JAMA Forum: Tackling the Ebola Epidemic

Lawrence Gostin, JD

Lawrence Gostin, JD

The Ebola virus epidemic in West Africa is now out of control, but it shouldn’t have come to this. Ebola virus disease (EVD) is a preventable disease, but the current epidemic is challenging efforts to contain it. Previous outbreaks that have occurred since the virus was first detected in 1976 have been confined to rural areas. This time, EVD has reached the urban landscape, with people and animals congregating together. Extensive travel across land borders and by air is furthering its spread.

Why Ebola Is Out of Control

The most affected countries—Guinea, Liberia, and Sierra Leone (with recent spread to Nigeria, which currently has a dozen cases)—are ranked lowest in global development and do not have the basic infrastructure to contain the Ebola epidemic. Even with international help, it will take at least 6 months to bring the crisis under control, according to Médecins Sans Frontières/Doctors Without Borders. For now, Ebola is spreading unchecked because of such factors as fragile health systems in resource-poor countries, cultural practices, and deep-seated distrust.

Broken Health Systems

Being treated or working in a hospital in affected states is hazardous. Health professionals are the most susceptible: they typically care for infected patients without personal protective equipment and infection controls; they lack training in differential diagnosis of and treatment for EVD; and they are underpaid. Patients, too, perceive that hospitals in the affected countries are unsafe places that offer little effective treatment. Consequently, patients with Ebola-type symptoms stay away, and those who need treatment for myriad health problems—from AIDS and malaria to cancer and heart disease—remain untreated in the community.

The persistence of traditional burial and other cultural practices in West Africa also make it more difficult to contain Ebola. Loved ones come in close contact with the deceased, including ritual touching and bathing. Burial practices create the conditions for transmitting EVD, which then can be spread throughout the community. Another practice, consuming bush meat, which might include animals that are reservoirs for Ebola virus, is a traditional source of food, especially for poor Africans, providing life-sustaining protein. Women, as the traditional caregivers, are more likely to contract the virus than men.

Further challenging attempts to contain the spread of Ebola are common misperceptions, such as the belief that aid workers from medical groups were spreading the disease. Public education has been neglected and governments have curtailed accurate news reporting about the crisis. Epidemic control requires trust and an informed public, so risk communication is fundamental to controlling Ebola’s spread.

Ethical Issues

Also related to the issue of trust has been the use of scarce experimental therapies. More than 20 Ebola outbreaks have erupted in sub-Saharan Africa, yet the world was unprepared for the current tragedy, with no licensed vaccines or treatments. (This lack of readiness would not have surprised Albert Camus. As he wrote in The Plague, “Everybody knows that pestilences have a way of recurring in the world; yet somehow we find it hard to believe in ones that crash down on our heads.”)

An experimental drug called ZMapp, which has neither been proven effective nor tested for safety in humans, was available in scarce amounts and was administered to 2 US aid workers and, reportedly, to a Spanish priest. The last remaining doses have now been delivered to West Africa, but the initial perceived preference given to white foreign workers fueled a sense of injustice. Although selecting who should get the untested treatment is an agonizing choice, it’s my opinion that priority should be given to African health workers, who die of Ebola in far greater numbers than do foreign workers. In any case, it is vital that allocation decisions be made fairly and transparently. The decision to treat the foreign workers was made behind closed doors without community consultation. Going forward, high-resource countries should create public-private partnerships to ramp up development and rigorous evaluation of vaccines and treatments.

Militarization of a Disease

Adding to the distrust that hinders attempts to control the epidemic is local populations’ fear not only of Ebola but also of the militarization of the disease. Countries have erected cordons sanitaires (guarded lines preventing anyone from leaving), but are using ancient methods to enforce the quarantine. In West African hot spots, armed troops have established blockades, closed roads, and banned travel beyond the guarded perimeter.

As a result, the populace is finding it hard to obtain food and other basic necessities. Targeted travel restrictions may be necessary, but there is a smarter way to go about them, through humane care and incentives. Governments should provide people with nourishing food, health care, and psychosocial support. Transmission hot zones can’t be ignored, but neither can the needs and human rights of communities.

What Can Be Done Now? A “Health Systems Fund”

Fragile health systems are at the root of the problem, and bolstering them is a key to fighting Ebola and preventing another uncontrolled outbreak. Affected countries are unprepared for Ebola’s complexities; they are unable to provide all their people basic health services, much less the requirements of an Ebola response, including full body protective gear, specially trained health workers, isolation units, and advanced laboratory capacity with higher biosafety capabilities. Building strong health systems would rebuild the most basic community asset: trust. Looking ahead, the international community should mobilize to provide sustainable funding scalable to needs.

This crisis represents a manifest failing of the international community, particularly its wealthier members, which ought to have been generous in supporting surveillance and response capacities obligatory under the International Health Regulations (IHR). The World Health Organization (WHO), the World Bank, and the United States Agency for International Development, among others, have made notable pledges of support. But what the region needs now is an assurance that these funds will be ample and sustainable.

To address this need, I propose an emergency, and then an enduring, “Health Systems Fund” administered by WHO (with participation of local governments and civil society) and supported by high-resource countries. Considering the funding needs, an immediate (emergency) down payment of $200 million is needed for the affected countries and their at-risk neighbors. The money should be spent to strengthen health systems. Building on recent pledges of support, these additional funds could reward and motivate frontline health workers, ensure humane conditions in communities subjected to cordon sanitaire, and establish surveillance and response preparedness.

This fund would be surprisingly affordable, with this initial installment of funding representing only 1% of international health assistance. Growing the fund over time into a multibillion dollar funding channel for lower-income countries would finally make it possible to mobilize the resources envisioned in the IHR, as well as the growing global commitments to universal health coverage. Eventually, the fund might be merged with the Global Fund to Fight AIDS, Tuberculosis and Malaria into a new Global Fund for Health.

It is in all states’ interests to contain health hazards that may eventually travel to their shores. But beyond self-interest are the imperatives of health and social justice: a humanitarian response that would actually work, now and for the long term.

 ***

About the author: Lawrence O. Gostin, JD, is University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, and Director of the World Health Organization Collaborating Center on Public Health Law and Human Rights. His most recent book is Global Health Law (Harvard University Press).

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

 

 

JAMA Forum: Is Keeping Firearms Out of the Hands of Mentally Ill People the Answer to Gun Violence?

Lawrence Gostin, JD

Lawrence Gostin, JD

The cultural divide over firearms in the United States is cavernous and appears unbridgeable. There seems to be no common ground, but increasingly there is one shared position: improving identification of mentally ill individuals while restricting their access to firearms.

The public overwhelmingly supports limiting firearm access to persons with mental illness, which is consistent with the National Rifle Association’s position that “guns don’t kill people; people kill people.” The problem is that focusing solely or primarily on persons with mental illness will not quell firearm violence. (In the case of suicide attempts—a major factor in gun injuries and deaths—the link with mental illness, particularly depression, is stronger. But even here firearm restrictions have a powerful effect in reducing harms to vulnerable individuals [see box on Guns, Suicides and Mental Illness].)

The Gun Control Act of 1968 prohibits selling firearms to individuals involuntarily committed to a mental institution. The National Instant Criminal Background Check System (NICS), however, is badly flawed because states never enter many prohibited persons into the database. Obama Administration initiatives—a grant program and rule changes—seek to make it easier for states to enter information into the database, but this hasn’t resulted in significant improvements.Meanwhile, those who are in the system can easily avoid background checks, such as by purchasing firearms at a gun show—a notorious loophole. States can also issue “Brady permits,” allowing licensed sellers to waive background checks.

In the wake of the Isla Vista shootings on May 23 and other mass killings, Congress and state legislatures circulated bills designed to keep firearms out of the hands of severely mentally ill individuals. House Democrats, for example, proposed on May 6 a major expansion of the number of mentally ill patients who would be barred from purchasing firearms. A bipartisan proposal last December powerfully incentivizes states to reform their standards for committing severely mentally ill persons to hospitals or outpatient treatment, while also authorizing court-ordered therapy and medication. California lawmakers are proposing a “gun violence restraining order” that would allow families to petition a court to bar a mentally unstable person from possessing firearms.

Historically, society has stereotyped persons with mental illness as dangerous, believing that restraining their liberty or rights would solve social problems. But the evidence does not support this position. Focusing on persons with mental illness allows politicians to claim they are acting in response to firearm violence, while neglecting the principal reason the United States has vastly greater gun deaths than any other developed country. The singular difference between the United States and the rest of the world is simply the number of firearms circulating in society.

What has long been understood in public health is that changing behavior is notoriously difficult. What is far more effective is to change the environment. In this case, limiting access to firearms would prevent many gun injuries and deaths—not just in mass shootings but also, more importantly, on the streets in every major city in the United States. (Mass killings account for only about 0.15% of all homicides but are given disproportionate attention in the media).

Although most mass killers are mentally ill, only a small minority of persons with mental illness is violent. Overall, only about 4% to 5% of overall violent crime can be attributed to persons with mental illness. At the same time, it is exceedingly difficult to predict violence based on a psychiatric diagnosis: psychiatrists’ predictions of violence are no better than chance. It is true that mental illness can be a risk factor for violence, but often only with comorbidities, such as alcohol or drug abuse. The latter are far more powerful predictors of violence than the diagnosis of mental illness. Still more powerful is a history of violence, particularly threatening or using a lethal weapon such as a firearm.

These data suggest that the legislative response to the Isla Vista murders deals with the problem of gun violence only at the margins. At the same time, the response reinforces deep and historical stereotypes of persons with mental illness as irrational and dangerous. At present, federal law restricts firearm access to persons involuntarily committed to a mental institution. This makes most sense, as civil commitment standards incorporate danger to self or others. Widening the net to voluntary admission or to outpatient treatment would not only be overinclusive but also would discourage persons with emotional problems to seek diagnosis and treatment. This would be the wrong result for individuals, their families, and society as a whole.

It is unlikely that it will be possible to stop all or most mass killings; there are too many isolated and angry people and too much access to the means of death. However, there are evidence-based courses of action fully available if the political will could be summoned.

First, and most simply, Congress could fix the badly broken system of reporting to the NICS, giving states more powerful incentives to comply. That would at least offer mental health and law enforcement professionals a reliable method of restricting gun access to those who are civilly committed. Closing the gun show loophole is also essential because legal norms should not be so easily skirted. It is only common sense that if lawmakers create a rule—in this case, banning gun access to civilly committed individuals—it should be enforced fairly and consistently.

Second, Congress could require national background checks for all firearm purchases, an approach that has overwhelming public support. It appears reasonable to make sure that everyone who buys a firearm should be checked to ensure he or she is fit to use the weapon responsibly. This does not interfere with the right of responsible individuals to bear firearms.

Third, restricting firearm access should focus on conduct demonstrating an elevated risk of dangerousness. This would include a history of violence, especially using a firearm. For example, individuals convicted of misdemeanors involving violence should be included within the category of those unable to own a firearm. This behavioral criterion is the best predictor of violent behavior and does not stereotype individuals or drive mentally ill persons underground.

There is a certain simplistic comfort to conflating guns, violence, and mental illness. However, although it may make policy makers feel better, it is unlikely to get to the core of the problem. The only way to meaningfully reduce violence is to prevent truly dangerous people from purchasing firearms and to enact reasonable limits on the means needed for lethal behavior.

 ***

About the author: Lawrence O. Gostin, JD, is University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, and Director of the World Health Organization Collaborating Center on Public Health Law and Human Rights. His most recent book is Global Health Law (Harvard University Press).

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

JAMA Forum: What Accounts for the Reduction in Obesity Rates for Preschool Children?

Lawrence Gostin, JD

Lawrence Gostin, JD

In a widely publicized study, Centers for Disease Control and Prevention researchers reported a statistically significant recent downward trend in obesity prevalence among US preschoolers in 18 states, based on data from 2008-2011. These findings have been followed by research published in JAMA showing a significant decline over the last decade in obesity prevalence among children aged 2 to 5 years. Although the media reported a dramatic 43% decline (calculated as a relative difference), the absolute difference was much more modest (a 5.5% decline from 14% in 2003-2004 to just over 8% in 2011-2012).

In other age groups, obesity rates remained at historic highs (and increased among women aged 60 years or older). Yet, the news reports signaled, perhaps prematurely, major advances in the fight against obesity.

To be sure, preschool children are an important demographic, as overweight in young children is a good predictor of weight status and obesity-related health problems in adulthood. And there is some indication that nutrition is trending in the right direction, with children consuming fewer calories in 2010 than they did a decade before. Importantly, eating fewer carbohydrates (including sugars) drove the calorie decline.

Assuming the data reflect a real advance in the fight against overweight and obesity, what might account for the reduction? And what policies might be most effective going forward?

Clearly, shifting something as complex as nutrition and physical activity is difficult, requiring engagement of a variety of stakeholders, including government, industry, civil society, and media. Personal behavior changes occur as people incorporate healthy habits into their daily lives.

Existing within a federalist system, US policies on nutrition and physical activity occur at the national, state, and local levels. Nationally, the nutritious foods promoted by the Special Supplemental Nutrition Program for Women, Infants, and Children (popularly known as WIC) have been selected to closely (although not fully) align with recommended dietary guidelines. At the same time, national initiatives, such as First Lady Michelle Obama’s Let’s Move program, have focused public attention on childhood obesity. Federal policies, however, are imbued with detrimental political influences, including agriculture and school policies reflecting the interests of industry rather than those of children. The farm bill subsidizes unhealthy products such as corn (think high-fructose corn syrup) rather than fruits and vegetables, and the school lunch program counts pizza (think tomato sauce) and french fries (think potatoes) as vegetables.

There is so much more that the federal government could do to improve childhood nutrition, and there is no area more important to address than the marketing of junk foods to children. As the Institute of Medicine pointed out, companies aggressively market unhealthy foods to children and adolescents, not only in television, but also on the Internet, through video games and in other digital platforms. Yet there are few, if any, rules against targeting these impressionable young minds. Companies’ voluntary measures are inadequate, and industry leaders claim it is really the responsibility of parents to monitor what their children are watching.

Most innovation is taking place at the state and local level, through such measures as nutrition and physical activity standards for early care and education. It makes sense to have states and cities act as “laboratories” to try, and to evaluate, new approaches. In fact, many federal initiatives either draw on (or, sadly, even undermine) creative local initiatives. New York City banned trans fat years ago, but the US Food and Drug Administration (FDA) only recently proposed that it might do so nationally. New York similarly introduced menu labeling—a concept then adopted in the Affordable Care Act (ACA). However, because the ACA sets a uniform national standard, it also preempts more stringent local labeling requirements, thus undermining innovation.

More recently, the FDA proposed altering food package labels. The proposed regulation—even if very late in coming—helps to clarify such things as serving size and added sugars. But it fails miserably in doing what is really needed: mandating food companies to provide prominent, comprehensible front-of-package labels. The United Kingdom encourages food companies to label their products with a voluntary “traffic light” system, which uses a vivid red label to flag excess fat, saturated fat, sugar, and salt content, with amber and green labels indicating medium and low levels of these nutrients, respectively. Prominent and clear labeling incentivizes industry to formulate healthy foods. What company wants to have 4 glaring red lights on the front of their package?

Municipal programs to improve nutrition have far outpaced federal action. The National Salt Reduction Initiative (NSRI) is a New York City-led public-private consortium of more than 90 health agencies and associations. Companies in the program voluntarily pledged to reduce sodium by 20% in overall sales within a given food category (eg, canned soup) by 2014. This still left ample room for high-sodium foods provided the producer offset these with low-sodium alternatives within the product category.  Many companies have joined NSRI, with 21 of them meeting sodium checkpoints in 2012.

It will be evident to any thoughtful observer that a major reason for expanding waistlines, especially among children, is larger portion sizes—with the biggest culprit being super-sized sugary drinks. Although a 12-ounce soda was considered “king-size” in 1950, it is now marketed as a child portion. A large Coca-Cola at McDonald’s is 32-ounces, whereas 7-Eleven’s “Double Gulp” contains 50 ounces, 600 calories, and no nutritional value. Yet, the only effort to date to curb portion size was the controversial limit on the sale of large sugar-sweetened beverages in New York City, imposed in 2012 by then-Mayor Bloomberg. The program, however, was unpopular, and the courts have thus far struck it down as mayoral overreach. Yet, creative policies to reduce portion sizes are critical to future success.

If one were to choose a single intervention that would be most likely to work, it might be taxation. Research suggests that even a relatively modest tax on sugary drinks, candy, and other decidedly unhealthy products might reduce consumption. Economic incentives, and disincentives, are powerful motivators of human behavior.

So what are the most important policies for the future to ensure that the decline in preschool obesity is a real trend that will stand the test of time? The truthful answer is that we do not know. But this much is nearly certain: if society were to adopt a suite of policies, sustained over a long period, the culture of overeating would change.

Look at tobacco as a model. It is nearly impossible to say which particular intervention worked in reducing prevalence so dramatically over the last several decades—taxes, laws ensuring smoke-free areas, package labeling, advertising bans, public education, and more. What we do know is that a broad range of policies can transform public perception, and ultimately human behavior. It can be done if there is a political will.

First Lady Michelle Obama recently announced a package of new obesity prevention measures under the Healthy, Hunger-Free Kids Act of 2010: a revamped version of the nutrition label on packaged food, new rules restricting junk food marketing in schools, and the expansion of a pilot program to feed nutritious meals to hungry children in need. From July 1, more than 22 000 schools that serve mainly low-income children will be eligible to serve free school meals to all students. Should these programs progress as planned, it would at least put the United States on the road to healthier, fitter children—a wonderful investment in our future.

***

About the author: Lawrence O. Gostin, JD, is University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, and Director of the World Health Organization Collaborating Center on Public Health Law and Human Rights. His most recent book is Global Health Law (Harvard University Press).

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

JAMA Forum: AIDS in South Africa: A Story of Social Mobilization Inspired by Nelson Mandela

Lawrence Gostin, JD

Lawrence Gostin, JD

By the time Nelson Mandela was elected as South Africa’s first post-apartheid president in 1994, the AIDS epidemic in that country was fast worsening. In 1983, just 1 year after it first emerged there among young gay men, blood specimens revealed a 16% infection rate among tested gay men in Johannesburg. By Mandela’s election, AIDS had also become embedded in a predominantly black heterosexual population, especially among women and their newborns, the latter infected through childbirth and breastfeeding.

Even before ascending to the presidency, Mandela (known as Madiba throughout his country) had deplored the social conditions that gave rise to AIDS (such as poverty, disempowered women, and migratory labor) and spoke out against stigma caused by the disease. But during his presidency, Mandela’s focus was on healing a bitterly divided country, burdened from the unconscionable weight of oppression under apartheid. As he dealt with the monumental task of building a new democracy, he delegated the government’s AIDS portfolio to his deputy, Thabo Mbeki.

When Mbeki succeeded Mandela as president in 1999, he became widely known as the infamous “AIDS denier”—questioning whether HIV was the cause of AIDS and accusing the West of profiteering from antiretroviral treatments. His politics of denial almost surely killed many South Africans—as many as 300 000, according to estimates by Harvard researchers—as his use of his political power to stress African tribal “remedies” impeded access to the effective treatments that were emerging at the time. Mbeki particularly evoked the ire of AIDS advocates when he limited access to nevirapine for pregnant women, even though a 1999 Ugandan study showed that the drug reduced the rate of perinatal transmission by 50%.

In contrast to Mbeki’s politics of denialism, Mandela spent time after his presidency providing the kind moral leadership that marked a path to fighting the South African AIDS epidemic based on science and human compassion. Before a rapt audience at the 2000 International AIDS conference in Durban, Madiba advocated for action on prevention, such as education about life skills, safe sex, and reducing perinatal transmission. He urged “action at an unprecedented intensity and scale,” including efforts to “break the silence” and “banish stigma and discrimination” associated with AIDS. And in January 2005, Mandela again provided a defining moment for AIDS and South Africa, when he shocked the world by announcing, “My son has died from AIDS.” Makgatho, who had been his sole surviving son, died at age 54 years, and Makgatho’s wife had died of AIDS just months earlier. In this revelation, Madiba signaled the need to end shrouding AIDS deaths in secrecy, a practice that perpetuated stigma and hindered attempts to fight the disease.

Although Madiba was no longer at the political helm of his country, his words and his stature still had the power to inspire those fighting the epidemic and advocating for the right to treatment. The Treatment Action Campaign (TAC)—the most prominent civil society group in South Africa—challenged Mbeki’s AIDS policy in the Constitutional Court. On the day of the hearing in Minister of Health v Treatment Action Campaign (2002), 5000 people marched to Johannesburg demanding the right to treatment. The court has 2 justices with deep roots in the antiapartheid movement who are champions of the right to health and embody the ideals and strength of Madiba: Deputy Chief Justice Dikgang Moseneke, Mandela’s cellmate on Robben Island, and Justice Edwin Cameron, a world-renowned AIDS activist and humanist who has passionately fought for treatment access. Siding with AIDS advocates, the Constitutional Court ruled that the nevirapine policy violated the constitutional duty under section 27 of the Constitution to “take reasonable measures within its available resources, to progressively achieve the right to health.” The Constitutional Court would go on to use section 27 to advance the right to health in other realms, such as housing and water rights, although it maintained deference to the elected government.

Access to antiretroviral treatments in South Africa never would have occurred without intense social mobilization, especially by the TAC and its legal arm, the AIDS Law Project (ALP). In 2010, the ALP became SECTION27, taking its name from the right-to-health article of South Africa’s Constitution. In the same year the nevirapine case was decided, Madiba visited the TAC and Médecins Sans Frontières in Khayelitsha (a township outside Cape Town) wearing a T-shirt with the words “HIV Positive.” Fareed Abdullah, MD, the head of South Africa’s National AIDS Council, recalled the effect of Mandela’s gesture: “With Nelson Mandela behind us—doctors, nurses, and people living with HIV—then who could be against us?”

The year after Mbeki stepped down, Jacob Zuma was elected as democratic South Africa’s fourth president. Although Zuma is not an AIDS denier, he has clashed with the Constitutional Court over corruption charges. In 2011, Justices Moseneke and Cameron penned an opinion mandating that the government create an anticorruption agency. Moreover, Zuma has been a deeply flawed role model for HIV prevention. Early in his term, in 2006, a Johannesburg court dismissed rape charges against Zuma, as he claimed that his unprotected sex with a young woman was consensual. At his trial, he infamously said he took a shower afterwards to reduce the risk of contracting HIV—a statement that the court and AIDS activists roundly condemned. The fact that he was accused of rape only reinforced the culture of sexual violence in the country. And his choice to have several wives and multiple sex partners, some of whom were young, conveyed exactly the wrong message about safer sex.

Madiba will live forever as a humanist who transformed the world, inspiring generations about peace, forgiveness, and the power of human freedom. When his son died, according to the Globe and Mail, Madiba pleaded for not hiding HIV/AIDS, “because the only way to make it appear like a normal illness, like TB, like cancer, is always to come out and to say somebody has died because of HIV.” Madiba’s words resonated in South Africa and throughout the continent. Fighting AIDS, which has robbed many young South Africans of a future, is part of the unfinished work of South Africa’s ambitious project in health, justice, and democracy.

***

About the author: Lawrence O. Gostin, JD, is University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, and Director of the World Health Organization Collaborating Center on Public Health Law and Human Rights.

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

JAMA Forum: Looking Beyond the Millennium Development Goals Toward a Sustainable Development Agenda

Lawrence Gostin, JD

Lawrence Gostin, JD

At the turn of the millennium, recognizing the failure of the international community to meet the needs of the world’s poor, the United Nations (UN) General Assembly unanimously adopted the Millennium Declaration. The Millennium Development Goals (MDGs), which followed the declaration, are the world’s most broadly supported and comprehensive development targets, creating numerical benchmarks for tackling poverty and hunger, ill health, gender inequality, lack of education, lack of access to clean water and adequate sanitation, and environmental degradation to achieve by 2015.

The MDG health goals include reducing child mortality (including the benchmark of a two-thirds reduction of the mortality rate of children younger than 5 years); improving maternal health (including a three-quarters reduction in the number of maternal deaths per 100 000 live births, between 1990 and 2015, from causes related to pregnancy or its management); making a three-quarters reduction in the maternal mortality ratio; and combating HIV/AIDS, malaria, and other diseases such as tuberculosis.

Despite major advances, most MDG targets have not been met, partly as a result of 4 global crises in finance, food, energy, and climate change. In 2008, World Health Organization (WHO) Director-General Margaret Chan observed that even though “the health sector had no say when the policies responsible for these crises were made… health bears the brunt.”

The MDGs end in 2015 and the UN is debating a set of post-2015 sustainable development goals (SDGs). The UN met on September 25 to foster global agreement on the SDGs, but the result was inconclusive. The Outcome Document from that meeting merely “resolved that the post-2015 development agenda should reinforce the international community’s commitment to poverty eradication and sustainable development.” Intergovernmental negotiations will begin at the 69th General Assembly next September, with the adoption of the SDGs set for a UN high-level meeting in September 2015.

The SDGs are likely to focus on poverty and the environment, but a debate is swirling within the international health community concerning what the health goals should be. The WHO favors universal health coverage, while others, such as the Gates Foundation, advocate for more easily measurable goals such as for child and maternal health. UN Secretary-General Ban Ki-moon stressed that the SDGs must be “rights-based,” with the first pillar being “a far-reaching vision of the future firmly anchored in human rights and universally accepted values and principles.” Go4Health, a European Commission–financed coalition of academics and civil society, recently threw its weight behind the right to health as the central building block of the health SDGs.

I believe that the health-related post-MDG vision should address the full scope of the primary conditions in which people can be healthy and safe, focusing on 3 mutually reinforcing conditions needed for better lives: public health, health care, and socioeconomic determinants.

  • Public health services address the task of building a habitable, safe environment for the population as a whole. Governments should provide all the goods and services needed for a safe and healthy life in a well-regulated society—hygiene and sanitation, potable water, clean air, nutritious food, vector abatement, injury prevention, and tobacco and alcohol control—as well as build environments conducive to good health, such as green spaces for recreation, walking and bike paths, safe vehicle and road design, and environmental controls.
  • Universal health coverage requires all vital health care services to be available, affordable, and accessible to the entire population, whether poor or rich, physically and mentally able or disabled, urban or rural. Effective health systems require health care facilities (such as clinics, hospitals, and nursing homes), human resources (physicians, nurses, community workers, and others), and essential medicines to serve the full range of population needs.
  • Socioeconomic determinants of health that undergird healthy and productive lives are the third essential condition. Key underlying determinants include education; income support; housing; employment; social inclusion; and racial, ethnic, and gender equality. Effective interventions require action beyond the governmental health sector and indeed beyond government—requiring an “all-of-government” and “all-of-society” strategy.

Global governance is essential for achieving a robust vision of health for all with justice. A coalition of organizations and individuals from civil society, governments, and academia, the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI), is proposing a Framework Convention on Global Health (FCGH) and initiating an inclusive campaign for an FCGH. UN Secretary Ban Ki-moon and UNAIDS Executive Director Michel Sidibé have endorsed the FCGH. A global health treaty grounded in human rights could provide necessary accountability behind the SDGs, such as fighting corruption; demanding transparency; facilitating civil society and community engagement and empowerment; setting targets, standards, and priorities; establishing obligations on financing and regulating private sector health actors; and monitoring results.

This approach would be a bottom-up strategy, demanding fulfillment of the human right to health. Building on the work of civil society from global networks like the People’s Health Movement to national organizations like SECTION27 in South Africa, the Lawyers Collective in India, and the Center for Health, Human Rights, and Development in Uganda, it would establish a platform for people to more effectively claim their rights in the future.

The future health and development agenda requires audacious thinking and action. Adopting narrow health goals (relating to AIDS or maternal health, for example)—while important—would not be transformative. Even universal health coverage is too medically oriented.

Instead, the international community could boldly pronounce a goal of “health throughout the life span for all” based on the human right to health, with a rich array of public health and health care services, and assurance of the key social determinants of health. That promise would be backed by a global health treaty such as an FCGH that would hold states and stakeholders accountable for ensuring the human right to health.

That is the only way to genuinely achieve the universal aim of global health with justice, reversing decades—even centuries—of vast differentials in health and longevity between the world’s rich and poor.

***

About the author: Lawrence O. Gostin, JD, is University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, and Director of the World Health Organization Collaborating Center on Public Health Law and Human Rights.

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

JAMA Forum: Supreme Court Decision on “Pay-for-Delay” Case Will Speed Marketing of Generic Drugs and Save Consumers and Taxpayers Billions

Lawrence Gostin, JD

Lawrence Gostin, JD

On June 7, 2013, the Supreme Court decided that the courts can hear suits against pharmaceutical patent holders who pay generic manufacturers not to produce a generic version of a brand-name drug until after the patent term expires. Under these “pay-for-delay” or “reverse settlement” agreements, payment flows from the brand-name drug company to the generic competitor that is challenging the patent.

The origins of the case date back to the Drug Price Competition and Patent Term Restoration Act of 1984, which permits a generic manufacturer to file an Abbreviated New Drug Application specifying that the generic product has the same “active ingredients” as the approved brand-name drug and is “biologically equivalent” to it. To increase price competition and lower pharmaceutical costs to consumers, the Hatch-Waxman Act granted the first generic manufacturer that successfully challenges a patent (such as a patent that covers a particular formulation of a drug rather than the active ingredient itself) an exclusive right to sell the generic drug for 180 days, as well as the roughly 30-month period that subsequent manufacturers would be required to wait before receiving US Food and Drug Administration (FDA) approval for their own generic version of the drug. The act also requires the parties to a patent dispute to report settlement terms to the Federal Trade Commission (FTC). The act therefore seeks to facilitate the marketing of generic drugs, reducing health care costs.

The Case Against Pay-for-Delay

In FTC v Actavis, Solvay Pharmaceuticals (subsequently acquired by Abbott Laboratories) obtained a patent for its brand-name drug AndroGel (a daily testosterone replacement therapy). As noted in an earlier ruling by the US Court of Appeals for the Eleventh Circuit, the patent for the active ingredient, a synthetic testosterone, had already expired decades earlier; Solvay’s patent was for the particular gel formulation of the synthetic hormone. Actavis then filed an FDA application to market a generic form of AndroGel, certifying that its product did not infringe the patent. Although it received FDA approval, Actavis entered into an agreement with Solvay to not bring its generic product to market for a number of years in exchange for millions of dollars. The FTC sued, alleging that the companies violated antitrust law when Actavis agreed to refrain from launching its low-cost generic and to share in Solvay’s large monopoly profits.

Justice Breyer, writing for the Court, said that such reverse settlements cause “concern” because they can have significant anticompetitive effects. First, pay-for-delay keeps prices at the level set by the patent holder, dividing the benefit between the 2 parties while the consumer loses. Second, the brand-name company has considerable power to cause harm to consumers, illustrated by the size of the financial inducement to generic manufacturers. Third, there are other ways to settle litigation disputes without artificially keeping drug prices high.

The Court ruled that reverse settlement agreements were not “presumptively unlawful” (unlawful on their face), as the FTC had claimed. Rather, courts should scrutinize these agreements under a “rule of reason,” which states that the agreements must be considered in the context of their possible benefits for consumers.

Justices Roberts, Scalia, and Thomas dissented, saying that litigation to block pay-for-delay deals would discourage the settlement of patent litigation. The dissenters felt that the settlement of disputes reduces costs and burdens on the parties. (Justice Alito recused himself from the case.)

Implications of the Decision

The Supreme Court’s decision on FTC v Actavis will require companies to have an independent business reason for pay-for-delay. These deals can no longer be purely an arrangement to share in the profits, depriving consumers and taxpayers of the benefits derived from lower drug costs. Future cases will probably rest on the size of the payment—whether the amount of the settlement is clearly a financial inducement not to market a generic drug. The parties to the settlement will also have to show that the payment was for something other than delaying market entry. Most current reverse payment agreements would not be lawful under these standards.

Actavis will probably save consumers more money than any other case before the Supreme Court this past term. Pharmaceutical sales reportedly totaled $320 billion in 2011, and although brand-name drugs represented 18% of total prescriptions that year, they accounted for 73% of consumer spending. Generics typically cost about 15% of the brand-name price and cause the company with the brand-name drug to rapidly lose up to 90% of its market share. By extending monopoly power and sharing the profits, reverse settlement agreements cost consumers and taxpayers an estimated $3.5 billion each year.

The Court’s decision will make it considerably harder for companies with patents for brand-name drugs to block market entry for generic drugs. It gives consumer groups, drug retailers, wholesalers, and insurance companies a clear pathway to legally challenge reverse payment settlement agreements. Given that 75% of cases in which a patent is challenged in court are decided in favor of the generic company, brand-name companies will find it hard to maintain monopoly pricing. Going forward, it is likely that cheaper generic brands will likely enter the market much sooner—a major win for consumers, but smaller profits for companies that produce brand-name drugs.

***

About the author: Lawrence O. Gostin, JD, is University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, and Director of the World Health Organization Collaborating Center on Public Health Law and Human Rights.

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

JAMA Forum: The Clash Between Industry and Civil Society Over Generic Drugs

Lawrence Gostin, JD

Lawrence Gostin, JD

On April 1, India’s Supreme Court ruled against drug company Novartis regarding its claim for a patent on the lucrative and widely used cancer drug imatinib (marketed by Novartis as Gleevec in the United States and as Glivec elsewhere). To many, this high-profile 7-year legal battle, Novartis v Union of India, epitomized a vexed relationship between health advocates and the pharmaceutical industry.

Civil society believes that affordable access to essential medicines is an ethical imperative, even a human right. But industry sees the intellectual property system as a vital incentive for innovation. Both positions are undoubtedly true, but they often come into tension. Companies point to the high costs of research and development in bringing a lifesaving or life-extending drug to market. But this view collides with human morality and personal tragedy when a patient cannot access a life-sustaining medication.

In denying Novartis’ claim, the Court affirmed that India’s standard for patentability exceeds that of the United States or the European Union. In the United States, companies can often extend the patent life of a drug simply by tweaking its formula or dosage (a practice known as “evergreening”). But the Court ruled that India’s patent laws require more: it is not enough that a new compound is different; the modified drug must also improve patient treatment.

The Court’s reasoning was narrow. To comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that is administered by the World Trade Organization, India began granting pharmaceutical patents in 2005, but only for drugs created after 1995. Novartis patented Gleevec’s original chemical form in 1993 and subsequently filed patents on modified forms of this compound. But the Court decided that Novartis did not prove that Gleevec offered “enhanced or superior efficacy” as required under India’s 2005 patent law. Gleevec can cost $70 000 annually in the United States, while Indian generic versions cost about $2500 a year. After the ruling, Novartis argued strenuously in a letter to the New York Times that Gleevec is not an instance of evergreening, insisting that its first patented compound was not viable as a medicine and that Gleevec is a transformational therapy.

What is most important about this case is that India now has a strong legal position against “me-too” drugs (making small changes to a drug to extend a patent) and that many other developing countries could now adopt a similar standard. Despite the Court’s narrow reasoning, the Novartis decision could have far-reaching implications. Multinational pharmaceutical companies are seeking strong patent protections in emerging economies, particularly given declining revenues for medications in Europe and North America. According to the New York Times, India is the world’s leading supplier of generic drugs, exporting $10 billion of generic medicines annually; together with China, it produces more than 80% of the active ingredients for all drugs used in the United States. A ruling in Novartis’ favor could have altered the global landscape in regard to access to medicines.

However, by deciding in India’s favor, the Court’s decision could embolden other emerging economies (such as Argentina, Brazil, Thailand, and the Philippines) as they debate domestic intellectual property regulation and its compatibility with their obligations under TRIPS. At the same time, developed countries are seeking stricter intellectual property protection in bilateral and regional trade agreements, such as the Trans-Pacific Partnership, which the United States is currently negotiating. The Indian Supreme Court’s decision will place pressure on richer countries to insist on stronger patent protection in future trade negotiations.

The clash between the right to health and protection of intellectual property has thwarted “north/south” relationships between developed and developing countries for more than a decade, culminating in the suspension of the Doha Round trade negotiations in 2008—with each side blaming the other. It may be that the tensions will never subside without a different formula for protecting intellectual property rights while allowing access to medicines. Proposals for tiered pricing of drugs depending on a country’s level of development would ease the tension.

Others have called for a Health Impact Fund, financed by governments, which would reward companies that register with the fund for medicines that save the most disability-adjusted life-years. The World Health Organization has been negotiating a research and development treaty to offset some of the cost of pharmaceutical research, but it is unlikely to go forward.

What seems entirely clear is that the vexing problem of access to medicines will continue to drive a wedge between developed and developing countries unless the international community finds an innovative solution. It is in all parties’ interests to seek common ground, with perhaps the most achievable progress being a negotiated agreement on tiered pricing.

***

About the author: Lawrence O. Gostin, JD, is University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, and Director of the World Health Organization Collaborating Center on Public Health Law and Human Rights.

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.