09.12.16

Climate Change: A Growing Threat to Our Health

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This post was written by Lawrence O. Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law and University Professor. Any questions about this post should be directed to gostin@law.georgetown.edu.

Photo Courtesy of: www.abc.net.au

A scientific consensus exists that climate change is anthropogenically forced, with impacts on ecological systems and human health already in evidence. The grim toll is estimated at 300,000 deaths annually. Although climate change affects the entire world, it imposes vastly disproportionate burdens on low- and middle-income countries.

Systemic health effects include increasingly intense and more frequent natural disasters such as floods, heat waves, droughts, and wildfires resulting in injury, disease, and mass dislocations. Although causal relationships for any single event are difficult to establish, humanitarian crises are currently unfolding in Ethiopia, Papua New Guinea and Timor-Leste due to extreme weather events made more devastating by the 2015-2016 El Niño.

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Posted in Global Health; Tagged: , .

09.09.16

The Exorbitant Pricing of Pharmaceuticals is in the News. Again.

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This week the pharmaceutical pricing discussion centers on Mylan, and its 548% boost in the price of EpiPens. The press coverage and industry promises are a familiar scene: a large drug company buys a well-established medication or technology, and then raises the price. There is outrage, there are statements of promises and remedies, and then there is silence.

In September 2015 the discussion focused on Turing Pharmaceuticals and its 5,455% price increase of Daraprim. In May 2015 it was Valeant Pharmaceuticals and its 300% and 700% of Nitropress and Isuprel, respectively. And the list goes on and on.

As we see this process repeat itself again and again, the public health community must look past the reactionary promises and situational remedies currently offered by pharmaceutical companies, and seek a solution to the larger problem. We need to better understand and adjust the factors which contribute to the pricing of drugs in the United States.

Although this is clearly a complicated and multifaceted issue, there is an element of pricing in the United States which stands out: direct to consumer advertising. Direct to consumer advertising (or DTC) for pharmaceuticals is marketing which is directed toward patients, rather than healthcare professionals who diagnose illness and prescribe medication.

A primary issue with DTC in the US is that the ability to advertise directly to the consumer gives pharmaceutical companies an incentive to make healthy people feel unhealthy. By creating a group of people who think they have a specific illness, or even demand from their doctor a precise medication, these companies create a market for their product. And as a basic principle of economics, when demand goes up, price goes up.

Encouraging is the fact that DTC advertising for pharmaceuticals in the US is a relatively new phenomenon. Until 1997, the Food and Drug Agency governed pharmaceutical advertising under a standard that required ads to contain a “true statement of information in brief summary relating to the side effects, contraindications, and effectiveness.” Although these regulations did not mention DTC specifically, they stated that any broadcast advertisement must “include information relating to the major side effects and contraindications,” essentially prohibiting the advertisement of pharmaceuticals in any other format than print, as the side effects, contraindications, and effectiveness are to onerous to be relayed verbally.

In 1997, the FDA amended this constraint, only requiring that companies meet an “adequate standard” when it came to describing risks to consumers. Under these new regulations, so long as advertisements referred the viewer to a location where they could access all the information, companies were free to market without a complete summary (this is why you find telephone numbers and references to print advertisements at the end of commercials).

As you would expect, the use of DTC advertising has expanded exponentially in the twenty years since this change. Prior to the 1997 regulations, pharmaceutical companies spent around $12 million a year on DTC advertising, however, by 2015, companies were spending $5.4 billion per year, and five of the ten fastest-growing ad spenders in the world were pharmaceutical companies.

But it is time for a change. It is time to return the market creation for the consumption of pharmaceuticals to the trained professionals who understand illness, drug interactions and all products available for treatment. As endorsed by the American Medical Association just under a year ago, we need to return to highly regulated direct to consumer advertising. “Some of the more thoughtful people in the USA recognize that part of the reason they have a drug expenditure bill that is completely out of control is this kind of advertising,” says Suzanne Hill, a scientist working on rational drug use and drug access at the World Health Organization.

If we are serious about changing the cost of drugs in the United States, we need to increase regulation on direct to consumer advertising. Although this action will not be a simple cure-all to the complex problem of drug cost, reducing the market demand for branded drugs is a great start.

Posted in FDA, Global Health, Uncategorized;

09.09.16

Yellow Fever: The Forgotten Epidemic That Nobody’s Talking About…Yet

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This post was written by Andrew Hennessy-Strahs, a 2017 Global Health Law LL.M. Candidate at Georgetown University Law Center. Any questions or comments can be directed to adh75@georgetown.edu.

_87953607_c0093043-feeding_mosquito-splWhile the Western Hemisphere has largely turned its attention to the Zika epidemic, another far-more-lethal epidemic is ravaging West Africa, largely unchecked just across the Atlantic. Moreover, this is hardly a new virus; the international community has had an effective, cheap vaccine for nearly seven decades.

In December 2015, plummeting oil prices devastated the oil dependent economy of Angola. The financial distress, in turn led to a reduction in public sanitation services in an effort to stabilize the budget. The buildup of garbage then created optimal breeding grounds for the pathogenic mosquito viral vectors, which lay their eggs in water. As the mosquitoes proliferated, Luanda, the capital of Angola began seeing an unprecedented number of yellow fever cases that signaled the beginning of a new epidemic. A distrust of the medical system from the populace within the borders of Angola, combined with a suspicion of the international health community by Angola’s authorities has raised cries that the global health community is repeating the mistakes that catalyzed the Ebola epidemic in 2014. At least 6,000 suspected and confirmed cases have been reported to date, with at least 369 deaths.

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Posted in Global Health; Tagged: , .

09.08.16

Exclude sugary drinks from nutrition program, but exclude stigma too

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Supplemental Nutrition Assistance Program logo

Recent years have seen periodic calls for unhealthy foods, most prominently sugary drinks, to be excluded from items that can be purchased through the Supplemental Nutritional Assistance Program (SNAP). SNAP is the federally-funded program that helps low-income people in the United States, presently about 45 million, pay for food. Several states and locales have sought waivers to permit these exclusions, including New York City’s 2010 proposal to ban sugary beverages, and Maine’s continued effort to ban use of SNAP to purchase sugary beverages or candy. This past January, the National Commission on Hunger, appointed by Democratic and Republican Members of Congress, recommended excluding sugary-sweetened beverages from SNAP eligibility. Public health experts widely support such changes to SNAP.

The public health rationale for banning sugary drinks and possibly other unhealthy foods from SNAP eligibility is straightforward. These foods contribute to high levels of obesity in the United States (and globally), which is a major risk factor for diabetes, heart disease, and other illnesses. Sugary drinks have been recognized as a particular culprit. Why should funding for a nutrition program be used in ways that contribute to malnutrition rather than better nutrition, that harm health rather than protecting it?

Yet to date, the U.S. Department of Agricultural (USDA), responsible for SNAP, has denied all waivers. There are a mix of reasons for USDA’s denials, including questions about how to define unhealthy foods that would be excluded, practical technological questions about implementing exclusions, and in the case of Maine, concerns about an inadequate evaluation plan.

USDA’s most significant concerns, particularly if we consider a narrowly tailored ban, such as only for sugary beverages, are concentrated in two areas. One is a question of effectiveness. Most SNAP participants pay for some of their food with their own money, so might simply pay for any banned food with cash, and purchase some of the food they would have paid for with cash through SNAP instead. A second is a set of concerns involving singling out the poor. If SNAP participants are unaware of exclusions, they may find items rejected at the checkout counter, which could be stigmatizing, and even deter some people who are eligible for SNAP from participating in the program. An exclusion might be seen to “‘perpetuate the myth’ that food-stamp users made poor shopping decisions.” And it would restrict the choices of SNAP participants (or at least for those for whom SNAP funding comprises most or all of their food purchases) in a way that most of us are not so confined.

Many anti-hunger groups oppose any restrictions on foods and beverages available through SNAP primarily for this second set of reasons. Meanwhile, USDA recommends a focus on incentives to encourage healthy food purchase rather than restrictions on unhealthy foods.

These are powerful reasons, particularly the risk of stigma, something that we need to eliminate, not risk exacerbating. Yet I also agree with Kelly Brownell, dean of Duke University’s Sanford School of Public Policy: “The government should not be in the business of making people sick.”

The solution, I would suggest, comes in a comprehensive sweep of policies, of which a targeted ban on unhealthy foods – perhaps starting where there is the most support, sugary drinks – would be one prong. Such an approach, outlined below, would have several aims. First, echoing Dean Brownell and other supporters of a ban, it would begin to move the government out of the role of supporting health-degrading behaviors, at least in the realm of government nutrition programs, and use government’s regulatory authorities to extend this discouragement of unhealthy eating beyond SNAP. Second, it would include actions to incentivize healthy eating. And third, it would protect against stigma.

More particularly, these policies could include:

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Posted in Human Rights, National Healthcare; Tagged: , , , , , , .

09.07.16

Colombia in Focus

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This post was written by Alicia Ely Yamin, O’Neill Institute Director, Health and Human Rights Initiative. Any comments or questions about this post can be directed to aey7@law.georgetown.edu.

At the O’Neill Institute, as part of the Health and Human Rights Initiative, we will try to share important subjects of our work from time to time, not just through our academic publications and events, as well as of course the courses we offer, but also through a variety of multi-media formats. These are intended to supplement our traditional means, and to foster new ways of thinking about and getting to know the contexts in which we work and the challenges with which we are grappling in advancing health and social justice. This month we are pleased to be partnering with Social Documentary Network (SDN) to bring their series of photography exhibits, “Focus on Colombia.”

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Posted in Human Rights; Tagged: , .

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