08.17.17

Is There Any Reason to Allow Cigarette Companies to Send Coupons (or Any Other Advertising) to Nonsmokers?

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A recent study in the Nicotine & Tobacco Research journal confirms that the tobacco industry sends discount cigarette coupons to non-smokers in the USA and that some of those receiving the coupons become smokers. The study concludes that its findings support more restrictive policies to curtail the use of tobacco product discount coupons because of their possible impact on prompting smoking initiation, reducing cessation, and increasing health disparities. But the study does not consider two more fundamental questions.

1. Given the enormous harms caused by smoking, including premature death, can it possibly be ethical or morally appropriate for a business to deliver discount coupons or other cigarette advertising or promotions directly to nonsmokers?

2. Given the U.S. Food & Drug Administration’s extensive tobacco control authorities including the power to restrict tobacco product advertising and other marketing, is there any public health, ethical, or legal justification for the agency’s failure to prohibit businesses from delivering cigarette coupons or other advertising directly to nonsmokers?

Although the second question requires some First Amendment analysis, the answer to both questions is no.

Any Ethical Justification for Cigarette Ads to Nonsmokers?

Because cigarettes are inherently and inescapably harmful and deadly to smokers and to exposed nonusers there cannot be any public health justification for tobacco company efforts to encourage nonsmokers to begin smoking – or for FDA to continue allowing tobacco companies to do so.

The enormous health (and economic) harms caused by smoking also make any possible ethical or moral justification unlikely if not impossible.

The only possible ethical or moral justifications for businesses advertising or otherwise promoting cigarettes and smoking (or for FDA allowing them to do so) would likely hinge on the fact that tens of millions of already-addicted smokers rely on currently legal cigarettes to feed their addiction. But any such addiction-based justification for advertising to existing smokers (if it exists) cannot provide any moral or ethical justification for advertising cigarettes directly to nonsmokers, who have no addiction to feed and will certainly be harmed if they begin smoking.

Some argue that adult nonsmokers have some ethical right to choose to smoke (despite the absence of any constitutional or legal basis for any such right in the USA).  But given all the serious smoking harms to nonusers, including children in smokers’ households (not to mention the harms to the economy caused by smoking), it is not clear that adults actually have any such ethical right.  Moreover, most adult smokers do not choose to do so but are addicted, and most smokers want to quit and try to do so.  In any case, any ethical adult right to choose to smoke would not make it ethical for tobacco businesses to actively encourage any nonsmokers to make that choice.

Because of the massive harms caused by smoking to users, exposed others, and society as a whole, it is also possible that almost any effective measures to prevent and reduce smoking harms is ethically viable.

So there does not appear to be any public health, moral, or ethical justification for any tobacco company activities that encourage nonsmokers to smoke, or for FDA not issuing new rules to ensure that the companies do not directly engage in any such activities (such as sending coupons or other advertising directly to nonsmokers).

It is possible that FDA‘s inaction in this area might be ethically justified by the agency implementing other stronger tobacco control rules, instead.  But FDA has not implemented any new rule that would significantly reduce smoking since the Tobacco Control Act provided FDA with extraordinary powers to do so in 2009.

That leaves only the possibility that legal obstacles might excuse FDA for not prohibiting tobacco businesses from delivering coupons or other cigarette advertising directly to nonsmokers.

Any Legal Obstacles to Prohibiting Cigarette Advertising to Nonsmokers?

Tthe Tobacco Control Act gives FDA direct authority to restrict tobacco advertising and promotions whenever doing so is “appropriate for the protection of the public health” and to the “full extent permitted by the First Amendment to the Constitution.” [Sec. 906(d)(1), 21 U.S.C. 387f(d)(1)] Because of the signficant health harms and risks caused by direct cigarette advertising to nonsmokers, prohibiting such advertising is certainly “appropriate to protect the public health.” But under currently applicable Supreme Court rulings, following the 4-part test set out in the Supreme Court’s 1980 Central Hudson ruling, such a prohibition on advertising to legal adult customers might not fit within First Amendment constraints if the government could secure the substantial government interests the prohibition would directly advance without restricting commercial speech as much.

At least one U.S. District Court and one U.S. Appellate Court have rejected First Amendment challenges (and other legal challenges) to local laws prohibiting all coupons offering free or discounted tobacco products. Put somewhat simply, the rulings found that the coupon bans were constitutional because they were pricing restrictions, not commercial speech restrictions.  But prohibiting businesses from sending any cigarette advertising at all to nonsmokers would clearly go beyond just restricting price and would leave businesses with no way to communicate directly to nonsmokers who are potential legal adult customers about the cigarettes the businesses manufacture or sell.

Strong arguments can be made, however, that forbidding any cigarette advertising sent directly to nonsmoking adults would still pass the evolving Central Hudson First Amendment test.  Besides the fact that such bans would directly promote a substantial government interest (by reducing initiation among nonsmokers), they would not impede the ability of the tobacco companies to communicate with their current smoking customers.  And the tobacco businesses could still reach nonsmokers through indirect advertising, such as magazine ads and ads at retail outlets.

Moreover, any constitutional right tobacco companies might have to advertise cigarettes to adult nonsmokers is not particularly important or significant to the companies because the vast majority of their sales are to already-addicted smokers, and the vast majority of the tobacco companies’ new customers come from initiation among youth (and there is no constitutional right to advertise cigarettes to youth).  Nor is the ability to receive any such cigarette advertising important to adult nonsmokers.  Because the vast majority of smoking starts during youth, it is also clear that the vast majority of non-smoking adults have no interest in smoking or in receiving related advertising.

In addition, the availability of other  measures to prevent initiation by nonsmokers that do not restrict commercial speech or restrict it less should be irrelevant to the application of the Central Hudson test and any related First Amendment analysis to any ban on advertising directly to nonsmokers.  Because the government has a substantial interest in minimizing smoking harms and costs as quickly and completely as possible, it needs to use all available tools that can work effectively to help accomplish that goal until it is secured, including measures that reasonably restrict commercial speech as well as those that do not.  Issuing other tobacco control measures, by themselves, would not prevent and reduce smoking harms as quickly and sharply as implementing them with a ban on direct advertising to nonsmokers, as well.

Nevertheless, if FDA (or a state or local government) issued a rule prohibiting businesses from sending coupons or other cigarette advertising directly to nonsmokers, and the tobacco industry had the gall to attack its constitutionality, it is not clear how the courts would rule. The scope of commercial speech rights continues to evolve, and the Supreme Court has recently shown a significant pro-corporation slant.

Making It Easier to Ban Cigarette Advertising to Non-Smokers By First Prohibiting Cigarette Sales to Nonsmokers

An FDA rule prohibiting the delivery of coupons or other cigarette advertising directly to nonsmokers could readily comply with any court’s application of First Amendment constraints if the rule also established that cigarettes (and, ideally, other smoked tobacco products) may be legally sold only to current adult smokers.  FDA has clear statutory authority to implement such a partial sales ban, and it would not face any First Amendment constraints because, as a sales restriction, it would not restrict any advertising or other commercial speech. But the partial sales ban would make it clear that the only legal customers for cigarette businesses are current adult smokers; and businesses have no First Amendment rights to advertise to anyone other than their legal customers. Accordingly, a new rule that permitted cigarette sales only to current adult smokers would eliminate any legal basis for bringing First Amendment challenges against the rule’s concurrent ban on delivering cigarette advertising directly to nonsmokers.

Permitting cigarette sales only to current adult smokers might sound odd or impractical. But it could be implemented by a rule establishing the restriction and requiring only that cigarette-selling businesses not sell to anyone other than verified adults who state that they are a current smoker (e.g., by signing a statement on the business’s sale receipt or clicking on a check-out screen).  Cheating by nonsmokers would certainly be easy, but it is unlikely that many would have the motivation to do so. Moreover, the rule would send a powerful new negative message about smoking and would prevent at least some nonsmokers from trying to purchase cigarettes. Most importantly, it would sharply reduce the scope of the First Amendment rights the tobacco companies have been using aggressively for decades to prevent, weaken, and delay effective government measures to require them to advertise their deadly products more ethically and responsibly.

Building on available technologies to prevent delivering tobacco products or ads to kids, it would be relatively easy for cigarette companies to confirm, before making any delivery, that any planned recipient of its coupons or direct-to-consumer advertising was not just an adult but also a self-confirmed current smoker.  Given their primary goal of maximizing profits, however, it is unlikely, that the tobacco companies will do that on their own, despite all the ethical, moral, and public health reasons that they should.  But those same ethical, moral, and public health reasons call on FDA to take action quickly to require the cigarette companies to stop all cigarette advertising and coupons delivered directly to nonsmokers, and FDA has the legal authority to do so within applicable First Amendment constraints.

Whether the White House and OMB would prevent FDA from issuing any such rule is another matter.

But instead of relying on this Administration to implement new FDA tobacco control rules, state and local governments could take action, themselves.  In particular, state and local governments could prohibit the delivery of cigarettes or other smoked tobacco product coupons or advertising directly to youth or to adult non-smokers within their own borders. To make it easier to defend those restrictions against First Amendment challenges, the state and local governments could also prohibit the sale of cigarettes and other smoked tobacco products to anyone within their borders other than verified adults who also identify themselves as being regular or addicted smokers.

Eric N. Lindblom, Director, Tobacco Control and Food & Drug Law
O’Neill Institute for National and Global Health Law, Georgetown Law
enl27@law.georgetown.edu


Posted in FCTC, FDA, Tobacco, Uncategorized; Tagged: , , , , , , , , , .

08.16.17

Long-Acting Agents for HIV Treatment and Prevention: Updates from the 9th IAS Conference on HIV Science

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This blog post was co-authored by Javier Saladich, a Summer Research Intern at the O’Neill Institute. Javier is a third-year law student at ESADE Business and Law School in Barcelona, Spain.

The global advocacy for HIV/AIDS has been a model of success for an array of initiatives such as the climate protection movement. Analysts point to the multi-stakeholder composition and the autonomy from governments as some of the features that have allowed for an increasing global consensus on the necessary steps toward scaling up HIV treatment and prevention. But another reason why the global advocacy for HIV/AIDS has had success is the periodical input it receives from academic and technical forums such as the International AIDS Society (IAS) Conference on HIV Science, where scientific innovations are discussed and used to inform science-based policies.

The 9th IAS Conference on HIV Science took place in Paris from July 23-26, 2017 and provided people living with and affected by HIV with new findings from research studies and clinical trials that promise to revolutionize the HIV landscape. Though many studies were presented at the conference, we would like to highlight those studies related to the development of long-acting agents, which are innovative therapies for treating and preventing HIV infection that are under development and do not require daily pill taking. Because the effectiveness of antiretroviral therapy (ART) for HIV treatment and prevention is contingent on adhering to specified regimens, long-acting agents have the potential to make HIV treatment and prevention even more effective.

The Paris Statement released in conjunction with the IAS Conference stresses the need to “prioritize the development of antiretroviral (ARV) formulations that support long-term adherence and reduce the risk of viral resistance.” In this regard, the Paris Statement notes that “[d]evelopment efforts must include nano, injectable and other long-acting formulations.”

Focusing on HIV treatment, one notable finding related to long-acting agents that was released at the IAS Conference includes the positive results of a weekly oral therapy, where a single low dose of the novel drug MK-8591 (also known as EFdA) was associated with a rapid and robust reduction in HIV viral load. However, the landmark study was the LATTE-2 study about long-acting injections of cabotegravir/rilpivirine. Through 96 weeks, a larger number of patients who were assigned to this every-4-week or every-8-week dosing therapy (87% and 94% respectively) maintained viral suppression as compared to patients who stayed under a daily three-drug oral regimen (84%). As long-acting ARV injections are evaluated in phase 3 clinical studies, findings from these studies are anxiously awaited.

Now turning to HIV prevention, researchers also presented findings related to long-acting injectable drugs for pre-exposure prophylaxis (PrEP). Important results were released regarding the HIV Prevention Trials Network (HPTN) 077 study, which sought to prove the safety, tolerability and pharmacokinetics of injectable cabotegravir in low-risk HIV negative men and women. It is remarkable that participants assigned to injections every 8 weeks (with the first two doses administered every 4 weeks) showed appropriate levels of medicines in their blood and high tolerance. These findings support the dosing frequency used in HPTN 083 and HPTN 084, two ongoing studies that will test the efficacy of long-acting cabotegravir for PrEP in two at-risk groups: cisgender men and transgender women who have sex with (HPTN 083) and women in sub-Saharan Africa (HPTN 084). On another note, MK-8591 (the novel weekly-dosing regimen tested for HIV treatment) showed promising results in a prevention study with macaques. All this suggests that long-acting ARV formulations that are effective for HIV treatment could work as well for HIV prevention.

Research to come up with new drugs and regimens for maintaining viral suppression and improving the lives of people living with and at risk for HIV represents a main contribution of the 9th IAS Conference to the advancement of HIV science. To prepare the policy community for long-acting agents for HIV treatment and prevention, the O’Neill Institute has established a project to explore a range of issues related to United States health system adoption and community acceptance of these agents if research ultimately demonstrates that they are safe and effective. Check out our webpage for future updates on this project.

Posted in Uncategorized; Tagged: , , .

08.15.17

Art, Health, and Human Rights: John Rae’s The Positive Community Wins Social Documentary Network’s Photo Contest

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This blog post was co-authored by Javier Saladich, a Summer Research Intern at the O’Neill Institute. Javier is a third-year law student at ESADE Business and Law School in Barcelona, Spain.

It is widely recognized that art can accomplish broader community goals. Here at the O’Neill Institute, the Health and Human Rights Initiative has been exploring art as a tool for making health and human rights issues more visible and comprehensible. Program Director Alicia Ely Yamin launched Dialogues on Being Human: The Intersections of Art, Health and Dignity with a reflection on this role. At an event with artist Jesse Krimes on February 23, 2017, Yamin stated, “Aspirationally, there is nothing more powerful than art, nothing more powerful than the portrait of one person to convey what is universal about human dignity, much more than a hundred international treaty texts or articles.”

The role of art in social change also drives the Social Documentary Network (SDN), an organization that recently presented the winners of its photo contest Celebrating the Global Community. First place went to photographer John Rae’s The Positive Community, a project that portrays the harsh present and sometimes uncertain future of people living with HIV/AIDS around the world.

The significance of Rae’s project lies in its approach to the needs and realities of people living with HIV/AIDS. Rae does not present a hopeless community, but rather emphasizes the resilience of people living with HIV/AIDS and their families. His project reflects the real difference that outreach and education can make when conducted by peers, especially those living with HIV/AIDS. Underlying the entire project is a call for supportive, peer-based treatment and care where people living with HIV/AIDS are not stigmatized but rather empowered to advance prevention and improve health.

In one of his photographs, a mother with HIV in Cambodia appears with her HIV negative daughter. After transmitting the virus to her first child, she joined an outreach program that taught her how to protect her child from HIV. Rae’s photographs feature vulnerable groups such as sex workers, drug users, inmates, and orphans living with HIV/AIDS, but avoid sensationalism and focus on the different interventions (including food, housing and education) that are working in these communities across the world.

The Positive Community shows the importance of peer education in HIV prevention and, at the same time, the need to move toward a more socially responsible approach to HIV/AIDS in visual arts. Rae stresses in the exhibit abstract that “HIV infection is no longer a death sentence and living with HIV has become an issue of maintenance.”

Almost 30 years have passed since Nicholas Nixon’s photographs of AIDS-affected Tom Moran, which depicted Moran as the Other, someone fragile and cut off from the world. In her book Art About AIDS, author Sophie Junge explains how in Nixon’s project “AIDS is portrayed as the fate of an outsider. The photo arouses horror and fear, but it does not call for political action or social action against the discrimination of people with AIDS.” Decades of progress in HIV/AIDS treatment and prevention allow for contributions like The Positive Community, where a message of hope and support for HIV community outreach can eventually give visibility to the work done by peer educators and have an enhanced impact on people living with HIV/AIDS.

Similarly, yet from a legal perspective, the O’Neill Institute’s Health and Human Rights Initiative and National HIV/AIDS Initiative work to move beyond the traditional approach to academic scholarship to create real-world policy solutions through research in partnership with local, national, and global communities. Our work rests on a collaborative and interdisciplinary approach that brings together diverse stakeholders including many of the groups that Rae’s project presents.

In addition to the Health and Human Rights Initiative’s Dialogues on Being Human, the National HIV/AIDS Initiative is working on the second part of two-part Blueprint for Biomedical HIV Prevention focused on supporting uptake of biomedical HIV prevention modalities for communities of color. The National HIV/AIDS Initiative also has a project exploring how to support uptake of effective HIV prevention and treatment for adolescents and young adults, with a focus on young Black gay and bisexual men, and a new project exploring HIV prevention among Latino gay and bisexual men. Recently, the National HIV/AIDS Initiative has begun to explore the impact of criminal laws and policies on sex workers’ access to HIV prevention and care services and launched its augural HIV/Health Justice Speaker Series, a series of talks for scholars, lawyers, and advocates on the relationship between HIV, health, and criminal justice, including the impact of criminal law on sex workers and people who use drugs. For more information about this work, please check out our webpage.

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

08.14.17

New litigation challenges Big Soda’s marketing strategy

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This blog post was co-authored by Javier Saladich, a Summer Research Intern at the O’Neill Institute. Javier is a third year law student at ESADE Business and Law School in Barcelona, Spain.

A Coca-Cola Foundation advertisement

Last month, two prominent African American pastors and a public health organization sued a major soda manufacturer and soda industry body, alleging that the defendants have misled the public about the health impacts of sugary drinks in breach of consumer protection laws. This post considers the impact of soda consumption on the health of Americans and the potential impacts of litigation against an industry that has prioritized profits over health.

An epidemic of overweight and obesity in the United States

The United States is facing an epidemic of overweight and obesity. Data from the Centers for Disease Control and Prevention (CDC) shows that, as of 2015, 35.7% of adults are overweight and almost 30% are obese. Approximately one in five children aged 6–19 is obese. African American and Latino populations are disproportionately affected by overweight and obesity. For example, data from 2011 and 2012 shows that 22.4% of Latino children aged 2-19 years were obese, compared to 20.2% of African American children, and 14.3% of White children.

Sugary drinks and disease

A growing body of evidence demonstrates that consumption of sugar-sweetened beverages (SSB) is linked to greater energy intake and weight gain, as well as increased risk for metabolic syndrome, type 2-diabetes and heart disease. The Dietary Guidelines for Americans 2015-2020 recommend limiting daily calorie intake from added sugars to 10% of total calories. Since almost half of added sugars in the diets of Americans come from sugary drinks, discouraging consumption is a priority for government health officials.

Big Soda obscures link and shifts blame

The soda industry, led by the American Beverage Association (ABA), denies and obscures the link between soda consumption and disease and lobbies against public health laws and policies designed to reduce consumption. The industry also devotes significant resources to shifting the blame for obesity from sugar intake to lack of physical activity (which is no doubt another national concern). Coca-Cola combines misleading ads with funding for scientific research focused on physical activity rather than the role of food and nutrition in obesity. Confusing and distracting consumers from public health messaging is nothing new for the soda giant, which paid three Harvard scientists in the 1960s to minimize the negative impact of sugar on heart health and shift the blame to saturated fats. The industry’s strategic objective remains the same: to maximize sales of harmful products, prioritizing profits over the public’s health.

Big Soda targets minority groups

In its quest to maximize profits, the soda industry (like Big Tobacco) has increasingly targeted specific communities. Predominately African American and lower-income neighborhoods bear a disproportionately heavy burden of ads for sugary drinks and junk food. In addition to targeted marketing, health disparities are exacerbated by limited access to, and affordability of, healthy and nutritious food options in many communities.

Fighting back: new litigation challenges Big Soda’s marketing strategy

In July, The Washington Post published the story of two African American pastors who got “tired of presiding over funerals for parishioners who died of heart disease, diabetes and stroke” and decided to file a suit against Coca-Cola and the ABA. Together with a public health organization, pastors William Lamar and Delman Coates allege that the defendants’ marketing is false and misleading and in breach of consumer protection laws. They argue that the industry has misled the public about the health impacts of sugary drinks, hampering efforts to protect parishioners. The suit demands a suit of remedies, including prohibiting future unfair and deceptive promotion of sugary drinks and prohibiting any marketing and promotion to children under 12. Coca-Cola states that the case is “legally and factually meritless” and has committed to mounting a vigorous defense.

Regardless of the final outcome, the lawsuit has brought national attention to Big Soda’s marketing strategies as well as the disproportionate burden of diet-related disease experienced by African Americans. As highlighted by Caitlin Dewey of the Washington Post, it “marks a break with tradition for African American and Latino community groups who have been reliable allies of Big Soda for years in policy fights across the country.”

The plaintiffs’ claims resemble litigation brought by several US state attorneys general against major cigarette companies, which resulted in the largest civil settlement in US history, including payments to cover the cost of tobacco-related health care, the public disclosure of millions of tobacco industry documents, and restrictions on tobacco advertising. Ultimately, we may look back on Lamar et al v. Coca-Cola et al. as the beginning of a long, litigious battle against the soda industry, reminiscent of hard-fought and impactful litigation against the tobacco industry.

Posted in Non-communicable diseases; Tagged: , .

08.11.17

Human Rights-Based Approaches to Health: How Do We Measure Them?

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Neil Sircar, J.D., is an LL.M Candidate in Global Health Law at Georgetown University Law Center & the O’Neill Institute for National and Global Health Law. Any questions or comments related to this post can be directed to nrs53@georgetown.edu.

Dr. Tedros, the newly-minted Director-General of the World Health Organization, has made human rights and health one of if not the primary framings for how he will guide WHO over his tenure. However, the reality has long been that health and human rights are often icing on a cake for health system strengthening: sugary and sweet but not the substance that gets baked. Dr. Tedros is cognizant of this situation, stating that “When it comes to rights issues in the reform, importantly, it’s not so much the design of the processes or structures that will make a difference. Far more important is ensuring that health as a human right is engrained into the mindset and attitudes of staff.”

So, how do we measure success in human rights and health? The human rights-based approach (HRBA) a process that for years health advocates have looked to in integrating human rights into programming, and HRBA certainly is a good vehicle in its many iterations for that. But, HRBA remains half-baked (to use the previous metaphor) when it comes to evaluating positive health outcomes resulting from a health-and-human-rights intervention. Many contemporary programs include HRBA or human rights-oriented framing but there is little clear evidence of follow-through or impact; indeed, HRBA may not have been a priority for programs beyond engrained mindsets. Where there are positive claims of successful human rights interventions we lack critical analysis of those claims, their replicability in other contexts, and how big an impact they made. By no means is this posting a critique of those efforts, but rather what I draw attention to is that having the right words on paper or on the minds of global health actors is not enough: we need to know what human rights interventions for health work, when they work, and how to both design and evaluate them.

Some in WHO are already thinking on how to go from concepts to projects and programs, remaining cognizant of the challenges that come from measuring a spectrum of change. Health outcomes are the result of multiple factors, so HRBA may impact any or all of the factors contributing to health and be successful or not. We will not know though unless our interventions are designed to be measurable. Heretofore many study designs have not been structured substantively enough to allow for careful analysis of a particular human rights intervention’s health impact, or are designed in such a way that the impact of particular interventions are difficult to accurately assess. As a consequence, the designers of future HRBA and human rights interventions cannot determine which interventions work best in which contexts. They may not even know where to begin in designing a program or project, even if acting on a well-drafted guidance document or tool.

Human rights in health are a critically important field, and there are plenty of spaces to develop HRBA within global health governance and local health programming. WHO and Dr. Tedros are not alone in seeking to instill a greater modus operandi in their operations and those of their partners. My suggestion: in addition to engraining human rights into the minds of WHO staffers, WHO and other global health actors should develop measurable, evidence-generating interventions that can show the links between greater human rights realization and positive health outcomes, as we must bake-in HRBA to what is being done, not just what is on the minds of those doing something.

SOURCE:http://www.cnn.com/2017/05/24/health/who-appoints-first-african-dg/index.html

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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.

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