describes the government’s right to claim eminent domain over all property within the United States if extenuating circumstances require such action. 28 U.S.C. § 1498 outlines the Takings Clause as applied to patents and copyrights. The law codifies the means (lawsuit) by which a patent holder can take against the government to address the breach, and the compensation to which he would be entitled.
The principle of Sovereign Immunity is that a government, or sovereign, cannot be sued in its own courts unless it expressly consents to do so. While this rule does not appear in the U.S. Constitution, it is inferred based on the principle that the government is what creates the courts to begin with, so the courts cannot compel the entity under whose authority it falls under. Think of it as workplace insubordination: as much as some employees would like to be the ones imposing rules over their bosses, that is not how the system is set up. In 1910, Congress passed 28 U.S.C. § 1498 to expressly state that the U.S. agrees to be sued in this type of patent breach matter, thus allowing a party to sue the federal government for compensation.
Prior Uses of 28 U.S.C. § 1498
The idea of invoking this statute to address high drug prices is not a novel one. This statute has been used in many times in the U.S., usually in a National Security context. The Department of Defense used the law to procure drugs in the 1960s and 1970s for millions of dollars cheaper than the patent holder’s price. Most recently, the U.S. Dept. of Health and Human Services (HHS) threatened to invoke Section 1498 to procure the antibiotic Cipro, the main drug used to treat Anthrax, which had become a public health and bioterrorism concern immediately following the attacks on 9/11.
Negotiation v. Litigation
Pharmaceutical companies have addressed the threat to their bottom line posed by Section 1498 by lobbying for the limited use of the law to only when national security requires it. Most companies have opted to enter into negotiations with government health authorities to bring down prices. It is unclear to what extent Louisiana has negotiated with manufacturers to get the drug costs down to a manageable amount.
It is clear that the state of Louisiana sees its Hepatitis C crisis as a public health priority, and in my Hep C policy world, that is great news. However, that is overshadowed by the apparent helplessness it feels to properly address the issue. Invoking Section 1498 should be seen as a last resort, and the proposal of such will hopefully motivate all relevant parties to come back to the negotiating table to allow the state to gain access to these life-saving treatments at a more manageable price.
(For further reading on the use of Section 1498 to acquire HCV drugs, see http://yjolt.org/sites/default/files/Kapczynski_18YJoLT275_gk_0.pdf)
Forty years ago, in June 1977, a nine-year old girl died of acute hemorrhagic fever at a hospital in Tandala, Zaire (now the Democratic Republic of Congo).[i] Her post-mortem blood sample arrived at CDC-Atlanta nine days later, and despite the lack of refrigeration during shipping and its subsequent bacterial infection, scientists were able to positively identify the Ebola virus disease as the cause of death.
This new outbreak in Tandala – despite being defined as a single fatal case – and its subsequent investigation were significant in broadening our understanding of this new and horrible disease. This was the first naturally-occurring outbreak since Ebola was discovered and named nearly six months prior during the simultaneous outbreaks of Nzara, southern Sudan (now South Sudan) and Yambuku, northern Zaire, which killed more than 400 people.[ii][iii] (NB: Another case of Ebola had since occurred by laboratory infection in England due to accidental stick of contaminated needle, but the single individual recovered.) To this day, scientists have been unable to determine any linkage between the Nzara and Yambuku outbreaks; in fact, they would not discover that they were separate outbreaks of two different strains for another four years, so in 1977, the virus was still “Ebola”.[iv]
First, the Tandala outbreak extended Ebola’s endemic zone almost completely across the width of northern Zaire, along the Zaire (now Congo) River basin. The distance between Nzara and Yambuku is about 450 miles; the Tandala outbreak took place an additional 200 miles west of Yambuku in northwest Zaire. Tandala informed us that the previous outbreak was not just “a lightning strike”, and that the disease had a presence in the region.
Second, the epidemiological investigations that took place following the Tandala outbreak revealed that the virus had been circulating in the area, both before and after June 1977. One such investigation that took place from late 1977 to early 1978, found that two suspect cases at Tandala Hospital matched the case definition of Ebola, retrospectively, but no laboratory samples had been obtained from the two individuals, who had died in November and December 1977, six months after the June case. A family member of one of the deceased had been ill with similar symptoms and survived. Serum testing on the survivor revealed Ebola antibodies.
Additionally, investigators obtained serum specimens that had been drawn from missionaries in February 1977, four months prior to the June case. One of these individuals’ samples tested positive for Ebola antibodies. The individual, a Tandala Hospital physician, described being sick from Ebola-like symptoms in May 1972, five years prior to the June case, and almost four years prior to the Nzara-Yambuku outbreak. The physician, whose hospital records backed up his story, had lacerated his finger during the autopsy of another person who had died from a hemorrhagic illness that had been clinically diagnosed as yellow fever.
Finally, the investigation surveyed the area proximal to Tandala for historical or serological evidence of Ebola. After obtaining blood samples from 1,096 people from nearby villages, 79 individuals (7%) were found to have Ebola antibodies, despite no one being able to give an account of clinically severe Ebola disease.
After Tandala, there would not be another Ebola outbreak until July-October 1979, nearly two years later. That outbreak would take place, amazingly, in Nzara, the same Sudanese village from 1976… but, that is a story for another time.[v]
40 years ago, Tandala showed us what we had been missing – the Ebola virus had been circulating for some time both before and after the 1976 outbreak, and in a wider area than previously known. Similarly, we are continuing to learn more in hindsight about other diseases that are affecting us today; a recent discovery has shown that Zika circulated freely and silently in West Africa for the last twenty years,[vi] and research is forthcoming that the virus circulated in Central Africa 35-45 years ago[vii]. These discoveries allow us to understand more fully the footprint of diseases, and stress the importance of looking backwards, as well as forwards, in order to best understand how to prepare for and detect disease outbreaks.
Tandala also showed us that the 1976 Ebola outbreak was not a “one-off”, and that we should be ready for it to emerge again. Today, we continue to emerge from the shadow of the 2014-2015 West African Ebola pandemic, the most catastrophic outbreak yet. Despite all we have learned about the virus in the last 40 years, there is still much we do not know, and are racing to discover, such as its natural reservoir, and how to vaccinate for and treat Ebola virus disease. Forty years and nearly thirty Ebola outbreaks later, we are still coming to terms with what we learned in Tandala in 1977.
[i] Heymann DL, Weisfeld JS, Webb PA, Johnson KM, Cairns T, Berquist H. 1980. Ebola Hemorrhagic Fever: Tandala, Zaire, 1977-1978. J Infect Dis. 142, 372-376.
[ii] WHO. Ebola haemorrhagic fever in Sudan, 1976. Bull World Health Organ. 1978;56:247–270.
[iii] WHO. Ebola haemorrhagic fever in Zaire, 1976. Bull World Health Organ. 1978;56:271–293.
[iv] Cox NJ, McCormick JB, Johnson KM, Kiley MP. Evidence for two subtypes of Ebola virus based on oligonucleotide mapping of RNA. J Infect Dis. 1983;147:272–275.
[v] Baron RC, McCormick JB, Zubeir OA. Ebola virus disease in southern Sudan: hospital dissemination and intrafamilial spread. Bull World Health Organ (1983) 61(6):997.
[vi] Bobby Brooke Herrera, Charlotte A Chang, Donald J Hamel, Souleymane Mboup, Daouda Ndiaye, Godwin Imade, Jonathan Okpokwu, Oche Agbaji, Amy K Bei, Phyllis J Kanki; Continued transmission of Zika virus in humans in West Africa, 1992-2016. J Infect Dis 2017 jix182.
[vii] Saluzzo JF, Miller J, Vincent T, and Gonzalez JP. 2017. A “Zika” Odyssey: A Case Study of Arbovirus Discovery (Central African Republic 1973-1983). Manuscript in preparation.
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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.