“Participating in the Health Rights Litigation course in September of 2013 granted me the opportunity to interact with some of the best minds on health and human rights in the world. I was among forty-four participants who were representative of twenty-four countries from around the world. I attended the course at a time when KELIN had a court case challenging the wrongful imprisonment of two TB survivors, who had interrupted their treatment. Plans were also underway to file a case to safeguard the rights of five women living with HIV who had been subjected to forced and coerced sterilization.
Listening to Manuel José Cepeda Espinosa, former Chief Justice of Colombia’s Constitutional Court, helped shape my thoughts on how to frame some of the remedies that I was seeking in relation to the two cases. Given that Colombia had similar constitutional provisions as Kenya, I could relate to the great talk by the learned Justice. The TB case was successful and some of the structural remedies that we included, based on what I learned, were granted by the court. I made connections with representatives of the International Community of Women Living with HIV- Global (ICW-Global), and they have since joined onto our ongoing cases as an interested party. Other global health professionals have joined onto the case as friends of the court. This is attributed to the global platform provided by this intensive but informative course. I recommend it to anyone keen to make a change in health by using the law.”
-Allan Maleche, Executive Director of KELIN
“Attending the Health Rights Litigation course on sexual and reproductive health and rights (SRHR) litigation in November of 2014 enabled me to engage with advocates with different political contexts and legal backgrounds from other countries and regions. As an SRHR advocate in Brazil and Latin America, I was able to deepen my knowledge of the historical and political differences and controversies between the sexual rights and the reproductive rights movements, share lessons learned at a historical moment, following the ICPD beyond 2014 review process, and discuss major gains and challenges remaining 20 years after the adoption of the Cairo Program of Action. We were also able to learn about pioneering legal research on the impact of SRHR litigation in different countries, advances in comparative law, new and emerging SRHR themes, and successful litigation strategies employed in countries like India, Colombia and Argentina.
In the months following the course, through my organization Ipas and with key support from the organizers of the Health Rights Litigation course and other regional partners such as Promsex and CLACAI, I was able to organize a regional workshop directed towards legal scholars and advocates from different countries in Latin America and aimed at sharing lessons learned and promoting the use of strategic litigation on SRHR based on recent progressive decisions from national and regional courts, building on decades of political struggle, mobilization and advocacy in the region.”
-Beatriz Galli, Senior Regional Policy Advisor for Latin America at Ipas
Applications for the 2017 Health Rights Litigation Intensive are available here and are due April 10, 2017.
President Trump’s budget blueprint slashes several social programs, including eliminating the 21st Century Community Learning Centers Program, which provides after school care to students of high-poverty and low-performing schools including snacks and meals, and cuts to funding for meals on wheels. Office of Management and Budget Director Mick Mulvaney defended the cuts to after school programs: “They’re supposed to help kids who don’t get fed at home get fed so they do better in school. Guess what? There’s no demonstrable evidence they’re actually doing that. There’s no demonstrable evidence they’re actually helping results, helping kids do better in school.” This blog argues that this charge runs contrary to the results of the program, and that investing in nutrition is economically and socially sound policy making.
The State of the Nation
Mulvaney’s utilitarian statement is amiss in a nation facing obesity and malnutrition side by side. One in three adults are thought to have obesity, including 1 in 2 adults experiencing extreme obesity. Further, 1 in 6 children aged 6-19 have obesity. Obesity is not merely an individual concern, but affects the society at large; in 2008 the medical costs associated with obesity were estimated at $147 billion. This does not include indirect costs of an estimated $3.38 billion. At the same time, in 2015 it was estimated that 12.7 % of households were food insecure, i.e. had difficulty at some time during the year providing sufficient food due to resources. While these numbers have declined in recent years, cuts to social programs may reverse this trend.
Results of Afterschool Programs
Further, the attack on after school programs runs contrary to available evidence. The 2013-14 performance report of the 21st Century Community Learning Centers Program demonstrates that 2.2 million children were served by the program, with 36.5% reporting improved math grades and 36.8% reporting better English grades. Teachers were also pleased with the program, with almost half reporting improvement in homework completion. Further, Mr Mulvaney’s charge is at odds with existing evidence that shows that a clear connection between students’ diets and school success.
The Societal Impact of Meals on Wheels
Meals on wheels provides meals to 2.4 million American senior citizens, including 500,000 veterans. While it not primarily dependent on federal funding (it mostly relies on individual contributions), these, and expected future cuts, are likely to have an impact on local service provision. As to the results of the program, reviews have found that meals on wheels improves recipients’ diets and increases food intake. The program can help avoid costly heath care bills and lower rates of nursing home care. Finally, meals on wheels can, in some cases, provide needed social contact.
These are just some of the proposed cuts that will harm vulnerable families if implemented. For now, the proposals run contrary to the nutritional deficiencies facing millions of Americans. Indeed, although President Trump seeks to beef up military, he may struggle to recruit in a nation facing diet-related disease. However, we won’t know the full specifics until the budget is finalized.
This week, the Trump Administration unveiled its proposed budget, calling for cuts in a number of agencies. The proposal will need to be approved by Congress before it can be enacted. As lawmakers take this on, I found it necessary to re-publish an old post from November of last year, following the election, for its relevance.
The take-home message is that infectious diseases know no borders, that countries with weak health systems will be unable to contain viruses that could eventually reach the U.S., and that, for these reasons, the Trump Administration should hold global health security as one of its key priorities.
If behind the budget cuts are concerns over reducing the U.S. deficit, we should remember that recent epidemics have showed us that a reactionary approach to epidemics and a failure to strengthen health systems can have a tremendous toll on a country’s economy–and we are not immune to this risk. The Commission on a Global Health Risk Framework (CGHRF), which was created following the Ebola epidemic, estimated that pandemics can cost $60 billion per year. This means at least $6 trillion in the 21st century. (For more analysis on this topic, see Global Health Security in an Era of Explosive Pandemic Potential). Ignoring this reality can lead to a grave economic and public health crisis.
There are many reasons for concern regarding the repercussions of a repeal of the Affordable Care Act, also known as Obamacare. Much of the focus as of late has been on the effect repeal would have on Medicaid recipients and how the cost of health insurance would change under a new plan. However, there are many other consequences to repealing parts of the law that are receiving less publicity, but would still have a significantly adverse effect on the quality of public health in this country as we know it.
The Prevention and Public Health Fund
When the ACA was passed in 2010, it included a reserve of funding for public health and prevention interventions, including prevention funding for immunizations, heart disease screenings, and the prevention of disease outbreaks. This fund, called the Prevention and Public Health Fund (PPHF), is mandated under the ACA to receive annual budget allocations and to provide for expanded and sustained investment in public health and prevention interventions. The PPHF accounts for over 12 percent of the Centers for Disease Control and Prevention’s (CDC) annual program budget.
Some of the initiatives made possible by this funding include the CDC’s adult and child immunization program, that protects millions of Americans from infectious diseases, lead poisoning prevention initiatives, chronic disease (diabetes, heart disease, cancer) screenings and prevention programs, and preventing healthcare-associated infections. The CDC uses this money to fund both agency-level programs, and to provide grants to states, municipalities and community groups to support local public health initiatives related to these issues. In 2016, the PPHF provided over $625 million in prevention programming grants to all 50 states and Washington D.C.
Under the proposed changes sought by Republicans to repeal and replace portions of the ACA, budget appropriations to the PPHF will be repealed effective in 2019, and any unobligated monies in the fund at the end of 2018 would be rescinded.
The proposed elimination of this fund is not receiving the same level of press as the proposed cuts to Medicaid and insurance subsidies, but it is nonetheless important. It is not as easy for the average person to qualify the value of prevention programs as easily as one can understand the consequences of taking away someone’s health care, so cuts like this fly under the radar of the general public. However, it is that low level of public scrutiny that make funds like this ripe fruit for lawmakers to slash with little public outcry or political consequence… That is, unless people read articles like this and start voicing their opinions and concerns about the PPHF to their federal and state government representatives.
The Importance of Supporting Public Health Prevention Programming
The Oxford English Dictionary defines PREVENTION as the action of stopping something from happening or arising. As it relates to health, that definition is emblematic of just why prevention programs are so important. These programs STOP people from getting sick. They avoid the consequences of medical expenses, illness, death, and lost income by educating people on how to protect their health, and by providing them with the resources to do so. The health interventions at risk of disappearing along with this funding are vaccination programs for infants, smoking cessation programs, interventions that teach people how to eat healthy, increase their physical activity, and reduce or eliminate their risks for Diabetes, high blood pressure or heart disease. Gone will be programs that engage older Americans in physical and mental activities that can protect them from developing dementia in their later years. Areas like Flint, Michigan, which is already facing gross underfunding to fix its lead contaminated drinking water, will have even fewer resources to protect children from the potentially fatal effects of lead poisoning.
The American Public Health Association reports that seventy-five percent of the overall health care costs in this country — a number that exceeds $2.5 trillion annually — is spent treating preventable diseases, yet only 3% of the nation’s health care spending goes towards prevention initiatives. Prevention programs, in addition to preserving health and improving quality of life, just make good economic sense.
To eliminate prevention programs like these will increase the number of sick people in the US who will become afflicted with the conditions these programs previously avoided. Couple that with proposed changes to the nation’s current health care laws that will likely reduce access to health care for many Americans, and you have ingredients for a public health crisis in this country. The people who benefit the most from these prevention programs – the poor, uninsured and under-insured – are also the ones who will suffer the most under the ACA repeal plans.
It is imperative that any changes made to the state of the American health care system ensure the preservation of health of the ENTIRE citizenry. It is equally important that the public not only be aware of the proposed changes, but voice their opinions and concerns so lawmakers make decisions aligned with the public interest. At a minimum, there should be some alternative proposed in the new bill to continue funding prevention programs. The ideal, however, is for the PPHF to remain untouched by the repeal process so it can continue to be of invaluable benefit to the American people and protect the health of its citizens, as that is supposed to be the objective — and is as well the duty — of those reforming the nation’s health care system.
Although the federal Tobacco Control Act gives the U.S. Food and Drug Agency extensive authorities to regulate tobacco products and their marketing, labeling, and sale, the Trump Administration’s new pro-business, anti-regulation approach might put some serious obstacles in the way of any significant new FDA regulations to reduce the massive amounts of tobacco use and harms still experienced in the USA.
But new informational tobacco product inserts or onserts to help consumers make more informed choices would fit well within the harm reduction and consumers’ right-to-choose approach to tobacco control that the major tobacco companies support and the new Trump Administration leadership will likely find most appealing. Done right, such informational leaflets placed in cigarette packs or temporarily affixed to the outside of the packs could also secure some significant public health gains. Even if were done wrong, the risks of significant harm would be minimal.
The industry-favored consumer right-to-choose approach to tobacco control gives top priority to ensuring that legal adult consumers may freely choose whether or not to use legally available tobacco products (no matter how harmful, deadly, and addictive the industry makes them). A harm reduction approach focuses specifically on making sure consumers are provided information about the relative-harmfulness of different types of tobacco products – e.g., so that users of those that are more harmful (e.g., cigarettes and other smoked tobacco products) may choose to switch to those that are less harmful (e.g., e-cigarettes).
Because a consumer-choice, harm-reduction approach to tobacco control uses market mechanisms, instead of government requirements or restrictions, it would be entirely consistent with the Trump Administration’s pro-business, anti-regulation ideology. Indeed, the new Trump Administration leadership might actively adopt this industry-favored approach in order to eliminate any consideration of more effective measures to reduce tobacco use — such as advertising and other marketing restrictions, regulations to make certain tobacco products less harmful or minimally addictive, or raising the minimum age to buy tobacco products.
Even if that is not done expressly, FDA’s best chance for getting permission from the new Trump Administration to issue any new tobacco control rules might be to propose new consumer-education requirements that would be entirely consistent with the consumer right-to-choose and harm reduction approaches – and require minimal new government or business expenditures.
How Might FDA Educate Consumers Under a Consumer-Choice, Harm-Reduction Approach?
While less directly effective than many other possible tobacco control measures, providing consumers with accurate relative-harm information would produce public health gains to the extent that it prompted ongoing users of more harmful tobacco products to switch entirely to using significantly less harmful tobacco products. But it would produce public health losses to the extent that it reduced or delayed total tobacco use cessation among current users, increased relapse into tobacco use among former users, or increased overall initiation into tobacco use.
Done right, such an effort would increase knowledge and understanding among the current users of the most harmful tobacco products about their options for reducing health harms and risks. Done wrong, it would confuse or mislead both users and nonusers into mistakenly acting in ways they think will reduce their health harms and risks but will actually increase them.
For example, a public education campaign that spread the word among all adults and youth that e-cigarettes are significantly less harmful than cigarettes could prompt some beneficial total switching from smoking to e-cigarette use. But, besides requiring considerable government spending, it could also encourage some adults and youth who would not otherwise ever try or use e-cigarettes to do so; prompt some former users to relapse into e-cigarette use; reduce quitting among e-cigarette users; and prompt some smokers who would otherwise have quit all tobacco and nicotine use to use e-cigarettes, instead, either alone or with continued smoking.
This problem of reaching the wrong audiences could be minimized by directing any relative-harm information about e-cigarettes or smokeless tobacco products only to smokers (the audience who could most benefit from that information). Perhaps the best way to do that would be to deliver the reduced-harm or relative-risk information with the cigarettes and other smoked products, themselves. That way, those who are already in possession of the cigarettes or other more harmful tobacco products would be the only ones who would directly see the harm-reduction information.
In contrast, new warning labels on e-cigarettes or new warnings on smokeless tobacco products which state that those products are significantly less-harmful than cigarettes would do little to reach smokers directly to encourage them switch to those less-harmful products. But they would directly reach current users and experimenters of the e-cigarettes or smokeless tobacco products, which could reduce related cessation and increase related initiation.
To better target this harm-reduction information just to current smokers, it could be delivered only through warning labels on cigarette packs. But cigarette warning labels are also seen by many non-smokers and former smokers because the same warnings required on cigarette packs are also required in cigarette ads and could be seen in images of cigarette packs used in cigarette signage and other ads. Much of this unhelpful exposure to the warning labels could be reduced by not permitting the relative-harm warnings to be used or shown in cigarette ads. But that would require new rules restricting business speech, which raises First Amendment issues and conflicts with a pro-business, anti-regulation approach. Moreover, even with such restrictions any reduced-harm warnings on packs could still be seen by the cigarette smokers’ children and other family members, friends, and colleagues.
In addition, warning labels cannot deliver very much information. For example, to prevent the relative-harm information from prompting smokers to act mistakenly against their best health interests, it should not only say that e-cigarettes are less harmful than cigarettes but should also include, at a minimum, all of the following relevant, accurate information.
But it would be difficult for a warning label that fits on a cigarette pack to include all of that basic information legibly, much less provide any detail or explanation necessary to avoid confusing or misleading those who read it. Nor could a warning label include any additional “instructions for use” for those smokers who do not quit or switch so that they can reduce the harms and risks their continued smoking causes to themselves and to exposed others.
Using Tobacco Product Inserts and Onserts to Deliver Relative-Harm Information
Cigarette pack inserts or onserts, however, could provide all of this basic information plus additional detail, explanation, and complementary information – thereby reducing the risk that the provided information would mislead consumers into making decisions against their health interests. [See example, below, after end of text.]
Like warnings, inserts or onserts would also go directly only to those persons who buy or open packs of cigarettes, which is the desired harm-reduction audience of cigarette smokers and experimenters. But, unlike warnings, the inserts and the relative-harm contents of the onserts would not be seen by any nonsmokers or former smokers who saw cigarette packs on display or pictured in ads. Moreover, the more extensive information provided in the inserts or onserts would help to ensure that any nonsmokers or former smokers who saw their relative-risk contents would not be encouraged to initiate or relapse into using the less-harmful tobacco products (and the provided information would also work to reduce the likelihood that they might initiate or relapse into smoking).
The tobacco companies have used cigarette inserts and onserts for marketing purposes, and inserts and onserts for prescription and over-the-counter drugs are widely used for health-directed purposes. So far, however, the only country requiring public health inserts in cigarette packs is Canada. Three published studies of the Canadian inserts indicate that inserts and onserts can work independently or in tandem with warning labels to promote cessation – and should work just as well to promote switching to less-harmful tobacco/nicotine use or just to help consumers make more informed decisions about their tobacco product use.
As detailed in a recent publication in the Food and Drug Law Journal, the federal Tobacco Control Act gives FDA clear authority to require cigarette and other tobacco product inserts or onserts, and the First amendment constraints that might apply to any such inserts or onserts are considerably less restrictive than those that could apply to warning labels on cigarette packs or in cigarette ads. FDA could readily develop and implement a new rule to require cigarette and other tobacco product inserts and onserts without encountering any First Amendment obstacles, especially if the rule was designed only to inform consumers (without explicitly encouraging them to quit or switch).
Although other FDA tobacco control rules would be more directly effective at reducing tobacco use and harms, a new requirement that cigarettes and other smoked tobacco products include inserts or onserts that provide accurate relative-harm information about smoking versus e-cigarette use could be one of the most effective rules the Trump Administration might allow FDA to implement.
Because consumers could use the provided information as they saw fit, without any coercion, an insert-onsert rule would fit well within the kind of pro-market, consumer right-to-choose, harm-reduction approach the Trump Administration is likely to support for tobacco control.
The rule would also be a good fit for the pro-business and anti-regulation approach of the Trump Administration because it would not regulate the tobacco products, themselves, or their externally visible packaging. Nor would the rule restrict any tobacco industry advertising, marketing, or sales. Any related costs or burdens on the tobacco industry would be minimal; and, to the extent that smokers actually switched to less-harmful tobacco products in response to the inserts or onserts, the tobacco industry would not lose customers (but their customers would be harmed less). Moreover, the reductions in tobacco use harms prompted by the informational inserts or onserts encouraging switching and cessation would translate directly into corresponding increases to worker productivity and reductions to business smoking-caused costs, producing even more reasons why a perceptive Trump Administration should not just allow but encourage FDA to implement well-designed informational inserts or onserts for cigarettes and other smoked tobacco products.
Poorly designed inserts or onserts that produce unnecessary health harms are certainly possible. But the Tobacco Control Act and other applicable laws prohibit FDA from requiring tobacco product inserts that are false or misleading, and the Tobacco Control Act generally provides that FDA may require specific cigarette or other tobacco product inserts or onserts only if FDA reasonably determines — after reviewing all relevant available evidence, both pro and con – that the inserts or onserts are “appropriate for the protection of the public health.” These provisions should ensure that any FDA-required cigarette or other tobacco product inserts or onserts would work effectively to produce public health benefits – so long as the new Trump Administration leadership does not interfere with the FDA’s Center for Tobacco Products efforts to interpret and apply the public health standards constructively and so long as any efforts to weaken those standards in Congress are rejected.
It would also be possible for the states to require cigarette inserts or onserts, especially if FDA did not take any action in this area.
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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.